Devices and methods for the treatment of vascular defects.

DEVICES AND METHODS FOR THE TREATMENT OF VASCULAR DEFECTS

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority and is a continuation of US Patent No. 13 / 727,029 entitled Devices and methods for the treatment of vascular defects filed on December 26, 2012, which is a continuation in part of US Patent Application No 13 / 421.122 entitled Devices and methods for the treatment of vascular defects filed on March 15, 2012, which is a continuation in part of US Patent Application No. 13 / 230,628 entitled Devices and methods for the treatment of vascular defects filed on September 12, 2011, which claims the priority and benefit of US Provisional Patent Application No. 61 / 381,770, entitled Electropositive Neurovascular Endothelialization Device filed on September 10, 2010, each of the descriptions hereby incorporated by reference herein in its entirety.

BACKGROUND OF THE INVENTION

The invention generally relates to medical devices and more particularly to expanding medical devices and methods for the treatment of vascular defects. For example, the invention may be related to expanding medical devices and methods for the treatment of an aneurysm. Aneurysms are dilations in a blood vessel caused by weakening of the wall of a blood vessel. The dilation is caused by the pressure exerted by normal blood flow, which can cause the weakened segment of the blood vessels that swell. In some cases, this inflammation produces a sac, or balloon-like polyp that protrudes from the main or origin vessels. Continuous growth and / or eventual rupture of the swollen arterial wall can have devastating results for a patient. As such, unbroken aneurysms should be treated to prevent bleeding. Additionally, broken aneurysms can be treated to prevent further rupture and / or additional damage.

Some known medical devices and treatment methods used to treat an aneurysm include supplying a platinum coil to the aneurysm sac. The platinum coil is electrolytically separated from a supply wire, thus inducing a charge on the coil that can cause a thrombotic effect on the aneurysm. In known procedures, approximately 30% of the aneurysm volume is packed with coils. Such known devices and methods, however, often have a 30% recanalization of recanalization rate, which means that the blood flow returns to the aneurysm again and can cause the coil-packed aneurysm to become further inflamed. Additionally, said known methods and devices require prolonged procedural times for the patient and consequently increased radiation exposure to the patient. On the other hand, said devices and methods of not treating the neck of the aneurysm, which is the area between the blood vessels of origin and the aneurys sac.

Another known treatment method includes the use of a coil and a stent. The coil is supplied in the aneurysm sac as described above, and the stent is placed inside the blood vessels of origin such that a portion of the stent is disposed on the aneurysm neck. Such procedures have several drawbacks. For one, the supply of two different types of devices (i.e. coil (s) and a stent) is a more complex procedure, often resulting in a procedure time for the patient. The stent may lead to intra-stent stenosis of the blood vessel. Additionally, a patient would probably be required to adopt a finer blood indefinitely following the procedure. On the other hand, such devices and methods are not suitable for the treatment of aneurysms that are placed in a bifurcation of blood vessels (that is, between adjacent branches of a vessel).

Other devices and known treatment method include the use of a flow diverter supplied to the main blood vessel adjacent to the aneurysm neck. Generally, the flow diverter is placed within the source blood vessel over the neck of the aneurysm to avoid additional blood flow in the aneurysm from the vessel. In current procedures, more than one flow diverter is required per aneurysm to ensure that blood flow is properly diverted from the aneurysm. Said treatment method and device has similar drawbacks to the use of a stent, described above. Specifically, the flow diverter can lead to stenosis of the blood vessel and the patient would probably need to take an anticoagulant indefinitely following the procedure. Additionally, known flow diverters are not suitable for the treatment of an aneurysm placed in a bifurcation of the blood vessel.

In addition, long-term follow-up of patients treated with a flow diverter is showing an increased rate of recanalization to the aneurysm.

Thus, there is a need for improved systems, devices and methods for the treatment of vascular defects, such as balloon aneurysms, as described herein.

BRIEF DESCRIPTION OF THE INVENTION

Devices and methods for the treatment of vascular defects, such as, for example, balloon-like aneurysms, are described herein. In one embodiment, a device includes an insertion portion and an expanded implant. The expanded implant is configured to be deployed in an aneurysm and is attached to the insertion portion. The expanded implant has a first portion and a second portion coupled to the first portion. The expanded implant is movable between a first configuration in which the first portion and the second portion are substantially linearly aligned and a second configuration in which the second portion at least partially overlaps the first portion.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a schematic illustration of a medical device according to an embodiment in a first configuration.

Figure 2 is a schematic illustration of a medical device according to an embodiment in a second configuration.

Figure 3 is a side view of a medical device according to an embodiment in a first configuration.

Figure 4 is a side view of a medical device according to an embodiment in a second configuration.

Figure 5A is a view of the medical device of Figure 3 in a first configuration during insertion into an aneurysm.

Figure 5B is a view of the medical device of Figure 3 in a second configuration during insertion into an aneurysm.

Figure 5C is a view of the medical device of Figure 3 in a third configuration during insertion into an aneurysm.

Figure 6 is a view of a portion of a medical device in an expanded configuration, in accordance with one embodiment.

Figures 7-13 are views of a medical device in an expanded configuration, according to modalities.

Figure 14 is a view of a medical device in a partially collapsed configuration, in accordance with one embodiment.

Figure 15 is a view of the medical device of Figure 14 in an expanded configuration, in accordance with one embodiment.

Figure 16 is a view of a portion of a medical device in an expanded configuration in accordance with one embodiment, with a first portion spaced apart from a second portion.

Figure 17A is a view of a portion of a medical device in a collapsed configuration according to one embodiment.

Figure 17B is a view of a portion of a medical device in an expanded configuration in accordance with one embodiment.

Figure 18 is a flow chart of a method according to one modality.

Figure 19A is a view of a portion of a medical device in an expanded configuration, in accordance with one embodiment.

Figure 19B is a schematic illustration of the medical device of Figure 19A.

Figure 20 is a view of a portion of a medical device in an expanded configuration, in accordance with one embodiment.

Figure 21 is a view of a portion of a medical device in an expanded configuration, in accordance with one embodiment.

<td>The</td><td>figure</td><td> 22</td><td>it's a view</td><td>of a portion of</td>

<td>device</td><td>doctor</td><td>from</td><td>figure 21</td><td>in a configuration</td>

<td>collapsed</td><td></td><td></td><td></td><td></td>

<td>The</td><td>figure</td><td> 23</td><td>it's a view &lt;</td><td>give him a portion of a</td>

<td>device</td><td colspan="3">doctor in a setting</td><td>collapsed okay</td>

With another modality.

<td>The</td><td>figure</td><td> 24</td><td>it is</td><td>a view of the portion of the</td>

<td>device</td><td>doctor</td><td>from</td><td>the</td><td>figure 23 in a configuration</td>

<td>expanded.</td><td></td><td></td><td></td><td></td>

<td>The</td><td>figure</td><td> 25</td><td>it is</td><td>a view of a portion of a</td>

medical device in a collapsed configuration, according to one modality.

<td>The</td><td>figure</td><td> 26</td><td>it is</td><td>a</td><td>view</td><td>from</td><td>the</td><td>portion</td><td>of the</td>

<td>device</td><td>doctor</td><td>from</td><td>the</td><td>figure</td><td> 25</td><td>in</td><td>a</td><td colspan="2">setting</td>

<td>partially</td><td colspan="2">expanded.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>The</td><td>figure</td><td> 27</td><td>it is</td><td colspan="2">a sight</td><td>from</td><td>a</td><td>portion</td><td>of the</td>

<td>device</td><td>doctor</td><td>from</td><td>the</td><td>figure</td><td> 25</td><td>in</td><td>a</td><td colspan="2">setting</td>

expanded.

Figures 28 and 29 are each, a different view of a portion of a medical device in an expanded configuration, in accordance with one embodiment.

Figures 3 0 and 31 are each, a view of a portion of a medical device in an expanded configuration, according to different modalities.

Figure 32 is a view of a portion of a medical device in a collapsed configuration, in accordance with one embodiment.

Figure 33 is a view of the portion of the medical device of Figure 32, shown in an expanded configuration.

Figure 34 is a schematic illustration of the portion of the medical device of Figure 33.

Figure 35 is a schematic illustration of a portion of an insertion device, according to modality, showing a first configuration and coupled to a schematic illustration of a portion of an expandable implant.

Figure 36 is a schematic illustration of the portion of the expandable insertion and implant device of Figure 35, shown in a second configuration.

Figure 37 is a schematic illustration of the portion of the insertion device of Figure 35 shown away from the expandable implant.

Figure 3 8 is a schematic illustration of a portion of an insertion device, in accordance with another embodiment.

Figure 3 9 is a view of a portion of an insertion device, in accordance with another embodiment.

Figure 4 0 is a schematic illustration of a portion of an insertion device coupled to an expandable implant, in accordance with another embodiment.

Figure 41 is a flow chart illustrating a method of implementing an expandable implant, according to one embodiment.

Figure 4 2 is a view of a portion of a medical device in an expanded configuration, according to modality.

Figure 4 3 is a view of a portion of the medical device of Figure 42 in a collapsed configuration.

Figure 44 is a view of a portion of a medical device in an expanded configuration, in accordance with one embodiment.

<td>The</td><td>figure</td><td> 45</td><td>it is</td><td>a sight</td><td>from</td><td>a</td><td>portion</td><td>of the</td>

<td>device</td><td>doctor</td><td>from</td><td>the</td><td>figure 44</td><td>in</td><td>a</td><td colspan="2">setting</td>

<td>collapsed</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>The</td><td>figure</td><td> 46</td><td>it is</td><td>a sight</td><td>from</td><td>a</td><td>portion</td><td>of the</td>

<td>device</td><td>doctor</td><td>from</td><td>the</td><td>figure 44</td><td colspan="2">shown</td><td colspan="2">partially</td>

deployed within an aneurysm.

Figures 47-54 are each a schematic illustration of a portion of an insertion device, according to a different embodiment.

Figure 55 is a side view of a portion of an insertion device according to one embodiment.

Figure 56 is a side view of a portion of the insertion device of Figure 55 shown coupled to an expandable implant.

Figure 57 is a view of a portion of a medical device, shown partially deployed, in accordance with another embodiment.

Figure 58 is a schematic illustration of a portion of a medical device shown in a collapsed configuration, in accordance with another embodiment.

Figure 59 is a view of the portion of the medical device of Figure 58, shown in an expanded configuration.

Figure 60 is a schematic illustration of a portion of an expanded implant, according to another embodiment, shown in a collapsed configuration.

DETAILED DESCRIPTION OF THE INVENTION

Medical devices and treatment methods are described here to treat patients suffering from a vascular defect, such as an aneurysm of a circulatory blood vessel and the effects of that defect, which includes hemorrhagic stroke. For example, the devices and methods described herein may be useful for the treatment of vascular defects present in the vasculature that is tortuous, of small diameter, and / or that is otherwise difficult to access. More specifically, the devices and methods described herein may be useful for treating saccular aneurysms (also referred to as balloon or berry type), bifurcated aneurysms, fistulas, and other vasculature defects, including neurovasculature defects. The medical devices and treatment methods described herein can reduce bleeding events while promoting endothelialization of an opening between an aneurysm and a blood vessel of origin from which the aneurysm pumping is formed (for example, in an aneurysm neck).

Various modalities of a medical device to occupy all or substantially all of the volume of an aneurysm and / or promote endothelialization at or near the aneurysm as described herein. In some embodiments, the medical device includes an expanded implant including an electropositive braided or woven material. The filaments or strands that form the braid or tissue are configured to encourage the contracting and / or retention of endothelial cells to the device and therefore within the defect. The expanded implant is configured to assume a non-linear, pre-determined three-dimensional shape within an aneurysm sac on the release of a tubular or other supply restriction (for example, a catheter or cannula). The electropositive braided or woven material has a particular porosity and includes multiple openings between the filaments or strands when the expanded implant is in the expanded configuration. These openings are ideal in the blood environment to house endothelial cells recruited at the site. The electropositivity of the material encourages endothelialization in the presence of electronegative charges of body tissues and blood. In other words, the electropositivity of the expandable implant in relation to a blood and tissue charge (which is electronegative in comparison) provides an environment in the defect that promotes endothelialization. Endothelialization within the defect may ultimately result in the defect of walls outside the vessel of origin. For example, the growth and development of an endothelial layer on a neck of an aneurysm can delimit the aneurysm from the vessel of origin and allows the flow dynamics to balance in the defect. As such, the device can be configured to facilitate cure of the defect and prevention of recanalization because the tissue is created from within the body that resists aberrant blood flow and redistributes the flow pressure that the defect may have created. In healing with endothelialization, the pressure is distributed evenly throughout the vessel of origin in a manner that excludes recanalization of the post-treatment defect. In addition, the blood inside the vessel of origin no longer has access to defect separation once the endothelialization process is complete. Additionally, at least a portion of the expandable implant may be placed on the neck of the aneurysm once the implant is implemented within the aneurysm such that the portion interrupts the flow of blood from the vessel of origin into the aneurysm. As such, the expandable implant provides interruption of blood flow before and in addition to the growth and development of the endothelial layer on the aneurysm neck.

A described medical device may include an insertion portion (for example, a guidewire) and an expandable implant formed with, for example, woven or braided filaments in a mesh-like configuration. The terms mesh and braid may each refer here to a fabric or a material of woven or braided filaments or strands of wire or polymer. The expandable implant of the medical device can be configured to compress or contract for delivery into a blood vessel. In some embodiments, the medical device may be inserted while in a collapsed or compressed configuration through a delivery device, such as, for example, a microcatheter, cannula, tube or delivery sheath. In some embodiments, the medical device can be deployed without the use of a delivery device.

The expandable implant of the medical device may have a collapsed or compressed configuration such that the expanded implant has a diameter that can be adjusted within the narrow limits of the neurovasculature, and / or within a lumen of a delivery catheter. The expanded implant of the medical device can be formed with, for example, an array of hedras (for example, an array of mesh or braid of hedras or filaments) that can compress and expand. Such materials include Nitinol, MP35N, stainless steel, cobalt chrome, titanium, platinum, tantalum, tungsten, or alloys thereof, or polyester, polyethylene (PET), Dacron, PEEK, vectron and suture materials and are available from Fort Wayne. You put Fort Wayne, Indiana, California Fine Wire Company of Grover Beach, California, other metal manufacturers, Ethicon Inc. of Somerville, New Jersey, Genzyme of Cambridge, Massachusetts, Poly-Med, Inc. from Anderson, South Carolina, and / or other medical grade fiber and suture manufacturers. The expanded implant can be compressed on and / or along the insertion portion of the medical device. The insertion portion may be, for example, a wire. In some embodiments, a medical device includes a movable insertion portion available within a lumen of a delivery device. A distal portion of the insertion portion can be attached to the expanded implant.

The expanded implant can be moved from a collapsed configuration to an expanded configuration while disposing within, or as inserted into, a defect (eg, an aneurysm).

In some embodiments, the expanded implant may be formed with filaments of shape or superelastic memory material (such as, for example, nitinol) and the braid or mesh may be stacked in a predefined manner before placing the expanded implant to the portion of Medical device insertion. In such mode, when the implant expands and unfolds, it assumes a predetermined biased shape. The predetermined form may be a generic form, such as that of a sphere, or it may be a custom made form in a form of an oejetive aneurysm within a patient. Such materials are described in more detail here.

The medical devices described herein may include one or more expandable implants, formed with a woven mesh or braid having openings of varying size (also known herein as '' openings or pores). In other words, the devices are formed with a material that has a particular porosity or pore density. In some embodiments, an expanded implant may have mesh or braid sections that have variation in the density of the filaments and may include densely spaced portions or bands of filaments (i.e., less porosity) separated by portions or bands that are less dense. (that is, greater porosity). The less dense braid portion may have larger openings in the braid, while the denser braid portion may have smaller openings in the braid. Material (for example, body tissue such as endothelial cells) may be encouraged to enter and / or attach to the interstices of the expanded implant mesh. For example, the denser braid portion may be used to promote greater endothelial cell attachment and the less dense braid portion may be used to reduce the total weight and / or material implanted in the patient. Less dense sections can also direct the final shape of the expanded implant. For example, the less dense (more open) mesh or braid sections can direct the expansion effects of the implant.

In some embodiments, a medical device may be delivered to a desired treatment site within a vasculature by inserting the medical device through a lumen of a delivery catheter (for example, a microcatheter). The expandable medical device can be inserted by the delivery catheter in a compressed or collapsed configuration. The expandable implant of the expandable medical device can be moved out through a distal end of the delivery catheter at the treatment site (eg, in a sac of an aneurysm) and moves to an expanded configuration. In some embodiments, the delivery catheter is used to compress or contract the expandable implant. For example, the expandable implant can be formed with an expanded skewed configuration and when placed within a lumen of a catheter is compressed. When the expandable implant moves out of the catheter, it can assume its expanded skewed configuration. In the expanded configuration, a first portion of the expandable implant substantially superimposes a second portion of the expandable implant. The first and second portions of the expandable implant may be discrete structures or may be portions of a unit or monolithic device constructed.

A medical device, such as an expandable implant, described herein may include a first porous member and a second porous member coupled to the first porous member. Each of the first and second porous members includes a first end and a second end. The first and second porous members each have a collapsed configuration for insertion through a blood vessel and an expanded configuration to occupy at least a portion of the volume defined by the sac of an aneurysm. In some embodiments, the first porous member is substantially elongated and has a greater width in its expanded configuration than in its collapsed configuration. The second porous member is substantially elongated and has a greater width in its expanded configuration than in its collapsed configuration. In some embodiments, the width of the first porous member is greater than the width of the second porous member, for example, when each of the first and second porous members in their expanded configurations.

In some embodiments, the first porous member is configured to occupy a first volume in its collapsed configuration and a second, larger, volume in its expanded configuration. For example, the first porous member may have a substantially spherical, oblong or other suitable shape in its expanded configuration that occupies a greater volume than the considerably elongated shape of the first porous member in its collapsed configuration. The second porous member may be configured to move or curve in a three-dimensional configuration in the expanded configuration such that it overlaps with a first segment of the second porous member with a second segment of the second porous member. In its expanded configuration, the second porous member may define an inner region configured to receive the first porous member in its expanded configuration. For example, in some embodiments, the second porous member has a spherical shape substantially with an open inner region configured to receive the first porous member.

In some embodiments, a medical device, such as an expandable implant, described herein may include a first porous member and a second porous member. Each of the first and second porous members includes a first end and a second end. The first and second porous members each have a collapsed configuration for insertion through a blood vessel and an expanded configuration to occupy at least a portion of the volume defined by a sac of an aneurysm. The first and second porous members are each substantially elongated in the collapsed configuration. In its expanded configuration, the first porous member has a three-dimensional shape, including a first segment configured to overlap with a second segment and define an inner region. The second porous member is configured to be disposed in the inner region of the first porous member when each of the first and second porous members is in their respective expanded configurations. In some embodiments, the second porous member may be formed integrally or monolithically with the first porous member. In some embodiments, the second porous member may be woven or braided using the same filaments that form the first porous member.

In some embodiments, the expandable implant is in the form of a braided tube that includes super-elastic memory alloy fibers, or polymeric fibers. In some embodiments, the expandable implant can effect a deformation so that it induces a substantially spherical contour. In some embodiments, the expandable implant can perform a deformation in a way that induces a helical contour. In some embodiments, shape deformation may include inducing radial expansion and / or axial shortening.

The medical devices described herein can be used to occupy at least a portion of the volume defined by a sac of an aneurysm and / or promote endothelialization of the aneurysm neck to inhibit or stop the flow of blood in the aneurysm, which can lead to, for example, hemorrhagic stroke. In some embodiments, the polymer wire or filaments can be used to form a woven mesh or braided strands that can be expanded, and have openings sized to promote the attachment of endothelial cells in the aneurysm.

