Device, system and method for delivering a curable material into bone

(54) Title: DEVICE AND SYSTEM FOR (57) Summary:

DISTRIBUTION OF A CURABLE MATERIAL TO

BONE (30) Unionist Priority: 08/02/2007 us 11 / 704,139 (73) Holder (s): Evan D. Linderman, John A. Krueger (72) Inventor (s): Evan D. Linderman, John A. Krueger (74) Attorney (s): Dannemann, Siemsen, Bigler & Ipanema Moreira (86) International Request: pct US2008001747 of 02/08/2008 (87) International Publication: wo 2008 / 097659de 14/08/2008

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Invention Patent Descriptive Report for DEVICE AND SYSTEM FOR DISTRIBUTION OF A MATERIAL CURABLE TO THE BONE.

This application is a part-continuation of United States patent application Serial No. 11 / 282,102, entitled Device, System and Method for Delivering a Curable Material Into Bone, filed on November 18, 2005, the entire which is incorporated herein by reference.

Background

The present invention relates to devices and methods for stabilizing bone structures. More particularly, it refers to devices, systems and methods for delivering a curable stabilizing material to a bone structure.

Surgical intervention on damaged or compromised bone sites has proven to be highly beneficial for patients, for example, patients with back pain associated with spinal damage.

The bones of the human skeletal system include mineralized tissue that can, in general, be classified into two morphological groups: cortical bone and spongy bone. The outer walls of all bones are composed of cortical bone, which has a dense, compact bone structure characterized by microscopic porosity. The spongy or trabecular bone forms the internal structure of the bones. The cancellous bone is composed of a lattice structure of thin interconnected rods and plates known by the term trabeculae.

During certain bone procedures, the cancellous bone is supplemented by an injection of palliative material (or dressing) used to stabilize the trabeculae. For example, the upper and lower vertebrae in the spine can be beneficially stabilized by injecting an appropriate curable material (for example, PMMA or other bone cement). In other procedures, percutaneous injection of stabilization material in compression vertebral fractures, for example, through transpedicular or parapedicular approaches, has proven to be beneficial in the area of ​​pain and stabilization of damaged bone sites. Other skeletal bones (for example, the femur) can be treated in a similar way. In any case, bone in general and cancellous bone in particular can be strengthened and stabilized through a palliative injection of bone-compatible material.

The conventional technique for delivering the bone stabilization material requires the use of a direct access device or cannula that pierces (or otherwise cuts) through the cortical bone to gain access to the spongy bone site. The bone stabilization material is then pushed through the cannula to fill a portion of the cancellous bone at the bone site. To minimize invasiveness of the procedure, the cannula is typically a small-diameter needle.

With the above in mind, due to the fact that the needle cannula interacts with the cancellous bone and other soft tissue structures, there is an inherent risk that, after initial insertion, the needle cannula may pierce or penetrate the nucleus of another tissue and / or bone mass that is being repaired (in a location far from the insertion site). Thus, during percutaneous vertebroplasty, great care must be taken to avoid perforation, penetrate the nucleus or otherwise disrupt the vertebral body. Similar concerns about post-insertion core penetration arise in other interior bone repair procedures. Along these same lines, to minimize the trauma and time required to complete the procedure, it is desirable that only a single insertion of the bone site is performed. Unfortunately, for many procedures, the surgical site in question cannot be fully accessed using a conventional straight needle cannula. For example, with vertebroplasty, the confined nature of the internal vertebral body often requires two or more insertions with the cannula with a straight needle in different locations of the vertebral approach (bipedicular technique). It would be desirable to provide a system for the distribution of bone stabilization material that can more readily adopt the anatomical requirements of a particular distribution site, for example, a system capable of promoting unipedicular vertebroplasty.

Instruments sold by Cook Medicai under the OSTEO-RX® product line use a curved needle to deliver bone stabilizing material as part of vertebroplasty or similar procedure. The curved needle purposely enhances the surgeon's ability to locate and inject the stabilization material in a desired location. Similar to a cannula with a conventional straight needle, the curved needle distributes the curable material through a single axial opening at the most distal tip. However, the curved needle is used in combination with an external cannula that helps in establishing general access to the bone site, as well as facilitating the percutaneous distribution of the needle to the distribution site (within the bone) in a desired way. More particularly, the outer cannula first gains access to the bone site, followed by distal sliding of the needle through the outer cannula. Since the tip of the needle extends from the distal to the distal end of the other cannula, the tip of the needle is exposed with respect to the bone site. To avoid penetration of the nucleus and thus potential tissue damage when inserting the distal tip of the needle into a bony site, an additional thread component is required, coaxially disposed within the needle and extending distally from the distal tip. The inner thread protects tissue or other body structures from traumatic contact with the distal tip of the needle as the tip is being positioned. The coaxial wire must be removed before infusing the bone stabilizing material through the needle. In addition, the needle can distribute only the stabilization material through the axial opening at the distal tip of the needle, perhaps impeding the surgeon's ability to infuse all desired areas and / or requiring an additional procedure step of withdrawing the needle tip to away from the desired distribution location. Also, due to the fact that the needle tip and thus the axial opening are likely to be in or facing the bone defect (for example, fracture in the vertebral body) that is being repaired, the stabilization material can be injected directly into the defect, giving rise to a distinct possibility that the stabilizing material must progress through and out of the defect. This is, of course, undesirable. The problems and concerns described above in the context of percutaneous vertebroplasty may also arise in similar surgical procedures in other bone locations.

The injection of palliative materials into damaged or compromised bone sites has proven to be highly beneficial for patients. However, known techniques of access and infusion require multiple needle sets and / or a risk of penetration of the bone or tissue nucleus. Therefore, there is a need for an improved device and system for delivering stabilizing material to damaged or compromised bone sites.

summary

The benefits obtained in accordance with the principles of the described invention include a dispensing cannula that provides a non-traumatic distal blunt end that minimizes the risks of penetrating the tissue nucleus or perforating the bone or tissue during intraosseous procedures without requiring additional components ( such as a separate wire). Other benefits refer to a delivery cannula that defines at least one lateral orifice adjacent to a distal blind end, where the orifice (s) allows for a radial infusion of a curable material into a location within the bone. , even in the case where the distal end is in contact with bone and / or tissue. Thus, a bone procedure can be performed with a reduced time in the operating skirt and with less approaches from surgical instruments to the bone site. For example, unipedicular vertebroplasty is promptly performed. In addition, virtually any area within the additional surgical site can be accessed. Also, the distal end of the delivery cannula can be placed as close as desired to an anatomical structure in particular to the surgical site (for example, a bone fracture) without fear that the subsequently distributed material will forcibly progress to or through that structure. .

