Devices and methods for the treatment of vascular defects.

(54) Title: DEVICES AND METHODS FOR THE TREATMENT OF VASCULAR DEFECTS. (54) Title: DEVICES AND METHODS FOR THE TREATMENT OF VASCULAR DEFECTS.

(57) Summary

The present invention relates to an expandable implant configured to be placed within an aneurysm, the implant comprises: a lath-like strand formed of a tubular mesh that has been flattened along at least a portion of its longitudinal axis, the strand ribbon type has: a first portion having a collapsed configuration and an expanded configuration, wherein, in the collapsed configuration, the first portion is configured to be contained in a delivery device, and wherein the first portion of the ribbon strand forms a first configuration three-dimensional default in expanded configuration; and a second portion having a collapsed configuration and an expanded configuration, wherein, in the collapsed configuration, the second portion is configured to be contained in the delivery device, and wherein the second portion of the ribbon strand forms a second default three-dimensional configuration in the expanded configuration.

(57) Abstract

Devices and methods for treating vascular defects, such as, for example, balloon-type aneurysms, are described herein. In one embodiment, an apparatus ineludes an insertion portion and an expandable implant. The expandable implant is configured to be deployed in an aneurysm and is coupled to the insertion portion. The expandable implant has a first portion and a second portion coupled to the first portion. The expandable 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.

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PATENT TITLE No. 358482

Titularas): MEDINA MEDICAL, INC.

Address: Hamilton Ave. 937, Menlo Park, California, 94025, USA.

Name: DEVICES AND METHODS FOR THE TREATMENT OF VASCULAR DEFECTS.

Classification: OP: A61F2 / 06; A61B17 / 12; A61M29 / 00

CPC: A61F2 / 06; A61B17 / 12; A61M29 / 00

Inventors): MARIA ABQYTES; ARTURO S. ROSQUETA

REQUEST

Number: International Presentation Date:

MX / a / 2018/000789 144eMarzocte2013

Divisional Patent Number: 353600

PRIORITY

Country: Coot: Number:

US March 15, 2012 13 / 421,122

Validity: Twenty years

Expiration Date: March 14, 2033 Issue Date: August 23, 2018

The reference patent is granted on the basis of articles 1 *. 2nd Fraction V, 6th fraction III, and 59 of the Industrial Property Law.

□ e in accordance with article 23 of the Industrial Property Law. This patent has a validity of twenty non-expendable years, counted from the date of filing of the international application, and the fee will be subject to the fee to maintain the rights in force.

Whoever subscribes to this title does so based on the provisions of articles 6, sections III and 7 * bis 2 of the Industrial Property Law (Official Gazette of the Federation (DOF) 06/27/1991, amended on 02 / 08/1994, 10/25/1996, 12/26/1997, 05/17/1999, 01/26/2004, 06/16/2005, 01/25/2006, 05/06/2009, 06/01 / 2010, 06/18/2010. 06/28/2010, 01/27/2012. 04/09/2012. 06/01/2016 and 03/13/2018): articles 1, 3 'section V subsection a ). 4th and 12th fractions I and III of the Regulations of the Mexican Institute of Industrial Property (DOF 12/14/1999, amended on 07/01/2002, 07/15/2004, 07/28/2004 and 07/09/2004 / 2007); 1 * items. 3*. 4". 5 * fraction V Item a), 16 fractions! and III and 30 of the Organic Statute of the Mexican Institute of Industrial Property (DOF 12/27/1999, amended on 10/10/2002, 07/29/2004, 08/04/2004 and 09/13/2007); 1 *, 3 * and 5th paragraph a) of the Agreement that delegates powers to the Deputy Directors General, Coordinator, Divisional Divisions, Head of the Regional Offices, Divisional Deputy Directors, Departmental Coordinators and other subordinates of the * Instituto Mexfeane de to Industrial Property. (DOF 12/15/1999, amended on 02/04/2000, 07/29/2004, 08/04/2004 and 09/13/2007).

This letter is signed with an advanced electronic signature (FIEL), based on articles 7 BIS 2 of the Industrial Property Law; 3 of its Regulations, and 1 section III, 2 section V, 26 BIS and 26 TER of the Agreement establishing the guidelines for the use of the Electronic Payment and Services Portal (PASE) of the Mexican Institute of Industrial Property, in the procedures indicated.

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DIVISIONAL DIRECTOR OF PATENTS NAHANNY CANAL REYES

Original string:

NAHANNY MARISOL CANAL REYES | 00001000000403252793 | Administration Service

Tax | 1695 || MX / 2018/82440 | MX / a / 2018/000789 | Normal patent title with divisional PCT | 1220 | RRGO | Page (s) | LI9frVBIXOb9pyf6kOzBKObDtnw =

Digital stamp:

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Arenal No. 550, Floor 1. Santa María Tepepan Town. Xochimilco. 16020. Mexico City.

(55) 53340700 www.gob.mx/lmpl

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IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

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DEVICES AND METHODS FOR THE TREATMENT OF DÉPfióTOS

VASCULAR

MX / a / 2018/000789

Cross Reference to Related Requests

This application is a continuation 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 the US Provisional Patent Application No.

61 / 381,770, entitled Electropositive Neurovascular

Endothelialization Device, filed September 10, 2010, the disclosures of which are incorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

The invention relates generally to medical devices and more particularly to expandable medical devices and methods for treating vascular defects. For example, the invention may refer to

IMPI

MEXICAN INSTITUTE OF PRONEDAD

INDUSTRIAL

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Expandable medical devices and methods for treating an aneurysm. Aneurysms are dilations in a blood vessel caused by the weakening of a wall of the blood vessel. Dilation is caused by pressure from normal blood flow, which can cause the weakened segment of the blood vessel to dilate. In some cases, this dilation results in a balloon-shaped sac or polyp that protrudes from the main or originating vessel. Continuous growth and / or eventual rupture of the bulged arterial wall can have devastating results for the patient. As such, unruptured aneurysms should be treated to prevent bleeding. Additionally, ruptured aneurysms can be treated to avoid subsequent rupture and / or further damage.

MX / a / 2018/000789 358482

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 the supply wire, thereby inducing a load 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. However, such known methods and devices often have a recanalization rate of about 30%,

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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

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which means that the blood flow returns back to the aneurysm and can cause the aneurysm packaged in the coil to increase in volume further. Furthermore, such known devices and methods require long procedure times for the patient and a corresponding increase in the patient's exposure to radiation. Furthermore, such devices and methods do not treat the neck of the aneurysm, which is the area between the originating blood vessel and the aneurysm sac.

Another known treatment method includes the use of both a coil and a stent. The coil is delivered to the aneurysm sac as described above, and the stent is positioned within the originating blood vessel such that a portion of the stent is disposed over the neck of the aneurysm. Such procedures have several disadvantages. On the one hand, the provision of two separate types of devices (ie, coil (s) and a stent) is a more complex procedure, often resulting in a longer procedure time for the patient. The stent may take to blood vessel stenosis within the stent. Additionally, a patient will likely be required to take a blood thinner indefinitely after the procedure. Furthermore, such devices and methods are not suitable for the treatment of aneurysms located at a bifurcation of the blood vessel.

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(ie, between adjacent branches of a vessel).

Another known treatment device and method includes the use of a flow diverter supplied to the blood vessel of origin adjacent to the neck of the aneurysm.

Generally, the flow diverter is located within the source blood vessel over the neck of the aneurysm to prevent additional blood flow from entering the aneurysm from the vessel. In current procedures, more than one aneurysm flow diverter is required to ensure that blood flow is properly diverted from the aneurysm. Such a device and method of treatment have similar drawbacks to the use of a stent, as described above. Specifically, a flow diverter can lead to blood vessel stenosis and the patient will likely be required to take a blood diluent indefinitely after the procedure. Additionally, known flow diverters are not suitable for treating an aneurysm located at the bifurcation of the blood vessel. Furthermore, long-term follow-up of patients treated using a flow diverter shows an increase in the rate of recanalization to the aneurysm.

Therefore, there is a need for improved vascular defect treatment systems, devices and methods, such as described above.

balloon-type aneurysms, such as

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OF THE PROPERTY

UNBUSTIAL

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Summary of the Invention

Devices and methods for the treatment of vascular defects, such as, for example, balloon-type aneurysms, are described herein. In one embodiment, an apparatus includes an insertion portion and an expanded implant. The expanded implant is configured to deploy in an aneurysm and engages the insertion portion. The expanded implant has a first portion and a second portion attached to the first portion. The expanded implant can be moved 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 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

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MX / a / 2018/000789 configuration.

Figure 4 is a side view of a device

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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

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medical according to a modality 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 the embodiments.

Figure 14 is a view of a medical device in a partially folded configuration, according to one embodiment.

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

Figure 16 is a view of a portion of a medical device in an expanded configuration according to

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with one modality, with a first portion separated from a second portion.

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

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

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

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.

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Figure 21 is a view of a portion of a medical device in an expanded configuration according to one embodiment.

<td>The</td><td>Figure</td><td> 22</td><td>it's a sight</td><td>of a portion of the</td>

<td>device</td><td>doctor</td><td>of</td><td>Figure 21</td><td>in a configuration</td>

folded.

Figure 23 is a view of a portion of a

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MEXICAN INSTITUTE

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INDUSTRIAL

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medical device in a folded configuration, according to different modalities.

Figure 24 is a view of a portion of the medical device of Figure 23 in an expanded configuration.

Figure 25 is a view of a portion of a medical device in a folded configuration, in accordance with one embodiment.

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<td>The</td><td>Figure</td><td> 26</td><td>is</td><td>a sight</td><td>of</td><td>a</td><td>portion of the</td>

<td>device</td><td>doctor</td><td>of</td><td>the</td><td>Figure 25</td><td>in</td><td>a</td><td>setting</td>

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

<td>The</td><td>Figure</td><td> 27</td><td>is</td><td>a sight</td><td>of</td><td>a</td><td>portion of the</td>

<td>device</td><td>doctor</td><td>of</td><td>the</td><td>Figure 25</td><td>in</td><td>a</td><td>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 30 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 folded configuration, in accordance with one embodiment.

Figure 33 is a view of the portion of the medical device of Figure 32 in a configuration

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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

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MX / a / 2018/000789 358482 expanded.

<td></td><td>The</td><td>Figure 34 is</td><td>a</td><td>schematic illustration</td><td>of</td><td>the</td>

<td>portion</td><td>of the</td><td colspan="2">medical device</td><td>from Figure 33.</td><td></td><td></td>

<td></td><td>The</td><td>Figure 35 is</td><td>a</td><td>schematic illustration</td><td>of</td><td>a</td>

<td>5 portion</td><td>of</td><td>a device</td><td>of</td><td colspan="2">insertion, according to</td><td>a</td>

modality, shown in a first configuration and coupled to a schematic illustration of a portion of an expanded implant.

Figure 36 is a schematic illustration of the portion of the insertion device and the expanded implant 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 removed from the expanded implant.

Figure 38 is a schematic illustration of a portion of an insertion device, according to another embodiment.

Figure 39 is a view of a portion of an insertion device, according to another embodiment.

Figure 40 is a schematic illustration of a portion of an insertion device coupled to an expanded implant, according to another embodiment.

Figure 41 is a flow chart illustrating a method of deploying an expanded implant, in accordance with one embodiment.

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MEXICAN INSTITUTE Say THE INDUSTRIAL PROPERTY

<img file="MX358482B_D0012.tif" />

Figure 42 is a view of a portion of a medical device in an expanded configuration, in accordance with one embodiment.

MX / a / 2018/000789

<td>The</td><td>Figure</td><td> 43</td><td>is</td><td>a view of a portion of the</td>

<td>device</td><td>doctor</td><td>of</td><td>the</td><td>Figure 42 in a configuration</td>

<td>folded.</td><td></td><td></td><td></td><td></td>

<td>The</td><td>Figure</td><td> 44</td><td>is</td><td>a view of a portion of a</td>

medical device in an expanded configuration, according to one embodiment.

<td>The</td><td>Figure</td><td> 45</td><td>is</td><td>a sight</td><td>of</td><td>a</td><td>portion of the</td>

<td>device</td><td>doctor</td><td>of</td><td>the</td><td>Figure 44</td><td>in</td><td>a</td><td>setting</td>

<td>folded.</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>is</td><td>a sight</td><td>of</td><td>a</td><td>portion of the</td>

<td>device</td><td>doctor</td><td>of</td><td>the</td><td>Figure 44</td><td colspan="2">displayed</td><td>partially</td>

deployed within an aneurysm.

Figure 47 is a schematic illustration of an insertion device, in accordance with one embodiment.

Figure 48 is a schematic illustration of an insertion device, in accordance with one embodiment.

Figure 49 is a schematic illustration of an insertion device, in accordance with one embodiment.

Figure 50 is a schematic illustration of an insertion device, in accordance with one embodiment.

Detailed description

Medical devices and treatment methods

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They are described herein to treat patients experiencing a vascular defect, such as an aneurysm, in a circulatory blood vessel and the effects of that defect, including hemorrhagic stroke. For example, the devices and methods described herein may be useful for treating vascular defects present in the vasculature that are tortuous, small in diameter, and / or that are difficult to access. More specifically, the devices and methods described herein may be useful for treating saccular aneurysms (also referred to as globe or blackberry type), bifurcated aneurysms, fistulas, and other defects in the vasculature, including defects in the neurovasculature. 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 bulge formed (eg, in the neck of the aneurysm). ).

Various modalities of a medical device to occupy all or substantially the entire volume of an aneurysm and / or promote endothelialization in or near the aneurysm are described herein. In some embodiments, the medical device includes an expanded implant that includes a woven or braided electropositive material. The

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INDUSTRIAL

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OO filaments or strands that form the braid or tissue are configured to motivate the recruitment and / or retention of endothelial cells to the device and therefore within the defect. The expandable implant is configured to assume a predetermined non-linear three-dimensional shape within an aneurysm sac upon release from a tubular or other delivery holding device (eg, a catheter or cannula). The woven or braided electropositive material has a particular porosity and includes multiple openings between the strands or strands when the expandable implant is in the expanded configuration. Such openings are ideal in the blood environment to house recruited endothelial cells at the site. The electropositivity of the material motivates endothelialization in the presence of the 15 electronegative charges in the blood and body tissues. In other words, the electropositivity of the expandable implant relative to a load of blood and tissue (which is electronegative in comparison) provides a defect environment that promotes endothelialization. Endothelialization within the defect can ultimately result in the wall of the defect defect from the vessel of origin. For example, the growth and development of an endothelial layer over the neck of an aneurysm may detach the aneurysm wall from the vessel of origin and allow flow dynamics to balance in the defect.