It should be noted that, as used in this written description and the appended claims, the singular forms one and the / include plural referents unless the context clearly dictates otherwise. Thus, for example, the term a lumen is intended to mean a single lumen or a combination of lumens. In addition, the words proximal and distal refers to the direction near and far from, respectively, an operator (for example, surgeon, doctor, nurse, technician, etc.) that could insert the medical device into the patient, with the tip ( that is, the distal end) of the device first inserted into a patient's body. Thus, for example, the first end inserted into a patient's body could be the distal end of the medical device, while the outer end of or inserted later into a patient's body could be the proximal end of the medical device. Additionally, the first second, third and so on terms used to describe likewise identified elements are for clarity purposes only, and are not intended to imply a priority or said numerical handle must be associated with this particular element in the claims.

Figures 1 and 2 are schematic illustrations of a vascular medical device 100 according to an embodiment in a first configuration and a second configuration, respectively. The medical device is configured to promote the healing of an aneurysm. More specifically, at least a portion of the medical device is configured to occupy at least a portion of the volume defined by an aneurysm sac and, in some embodiments, at least a portion of the medical device is configured to promote the attachment of endothelial cells on A neck of the aneurysm. Once endothelialization over the aneurysm neck is completed, blood flow in the aneurysm sac of a blood vessel of origin (i.e., the vessel in which the aneurysm formed) is prevented.

The medical device 100 may include an insertion portion 102 and an expanded implant 110. The insertion portion 102 is coupled to the expanded implant 110, such as, for example, in a proximal portion 112 of the expanded implant 110. In some embodiments, the insertion portion 102 is removably coupled to expanded implant 110. In this way, the insertion portion 102 of the expanded implant 110 can be separated after the implant follow-up expanded to the aneurysm and removed from the patient's vasculature. The insertion portion 102 may be, for example, a guidewire or a distal end portion of a wire. The medical device 100 can be used with a cannula or catheter 104 (shown in dashed lines in Figures 1 and 2) to, for example, deliver the expanded implant 110 to the aneurysm.

The expanded implant 110 is configured to be deployed in the aneurysm (for example, in a sac of an aneurysm). The expanded implant 110 has a first portion 120 and a second portion 130. As shown in Figure 1, the expanded implant 110 has a first configuration in which the first portion 120 and the second portion 130 substantially linearly aligned. In its first configuration, the implant expanded 110 is configured for insertion through a blood vessel.

The expandable implant 110 is also configured for insertion through an aneurysm neck when in its first configuration.

The expandable implant 110 is movable between its first configuration and a second configuration in which the second portion 130 at least partially overlaps the first portion 120, as shown in Figure 2. For example, the second portion 130 may be configured to bend , bend and / or rotate in the multiple turns such that multiple segments of the first portion 120 and the second portion 130 overlap. Additionally, at least one of the first portion 120 and the second portion 130 may be configured to bend or bend in the multiple turns such that the respective first or second portion overlaps with itself. In some embodiments, the expandable implant 110 can be understood to have multiple first portions and multiple second portions. In other words, the continuously expandable implant can overlap itself in its deployed configuration to occupy all or substantially all of the aneurysm volume.

In its second configuration, the expandable implant 110 is configured to occupy at least a portion of the volume defined by the aneurysm sac. In some embodiments, when the expandable implant 110 is in its second configuration, at least a portion of the expandable implant is configured to be placed on the aneurysm neck. For example, the portion of the expandable implant 110 in which the second portion 130 overlaps the first portion 120 may be configured to be placed on the aneurysm neck. Thus, the portion of the expandable implant 110 disposed on the neck of the aneurysm has an increased density (for example, a double density compared to the first portion 120 or the second portion 130 individually), which helps to limit or prevent the flow blood enter the aneurysm sac. The portion of the expandable implant 110 placed on the neck of the aneurysm may be a scaffold for the union of endothelial cells in the neck of the aneurysm. For example, the portion of the expandable implant 110 placed on the neck of the aneurysm may be porous, such as by including a porous mesh, as described in more detail herein. In some embodiments, the first portion 120 and the second portion 130 of the expandable implant 110 is biased to the second configuration.

As noted above, in some embodiments, at least a portion of the expanded implant 110 is porous. For example, in some embodiments, at least a portion of the expanded implant 110 may include and / or be constructed of a mesh material (eg, woven, braided or laser cut) such that a wall or layer of the implant expanded 110 defines multiple openings or interstices 118. More specifically, in some embodiments, at least one or both of the first portion 120 and the second portion 130 of the expanded implant 110 may include the porous mesh. The porous mesh may have a first porosity when the implant expanded 110 is in its first configuration and a second porosity when the implant expanded is in its second configuration. More specifically, in some embodiments, the porous mesh may have a greater porosity when the implant expanded 110 is in its second configuration than when the implant expanded in its first configuration. The porosity of the porous mesh can be increased, for example, because one or more individual pores or openings are larger when in the second configuration than in the first configuration. For example, the porous mesh can expand in the second configuration, thereby increasing the space between the filaments of the mesh (and therefore the size of one or more openings of the mesh). In other words, a total volume of pore openings can be increased. In another example, the porosity of the porous mesh can be increased due to one or more openings that close when the expandable implant 110 collapses in its first configuration is reopened when the expandable implant moves to its second configuration. In other words, a number of open pores can be increased.

In some embodiments, the first portion 120 and the second portion 130 may have one of the same or different porosities. For example, the first portion 120 may have a porosity greater than the porosity of the second portion 130. In another example, the second portion 130 may have a porosity greater than the porosity of the first portion 120. In yet another example, the first and second portions 120, 130 may have substantially equivalent porosities in the expanded configuration.

In some embodiments, at least one of the first portion 120 and the second portion 130 includes one, two, three or more layers. For example, in some embodiments, the first portion 120 of the expandable implant 110 includes a first layer (not shown in figures 1 and 2) of porous mesh and a second layer (not shown in figures 1 and 2) of porous mesh.

The first layer and the second layer may have the same or different porosities. In some embodiments, the first adjustment layer of the second layer. As such, the porosity of the first portion is determined by the porosities of the first and second layers and the manner in which the first layer is adjusted from the second layer.

In some embodiments, at least a portion of the expandable implant 110, such as at least one of the first portion 120 or the second portion 130 may include a shape memory material, such as, for example, nitinol and may be preformed to Assume a desired form. Thus, in said embodiment, the expandable implant portion 110 (for example, the first portion 120 and / or the second portion 130) can be skewed in a second expanded configuration and moved to a first configuration collapsed by restriction or compression of the portion of the expandable implant

In some embodiments, at least a portion of the expandable implant 110, such as at least one of the first portion 120 or the second portion 130 may include an electropositive material, described in more detail below.

The expandable implant 110 when in the expanded configuration can have a variety of different shapes, sizes and configurations. For example, in some embodiments, when in the expanded configuration the expandable implant 110 may be substantially spherical. In some embodiments, the expandable implant 110 may be substantially helical. In some embodiments, the expandable implant 110 may be substantially circular, disk-shaped, or ring-shaped. In some embodiments, the expandable implant 110 may be a custom form based on a form of an objective aneurysm within a patient; for example, a form modeled after the shape of the target aneurysm is detected by an imaging device. For example, an image of the aneurysm shape can be acquired using an angiogram, and the expandable implant 110 can be modeled after the aneurysm shape is shown on the angiogram. In some embodiments, the expandable implant 110 may include multiple portions that have variation of outer perimeters or outer diameters. For example, in some embodiments, when in the expanded configuration the expandable implant 110 may include a first portion having a first outer perimeter, a second portion having a second outer perimeter and a third portion having a third external perimeter. In said embodiment, the second outer perimeter may be smaller than each first outer perimeter and the third outer perimeter.

In an example use of the medical device 100, a catheter 104 may be inserted into a blood vessel and directed to a desired treatment site near a vascular defect, such as the aneurysm. The expandable implant 110 is inserted into an elongated lumen of the catheter 104 for delivery at the treatment site. A distal portion of catheter 104 is placed adjacent to the aneurysm inside the blood vessel. The expandable implant 110 moves from a first position inside the catheter to a second position outside the catheter. When the expandable implant 110 is in its first position, each of the first portion 120 and the second portion 130 are in a first configuration. For example, in the first configuration, each of the first and second portions 120, 130 may be compressed or collapsed within the lumen of the catheter 104 and are substantially linear in configuration.

The expandable implant 110 can be oriented with respect to an opening in the vessel wall in fluid communication with the aneurysm such that the expandable implant can enter a sac of the aneurysm when the expandable implant 110 moves to its second position. The expandable implant 110 can be moved from its first position to its second position with the help of the insertion portion 102 such that the expandable implant 110 directed towards and placed within an aneurysm sac. When the expandable implant 110 is in its second position, the first and second portions each have a second configuration. For example, in the second configuration, each of the first and second portions 120, 130 may be expanded in a three-dimensional manner. The three-dimensional shape of the first portion 120 in the second configuration may be similar or different from the three-dimensional shape of the second portion 130. In the second configuration, the first portion 120 of the expandable implant 110 substantially overlaps the second portion 130. In some embodiments, the second portion 130 is disposed in an inner region defined by the first portion when each of the first portion and second portion is they find in their respective second configurations.

The first and second portions 120, 130 can be moved to their respective second configurations concurrently or sequentially. For example, in some embodiments, the second portion 130 moves to its second configuration before the first portion 120 moves to its second configuration. The expandable implant 110 may assume a biased expanded configuration such that the walls of the expanded implant 110 make contact with at least a portion of the aneurysm wall and / or such that a portion of the expanded implant is disposed on the neck of the aneurysm. The presence of the expandable implant 110 on the neck of the aneurysm can substantially reduce and / or prevent additional blood flow from the vessel of origin in the aneurysm sac because the expandable implant can act as a physical rupture of blood flow flowing from the vessel of origin and a scaffold for the fixation of endothelial cell in the neck of the aneurysm to promote endothelialization of the wall of the neck / vessel. The insertion portion 102 can then be disconnected from a proximal end of the expandable implant 110 and removed through the catheter 104.

Figures 3, 4, 5A, 5B and 5C illustrate a medical device according to one embodiment. The medical device 200 may include all or some of the same features and functions as described above for the medical device 100. The medical device 200 includes an insertion portion 202 and an expandable implant 210. The expandable implant 210 is detachably coupled in its end proximal to a distal end of insertion portion 202.

The expanded implant 210 includes a first portion 220 and a second portion 230. As shown in Figures 3 and 5A, the expanded implant 210 has a first, or collapsed, configuration in which the first and second portions 220, 230 are substantially aligned linearly Thus, the expanded implant 210 can be disposed within a lumen of a catheter 2 04 for delivery through a blood vessel V at a treatment site, such as an aneurysm A. In its first configuration, the expanded implant 210 has a first width W_lz As shown in Figure 2. As shown in Figures 4 and 5B-5C, the expanded implant 210 is movable to a second, expanded or deployed, configuration. The insertion portion 202 is configured to move the expanded implant 210 from the first configuration to the second configuration. The insertion portion 202 may be disconnected from the expanded implant 210 when the expanded implant 210 is in the second configuration.

In its second configuration, the expanded implant 210 is configured to occupy at least a portion of the volume defined by a sac of aneurysm A. As such, the expanded implant 210 has a second width W₂ in the second, expanded, configuration greater than its first Wi width. For example, the expandable implant 210 may be substantially narrow and elongated in its first configuration and may assume a three-dimensional shape in its second configuration. In the embodiments illustrated in Figure 3-5C, the expandable implant 210 has a substantially spherical shape in its second configuration. The expandable implant 210 can be compatible so that its three-dimensional shape can accommodate any irregularity in the aneurysm shape. In the second configuration, the second portion 230 of the expandable implant 210 at least partially overlaps the first portion 220. At least a portion of the expandable implant 210 is configured to be placed on a neck N of the aneurysm A when the expandable implant is in its second configuration within the sac of aneurysm A. The expandable implant 210 is configured to facilitate the attachment of endothelial cells in neck N of aneurysm A, as described in more detail here.

In the embodiment illustrated in Figure 3, the first portion (or member) 220 is a first tape type strand and the second portion (or member) 230 is a second discrete tape type strand of the first portion. In other embodiments, an expanded implant may include a first portion and a second portion of a single tape type strand (eg, integrally or monolithically constructed), rather than discrete portions. A first end 222 of the first portion 220 is coupled to a first end 232 of the second portion 230. Any mechanism suitable for coupling the first end 222 of the first portion 220 to the first end 232 of the second portion 230 may be used, such as an adhesive, a mechanical coupler, a weld, or the like, or any combination of the foregoing. For example, the first ends 222, 232 may be coupled by a band 240. The band 240 can also be configured to help couple the insertion portion 202 to the expandable implant 210. The band 240 may be or may include, for example, a radiopaque marker.

A second end 224 of the first portion 220 and a second end 234 of the second portion 23 0 each have a radiopaque marker 242, 244, respectively, coupled thereto. Radiopaque markers 242, 244 are configured to facilitate imaging of expandable implant 210 during delivery to the treatment site and / or after implantation. Markers 242, 244 are configured to be fully disposed within aneurysm A sac when expandable implant 210 is in its second configuration. As such, markers 242, 244 will not pierce the wall of aneurysm A or vessel V, and markers 242, 244 will not interfere with the attachment of endothelial cells in the aneurysm neck. This is also beneficial because if markers 242, 244 are placed at or near the neck of the aneurysm, blood from a source blood vessel may have a tendency to clot in the marker.

When the expandable member 210 moves between its first configuration and its second configuration, at least one of the first portion 220 and the second portion 230 is also movable between a first configuration and a second configuration. The first portion or member 220 has a first, collapsed, configuration in which the first portion 220 is substantially elongated and has a first width. The first portion 220 has a second, expanded, configuration in which the first portion 220 has a second width greater than the first width. For example, the first portion 220 may be movable from a substantially linear, elongated configuration collapsed to a multidimensional (eg, three-dimensional) shape in the expanded or deployed configuration. As shown in Figures 4 and 5C, the first portion 220 may have a three-dimensional shape in the expanded configuration that leads to a generally spherical shape for the expanded implant 210. The first portion 220 may be skewed to its second, expanded configuration .

The first portion or member 220 is porous and, for example, may include or be constructed of a porous mesh. The porous mesh can be formed using filaments that are woven or braided together so that the openings or interstices are present between the portions of the filaments at least when the expanded implant 210 is in its second configuration. For example, the porous mesh may include a plurality of braided wires. Suitable mesh material is described in more detail in this document. The porous mesh may have a first porosity when the first portion 220 is in the first configuration and second porosity when the first portion 220 is in the second configuration. For example, when the first portion 220 moves from its first, collapsed, configuration to its second, expanded, configuration, the mesh can expand such that the size of the mesh openings is increased, which increases the porosity of the mesh . The porous mesh is configured to act as a scaffold that promotes clot formation and endothelial cell binding when the mesh is arranged within aneurysm A. Specifically, endothelial cells will migrate to mesh openings.

The first portion 220 of the expander implant 210 includes a first layer of porous mesh and a second layer of porous mesh. In this way, the density of the first portion 220 is greater than the density of the first or second layers individually. Said double density structure can help limit or impede blood flow in aneurysm A, for example when the first and second layers of the first portion 220 are arranged on neck N of aneurysm A. The first layer of porous mesh and the second layer of porous mesh can have the same porosities, or different porosities. The first layer of porous mesh can be adjusted from the second layer of porous mesh. Thus, the total porosity of the first portion 220 is greater than the porosity of the first or second layers individually. The first and second layers of porous mesh can be coupled together in any suitable manner. For example, the first portion 220 may be formed using an elongated tubular mesh having an elongated lumen between them. In said embodiment, the elongated mesh can be flattened from a tubular structure to a tape-like structure such that a first side, or layer, of the mesh is disposed

<td>in o</td><td>next</td><td>to a second side,</td><td>or</td><td>cap,</td><td>from</td><td colspan="2">the mesh as well</td>

<td colspan="2">forming a</td><td>mesh structure</td><td>from</td><td colspan="2">density</td><td>double,</td><td>or double</td>

<td>cap.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td></td><td>The</td><td>second portion or</td><td colspan="2">member,</td><td> 230</td><td>of the</td><td>implant</td>

Expandable 210 can be configured the same or similar to, and can be used in the same or similar manner, as the first portion 220. When the expandable member 210 moves between its first configuration and its second configuration, the second portion 230 is also movable between a first, collapsed, configuration in which the second portion is substantially elongated and has a third width and a second, expanded configuration, wherein the second member has a fourth width greater than the third width. For example, the second portion 230 may be movable from a substantially linear, elongated configuration collapsed to a multidimensional (eg, three-dimensional) shape in the expanded configuration. As shown in Figures 4 and 5C, the second portion 23 0 may have a three-dimensional shape in the expanded configuration that provides a generally spherical shape for the expandable implant 210. The second portion 230 may be skewed to its second, expanded configuration .

The second portion 230 is porous and may include or be constructed of a porous mesh. The porous mesh may be configured the same or similar to, and may be used in the same or similar manner, as the porous mesh described above with respect to the first portion 220 of the expandable implant 210. For example, the porous mesh may include a tissue or Stranded filament that is porous at least when the expandable implant 210 is in the second configuration. Additionally, the porous mesh of the second portion 230 may have a first porosity when the second portion 230 is in the first configuration and second porosity when the second portion 230 is in the second configuration. In some embodiments, the second portion 230 of the expandable implant 210 includes a first layer of porous mesh and a second layer of porous mesh, which may be of the same or different porosities. Thus, the total density of the second portion 230 is greater than the density of the first or second layers individually. The first porous mesh layer can be adjusted from the second porous mesh layer such that the total porosity of the second portion 230 is greater than the porosity of the first or second layers individually.

Similarly as described above with respect to the first portion 220, the first and second layers of porous mesh of the second portion 230 may be formed of an elongated tubular mesh constructed that is flattened into a tape-like structure.

The first portion 220 and the second portion 230 of the expanded implant 210 may be the same or different sizes. For example, as shown in Figure 5A, the first portion 220 may have a length in its first configuration, collapsed, which is less than a length of the second portion 230 in its first configuration, collapsed. In this way, markers 242, 244 will be introduced sequentially through neck N of aneurysm A, which allows the implant to expand 210 to be introduced through a narrower neck N. In another example, the first portion 220 and the second portion 230 may have the same or different widths. In some embodiments, for example, the first width of the first portion 220 in its first configuration is wider than the third width of the second portion 230 in its first configuration. The second width of the first portion 220 in its second configuration may also be wider than the fourth width of the second portion 230 in its second configuration. In another example, the fourth, expanded, width of the second portion 230 may be greater than the second, expanded, width of the first portion 220. In some embodiments, the porous mesh of the first portion 220 may have a multidimensional shape with a first width when the expandable implant 210 in its second configuration, and the porous mesh of the second portion 230 may have a multidimensional shape with a second width smaller than the first width when the expandable implant is in its second configuration.

In some embodiments, for example, the first portion 220 (or the porous mesh of the first portion) may be approximately 8 mm wide when the expandable implant expands in its second configuration, and the second portion 230 (or the porous mesh of the second portion) may have a width of approximately 9.5 m when the expandable implant expands in its second configuration. As such, in an embodiment in which the first portion 220 has a smaller overall size in the expanded configuration than the second portion 230, the first portion 220 may be configured to be disposed within an open interior region formed by the second portion 230 in Your second configuration.

In some embodiments, a variation of the medical device 200 is contemplated. For example, in said embodiment, the first portion of the expandable implant may include a first tubular mesh defining a lumen through it, and the second portion of the expandable implant may include a second tubular mesh disposed within the lumen of the first tubular mesh . The first and second tubular mesh structures can be formed substantially in a tape-like strand. As such, the expandable implant has a density of four layers. The expandable implant may include additional tape type strands in addition to the strand formed by the first and second portions. For example, the expandable implant may include one, two, three, four, five, six, seven, eight or nine strands, each of the strands having a desired number of layers (for example, two, four or more layers) . As such, an expandable implant can be formed having a desired amount of density. As noted above, a highly dense structure helps prevent blood flow from the blood vessels of origin in the aneurysm. Each layer or portion of the expandable implant can have the same or different density as the other layers or portions. In addition, each layer or portion of the expandable implant may have the same or different porosity as the other layers or portions.