Some aspects of the present invention relate to a dispensing cannula device for delivering a curable material to the bone. The device includes a dispensing cannula and a hub that forms a fluid orifice. The dispensing cannula defines a proximal end, a deflectable segment, a distal end, light and at least one side orifice. The proximal end is axially open to the lumen. The deflectable segment is formed opposite the proximal end and ends at the distal end which is otherwise axially closed. In addition, the distal end has a blunt tip. The light extends from the proximal end and is connected, in fluid communication, with the lateral orifice (s). For this purpose, the lateral orifice (s) is (are) formed adjacent to and proximally spaced from the distal end. Finally, the deflectable segment forms a curved shape in the longitudinal extension and has the characteristic of format memory. With this configuration, the deflectable segment can be forced into a substantially rectified shape and will revert to the curved shape when removing the force. The hub is coupled, in fluid communication, to the proximal end of the delivery catheter. With this construction and during use, the distal end will not damage or penetrate the tissue nucleus when inserted into a distribution site within the bone due to the blunt end. In addition, the side orifice (s) provides the ability to inject a curable material, regardless of whether the distal end is housed against the body material and can achieve more complete distribution.

Other aspects of the present invention relate to an intraosseous curable material delivery system for delivering a curable material, such as bone cement, to a distribution site within the bone. The system includes the dispensing cannula and hub as described in the previous paragraph, along with a guide cannula. The delivery cannula and the guide cannula are sized so that the delivery cannula is slidable within the guide cannula. For this purpose, the deflectable segment is configured to deflect to a substantially rectified shape when inserted into the cannula and revert to the curved shape when extended distally in the guide cannula for distribution of curable material. In one embodiment, the guide cannula and the distribution cannula are sized to perform a vertebroplasty procedure.

Still other aspects of the present invention relate to a method of stabilizing a bone structure in a human patient. The method includes providing a delivery cannula as previously described. A distal tip of a guide cannula is located within the bone structure. The dispensing cannula is inserted into the cannula. In this regard, the deflectable segment deflects to a substantially rectified shape within the guide cannula. The delivery cannula is distally advanced with respect to the guide cannula, so that the distal end and at least a portion of the deflectionable segment of the delivery cannula project distally to the distal tip of the guide cannula. For this purpose, the portion of the segment liable to deflection distal to the distal tip of the guide cannula naturally reverts to the curved shape. The distal end of the delivery cannula is positioned adjacent to a desired location of distribution within the bone structure. A material is injected into the lumen. The injected curable material is distributed to the distribution site via the lateral orifice (s). Once distributed, the curable material is allowed to cure in order to stabilize the bone structure. In one embodiment, the method also includes rotation of the distribution cannula with respect to the guide cannula in order to alter a spatial position of the lateral orifice (s) ^, thus providing the ability to inject the curable material into different plans.

Yet another aspect of the present invention relates to a method of injecting curable material into a distribution site within a bone structure. The method includes the steps of providing a delivery cannula having an open proximal end, a deflectable segment opposite the proximal end having a distal end and the lumen extending from the proximal end. The deflectable segment has a format memory characteristic and naturally assumes a curved shape in longitudinal extension. The method also includes the step of locating a distal tip of a guide cannula within the bone structure. The method also includes the step of inserting the delivery cannula into the guide cannula, in which the deflectable segment deflects to a substantially rectified shape within the guide cannula and advances the distribution cannula distally, so that the distal end and at least a portion of the deflectable segment protrudes distally to the distal tip. The portion of the segment liable to deflection distal to the distal tip, then, naturally reverts to the curved shape. The method also includes the stage of manipulation of the delivery cannula, so that at least a portion of the deflectable segment creates one or more voids in the soft body tissue within the bone structure. The method also includes the stage of distributing the curable material to the distribution site, in which the curable material is distributed to one or more voids in the soft-bodied tissue created by the deflectable segment.

Yet another aspect of the present invention relates to a method of injecting a curable material to a distribution site within a bone structure. The method includes the step of providing a delivery cannula having an opening, proximal end, a deflectable segment opposite the proximal end having a distal end and the light extending from the proximal end. The deflectable segment has a format memory characteristic and naturally assumes a curved shape in the longitudinal extension. In the method, the distal tip of a guide cannula is located within the bone structure. The dispensing cannula is inserted into the guide cannula, characterized by the fact that the deflectable segment deflects to a substantially rectified shape within the guide cannula. The delivery cannula is distally advanced, so that the distal end and at least a portion of the deflectable segment protrude distally to the distal tip, characterized by the fact that the portion of the distal deflectionable segment to the distal tip reverts naturally to the curved shape. The distal end is positioned distally adjacent to a first region within the distribution site. The curable material is then distributed to the first region within the distribution site. The distal end is then positioned adjacent to a second region within the distribution site and curable material is distributed to the second region within the distribution site.

Yet another aspect of the present invention relates to a cannula device for delivering a curable material, such as bone cement, to the bone as part of a curable material delivery system. The device includes a distribution cannula preloaded with bone cement that defines an opening, proximal end, a deflectable segment opposite the proximal end and ending at a closed distal end. The device also includes the lumen that extends from the distal end. The device also includes at least one lateral orifice formed adjacent and proximally spaced from the distal end and connected, in fluid communication, with the lumen, in which the deflectable segment forms a curved shape in longitudinal extension and has a memory feature of Format, so that the deflectable segment is configured to take a substantially longitudinally ground shape when subjected to a force and naturally reverts to the curved shape when removing the force.

Yet another aspect of the present invention relates to an intraosseous curable material delivery system for delivering a curable material, such as bone cement, to a distribution site within the bone. The system includes a dispensing cannula having an opening, proximal end, a deflectable segment opposite the proximal end and ending at a distal end, the lumen extending from the proximal end, where the deflectable segment has a characteristic format memory and assumes a curved shape in longitudinal extension. The system also includes a guide cannula that defines an inner diameter larger than an outer diameter of the dispensing cannula and having an open distal tip, where the deflectable segment is configured to revert to the curved shape when extended distally to the tip distal for delivery of a curable material within an implant site via the distal end and where the delivery cannula is evenly slidable within the guide cannula.

Yet another aspect of the present invention relates to a structure of curable material for stabilizing a vertebral body. The structure includes a first deposit of curable material proximal to an end plate of a vertebral body to provide support for a first end plate of the vertebral body. The structure also includes a second deposit of curable material proximal to an end plate of a vertebral body to provide support for a second end plate of the vertebral body. The structure also includes a column of curable material between the first deposit of curable material and the second deposit of curable material to provide support to the vertebral body.

Brief Description of Drawings

The attached drawings are included to provide an additional understanding of the present invention and are incorporated into and are a part of the present specification. Other embodiments of the present invention and many of the intended advantages of the present invention will be readily appreciated, as they can be better understood by reference to the detailed description below. The elements of the drawings are not necessarily to scale with respect to each other. Similar reference numbers designate corresponding similar parts.