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MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

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As such, the device can be configured to facilitate ΓΟ healing of the defect and prevent recanalization because tissue is created from within the body that resists aberrant blood flow and redistributes the pressure of the flow that may have created the defect. Upon healing with endothelialization, the pressure is evenly distributed throughout the vessel of origin so that recanalization is ruled out in the subsequent treatment of the defect. In addition, the blood that comes from inside the vessel of origin no longer has access to the detached defect once the endothelialization process is completed.

Additionally, at least a portion of the expanded implant may be placed over the neck of the aneurysm after the implant has been deployed within the aneurysm such that the portion interrupts the flow of blood from the vessel of origin to the aneurysm. As such, the expanded implant provides an interruption of blood flow in advance of and in addition to the growth and development of the endothelial layer over the neck of the aneurysm.

A medical device described herein may include an insertion portion (eg, a guidewire) and an expanded implant formed with, for example, woven or braided filaments in a mesh-like configuration. The terms mesh and braid may each refer herein to a woven fabric or filament material or

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IMPI _ U - MEXICAN INSTITUTE ^X DP LA ΡΚΟΝΒΟΑΓ

INDUSTRIAL

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twisted or strands of wire or polymer. The expandable implant of the medical device can be configured to compress or fold to deliver within the vessel of origin. In some embodiments, the medical device can be inserted while in a compressed or folded configuration through a delivery device, such as, for example, a microcatheter, cannula, delivery tube, or sleeve. In some embodiments, the medical device can be deployed without using such a delivery device.

The expandable implant of the medical device may have a folded or compressed configuration such that the expandable implant has a diameter that can fit within the narrow limits of the neurovasculature and / or within a lumen of a delivery catheter. The expandable implant of the medical device may be formed with, for example, a strand arrangement (eg, a strand or filament mesh or braid arrangement) that can be compressed and expanded. 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 Metals of Fort Wayne, Indiana, Carolina Fine Wire Company of Grover Beach,

California, other metal fabricators, Ahticon Inc. of

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<img file="MX358482B_D0017.tif" />

MEXICAN INSTITUTE Μζρίήί DE LA MOPIEDAD

INDUSTRIAL '' íq

Somerville, New Jersey, Genzyme of Cambridge, Massachusetts, Poly-Med, Inc. of Anderson, South Carolina, and / or other manufacturers of medical grade sutures and fibers. The expandable implant can be compressed over and / or along the insertion portion of the medical device. The insertion portion can be, for example, a wire. In some embodiments, a medical device includes an insertion portion that can be movably discarded within a lumen of a delivery device. A distal portion of the insertion portion can be coupled to the expandable implant. The expandable implant can be moved from a folded configuration to an expanded configuration while it is disposed within, or while it is inserted within a defect (eg, an aneurysm).

In some embodiments, the expandable implant may be formed with filaments of superelastic or shape memory material (such as, eg, nitinol) and the braid or mesh may be set to a predetermined shape prior to attaching the expandable implant to the insertion portion of the medical device. In such an embodiment, when the expandable implant unfolds and expands, it assumes a predetermined inclined shape. The default shape can be a generic shape, such as a sphere, or it can be a custom shape based on the shape of a target aneurysm within a patient.

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The right materials are

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described in more detail herein.

The medical devices described herein may include one or more expandable implants formed within a woven or braided mesh having apertures of varying sizes (also referred to herein as holes or pores). In other words, the devices are formed from a material that has a particular porosity or pore density. In some embodiments, the expandable implant may have mesh or tissue sections that vary in filament density and may include densely spaced (ie, low porosity) portions or bands of filaments separated by portions or bands that are less dense (ie , high 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. The material (eg, body tissue such as endothelial cells) can be motivated to enter and / or join the interstices of the mesh of the expanded implant. For example, the denser braid portion can be used to motivate greater endothelial cell attachment and the less dense braid portion can be used to reduce the total weight and / or material to be implanted in the patient. The less dense sections can also direct the final configuration of the expanded implant. For example, co

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the less dense (more open) sections of the mesh or braid can direct the expansion effects of the implant.

In some embodiments, a medical device can be delivered to a desired treatment site within a vasculature by inserting the medical device through the lumen of a delivery catheter (eg, a microcatheter). The expanded medical device can be inserted through the delivery catheter in a folded or compressed configuration. The expanded implant of the expanded medical device can be removed through a distal end of the delivery catheter at the treatment site (eg, within the sac of an aneurysm) and moved to an expanded configuration. In some embodiments, the delivery catheter is used to compress or fold the expanded implant. For example, the expanded implant may be formed in a sloping expanded configuration and when placed within a lumen of a catheter it is compressed. When the expanded implant is moved out of the catheter, it can assume its tilted expanded configuration. In the expanded configuration, a first portion of the expanded implant substantially overlaps a second portion of the expanded implant. The first and second portions of the expanded implant may be separate structures or may be portions of a unitary or monolithic constructed device.

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Mexican INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0020.tif" />

A device, such as an expandable implant, described herein includes a first porous member and a second porous member coupled to the first porous member. The first and second porous members each include a first end and a second end. The first and second porous members each have a folded 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 folded configuration. The second porous member is substantially elongated and has a greater width in its expanded configuration than in its folded 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 is in its expanded configuration.

In some embodiments, the first porous member is configured to occupy a first volume in its folded 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 larger volume than the substantially elongated shape of the first

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<img file="MX358482B_D0021.tif" />

porous member in its folded configuration. The second porous member may be configured to move or curve in a three-dimensional shape in the expanded configuration such that a first segment of the second porous member overlaps a second segment of the second porous member. In its expanded configuration, the second porous member can define an interior region configured to receive the first porous member in its expanded configuration. For example, in some embodiments, the second porous member is substantially spherical in shape 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 folded 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. The first and second porous members are each substantially elongated in the folded configuration. In its expanded configuration, the first porous member has a three-dimensional shape that includes a configured first segment

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to overlap with a second segment and defining an interior region. The second porous member is configured to be disposed in the interior region of the first porous member when each of the first and second porous members is in its respective expanded configuration. In some embodiments, the second porous member can be formed integrally or monolithically with the first porous member. In some embodiments, the second porous member can be woven or braided using the same filaments that make up the first porous member.

In some embodiments, the expandable implant is in the form of a braided tube that includes superelastic shaped memory alloy fibers, or polymeric fibers. In some embodiments, the expandable implant can deform so as to induce a substantially spherical contour. In some embodiments, the expandable implant can deform so as to induce a helical contour. In some embodiments, the shape deformation can 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 the sac of an aneurysm and / or to promote endothelialization of the aneurysm neck to inhibit or stop blood flow within the aneurysm, thereby

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<img file="MX358482B_D0023.tif" />

Which can lead to, for example, hemorrhagic stroke. In some embodiments, polymer wire or filaments can be used to form woven mesh or braided strands that can be expandable, and have openings sized to promote endothelial cell attachment in the aneurysm.

It should be noted that, as used in this written description and the appended claims, the singular forms un / una and el / la include referents 10 to the plural 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. Furthermore, the words proximal and refer to a direction near and respectively, an operator (eg, surgeon, doctor, nurse, technician, etc.) who will insert the medical device into the patient, with the end tip (ie, distal end) of the device inserted first into the patient's body. Thus, for example, the end that is inserted first into the patient's body will be the distal end of the medical device, while the end outside, or that will then be inserted into, the patient's body, will be the end proximal to the device . doctor. Ad ditionally, the terms first, second, third, and so on, used to describe the

MX / a / 2018/000789 'distal away from,

ΙΜΡΙ

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0024.tif" />

Items similarly identified are used for clarity purposes only, and are not intended to imply a priority or that such a numeric identifier should be associated with that particular item 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 endothelial cell attachment over the neck of the aneurysm. Upon completion of endothelialization over the aneurysm neck, blood flow within the aneurysm sac from the originating blood vessel (ie, the vessel in which the aneurysm forms) is prevented.

MX / a / 2018/000789

The medical device 100 may include an insertion portion 102 and an expanded implant 110. Insertion portion 102 engages the expanded implant 110, such as, for example, in a nearby portion 112 of the expanded implant 110. In some embodiments, the insertion portion 102 is removably coupled to the implant

<img file="MX358482B_D0025.tif" />

IMPI _ ΤΟ _ 'N'TTUTOM &amp; XICANli

W LA WOMgOAD

INDUSTRIAL expanded 110. In this way, the insertion portion 102 can be separated from the expanded implant 110 after delivery of the expanded implant to the aneurysm and removed from the patient's vasculature. Insertion portion 102 may be, for example, a guidewire or a distal end portion of a wire. Medical device 100 can be used with a cannula or catheter 104 (shown in broken lines in Figures 1 and 2) to, for example, deliver the expanded implant to the aneurysm.

The expanded implant 110 is configured to deploy in the aneurysm (eg, in the 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 are substantially aligned. linear. In its first configuration, the expanded implant 110 is configured for insertion through a blood vessel. Expanded implant 110 is also configured for insertion through an aneurysm neck when in its first configuration.

Expandable implant 110 can be moved between its first configuration and a second configuration in which the second portion 130 overlaps at least partially with the first portion 120, as shown in Figure 2. By

MX / a / 2018/000789

IMPI

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX358482B_D0026.tif" />

For example, the second portion 130 may be configured to bend, curl, and / or twist multiple times such that multiple segments of the first, portion 120, and second portion 130 overlap. Additionally, at least one of the first portion 120 and the second portion 130 can be configured to fold or curl multiple times such that the respective first or second portion overlaps itself. In some embodiments, the expanded implant 110 can be understood to have multiple first portions and multiple second portions. In other words, the expanded implant can be continuously superimposed on itself in its deployed configuration to occupy all or substantially the entire volume of the aneurysm.

In its second configuration, the implant expanded

110 it is configured to occupy at least a portion of the volume defined by the aneurysm sac. In some embodiments, when the expanded implant 110 is in its second configuration, at least a portion of the expanded implant is configured to be positioned over the neck of the aneurysm. For example, the expanded implant portion 110 where the second portion 130 overlaps the first portion 120 can be configured to be positioned over the neck of the aneurysm. As such, the expanded implant portion 110 disposed over the neck of the aneurysm has a density

MX / a / 2018/000789

IMPI

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX358482B_D0027.tif" />

increased (eg, a dual density compared to the first portion 120 or the second portion 130 individually), which helps limit or prevent blood flow from entering the aneurysm sac. The portion of the expandable implant 110 located above the neck of the aneurysm may be a scaffold for attachment of the endothelial cell to the neck of the aneurysm. For example, the portion of expandable implant 110 that can be positioned over the neck of the aneurysm may be porous, such as 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 are tilted toward the second configuration.

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MX / a / 2018/000789

As noted above in some embodiments, at least a portion of the expandable implant 110 is porous. For example, in some embodiments, at least a portion of the expandable implant 110 may include and / or be made of a mesh material (eg, woven, braided, or laser cut) such that a wall or layer of the expandable implant 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 expandable implant 110 may include the porous mesh. The porous mesh may have a first porosity when the expandable implant 110 is

- 26 IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0028.tif" />

found in its first configuration and a second porosity when the expanded implant is in its second configuration. More specifically, in some embodiments the porous mesh may have a greater porosity when the expanded implant 110 is in its second configuration than when the expanded implant is 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 may expand in the second configuration, thereby increasing the space between the mesh filaments (and thus the size of one or more mesh openings). In other words, the total volume of the pore openings can be increased. In another example, the porosity of the porous mesh can be increased because one or more openings that were closed when the expanded implant 110 was folded in its first configuration reopens when the expanded implant is moved to its second position. In other words, the number of open pores can be increased.

In some embodiments, the first portion 120 and the second portion 130 may have the same or different porosities. For example, the first portion 120 may have a porosity greater than the porosity of the second portion.

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MX / a / 2018/000789

ΙΜΡΙ

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0029.tif" />

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 equivalents in the expanded configuration.

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MX / a / 2018/000789

In some modalities, at least one of the first

<td>serving 120</td><td>and the</td><td>second</td><td>serving 130</td><td>includes one,</td><td>two,</td><td>three o</td>

<td>more layers.</td><td>By</td><td>example,</td><td>in some</td><td>modalities,</td><td>the</td><td>first</td>

<td>serving 120</td><td>of the</td><td>implant</td><td>expandable</td><td>110 includes</td><td>a</td><td>first</td>

<td colspan="3">10 layer (not shown on</td><td>Figures 1 o</td><td>2) mesh</td><td colspan="2">porous and the</td>

second layer (not shown in Figures 1 or 2) of porous mesh. The first layer and the second layer can have the same or different porosities. In some embodiments, the first layer is separated from the second layer. As such, the porosity of the first portion is determined by the porosities of the first and second layers and by the way in which the first layer is separated 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 shape. Thus, in such an embodiment, the expandable implant portion 110 (eg, the first portion 120 and / or the second portion 130) can be tilted toward a second expanded configuration and

ΙΜΡΙ

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0030.tif" />

move to a first folded configuration by restricting or compressing the expandable implant portion.

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.

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MX / a / 2018/000789

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, expandable implant 110 can be substantially helical.

In some embodiments, expandable implant 110 may be substantially circular, disk-shaped, or ring-shaped. In some embodiments, expandable implant 110 may have a custom shape based on the shape of a target aneurysm within the patient; for example, a shape modeled from the shape of the target aneurysm as detected by a display device. For example, an image of the shape of the aneurysm can be acquired using an angiogram, and the expandable implant can be modeled from the shape of the aneurysm shown on the angiogram. In some modalities, the implant

- 29 IMPI

MEXICAN INSTITUTE OF INDUSTRIAL MONEDAD

<img file="MX358482B_D0031.tif" />

Expander 110 may include multiple portions having varying outer perimeters or outer diameters. For example, in some embodiments, when in the expanded configuration, the expanded implant 110 may include a first portion that has a first outer perimeter, a second portion that has a second outer perimeter, and a third portion that has a third outer perimeter. In such an embodiment, the second outer perimeter may be less than each of the first outer perimeter and the third outer perimeter.