Figure 6 illustrates a portion of another embodiment of a medical device. The medical device 300 may include the same or similar features and functions described above in previous embodiments. For example, medical device 300 includes an expandable implant 310 and an insertion or member portion (not shown in Figure 6). The expandable implant 310 is shown in an expanded configuration and can be moved between a compressed or collapsed configuration in which the expandable implant is substantially elongated and the expanded configuration in the same or similar manner as described above for the expandable implant 210 In the expanded configuration, a first portion 320 of the expandable implant 310 is superimposed by a second portion 330 of the expandable implant. Additionally, at least a portion of the first portion 320 is disposed within an open inner region 336 defined by the second portion 330 when the expandable implant 310 is in its expanded configuration.

The expandable implant 310 includes a porous mesh tape type thread. At least a portion of the porous mesh is configured to be placed on a neck of an aneurysm when the expandable implant 310 is in the expanded configuration. The porous mesh is configured to bend, bend and / or rotate multiple turns in a substantially spherical shape when the expandable implant 310 is in the expanded configuration. The porous mesh can be a tape-like structure that is wider than the porous mesh of the expandable implant 210. In this way, the porous mesh of the expandable implant 310 can be shorter in length than that of the expandable implant 210 and still provide an amount similar coverage within the aneurysm (and on the neck of the aneurysm) as an expandable implant 210. The porous mesh may include one, two or more layers depending on the desired density and porosity of the expandable implant 310. In some embodiments, a first radiopaque marker 342 is coupled to a first end 312 of the expandable implant 310 and a second radiopaque marker 344 it is coupled to a second end 314 of the expandable implant. The expandable implant 310 is configured to be fully disposed within the aneurysm such that the radiopaque markers 342, 344 are fully disposed within the aneurysm sac and the porous mesh is disposed on the aneurysm neck. In some embodiments, radiopaque markers are configured to be placed on the side of the aneurysm (ie, arranged away from the neck of the aneurysm).

Figure 7 illustrates another embodiment of a medical device. The medical device 400 may include the same or similar features and functions described above in previous embodiments. For example, medical device 400 includes an expandable implant 410 and an insertion portion or member 402. The expandable implant 410 is sized to occupy the aneurysm sac, and the insertion member 402 is configured to facilitate the supply of expandable implant in the aneurysm sac. The expandable implant 410 is shown in an expanded configuration and can be moved between a compressed or collapsed configuration and the expanded configuration in the same or similar manner as described above for previous modalities.

The expandable implant 410 includes at least one porous mesh tape-like thread configured to expand in the aneurysm as a 360-degree spiral or ring-shaped structure. In the expanded configuration, a first portion 420 of the expandable implant 410 is superimposed by a second portion (not shown in Figure 7) of the expandable implant, which is superimposed by a third portion 450 of the expandable implant. Thus, at least a portion of the expandable implant 410 includes two, three, four or more layers of implant material (eg, porous mesh, as described above in previous embodiments), which can be placed on the neck of the aneurysm. from within the aneurysm to function as a dense flow rupture.

Figure 8 illustrates another embodiment of a medical device. The medical device 500 may include the same or similar features and functions as described above for the medical device 400. For example, the medical device 500 includes an expandable implant 510 and an insertion portion or member 502. The medical device 500 may be supplied to an aneurysm or other vascular defect using a 504 microcatheter. The expandable implant 510 is sized to occupy at least a portion of the volume defined by the aneurysm sac, and the insertion member 502 is configured to facilitate delivery of the expandable implant into the aneurysm sac. The expandable implant 510 is shown in an expanded configuration and can be moved between a compressed or collapsed configuration and the expanded configuration in the same or similar manner as described above for previous modalities.

The expanded 510 implant includes a porous mesh configured to expand within the aneurysm as a substantially circular or disk-shaped structure, as shown in Figure 8. In the expanded configuration, a first end portion 512 of the expanded 510 implant is coupled with and / or superimposed with a second end portion 514 of the implant expanded. The expanded 510 implant includes a first portion 520 having a first porous mesh density and a second portion 530 having a second, higher, porous mesh density. More specifically, a tissue or braid of the porous mesh has a higher density in the second portion 530 than in the first portion 520 of the expanded implant. The expanded 510 implant is configured to be disposed within the aneurysm (or other vascular defect) such that at least a portion of the second portion 53 0 is disposed on the neck of the aneurysm, since the higher density promotes the attachment of endothelial cells to the implant expanded. The expanded implant 510 includes at least one radiopaque marker 542, which can be arranged in one of the first end portion 512 (as shown in Figure 8) and / or the second end portion 514. When the expandable implant 510 is disposed within the aneurysm in its expanded configuration such that the second highest density portion 53 0 is disposed on the neck of the aneurysm, at least one radiopaque marker 542 is disposed within the aneurysm sac away from the neck of the aneurysm.

Figure 9 illustrates another embodiment of a medical device. The medical device 600 may include the same or similar features and functions as described above for previous modalities. For example, medical device 600 includes an expandable implant 610 and an insertion portion or member 602. The expandable implant 610 is sized to occupy at least a portion of a volume defined by the aneurysm sac, and the insertion member 602 is configured to facilitate delivery of the expandable implant into the aneurysm sac. The expandable implant 610 is shown in an expanded configuration and can be moved between a compressed or collapsed configuration and the expanded configuration in the same or similar manner as described above for previous modalities.

The expandable implant 610 includes a porous mesh tape type thread having at least two layers of mesh. The expandable implant 610 is configured to be expanded within the aneurysm as a substantially helical or spiral structure, as shown in Figure 9. The expandable implant 610 may be disposed within the aneurysm (or other vascular defect) such that at least a portion of the implant is disposed on the aneurysm neck to facilitate the attachment of endothelial cells in the neck. The expandable implant 610 includes at least one radiopaque marker 642, which can be arranged at one end of the expandable implant 610, as shown in Figure 9.

<td>The member</td><td>from</td><td>insertion</td><td>602 se</td><td>may</td><td>couple</td>

<td colspan="2">detachably at</td><td>implant</td><td>&gt; expandable</td><td>in the</td><td>marker</td>

<td>radiopaque</td><td></td><td></td><td></td><td></td><td></td>

<td>I read</td><td>figure</td><td colspan="2">10 illustrates another</td><td>modality</td><td>of a</td>

medical device. A medical device 700 includes all of the same or similar features and functions described above for medical device 600. For example, medical device 700 includes an expandable implant 710, an insertion portion or member 702, and a radiopaque marker 742 coupled to a Expandable implant end. The expandable implant 710 includes a porous mesh formed by a tubular or round braid structure. The rounded braiding structure may lend more softness to the expandable implant 710 than, for example, the flattened ribbon type structure described previously.

Figure 11 illustrates another embodiment of a medical device. The medical device 800 may include the same or similar features and functions as described above for previous modalities. For example, medical device 800 includes an expandable implant 810 and an insertion portion or member 802. Medical device 800 can be delivered to an aneurysm or other vascular defect using a microcatheter 804. The expandable implant 810 is sized to occupy at least a portion of the aneurysm sac volume and the insertion member 802 is configured to facilitate delivery of the expandable implant from the microcatheter 804 into the aneurysm sac. The expandable implant 810 is shown in an expanded configuration and can be moved between a compressed or collapsed configuration and the expanded configuration in the same or similar manner as described above for previous modalities.

The expandable implant 810 includes a first member 820 and a second member 830. The first and second members 820, 830 are coupled at a first end 812 of the expandable implant 810 and a second end 814 of the expandable implant. The first and second members 820, 830 are also coupled to each other in at least a half portion of the expanded implant 810 between the first end 812 and the second end 814. The first and second members 820, 830 can be coupled, for example, using radiopaque markers 842, 844, 846. Each coupling site is configured to be a folded point of the expanded implant 810 when the expanded implant is supplied in the aneurysm and is It expands within the aneurysm to meet the aneurysm shape. As such, the 810 expanded implant may be more densely populated in the aneurysm, for example, compared to an implant that cannot be folded or folded in response to the aneurysm shape. At least one of the first member 820 and the second member 830 of the expanded implant 810 includes a porous mesh formed by a round tubular or braided structure.

Figure 12 illustrates another embodiment of a medical device. The medical device 900 may include the same or similar features and functions described above for previous modalities. For example, medical device 900 includes an expanded implant 910 and an insertion portion or member 902. The expanded implant 910 is sized to occupy the aneurysm sac, and the insertion member 902 is configured to facilitate the delivery of the expandable implant of a microcatheter (not shown in Figure 12) into the aneurysm sac. The expandable implant 910 is shown in an expanded configuration and can be moved between a compressed or collapsed configuration and the expanded configuration in the same or similar manner as described above for previous modalities.

The expandable implant 910 includes a series of expandable portions 920, 922, 924, 926, 928 separated by a series of narrow portions 93 0, 932, 934, 936. The expandable portions 920, 922, 924, 926, 928 can be configured to expand to any suitable multidimensional form, including, for example, that which resembles a sphere, a disk, a parabola or the like. Additionally, each expandable portion 92 0, 922, 924, 92 6, 928 may have an expanded form other than an expanded form of another expandable portion.

When the expandable implant 910 is in its expanded configuration, as shown in Figure 12, the expandable portions 920, 922, 924, 926, 928 are more porous and less dense after narrowed portions 930, 932, 934, 93 6. The density and / or porosity of each expandable portion 920, 922, 924, 926, 928 may vary from the other expandable portions 920, 922, 924, 926, 928 and the density and / or porosity of each expandable portion 920, 922, 924, 926, 928 may vary along a length and / or width of the respective expandable portion. For example, a first expandable portion 920 may be denser and / or less porous near a first constriction portion 930 and less dense and / or more porous in the middle part, the widest portion of the first expandable portion 920. Additionally, the expandable portions 920, 922, 924, 926, 928 each configured to have a width greater than when the expandable implant 910 is in its collapsed configuration, and the narrow portions 930, 932, 934, 936 are each configured to have a narrower width than the width of the expandable portions 920, 922, 924, 926, 928. As such, the expandable implant 910 is configured to bend, bend and / or fold into the narrow portions 930, 932, 934, 936 to help meet the aneurysm shape.

When the expandable implant 910 is in its expanded configuration, the first expandable portion 920 is configured to have a width greater than the width of the other expandable portions 922, 924, 926, 928. The first expandable portion 920 may be, as illustrated in Figure 12, the most proximal of the expandable parts 920, 922, 924, 926, 928. The first expandable portion 920 is configured to be placed on an aneurysm neck when the expandable implant 910 is disposed within the aneurysm in its expanded configuration. In this way, the first expandable portion 920 is configured to act as a rupture of flow in the neck of the aneurysm to help limit the flow of blood in the aneurysm of the blood vessels of origin. The remaining, more distal, expandable portions 922, 924, 926, 928 are configured to be packed in the aneurysm to embolize the aneurysm.

The expandable implant 910 includes a first radiopaque marker 942 coupled to a first end 912 of the implant and a second radiopaque marker 944 coupled to a second end 914 of the implant. The radiopaque markers 942, 944 are configured to be fully disposed within the aneurysm sac when the expandable implant 910 is disposed in the aneurysm in its expanded configuration.

Figure 13 illustrates another embodiment of a medical device. The medical device 1000 may include the same or similar features and functions described above for previous modalities. For example, medical device 1000 includes an expandable implant 1010 and an insertion portion or member 1002. The expandable implant 1010 is sized to occupy the aneurysm sac, and the insertion member 1002 is configured to facilitate delivery of the expandable implant into the aneurysm sac. The expandable implant 1010 is shown in an expanded configuration and can be moved between a compressed or collapsed configuration and the expanded configuration in the same or similar manner as described above for previous modalities.

The expandable implant 1010 includes a first porous member 1020 and a second porous member 1030. The first porous member 1020 includes a porous mesh configured to have a multidimensional shape when the expandable implant 1010 is in its expanded configuration. Thus, the first porous member 1020 has a second width in the expanded configuration that is greater than the first width of the first porous member in the collapsed configuration. The first porous member 1020 can be configured to expand to any suitable multidimensional shape, including, for example, that which resembles a parabola, as shown in Figure 13, a sphere, a disk or the like. The first porous member 1020 is configured to be placed on an aneurysm neck when the expanded member 1010 is disposed within the aneurysm sac to interrupt and / or stop the flow of blood into the aneurysm of the blood vessels of origin. Additionally, the porous mesh of the first porous member 1020 is configured to promote the attachment of endothelial cells in the aneurysm neck, which can help heal over the aneurysm neck.

The second porous member 1030 includes a porous mesh configured to have a multidimensional shape when the expanded implant 1010 is in its expanded configuration. As such, the second porous member 1030 has a fourth width in the expanded configuration greater than a third width of the second porous member in the collapsed configuration. The second porous member 1030 may be configured to expand to any suitable multidimensional shape, including, for example, that which resembles a tube, as shown in Figure 13, a sphere, a disk, a parabola or the like. In the embodiment illustrated in Figure 13, the second width of the first porous member 1020 is greater than the fourth width of the second porous member 1030. The second porous member 1030 is configured to be disposed within the aneurysm sac such that the first porous member 1020 is disposed between the second porous member 1030 and the aneurysm neck. The second porous member 1030 is configured to be packed in the aneurysm to embolize the aneurysm.

A radiopaque marker 1044 is disposed between the first porous member 1020 and the second porous member 1030 and can be used to couple the first and second porous members. The expandable implant 1010 is configured to bend, bend and / or fold in the radiopaque marker 1044, which can help the expandable implant 1010 comply with the shape of the aneurysm sac. Another radiopaque marker 1042 may be disposed at a proximal end of the expandable implant 1010, and may be used to couple the insertion portion 1002 to the expandable implant. Radiopaque markers 1042, 1044 are configured to be fully disposed within the aneurysm sac when the expandable implant 1010 is disposed in the aneurysm in its expanded configuration.

Figures 14-15 illustrate another embodiment of a medical device. The medical device 1100 may include the same or similar features and functions as described above for previous modalities. For example, medical device 1100 includes a first porous member

1120, a second porous member 1130, and an insertion portion or member 1102 removably attachable to the first and second porous members 1120, 1130.

The first porous member 1120 has a first end 1122 and a second one 1124. As shown in Figure 14, the first porous member 1120 has a collapsed configuration for insertion through a blood vessel. In its collapsed configuration, the first porous member 1120 is considerably elongated with a first length. As shown in Figure 15, the first porous member 1120 has an expanded configuration occupying a sac of an aneurysm. When the first porous member 1120 in its expanded configuration has a three-dimensional shape and defines an open inner region 1126. The first porous member 1120 can have any suitable three-dimensional shape. For example, the first porous member 1120 may be curved in a substantially spherical shape, as shown in Figure 15. Additionally, in its expanded configuration, the first porous member 1120 includes a first segment configured to overlap with a second segment, which may be similar in many respects as described above with respect to expandable implants 210 and 310, for example. For example, the first porous member 1120 may include a mesh having a first segment configured to overlap with a second segment of the porous mesh to form a higher density portion of the first porous member 1120.

The second porous member 1130 has a first end 1132 and a second end 1134. The second porous member 1130 has a collapsed, first, configuration (not shown in Figure 14 or 15) for insertion through a blood vessel. In its collapsed configuration, the second porous member 1130 is substantially elongated with a second length less than the first length of the first porous member, and is configured to occupy a first volume. As shown in Figures 14 and 15, the second porous member 1130 has an expanded, second, configuration to occupy at least a portion of the aneurysm sac volume. When the second porous member 1130 is in its expanded configuration, it has a three-dimensional shape and is configured to occupy a second volume larger than the first volume. The second porous member 1130 may have any suitable three-dimensional shape. For example, the second porous member 1130 can be configured to expand in a substantially balloon shape (e.g., spherical, round, oblong, or the like), as shown in Figures 14 and 15. In the expanded configuration, the second member Porous 1130 may have a porosity equal to, or different from, a porosity of the first porous member 1120. The second porous member 1130 is configured to be arranged in the inner region 1126 of the first porous member 1120 when each of the first porous member and the second porous member are the deployed or expanded configurations.

In the embodiment illustrated in Figures 14 and 15, the second porous member 1130 is coupled to the first porous member 1120. Specifically, the first end 1122 of the first porous member 1120 is coupled to the first end 1132 of the second porous member 1130. At least one of the first porous member 1120 and the second porous 1130 includes a radiopaque marker. As shown in Figure 14, a first radiopaque marker 1142 may be arranged at the first ends 1122, 1132 of the first and second porous members 1120, 1130 to couple the first and second porous members together. A second radiopaque marker 1144 may be disposed at the second end 1134 of the second porous member 1130. When the first and second porous members 1120, 1130 are in their respective expanded configurations, the second radiopaque marker 1144 is disposed within the interior region defined by the first porous member 1120.

In use, the first and second porous members 1120, 1130 and the first and second radiopaque markers 1142, 1144, are fully disposed within the aneurysm. The second porous member 1130 can be inserted into the first aneurysm and assume its expanded configuration in this. The first porous member 1120 can then be inserted into the aneurysm such that the first curves of the porous member, coils or otherwise are wrapped around the second porous member 1130 as the first porous member moves to its expanded configuration. The first porous member 1120 is configured to be disposed within the aneurysm such that a portion of the first porous member is disposed on the neck of the aneurysm. For example, the highest density portion of the first porous member 1120 in which the first segment overlaps the second segment may

<td>Be placed</td><td>on</td><td colspan="3">aneurysm neck</td><td>for</td><td>promote</td><td>the</td>

<td>binding of</td><td>cells</td><td>endothelial</td><td>in the</td><td>neck</td><td>of the</td><td>aneurysm.</td><td>The</td>

<td colspan="2">second member</td><td>porous 1130</td><td>may</td><td>help</td><td>to</td><td>embolize</td><td>the</td>

<td>aneurysm</td><td colspan="2">by providing the</td><td>mesh</td><td>porous</td><td colspan="3">additional inside</td>

of the aneurysm sac for cell union and / or clot formation. As such, the second porous member occupies a portion of the aneurysm sac volume such that blood flow through the aneurysm is further inhibited.

Although the medical device 1100 includes first and second discrete porous members 1120, 1130, respectively, in other embodiments, the first and second porous members may be constructed differently. For example, referring to Figure 16, one embodiment of a medical device 1200 is illustrated. Medical device 1200 may include the same or similar features and functions as described above for medical device 1100, or other prior modalities. For example, the medical device 1200 includes a first porous member 1220, a second porous member 1230 and an insert or member portion (not shown in Figure 16) removable in a way that can be coupled to the first and second porous members. Each of the first porous member 1220 and the second porous member 1230 may be similar in shape and

<td>function</td><td>how</td><td>the</td><td>first</td><td>porous member</td><td>1120 and the</td><td>second</td>

<td>member</td><td colspan="2">porous</td><td> 1130 ,</td><td>respectively,</td><td>how I know</td><td>describe</td>

<td colspan="2">previously.</td><td></td><td></td><td></td><td></td><td></td>

<td></td><td>In</td><td>the</td><td colspan="2">illustrated mode</td><td>in figure</td><td>16 without</td>

However, the second porous member 1230 is monolithically constructed with the first porous member 1220. It should be noted that in Figure 16, the first and second porous members 1220, 1230, are shown in an expanded configuration but the second porous member 1230 is shown spaced the first porous member 1220 apart for illustrative purposes only. In use, in their respective expanded or deployed configurations, the second porous member 1230 is disposed within an inner region 1226 defined by the first porous member 1220 in a similar manner as illustrated in Figure 15 with respect to the medical device 1100. Additionally, medical device 1200 includes two radiopaque markers 1242, 1244. A first radiopaque marker 1242 is disposed at one end of a porous mesh of the first porous member 1220, and the second radiopaque marker 1244 is disposed at an opposite end of a porous mesh of the second porous member 1230.