Figure 1 illustrates components of an intraosseous curable material delivery system in accordance with the principles of the present invention;

Figure 2A is an exploded cross-sectional view of a cannula device component of the system of Figure 1;

Figure 2B is a front view of a dispensing cannula and hub portions of the device of Figure 2A;

Figure 3A is an enlarged plan view of a distal portion of the delivery cannula of Figure 2A;

Figure 3B is a cross-sectional view of the dispensing cannula of Figure 3A;

Figure 3C is an enlarged plan view of a distal portion of the delivery cannula of Figure 2A according to another preferred embodiment of the present invention;

Figure 3D is an enlarged plan view of a distal portion of the distribution cannula of Figure 2A according to another preferred embodiment of the present invention;

Figure 3E is an enlarged plan view of a distal portion of the delivery cannula of Figure 2A according to another preferred embodiment of the present invention;

Figure 4 is a cross-sectional view of the dispensing cannula device of Figure 2A when final assembly;

Figure 5 is a side plan view of an alternative delivery cannula device according to the principles of the present invention;

Figure 5A is a side plan view of an alternative delivery cannula device according to the principles of the present invention;

Figure 5B is a side plan view of an alternative delivery cannula device according to the principles of the present invention;

Figure 6A is a simplified plan view of an intraosseous curable material delivery system employed in a palliative bone procedure in accordance with the principles of the present invention;

Figure 6B is a cross-sectional view of a portion of the system of Figure 6A;

Figure 6C illustrates a final stage of a procedure performed by the system of figure 6A;

Figure 6D is a cross-sectional view of a vertebral body in combination with a portion of the system of Figure 6A, illustrating the injection of curable material;

Figure 6E is a cross-sectional view of a vertebral body illustrating various vertebroplasty approach positions available in accordance with the principles of the present invention;

Figures 7A and 7B are simplified front views of a vertebral body illustrating the use of the system in accordance with the principles of the present invention;

Figures 8A and 8B are simplified side views of a vertebral body illustrating the use of the system in accordance with the principles of the present invention;

Figure 9 is a simplified side view of a vertebral body illustrating the use of the system in accordance with the principles of the present invention;

Figure 10 is a simplified side view of a vertebral body illustrating the use of the system in accordance with the principles of the present invention;

Figures 11A - 11C are simplified front views of a vertebral body illustrating the use of the system in accordance with the principles of the present invention;

Figure 12 is a simplified anterior view of a sacrum illustrating the use of the system in accordance with the principles of the present invention. Detailed Description

Figure 1 illustrates the components of an intraosseous curable material delivery system 20 according to the principles of the present invention. System 20 includes an external guide cannula 22 and a dispensing cannula device 26 (mentioned generally). Details on the various components are provided below. Generally speaking, however, a portion of the dispensing cannula device 26 is dimensioned to be slidably disposed within the guide cannula 22 which otherwise serves to form and / or locate a desired distribution site within the bone. Once positioned, the dispensing cannula device 26 is employed to inject a curable bone stabilizing material into the dispensing site. The system 20 can be used for a number of different procedures including, for example, vertebroplasty and other bone augmentation procedures in which a curable material is distributed to a location within the bone, as well as to remove or aspirate material from a location within the bone. bone.

The system 20, and in particular the dispensing cannula device 26, is highly useful for dispensing a curable material in the form of a bone cement material. The phrase curable material, within the context of the substance that can be delivered by the system / device of the invention described here, is intended to refer to materials (for example, compounds, polymers and the like) that have a fluid state or phase and a solid or cured hardened state or phase. Curable materials include, but are not limited to, polymethyl methacrylate (PMMA) injectable bone cement, which has a fluid state, in which it can be delivered (for example, injected) through a cannula to a location and subsequently , curing in a hardened cement. Other materials, such as calcium phosphates, bone growth materials, antibiotics, proteins, etc. they could be used in place of or to increase PMMA (but do not affect a predominant feature of the resulting formulation having a fluid state and a solid or cured hardened state). This would allow the body to reabsorb the cement or improve clinical results based on the type of filler implant material. With that in mind and, in one embodiment, system 20 still includes a source (not shown) of curable material coupled, in fluid communication, with the dispensing cannula device 26.

Given the above, the external guide cannula 22 generally allows access of the dispensing cannula device 26 to a bone site of interest and thus can take a wide variety of shapes. In general terms, however, the guide cannula 22 is dimensioned to slide a portion of the dispensing cannula device 26, terminating at an open distal tip 28. The distal tip 28 can also be adapted to facilitate penetration into the nucleus of bone tissue, such as when using the guide cannula 22 to form a distribution site within the bone. To provide a desired interface between the guide cannula 22 and a portion of the dispensing cannula device 26 otherwise slidably inserted into the guide cannula 22 during use (described below), in one embodiment, a cannula inner diameter surface -Guide 22 is highly smooth in a matte or mirror finish (ie, RMS range from about 0 to 16). In another preferred embodiment, the inner diameter surface of the null guide tube 22 or the outer diameter surface of the dispensing cannula 26 can be coated with Teflon to promote a desired uniform interface between the guide cannula 22 and a portion of the delivery device. dispensing cannula 26 otherwise slidably inserted into guide cannula 22 during use. A Teflon glove between the guide cannula 22 and a portion of the dispensing cannula device 26 can also be used. In addition, the outer diameter surface of the dispensing cannula 26 can be highly smoothly polished in a matte or mirror finish (i.e., RMS range from about 0 to 16). In addition, and in some embodiments, the guide cannula 22 can also be attached, at a proximal end thereof, to a cable 30 to enhance a surgeon's ability to manipulate the system 20. Alternatively, the cable 30 can be eliminated .

The dispensing cannula device is shown in greater detail in Figure 2A and, in general, includes a cable assembly 32 (mentioned generally), a hub 34 and a dispensing cannula 36. Hub hole 34 forms a hole fluid and is connected, in fluid communication, to the distribution cannula 36, ​​with the cable assembly 32 retaining the hub 34 / distribution cannula 36 combination. As described in more detail below, the dispensing cannula 36 is sized to be coaxially received slidably within the guide cannula 22 (figure 1) and is adapted to deliver a curable material injected into it through hub 34.

The cable assembly 32 includes, in one embodiment, a cable 40 and a retainer 42. The cable 40 is adapted to receive the hub 34, with the retainer 42 securing the hub 34 (and thus the dispensing cannula 36) to the cable 40.

The cable 40, in one embodiment, includes a first section 44 and a second section 46. The first section 44 is adapted for fitting to the second section 46, as well as through a complementary annular projection) 48 and grooves 50. In addition , the first section 44 forms a central passageway 52 which extends internally from an outer surface 54 thereof.