In exemplary use of medical device 100, catheter 104 may be inserted into a blood vessel and directed to a desired treatment site near a vascular defect, such as the aneurysm. Expanded implant 110 is inserted into an elongated lumen of catheter 104 for delivery to the treatment site. A distal portion of catheter 104 is located adjacent to the aneurysm within the blood vessel. The expanded implant 110 moves from a first position within the catheter to a second position outside the catheter. When the expanded 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 folded into the

MX / a / 2018/000789

IMPI _. MEXICAN INSTITUTE

-30- of the property

INDUSTRIAL

<img file="MX358482B_D0032.tif" />

lumen of catheter 104 and has a substantially linear configuration.

Expandable implant 110 can be oriented relative to an opening in the vessel wall in fluid communication with the aneurysm such that the expandable implant can enter the aneurysm sac when the expandable implant 110 is moved to its second position. Expandable implant 110 can be moved from its first position to its second position with the help of insertion portion 102 such that expandable implant 110 is directed toward and located within the 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 can expand to a three-dimensional shape. The three-dimensional shape of the first portion 120 in the second configuration may be similar or different to 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 interior region defined by the first portion when each of the first portion and the second portion are in their respective second configuration.

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QO tfs.

QO ro

MX / a / 2018/000789

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0033.tif" />

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 is moved to its second configuration before the first portion 120 is moved to its second configuration. The expanded implant 110 may assume an expanded inclined configuration such that the walls of the expanded implant 110 contact 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 expanded implant 110 over the neck of the aneurysm can substantially reduce and / or prevent additional blood flow from the vessel of origin into the aneurysm sac because the expanded implant can act as a physical flow disruptor for blood that it flows from the vessel of origin and as a scaffold for endothelial cell junction in the neck of the aneurysm to promote endothelialization of the neck / vessel wall. Insertion portion 102 can then be disconnected from a proximal end of expanded implant 110 and withdrawn through catheter 104.

MX / a / 2018/000789

<td>The figures</td><td>3, 4, 5A,</td><td>5B and</td><td>5C illustrate</td><td>a</td>

<td>medical device</td><td>agree with</td><td>a</td><td>modality.</td><td>The</td>

<td>25 medical device 200</td><td>can include</td><td>all</td><td>or some of</td><td>the</td>

IMPI

Mexican Institute of Industrial Property

<img file="MX358482B_D0034.tif" />

Same features and functions as described above for medical device 100. Medical device 200 includes insert portion 202 and expandable implant 210. Expandable implant 210 is removably coupled at its proximal end to a distal end of the portion insertion 202.

MX / a / 2018/000789

The expandable implant 210 includes a first portion 220 and a second portion 230. As shown in Figures 3 and 5A, the expandable implant 210 has a first or folded configuration in which the first and second portions 220, 230 are substantially located linearly aligned. In this way, expandable implant 210 can be disposed within the lumen of a catheter 204 for delivery through a blood vessel

V to a treatment site, such as aneurysm A. In this configuration, expandable implant 210 has a first width Wi, as shown in Figure 2. As shown in Figures 4 and 5B-5C, the implant Expandable 210 can be moved to a configuration, second, or expanded or unfolded. Insertion portion 202 is configured to move expandable implant 210 from the first configuration to the second configuration. Insertion portion 202 can be disconnected from expandable implant 210 when expandable implant 210 is in its second configuration.

IMPI

MEXICAN INSTITUTE Ot INDUSTRIAL PROPERTY

<img file="MX358482B_D0035.tif" />

In its second configuration, expandable implant 210 is configured to occupy at least a portion of the volume delineated by aneurysm sac A. As such, expandable implant 210 has a second width W₂ in the second expanded configuration larger than its first width W_x. For example, expandable implant 210 can be substantially narrow and elongated in its first configuration and can assume a three-dimensional shape in its second configuration. In the modalities illustrated in the

Figures 3-5C, the expandable implant 210 has a substantially spherical shape in its second configuration. Expandable implant 210 can be adjusted such that its three-dimensional shape can accommodate any irregularities in the shape of the aneurysm. In the second configuration, the second portion 230 of the expandable implant 210 overlaps at least partially with the first portion 220. At least a portion of the expandable implant 210 is configured to be positioned over an N neck of aneurysm A when the expandable implant is in its second configuration within the sac of aneurysm A. Expandable implant 210 is configured to facilitate attachment of the endothelial cell in

MX / a / 2018/000789

<td>the N neck of the</td><td>aneurysm A,</td><td>as described in more</td><td>detail</td>

<td>at the moment.</td><td></td><td></td><td></td>

<td>In the</td><td>modality</td><td>illustrated in Figure</td><td>3, the</td>

<td>25 first portion</td><td>(or member)</td><td colspan="2">220 is a first type strand</td>

IMPI

MEXICAN INSTITUTE M PROPERTY

INDUSTRIAL

<img file="MX358482B_D0036.tif" />

lath and second portion (or member) 230 is a second lath strand separated from the first portion. In other embodiments, the expandable implant may include a first portion and a second portion from a single lath-like strand (eg, integral or monolithically constructed), rather than separate portions. A first end 222 of the first portion 220 is coupled to a first end 232 of the second portion 230. Any suitable mechanism can be used to couple the first end 222 of the first portion 220 to the first end 232 of the second portion 230, such as an adhesive, a mechanical coupler, a solder, or the like, or any combination of the foregoing. For example, the first ends 222, 232 can be attached by a band 240. The band 240 can also be configured to help couple the insertion portion 202 to the expandable implant 210. Band 240 may or may include, for example, a radiopaque marker.

CO «Λ

MX / a / 2018/000789

A second end 224 of the first portion 220 and a second end 234 of the second portion 230 may each have a radiopaque marker 242, 244, respectively, coupled thereto. Radiopaque markers 242, 244 are configured to facilitate visualization of expandable implant 210 during delivery to the treatment site and / or subsequent to implantation. Markers 242, 244 are configured to be fully arranged within the

IMPI

MEXICAN INSTITUTE Dt THE PROPERTY

INDUSTRIAL

<img file="MX358482B_D0037.tif" />

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 endothelial cell binding in the neck of the aneurysm.

This is also beneficial because if markers 242, 244 were located at or near the neck of the aneurysm, blood from a blood vessel of origin could have a tendency to clot around 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 can also move between a first configuration and a second configuration. The first portion or member 220 has a first folded 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 an elongated, substantially linear, folded configuration to a multidimensional (eg, three-dimensional) shape in the expanded or unfolded configuration. As shown in Figures 4 and 5C, the first portion 220 may have a three-dimensional shape in the expanded configuration that gives it

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oo ro

MX / a / 2018/000789

IMPI

<img file="MX358482B_D0038.tif" />

<img file="MX358482B_D0039.tif" />

a general spherical shape to the expanded implant 210. The first portion 220 can be tilted towards its second expanded configuration.

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CJf

QO ro

MX / a / 2018/000789

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 such that openings or interstices are present between the filament portions at least when the expandable implant 210 is in its second configuration. For example, the porous mesh can include a plurality of braided wires. The suitable mesh material is described in greater detail herein. The porous mesh can have a first porosity when the first portion 220 is in the first configuration and a second porosity when the first portion 220 is in the second configuration. For example, when the first portion 220 is moved from its first folded configuration to its second expanded configuration, the mesh may expand such that the size of the mesh openings increases, thereby increasing the porosity of the mesh. The porous mesh is configured to act as a scaffold that promotes clot formation and endothelial cell attachment when the mesh is disposed within aneurysm A.

Specifically, endothelial cells will migrate to

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0040.tif" />

mesh openings.

The first portion 220 of the expanded 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 either the first or second layer individually. Such a dual density structure can help limit or prevent blood flow to aneurysm A, for example, when the first and second layers of first portion 220 are disposed 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 separated from the second layer of porous mesh. In this way, the total porosity of the first portion 220 is greater than the porosity of either the first or second layers individually. The first and second layers of porous mesh can be coupled together in any suitable way. For example, the first portion 220 can be formed using an elongated tubular mesh having an elongated lumen therethrough. In such an embodiment, the elongated mesh can be flattened from a tubular structure to a lath-like structure such that a first side or layer of the mesh is disposed on or close to a second side or layer of the mesh, thereby forming a dual density, or double layer mesh structure.

MX / a / 2018/000789

IMPI

MtXICANO INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0041.tif" />

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The second portion or member 230 of the expandable implant 210 can be configured the same or similar and can be used the same or similar to the first portion 220. When the expandable member 210 moves between its first configuration and its second configuration, the second portion 230 can also move between a first folded configuration in which the second portion is substantially elongated and has a third width and a second expanded configuration in which 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 folded configuration to a multidimensional (eg, three-dimensional) shape in the expanded configuration. As shown in Figures 4 and

5C, the second portion may have a three-dimensional shape in the expanded configuration that gives the expandable implant 210 a general spherical shape. The second portion 230 may be inclined to its second expanded configuration.

The second portion 230 is porous and can include or be constructed of a porous mesh. The porous mesh may be of the same or similar configuration 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 woven or filament braid that is porous at least when the

MX / a / 2018/000789

ΙΜΡΙ

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0042.tif" />

220 expanded implant is in its second configuration. Additionally, the porous mesh of the second portion 230 can have a first porosity when the second portion 230 is in the first configuration and a second porosity when the second portion 230 is in the second configuration. In some embodiments, the second portion 230 of the expanded 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. In this way, the total density of the second portion 230 is greater than the density of either the first or second layers individually. The first porous mesh layer may be separated from the second porous mesh layer such that the total porosity of the second portion 230 is greater than the porosity of either the first or second layers individually. Similarly as described above with respect to first portion 220, the first and second porous mesh layers of second portion 230 may be formed of a monolithically constructed elongated tubular mesh that flattens into a lath-like structure.

The first portion 220 and the second portion 230 of the expanded implant 210 may be of the same or different sizes. For example, as shown in Figure 5A, the first portion 220 may have a length at its first

MX / a / 2018/000789

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0043.tif" />

folded configuration, less than the length of the second portion 230 in its first folded configuration. In this way, markers 242, 244 will be introduced sequentially through the N-neck of aneurysm A, allowing the expanded implant 210 to be introduced through a narrower N-neck. 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 four expanded width of the second portion 230 may be larger 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 expanded implant 210 is in its second configuration, and the porous mesh of the second portion 230 may have a multidimensional shape with a second width less than the first width when the implant expanded is in its second configuration.

In some embodiments, for example, the first portion 230 (or the porous mesh of the first portion) may

MX / a / 2018/000789

IMPI

INSTITUTO MEXICAN DF LA FROFIEDAD INDUSTRIAL

<img file="MX358482B_D0044.tif" />

have a width of approximately 8 mm when the expanded implant expands in its second configuration, and the second portion 230 (or the porous mesh of the second portion) can be approximately 9.5 mm wide when the expanded implant expands in its second configuration setting. 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 dispose within an interior aortic region formed by the second portion 230 in your second setup.

In some embodiments, a variation of medical device 200 is contemplated. For example, in such an embodiment, the first portion of the expanded implant may include a first tubular mesh defining a lumen therethrough, and the second portion of the expanded implant may include a second tubular mesh disposed within the lumen of the first tubular mesh. The first and second

MXIa / 2018/000789

<td>structures</td><td>of</td><td>tubular mesh</td><td>can form</td><td>in a strand</td>

<td colspan="2">20 substantially</td><td>ribbon type.</td><td>As such,</td><td>the implant</td>

<td>expanded</td><td colspan="2">has a density</td><td>four layer.</td><td>The implant</td>

<td>expanded</td><td colspan="3">may include additional threads</td><td>ribbon type</td>

<td>in addition to</td><td>the</td><td>strand formed</td><td colspan="2">for the first and second</td>

<td>servings.</td><td>By</td><td colspan="2">example, the implant expanded</td><td>can include</td>

<td>25 one, two,</td><td>three,</td><td>four five</td><td>, six seven,</td><td>eight or nine</td>

<img file="MX358482B_D0045.tif" />

IMPI _ Λ O _ MEXICAN INSTITUTE ^{4 Z} OF INDUSTRIAL PROPERTY strands, each strand having a desired number of layers (eg, two, four or more layers). As such, an expandable implant can be formed having a desired amount of density. As noted earlier, a highly dense structure helps prevent blood flow from the originating blood vessel to the aneurysm. Each layer or portion of the expandable implant can have the same or different density as the other layers or portions. Furthermore, 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 as described above for prior modalities. For example, medical device 300 includes an expandable implant 310 and an insertion portion or member (not shown in Figure 6). Expandable implant 310 is shown in an expanded configuration and can move between a compressed or folded configuration in which the expandable implant is substantially elongated and the expanded configuration in the same or similar manner as described above for expandable implant 210. In the configuration expanded, a first portion 320 of the expandable implant 310 is overlaid by a second portion 330 of the

MX / a / 2018/000789

<img file="MX358482B_D0046.tif" />

IMPI _ / 3 _ MEXICAN INSTITUTE ^J PROPERTY industrial expandable implant. Additionally, at least a portion of the first portion 320 is disposed within an open interior 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 lath strand. At least a portion of the porous mesh is configured to sit on the neck of an aneurysm when the expandable implant 310 is in the expanded configuration. The porous mesh is configured to fold, bend, and / or twist multiple times into a substantially spherical shape when the expandable implant 310 is in the expanded configuration. The porous mesh may be a lath-like structure that is wider than the porous mesh of expandable implant 210. Thus, the porous mesh of expandable implant 310 may be shorter in length than that of expandable implant 210 and still provide a similar amount of coverage within the aneurysm (and over the neck of the aneurysm) as the expandable implant 210. The porous mesh may include one, two, or more layers depending on the density and desired porosity of expandable implant 310. In some embodiments, a first radiopaque marker 342 is coupled to a first end 312 of expandable implant 310 and a second radiopaque marker 344. is coupled to a second end 314 of the

MX / a / 2018/000789

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL EROFLITY

<img file="MX358482B_D0047.tif" />

expandable implant. Expandable implant 310 is configured to be fully disposed within the aneurysm such that radiopaque markers 342, 344 are fully disposed within the aneurysm sac and the porous mesh is disposed over the neck of the aneurysm. In some embodiments, radiopaque markers are configured to be located on one 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 as described above for prior modalities. For example, medical device 400 includes an expandable implant 410 and an insert portion or member 402. Expandable implant 410 is dimensioned to occupy the sac of an aneurysm, and insertion member 402 is configured to facilitate delivery of the expandable implant into the aneurysm sac. Expandable implant 410 is shown in an expanded configuration and can be moved between a compressed or folded configuration and the expanded configuration in the same or similar manner as described above for prior modalities.