In some embodiments, a medical device includes an expanded implant that has a substantially continuous outer surface when in an expanded configuration. Referring to Figures 17A and 17B, a portion of a medical device 13 00 according to one embodiment illustrates a collapsed configuration and an expanded configuration, respectively. The medical device 1300 may include the same or the same features and functions as described herein for other modalities. For example, medical device 1300 may include an expandable implant 1310 configured to move the collapsed configuration (for example, to deliver through a blood vessel) into the expanded configuration (for example, for implementation within an aneurysm). The expandable implant 1310 includes at least a first portion 1320 and a second portion of 1330, and may include additional portions 1340, 1350, 1360. When the expandable implant 1310 in its expanded configuration, the expandable implant 1310 has a three-dimensional shape (by example, a substantially spherical shape) with a substantially continuous outer surface such that the edges of at least two of the portions 1320, 1330, 1340, 1350, 1360 overlap. For example, the edges of the first portion 1320 and the second portion 1330 can be superimposed, as shown in Figure 17B. In other words, the expandable implant 1310 moves in the expanded configuration such that there are few or no openings or spaces between the edges of the portions 1320, 1330, 1340, 1350, 1360 of the expandable implant 1310.

Figure 18 is a flow chart illustrating a method 80 of using a medical device to interrupt blood flow in an aneurysm and to promote aneurysm healing, as described herein, in accordance with one embodiment. Method 80 includes 82, the placement of a catheter adjacent to an aneurysm of a blood vessel. For example, a distal portion of the catheter can be placed adjacent to an opening of the blood vessels in the aneurysm. The catheter defines an elongated lumen, which can be configured to receive at least a portion of the medical device for delivery to the aneurysm.

In 84, optionally, an expandable implant of the medical device is inserted into the catheter. The expandable implant includes a first portion and a second portion, each having a first (for example, insertion or collapsed) configuration and a second (for example, deployed or expanded) configuration. In the second configuration, the first portion substantially overlaps the second portion. Each of the first portion and the second portion also includes a porous mesh. The porous mesh has a first porosity when in the first configuration and a second porosity when in the second configuration. The second porosity may be, for example, greater than the first porosity. The expandable implant can be deflected in its second configuration before being inserted into the catheter. The expandable implant is in its first configuration when the expandable implant is arranged in the lumen of the catheter. The expandable implant can insert the catheter after the catheter is

<td colspan="5">placed inside the blood vessel, before the catheter is</td>

<td>enter in</td><td>the</td><td>glass</td><td>blood, or any</td><td>time between</td>

<td>these.</td><td></td><td></td><td></td><td></td>

<td>In</td><td> 86,</td><td>the</td><td>expandable implant is</td><td>optionally</td>

oriented to the opening in the vessel wall in fluid communication with the aneurysm. In this way, the expandable implant is oriented to enter an aneurysm sac when the expandable catheter implant is moved, as described in more detail here.

At 88, the expandable implant moves from a first position inside the catheter to a second position outside the catheter. For example, the expandable implant can be moved from a first position within the lumen of the catheter to a second position in at least one of the blood vessel or the aneurysm outside the catheter. As noted above, the expandable implant is in its first configuration when in its first inner position of the catheter. The expandable implant moves to its second configuration when in its second position outside the catheter restriction. The second portion of the expanded implant can be moved to its second configuration before the first portion moves to its second configuration. In their respective second configurations, the second portion may be arranged in an interior region defined by the first portion. For example, the second portion can be moved to its second configuration in which it has an expanded multidimensional shape, and then the first portion can be moved to its second configuration in which the curves are in an expanded multidimensional shape around the second portion.

The medical device may include an insertion portion configured to move the expanded implant from its first position to its second position. The insertion portion may be, for example, a wire coupled to one of the first portion or the second portion of the expanded implant. At 90, the insertion portion is optionally disconnected from the expanded implant. For example, the insertion portion may be disconnected from a proximal end of the expanded implant, such as after the expandable implant has been inserted into the aneurysm. In 92, the insertion portion is optionally removed from the blood vessel through the catheter.

After the expandable implant is disposed within the aneurysm, or other objective vascular defect, the portion of a patient's body that includes the aneurysm can be reflected (for example, by X-rays or other suitable imaging techniques) to determine if the Expandable implant is correctly placed inside the aneurysm. For example, the expandable implant may include one or more radiopaque markers that are visible by X-rays. In another example, the patient may be injected intravenously with a radiopaque ink at a desired time after implantation of the expandable implant to determine the success of endothelial cell attachment and / or healing on the neck of the aneurysm after the procedure. . If the radiopaque ink is visible inside the blood vessel of origin adjacent to the aneurysm, but not within the aneurysm itself, the expandable implant has worked to successfully prevent more blood flow to the aneurysm. If radiopaque ink is visible within the aneurysm, blood flow from the source blood vessel has not been completely prevented and additional treatment options may be considered by the personal care physician.

Figure 19A illustrates a portion of another embodiment of a medical device. The medical device 1400 may include the same or similar features and functions as described above by previous modalities. For example, medical device 1400 includes an expandable implant 1410 and an insert or member portion (not shown in Figure 19A). The expandable implant 1410 is shown in an expanded configuration and can be moved between a compressed or collapsed configuration in which the expandable implant 1410 is substantially elongated and the expanded configuration in the same or similar manner as described above for previous modalities.

The expandable implant 1410 includes a porous mesh tape type thread and includes petal portions or sections 1425 and 1427 along its length. At least a portion of the porous mesh is configured to be placed on a neck of an aneurysm when the expandable implant 1410 is in the expanded configuration. The expandable implant 1410 includes a first portion 1420 that includes the petal-like portions 1425 and a second portion 1430 that includes the petal-like portions 1427. The petal-like portions 1425 of the second portion 143 0 are larger than the petal-like portions 1427 of the first portion 1420 such that when the expandable implant 1410 is moved to its expanded configuration, the petal-like portions 1425 of the second portion therefore less partially overlap the petal-like portions 1427 of the first portion 1420. During the implementation of the expandable implant 1410 (for example, when moving from its collapsed configuration to its expanded configuration) the petal-like portions 1425 of the second portion 1430 will first deploy, and then the petal-like portions 1427 of the second portion 1420 will deploy to the less partially within an interior region defined by the second portion 1430. The petal-like portions 1425 of the second portion 1430 can be sized and configured to be arranged on a neck of an aneurysm when the expandable implant 1410 is in the expanded configuration. The petal-like portions 14 27 of the first portion 1420 can be formed in an artifact of smaller diameter than the petal-like portions 1425 and can be sized and configured substantially to fill the aneurysm and to keep the second portion 1430 in place in the neck of the aneurysm when the expandable implant 1410 is in the expanded configuration. For example, the petal-like portions 1427 of the first portion 1420 may have a diameter of approximately 2mm-12mm and the petal-like portions 1425 of the second portion 1430 may have a corresponding diameter of approximately 1mm long than the type portions petal 1427 of the first portion 1420. For example, the petal-like portions 1425 of the second portion 14 30 may be approximately 3 mm-13 mm. Figure 19B is a schematic illustration of the expandable implant 1410 in its expanded configuration showing the positional relationship of the first portion 1420 to the second portion 1430.

As described by previous embodiments, a first radiopaque marker 1442 is coupled to a first end of the expandable implant 1410 and a second radiopaque marker (not shown) is coupled to a second end of the expandable implant 1410. The expandable implant 1410 is configured to be disposed entirely within the aneurysm such that the radiopaque markers are arranged completely within the aneurysm sac and the porous mesh is disposed on the aneurysm neck. In some embodiments, radiopaque markers are configured to be placed on the side of the aneurysm (ie, arranged away from the neck of the aneurysm).

Figure 20 illustrates a portion of another embodiment of a medical device. The medical device 1500 may include the same or similar features and functions as described above by previous modalities. For example, medical device 1500 includes an expandable implant 1510 and an insertion or member portion (not shown in Figure 20). The expandable implant 1510 is shown in an expanded configuration and can be moved between a compressed or collapsed configuration in which the expandable implant 1510 is substantially elongated and the expanded configuration in the same or similar manner as described above for previous modalities.

As with the previous embodiment, the expandable implant 1510 includes a strand type of porous mesh tape. At least a portion of the porous mesh is configured to be placed on a neck of an aneurysm and at least another portion of the porous mesh substantially fills the aneurysm volume when the expandable implant 1510 is in the expanded configuration. The expandable implant 1510 includes a first portion 1520 and a second portion 1530. In this embodiment, each of the first portion 152 0 and the second portion 1530 forms a sphere when the expandable implant 1510 is in its expanded configuration. One of the first portion 1520 or the second portion 1530 may be configured to be arranged in a neck of the aneurysm and the other of the first portion 1520 or

the second portion 1530 can substantially fill the aneurysm volume. For example, in this embodiment, the first portion 1520 may be configured to be deployed in the aneurysm dome and serves as an anchor for the second portion 1530 and the second portion 1530 may be disposed through the neck of the aneurysm when the expandable implant 1510 is in The expanded configuration. The expandable implant 1510 may also include radiopaque markers (not shown) as described above by previous modalities.

Figures 21 and 22 illustrate another embodiment of a medical device. The medical device 1600 may include the same or similar features and functions described above by previous modalities. For example, medical device 1600 includes an expandable implant 1610 and an insertion portion or member (not shown). The expandable implant 1610 is shown in an expanded configuration and can be moved between a compressed or collapsed configuration as shown in Figure 22 and the expanded configuration as shown in Figure 21 in the same or similar manner as described above for modalities. previous.

As with the previous embodiment, the expandable implant 1610 includes a porous mesh tape-like thread that includes a first portion 162 0 in the form of a disk-shaped structure and a second portion 1630 that includes petal-like portions or sections along of its length (similar to the modality of figure 19A). The spherical disk or structure of the first portion 1620 may be disposed at various locations along the length (eg, middle, final, etc.) of the 1610 expanded implant. At least a portion of the porous mesh It is configured to be placed on an aneurysm neck when the 1610 expanded implant is in the expanded configuration. In this embodiment, when the expanded implant 1610 is in the expanded configuration, the petal-like portions of the second portion 1630 at least partially overlap the disk-shaped structure of the first portion 1620. For example, when the implant expanded 1610 in its expanded configuration, the petal-like portions of the second portion 1630 may define a diameter greater than a diameter defined by the disc or the spherical structure of the first portion 1620. The expanded implant 1610 may also include a first radiopaque marker 1642 coupled to a first end 1612 of the expanded implant 1610 and a second radiopaque marker (not shown) coupled to a second end (not shown) of the expanded implant.

1610 .

When the expandable implant 1610 is in its expanded configuration, the expandable implant 1610 has a three-dimensional shape (for example, a substantially spherical shape) with a substantially continuous outer surface such that the edges of at least two of the petal-like portions 1625 overlap with each other (in a similar manner as the embodiment of Figures 17A and 17B) and at least partially overlap the disk-shaped portion 1620. The expandable implant 1610 can move the expanded configuration such that some or no opening or spaces remain between petal-like portions 1625 of the expandable implant 1610.

Figures 23 and 24 illustrate a portion of another embodiment of a medical device. Medical device 1800 may include the same or similar features and functions as described above by previous modalities. For example, medical device 1800 includes an expandable implant 1810 and an insert or member portion (not shown in Figures 23 and 24). The expandable implant 1810 can be moved between a collapsed configuration as shown in Figure 23 and an expanded configuration as shown in Figure 24.

Similar to the embodiment of Figure 19A, the expandable implant 1810 includes a porous mesh tape type thread, which includes 1825 petal portions or sections along its length. At least a portion of the porous mesh is configured to be placed on a neck of an aneurysm when the expandable implant 1810 is in the expanded configuration. When the expandable implant 1810 is in its expanded configuration, the expandable implant 1810 has a three-dimensional shape (for example, a substantially spherical shape) with a substantially continuous outer surface such that the edges of at least two of the petal-like portions 1825 overlap as shown in figure 24.

In this embodiment, when the implantable implant 1810 is formed, the porous mesh tape type thread is wrapped around the accessory forming in a multidirectional manner. For example, a portion of the mesh can be continuously wrapped around the device as indicated in C in Figure 23, and a portion of the mesh can be wrapped in an S-shape as indicated in S in the figure 2. 3. With such formation, when the expandable implant 1810 moves to its expanded configuration, the petal-like portions 1825 that have been formed by the wrapper will continuously follow each other (each petal-like portion 1825 will cause the adjacent petal-like portion 1825 to collapse ) and the 1825 petal-like portions that have been formed in an s-shape will self-plummet individually or collapse. The multidirectional heat formation of the expandable implant 1810 may allow the expandable implant 1810 to deploy fragmented within an aneurysm.

In this embodiment, the medical device 1800 also includes a PT coil or PT 1835 strand arranged along the length of the expandable implant 1810 to provide a portion of the expandable implant 1810 to be radiopaque. As shown in Figure 23, the PT 1835 strand is disposed along a length of the expandable implant 1810 and through or within the petal-like portions 1825. The PT 1835 strand can be coupled to, for example, marker bands (not shown) disposed on a proximal end and a distal end of the expandable implant 1810. In some embodiments, a PT 1835 strand can be braided into the mesh of the expandable implant. 1810

In some embodiments, the PT 1835 strand can also be used to prevent over-stretching of the expandable implant 1810 when delivered to a treatment site. For example, as described above, the PT 1835 strand can be coupled to the proximal end and the distal end of the expandable implant 1810. Thus, the PT 1835 strand can define a maximum length in which the expandable implant 1810 can be stretched or extended longitudinally during insertion and avoid overstretching. In alternative embodiments, a separate component can be used to limit the length of the expandable implant 1810. For example, in some embodiments, a different wire member in addition to a PT strand can be used. In some embodiments, an expandable implant may not include a PT strand, such as the PT 1835 strand. In such embodiments, a separate wire member may be coupled at the proximal and distal end of the expandable member and used to limit the length or the stretch amount of the expandable implant similarly.

In some embodiments, a medical device may include a strand formed with, for example, a suture that extends along or within the medical device. The suture thread can reinforce the medical device along its length. In some embodiments, a radiopaque coil may be placed on the suture strand to improve the visibility of medical devices under fluoroscopy.

Figures 25-27 illustrate a portion of another embodiment of a medical device. The medical device 1900 may include the same or similar features and functions described above by previous modalities. For example, medical device 1900 includes an expandable implant 1910 and an insertion portion or member (not shown in Figures 25-27). The expandable implant 1910 can be moved between a collapsed configuration (as shown in Figure 25, a partially expanded configuration as shown in Figure 26, and an expanded configuration as shown in Figure 27.

The expandable implant 1910 includes a porous mesh tape type thread, which includes a first portion 1920 (see Figures 25-27) and a second portion 1930 (shown only in Figure 27). In this embodiment, the first portion 1920 and the second portion 1930 are separate components that can be deployed together. The first portion 1920 includes disc-shaped portions 1945 along its length, and the second portion 1930 includes petal-type portions 1925, as described above for earlier embodiments. When the expandable implant 1910 is in its expanded configuration, the expandable implant 1910 has a three-dimensional shape (eg, a substantially spherical shape) as shown in Figure 27.

During the implementation of the medical device 1900, the second portion 1930 may first be deployed such that petal portions 1925 move to an expanded configuration and define an inner region 1936. The first portion 1920 may then be deployed such that the disk-shaped portions 1945 they will collapse with each other (as shown in Figures 26 and 27) within the inner region 1936 of the second portion 1930, as shown in Figure 27. In other words, when the expandable implant 1910 is in the expanded configuration, the second portion 1930 at least partially overlaps the first portion 1920, as shown in Figure 27. At least a portion of the porous mesh is configured to be placed on a neck of an aneurysm when the 1910 expandable implant is in the expanded configuration. For example, when the expandable implant 1910 is in its expanded configuration, the second portion 1930 may be arranged in the neck of the aneurysm to interrupt the flow of blood, and the first portion 1920 may help occlude the aneurysm at a relatively rapid rate. Although this embodiment illustrates the first portion 1920 and the second portion 1930 as separate components, in an alternative embodiment, the first portion 1920 and the second portion 1930 may be formed with a single coupling component.

In this embodiment, the medical device 1900 may also include a PT coil or PT strand (not shown) arranged along the length of the first portion 1920 and / or the second portion 1930 of the expandable implant 1910 in a similar manner as described above for medical device 1800. The PT strand can be coupled to a first marker band 1942 disposed at a first end 1912 of the expandable implant 1910 and a second marker band 1944 at a second end of the expandable implant 1910 as shown in Figure 27. As described above. , the PT strand can be braided into the mesh of the 1910 expandable implant. As shown in Figures 2 6 and 27, the expandable member 1910 also includes a connecting member 1952 that can be used to couple the expandable member 1910 to a separation device as described in more detail below (see for example, discussion of figure 40).

Figures 28 and 2 9 illustrate another embodiment of a medical device. A medical device 2000 may include all of the same or similar features and functions as described above by previous modalities. For example, the medical device 2000 includes an expanded implant 2010, an insertion portion or member 2002, a first radiopaque marker 2042 coupled to a first 2012 end of the implant expanded 2010 and a second radiopaque marker 2044 coupled to a second end 2014 of the implant expandióle 2010. The expaióle 2010 implant can be moved between a collapsed configuration (not shown) and an expanded configuration as shown in Figures 28 and 29.

In this embodiment, the 2010 expanded implant includes three tubular or rounded strands 2020, 2030 and 2015 formed by a porous mesh similar to the tubular structures described above, for example, with respect to Figures 10 and 11. In some embodiments, the strands 2020, 2030 and 2015 can be braided. In alternative modalities, the strands 2020, 2030 and 2015 can be formed with porous mesh tape type strands instead of tubular strands. When the 2010 expanded implant is in its expanded configuration, at least a portion of the 2020, 2030 and 2015 tubular strands can overlap each other as shown in Figure 29. The 2010 expanded implant can be used to fill a volume of a aneurysm and can be used alone or in conjunction with another expandable implant to fill the volume of an aneurysm.

The tubular mesh can be, for example, 1 mm tubular mesh. In this embodiment, the tubular strands 2020, 2030, 2015 can be in the form of heat such that the expandable implant 2010 has a 2D configuration when the expandable implant 2010 is in its expanded configuration. In this modality, three tubular strands are included, but in alternative modalities a different number of tubular strands can be included. For example, an expandable implant can be formed with tubular strands of 1-10. Tubular strands 2020, 2030 and 2015 can be coupled together at various locations along their lengths with marker bands, such as marker band 204 6 shown in Figure 29. In alternative embodiments, tubular strands can be rotated together or braided together instead of using marker bands. In some embodiments, the strands are not coupled together.

Figure 30 illustrates another embodiment of a medical device that includes tubular structures. A medical device 2100 may include all of the same or similar features and functions as described above by previous modalities. For example, medical device 2100 includes an expandable implant 2110 and an insertion portion or member 2102. Although not shown in Figure 30, the medical device 2100 may also include radiopaque markers coupled to end portions to the expandable implant 2110. The expandable implant 2110 can be moved between a collapsed configuration (not shown) and an expanded configuration as shown in figure 30.