The second section 46 defines an internal opening 56 which, when final assembly of the cable 40, is aligned with the central passage 52. The opening 56 can take a variety of shapes dimensioned to receive the hub 34 in a housed manner. The interface housed between cable 40 and hub 34 is preferably adapted so that hub 34 cannot rotate with respect to cable 40 when final assembly (i.e., hub interface 34 / cable 40 resists torque) implanted on any component, so that the rotational movement of the cable 40 results in an identical rotation of the hub 34 / delivery cannula 36 even when the delivery cannula 36 is inserted into a confined surgical site). Thus, in one embodiment, aperture 56 and cube 34 (as described below) have corresponding non-symmetrical or non-circular shapes in the cross section. With respect to the longitudinal cross-sectional view of figure 2A, the non-circular shape of the opening 56 is characterized by the opening 56 being defined by a side wall 58 having a shoulder 60 corresponding to the shape of the cube 34, as described in greater detail below. Alternatively, the sidewall 58 can take on a variety of other configurations. In addition, and in one embodiment, the second section 46 forms external thread filaments 62.

The retainer 42 is configured to attach the hub 34 / dispensing cannula 36 to the cable 40 and forms a central opening 64 that defines a proximal portion 66 and a distal portion 68. The proximal portion 66 forms the central opening 64 to have a slightly larger diameter. larger than that of cube 34, together with internal thread filaments 70 dimensioned to fit, by thread, the external thread filaments 62 of cable 40. The distal portion 68 forms the opening 64 to have a diameter that approximates an outer diameter of the distribution cannula 36, ​​so as to provide a more rigid connection between the cable assembly 32 and the hub 34 / distribution cannula 36. Alternatively , the cable assembly 32 can take a wide variety of other forms and, in some embodiments, can be eliminated entirely.

In one embodiment, the cube 34 is of a conventional fluid orifice design and defines a fluid passage 71 and an external thread filament 72 over a proximal end 74 thereof. In one embodiment, thread filament 72 is a double clockwise spinning Luer including a 5 mm thread, although other thread filament conformations and thread sizes are also acceptable. In addition, as previously mentioned, in one embodiment, hub 34 is configured to be pivotally locked with respect to cable assembly 32 when final assembly. Thus, in one embodiment, a body of the cube 34 forms a generally cylindrical surface 76, a portion of which is flattened in an area 78, as shown in figure 2B. The size and shape of the flattened area 78 correspond to the side wall of the opening 58 (figure 2A) provided with the cable 40 (figure 2A).

Cube 35 is formed, in one embodiment, from a sterilizable polymeric material. As an example, cube 34 can be formed from a polylac 717C acrylonitrile-butadiene-styrene (ABS) copolymer, although other sterilizable polymers and / or copolymers are also acceptable.

In another preferred embodiment, a removable cap 38 is adapted to attach to the first section 44 of the cable assembly 32 and cover the fluid passage 71 of the hub 34. When the dispensing cannula 36 is inserted into the guide cannula 22, blood or other fluids can travel inside the dispensing cannula 36 and exit through the fluid passage 71 of the hub 34. A removable cap 38 can be attached to the cable assembly 32 as the dispensing cannula 36 is introduced into the guide cannula 22. After insertion of the dispensing cannula 36 to the desired location, the removable cover 38 is removed to allow access to the hub 34.

Returning to figure 2A, the dispensing cannula 36 defines a proximal end 80 and a distal end 82 and forms one or more lateral holes 84 adjacent to the distal end 80 and in fluid communication with the inner lumen 86. In addition, the cannula of Distribution 36 includes a deflectable segment 88 (mentioned generally) that defines a preset curve or curvature 90. As described below, deflectable segment 88, and in particular curve 90, includes or extends from distal end 82 and has a shape memory attribute, so deflectable segment 88 can be forced from curved shape (shown in figure 2A) to a substantially rectified shape and will naturally revert back to the curved shape when removing force.

The proximal end 80 is axially open to lumen 86. Conversely, distal end 82 is axially closed to lumen 86 (i.e., material cannot be axially expelled from distal end 82 with respect to an axis of lumen 86). That is, the material in lumen 86 cannot be forced distally from it axially. Furthermore, the distal end 82 defines or includes a blunt tip 100. For example, in one embodiment, the blind tip 100 defines a hemispherical surface, although other blind shapes (ie, curved or curvilinear) are also acceptable. The blunt tip surface 100 is adapted to provide a non-traumatic surface for access, contact and insertion into a bone or tissue, while minimizing the risk of perforation and / or penetration of the tissue core or damage to the bone. To enhance a desired softness, the blind tip 100 may have a different thickness when compared to the rest of the distribution cannula 36, ​​such as by sintering distal end 82 to form the blind tip 100 (when the distribution cannula 36 is initially supplied as a continuous tube). Alternatively, the blind tip 100 can be formed separately from the rest of the dispensing cannula 36 and subsequently attached to the dispensing cannula 36 to form the distal end 82 (for example, the dispensing cannula 36 can include a first tubular body formed of a material hardened together with a second solid body formed of a softer material attached (e.g., welded) to the tubular body to form the distal end 82 / blunt end 100).

With reference to figures 2A and 2B, the lateral orifice (s) 84 is (are) formed adjacent the distal end 82, extending through a thickness of a cannula sidewall of distribution 36. In one embodiment, a single orifice 84 is provided and is located opposite a direction of curve 90. In other words, with respect to the longitudinal cross-sectional view of Figure 2A, a direction of the curve 90 serves to form the distribution cannula 36 to define an inner curved side 102 and an outer curved side 104. With these designations in mind, the orifice 84 is formed along and is open with respect to the outer curved side 104. Surprisingly, it has been found that, by positioning the lateral orifice 84 opposite curve 90, users can experience enhanced control over the direction in which the curable material is distributed from the dispensing cannula 36, ​​as well as improved safety. Alternatively, a greater number of holes 84 may be provided, which may or may not be circumferentially aligned and may or may not be located along the outer curved side 104 of the dispensing cannula 36. In general, side hole 84 is compensated for at least one distance D1 from the distal end 82. In one embodiment, the distance Dl is between 0.127 cm (0.05 inches) and 0.127 cm (0.5 inches) and, preferably, the distance Dl is between 0.254 cm (0.1 inch) and 0.63 cm ( 0.25 inches). With this configuration, even when the blind tip 100 is compressed against the tissue or bone, the lateral orifice (s) 84 is open and, thus, available for distribution (or aspiration) of material. In addition, the lateral orifice (s) 84 provides a radial flow distribution or direction with respect to a longitudinal axis of the distribution cannula 36.