Expandable implant 410 includes at least one porous mesh lath strand configured to expand within the aneurysm as a spiral or

MX / a / 2018/000789

IMPI

MEXICAN INSTITUTE OF LA MOHEDAL

INDUSTRIAL

<img file="MX358482B_D0048.tif" />

360 degree ring shape. In the expanded configuration, a first portion 420 of the expanded implant 410 is overlapped by. a second portion (not shown in Figure 7) of the expanded implant, which is overlapped by a third portion 450 of the expanded implant. Thus, at least a portion of the expanded implant 410 includes two, three, four, or more layers of the implant material (eg, porous mesh, as previously described in previous embodiments), which can be positioned over the neck of the aneurysm from within of the aneurysm to function as a dense flow disruptor.

MX / a / 2018/000789

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 expanded implant 510 and an insertion portion or member 502. The medical device 500 can be supplied to an aneurysm or other vascular defect using a 504 microcatheter. Expanded implant 510 is dimensioned to occupy at least a portion of the volume defined by the aneurysm sac and insertion member 502 is configured to facilitate delivery of the expanded implant into the aneurysm sac. Expandable implant 510 is shown in an expanded configuration and can be moved between a

<img file="MX358482B_D0049.tif" />

IMPI

- 4 6 - MEXICAN INSTITUTE

OF THE RROWBDAD

INDUSTRIAL «faith

OO _ ---- 'ΓΟ compressed or folded configuration and the expanded configuration in the same or similar way as described above for previous modalities.

Expandable implant 510 includes a porous mesh 5 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 expandable implant 510 is clutches with and / or overlaps a second end portion 514 of the expandable implant. The expandable implant

510 it 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, the tissue or braid of the porous mesh has a higher density in the second portion 530 than in the first portion 520 of the expandable implant. Expandable implant 510 is configured to dispose within the aneurysm (or other vascular defect) such that at least a portion of the second portion 530 is disposed over the neck of the aneurysm, because a higher density promotes attachment of the endothelial cell to expandable implant. Expandable implant 510 includes at least one radiopaque marker 542 that can be disposed on one of the first end portion 512 (as shown in Figure

8) and / or the second end portion 514. When the implant

MX / a / 2018/000789

- 47 IMPI

MEXICAN INSTITUTE OF INDUSTUAI PROPERTY

<img file="MX358482B_D0050.tif" />

Expanded 510 is disposed within the aneurysm in its expanded configuration such that the second highest density portion 530 is disposed over the neck of the aneurysm, the at least one radiopaque marker 542 is disposed within the aneurysm sac away from the aneurysm neck .

Figure 9 illustrates another embodiment of a medical device. The medical device 600 may include the same or similar features and functions described above for prior modalities, eg, the medical device 600 includes an expandable implant 610 and an insert portion or member 602. Expandable implant 610 is sized to occupy at least a portion of the volume defined by the aneurysm sac, and insertion member 602 is configured to facilitate delivery of the expandable implant into the sac. Expandable implant 610 is shown in a co

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expanded configuration compressed configuration expanded in the same way can move between a folded and the configuration or similar to that described above for previous modalities.

The 610 Expandable Implant includes a porous mesh lath strand that has at least two layers of mesh. Expandable implant 610 is configured to expand within the aneurysm as a substantially helical or coil-shaped structure, as shown in Figure

ΙΜΡΙ

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

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9. Expandable implant 610 can be disposed within the aneurysm (or other vascular defect) such that at least a portion of the implant is disposed on the neck of the aneurysm to facilitate attachment of the endothelial cell to the neck. Expandable implant 610 includes at least one radiopaque marker 642, which can be disposed on one end of expandable implant 610, as shown in Figure 9. Insertion member 602 can be removably attached to the expandable implant in the radiopaque marker.

Figure 10 illustrates another embodiment of a medical device. Medical device 700 includes all the same or similar features and functions as described above for medical device 600. For example, medical device 700 includes an expandable implant 710, an insertion portion or member 702, and a coupled radiopaque marker 742 to one end of the expandable implant. The expandable implant 710 includes a porous mesh formed of a tubular or round braided structure. The Round Wound structure can give the expandable implant 710 more softness than, for example, the previously described flattened batten structure.

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Figure 11 illustrates another embodiment of a medical device. The medical device 800 can include features and functions equal to or similar to the ones described above for previous modalities.

By

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL MONEDAD

<img file="MX358482B_D0052.tif" />

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. Expanded implant 810 is sized to occupy at least a portion volume of the aneurysm sac, and insertion member 802 is configured to facilitate delivery of the expanded implant from microcatheter 804 into the aneurysm sac. The expanded implant 810 is shown in an expanded configuration and can be moved between a compressed or folded configuration and the expanded configuration in the same or similar manner as described above for previous modalities.

The expanded implant 810 includes a first member 820 and a second member 830. The first and second members 820, 830 are coupled to a first end 812 of the expanded implant 810 and a second end 814 of the expanded implant. The first and second members 820, 830 are also coupled to each other in at least one middle portion of the expandable 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 syrian is configured to be a bending point of the expandable implant

810 when the expandable implant is delivered to the

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MX / a / 2018/000789

- 50 IMPI

MEXICAN INSTITUTE OF UA INDUSTRIAL PROPERTY

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aneurysm and expands within the aneurysm to accommodate the shape of the aneurysm. As such, expandable implant 810 can be packed denser in the aneurysm, for example, compared to an implant that cannot fold or fold in response to the shape of the aneurysm. At least one of the first member 820 and the second member 830 of the expandable implant 810 includes a porous mesh formed of a tubular or round braided structure.

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

The expandable implant 910 includes a series of expandable portions 920, 922, 924, 926, 928 separated by

MX / a / 2018/000789

ΙΜΡΙ

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0054.tif" />

a series of compressed portions 930, 932, 934, 936. The expandable portions 920, 922, 924, 926, 928 can be configured to expand to any suitable multidimensional shape including, for example, that which resembles a sphere, a disk, a parable, or the like. Additionally, each portion expanded 920, 922, 924, 926,

928 it may have an expanded shape other than the expanded shape of another expanded portion.

MX / a / 2018/000789

When the expanded implant 910 is in its expanded configuration, as shown in Figure 12, the expandable portions 930, 932, 934, 936. The density and / or porosity of each expanded 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 expanded portion 920, 922, 924, 926, 928 may vary along the length and / or or the width of the respective expanded portion. For example, a first expanded portion 920 may be more dense and / or less porous in proximity to a first compressed portion 930 and less dense and / or more porous in the wider mid-portion of the first expanded portion 920. Additionally, expandable portions 920, 922, 924, 926, 928 are each configured to have a larger width than when expanded implant 910 is in its folded configuration, and compressed portions 930, 932, 934, 936 are configured each one for

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL AMMONITY

<img file="MX358482B_D0055.tif" />

have a width narrower than the width of the expandable portions 920, 922, 924, 926, 928. As such, the expandable implant 910 is configured to fold, bend, and / or bend in the compressed portions 930, 932, 934, 936 to help adjust to the shape of the aneurysm.

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 The most proximal of the expandable portions 920, 922, 924, 926, 928 is illustrated in Figure 12. The first expandable portion 920 is configured to be positioned over the neck of the aneurysm 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 flow disruptor in the neck of the aneurysm to help limit blood flow to the aneurysm from the originating blood vessel. The expanded portions 922, 924,

Remaining distal 926, 928 are configured to pack into the aneurysm to embolize the aneurysm.

Expandable implant 910 includes a first radiopaque marker 942 coupled to a first end 912 of the implant and a second radiopaque marker coupled to a second end 914 of the implant. Radiopaque markers ω

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MX / a / 2018/000789

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IMPI r T MEXICAN INSTITUTE □ J “DF LA PROPIEDAD

INDUSTRIAL

942, 944 are configured to be fully disposed within the aneurysm sac when 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 as described above for prior modalities. For example, medical device 1000 includes an expandable implant 1010 and an insert portion or member 1002.

Expandable implant 1010 is sized to occupy the aneurysm sac, and insertion member 1002 is configured to facilitate delivery of the expandable implant into the aneurysm sac. The expanded implant 1010 is shown in an expanded configuration and can be moved between a compressed or folded configuration and the expanded configuration in the same or similar manner as described above for previous modalities.

Expandable implant 1010 includes a first porous member 1020 and a second porous member 1030. First porous member 1020 includes a porous mesh configured to have a multidimensional shape when expanded expander 1010 is in its expanded configuration. As such, the first porous member 1020 has a second width in the expanded configuration that is larger than the first width of the first porous member in the

MX / a / 2018/000789

IMPI

<img file="MX358482B_D0057.tif" />

<img file="MX358482B_D0058.tif" />

folded configuration. The first porous member 1020 can be configured to expand to any multidimensional shape including, for example, one that resembles a parabola, as shown in Figure 13, a sphere, a disk, or the like. The first porous member 1020 is configured to be positioned over the neck of the aneurysm when the expandable member 1010 is disposed within the aneurysm sac to interrupt and / or stop the flow of blood to the aneurysm from the originating blood vessel.

Additionally, the porous mesh of the first porous member 1020 is configured to promote endothelial cell attachment in the neck of the aneurysm, which may aid healing of the neck of the aneurysm.

MX / a / 2018/000789

The second porous member 1030 includes a porous mesh configured to have a multidimensional shape when the expandable implant 1010 is in its expanded configuration. As such, the second porous member 1030 has a fourth width in the expanded configuration larger than the third width of the second porous member in the folded configuration. The second porous member 1030 can be configured to expand to any multidimensional shape · including, for example, that which resembles a tube, as shown in the Figure, any multidimensional shape including, for example, that which resembles a tube, such as shown in Figure 13, a sphere, a

IMPI

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<img file="MX358482B_D0060.tif" />

disk, a parable or the like. In the embodiment illustrated in Figure 13, the second width of the first porous member 1020 is larger 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 second porous member 1030 and the neck of the aneurysm. The second porous member 1030 is configured to pack into 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 fold, curl, and / or fold in the radiopaque marker

1044, which can help expandable implant 1010 adjust to the configuration of the aneurysm sac. Another radiopaque marker 1042 can be disposed on a proximal end of expandable implant 1010, and can be used to couple insertion portion 1002 to expandable implant.

Radiopaque markers 1042, 1044 are configured to be fully disposed within the aneurysm sac when expandable implant 1010 is disposed in the aneurysm in its expanded configuration.

MX / a / 2018/000789

Figures 14-15 illustrate another embodiment of a medical device. The 1100 medical device may include

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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

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characteristics and functions equal or similar to those described above for the previous modalities. For example, medical device 1100 includes a first porous member 1120, a second porous member 1130, and a portion or insertion member 1102 removably engageable to the first and second porous members 1120, 1130.

The first porous member 1120 has a first end 1122 and a second end 1124. As shown in Figure 14, the first porous member 1120 has a folded configuration for insertion through a blood vessel. In its folded configuration, the first porous member 1120 is substantially elongated with a first length. As shown in Figure 15, the first porous member 1120 has an expanded configuration to occupy the sac of an aneurysm. When the first porous member 1120 is in its expanded configuration, it has a three-dimensional shape and defines an open inner region 1126. The first porous member 1120 may have any suitable three-dimensional shape. For example, the first porous member 1120 can be configured to curve into a substantially spherical configuration, 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.

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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0062.tif" />

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 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 first folded configuration (not shown in Figures 14 or 15) for insertion through a blood vessel. In its folded 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 a second expanded configuration to occupy at least a portion of the volume of the aneurysm sac. 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 greater than the first volume. The second porous member 1130 can have any suitable three-dimensional shape. For example, the second porous member 1130 may be configured to expand to a substantially ball-shaped configuration (eg, spherical, round, oblong, or the like), as shown in

MX / a / 2018/000789

- 58 IMPI

MEXICAN INSTITUTE

OE LA MOHEDA · industrial

<img file="MX358482B_D0063.tif" />

Figures 14 and 15. In the expanded configuration, the second porous member 1130 may have a porosity equal to or different from the porosity of the first porous member 1120. The second porous member 1130 is configured to be disposed in the interior region 1126 of the first porous member 1120 when each of the first porous member and the second porous member is in the deployed or expanded configuration.

In the embodiment illustrated in Figures 14 and 15, the second porous member 1130 couples to the first porous member 1120. Specifically, the first end 1122 of the first porous member 1120 couples to the first end 1132 of the second porous member 1130. At least one the first porous member 1120 and the second porous member 1130 include a radiopaque marker. As shown in Figure 14, a first radiopaque marker 1142 may be disposed on the first ends 1122, 1132 of the first and second porous members 1120, 1130 to couple the first and second porous members with each other. A second radiopaque marker 1144 may be disposed on 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.

MX / a / 2018/000789

In use, the first and second porous members

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0064.tif" />

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1120, 1130, and the first and second radiopaque markers

1142, 1144, are completely disposed within the aneurysm. The second porous member 1130 may be inserted into the aneurysm first and assume its expanded configuration within it. The first porous member 1120 can then be inserted into the aneurysm such that the first porous member curves, coils, or otherwise wraps around the second porous member 1130 as the first porous member moves into 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 1129 in which the first segment overlaps the second segment may be placed over the neck of the aneurysm to promote endothelial cell attachment to the neck of the aneurysm. The second porous member 1130 can help to embolize the aneurysm by providing an additional porous mesh within the aneurysm sac for cell attachment and / or clot formation. As such, the second porous member occupies a portion of the volume of the aneurysm sac in such a way that the flow of blood to the

MX / a / 2018/000789 through the aneurysm.

Although the 1100 medical device includes first and

IMPI

INSTITUTO MUICANO Di LA PROPIIDAD INDUSTRIAL

<img file="MX358482B_D0065.tif" />

separate second 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. The medical device 1200 may include the same or similar features and functions as described above for the medical device 1100, or other prior embodiments. For example, medical device 1200 includes a first porous member

1220, a second porous member 1230 and an insertion portion or member (not shown in Figure 16) removably engageable to the first and second porous members. The first porous member 1220 and the second porous member 1230 may each be similar in form and function to the first porous member 1120 and the second porous member 1130, respectively, described above.

However, in the embodiment illustrated in Figure 16, 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 a configuration expanded but the second porous member 1230 is shown separate from the first porous member 1220 for illustration purposes only. In use, in their respective deployed or expanded configurations, the second member

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IMPI

INSTITUTO MEXICANO DI LA EROEIEDAD

INDUSTRIAL

<img file="MX358482B_D0066.tif" />

Porous 1230 is disposed within an inner region 1226 defined by first porous member 1220 in a manner similar to that illustrated in Figure 15 with respect to medical device 1100. Additionally, medical device 1200 includes two radiopaque markers 1242, 1244. The first radiopaque marker 1242 is disposed at one end of the porous mesh of the first porous member 1220, and the second radiopaque marker 1244 is disposed at an opposite end of the porous mesh of the second porous member 1230.