The expandable implant 2110 includes three tubular or rounded strands 2120, 2130 and 2115 formed by a porous mesh similar to the tubular strands described above for the medical device 2000. When the expandable implant 2110 is in its expanded configuration, at least a portion of The tubular strands 2120, 2130 and 2115 can be superimposed as shown in Figure 30. In this embodiment, the tubular strands 2120, 2130, 2115 can be in the form of heat to have a 3D configuration when the expandable implant 2110 is in the expanded configuration. In this modality, three tubular strands are included, but in alternative modalities a different number of tubular strands can be included. For example, an expandable implant can be formed with tubular strands 1-

10. The tubular strands 2120, 2130 and 2115 can be coupled together at various locations along their lengths with marker bands (not shown) as described above for the medical device 2000, or they can be coupled with other coupling methods, such like being turned together, or braided together. In some embodiments, the tubular strands are not coupled together.

Figure 31 illustrates another embodiment of a medical device that includes tubular structures. A medical device 2200 may include the same or similar features and functions as described above by previous modalities. For example, medical device 2200 includes an expanded implant 2210 and an insertion portion or member 2202. Although not shown in Figure 31, medical device 2200 may also include radiopaque markers coupled to end portions of the expanded implant 2210, such as radiopaque marker 2242 coupled to one end 2212 as shown in Figure 31. The implant expanded 2210 It can be moved between a collapsed configuration (not shown) and an expanded configuration as shown in Figure 31.

In this embodiment, the expanded implant 2210 includes a single rounded tubular or braided structure 2215 formed of a porous mesh similar to the tubular structures described above for medical devices.

2000 and 2100. When the expanded implant 2210 is in its expanded configuration, at least a first portion of the tumoular structure 2215 may overlap a second portion of the tumole structure 2215, as shown in Figure 31. In this embodiment, the structure tuóular 2215 is formed in a 2D configuration and the tuóular structure is formed with a porosity mesh larger than the 2000 and 2100 medical devices. For example, the 2215 tuóular structure can be formed with a 3 mm mesh.

Figures 32-33 illustrate a portion of another embodiment of a medical device. The medical device 2400 may include the same or similar features and functions as described above by previous modalities. The medical device 2400 includes an expanded implant 2410 and may include an insertion portion or a member (not shown in Figures 32-33). The expanded implant 2410 can be moved between a collapsed configuration as shown in Figure 32 and an expanded configuration as shown in Figure 33.

In this embodiment, the expanded implant 2410 includes a first portion 2420 formed with a porous mesh tape type herara and includes petal-like portions 2425, and a second portion 2430 in the form of a rounded or tuóular heron 2415 formed by a similar porous mesh to the tubular strands described above, for example, with respect to Figures 28-30. The tubular strand 2415 can be heat formed as with the 2D or 3D configuration. In some embodiments, the tubular strand 2415 can be braided.

When the expandable implant 2410 is in its expanded configuration, at least a portion of the first portion 2420 (eg, petal-like portions 2425) can overlap the tubular strand 2415 of the second portion 2430. At least a portion of the expandable implant 2410 is configured to be placed on an aneurysm neck when the expandable implant 2410 is in the expanded configuration. The petal-like portions 2425 and the tubular strand 2415 each can be a variety of different sizes (e.g., diameters), such that when the expandable implant 2410 moves to its expanded configuration, the petal-like portions 2425 of the second portion 2410 they define an inner region and the tubular strand 2415 of the first portion 2420 substantially fills the inner region of the second portion 2430. Thus, tubular strand 2415 can be used as a filler to substantially fill a volume of an aneurysm as described above for expandable implants 2010 and 2110.

The first portion 2420 and the second portion 2430 may be coupled together, for example, with marker bands at the end portions of the first portion 242 0 and the second portion 243 0 or at other locations along a length of each of the first portion 2420 and the second portion 2430. The first portion 2420 and the second portion 2430 may have the same or substantially the same length or may have different lengths. For example, in some embodiments, the second portion 2430 may be longer than the first portion and vice versa.

The expandable implant 2410 also includes a first radiopaque marker band 2442 disposed at a first end 2412 of the expandable member and a second radiopaque marker band 2444 disposed at a second end 2414 of the expandable implant 2410 as shown in Figure 35, which is a schematic illustration of the expandable implant 2410. As shown in Figure 34, which is a schematic illustration of the expandable implant 2410, the expandable member 2410 also includes a connecting member 2452 that can be used to couple the expandable member to a separation device as described in more detail below. .

Figures 35-37 are each a schematic illustration of an insertion device that can be used to insert and deploy an implant, such as an expandable implant as described herein, at a desired location within a patient's body (e.g., within an aneurysm). An insertion device 2554 can be used in conjunction with a cannula, such as, for example, cannula 104 described herein. For example, the insertion device 2254 may be used in place of the insertion portion 102 described herein and may be releasably coupled or detached from an implant as described in more detail below.

The insertion device 2554 includes a first elongate member 2556 defining a lumen 2557 through which a second elongate member 2558 can be disposed movably. A marker band 2564 is coupled to a distal end portion of the first elongate member 2556. An expandable coupling member 2562 is also coupled to the distal end portion of the first elongate member 2556, for example, by adhesive coupling to a portion of the expandable coupling member 2562 between the band of the marker 2564 and an outer wall of the first elongate member 2556. The expandable coupling member 2562 may be of various lengths and may in some embodiments have a length, for example, of about 1-2 mm. The expandable coupling member

2562 it can be formed, for example, with a mesh material and / or a braided material.

The second elongate member 2558 may be, for example, a base wire and includes a balloon member 2560 (also referred to as a coupling member) disposed at a distal end of the second elongate member 2558. The second elongate member 2558 can be moved between a first position in which the balloon member 2560 is disposed outside the expandable coupling member 2562 as shown in Figures 35 and 37, and a second position in which the balloon member 2560 is disposed within an interior region defined by the expandable coupling member 2562 as shown in Figure 36. Although the ball member 2560 appears circularly formed, in alternative embodiments, the ball member 2560 may be other shapes, such as, for example, oval, elliptical, square, rectangular, triangular or other desired shape (as shown in a view side).

To insert and implant an expandable implant (for example, an expandable implant as described herein) into a patient's body, a proximal end portion of the expandable implant can be coupled to a distal end portion of the insertion device 2554.

Specifically, as shown in Figure 35, an expandable implant 2510 (also known as an implant) can

<td colspan="2">include a band</td><td colspan="3">external marker 2543</td><td colspan="3">and a band of</td>

<td>marker</td><td>internal</td><td> 2541</td><td>each coupled</td><td>to</td><td>a</td><td>portion</td><td>from</td>

<td>extreme</td><td>proximal</td><td> 2512</td><td colspan="2">of implant 2510.</td><td>The</td><td>band</td><td>of the</td>

<td>marker</td><td>external</td><td> 2543</td><td>can be used</td><td colspan="2">for</td><td>to hold</td><td>the</td>

<td>implant</td><td>2510, and</td><td colspan="2">the marker band</td><td colspan="2">internal</td><td colspan="2">2,554 can</td>

disposed within the outer marker band 2543. The inner marker band 2541 may provide a channel through which a portion of the distal end of the insertion device 2554, including the expandable coupling member 2562 and the balloon member 2560, can be inserted The second elongate member 2558 is then polished proximally (in a direction of the arrow A in Figure 36) causing the balloon member 2 560 to deform into the expandable coupling member 2562 as shown in Figure 36. For example, the expandable coupling member 2562 may move between the collapsed or relaxed configuration as shown in Figure 35 to an expanded configuration as shown in Figure 3 6 in which the expanded coupling member 2562 is flexed outward or expands as balloon member 2560 moves proximally in expandable coupling member 2562. A locking mechanism (not shown) can be used to lock the second elongate member 2558 in position relative to the first elongated member 2556. For example, a handle (not shown) can be coupled to the second elongate member 2558 and may include a mechanism lock that can block the second elongate member 2558 in the position shown in Figure 36. With the expanded expandable coupling member 2562 as shown in Figure 36, the implant 2510 is held coupled to the insertion device 2554.

With the insertion device 2554 coupled to the implant 2510, a distal end portion (not shown) of the implant 2510 can be inserted into, for example, an insertion cannula or catheter (not shown) (e.g., cannula 102 described above), and the insertion cannula can be used to insert implant 2510 into a blood vessel in a similar manner as described above with respect to Figures 1 and 2. For example, the implant 2510 with the insertion device 2554 coupled thereto can be inserted into the insertion cannula such that the implant 2510 moves in a collapsed configuration. The insertion cannula can then be inserted into a patient's blood vessel to deliver the 2510 implant to a desired location (for example, an aneurysm) within the patient. At the desired location, implant 2510 can be moved from a distal end of the cannula and moved to its expanded configuration as described above. After implant 2510 has been deployed, implant 2510 can be separated from insertion device 2554. Specifically, to disconnect the insertion device 2554 from the implant 2510, the second elongate member 2558 is unlocked and moved distally (in a direction of the arrow B shown in Figure 37) such that the ball member 2560 moves distally out of the member expandable coupling 2562 allowing the expandable coupling member 2562 to return to its collapsed or relaxed configuration as shown in Figure 37. The insertion device 2554 can then be removed by pulling the insertion device 2554 proximally (in an arrow direction A in Fig. 37).

Figure 38 is a schematic illustration of another embodiment of an insertion device that can be used to insert and deploy an implant, such as an expandable implant as described herein. An insertion device 2654 can be used in conjunction with a cannula and releasably or detachably coupled to an implant 2610, as described above for insertion device 2554.

The insertion device 2654 includes a first elongate member 2656 defining a lumen 2657 through a second elongate member 2658 that can be movably arranged. A coupling element 2666 is coupled to a distal end portion of the first elongate member 2656, for example, by attaching a portion of the coupling element 2666 to an inner wall of the first elongate member 2656. The coupling element 2666 may include, for example, a length of suture material, and may be of various lengths. For example, the coupling element 2666 may in some embodiments have a length of approximately 1-2 mm. The first elongate member 2656 may also include a marker band (not shown) similar to the marker band 25 that can be coupled to a distal end portion of the first elongate member 2656.

The second elongate member includes a balloon member 2660 disposed at a distal end of the second elongate member 2658 and can be moved between a first position in which the balloon member 2660 is disposed at a distance from the coupling element 2666 (for example , in a distal position of the coupling element 2666) and a second position in which the balloon member 2660 is arranged in contact with the coupling element 2666. For example, when the second elongate member 2658 is in its second position, the balloon member 2660 is disposed at a location along a length of the coupling element 2666 and contacts the coupling element 2666 such that a Interference adjustment is created between the ball member 2660 and the coupling element 2666 as shown in Figure 38.

Inserting and deploying an expandable implant, such as the expandable implant 2610 shown in Figure 38 into a patient's body, a proximal end portion of the expandable implant 2610 (also known as an implant) can be coupled to a distal end portion of insertion device 2654. Specifically, implant 2610 may include an outer marker band 2643 and an inner marker band 2641 each coupled to a proximal end portion of implant 2610. With the prior embodiment, the outer marker band 2643 can be used to support the implant 2610 and the inner marker band 2641 can be disposed within the outer marker band 2643 and provide a channel 2647 through which the distal end portion of the insertion device 2654 can be inserted.

With the second elongate member 2658 in its first position (i.e., with the ball member 2660 arranged at a distance from the coupling element 2666) and the coupling element 2666 in its first configuration, the ball member 2660 and the element Coupling 2666 are inserted through the internal marker band 2641 and disposed within the implant. The second elongated member 2658 is then pulled proximally (in the direction of the arrow A in Figure 38) such that the second elongated member 2658 moves to its second position (with the ball member 2660 which contacts the element coupling 2666) and coupling element 2666 moves to a second configuration as shown in Figure 38. When the second elongate member 2658 is in its second position and the coupling element 2666 in its second configuration an interference fit is created between the ball member 2660 and the coupling element 2666. This interference adjustment keeps the implant 2610 at

100 insertion device 2654. As described above for the previous embodiment, a locking mechanism (not shown) can be used to lock the second elongate member 2658 in position relative to the first elongate member 2656. For example, a handle 2655 coupled to the second elongate member 2658 and may include a locking mechanism (not shown) that can block the second elongated member 2658 in its second position, as shown in Figure 38.

With the insertion device 2654 coupled to the implant 2610, a portion of the distal end of the implant 2610 can be inserted into, for example, an insertion cannula (not shown) (e.g., cannula 102 described above), and the insertion cannula can used to insert implant 2610 into a blood vessel in a similar manner as described above with respect to figures 1 and 2 and figures 35-37. For example, the implant 2610 with the insertion device 2654 coupled thereto can push distally into the cannula to move the implant 2610 to a collapsed configuration. The cannula can then be inserted into a patient's blood vessel to deliver implant 2610 to a desired location within the patient, such as, for example, within

101 of an aneurysm, as described above. After the implant 2610 has been deployed (for example, moving out of a distal end of the cannula), the insertion device 2654 can be separated from the implant 2610 in a similar manner as described above for the previous modality. Specifically, to disconnect the insertion device 2654 from the implant 2610, the second elongate member 2658 is unlocked and moved distally (in the direction of the arrow B in Figure 38) such that the balloon member 2660 moves away (e.g., distally ) of the coupling element 2666, eliminating the interference fit between the ball member 2660 and the coupling element 2666. The insertion device 2654 can then be removed by pulling the insertion device 2654 proximally (in a direction of the arrow A in Figure 38).

Figure 3 9 illustrates one embodiment of an insertion device 2754 that is similar to the insertion device 2654. The insertion device 2754 may include the same or similar features and function of the same or similar insertion device 2654. For example, the insertion device 2754 can be used in the implantation of an implant as described

102 previously. The insertion device 2754 includes a first elongate member 2756 defining a lumen (not shown) through which a second elongate member 2758 (for example, a base wire) can be disposed movably. A coupling element 2766 is coupled to a distal end portion of the first elongate member 2756, for example, by attaching a portion of the coupling element 2766 to an inner wall of the first elongate member 2756. The coupling element 2766 may be of various lengths and may in some embodiments have a length, for example, of about 1-2 mm. The first elongate member 2756 may also include a marker band (not shown) coupled to a portion of the distal end of the first elongate member 2756.

A balloon member 2760 is disposed at a distal end of the second elongate member 2758 and the second elongate member 2758 can be moved between a first position in which the balloon member 2760 is disposed at a distance from the coupling element 2766 (by example, distal of the coupling element 2766) as shown in Figure 4 0 and a second position in which the ball member 27 60 is arranged in contact with the coupling element 2766 at a location along

103 a length of the coupling element 2762 such that an interference fit is created between the ball member 2760 and the coupling element 2766. The insertion device 2754 can be used to insert and deploy an implant and be separated from the implant thereof or similarly as described above for insertion device 2654.

Figure 40 is a schematic illustration of another embodiment of an insertion device that can be used to insert and deploy an implant, such as an expandable implant as described herein. An insertion device 2854 can be used in conjunction with a cannula and can be releasably or detachably coupled to an implant, as described above for example, for insertion device 2554.

The insertion device 2854 includes a first elongate member 2856 defining a lumen 2857 by which a second elongate member 2858 can be disposed movably. The first elongate member 2856 may also include a marker band (not shown) coupled to a portion of the distal end of the first elongate member 2756. An insertion balloon member 28 60 is disposed at a distal end of the second elongate member 2858. The device of

104 Insert 2854 can be coupled to an expanded 2810 implant similar to or equal to the expansion implants described herein. The 2810 expanded implant includes a marker 4242 and a connector member 2852 coupled to the marker 2842. The connector member 2852 includes a wire 2868 coupled to the marker 2842 and / or the implant 2 810 and a bone member 2870 implant coupled to (or formed integrally or monolithically with) the alamóre 2868. The wire 2 86 8 and implant bore member 28 70 can collectively have a length L which in some embodiments can be, for example, 1.5 mm. Although not discussed in detail above, the connector members 1652, 1952, 2352 and 2452 described above for previous modalities of an expanded implant may include the same or similar characteristics and functions as connector 2852.

To insert and deploy the 2810 expanded implant into a patient's body, the expanded 2810 implant is first coupled to the insertion device 2854. Specifically, the second elongated member 2858 moves distally (in a direction of arrow B in Figure 40 ) such that the insertion balloon member 2860 is disposed outside a distal end of the first elongate member 2856.

105

The implant balloon member 2870 is then inserted into the distal end of the first elongate member 2856 as shown in Figure 40. The second elongate member 2858 is then moved proximally (in the direction of arrow A in Figure 40) such that the insertion balloon member 2860 blocks or catches the implant balloon member 2870 within the lumen 2857 of the first elongate member 2856 as shown in Figure 40. For example, each of the insertion balloon member 2860 and the implant balloon member 2870 may have a diameter greater than half the diameter of the lumen 2857 of the first elongate member 2856 such that when the implant balloon member 2870 is disposed within lumen 2857 and insertion balloon member 2860 moves proximally in lumen 2857, implant balloon member 2860 cannot be removed from lumen 2857.

With the implant balloon member 2870 trapped within the lumen 2857 of the first elongate member 2856, the expanded implant 2810 will support the insertion device 2854. As described above for the previous embodiment, a locking mechanism (not shown) can be used to lock the second elongated member 2658 in this position relative to the first elongated member

2856 With the 2854 insertion device coupled to the

106 expandable implant 2810, a distal end portion (not shown) of expandable implant 2810 can be inserted into, for example, an insertion cannula (not shown) (e.g., cannula 102 described above) and the insertion cannula can be used to insert implant 2810 in a blood vessel in a similar manner as described above with respect to previous modalities. After the expandable implant 2810 has been deployed, the insertion device 2854 can be separated from the expandable implant 2810 in a similar manner as described above for the previous modality. Specifically, to separate the insertion device 2854 from the expandable implant 2810, the second elongate member 2858 is unlocked and moved distally (in the direction of arrow B) such that the insertion balloon member 2860 moves distally out of the first elongate member 2856, do not catch the implant balloon member 2870. The insertion device 2854 can then be removed by pulling the first elongate member 2856 and the second elongate member 2858 proximally.

Figure 41 is a flow chart illustrating a method of implementing an expandable implant within an aneurysm by means of an insertion device as

107 described in this document. The method includes in 2982, coupling a distal end portion of an insertion device to a proximal end portion of an expandable implant. For example, the insertion device may be an insertion device as described herein and the expandable implant may be an expandable implant as described herein. The insertion device may include a first elongate member defining a lumen and a second movable elongate member disposed at least partially within the lumen of the first elongate member. The coupling may include moving the second elongate member proximally in relation to the first elongated member such that a first coupling member at a distal end of the second elongated member couples a second coupling member at least one of the first elongated member or the expandable implant and ensures a portion of the expandable implant for the insertion device. In some embodiments, the second coupling member may be arranged in the first elongated member, and the movement of the second elongate member proximally in relation to the first elongated member causes the second coupling member to move from a collapsed configuration to an expanded configuration . In some modalities, the second

108 coupling member is disposed in the expandable implant, and before moving the second elongate member proximally, the second coupling member is inserted through a distal end of the first elongated member such that the second coupling member is disposed within the lumen of the first elongated member

In 2984, the expandable implant can be inserted into a patient's blood vessel while the expandable implant is in a collapsed configuration and coupled to the insertion device. For example, the expandable implant can be moved to a collapsed configuration by means of a cannula as described herein. In 2986, the expandable implant can be deployed within an aneurysm such that the expandable implant moves to an expanded configuration within the aneurysm. For example, the expandable implant can be moved out of the cannula such that it can be moved to its expanded configuration. In 2988, the insertion device can be decoupled from the expandable implant, and in 2990, the insertion device can be removed from the patient's blood vessels.

Figures 42 and 43 illustrate a portion of another embodiment of a medical device. The medical device

109

3000 It may include the same or similar features and functions described above by previous modalities. For example, medical device 3000 includes an expandable implant 3010 and an insertion portion or member 3002. The expandable implant 3010 can be moved between a collapsed configuration, as shown in Figure 4 and an expanded configuration, as shown in figure 42.