The side orifice (s) 84 can take on a wide variety of shapes and sizes (with respect to an external surface of the dispensing cannula 36). For example, the side orifice (s) can be oval, circular, curvilinear, etc. In one embodiment and with reference to figure 3A, a chamfered region 106 can be formed around the side orifice 84 to eliminate sharp points along the outside of the dispensing cannula 36, ​​as well as promoting consistent flow in curable material from the side orifice 84 ( via the expanded hole size obtained by the chamfered region 106). With embodiments where the side hole 84 is non-circular, hole length L and width W are defined. For this purpose, the length L is greater than 1.270 mm (0.050 inches), preferably greater than 1.905 mm (0.075 inches) and, even more preferably, greater than 2.540 mm (0.100 inches). Although the width W of the side hole 84 may or may not be less than the length L (for example, on the order of 1.067 mm (0.042 inches) in one embodiment), the side hole 84 is appropriately characterized as being relatively large, especially when compared to conventional bone cement dispensing needles that otherwise provide only an axial orifice or opening at the distal tip.

In particular and with additional reference to figure 3B (otherwise illustrating a cross-sectional view of the dispensing cannula 36 taken through side hole 84), the dispensing cannula 36 defines an inner diameter D1 (i.e., a lumen diameter 86 ). Side orifice 84 is connected, in fluid communication, to lumen 86 and extends radially. With these conventions in mind, in one embodiment, the length L of side orifice 84 is greater than the inner diameter D1 of the dispensing cannula 36. As such, at least one linear dimension of side orifice 84 is greater than any dimension of orifice that would otherwise be obtained for an orifice to be formed at the distal end 82 (i.e., an orifice extending axially). That is, a hole formed at the distal end 82 of the dispensing cannula 36 (as conventionally employed in the bone cement dispensing needle technique) is limited in size (i.e., diameter) by the inner diameter D1 of the dispensing cannula 36. In contrast, the side orifice 84 according to the principles of the present invention is much larger, representing a distinct advantage when trying to pass a low viscosity liquid (curable material, such as bone cement) through it.

With reference to figures 3C - 3E, the closed distal end 82 of the dispensing cannula 36 can employ numerous different configurations, in addition to the rounded distal end 82 shown in figure 3A. The closed distal end 82 can also be a substantially flat tip, as shown in Figure 3C, a sharp interchangeable tip, as shown in Figure 3D, or a sharp tip, as shown in Figure 3E. The flat tip advantageously reduces the risk of perforation through the body tissue. Conversely, when desired, sharp-tip configurations advantageously allow a physician to push delivery cannula 36 through body tissue with less force than with a blunt tip.

Returning to figure 2A, in one embodiment, the dispensing cannula 36 defines a continuous extension between the proximal end 80 and the distal end 82, with the deflectable segment 88 and, in particular, the curve 90 extending along approximately 25% of the length from the distal end 82 (where the length of the dispensing cannula 36 is the length of the hub extension 34 when final assembly). In other modalities suitable for other surgical procedures, the deflectable segment 88 and, in particular, curve 90, extends between 10% to 50% of the length of the dispensing cannula 36 when measured from the distal end 82 .

To facilitate the distribution of a curable material (for example, bone cement) to a confined location within the bone (such as with a vertebroplasty procedure), deflectable segment 88 can be formed to define curve 90 at a predetermined radius curvature R appropriate for the procedure in question. In one embodiment, curve 90 is J-shaped (approaching at least a 90-degree curve) and defines the radius of curvature R as being less than 38.1 mm (1.5 inches), preferably in the range of 6.35 mm (0.25 inch) - 38.1 mm (1.5 inches). In a preferred embodiment, curve 90 defines the radius of curvature R to be approximately 25.4 mm (1 inch). Alternatively and as described in greater detail below, the radius of curvature R can be larger or smaller, depending on the particular procedure for which the dispensing cannula 36 has to be employed.

In addition, to facilitate ready deflection of the deflectable segment 88 from the curved shape to a substantially rectified state (such as when the dispensing cannula 36 is inserted into the outer cannula 22 (figure 1)) and reversion back to the curved shape, the distribution blank 20 or at least the deflectable segment 88 is formed of a shaped memory metal. In one embodiment, the dispensing cannula 36 comprises Nitinol®, a known nickel (Ni) and titanium (Ti) memory alloy. In one embodiment, curve 90 is formed in the dispensing cannula 36 through deformation of a straight fluid dispensing cannula under extreme heat for a prescribed period of time, which preset a curved shape in the dispensing cannula 36.

In another embodiment, the preset curve or curvature 90 is formed in an initially straight cannula by cold machining the straight cannula and applying a mechanical tension. Cold machining permanently blocks a crystalline structure (for example, a partial martensitic crystalline structure) in a portion (i.e., the deflectable segment 88) of the cannula, while a tensionless portion remains, for example, in an austenitic structure .

In addition to Nitinol, other materials that exhibit this format memory behavior can be employed, including superelastic or pseudoelastic copper alloys, such as copper, aluminum and nickel alloys, and copper, aluminum and zinc alloys and copper and zinc alloys. In addition, the deflectable segment 88 is formed to be resilient and naturally assume the desired radius of curvature R. In this way, after the dispensing cannula 36 and, in particular, the deflectable segment 88, is flexed to a substantially rectified shape (not shown), upon subsequent relaxation, the deflectionable segment 88 resembles the pre-curved shape adjusted and relaxes / reversibly returns to curve 90, as described in detail below.

It was surprisingly found that the selection of material above, in combination with distribution of curable liquid through one or more relatively large lateral holes (otherwise positioned proximal to the distal end 82) and the blind tip 100 allows the cannula to distribution 36 is smaller and thinner than conventional bone cement dispensing needles (ie, having an outside diameter of approximately 3.175 mm (0.125 inches), while still providing sufficient structural integrity to perform all desired procedures that require distribution of curable material to or removal of material from a location within the bone. More particularly and as best shown in figure 3B, the dispensing cannula 36 defines an inner diameter (D1) and an outer diameter (DE). In one embodiment, the internal diameter Dl is in the range of 1.016-2.286 mm (0.040-0.090 inches), preferably in the range of 1.270-2.032 mm (0.050-0.080 inches) and, more preferably, in the range of 1.194-1.702 mm (0.047-0.067 inches). The outer diameter DE is selected to allow the dispensing cannula 36 to be coaxially received by the guide cannula 22 (figure 1). With that in mind and, in one embodiment, the outer diameter DE is in the range of 0.762 - 2.54 mm (0.030-0.10 inches), preferably no more than 0.090 inches, more preferably in the range of 1.524 - 2.286 mm (0.0600.090 inches) and, more preferably, in the range of 1.829 - 2.083 mm (0.072-0.082 inches). Thus, in one embodiment, the dispensing cannula 36 is of reduced outer diameter and thickness when compared to the available bone cement dispensing needles (for example, the curved needle available with the OSTEO-RX® product line has a diameter 2.337 mm (0.092 inches) and a wall thickness of 0.686 mm (0.027 inches). By way of example, but not by way of limitation, an exemplary delivery catheter was constructed in accordance with the principles of the present invention having an outside diameter of approximately 1.956 mm (0.077 inches) and a wall thickness of 0.381 mm (0.015 inches) ) and was found to be highly suitable for performing a vertebroplasty procedure. This represents a distinct breakthrough not yet available to surgeons.