In some embodiments, the medical device includes an expandable implant that has a substantially continuous outer surface when in an expanded configuration. Referring to Figures 17A and 17B, a portion of medical device 1300 is illustrated in accordance with one embodiment in a folded configuration and in an expanded configuration, respectively. The medical device 1300 may include the same or similar features and functions as those described herein for other modalities. For example, medical device 1300 may include an expandable implant 1310 configured to move from the folded configuration (eg, for delivery through a blood vessel) to the expanded configuration (eg, for deployment within the aneurysm). Expandable implant 1310 includes at least a first portion 1320 and a second portion 1330, and may include portions 1340,

MX / a / 2018/000789

IMPI

MEXICAN INSTITUTE OF THE «INDUSTRIAL OPIEDAD

<img file="MX358482B_D0067.tif" />

Additional 1350, 1360. When the expandable implant 1310 is in its expanded configuration, the expandable implant 1310 has a three-dimensional shape (eg, 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 may overlap as shown in Figure 17B. In other words, the expandable implant 1310 moves into the expanded configuration such that little or no opening or space remains between the edges of the portions 1320, 1330, 1340, 1350,

1360 of the expandable implant 1310.

FIG. 18 is a flow chart illustrating a method 80 for using a medical device to interrupt blood flow to an aneurysm and to promote healing of the aneurysm, as described herein, in accordance with one embodiment. Method 80 includes at 82, the placement of a catheter adjacent to a blood vessel aneurysm. For example, a distal portion of the catheter can be located adjacent to an opening from the blood vessel to 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.

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<img file="MX358482B_D0068.tif" />

At 84, optionally, an expandable medical device implant is inserted into the catheter. The expandable implant includes a first portion and a second portion, each of which has a first configuration (eg, insert or folded) and a second configuration (eg, deployed or expanded). 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 it is in the first configuration and a second porosity when it is in the second configuration. The second porosity may, for example, be greater than the first porosity. The expandable implant can be tilted into its second configuration before being inserted into the catheter. The expandable implant is in its first configuration when the expandable implant is disposed in the lumen of the catheter. The expandable implant can be inserted into the catheter after placing the catheter into the blood vessel before inserting the catheter at any time

MX / a / 2018/000789 catheter in the intermediate blood vessel.

<td>In</td><td> 86,</td><td>the</td><td>implant</td><td>expandable</td><td colspan="2">is oriented</td>

<td>optionally</td><td>toward</td><td>the</td><td>opening</td><td>on the wall</td><td>of the glass</td><td>in</td>

<td>communication</td><td>fluid</td><td>with</td><td colspan="3">the aneurysm. In this way,</td><td>the</td>

<td colspan="2">expandable implant</td><td>I know</td><td>guides</td><td>to enter</td><td>to the sack</td><td>of the</td>

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MEXICAN INSTITUTE • F LA MONEDAD INDUSTRIAL

<img file="MX358482B_D0069.tif" />

aneurysm when the expanded implant is moved out of the catheter, as described in greater detail herein.

At 88, the expanded implant moves from a first position inside the catheter to a second position outside the catheter. For example, the expanded 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 expanded implant is in its first configuration when it is in its first position within the catheter. The expanded implant moves to its second configuration when it is in its second position outside the catheter restriction. The second portion of the expanded implant can be moved to its second configuration before moving the first portion to its second configuration. In their respective second configurations, the second portion can be arranged in an interior region defined by the first portion. For example, the second portion may be moved to its second configuration in which it has an expanded multidimensional shape, and then the first portion may be moved to its second configuration in which it bends in an expanded multidimensional shape around the second portion.

The medical device may include an insertion portion configured to move the implant expanded from

MX / a / 2018/000789

IMPI

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX358482B_D0070.tif" />

his first position to his second position. The insertion portion may be, for example, a wire coupled to one of the first portion or the second portion of the expandable implant. At 90, the insertion portion is optionally disconnected from the expandable implant. For example, the insertion portion may be disconnected from a proximal end of the expandable implant, such as after inserting the expandable implant into the aneurysm. At 92, the insertion portion is optionally removed from the blood vessel through the catheter.

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After the expandable implant is placed within the aneurysm or other target vascular defect, the portion of the patient's body that includes the aneurysm can be visualized (eg, using X-rays or other appropriate visualization techniques) to determine if the expandable implant is properly positioned within of the aneurysm. For example, the expandable implant can include one or more radiopaque markers that are visible using X-rays. In another example, the patient may be injected intravenously with a radiopaque dye at the desired time after implantation of the expandable implant to determine the success of endothelial cell attachment and / or healing to the aneurysm neck after the procedure. If the radiopaque dye is visible within the blood vessel of origin adjacent to the aneurysm, but not

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INDUSTRIAL within the aneurysm itself, the expandable implant has operated to successfully prevent additional blood flow to the aneurysm. If the radiopaque dye is visible within the aneurysm, blood flow from the originating blood vessel has not been completely prevented and the medical assistant may consider additional treatment options.

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 for prior modalities. For example, medical device 1400 includes an expandable implant 1410 and an insertion portion or member (not shown in Figure 19A). The expandable implant 1410 is shown in an expanded configuration and can move between a compressed or folded 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.

Expandable implant 1410 includes a porous mesh lath strand and includes petal-like portions or sections 1425 and 1427 along its length. At least a portion of the porous mesh is configured to sit on the neck of the aneurysm when expandable implant 1410 is in the expanded configuration. The expandable implant 1410 includes a first portion 1420 that includes

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<img file="MX358482B_D0072.tif" />

the petal-like portions 1427 and a second portion 1430 including the petal-like portions 1425. The petal-like portions 1425 of the second portion 1430 are larger than the petal-like portions 1427 of the first portion 1420 such that when the implant expanded 1410 is moved to its expanded configuration, the petal-like portions 1425 of the second portion at least partially overlap the petal-like portions 1427 of the first portion 1420. During deployment of the expanded implant 1410 (eg, when moving from its folded configuration to its expanded configuration) the petal-like portions 1425 of the second portion 1430 will unfold first and then the petal-like portions 1427 of the first portion 1420 will unfold to the less partially within an interior region defined by second portion 1430. The petal-like portions 1425 of the second portion 1430 can be sized and configured to be arranged in the neck of an aneurysm when the expanded implant 1410 is in the expanded configuration. The petal-like portions

1427 of the first portion 1420 can be formed in an arrangement of a smaller diameter than the petal-like portions 1425, and can be dimensioned and configured to substantially fill the aneurysm and hold the second portion 1430 in place in the neck of the aneurysm when the implant expanded 1410 is in the configuration

MX / a / 2018/000789

IMPI

MEXICAN INSTITUTE D € THE INDUSTRIAL PROPERTY

<img file="MX358482B_D0073.tif" />

expanded. For example, the petal-like portions 1427 of the first portion 1420 may have a diameter of approximately 2mm to 12mm, and the petal-like portions 1425 of the second portion 1430 may have a corresponding diameter approximately 1mm larger than the standard portions. petal 1427 of the first portion 1420. For example, the petal-like portions 1425 of the second portion 1430 may be from about 3mm to 13mm. 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

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MX / a / 2018/000789

1430.

As described for the previous modalities, a first radiopaque marker 1442 is coupled to a first end of expandable implant 1410 and a second radiopaque marker (not shown) is coupled to the second end of expandable implant 1410. Expandable implant 1410 is configured to be fully disposed within the

<td>aneurysm</td><td>of</td><td>such way</td><td>than</td><td>the</td><td>markers</td><td>radiopaque</td><td>I know</td>

<td>20 have</td><td colspan="3">completely inside</td><td>of the</td><td>I take the</td><td>aneurysm and</td><td>the</td>

<td colspan="2">porous mesh</td><td>is arranged</td><td>on</td><td>the</td><td>neck of</td><td>aneurysm.</td><td>In</td>

In some modalities, radiopaque markers are configured to be located on one side of the aneurysm (ie, arranged away from the neck of the aneurysm).

Figure 20 illustrates a portion of another embodiment.

IMPI

MtXICANO INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0074.tif" />

of a medical device. The medical device 1500 can include the same or similar features and functions as described above for prior modalities. For example, medical device 1500 includes an expandable implant 1510 and an insertion portion or member (not shown in Figure 20). The expandable implant 1510 and the insertion portion or member (not shown in Figure 20). The expandable implant 1510 is shown in an expanded configuration and can be moved between a compressed or folded 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 modality, the expandable implant 1510 includes a porous mesh lath strand. At least a portion of the porous mesh is configured to sit on the neck of an aneurysm and at least one other portion of the porous mesh substantially fills the volume of the aneurysm when the expandable implant 1510 is in the expanded configuration. Expandable implant 1510 includes a first portion 1520 and a second portion 1530. In this embodiment, each of the first portion 1520 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 ω

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MX / a / 2018/000789

IMPI

MEXICAN INSTITUTE Di LA INDUSTRIAL RRORIEDAD

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Crt oo oo can be configured to be arranged in the neck of one ΓΟ aneurysm and the other of the first portion 1520 or the second portion 1530 can substantially fill the volume of the aneurysm. For example, in this embodiment, the first portion 1520 may be configured to deploy in the aneurysm dome and serve 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 in the expanded configuration. Expandable implant 1510 can also include radiopaque markers (not shown) as described above for previous modalities.

MX / a / 2018/000789

Figures 21 and 22 illustrate another embodiment of a medical deviceO. The medical device 1600 may include the same or different features and functions as those described above for prior modalities. For example, medical device 1600 includes an expandable implant 1610 and an insertion portion or member (not shown). Expandable implant 1610 is shown in an expanded configuration and can move between a compressed or folded 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 previous modalities.

As with the previous modality, the implant

- 71 IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0076.tif" />

Expansion 1610 includes a porous mesh lath strand that includes a first portion 1620 in the form of a disk-shaped structure and a second portion 1630 that includes petal-like portions or sections along its length (similar to the embodiment of the Figure 19A). The disk-shaped or spherical structure of the first portion 1620 can be disposed at various locations along the length (eg, mid, end etc.) of the expandable implant 1610. At least a portion of the porous mesh is configured to sit on the neck of an aneurysm when expandable implant 1610 is in the expanded configuration. In this embodiment, when the expandable implant 1610 is in the expanded configuration, the petal-like portions of the second portion 1630 at least partially overlap the disc-shaped structure of the first portion 1620. For example, when expandable implant 1610 is in its expanded configuration, the petal-like portions of second portion 1630 may define a diameter greater than the diameter defined by the disc or spherical structure of first portion 1620. Expandable implant 1610 can also include a first radiopaque marker 1642 coupled to a first end 1612 of expandable implant 1610 and a second radiopaque marker (not shown) coupled to a second end (not shown) of expandable implant 1610.

MX / a / 2018/000789 358482

- 72 IMPI

MEXICAN INSTITUTE OF PROPERTY IN »UST» 1AI

<img file="MX358482B_D0077.tif" />

When the expandable implant 1610 is in its expanded configuration, the expandable implant 1610 has a three-dimensional shape (eg, a substantially spherical shape) with a substantially continuous outer surface such that the edges of at least two of the 1625 petal-like portions they overlap each other (similarly to the embodiment of Figures 17A and 17B) and at least partially overlap the disc-shaped portion 1620. The expandable implant 1610 can be moved into the expanded configuration such that few or no openings remain between the petal-like portions 1625 of the expandable implant 1610.

Figures 23 and 24 illustrate a portion of another embodiment of a medical device. The medical device

1800 it can include the same or similar characteristics and functions as those described above for previous modalities. For example, medical device 1800 includes an expandable implant 1810 and an insertion portion or member (not shown in Figures 23 and 24). The expandable implant

1810 can move between a folded configuration as shown in Figure 2on folded 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 lath strand of

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ΙΜΡΙ

INSTITUTO MEXICANO OT LA PHOFIÍDAD INDUSTRIAL

<img file="MX358482B_D0078.tif" />

Porous mesh that includes 1825 petal-like portions or sections along its length. At least a portion of the porous mesh is configured to sit on the neck of an aneurysm when 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 (eg, a substantially spherical shape) with a substantially continuous outer surface such that the edges of at least two of the 1825 petal-like portions overlap each other as shown in Figure 24.

In this embodiment, when the implantable implant 1810 is formed the porous mesh lath strand is wrapped around the forming arrangement in a multidirectional manner. For example, a portion of the mesh may be continuously wrapped around the arrangement as indicated at C in Figure 23, and a portion of the mesh may be wrapped in an S-shaped manner as indicated by S in Figure. 2. 3. With such formation, when the expandable implant 1810 is moved into its expanded configuration, the 1825 petal-like portions that have been formed by continuously wrapping will follow each other (each 1825 petal-like portion will cause the adjacent 1825 petal-like portion to fold), and the 1825 petal-like portions that have been formed in an s-shaped manner are

MX / a / 2018/000789 358482

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<img file="MX358482B_D0079.tif" />

they will auto-unfold or fold individually. The successful multidirectional formation of the expandable implant 1810 can allow the expandable implant 1810 to deploy fragmented within an aneurysm.

In this embodiment, medical device 1800 also includes a PT or PT 1835 coil strand disposed along the length of expandable implant 1810 to provide radiopacity to a portion of expandable implant 1810. As shown in Figure 23, the strand

PT 1835 is disposed along the length of expandable implant 1810 and through or within petal-like portions 1825. PT 1835 strand can be attached to, for example, marker bands (not shown) disposed on a proximal end and a distal end of expandable implant 1810. In some embodiments, the PT strand can be braided within the mesh of the expandable implant 1810.

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 as those described above for prior 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 folded configuration (as shown in Figure 25), a partially

MX / a / 2018/000789 358482

ΙΜΡΙ

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0080.tif" />

expanded as shown in Figure 26 and an expanded configuration as shown in Figure 27.

Expandable implant 1910 includes a porous mesh ribbon strand that 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 1945 disk-shaped portions along its length, and the second portion 1930 includes 1925 petal-like portions, as described above for prior 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 deployment of medical device 1900, second portion 1930 may first be deployed such that petal-like portions 1925 move to an expanded configuration and define an interior region 1936.