The expandable implant 3010 includes a porous mesh tape type thread that includes a first portion 3020 and a second portion 3030 formed as a single component. In this embodiment, when the expandable implant 3010 is in the expanded configuration, the second portion 3030 forms a balloon-like structure that defines an inner region 3036 and the second portion 3020 can be deployed within the inner region 3036. Specifically, during the implementation of the medical device 3000, the second portion 3030 can be deployed first such that it can be extended to the balloon-shaped structure within an aneurysm, and then the first portion 3020 can be deployed within the interior region 3036 to fill substantially the second portion 3030 as shown in Figure 42.

Figures 44-46 illustrate a portion of another embodiment of a medical device. The medical device

110

3100 It may include the same or similar features and functions as described above by previous modalities. For example, the medical device 3100 includes an expandable implant 3110 and an insertion portion or member 3102. The expandable implant 3110 can be moved between a collapsed configuration, as shown in Figure 45 and an expanded configuration, as shown in the figure 44.

The expandable implant 3110 is an example of a multilayer implant that includes a porous mesh tape type thread that includes a first portion 3115, a second portion 3120 and a third portion 3130 formed with a single mesh component. Such a modality may be desirable in that the implant can fit in a small delivery catheter, but may have high flow interruption by having more than two layers of material, and forming the layers in vivo. For example, in this embodiment, when the expandable implant 3110 is in the expanded configuration, the second portion 3120 may expand within the third portion 3130 and the first portion may expand within the second portion 3120. Specifically, during implementation within an aneurysm A, as shown in Figure 46, the medical device 3100 can first be inserted into a catheter 3104 such that the expandable implant

111

3110 It moves to its collapsed configuration. At the implantation site, the expandable implant 3110 can move out of the delivery catheter 3104 and deploy into an aneurysm. During implementation, the third portion 3130 may be deployed first, then the second portion 3120 may be deployed within an interior region defined by the third portion 3130, and then the first portion 3115 may be deployed within an interior region defined by the second portion 3120 Figure 46 illustrates the expandable implant 3110 with the third portion 3130 and the second portion 3120 deployed and the first portion 3115 still inside the catheter 3104. In some embodiments, the insertion portion 3102 may be coupled to the second portion 3120, such that during separation of the insertion portion 3102 (for example, after the expandable implant 3110 has been deployed within an aneurysm), the detachment can occur within the second portion to prevent any part of the implant from spreading or hanging inside the blood vessel V.

Figure 47 is a schematic illustration of another embodiment of an insertion device that can be used to insert and deploy an implant, such as an expandable implant as described herein. A device

112 Insert 3254 can be used in conjunction with a cannula or catheter, and can be releasably or detachably coupled to an implant, as described for previous embodiments.

The insertion device 3254 includes a first elongate member 3256 defining a lumen 3257 through which a second elongate member 3258 can be movably disposed. The first elongate member 3256 includes an internal marker band 3265 coupled to a portion of the distal end of the first elongate member 3256. In this embodiment, a distal end portion 3267 of the second elongate member 3258 is conical as shown in the figure

47 The insertion device 3254 also includes a handle 3255 disposed in a portion of the proximal end of the insertion device 3254.

The insertion device 3254 can be coupled to an expandable implant 3210 similar to, or equal to, the expandable implants described herein. The expandable implant 3210 includes a marker band 3 242 and a connector member 3252 coupled to the marker band 3242. The connector member 3252 may be similar to, or equal to, for example, the connector member 2852 described above.

For example, connector member 3252 includes a wire

113

3268 coupled to marker band 3242 and implant balloon member 3270 coupled to (or formed monolithically or integrally with) wire 3242.

To insert and deploy the expandable implant 3210 into the patient's body, the expandable implant 3210 is first coupled to the insertion device 3254. Specifically, in this embodiment, the second elongate member 3258 moves proximally (in the direction of arrow A in Figure 47) such that the conical distal end portion 3267 moves proximally within lumen 3257. This allows the implant balloon member 3270 to be inserted into lumen 3257 of the first elongate member 3256. The second elongate member 3258 then moves distally (in the direction of arrow B in Figure 47) such that the conical distal end portion 3267 of the second elongated member 3256 couples the implant balloon member 32 7 0 and catches or wedges to the balloon member of the implant 3270 within lumen 3257 of the first elongate member 3256 between the conical distal end portion 3267 and the inner marker band 3265.

With the implant balloon member 3270 locked or engaged within the lumen 3257 of the first elongate member 3256, the expandable implant 3210 will be carried out in the insertion device 3254. As described

114 previously by prior embodiments, a locking mechanism (not shown) coupled to the handle 3255 can be used to lock the second elongate member 3258 in this position relative to the first elongate member 3256. With the insertion device 3254 coupled to the expandable implant 3210, the expandable implant 3210 can be inserted into, for example, an insertion cannula (not shown) (eg, cannula 102 described above) to move the expandable implant 3210 to a configuration collapsed, and the insertion cannula can be used to

<td>insert</td><td>the implant in a</td><td>blood vessel of</td><td colspan="2">a way</td>

<td>Similary</td><td>as described</td><td>previously with</td><td>respect</td><td>to</td>

<td colspan="2">previous modalities</td><td></td><td></td><td></td>

<td></td><td>After the</td><td>expandable implant</td><td>3210 se</td><td>he has</td>

deployed within, for example, an aneurysm, the insertion device 3254 can be separated from the expandable implant 3210 and removed from the patient's body. Specifically, to separate the insertion device

3254 of the expandable implant 3210, in this embodiment, the second elongate member 3258 is unlocked from the handle

3255 and moves proximally (in the direction of arrow A) such that the conical distal end portion 3267 moves proximally and disengages the implant balloon member

115

3270 As the conical distal end portion 3267 moves proximally, the implant balloon member 3260 will be free to move out of the lumen 3257 of the first elongate member 3256. The insertion device 3254 can then be removed by pulling the insertion device 3254 proximally .

Figure 48 is a schematic illustration of another embodiment of an insertion device that can be used to insert and deploy an implant, such as an expandable implant as described herein. An insertion device 3354 may be used in conjunction with a cannula or catheter, and may be releasably or detachably coupled to an implant, as described by prior embodiments.

The insertion device 3354 includes a first elongate member 3356 defining a lumen 3357 through which a second elongate member 3358 can be movably disposed. The first elongate member 3358 includes a conical distal end portion 3392 as shown in Figure 48. In alternative embodiments, the first elongate member 3356 may have a constant diameter as with the previous modalities. The first elongate member 3356 also includes an outer marker band 3364 coupled to the

116 conical distal end portion 3392. An insertion balloon member 3360 is disposed at a distal end of the second elongate member 3358 as shown in the figure

48. The insertion device 3354 may also include a handle (not shown) disposed in a portion of the proximal end of the insertion device 3354 as described above by prior embodiments.

The insertion device 3354 can be coupled to an expanded implant 3310 similar to, or equal to, the expanded implants described herein. The expanded implant 3310 includes a marker band 3342 in a portion of the proximal end of the expanded implant 3310, and a connector member 3352 coupled to the band of the marker 3342. The connector member 3352 may be similar to, or the same as, for example. , the connecting member 2852 described above.

For example, the connector member 3352 includes a wire 3368 coupled to the marker band 3342 and implant balloon member 3370 coupled to (or formed monolithically or integrally with) the wire 3342. In this embodiment, as shown in Figure 48, the insertion balloon member

3360 it is larger than the implant balloon member 3370 and defines a groove 3371 in its lateral portion through which the wire 3368 of the connector member 3352 can

117 arranged when implant 3310 is coupled to insertion device 3354.

To insert and deploy the expandable implant 3310 into the patient's body, the expandable implant 3310 is first coupled to the insertion device 3354. Specifically, in this embodiment, the second elongate member 3358 moves distally (in a direction of arrow B in figure 48) such that the insertion balloon member 3360 moves distally out of lumen 3357 of the first elongate member 3356. The implant balloon member 3370 can be inserted into the lumen 3357 of the first elongate member 3356 and the wire 3368 can be placed or disposed within the groove 3371 of the insertion balloon member 3360. The second elongate member 3358 then moves proximally (in the direction of the arrow A in Fig. 48) such that the insertion balloon member 3360 and the implant balloon member 3370 moves in the lumen 3357 of the first elongated member 3356 and the insertion balloon member 3360 blocks or catches the insertion balloon member 3360 within lumen 3357 of the first elongate member 3356 as shown in Figure 48.

As implant balloon member 3370 catches within lumen 3357 of first elongate member 3356,

118 The expandable implant 3310 will be coupled with the insertion device 3354. As described above for previous embodiments, a locking mechanism (not shown) coupled to the handle (not shown) can be used to lock the second elongate member 3358 in this position in relation to with the first elongated member 3356. With the insertion device 3354 coupled to the expandable implant 3310, the expandable implant 3310 can be inserted into, for example, an insertion cannula (not shown) to move the expandable implant 3310 to a collapsed configuration. The insertion cannula can be used to insert the 3310 implant into a blood vessel in a similar manner as described above with respect to previous modalities.

After the expandable implant 3310 has been deployed within, for example, an aneurysm, the insertion device 3354 can be separated from the expandable implant 3310 and removed from the patient's body. Specifically, to separate the insertion device

3354 of the expandable implant 3310, in this embodiment, the second elongated member 3358 is unlocked from the handle

3355 and moved distally (in the direction of arrow B in figure 48) such that the insertion balloon member 3360 moves distally allowing the balloon member to

119 Implant 3370 is free to be moved out of lumen 3357 of the first elongated member 3356. The insertion device

3354 It can then be removed by pulling the insertion device 3354 proximally.

Figure 49 is a schematic illustration of another embodiment of an insertion device that can be used to insert and deploy an implant, such as an expandable implant as described herein. An insertion device 3454 can be used in conjunction with a cannula or catheter, and can be releasably or detachably coupled to an implant, as described by prior embodiments.

The insertion device 3454 includes a first elongate member 3456 defining a lumen 3457 through which a second elongate member 3458 can be movably disposed. The first elongate member 3458 includes a conical distal end portion 3492 as shown in Figure 49, but may, in alternative embodiments, have a constant diameter. The first elongate member 3456 also includes an outer marker band 3464 coupled to the conical distal end portion 3492. A plunger or stop member 34 94 is disposed at a distal end of the second elongate member 3458, as shown in Figure 49 . The

120 Insertion device 3454 may also include a handle (not shown) disposed in a portion of the proximal end of insertion device 3454 as described above by prior embodiments.

The insertion device 3454 can be coupled to an expandable implant 3410 similar to, or equal to, the expandable implants described herein. The expandable implant 3410 includes a marker band 3442 at a portion of the proximal end of the expandable implant 3410, and a connector member 3452 coupled to the marker band 3442. The connecting member 3452 may be similar to, or equal, for example, to the connecting member 2852 described above and includes a wire 3468 coupled to the marker band 3442 and implant balloon member 3470 coupled to (or formed monolithically or integrally with) the wire 3442.

To insert and deploy the expandable implant 3410 into the patient's body, the expandable implant 3410 is first coupled to the insertion device 3454. Specifically, in this embodiment, the second elongate member 3458 moves distally (in a direction of arrow B in figure 49) such that the insertion plunger member 3494 moves distally out of the lumen 3457 of the first elongate member 3456. The implant balloon member 3470 can

121 then inserted into lumen 3457 of the first elongate member 3456. The second elongate member 3458 then moves proximally (in the direction of arrow A in Figure 49) such that the piston member 3494 blocks or catches the insertion ball member 3460 within lumen 3457 of the first elongate member 3456 as shown in the figure

49.

With the implant balloon member 3470 trapped within lumen 3457 of the first elongate member 3456, a locking mechanism (not shown) coupled to the handle (not shown) can be used to lock the second elongated member 3458 in this position relative to the first elongate member 3456. With the insertion device 3454 coupled to the expandable implant 3410, the expandable implant 3410 can be inserted into, for example, an insertion cannula (not shown) to move the expandable implant 3410 to a collapsed configuration. The insertion cannula can be used to insert the 3410 implant into a blood vessel in a similar manner as described above with respect to previous modalities.

After the expandable implant 3410 has been deployed within, for example, an aneurysm, the insertion device 3454 can be separated from the implant

122 Expandable 3410 and extracted from the patient's body.

Specifically, to separate the insertion device

3454 of the expandable implant 3410, in this embodiment, the second elongate member 3458 is unlocked by the handle and moved distally (in the direction of the arrow B in figure

49) such that the piston member 34 94 moves distally allowing the implant balloon member 3470 to be free to be moved out of the lumen 3457 of the first elongate member 3456. The insertion device 3454 can then be moved by pulling the 3454 insertion device proximally.

Figure 50 is a schematic illustration of another embodiment of an insertion device that can be used to insert and deploy an implant, such as an expandable implant 15 as described herein. An insertion device 3554 may be used in conjunction with a cannula or catheter, and may be releasably or detachably coupled to an implant, as described above by prior embodiments.

The insertion device 3554 includes a first elongate member 3556 defining a lumen 3557 through which a second elongate member 3558 can be movably disposed. The first elongate member 3558 includes a

123 Conical distal end portion 3592 as shown in Figure 50, but may in alternative embodiments, have a constant diameter. The first elongate member 3556 also includes an outer marker band 3564 coupled to the conical distal end portion 3592. An insertion balloon member 3560 is disposed at a distal end of the second elongate member 3558, as shown in Figure 50. In this embodiment, the insertion device 3554 also includes an elongate locking member 3596. The locking member 3596 can have a constant diameter or outer perimeter along its length or can be conical. For example, a portion of the distal end of the blocking member 3596 may have a smaller diameter than a portion of the proximal end of the blocking member 3596. The blocking member 3596 is used in conjunction with the insertion balloon member 3560 to block the implant balloon member 3570 to the insertion device 3554 as described in more detail below. The insertion device 3554 may also include a handle (not shown) in a portion of the proximal end of the insertion device 3554 as described above in previous embodiments.

As with the previous modalities, the device

124 Insert 3554 can be coupled to an expandable implant 3510 similar to, or equal to, the expandable implants described herein. The expandable implant 3510 includes a marker band 354 2 in a portion of the proximal end, and a connector member 3552 coupled to the marker band 3542. The connecting member 3552 may be similar to, or equal to, for example, the connecting members described above and include a wire 3568 coupled to the marker band 3542 and an implant balloon member 3570 coupled to (or formed monolithically or integrally formed with ) wire 3542.

To insert and deploy the expandable implant 3510 into the patient's body, the expandable implant 3510 is coupled to the insertion device 3554. Specifically, in this embodiment, the locking member 3596 moves proximally (in the direction of the arrow A in the Figure 50) such that a portion of the distal end of the blocking member 3596 is disposed proximally of the insertion balloon member 3560. This allows the implant balloon member 3570 to be inserted into the lumen 3557 of the first elongate member 3556. In other words, the insertion balloon member 3560 and the implant balloon member 3570 can each be sized (for example, each one can have a diameter) such that when the member of

125 Locking 3594 moves proximally, decoupling the insertion balloon member 3560, the implant balloon member 3570 can be moved in and out of the lumen 3557 while the implant balloon member 3570 is disposed within the lumen 3557. After the implant balloon member 3570 is placed within the lumen 3557 of the first elongate member 3556, it can move the blocking member 3596 distally (in a direction of the arrow B in Figure 50) such that the distal end portion of the member Lock 3596 is fitted between an inner wall of the first elongate member 3556 and the insertion balloon member 3560. With the locking member 3596 in this position, the implant balloon member 3570 is held or trapped within the lumen 3557 of the first elongate member 3556 as shown in the figure

50.

With the implant balloon member 3570 trapped within the lumen 3557 of the first elongate member 3556, a locking mechanism (not shown) coupled to the handle (not shown) can be used to lock the locking member 3596 in position relative to the first elongated member 3556. With the insertion device 3554 coupled to the expanded implant 3510, the expanded implant 3510 can be inserted into, for example, an insertion cannula (not

126 shown) to move the expandable implant 3510 to a collapsed configuration. The insertion cannula can be used to insert the 3510 implant into a blood vessel in a similar manner as described above with respect to previous modalities.

After the expandable implant 3510 has been deployed within, for example, an aneurysm, the insertion device 3554 can be separated from the expandable implant 3510 and removed from the patient's body. Specifically, to separate the insertion device 3554 from the expandable implant 3510, in this embodiment, the locking member 3596 is unlocked by the handle and moved proximally (in the direction of arrow A in Figure 50) such that the distal end portion of the blocking member 3596 moves proximally of the insertion balloon member 3560 which allows the implant balloon member 3570 to be free to be moved out of the lumen 3557 of the first elongate member 3556. The insertion device 3554 can then be removed by pulling the insertion device 3554 proximally.

Figure 51 is a schematic illustration of another embodiment of an insertion device that can be used to insert and deploy an implant, such as a

127 Expandable implant as described in this document. An insertion device 3654 may be used in conjunction with a cannula or catheter, and may be releasably or detachably coupled to an expandable implant, as described by prior embodiments.

The insertion device 3654 includes a first elongate member 3656 defining a lumen 3657 through which a second elongate member 3658 can be movably disposed. The first elongate member 3656 also includes an extension member 3672 a plug 3674 disposed within the lumen 3657. The extension member 3672 defines an opening or window 3673. An insertion balloon member 3660 is disposed at a distal end of the second elongate member 3658 and butt member 3694 disposed at a distance spaced proximally from the insertion balloon member 3660, as shown in Figure 51. The insertion device 3654 it can also include a handle 3655 in a portion of the proximal end of the insertion device 3654 as described above by prior embodiments.

As with the previous embodiments, the insertion device 3654 can be coupled to an expandable implant 3610 similar to, or equal to, the described expandable implants

128 here. In this embodiment, the expandable implant 3610 includes a marker band 3642 at a portion of the proximal end, and a connector member 3652 coupled to the band of the marker 3642. The connector member 3652 may be similar to, or equal, for example, to the connecting members described above and include a wire 3668 coupled to the marker band 3642 and implant balloon member 3670 coupled to (or formed monolithically or integrally with) the wire 3642.

The expandable implant 3610 may also include a guide portion 3676 (also known herein as a guide member) disposed on a portion of the distal end of the expandable implant 3610. The guide portion 3676 may be formed with, for example, a memory material such as nitinol, such that the guide portion 3676 has a skewed curved shape when not limited to, for example, a cannula. The curved shape of the guide portion 3676 can reduce or eliminate possible sharp edges when the expandable implant 3610 is inserted into a vasculature of a patient. The guide portion 3676 may be a separate component coupled to the expandable implant 3610 or may be formed integrally or monolithically with the expandable implant 3610. In some embodiments, the guide portion 3676

129 it can be processed to the distal end portion of the expandable implant 3610. In some embodiments, the guide portion 3676 can be integrally or monolithically formed with a radiopaque wire or wire member (as described for example with respect to Figures 23 and 24) which extends through the expandable implant 3610. For example, said wire member may extend beyond the distal end portion of the expandable implant 3610 and form the guide portion 3676.

To insert and deploy the expandable implant 3610 into the patient's body, the expandable implant 3610 is coupled to the insertion device 3654. Specifically, in this embodiment, the second elongate member 3658 moves proximally (in a direction of the arrow A in the Figure 51) such that the insertion balloon member 3660 is disposed proximally of the window 3670 defined in the extension member 3672. This allows the implant balloon member 3 67 0 to be inserted through an opening (not shown) defined at a distal end of the first elongate member 3656 and in lumen 3657 of the first elongate member 3656. For example, the member of insert ball 3 660 and the implant balloon member 3 6 70 can each be sized (for example, each

130 it can have a diameter) such that collectively the insertion balloon member 3660 and the implant balloon member 3670 have a size (for example diameter) greater than a diameter of the lumen 3657. Thus, the insertion balloon member 3660 is moved to a position to provide free space or space for implant balloon member 3670 to be inserted into lumen 3657 and arranged near or adjacent to window 3670. The second elongate member 3658 can then move distally (in an arrow direction B in Figure 51) such that the insert ball member 3 660 moves distally and comes into contact with the implant balloon member 3670 and moves or pushes the implant balloon member 3 67 0 at least partially through the window 3673. The second elongate member 3658 moves distally until the insertion balloon member 3660 moves to a distal position of the implant balloon members 3670, allowing the implant balloon member 3 670 to back off in lumen 3657. In addition, as the second elongated member 3658 moves distally, the stop member 3 694 in the second elongated member 3658 can make contact with the cap 3674 to limit the movement of the second elongated member 3658 in the distal direction. With insertion ball member

131

3660 and the implant balloon member 3670 interlocked within lumen 3657 and the implant balloon member 3670 now placed proximal to the insertion balloon member

3660, the implant 3610 remains attached to the insertion device 3654.