An additional feature of the delivery cannula 36 according to one embodiment is best shown in the plan view of figure 1. More particularly, the delivery cannula 36 includes indicia 110 (reference generally) adjacent to the proximal end 80. Indications 110 are indicative of a location of the distal end 82 with respect to the distal tip 28 of the guide cannula 22 when inserting the delivery cannula 22 into the guide cannula 22. For example, evidence 110 may include first, second and third deep markings 110a, 110b, 110c. A longitudinal location of the first deep marking 110a with respect to the distal end 82 (when the dispensing cannula 36 is forced into a substantially ground state) is commensurable with a depth of the guide cannula 22 in combination with the handle 30 (where provided). That is, the first depth marking 110a is located at a linear distance from the distal end 82 so that when inserting the delivery cannula 36 into the guide cannula 22 (otherwise, forcing the cannula 36 into a substantially rectified state), when the distal end 82 is in or even with the distal end 28 of the guide cannula 22, the depth marking 110a will be proximally adjacent to or aligned with (and visible with respect to) a proximal side of the cable 30. Thus, a user can quickly and easily have visual confirmation that the distal end 82 is within the guide cannula. 22. The second and third deep markings 110b, 110c are proximally spaced from the first deep mark 110a in known increments (e.g., 0.5 cm, 1.0 cm, etc.) that represent the distal extension of the distal end 82 with respect to to the distal tip 28. For example, where the second deep mark 110b is spaced longitudinally (proximally) a distance of 0.5 cm from the first deep mark 110a and the third deep mark 110c is spaced 0.5 cm from the second deep mark 110b, during use when the dispensing cannula 36 is inserted into the guide cannula 22, so that the second deep marking 110b is aligned with the proximal side of the cable 30, a user can visually confirm (from a location distant from the surgical site and external to the patient) that a length of approximately 0.5 cm from the dispensing cannula 36 is extending distally from the distal tip 28 of the guide cannula 22. Similarly, when the third marking 110c is aligned with the proximal side of the cable 30, a length of approximately 1.0 cm from the distribution cannula 36 is exposed distally to the distal tip 28. Evidence 110 can take on a wide variety of forms differing from those shown in Figure 1 and, in some embodiments, can be eliminated.

Referring to figure 4, assembly of the dispensing cannula device 26 includes first attachment of the hub 34 to the dispensing cannula 36. In one embodiment, the hub 34 is over-molded on the dispensing cannula 36. To provide increased stress resistance at the hub 34 / dispensing cannula interface 36, in one embodiment, a support body 112 is attached to the dispensing cannula 36 adjacent to the proximal end 80 (mentioned generally) prior to forming / overmolding the hub 34. The support body 112 is preferably a rigid material which can be attached to the material of the distribution cannula 36 (for example, where the distribution cannula 36 is formed of Nitinol, the support body 112 can also be formed of Nitinol and thus easily welded to the dispensing cannula 36). The support body 112 can take on a variety of shapes and sizes but, in one embodiment, it is rectangular (a thickness of the order of 0.089 cm (0.035 inches), width of the order of 0.127 cm (0.05 inches) and a length of order of 0.50 cm (0.2 inches), although other dimensions are equally acceptable) so that, when applied to the distribution cannula 36 otherwise circular (in terms of cross section), the support body 112 provides flat surfaces on which the cube 34 is overmolded. This flat surface interface, in turn, evidently resists the sliding of the hub 34 with respect to the distribution cannula 36 and vice versa in response to a tension, compressive and / or torsional force (s) placed on any component. For example, in cases where the distal end 82 of the delivery cannula 36 is inserted or lodged within the body material (eg bone or tissue) in a surgical location and a proximal buoyant force is placed on hub 34 (eg , via cable 40), the dispensing cannula 36 will not come off the hub 34 even though the distal end 82 resists proximal movement (due to housing within the body material). Similarly, a rotational or torsional force placed on the cube 34 will consistently translate over the distribution cannula 36 through the in24 cube interface 34 / support piece 112, regardless of whether the distal end 82 resists the rotational movement due to interactions at the surgical site. Alternatively, however, the support body 112 can be omitted and is not a necessary element.

After fixing the hub 34 to the dispensing cannula 36, ​​the hub 34 is mounted within the cable assembly 32 as previously described. For example, hub 34 is housed within opening 56 of cable 40 and retainer 42 is coaxially disposed over hub 34 / dispensing cannula 36 and attached (e.g. threaded) to cable 40. For this purpose, and in one embodiment, hub 34 is oriented with respect to distribution cannula 36 so that the flat area 78 of hub 34 faces a spatial direction of curve 90. The previously described configuration of cable assembly 32 thus, it guides that, when assembling the hub assembly 34 to the cable 40, the curve 90 will also extend in a known spatial direction with respect to the cable 40. Alternatively, a spatial direction of curve 90 with respect to cable 40 can be visually determined after mounting hub 34 to it. In addition, in one embodiment and, as best shown in Figure 1, the cable assembly 32 still includes directional indications 114 (mentioned generally) along the outside of the cable 40 which provide a user with an indication of the direction of the curve 90 with respect to cable 40. For example, in one embodiment, directional signs 114 include an arrow 114a pointing in the direction of curve 90. With this configuration, a user can readily determine a spatial position of curve 90 with respect to cable 40 when curve 90 is inserted into the boundaries of a surgical site (and thus not otherwise visible to the user). The directional indicia 114 can be applied at various locations along the cable 40, such as on both main faces (one of which is visible in Figure 1), as well as a proximal end thereof and can take a variety of shapes. In other ways, directional signs 114 can be eliminated. In addition, after mounting the hub 34 to the cable assembly 32, the dispensing cannula device 26 can be used to deliver a curable material to the bone.

In another preferred embodiment, the present invention includes a probe (not shown) in the form of a wire that can be inserted into the delivery cannula 26 to remove blockages that may form within the delivery cannula 26. Preferably, the probe has a diameter that is smaller than the inner diameter of the delivery cannula 26 to allow material within the delivery cannula 26 to flow around the probe as the probe is inserted into the delivery cannula 26. In a preferred embodiment, the probe is flexible enough to travel through the curvature of the dispensing cannula 26, but still rigid enough to remove blockages within the dispensing cannula 26.