The first portion 1920 can then be deployed in such a way that the disk-shaped portions 1945 will fold one over the other (as shown in Figures 26 and 27) within the interior region 1936 of the second portion 1930, as shown in Figure 27. In other words, when the 1910 expandable implant is in the configuration

MX / a / 2018/000789 358482

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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0081.tif" />

expanded, the second portion 1930 overlaps at least partially with the first portion 1920, as shown in Figure 27. At least a portion of the porous mesh is configured to sit on the neck of an aneurysm 5 when the expandable implant 1910 is found in the expanded configuration. For example, when the expandable implant 1910 is in its expanded configuration, the second portion 1930 may be disposed in the neck of the aneurysm to interrupt blood flow, and the first portion 1920 can help occlude the aneurysm at a relatively high rate. fast. 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 from a single mesh component.

In this embodiment, medical device 1900 may also include a PT coil or PT strand (not shown) disposed along the length of first portion 1920 and / or second portion 1930 of expandable implant 1910 20 in a manner similar to that of described for 1800 medical device. The PT strand can be coupled to a first marker band 1942 provided at a first end 1912 of the expandable implant 1910 and a second marker band (not shown) provided on a second end (not shown) 25 of the expandable implant 1910.

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MX / a / 2018/000789

As described

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL MONEDAD

<img file="MX358482B_D0082.tif" />

above, the PT strand can be braided into the mesh of the 1910 expandable implant. As shown in Figure 26. and 27, expandable member 1910 also includes a connecting member 1952 that can be used to couple expandable member 1910 to a release device as described in greater detail below (see, eg, discussed in Figure 40).

Figures 28 and 29 illustrate another embodiment of a medical device. A medical device 2000 can include all the same or similar features and functions as those described for previous modalities. For example, medical device 2000 includes an expandable implant 2010, an insertion portion or member 2002, a first radiopaque marker 2042 coupled to a first end 2012 of expandable implant 15 2010, and a second radiopaque marker 2044 coupled to a second end 2014 of the 2010 expandable implant. The 2010 expandable implant can be moved between a folded configuration (not shown) and an expanded configuration as shown in Figures 28 and 29.

In this embodiment, the expandable implant 2010 includes three tubular or rounded strands 2020, 2030, and 2015 formed from a porous mesh similar to the tubular structures described above, for example, with respect to Figures 10 and 11. In some embodiments, the strands

202, 2030 and 2015 can be braided.

MX / a / 2018/000789

In modalities

<img file="MX358482B_D0083.tif" />

MX / a / 2018/000789 358482 a tubular mesh such shape

ΙΜΡΙ _ 7 A - MEXICAN INSTITUTE ^υ Of the alternative industrial PROPERTIES, the 2020, 2030 and 2015 strands can be formed with porous mesh lath strands rather than tubular strands. When the 2010 expandable implant is in its expanded configuration, at least a portion of the 5 tubular strands 2020, 2030, and 2015 may overlap each other as shown in Figure 29. The 2010 Expandable Implant can be used to fill the volume of an 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, 1mm tubular. In this modality, the strands

2020, 2030, 2015 can be formed with heat being that the expandable implant 2010 has a two-dimensional configuration when the expandable implant 2010 is in its expanded configuration. In this embodiment, three tubular strands are included, but in alternative embodiments, a different number of tubular strands may be included. For example, an expandable implant can be formed with 1-10 tubular strands. The tubular strands 20 2020, 2030 and 2015 can be coupled together at various locations along their lengths with marker bands, such as the marker band 2046 shown in Figure 29. In alternative embodiments, the tubular strands are twisted together, or braided each other rather than using 25 marker bands. In some modalities, the threads are not

- 79 couple with each other.

The figure

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0084.tif" />

MX / a / 2018/000789 358482 illustrates another modality of medical device that includes tubular structures.

2100 medical device features and equal functions described for previous modalities.

a

A can include all or similar to

For example, the expandable implant folded configuration 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 attached to the end portions of the expandable implant 2110.

2110 can move between expanded (not shown) as shown in Figure 30.

Expandable implant 2110 includes three tubular or rounded strands 2120, 2130, and 2115 formed from a porous mesh similar to the tubular strands described above for medical device 2000. When expandable implant 2110 is in its expanded configuration, at least a portion The tubular strands 2120, 2130, and 2115 may overlap each other as shown in Figure 30. In this embodiment, tubular strands 2120, 2130, 2115 can be heat formed to have a three-dimensional configuration when expandable implant 25 2110 is in the expanded configuration.

The one and one configuration

In this

IMPI

<img file="MX358482B_D0085.tif" />

<img file="MX358482B_D0086.tif" />

modality, three tubular strands are included, but in alternative modalities a different number of tubular strands may be included. For example, an expandable implant can be formed with 1-10 tubular strands. 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 medical device 2000, or can be coupled using other coupling methods, such as twisting between yes, or braid each other. In some embodiments, the tubular strands do not mate together.

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Figure 31 illustrates another embodiment of a medical device that includes tubular structures. A medical device 2200 can include all the same or similar features and functions as those described for previous modalities. For example, medical device 2200 includes an expandable implant 2210 and an insert portion or member 2202. Although not shown in Figure 31, medical device 2200 may also include radiopaque markers attached to the end portions of expandable implant 2210, such as radiopaque marker 2242 attached to one end 2212 shown in Figure 31. Expandable implant 2210 it can move between a folded configuration (not shown) and an expanded configuration as shown in Figure 31.

<img file="MX358482B_D0087.tif" />

₈₁ IMPI

- 81 - Mexican institute

OF THE INDUSTRIAL MONEDAD

OD

--—---- In this embodiment, the expanded implant 2210 includes a single tubular or round braided structure 2215 formed of a porous mesh similar to the tubular structures described above for medical devices 2000 and 2100. When the implant expanded 2210 In its expanded configuration, at least a first portion of tubular structure 2215 may overlap a second portion of tubular structure 2215, as shown in Figure 31. In this embodiment, tubular structure 2215 is formed in a two-dimensional configuration and the tubular structure is formed with a mesh of greater porosity than medical devices 2000 and 2100. For example, tubular structure 2215 may be formed with a 3mm 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 those described above for prior modalities. Medical device 2400 includes an expanded implant 2410 and may include an insertion portion or member (not shown in Figures 32-33). The expanded implant 2410 can be moved between a folded 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 type strand

MX / a / 2018/000789

IMPI

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX358482B_D0088.tif" />

porous mesh lath and includes petal-like portions 2425, and a second portion 2430 in the form of a tubular or rounded strand 2415 formed of a porous mesh similar to the tubular strands described above, for example, with respect to Figures 28-30. Tubular strand 2415 can be formed with heat in either a two-dimensional or three-dimensional configuration. In some embodiments, tubular strand 2415 may be braided.

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When the expandable implant 2410 is in its expanded configuration, at least a portion of the first portion 2420 (eg, the petal-like portions 2425) may overlap the tubular strand 2415 of the second portion 2430. At least a portion of the implant Expandable 2410 is configured to sit on the neck of an aneurysm when expandable implant 2410 is in the expanded configuration. The petal-like portions 2425 and the tubular strand 2415 can each be of a variety of different sizes (eg, diameters), such that when the expandable implant 2410 is moved into its expanded configuration, the petal-like portions 2425 of the second portion 2410 defines an interior region and the tubular strand 2415 of the first portion 2420 substantially fills the interior region of the second portion 2430. Thus, tubular strand 2415 can be used as a filler to substantially fill the volume of an aneurysm as

IMPI

MEXICAN INSTITUTE I heard THE INDUSTRIAL PROPERTY

<img file="MX358482B_D0089.tif" />

previously described for 2010 and 2110 expandable implants.

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The first portion 2420 and the second portion 2430 may be coupled to each other, for example, with the marker bands at the end portions of the first portion 2420 and the second portion 2430 and / or at other locations along the length of each one 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 expanded implant 2410 also includes a first radiopaque marker band 2442 disposed at a first end 2412 of the expanded member and a second radiopaque marker band 2444 disposed at a second end 2414 of the expanded implant 2410 as shown in FIG. 35, which is A schematic illustration of the implant expanded 2410. As shown in Figure 34, which is a schematic illustration of the expander implant 2410, the expander member 2410 also includes a connector member 2452 that can be used to couple the expander member to a release device as described in greater detail below.

Figures 35-37 are each an illustration

IMPI

MEXICAN INSTITUTE M PROPERTY

INDUSTRIAL

<img file="MX358482B_D0090.tif" />

Schematic 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 (eg, 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, insertion device 2254 can be used in place of insertion portion 102 described herein and can be releasably or removably attached to an implant as described in greater detail below.

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Insertion device 2554 includes a first elongated member 2556 defining a lumen 2557 through which a second elongated member 2558 can be movably disposed. A marker band 2564 engages a distal end portion of the first elongated member 2556. An expandable coupling member 2562 also engages the distal end portion of the first elongated member 2556, for example, by adhesively coupling a portion of the expandable coupling member 2562 between the marking band 2564 and an outer wall of the first elongated member 2556. The expandable coupling member 2562 may be of various lengths and in some embodiments may have a length, for example, of about 125mm. The expandable coupling member 2562 can

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0091.tif" />

formed, for example, from a mesh material and / or a braided material.

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

To insert and deploy an expandable implant (eg, an expandable implant as described herein) within 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, a 2510 expandable implant (also referred to as an implant)

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MEXICAN INSTITUTE OF LA MONEDAD

INDUSTRIAL

<img file="MX358482B_D0092.tif" />

may include an outer marker band 2543 and an inner marker band 2541 each coupled to a proximal end portion 2512 of the implant 2510. The outer marker band 2543 can be used to hold the implant 2510, and the inner marker band 2541 can be disposed within outer marker band 2543. Inner marker band 2541 can provide a channel through which a distal end portion of inserter 2554, which includes expanded coupling member 2562 and spherical member 2560, can be inserted. The second elongated member 2558 is then pulled proximally (in the direction of arrow A in Figure 36) causing the spherical member 2560 to fit within the expanded coupling member 2562 as shown in Figure 36.

For example, the expanded coupling member 2562 can move between the folded or relaxed configuration as shown in Figure 35 and the expanded configuration as shown in Figure 36 in which the expanded coupling member 2562 flexes outward or is expands as spherical member 2560 moves proximally within expanded coupling member 2562. A locking mechanism (not shown) can be used to secure the second elongated member 2558 in position relative to the first elongated member 2556. For example, a handle (not shown) can be attached to the second elongated member

MX / a / 2018/000789

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MEXICAN INSTITUTE OF PROPERTY

INDUSTWAL

<img file="MX358482B_D0093.tif" />

2558 and may include a locking mechanism that can secure the second elongated member 2558 in the position shown in Figure 36. With the expandable coupling member 2562 expanded as shown in Figure 36, the implant 2510 remains attached to the insertion device. .2554.

MX / a / 2018/000789

With insertion device 2554 attached to implant 2510, a distal end portion (not shown) of implant 2510 can be inserted, for example, into an insertion cannula or catheter (not shown) (eg, the cannula

102 described above), and the insertion cannula can be used to insert implant 2510 into a blood vessel in a manner similar to that described above with respect to Figures 1 and 2. For example, implant 2510 with insertion device 2554 coupled to the It can itself be inserted into the insertion cannula such that the implant 2510 moves into a folded configuration. The insertion cannula can then be inserted into a patient's blood vessel to deliver implant 2510 to a desired location (eg, an aneurysm) within the patient. In the desired location, implant 2519 can be moved out of a distal end of the cannula and moved to its expanded configuration as described above. After deploying implant 2510, implant 2510 can be detached from insertion device 2554.

IMPI

MEXICAN INSTITUTE OF LA MONEDAD industrial

<img file="MX358482B_D0094.tif" />

Specifically, to detach insertion device 2554 from implant 2510, second elongate member 2558 is released and moved distally (in the direction of arrow B shown in Figure 37) such that spherical member 2560 moves distally out of the expandable coupling member 2562 allowing the expandable coupling member 2562 to move back into its folded or relaxed configuration as shown in Figure 37. Insertion device 2554 can then be removed by pulling insertion device 2554 proximally (in the direction of arrow A in Figure 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 can be releasably or removably attached to an implant, as described above for insertion device 2554.

Insertion device 2654 includes a first elongated member 2656 defining a lumen 2657 through which a second elongated member 2658 can be movably disposed. A coupling element 2666 couples to a distal end portion of the first elongated member

2656, for example, pasting a portion of the

MX / a / 2018/000789

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MEXICAN INSTITUTE Dt THE PROPERTY

INDUSTRIAL

<img file="MX358482B_D0095.tif" />

Coupling 2666 to an inner wall of the first elongated member 2656. Coupling element 2666 may include, for example, a length of suture material, and may be of various lengths. For example, the coupling element 2666 in some embodiments can be approximately 1-2mm in length. The first elongated member 2656 may also include a marker band (not shown) similar to marker band 2564 coupled to a distal end portion of the first elongated member 2656.

The second elongated member includes a spherical member 2660 disposed at a distal end of the second elongated member 2658 and is movable between a first position in which the spherical member 2660 is disposed at a distance from suture member 2666 (eg, in a distal position of the coupling element 2666), and a second position in which the spherical member 2660 is placed in contact with the suture element 2666. For example, when the second elongated member 2658 is in its second position, the spherical member 2660 is disposed at a location along the length of the suture element 2662 and contacting the coupling element 2666 in such a way that a Tight fit between ball member 2660 and suture member 2666 as shown in Figure 38.

To insert and unfold an expandable implant

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MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX358482B_D0096.tif" />

(not shown), such as the extensible implants described herein, within the body of a patient, a proximal end portion of the expandable implant (also referred to as an implant) may be coupled to a distal end portion of the insertion device 2654. Specifically , the implant may include an outer marker band 2643 and an inner marker band 2641 each coupled to a proximal end portion of the implant (not shown). As with the previous embodiment, the outer marker band 2643 can be used to hold the implant 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 elongated member 2658 in its first position (ie, with the spherical member 2660 disposed at a distance from the coupling element 2666) and the coupling element 2666 in its first configuration, the spherical member 2660 and the coupling element 2666 are They insert through the inner marker band 2641 and are disposed within the implant. The second elongated member 2658 is then pulled proximally (in the direction of arrow A in Figure 39) such that the second elongated member 2658 is nine in its second position (with the spherical member 2660 contacting the coupling element 2666) and co in oo ro

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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX358482B_D0097.tif" />

the coupling element 2666 is moved to a second configuration as shown in Figure 38. When the second elongated member 2658 is in its second position and the coupling element 2662 is in its second configuration, a tight fit is created between the spherical member 2660 and the coupling element 2666. This tight fit holds the implant to the insertion device 2654. As described above for the previous embodiment, a locking mechanism (not shown) can be used to secure the second elongated member 2658 in position relative to the first elongated member 2656. For example, a handle 2655 engages the second elongated member 2658 and may include a locking mechanism (not shown) that can secure the second elongated member

2658 in its second position, as shown in Figure 38.