With the implant balloon member 3670 held or trapped within the lumen 3657 of the first elongate member 3656, a locking mechanism (not shown) coupled to the handle 3655 can be used to lock the second elongated member 3658 in this position relative to the first elongated member 3656. With the insertion device 3654 coupled to the expanded implant 3610, the expanded implant 3610 can be inserted into the lumen of an insertion cannula 3604 to move the expanded implant 3610 to a collapsed configuration. The insertion cannula 3604 can be used to insert the implant 3610 into a blood vessel in a similar manner as described above with respect to previous embodiments.

After the 3610 expanded implant has been deployed into, for example, an aneurysm, the insertion device 3654 can be separated from the 3610 expanded implant and removed from the patient's body. Specifically, to separate the insertion device

132

3654 of the expandable implant 3610, the second elongate member 3558 moves proximally such that the insertion balloon member 3660 makes contact with the implant balloon member 3670 and the implant balloon member 3670 moves at least partially within the window 3673 The second elongate member 3658 moves proximally until the insertion balloon member 3 6 60 is disposed proximally of the window 3673 such that the implant balloon member 3670 can retract into the lumen 3657 of the first elongate member 3656. The plug 3674 You can limit the movement of the second elongated member 3658 by attaching the insertion ball member 3660. With the implant balloon member 3670 disposed distally of the insertion balloon member 3660, the implant 3610 can be released from the insertion device 3654. The insertion device 3654 can then be removed by pulling the insertion device 3654 proximally.

Figure 52 is a schematic illustration of another embodiment of an insertion device that can be used to insert and deploy an implant, such as an expandable implant as described herein. An insertion device 3754 may be used in conjunction with a cannula or catheter, and may be releasably or

133 detachably coupled to an implant, as described for previous modalities.

The insertion device 3754 includes a first elongate member 3756 defining a lumen 3757 through which a second elongate member 3758 can be movably disposed. The first elongate member 3756 includes an inner cap 3774 coupled to a portion of the distal end of the first elongate member 3756 within the lumen 3757. The inner cap 3774 defines a channel 3775 that can be used to trap or hold an implant 3710 to the insertion device 3654 as described in more detail below.

The second elongate member 3758 includes a distal end portion 3767 that may be smaller in size (eg, diameter) than a remaining portion 3777 of the second elongate member 3758. In some embodiments, the distal end portion 3767 may be conical. In some embodiments, the distal end portion 3767 may be a separate component coupled to the remaining portion 3777 of the second elongate member 3758. The second elongate member 3758 can be formed, for example, with a shape memory material and define a curve or curves along its length. The 3754 insertion device also includes

134 a handle 3755 disposed in a portion of the proximal end of the insertion device 3754.

The insertion device 3754 can be coupled to an expandable implant 3710 similar to, or equal to, the expandable implants described herein. The expandable implant 3710 includes a marker band 3742 and a connector member 3752 coupled to the marker band 3742. The connector member 3752 may be similar to, or equal to, for example, the connector members described above by prior embodiments. For example, the connecting member 3752 includes a wire 3768 coupled to the marker band 3742 and an implant balloon member 3770 next to (or formed monolithically or integrally with) the wire 3768.

To insert and deploy the expandable implant 3710 into the patient's body, the expandable implant 3710 is first coupled to the insertion device 3754. Specifically, in this embodiment, the second elongate member 3758 moves proximally (in a direction of arrow A in Figure 52) such that the distal end portion 3767 moves proximally within lumen 3757. This allows the implant balloon member 377 0 to be inserted into lumen 3757 of the first elongated member 3756. The second elongate member 3758 then moves

135 distally (in the direction of arrow B in figure 52) such that the distal end portion 3767 of the second elongate member 3756 is coupled and urges the implant balloon member 3770 at least partially within the channel 3775, trapping or wedging the implant balloon member 3770 within lumen 3757 of the first elongate member 3756 between the conical distal end portion 3 767 and the inner cap 3774.

With the implant balloon member 3770 embedded or trapped within the lumen 3757 of the first elongate member 3756, the expandable implant 3710 will be held in the insertion device 3754. As described above in previous embodiments, a locking mechanism (not shown) coupled to the handle 3755 can be used to lock the second elongate member 3758 in this position relative to the first elongate member 3756. With the insertion device 3754 coupled to the expandable implant 3710, the expandable implant 3710 can be inserted into, for example, an insertion cannula (not shown) to move the expandable implant 3710 to a collapsed configuration, and the insertion cannula can be used for Inserting the 3710 implant into a blood vessel in a similar manner as described above with respect to previous modalities.

136

After the expandable implant 3710 has been deployed within, for example, an aneurysm, the insertion device 3754 can be separated from the expandable implant 3710 and removed from the patient's body. Specifically, to separate the insertion device 3754 from the expandable implant 3710, the second elongate member 3758 is unlocked from the handle 3755 and moves proximally (in the direction of arrow A) such that the conical distal end portion 3767 moves proximally and decouple the 3770 implant balloon member. With the conical distal end portion 3767 moved proximally, the implant balloon member 3770 will be free to move out of the lumen 3757 of the first elongate member 3756. The insertion device 3754 can then be removed by pulling the insertion device 3754 proximally.

Figure 53 is a schematic illustration of another embodiment of an insertion device that can be used to insert and deploy an implant, such as an expandable implant as described herein. An insertion device 3854 may be used in conjunction with a cannula or catheter, and may be releasably or detachably coupled to an implant, as described by prior embodiments.

137

The insertion device 3854 includes a first elongate member 3856 defining a lumen 3857 through which a second elongate member 3858 can be movably arranged. The insertion device 3854 may also include a handle (not shown) disposed in a portion of the proximal end of the insertion device 3854 as described above by prior embodiments. The first elongate member 3856 includes an inner plug 3874 coupled to a portion of the distal end of the first elongated member 3856. The inner plug 3874 can be, for example, and the inner marker band as described by previous embodiments.

The second elongate member 3858 includes a distal end portion 3867 that can engage a portion of an expandable implant as described in more detail below. In some embodiments, the distal end portion 3867 may be conical. The second elongate member 3858 also includes a stop member 3894 and a coil member 3876. In some embodiments, the distal end portion 3867 may be a separate component coupled to the stop member 3894. In some embodiments, the distal end portion 3867 is integrally or monolithically formed with a remaining portion 3877 of the second elongate member 3858.

138

For example, the distal end portion and / or the remaining portion 3877 may extend through a lumen (not shown) of the stop member 3 8 94 and a lumen (not shown) of the coil member 3876, and extends to a proximal end of the insertion device 3854.

The insertion device 3854 can be coupled to an expandable implant 3810 similar to, or equal to, the expandable implants described above. The expandable implant 3 810 includes a marker band 3842 and a connector member 3852 coupled to the marker band 3842. The connector member 3852 may be similar to or equal to, for example, the connector members described above. For example, the connecting member 3852 includes a wire 3868 coupled to the marker band 3842 and an implant balloon member 3870 coupled to (or formed monolithically or integrally with) the wire 3842.

To insert and deploy the expandable implant 3810 into the patient's body, the expandable implant 3810 is first coupled to the insertion device 3854. Specifically, in this embodiment, the second elongate member 3858 moves proximally (in an arrow direction A in Figure 53) such that the distal end portion 3867 moves proximally to the proximal position of the

139 inner cap 3874. This allows the implant balloon member 3 870 to be inserted through an opening at a distal end of the first elongated member 3856 and in the lumen 3857 of the first elongated member 3856. The second elongate member 3858 then moves distally (in the direction of the arrow B in Figure 53) such that the distal end portion 3867 of the elongated second member 3856 couples the implant balloon member 3870 and catches or wedges the member of Implant balloon 3870 within lumen 3857 of the first elongate member 3856 between the distal end portion 3867 and the inner cap 3874.

With the implant balloon member 3870 locked or fitted within the lumen 3857 of the first elongate member 3856, the expandable implant 3810 will be maintained in the insertion device 3854. As described above by prior embodiments, a locking mechanism (not shown) it can be attached to the handle and can be used to lock the second elongated member 3858 in this position relative to the first elongated member 3856. With the insertion device 3854 coupled to the expandable implant 3810, the expandable implant 3810 can be inserted into, for example, an insertion cannula (not shown) (for example, cannula 102 described above)

140 to move the expandable implant 3810 to a collapsed configuration, and the insertion cannula can be used to insert the implant 3810 into a blood vessel in a similar manner as described above with respect to previous modalities.

After the expandable implant 3810 has been deployed within, for example, an aneurysm, the insertion device 3854 can be separated from the expandable implant 3810 and removed from the patient's body. Specifically, to separate the insertion device 3854 from the expandable implant 3810, the second elongate member 3 858 is unlocked from the handle and moves proximally (in the direction of arrow A) such that the distal end portion 3867 moves proximally and is decouple the implant balloon member 3870. With the distal end portion 3867 moved proximally, the implant balloon member 3870 will be free to move out of the lumen 3857 of the first elongate member 3856. The insertion device 3854 can then be removed by pulling the insertion device 3854 proximally.

Figure 54 is a schematic illustration of another embodiment of an insertion device that can be used to insert and deploy an implant, such as an implant.

141 Expandable as described in this document. An insertion device 3954 can be used in conjunction with a cannula or catheter, and can be releasably or detachably coupled to an implant, as described by prior embodiments.

The insertion device 3954 includes a first elongated member 3956, a second elongated member 3958 and an outer retractable tube 3938. The first elongated member 3958 defines a lumen 3957 through which the second elongated member 3958 can be disposed movably and the retractable tube 3938 and the first elongate member 3956 collectively define a lumen 3939 such that the second elongate member 3958 can also be disposed movably.

The first elongate member 3956 defines a scraped or trimmed portion 3953 that extends between an intermediate portion 3959 of the first elongated member 3956 and a distal end portion 3972 of the first elongated member 3956. The outer retractable tube 3938 can be coupled to the first elongated member 3956 at least along a portion of the first elongate member 3956 defining the scraped portion 3953. The scraped portion 3953 can reduce the mass of the first elongated member 3 956 and allow the first elongated member 3 956 to be more flexible along

142 of the scraped portion. The outer shrink tube 3938 can be, for example, a material that shrinks is the heat to the outer surface of the first elongate member 3956 to provide an outer boundary or perimeter of the insertion device 3 954 along the scraped portion 3 953 of the first elongated member 3956. The outer retractable tube 3938 can be formed with a flexible material such that the portion of the first elongate member 3956, including the scraped portion 3953 and the outer retractable tube 3938 is flexible and can be maneuvered through the tortuous vasculature.

The distal end portion 3972 of the first elongate member 3956 defines a side window 3973 in fluid communication with a lumen 3937 defined by the distal end portion 3 972. One or more flange members 3 951 (three are shown in Figure 54) they are disposed in the first elongated member 3956 in spaced places along a length of the first elongated member 3956. The flange members 3951 can be, for example, semicircular or c-shaped that define an open portion or they can be circular or ring-shaped forming a closed loop. The flange members 3951 may be separate components coupled to the first elongate member 3956 or formed integrally or monolithically with the first

143 elongated member 3956. A sleeve member 3949 is coupled to one of the flange members 3951 and / or the first elongated member 3956. The sleeve member 3949 can, for example, be welded to the flange member 3951 and / or the first member elongated 3956. The sleeve member 3949 defines a lumen (not shown) through which the second elongated member 3958 can be disposed movably.

As shown in Fig. 54, the second elongated member 3958 can be movably disposed through lumen 3957, lumen 3939, a lumen 3933 of sleeve member 3949 and lumen 3937 of distal end portion 3972. A balloon member Insert 3960 is disposed at a distal end of the second elongate member 3958 and stop 3994 is coupled to the second elongate member 3958 proximally of the insertion balloon member 3960. In addition, a plug 3948 is coupled to the second elongate member 3958 at a spaced distance proximal to the stop 3994 and a radiopaque marker 3961 is coupled to the second elongated member 3958 proximal to the plug 3948. The stop 3994, the plug 3948 and the radiopaque marker 3961 can each, for example, weld to the second elongated member 3958. The insertion device 3954 may also include a handle (not shown) in a portion of the proximal end of the insertion device 3954 as described.

144 previously by previous modalities.

As with the above embodiments, the insertion device 3954 can be coupled to an expandable implant 3910 similar to, or equal to, the expandable implants described herein. In this embodiment, the expandable implant 3 910 includes a marker band 3 942 at a portion of the proximal end, and a connector member 3952 coupled to the marker band 3942. The connector member 3952 may be similar to, or equal to, for example, the connector members described above and include a wire 3968 coupled to the band of the marker 3942 and implant balloon member 3970 coupled to (or formed monolithically or integrally with) the wire 3942.

In use, to insert and deploy the expandable implant 3910 into the patient's body, the expandable implant 3910 is first coupled to the insertion device 3954. Specifically, in this embodiment, the second elongate member 3958 moves proximally (in a direction of the arrow A in Figure 54) such that the insertion balloon member 3960 is disposed proximally of the window 3973 defined by the distal end portion 3972 of the first elongate member 3956. This allows the implant balloon member 3970 to be inserted through an opening

145

3963 defined at a distal end of the first elongate member 3956 and at lumen 3937 of the distal end portion 3972 of the first elongated member 3956. For example, the insertion balloon member 3 96 0 and the implant balloon member 3970 can each be sized (for example, each can have a diameter) such that collectively the insertion balloon member 3 960 and the member of Implant balloon 3970 has a size (for example, a diameter) greater than a diameter of the lumen 33937. Thus, the insertion balloon member 3960 is moved to a proximal position of the window 3973 to provide free space or space for the implant balloon member 397 0 to be inserted into the lumen 3 937 and arranged near or adjacent to the window 3973 With the implant balloon member 3970 arranged near the window 3973, the second elongate member 3958 can then be moved distally (in an direction of the arrow B in Figure 54) such that the insertion balloon member 3960 moves distally and comes into contact with the implant balloon member 3 9 70 and the implant balloon member 3970 is moved or pushed at least partially through the window 3973. The stop 3994 provides rigidity to the distal portion of the second elongate member 3958 as the insertion balloon member 3960 moves distally.

146

The second elongate member 3958 moves distally until the insertion balloon member 3 960 moves to a distal position of the implant balloon member 3970, allowing the implant balloon member 3970 to back off at least partially within the lumen 3937 . In addition, as the second elongated member 3958 moves distally, the plug 3948 of the second elongated member 3958 can make contact with the sleeve member 3 94 9 to limit the movement of the second elongated member 3958 in the distal direction. With the insertion balloon member 3960 and the implant balloon member 3970 inter-locked within the lumen 3937 and the implant balloon member 3970 now positioned proximal to the insertion balloon members 3960, the implant 3910 remains attached to the device of insertion 3954.

With the implant balloon member 3970 held or trapped within the lumen 3937 of the distal end portion 3972, a locking mechanism (not shown) can be used to lock the second elongated member 3958 in this position relative to the first elongated member 3956. For example, a locking mechanism can be coupled to a handle (not shown), as described above by previous embodiments. With insert device 3954

147 coupled to the expandable implant 3910, the expandable implant 3910 can be inserted into the lumen of an insertion cannula (not shown) to move the expandable implant 3910 to a collapsed configuration. The insertion cannula can be used to insert the 3910 implant into a blood vessel in a similar manner as described above with respect to previous modalities.

After the expandable implant 3910 has been deployed within, for example, an aneurysm, the insertion device 3954 can be separated from the expandable implant 3910 and removed from the patient's body. Specifically, to separate the insertion device 3954 from the expandable implant 3910, the second elongated member 3958 moves proximally (in the direction of arrow A) such that the insertion balloon member 3960 makes contact with the implant balloon member 3970 and the implant balloon member 3970 is moved at least partially through the window 3973. The second elongate member 3958 moves proximally until the insertion balloon member 3960 is disposed proximally of the window 3973 such that the implant balloon member 3970 can retract into the lumen 3937 of the distal end portion 3972. The sleeve 3949 can limit movement ^{148 k&gt;}'·' · Proximal of the second elongated member 3958 when the insertion of the insertion balloon member 3960. For example, the insertion balloon member 3960 may have a diameter greater than an internal diameter of the sleeve member 3949. With the balloon member of implant 3970 disposed distally of insertion balloon members 3960, implant 3910 can be released from insertion device 3954. For example, the insertion device 3954 can be removed by pulling the insertion device 3954 proximally and as the insertion device 3954 moves proximally, the implant balloon member 3970 can move through the distal opening 3963 leaving the implant 3910 implanted inside the patient's body.

Figures 55 and 56 show another embodiment of an insertion device. An insertion device 4054 includes a first elongate member 4056, a second elongate member 4058 and an outer retractable tube 4038. The first elongate member 4058 defines a lumen (not shown) through which the second elongate member 4058 can be movably disposed and the retractable tube 4038 and the first elongate member 4056 collectively define a lumen (not shown) such that the second elongate member 4058 It can also be arranged movably. The insertion device 4054

149 it can be used in conjunction with a cannula or catheter, and it can be releasably or detachably coupled to an implant, as described by previous modalities.

The first elongate member 4056 defines a scraped or cut portion 4053 that extends between an intermediate portion 4059 of the first elongated member 4056 and a distal end portion 4072 of the first elongated member 4056. The first elongated member 4056 may also include additional portions of scraping or cutting (not shown). The outer retractable tube 4038 can be coupled to the first elongate member 4056 at least along a portion of the first elongate member 4056 defining the scraped portion 4053. The scraped portion 4053 can reduce the mass of the first elongate member 4056 and allows the First elongate member 4056 is more flexible along the scraped portion. The outer shrink tube 4038 may be, for example, a material that is hot scraped to the outer surface of the first elongate member 4056 to provide an outer boundary or perimeter of the insertion device 4054 along the scraped portion 4053 of the first member elongated 4056. The outer shrink tube 4038 can be formed with a flexible material such that the portion of the first elongate member 4056, including the portion

150 scraped 4053 and the outer retractable tube 4038 is flexible and can be maneuvered through the tortuous vasculature.

The distal end portion 4072 of the first elongate member 4056 defines a side window 4073 and a lumen (not shown) in fluid communication with the side window 4073. One or more flange members 4051 (only one flange member is shown in the figures 55 and 56) are disposed on the first elongated member 4056 in spaced places along a length of the first elongated member 4056. As shown in Figures 55 and 56, in this embodiment, the flange member 4051 is substantially c-shaped that defines an open portion. The flange member 4051 can be, for example, welded to the first elongate member 4056.

As shown in Figures 55 and 56, the second elongate member 4058 can be disposed movably through the lumen of the first elongate member 4056, the lumen collectively defined by the first elongate member 4056 and the outer retractable tube 4038 and the portion lumen distal end 4072. An insertion balloon member (not shown) is disposed at a distal end of the second elongate member 4 058 and a stop 4 094 is coupled to the second elongate member 4058 proximally of the insertion balloon member. How I know

151 shown in figures 55 and 56, in this embodiment, the stop 4094 includes a spring. In addition, a plug (not shown) and a radiopaque marker (not shown) can be attached to the second elongate member 4058 at a proximal spaced abutment distance 4094 as with the above embodiments and can provide the same function as described above for the device insertion 3954. The insertion device 4054 may also include a handle (not shown) disposed in a portion of the proximal end of the insertion device 4054 as described by the previous embodiments. The stop 4094, the plug and the radiopaque marker can each, for example, be welded to the second elongate member 4058.