Although the dispensing cannula device 26 has been described as including dispensing cannula 36 otherwise forming a side hole 84, a variety of other configurations are also acceptable. For example, two circumferentially aligned side holes can be provided. In addition, figure 5 illustrates portions of another embodiment of the dispensing cannula device 120 in accordance with the principles of the present invention. The dispensing cannula device 120 includes a dispensing cannula 122 which extends a length between a proximal end 124 and a distal end 126 and a hub 128 coupled to the proximal end 124. The dispensing cannula 122 is similar to the dispensing cannula 36 (figure 2A) described above (including a blunt tip), but forms a series of longitudinally aligned side holes 130, spaced along a length of the dispensing cannula 122 and connected, in fluid communication, the internal lumen (not shown). In addition, the delivery cannula 122 includes a deflectable segment 132 that forms a preset curve 134, similar to the previous embodiments.

A more distal lateral orifice 130a is compensated for the distance D1 from the distal end 116. Again, the distance D1 is, in one embodiment, in the range of 0.127 cm (0.05 inch) - 1.27 cm (0, 5 inch), preferably in the 0.254 cm (0.1 inch) - 0.63 cm (0.25 inch) range. A longitudinal spacing between the remaining side holes 130 proximal to the most distal side hole 130a can vary. Preferably, however, the second side orifice 130b defines a smaller opening when compared to the more distal side orifice 130a and the third side orifice 130c is less than the second side orifice 130b. This reduction in the size of the lateral orifice proximal to the distal end 126 promotes consistent distribution of curable material that is otherwise being forced through the distribution cannula 122.

Although three of the side holes 130 are shown, other configurations are also acceptable. For example, multiple side holes (i.e., more than three side holes) can be formed longitudinally along the length of the delivery cannula 122, and in addition, side holes 130 can include more than one longitudinally aligned series of side holes. . In an exemplary embodiment, the side holes 130 that are visible in figure 5 are matched by another column of longitudinally aligned side holes formed on the opposite side of the delivery cannula 122 (and therefore not visible in the view of figure 5). Aspects of the present invention provide that the side holes 130 define circular side holes, non-circular side holes, or a set of circular and non-circular side holes.

As a reference point, the preset curve 134 is curved away from a central axis C of the sending cannula 122 so that the curvature of preset curve 134 is less than the radius of curvature R of the curve preset 90 (figure 2A) previously described, thus illustrating another embodiment according to the principles of the present invention. Additionally, although the side holes 130 are illustrated as formed along the preset curve 134, in another embodiment at least one of the side holes 130 is formed proximal to the preset curve 134.

In other preferred embodiments, the delivery cannula 36 may comprise multiple preset curves to allow for better delivery of curable material within a cavity. With reference to figures 5A and

5Β, additional preferred delivery tube configurations are shown. In each of said configurations with multiple preset curves, the delivery cannula may comprise an open end 147 or a closed end 148 and contains one or more side holes 149. The delivery cannula provided with multiple preset curves can be formed according to the methods described here previously and be provided with a format memory feature.

Regardless of an exact configuration, the assembled delivery cannula device (such as a delivery cannula device 26 of figure 4) according to the principles of the present invention is highly useful in carrying out a wide variety of bone stabilization procedures as part of a general curable material delivery system. For this purpose, figure 6A illustrates an intraosseous curable material delivery system 150 according to a modality of the present invention, used to perform a vertebroplasty procedure. The system 150 includes the outer guide cannula 22, a cannula device 26, a source of curable material 152 fluidly coupled to a cannula device 26, and a controller 154 coupled at least to the source of curable material 152.

The source of curable material 152 includes, in one embodiment, a container 160 containing a curable material as previously described, and tubes 164 extending from container 160 to the stem assembly 30 of a shipping cannula device 26. With respect to to this, tubes 164 terminate in a socket 166 configured to be removably attached to hub 34. In particular, the socket 166 is configured to fit inside the passage 52 of the stem 40 and removably couple to the hub 34. In one embodiment, the socket 166 threads over a Luer thread defined by the hub 34. In another embodiment, the slot 166 fits under pressure on hub 34. Alternatively, a wide variety of other mounting configurations are also available.

Controller 154 can take any shape known in the art and is coupled to the source of curable material 152. In an exemplary embodiment, controller 154 controls a mass flow and a mass flow coefficient (i.e., a fluid) of curable material from container 160 to a delivery cannula device 26. Controller 154 may include a variety of actuators (eg, key (s), pedal (s), etc.) providing the user with the ability to remotely control liquid flow within a shipping cannula 36. Alternatively, manual control can be employed so that controller 154 can be eliminated.

During a palliative bone procedure, with the sending cannula 36 partially retracted within, or entirely removed from, the outer guide cannula 22, the outer guide cannula 22 is located at a desired sending field within the bone. For example, in a vertebroplasty procedure, the external guide cannula 22 is inserted in a vertebra 180, preferably in the pedicle 182. In this regard, vertebra 180 includes a vertebral body 184 defining a vertebral wall 186 surrounding body material (e.g., spongy bone, blood, marrow, and other soft tissue) 188. Pedicle 182 extends from a vertebral body 184 and surrounds a vertebral foramen 190. In particular, pedicle 182 is attached posteriorly to a vertebral body 184 and together they comprise a vertebra 180 and form the walls of a vertebral foramen 190. As a reference point, the intraosseous system 150 is suitable for evaluating a variety of bone fields. Thus, although a vertebra 180 is illustrated, it should be understood that other bone fields can be evaluated by the system 150 (i.e., femur, long bones, ribs, sacrum, etc.).

The external guide cannula 22 forms an access path to a sending field 192 (or forms sending field 192) through pedicle 182 into body material 188. Thus, as illustrated, the external guide cannula 22 was directed through pedicle 182 through a trans-pediatric approach. The transpedicular approach locates the external guide cannula 22 between the nipple process and the accessory process of the pedicle 182. Therefore, the external guide cannula 22 provides access to the sending field 192 at the distal open end 28. With other procedures, the external guide cannula 22 can similarly perform an operation similar to removing a core, forming an enlarged opening in the bone interior. In a preferred embodiment illustrated in figure 6A, the distal tip 28 of cannula 22 is positioned close to the entry point within the sending field 192. As will be explained in more detail here, the smaller the projection of the distal tip 28 into the sending field 192 allows greater access for the sending cannula 36 to be positioned inside the sending field 192 and to send curable material to desired locations within the sending field. shipping field 192.