With the 2654 insertion device attached to the implant, a distal end portion (not shown) of the

MX / a / 2018/000789

<td>implant</td><td>can</td><td>insert,</td><td>by</td><td>example in a</td><td>cannula</td>

<td>insertion</td><td>(not</td><td>displayed) ('</td><td>eg,</td><td>cannula 102</td><td>described</td>

<td colspan="2">20 above),</td><td>and the cannula</td><td>of</td><td>insertion can</td><td>be used</td>

for inserting the implant into a blood vessel in a manner similar to that described above with respect to Figures 1 and 2 and Figures 35-37. For example, the implant with insertion device 2654 attached to it can be pushed distally into the cannula to move the

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MEXICAN INSTITUTE OF INDUSTRIAL MONEDAD

<img file="MX358482B_D0098.tif" />

implant in a folded configuration. The cannula can then be inserted into a patient's blood vessel to deliver the implant to a desired location within the patient, such as, for example, within an aneurysm, as described above. After unfolding the implant (eg, moving it away from a distal end of the cannula), insertion device 2654 can be detached from the implant in a similar manner to that described above for the previous embodiment. Specifically, to detach the insertion device 2654 from the implant, the second elongated member 2658 is released and moves distally (in the direction of arrow B in Figure 38) such that the spherical member 2660 moves away (eg, distally) of the coupling element 2666, eliminating the tight fit between spherical member 2660 and coupling element 2666. Insertion device 2654 can then be removed by pulling insertion device 2654 proximally (in the direction of arrow A in Figure 38).

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Figure 39 illustrates an embodiment of an insertion device 2754 similar to the insertion device 2654. The insertion device 2754 may include the same or similar features and operate in the same or similar manner as the insertion device 2654. For example, the insertion device 2754 can be used in

<img file="MX358482B_D0099.tif" />

deployment of an implant as described above.

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

A spherical member 2760 is disposed at a distal end of the second elongated member 2758 and the second elongated member 2758 can be moved between a first position in which the spherical member 2760 is disposed at a distance from the coupling element 2766 (eg, distal coupling element 2766) as shown in Figure 40 and a second position in which spherical member 2760 is brought into contact with coupling element 2766 at a location along the length of coupling element 2762 of such that a fit is created with

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<img file="MX358482B_D0100.tif" />

squeeze between spherical member 2760 and coupling element 2766. Insertion device 2754 can be used to insert and unfold an implant and detach from the implant in the same or similar manner 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 removably attached to an implant, as described above, for example, for insertion device 2554.

Insertion device 2854 includes a first elongated member 2856 defining a lumen 2857 through which a second elongated member 2858 can be movably disposed. The first elongated member 2856 may also include a marker band (not shown) coupled to a distal end portion of the first elongated member

2756. A spherical insertion member 2860 is disposed at a distal end of the second elongated member 2858. Insertion device 2854 can be attached to an expandable implant 2810 similar to or equal to the expandable implants described herein. The 2810 expandable implant includes a 2842 marker band and a 2852 connecting member

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<img file="MX358482B_D0101.tif" />

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- 95 coupled to marker band 2842. Connector member 2852 includes a 2868 wire coupled to marker band 2842 and / or implant 2810 and a spherical implant member 2870 coupled to (or formed integrally or monolithically with) 2868 wire. Wire 2868 and spherical implant member 2870 may collectively have a length L which in some embodiments may 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 expandable implant may include the same or similar features and functions as those of the 2852 connector.

To insert and deploy the 2810 expandable implant into a patient's body, the expandable implant

2810 first attached to insertion device 2854.

Specifically, the second elongated member 2858 moves distally (in the direction of arrow B in Figure 40) such that insert-spherical member 2860 is disposed outside a distal end of first elongated member 2856. The spherical member Implant 2870 is then inserted into the distal end of the first elongated member 2856 as shown in Figure 40. The second elongated member 2858 then moves proximally (in the direction of arrow A in Figure 40) such that spherical insertion member 2860 secures or catches the

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<img file="MX358482B_D0102.tif" />

with tn

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QO r \ s spherical implant member 2870 into lumen 2857 of first elongated member 2856 as shown in Figure 40. For example, each of the spherical insertion member 2860 and the spherical implant member 2870 may have a diameter greater than half the diameter of the lumen 2857 of the first elongated member 2856 such that when the spherical implant member 2870 is disposed within From lumen 2857 and spherical insertion member 2860 is moved proximally toward lumen 2857, spherical implant member 2860 cannot be pulled back out of lumen 2857.

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With the spherical implant member 2870 entrapped within the lumen 2857 of the first elongated member 2856, the expandable implant 2810 will be attached to the insertion device 2854. As described above for the previous embodiment, a locking mechanism (not shown) can be used to securing the second elongated member 2658 in this position relative to the first elongated member 2856. With insertion device 2854 attached to expandable implant 2810, a distal end portion (not shown) of expandable implant 2810 can be inserted, for example, into an insertion cannula (not shown) (eg, cannula 102 described above), and the insertion cannula can be used to insert implant 2810 into a blood vessel in a manner similar to that described above with respect to previous modalities. After

IMPI

<img file="MX358482B_D0103.tif" />

Having deployed expandable implant 2810, insertion device 2854 can be detached from expandable implant 2810 in a manner similar to that described above for the previous embodiment. Specifically, to detach insertion device 2854 from expandable implant 2810, second elongate member 2858 is released and moved distally (in the direction of arrow B) such that spherical insertion member 2860 moves distally out of the first elongate member 2856, releasing spherical implant member 10 2870. Insertion device 2854 can then be removed by pulling on the first elongated member

2856 and the second elongated member 2858 proximally.

Figure 41 is a flowchart illustrating a method for deploying an expandable implant into an aneurysm using an insertion device as described herein. The method includes, at 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 elongated member defining a lumen and a second elongated member movably disposed at least partially within the lumen of the first elongated member.

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IMPI

<img file="MX358482B_D0104.tif" />

Coupling may include moving the second elongated member proximally relative to the first elongated member such that a first coupling member on a distal end of the second elongated member engages a second coupling member on at least one of the first elongated member or the expandable implant and secures a portion of the expandable implant to the insertion device. In some embodiments, the second coupling member may be disposed on the first elongated member, and movement of the second elongated member proximally relative to the first elongated member causes the second coupling member to move from a folded configuration to an expanded configuration. . In some embodiments, the second coupling member is disposed on the expandable implant, and before the second elongated member is moved 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.

At 2984, the expandable implant can be inserted into a patient's blood vessel while the expandable implant is in a folded configuration and coupled to the insertion device. For example, the expandable implant can be moved to a folded configuration

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<img file="MX358482B_D0105.tif" />

using a cannula as described herein. At 2986, the expandable implant can be deployed within an aneurysm such that the expandable implant is moved to an expanded confiquration within the aneurysm. For example, the expandable implant can be moved out of the cannula so that it can be moved to its expanded configuration. At 2988, the insertion device can be decoupled from the expandable implant, and at 2990, the insertion device can be removed from the patient's blood vessel.

Figures 42 and 43 illustrate a portion of another embodiment of a medical device. The medical device 3000 may include the same or similar features and functions as described above for prior modalities. For example, medical device 3000 includes an expandable implant 3010 and an insert portion or member 3002. The expandable implant 3010 can be moved between a folded configuration, as shown in Figure 4 and an expanded configuration, as shown in Figure 42.

The expandable implant 3010 includes a porous mesh lath strand 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 ball-like structure that defines a region

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IMPI

<img file="MX358482B_D0106.tif" />

100 Inner 3036 and second portion 3020 can be deployed within inner region 3036. Specifically, during deployment of medical device 3000, second portion 3030 can be first deployed such that it can expand into the ball-shaped structure within an aneurysm. , and then the first portion 3020 can be deployed within the inner region 3036 to substantially fill the second portion 3030 as shown in Figure 42.

Figures 44-46 illustrate a portion of another embodiment of a medical device. The 3100 medical device may include the same or similar features and functions as described above for prior modalities. For example, medical device 3100 includes an expandable implant 3110 and an insert portion or member 3102. The expandable implant 3110 can be moved between a folded configuration, as shown in Figure 45 and an expanded configuration, as shown in Figure 44.

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The expandable implant 3110 is an example of a multilayer implant that includes a porous mesh lath strand that includes a first portion 3115, a second portion 3120, and a third portion 3130 formed from a single mesh component. Such an embodiment may be desirable in that the implant can fit into a small delivery catheter, but may have high disruption of

<img file="MX358482B_D0107.tif" />

ΙΜΡΙ

101 flow having more than two layers of material, and form the layers in-vivo. For example, in this embodiment, when the expandable implant 3110 is in the expanded configuration, the second portion 3120 can expand within the third portion 3130 and the first portion can expand within the second portion 3120. Specifically, during deployment within aneurysm A, as shown in Figure 46, medical device 3100 can first be inserted into delivery catheter 3104 such that expandable implant 3110 moves into its folded configuration. At the deployment site, expandable implant 3110 can be moved out of delivery catheter 3104 and deployed into an aneurysm. During deployment, 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 within catheter 3104. In some embodiments, insertion portion 3102 may be coupled to second portion 3120 such that during detachment of insertion portion 3102 (eg, after deploying expandable implant 3110 within a to tn oo te * oo ro

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- 102

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<img file="MX358482B_D0108.tif" />

aneurysm), the detachment may occur within the second portion to prevent any part of the implant from spreading or hanging within the V blood vessel.

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. An insertion device 3254 can be used in conjunction with a cannula or catheter, and can be releasably or removably attached to an implant, as described for previous modalities.

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

Figure 47. Insertion device 3254 also includes a handle 3255 disposed at a proximal end portion of insertion device 3254.

Insertion device 3254 can be attached to an expandable implant 3210 similar to, or equal to, the expandable implants described herein. The implant &amp; O

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<img file="MX358482B_D0109.tif" />

OO

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OO

103 Expandable 3210 includes a 3242 marking band and a 3252 connecting member coupled to 3242 marking band. The connecting member 3252 may be similar to or equal to, for example, the connecting member 2852 described above. For example, connecting member 3252 includes a wire 3268 coupled to marker band 3242 and a spherical implant member 3270 coupled to (or formed monolithically or integrally with) wire 3242.

MX / a / 2018/000789

To insert and unfold the expandable implant

3210 within a patient's body, the expandable implant

3210 firstly engages the insertion device 3254. Specifically, in this embodiment, the second elongated member 3258 moves proximally (in the direction of arrow A in Figure 47) such that the tapered distal end portion 3267 is it moves proximally into lumen 3257. This allows spherical implant member 3260 to be inserted into lumen 3257 of first elongated member 3256. The second elongated member 3258 is then moved distally (in the direction of arrow B in Figure 47) such that the tapered distal end portion 3267 of the second elongated member 3256 engages the spherical insertion member 3260 and traps or interlocks the spherical implant member 3270 into the lumen 3257 of the first elongated member 3256 between the tapered distal end portion 3267 and the inner marker band 3265.

IMPI

<img file="MX358482B_D0110.tif" />

- 104

With spherical implant member 3270 secured

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<td>or meddled</td><td>inside of the</td><td>lumen 3257</td><td>of the</td><td>first member</td>

<td>elongated 3256,</td><td>the implant</td><td>expandable</td><td> 3210</td><td>will be attached to</td>

<td>device</td><td>insertion</td><td> 3254.</td><td>How</td><td>was described</td>

Above for prior embodiments, a securing mechanism (not shown) coupled to handle 3255 can be used to secure second elongated member 3258 in this position relative to first elongated member 3256. With insertion device 3254 attached to expandable implant 3210, expandable implant 3210 can be inserted, for example, into an insertion cannula (not shown) (eg, cannula 102 described above) to move expandable implant 3210 into a folded configuration , and the insertion cannula can be used to insert the implant into a blood vessel in a manner similar to that described above with respect to previous modalities.

After the expandable implant 3210 has been deployed into, for example, an aneurysm, insertion device 3254 can be detached from the expandable implant

3210 and withdraw from the patient's body. Specifically, to detach insertion device 2854 from expandable implant 3210, in this embodiment, second elongated member 3258 is released from handle 3255 and is moved proximally (in the direction of arrow A) such that the portion of distal end tapered 3267 moves so

<img file="MX358482B_D0111.tif" />

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- Proximal 105 and disengages the spherical insertion member 3260. With the tapered distal end portion 3267 moved proximally, the spherical insertion member 3260 will be free to move out of the lumen 3257 of the first elongated member 3256. The insertion device 3254 it can then be removed by pulling 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 expanded implant as described herein. An insertion device 3354 can be used in conjunction with a cannula or catheter, and can be releasably or removably attached to an implant, as described for previous modalities.

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

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<img file="MX358482B_D0112.tif" />

106 spherical insertion member 3360 at a distal end of the second elongated member 3358 as shown in Figure 48. Insertion device 3354 may also include a handle (not shown) disposed on a proximal end portion of insertion device 3254 as previously described for previous modalities.

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

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

3360 it is longer than the spherical implant member 3370 and defines a slot 3371 in a side portion thereof through which the wire 3368 of the connector member 3352 may be disposed when the implant 3310 is coupled to the insertion device 3354.

To insert and unfold the implant expanded

IMPI

<img file="MX358482B_D0113.tif" />

- 107

3310 Within the body of a patient, the expandable implant 3310 is first coupled to the insertion device 3354. Specifically, in this embodiment, the second elongated member 3358 moves distally (in the direction of arrow B in Figure 48) in such a way that the spherical insertion member 3360 is moved distally out of the lumen 3357 of the first elongated member 3356. The spherical implant member 3370 can be inserted into the lumen 3357 of the first elongated member 3356 and the wire 3368 can be positioned or disposed within the slot 3371 of the spherical insertion member 3360. The second elongated member 3358 is then moved distally (in the direction of arrow A in Figure 48) such that the spherical insertion member 3360 and the spherical insertion member

3370 they move into the lumen 3357 of the first elongated member 3356 and the spherical insertion member 3360 secures or traps the spherical insertion member 3360 within the lumen 3357 of the first elongated member 3356 as shown in Figure 48.