As with the previous embodiments, the insertion device 4054 can be coupled to an expandable implant 4010 similar to, or equal to, the expandable implants described herein. The expandable implant 4010 includes a marker band 4042 in a portion of the proximal end, and a connector member 4052 coupled to the marker band 4042. The connecting member 4052 includes a wire 4068 coupled to the marker band 4042 and an implant balloon member 4070 (see Figure 56) coupled to (or formed monolithically or integrally with) the wire 4042. Figure 56 illustrates the member of 4070 implant balloon

152 inserted into the distal end portion 4072 of the first elongate member 4056 and disposed near the window 4073.

In use, the insertion device 4054 may operate the same or similar to the insertion device 3954 described above. For example, implant 4010 may be coupled to insertion device 4054 and locked in position by insertion balloon member in the same or similar manner as described above for insertion device 3954. Also, implant 4010 can be released from insertion device 4054 in the same or similar manner as described above for insertion device 3954.

Figure 57 illustrates another embodiment of a medical device that includes a guide portion or member disposed in a portion of the distal end of the expandable implant. The medical device 4100 includes an expandable implant 4110 that can be configured the same or similar to any of the modalities of an expandable implant described herein. For example, expandable implant 4110 can be deployed within an aneurysm of a patient, as described herein. As shown in Figure 57, a guide member 4176 is coupled to a portion of the distal end of the expandable implant 4110. In this embodiment, the

153 guide member 4176 is coupled to the distal end portion of the expandable implant 4110 with a press 4178. The guide member 4176 can be formed with, for example, a shape memory material such as nitinol, such that the guide member 4176 has a shape curved skewed when not limited inside, for example of a cannula 4105. Thus, the guide member 4176 can provide a smooth surface free of sharp edges when the expandable implant 4110 is inserted into a vasculature of a patient. The guide member 4176 may have a substantially linear configuration when limited within the cannula 4105, or a delivery device as described herein. Although not shown in Figure 57, medical device 4100 can be delivered into a patient's vasculature using a delivery device as described herein for other modalities.

Figures 58-60 illustrate a portion of a medical device 4200 according to one embodiment. The medical device 4200 may include the same or similar functions as described herein for other modalities. For example, medical device 4200 may include an expandable implant 4210 configured to move from the collapsed configuration (for example, for delivery through a blood vessel) to the configuration

154 expanded (for example, for deployment within an aneurysm) and an insertion member or device 4254 (see Figure 59) as described herein.

Similar to the expandable implant 1810, the expandable implant 4210 includes a porous mesh tape-like thread that includes one or more petal-like portions or sections 4225 along its length. In this embodiment, there are four petal portions 4225 included within an outer petal segment 4290 of the expandable implant 4210 and three petal portions 4225 included within an inner petal segment 4291 of the expandable implant 4210.

At least a portion of the porous mesh can be configured to be placed on a neck of an aneurysm when the expandable implant 4210 is in the expanded configuration. When the expandable implant 4210 is in its expanded configuration, the expandable implant 4210 has a three-dimensional shape (e.g., a substantially spherical shape) with a substantially continuous outer surface such that a portion (e.g., edges) of at least two of the Petal-like portions 4225 overlap each other as shown in Figure 59. For example, like the expandable implant 4210 that is deploying inside an aneurysm, the petal-like portions

155

...... .

4225 of the outer petal segment 4290 expands first and an outer layer is formed that covers the aneurysm. The petal-like portions 4224 of the inner petal segment 4291 then form a second spherical layer of material within the petal-like portions 4225 of the outer petal portion 4290 to provide a larger surface area to further promote thrombosis.

In this embodiment, a suture strand 4235 extends along the length of the expandable implant 4210 to provide reinforcement to the expandable implant 4210 and can also provide for a radiopaque coil to be disposed on at least a portion of the suture strand. 4235 to provide visibility of the expandable implant 4210 during, for example, fluoroscopy. As shown in Figures 58 and 59, the suture strand 4235 is disposed along a length of the expandable implant 4210 and through or within the petal-like portions 4225. The suture strand 4235 can be coupled to, for example, marker bands 4242 and 4244 arranged on a proximal end and a distal end, respectively, of the expandable implant 4210.

In this embodiment, the external petal segment 4290 and the internal petal segment 4291 can be formed

156 as components separated and coupled to each other by the suture thread 4235. This creates an articulation point or joint 4279 between the outer petal segment 4290 and the inner petal segment 4291. For example, the outer petal segment 4290 may include the marker band 4242 at a proximal end and a marker band 4294 at a distal end. The inner petal segment 4291 may include marker band 4244 at a distal end and a marker band 4295 at a proximal end. The articulation joint 4279 is defined where the marker band 4294 and the marker band 4295 are coupled to the suture strand 4235.

The articulation joint 4279 may provide greater freedom of movement of the petal-like portions 4225, which may allow for more uniform expansion of the petal-like portions 4225. In addition, the separate construction of the outer petal segment 4290 and the internal petal segment 4291 may allow a spherical layer of the expandable implant to be formed at a time, which can be advantageous and / or easier to manufacture. The ability to manufacture the expandable implant 4210 in several segments may also allow the addition to, or removal of, segments of an expandable implant to provide a length

157

W «X« X .......

Selected from the implant expanded to meet a particular need.

As shown in Figure 58, the expanded implant 4210 may also include a guide member 4276 coupled to a portion of the distal end of the expanded implant 4210 with the marker band 4242. The guide member 427 6 can be formed with, for example, a shape memory material such as nitinol, such that the guide member 4276 has a skewed curved shape when it is not limited within, for example a cannula (not shown) as described above for the expanded implant 4110. In some embodiments, the guide member 4276 can be coupled to the distal end portion of the expanded implant 4210 with a press similar to the implant 4110. Although not shown, the 4210 expanded implant may also include a coupling member for releasably coupling the expanded 4210 implant to the delivery device 4254 as described above by prior embodiments.

Figure 60 illustrates another embodiment of a medical device 4300 that includes an expanded implant 4210 having multiple joint joints 4379. The medical device 4300 may include the same or similar features and functions as described herein by others.

158 modalities For example, medical device 4310 may be configured to move a collapsed configuration shown in Figure 60 (for example, for delivery through a blood vessel) to an expanded configuration ( not shown) (for example, for deployment within an aneurysm). The medical device 4300 may also include an insertion member or device (not shown in Figure 60) whose expandable implant 4210 can be releasably coupled, as described above by prior embodiments.

The expandable implant 4310 includes a porous mesh tape type thread that includes one or more petal portions or sections 4325 along its length. In this embodiment, there are three petal portions 4325 included within a first petal segment 4392 of the expandable implant 4310, four petal portions 4325 included within a second petal segment 4391, and three petal portions 4325 included within a third 4390 petal segment of the 4310 expandable implant.

As with the previous embodiment, at least a portion of the porous mesh can be configured to be placed on a neck of an aneurysm when the expandable implant 4310 is in the expanded configuration. When he

159 expandable implant 4310 is in its expanded configuration, expandable implant 4310 may have a three-dimensional shape (eg, a substantially spherical shape) with a substantially continuous outer surface as described above by previous embodiments.

A suture thread 43 3 5 extends along the length of the expandable implant 4310 to provide reinforcement to the expandable implant 4310 and can also provide for a radiopaque coil to be disposed on at least a portion of the suture thread 4335 for provide visibility of the 4310 expandable implant during, for example, fluoroscopy. Suture thread 4335 can be coupled to, for example, marker bands 4342 and

<td>4344 arranged on</td><td>a</td><td>proximal end and</td><td>a</td><td>extreme</td>

<td>distal, respectively,</td><td>of the</td><td>expandable implant</td><td> 4310</td><td> •</td>

<td colspan="2">As shown</td><td>in figure 60,</td><td>the</td><td>implant</td>

Expandable 4310 may also include a guide member 4376 coupled to a portion of the distal end of the expandable implant 4310 with the marker band 4342. The guide member 4376 can be formed equal to or similar to the guide members described above. Although not shown, the 4310 expandable implant may also include a member of

160 coupling for releasably coupling the expandable implant 4310 to a delivery device as described above by prior embodiments.

In this embodiment, the first petal segment 4392, the second petal segment 4391 and the third petal segment 4390 can be formed as separate components and coupled together by the suture thread 4335. This creates a first joint or joint point 4379. between the first segment of petal 4392 and the second segment of petal 4391, and a second point of articulation or joint 4379 'between the second segment of petal 4391 and the third segment of petal 4390. In this embodiment, the first petal segment 4392 includes the marker band 4344 at a distal end and a marker band 4397 at a proximal end, the second petal segment 4391 includes a marker band 4396 at a distal end and a band of marker 4395 at a proximal end, and the third segment of petal 4390 includes the

<td>Band of</td><td>marker</td><td> 4342</td><td colspan="2">at one end</td><td>proximal and</td><td>a</td><td>band</td><td>from</td>

<td>marker</td><td>4394 in</td><td>a</td><td>extreme</td><td>distal</td><td colspan="2">The first</td><td>meeting</td><td>from</td>

<td colspan="2">joint 4379</td><td>it is</td><td>defined</td><td>where</td><td>the band</td><td>of the</td><td colspan="2">marker</td>

4397 and the marker band 4396 are coupled to the suture thread 4335, and the second joint joint 4379 'is defined where the marker band 4395 and the band of the

161 4394 marker is attached to the 4335 suture strand.

As we have commented previously for the expandable implant 4210, the articulation joints 4379 ', can provide greater freedom of movement of the petal-like portions 4325 of the expandable implant 4310, which may allow more uniform expansion of the petal-like portions 4325 within a aneurysm. In addition, with three 4392, 4391, 4391 petal segments, the 4310 expandable implant may have a higher density when deployed within an aneurysm that can further improve thrombosis.

In alternative embodiments, an expandable implant may have a different number of articulation joints and a different number of petal segments described above for expandable implants 4210 and 4310. In some embodiments, it may be desirable to have at least two petal-type portions. (for example, 4225, 4325) between the articulation joints. In other words it may be desirable for each petal segment to have at least two petal type portions. A greater number of articulation points or joints can provide greater freedom of movement of the petal-like portions, which can lead to a more uniform expansion of the expandable implant. The

162 Petal segments or layers may also have varying stiffness. For example, in an expandable implant, such as expandable implant 4310, it may be desirable for the first petal segment that has a stiffness greater than the first petal segment (e.g., petal segment 4392) may frame the aneurysm as an expandable implant that unfolds within the aneurysm. In this example, it may be desirable for the second petal segment (for example, petal layer 4391) to have a medium stiffness (for example, less stiffness than the first petal segment and greater than the third petal segment) to fill the aneurysm , and the third petal segment (for example, 4390 petal segment) to be the softest segment to pack the aneurysm.

The width of the petal can also vary between segments. For example, it may be desirable for the distal segment (for example, first petal segment 4392) to be wider than the remaining segments and proximal petal segments (for example, the second petal layer 4391 and / or the third segment Petal 4390) which is shorter and narrower to fit within the distal segment (for example, the first petal segment).

Insertion devices (for example, 2554, 2654, 2754, 2854, 3254, 3354, 3454, 3554, 3654, 3754, 3854,

163

3954, 4054) described herein can be used to deliver an expandable implant as described herein. For example, any of the expandable implants described herein may include an external marker band and an internal marker coupled to a proximal end portion of the expandable implant that can be used to couple the expandable implant to an insertion device, such as, for example. , insertion devices 2554, 2654 and 2754. In addition, any of the expandable implants described herein may include a connecting member (e.g., 1652, 1952, 2452, 2852, 3252, 3352, 3452, 3552, 3652, 3752, 3852, 3952, 4052) as described above, including a wire or balloon member configured to engage an insertion device, such as, for example, insertion devices 2854, 3254, 3354, 3454, 3554, 3654, 3754, 3854, 3954 and 4054. In addition, although the balloon members (implant or insertion balloon members) are shown as circular, any of the balloon members described herein may be other shapes, such as, for example, oval, elliptical, square, rectangular, triangular or another desired shape (as shown in a side view).

The various devices described here can be made of any material suitable for the purpose.

164 defined, including, for example, archived tube extracted DFT®. DFT is available as wire, cable or tape. DFT is a mixed metal-to-metal compound developed to combine the desired physical and mechanical attributes of two or more materials into a single wire or tape system, which can be used for the expandable implant.

Strands or wires for braiding or mesh (for example, expandable implants) may include, for example, filaments of materials such as MP35N, stainless steel, nitinol, cobalt chromium, titanium, platinum, tantalum, tungsten, or their alloys, or polyester, polyethylene (PET), Dacron, PEER, vectron and suture materials. Each strand can have a diameter between .0005 .010, for example, approximately .002. In some embodiments, an external mesh or braid material can be formed with nitinol that is super elastic at body temperature, and an internal material can be radiopaque, or alternatively platinum wires can be included in the braid to provide additional radiopacity. For example, in some embodiments, an expandable implant may include tissue of radiopaque material (s) within the mesh material such that the expandable implant can be highly visible without the use of a nozzle.

165 radioactive

Suitable materials can be chosen based on their electropositivity. For example, an expandable implant may include titanium, tungsten or other material listed below in Table 1, or any combination thereof. In use, the electropositive material of the expanded expandable implant creates an electrically favorable region within the vascular defect and through the blood, and the region in the defect containing blood, fluid or tissue is then predisposed for endothelialization to occur.

TABLE 1

<td>ELEMENT OF THE PERIODIC TABLE</td><td>ABBREVIATION</td><td>FULL NAME</td><td>VALUE OF LOAD OF MIXED COMPOUND</td>

<td> 22</td><td>You</td><td>Titanium</td><td> 1,36</td>

<td> 23</td><td>V</td><td>Vanadium</td><td> 1,53</td>

<td> 40</td><td>Zr</td><td>Zirconium</td><td> 1,22</td>

<td> 41</td><td>Nb</td><td>Niobium or columbium</td><td> 1,33</td>

<td> 42</td><td>Mo</td><td>Molybdenum</td><td> 1,47</td>

<td> 72</td><td>Hf</td><td>Hafnium</td><td> 1,16</td>

<td> 73</td><td>Ta</td><td>Tantalum</td><td> 1,30</td>

<td> 74</td><td>W</td><td>Tugstene</td><td> 1,47</td>

In some embodiments, the expansion implants described herein may be formed with tubular braid, or

166 woven filament sheets (forming a mesh, fabric or cloth). The filaments can be wire or polymer or other suitable material. The expandable implants can be braided wire (for example, NiTi wire), and can include a mixture of wire types and wire sizes (for example NiTi and platinum wire, and for example 0.001 wire braided with 0 wire, 00125). Expandable implants can also be made with polymer fibers, or polymer fibers and metal wire mixed together. In some embodiments, the strands or wires for the braid or mesh can be formed with a radiopaque material. In some embodiments, the strands or wires for the braid or mesh may include, for example, a co-extruded wire with a platinum base surrounded by nitinol (NiTi). In other words, the wire includes two concentric circles when viewed in a cross-sectional view, with the center core wire that is platinum, and the outer wire that is nitinol. The platinum percentage may be, for example, between 5% platinum to 50% platinum and several variations between (for example, 10%, 15%, 20%, 25%, 30%, 35%, 40%, Four. Five%). In other words, a percentage of the diameter of the wire can be, for example, from 5% to 50% platinum. In some modalities, the percentage of platinum at

167 Nitinol is 30% platinum and 70% nitinol. In some embodiments, expandable implants can be formed with one or more bioabsorbable materials. In some embodiments, after the expandable implant is formed, the implant mesh can be etched to remove an outer oxide layer. This can provide corrosion reduction and / or help form thrombosis faster.

The expandable implants described herein can be formed with one or more soft flexible materials such that the expandable implant can be deployed, for example, in a broken or unbroken aneurysm. In some embodiments an expandable implant as described herein can be formed with one or more materials such that the expandable implant has variable stiffness. For example, a first portion of the expandable implant may be formed with a first material and a second portion of the expandable implant may be formed with a second material different from the first material, or the first material may have a different thickness than the second material. For example, in some embodiments, a portion of the distal end of the expandable implant may be formed with a first material and a portion of the proximal end of the expandable implant may be formed with a second material different than the first

168 material. In some embodiments, a proximal end portion of an expandable implant may be formed with a first material that provides greater rigidity than a second material with which a portion of the distal end of the expandable implant is formed. Such an embodiment may be desirable such that the softer distal end portion of the implant can be deployed within an aneurysm and the stiffer proximal end portion can provide more structure to help support the implant in, for example, a neck of the aneurysm.

The mesh of the expanded implants can be done in a variety of different ways, including but not limited to, braiding, weaving, welding or laser cutting. The mesh may have an operating length, for example, in a range of about 0.5 cm to about 70 cm. In some modalities, the mesh may have a length of 30 cm. In some embodiments, the mesh may have a diameter in a range of approximately 0.5-60 mm. In some embodiments, the mesh may have a diameter of up to about 10 mm when expanded (for example, about 9.5 mm for an outer porous member or portion, about 8 mm for an inner porous member or portion). The mesh can have a density

169 individual or can have two or more densities. For example, in some embodiments, the number of variable densities can be in a range of about 2 to about 10. For example, a first density can be about 100 PPI and a second density can be about 4 0 PPI (PPI = photos per inch). The braid pattern can be any suitable pattern, for example, a one-on-one configuration, or two-on-one configuration, etc. The thread count for the mesh can be in a range of about 4 strands to about 288 strands. In some embodiments, the thread count is approximately 48 strands. Common multiples of 4, 8, 16, 24, 32, 64, 72, 96, 128, 144, 192 and 288 strands for braiding are available using commercial braids.

The single expandable implant A can include wires of the same size or a combination of 2 different wire sizes. For example, the expandable implant can have 24 wires of 0.001 and 24 wires of 0.0005. Thicker wires can impart additional force to the expandable implant and the thinner wire can provide density. In addition, any combination of wire count, wire diameter, mesh angle or photos per inch can be used to make the mesh of the

170 expandable implant

conclusion

While several embodiments of the invention have been described above, it should be understood that they have been presented by way of example only, and not by way of limitation. When the methods and steps described above indicate certain events that occur in a certain order, those of ordinary experience in the art that have the benefit of this description will recognize that the order of certain steps can be modified and that said modifications are in accordance with the variations of the invention. Additionally, certain of the steps can be performed simultaneously in a parallel process when possible, as well as performed sequentially as described above. For example, the expandable implant can be inserted into the catheter simultaneously with the placement of the expandable catheter adjacent to the aneurysm.

The modalities have been particularly demonstrated and described, but it will be understood that various changes in form and details may be made. For example, although various modalities have been described as having specific characteristics and / or combinations of components, other modalities are possible that have

171 any combination or sub-combination of any of the features and / or components of any of the modalities described herein. The specific configurations of various components can also be varied.

For example, although the modalities (eg, medical device 1010) illustrated and described herein include one or two porous members or portions (eg, porous members 1020, 1030), in other embodiments, any suitable number of porous members or portions may be included For example, in some embodiments, the medical device 1010 may also include a third porous member (not shown) having a first end and a second end and coupled to at least one of the first porous member 1020 and the second porous member 1030. Like the first and second porous members 1020, 1030, the third porous member may have a collapsed configuration for insertion through the blood vessels and an expanded configuration to occupy the aneurysm sac. The third porous member can be considerably elongated and have a width in its expanded configuration that is greater than its width in its collapsed configuration.

In another example, a radiopaque marker of a medical device illustrated and described differently may

172 be placed in an expandable implant of the medical device. On the other hand, the size and specific shape of several components may be different from the modalities shown, while still providing functions 5 as described herein.