With the spherical implant member 3370 secured within the lumen 3357 of the first elongated member 3356, the expandable implant 3310 will engage the insertion device 3354. As described above for prior embodiments, a belay mechanism (not shown) coupled to the handle (not shown)

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<img file="MX358482B_D0114.tif" />

CO

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QO

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108 to secure the second elongated member 3358 in this position relative to 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 3310 expandable implant to a folded configuration. The insertion cannula can be used to insert implant 3310 into the blood vessel in a manner similar to that described above with respect to previous modalities.

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After deploying expandable implant 3310 into, for example, an aneurysm, insertion device 3354 can be detached from expandable implant 3310 and the patient's body removed. Specifically, to detach insertion device 3354 from expandable implant 3310, in this embodiment, the second elongated member 3358 is released from handle 3355 and is moved distally (in the direction of arrow B in Figure 48) such that the spherical insertion member 3360 moves distally allowing spherical implant member 3370 to be free to move out of lumen 3357 of first elongated member 3356. The insertion device 3354 can then be removed by pulling the insertion device 3354 proximally.

Figure 49 is a schematic illustration of another

<img file="MX358482B_D0115.tif" />

- 109 embodiment of an insertion device that can be used to insert and deploy an implant, such as an expandable implant as described herein. A 3454 insertion device can be used in conjunction with a cannula or catheter, and can be detachably or removably attached to an implant, as described for previous modalities.

Insertion device 3454 includes a first elongated member 3456 defining a lumen 3457 through which a second elongated member 3458 can be movably disposed. First elongated member 3458 includes a tapered distal end portion 3492 as shown in Figure 49, but in alternative modalities, it can have a constant diameter. The first elongated member 3456 also includes an outer marker band 3464 coupled to the tapered distal end portion 3492. A plunger or fender 3494 is provided at a distal end of the second elongated member 3458, as shown in Figure 49. The device Insert 3454 may also include a handle (not shown) disposed on a proximal end portion of insert 3454 as described above for prior embodiments.

Insertion device 3454 can be attached to an expandable implant 3410 similar to, or equal to, the expandable implants described herein. The implant

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<img file="MX358482B_D0116.tif" />

- 110

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY expandable 3410 includes a 3442 marker band at a proximal end portion of the 3410 expandable implant, and a 3452 connector member coupled to the 3442 marker band. The connector member 3452 may be similar to, or equal to, for example, the connector member 2852 described above and includes a wire 3468 coupled to the marker band 3442 and a spherical implant member 3470 coupled to (or formed monolithically or integrally with) wire 3442.

To insert and deploy the expandable implant 10 3410 into the patient's body, the expandable implant 3410 is first attached to the insertion device 3454. Specifically, in this embodiment, the second elongated member 3458 is moved distally (in the direction of arrow B in Figure 49) such that the insert plunger member 3494 moves distally out of the lumen 3457 of the first elongated member 3456. The spherical implant member 3470 can then be inserted into the lumen 3457 of the first elongated member 3456. The second elongated member 3458 is then moved distally (in the direction of arrow A in Figure 49) such that the plunger member 3494 secures or traps spherical insertion member 3460 within lumen 3457 of first elongated member 3456 as shown in Figure 49.

With the spherical implant member 3470 trapped within the lumen 3457 of the first elongated member 3456, you can

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IMPI

<img file="MX358482B_D0117.tif" />

- A locking mechanism (not shown) coupled to the handle (not shown) will be used to secure the second elongated member 3458 in this position relative to the first elongated 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 expandable implant 3410 into a folded configuration. The insertion cannula can be used to insert implant 3410 into the blood vessel in a manner similar to that described above with respect to previous modalities.

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

3410 and withdraw from the patient's body. Specifically, to detach insertion device 3454 from expandable implant 3410, in this embodiment, the second elongated member 3458 is released from the handle and moved distally (in the direction of arrow B in Figure 49) such that the member Plunger 3494 is moved distally allowing the spherical implant member 3470 to be free to move out of lumen 3475 of the first elongated member 3456.

The insertion device 3454 can then be removed by pulling the insertion device 3454 proximally.

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Figure 50 is a schematic illustration of another

IMPI

<img file="MX358482B_D0118.tif" />

CO

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- 112 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 3554 can be used in conjunction with a cannula or catheter, and can be detachably or removably attached to an implant, as described for prior modalities.

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Insertion device 3554 includes a first elongated member 3556 defining a lumen 3557 through which a second elongated member 3558 can be movably disposed. First elongated member 3558 includes a tapered distal end portion 3592 as shown in Figure 50, but in alternative modalities, it can have a constant diameter. The first elongated member 3556 also includes an outer marker band 3564 coupled to the tapered distal end portion 3592. A spherical insertion member 3560 is provided at a distal end of the second elongated member 3558, as shown in Figure 50. In this As an embodiment, inserter 3554 also includes an elongated locking member 3596. The securing member 3594 may have a constant outer diameter or perimeter along its length or it may taper. For example, a distal end portion of the locking member 3596 may have a smaller diameter than a proximal end portion of the locking member.

IMPI

<img file="MX358482B_D0119.tif" />

113 belay 3596. Belay member 3596 is used in conjunction with spherical insertion member 3560 to secure spherical implant member 3570 to insertion device 3554 as described in more detail below. Insertion device 3554 may also include a handle (not shown) disposed on a proximal end portion of insertion device 3554 as previously described in previous embodiments.

As in previous embodiments, insertion device 3554 can be attached to an expandable implant 3510 similar to, or equal to, the expandable implants described herein. Expandable implant 3510 includes a marker band 3542 at a proximal end portion, and a connecting member 3552 coupled to marker band 3542. The connector member 3552 may be similar to, or equal to, for example, the connector members described above and includes a wire 3568 coupled to the marker band 3542 and a spherical implant member 3570 coupled to (or formed monolithically or integrally with) wire 3542.

To insert and unfold the expandable implant

3510 Within the patient's body, the expandable implant 3510 is first coupled to the insertion device 3554. Specifically, in this embodiment, the locking member 3596 moves proximally (in the direction of arrow A in Figure 50) in such a manner way that

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ΙΜΡΙ

<img file="MX358482B_D0120.tif" />

co σι

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114 a distal end portion of the locking member 3596 is disposed proximal to the spherical insertion member 3560. This allows the spherical implant member 3570 to be inserted into the lumen 3557 of the first elongated member 3556. In other words, the spherical insertion member 3560 and the spherical implant member 3570 can each be dimensioned (eg, each can have a diameter) such that when the locking member 3594 moves proximally, disengaging the member spherical insert 3560, the spherical implant member 3570 can be moved in and out of the lumen 3557 while the spherical implant member 3570 is disposed within the lumen 3557. After positioning the spherical implant member 3570 within the lumen 3557 of the first elongated member 3556, the locking member 3596 can be moved distally (in the direction of arrow B in Figure 50) such that. the distal end portion of the securing member 3596 is sandwiched between an inner wall of the first elongated member 3556 and the spherical insertion member 3560. With the locking member 3596 in this position, the spherical implant member 3570 will be clamped or entrapped within the lumen 3557 of the first elongated member 3556 as shown in Figure 50.

With the spherical implant member 3570 trapped within the lumen 3557 of the first elongated member 3556, you can

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<img file="MX358482B_D0121.tif" />

co en re

115 a locking mechanism (not shown) coupled to a handle (not shown) is used to secure the locking member 3596 in position relative to the first elongated member 3556. With the insertion device 3554 coupled to the expandable implant 3510, the expandable implant 3510 can be inserted into, for example, an insertion cannula (not shown) to move expandable implant 3510 into a folded configuration. The insertion cannula can be used to insert implant 3510 into a blood vessel in a manner similar to that described above with respect to previous modalities.

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After the expandable implant 3510 has been deployed within, for example, an aneurysm, insertion device 3554 can be detached from the expandable implant 3510 and removed from the patient's body. Specifically, to detach the insertion device 3554 from the expandable implant 3510, in this embodiment, the securing member 3596 is released from the handle and moved proximally (in the direction of arrow A in Figure

50) such that the distal end portion of the locking member 3596 moves proximally away from the spherical insertion member 3596 allowing the spherical implant member 3570 to be free to move out of lumen 3557 of the first elongated member 3556 .

The insertion device 3554 can then be removed

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<img file="MX358482B_D0122.tif" />

116

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GO £ * 1

GO by pulling the 3554 insertion device proximally. ΙΌ Insertion devices (eg, 2554, 2654,

2754, 2854, 3254, 3354, 3454, 3554) 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 outer marker band and an inner marker attached to a proximal end portion of the expandable implant that can be used to couple the expandable implant with an insertion device, such as, for example, by Example, insert devices 2554, 2654, and 2754.

Furthermore, any of the expandable implants described herein may include a connector member (eg, 1652,

1952, 2452, 2852, 3252, 3352, 3452, 3552) as described above, including a wire and a spherical member configured to engage an insertion device, such as, for example, insertion devices 2854, 3254,

3354, 3454 and 3554.

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The various devices described herein can be made of any material suitable for the defined purpose, including, for example, DFT® drawn filed tube. The DFT is available as a wire, cable, or ribbon. DFT is a metal-to-metal compound developed to combine the desired physical and mechanical attributes of two or more

IMPI

<img file="MX358482B_D0123.tif" />

- 117 materials in a single wire or lath system, which can be used for the expandable implant.

Filaments or wires for braiding or mesh (eg, expandable implants) may include, for example, filaments or materials such as MP35N, stainless steel, nitimol, cobalt chrome, titanium, platinum, tantalum, tungsten, or alloys thereof, or polyester, polyethylene (PET), Dacron, PEEK, vectron, and suture materials. Each strand can have a different diameter between

0005 '' - .010 '', eg, approximately .002 ''. In some embodiments, an outer mesh or braid material can be formed with nitinol that is super elastic at temperature

MX / a / 2018/000789 ambient, and the interior material may be radiopaque, or alternatively platinum wires may be included in the braid to provide fastness. For example, in some embodiments, the expandable implant may include woven radiopaque material (s) within the mesh material such that the expandable implant can be highly visible without the use of a radioactive dye.

Suitable materials can be selected based on their electro-porosity. For example, an expandable implant can include titanium, tungsten, or other material listed in Table 1 below, or any combination thereof. In use, the electropositive material of the expanded expandable implant creates one. region electrically

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<img file="MX358482B_D0124.tif" />

- 118 favorable within the vascular defect and through the blood, and the region containing blood, fluid or tissue in the defect is then predisposed for endothelialization to occur.

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

<td> 22</td><td>You</td><td>titaniuo</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>tungsten</td><td> 1.47</td>

In some embodiments, the expandable implants described herein can be formed with tubular braid, or sheets of woven filaments (which form a mesh, fabric, or cloth). The filaments can be wire or polymer or another suitable material. Expandable implants can be stranded wire (eg, NiTi wire), and can include a mix of wire types and wire sizes (eg, NiTi and Platinum wire, and eg, stranded wire of

0.001 '' with 0.00125 '' wire). Expandable implants can also be made of polymer fibers, or of polymer fibers and metal wire mixed together. In some embodiments, expandable implants can be formed from one or more bioabsorbent materials.

The expandable implants described herein

<img file="MX358482B_D0125.tif" />

- 119 can be formed with one or more soft foldable materials such that the expandable implant can be deployed, for example in a ruptured and non-ruptured aneurysm. In some embodiments, an expandable implant can be formed as described herein 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 proximal end portion of an expandable implant can be formed with a first material that provides greater rigidity than the second material with which a distal end portion 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 the implant hold, for example, in the aneurysm neck.

Expandable implant mesh can be manufactured in a variety of different ways, including, but not limited to, braiding, weaving, welding, or laser cutting. The mesh can have an operating length,

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<img file="MX358482B_D0126.tif" />

- 120 for example, in a range of about 0.5cm to about 70cm. In some modalities, the mesh can be 30 cm long. In some embodiments, the mesh can be up to about 10mm in diameter when expanded (eg, about 9.5mm for an outer porous member or portion, about 8mm for an inner porous member or portion). The mesh can have a single density or it can have two or more densities. For example, in some embodiments, the number of variable densities can be in the range of about 2 to about 10. For example, a first density can be about 100 PPI and a second density can be about 40 PPI. (PPI = images per inch). The braiding pattern can be any suitable pattern, for example, a one-on-one configuration, or a two-on-one configuration, etc. The number of strands for the mesh can be in the range of about 4 strands to about 288 strands. In some embodiments, the thread count is approximately 48 strands. Threads of common multiples of 4, 8, 16, 24, 32, 64, 72, 96, 128, are available.

144, 192 and 288 for braiding using commercial braiding machines.

A single expandable implant can include wires of the same size or a combination of two wire sizes

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<img file="MX358482B_D0127.tif" />

- 121 different. For example, the expandable implant can have 24 .001 '' wires and 24 .0005 '' wires. Thicker wires can impart additional strength to the expandable implant, and thinner wire can provide density. In addition, any combination of wire quantity, wire diameter, braiding angle, or image per inch can be used to make the expandable implant mesh.

conclusion

Although various 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 occurring in a certain order, those skilled in the art having the benefit of the disclosure will recognize that the order of certain steps can be modified and that such modifications are in accordance with variations of the invention. . Additionally, certain steps can be carried out simultaneously in a parallel process when possible, as well as - carried out sequentially as described above. For example, the expandable implant can be inserted into the catheter simultaneously with the positioning of the expandable catheter adjacent to the aneurysm.

Particularly have been shown and described

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122 modalities, but it will be understood that various changes in form and details can be made. For example, although various modalities having particular characteristics and / or combinations of components have been described, other modalities having any combination or sub-combination of any characteristic and / or components are possible from any of the modalities described herein. . The specific configurations of the various components may also vary.

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 limbs or porous portions. For example, in some embodiments, medical device 1010 may also include a third porous member (not shown) having a first end and a second end and engaging at least one of the first porous member 1020 and the second porous member

1030. As the first and second porous members 1020,

1030, the third porous member may have a folded configuration for insertion through the blood vessel and an expanded configuration to occupy the aneurysm sac. The third porous member may be substantially elongated and have a width in its expanded configuration that is greater

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QO ro than its width in its folded configuration.

In another example, a radiopaque marker of an illustrated and described medical device may be positioned differently on an expandable implant of the medical device. Furthermore, the size and specific shape of the various components may be different from the modalities shown, while still providing the functions described herein.

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124