Once the external guide cannula 22 has formed, or is otherwise positioned inside the bone in the desired delivery field 192, the delivery cannula 36 is slidably inserted / distally advanced into the external guide cannula 22 As generally illustrated in Figure 6A, the distal end 82 of the sending cannula 36 is plumbed at the distal end 28 of the outer guide cannula 22. The approximate alignment of the first depth marking 110a with the rod 30 provides a user with visual confirmation (at a point external to the patient) of the position of the distal end 82 with respect to the distal tip 28 of the external guide cannula 22. Before further distal movement, the sending cannula 36 is entirely within the outer guide cannula 22 so that the deflection-sensitive segment 88 (figure 2A) of the sending cannula 36 is forced (i.e., flexed) into a shape substantially rectilinear, which generally conforms to the shape of the external guide cannula 22. This relationship is shown more clearly in figure 6B with which the force is effectively provided by the guide cannula 22 on the deflection segment 88 due to the radius of curvature R (figure 2A) defined by the deflection segment 88 in a natural state being greater than an internal diameter of the guide cannula 22. Said interaction essentially removes the pre-adjusted curvature of the fold 90 (figure 2A), forcing or making the segment liable to deflection 88 to a substantially straight state (it being understood that because the inner diameter of the guide cannula 22 is greater than whereas the outer diameter of the sending cannula 36, ​​the deflectable segment 88 will continue to show a slight coverage inside the guide cannula 22;

thus, substantially straight is in reference to a delivery cannula 36 being substantially, but not necessarily entirely, linear). Thus, prior to interaction with the sending field 192 (figure 6A), the sending cannula 36 is flexed in a substantially straight, non-curved orientation within the outer guide cannula 22.

A delivery cannula device 26, and in particular delivery cannula 36, ​​is then distally advanced into the guide cannula 22 as shown in figure 6C. In particular, the sending cannula 36 is distally maneuvered so that at least a portion of the deflectable segment 88 extends ahead of the open tip 28 of the guide cannula 22 and within the sending field 192. The now unrestricted portion of the deflectable segment 88 naturally deviates laterally (from the substantially straight shape described above) when exiting the guide catheter 22, reverting to a pre-adjusted curvature of the fold 90 previously described due to the feature of format memory. The user can visually confirm a distal extension length of the sending catheter 36 from the guide catheter 22 by means of a longitudinal positioning of the signs 110b or 110c (the signs 110c being visible in figure 6C) in relation to the stem 30. Additionally, the directional indication 114 indicates to a user (at a point outside the patient) a spatial direction of the fold 90 within the sending field 192 with respect to the spatial position of the stem 40.

In connection with the distal advancement of the sending cannula 36, ​​the blind tip 100 of the distal end 82 is hemispherically formed (or another unsharp or blind shape) and thus atruammatic with respect to contacted tissue / bone. Therefore, the blind tip 100 can contact and / or probe the vertebral wall 186 with a minimum risk of puncture or enuclear a vertebral body 184. Thus, blunt tip 100 offers an advantage over conventional sharp-edged bone cement delivery needles, and does not require a separate thread to prevent enucleation as is otherwise necessary with available curved needles.

The side orifice 84 is displaced from the distal end 82 and is therefore available to send curable material into, and remove 31 material from, the delivery field 192. In particular, the side orifice 84 can eject material radially curable from, and aspirate body material into, the delivery cannula 36, ​​even when the distal end 82 is pressed against a surface, such as an inner wall of a vertebral body 184.

With the above said in mind, in one embodiment, the fluid source 152 is then operated (for example, via controller 154) to send a curable material (not shown) to the sending cannula 36 via hub 34 Curable material entering the sending cannula 36 is forced through the light 86 (figure 2A) towards the side orifice 84. As shown in figure 6D, the curable material is then dispensed / injected from the sending cannula 36 in a radial form from the side orifice (s) 84 and into the sending field 192 in a pattern. similar to clouds 194. Alternatively or additionally, delivery field 192 can be aspirated by replacing the source of curable material 152 (figure 6A) with a vacuum source (not shown).

In another embodiment, the curable material is sent to the sending cannula 36 before introducing the sending cannula 36 into the guide cannula 22. In practice, an operator can advance the curable material ahead of the side orifice (s) (s) 84 of the sending cannula 36 so as to completely fill the sending cannula 36 and then clean the side orifice (s) 84 of excess curable material before insertion into the guide cannula 22. The sending cannula 36 is thus pre-filled with curable material before the sending cannula 36 is connected with the guide cannula 22. Once the sending cannula 36 is inserted into the guide cannula 22 the curable material is immediately available for use. be sent into the deployment field. Said pre-filling step advantageously reduces the time required to send the curable material into the patient by the fact that this can be done substantially at the same time as the guide cannula 22 is being directed into the delivery field.

Equally important, when injecting the curable material radially from one side of the delivery cannula 36 instead of axially from the most distal end (as would otherwise occur with conventional shipping needles), system 150 (figure 6A) you can avoid forcing the curable material into a fracture or other defect that can in turn lead to an undesirable leakage of the curable material through the fracture. Just as an example, figure 6D illustrates a fracture 196 in a vertebral body wall 186. Vertebroplasty is a common solution for said vertebral fractures, with the accepted repair technique requiring the positioning of the distal end 82 in or facing fracture 196 to ensure that curable material is dispensed in relative proximity to it. With known shipping needles, said preferred approach results in the curable material being injected directly towards fracture 196. Differently, with shipping catheter 36 of the present invention, the distal end 82 is still facing fracture 196, although the cloud of injected curable material 194 is not forced directly towards fracture 196. Instead, the cloud of curable material 194 indirectly reaches fracture 196 with minimal propulsion force retained so that the cloud of curable material 194 is unlikely to forcefully leak through fracture 196. However, shipping field 192 is, as a whole, still filled with the cloud of curable material 194 to effect the desired repair.

As shown in figure 6D, the entire sending field 192 is accessible via the sending cannula 36. To this end, although cannula 22 has been inserted using a right posterior-lateral approach, system 150 can perform a vertebroplasty procedure at from the left posterior-lateral approach, or in the left anterior or right lateral approaches as shown in figure 6E.

In one embodiment, and returning to figure 6C, a desired volume of curable material is sent entirely through the sending cannula.

36. In other embodiments according to the principles of the present invention, after injecting a first volume of curable material through the sending cannula 36, ​​the sending cannula 36 is disconnected from the source of curable material 152 and removed from the guide cannula. 22. The source of curable material 152 is then fluidly connected to the guide cannula 22 (for example, the socket 166 is fluidly connected to a corresponding fluid orifice provided with the stem 30) and then operated to inject a second volume of material curable to the delivery field 192 by means of the guide cannula 22.

In another preferred embodiment, tubes 164 that supply curable material are rotatably coupled to a delivery cannula device 26. With additional reference to figure 6C, in said modality an optional rotary connector 29 is located between the shipping cannula 26 and the source 152 of curable material to allow the sending cannula 26 and the source 152 of curable material to rotate with respect to each other. Swivel connectors suitable for curable material shipping devices are described in US patent application serial number 11 / 526,164, incorporated herein by reference with respect to your description of the swivel connectors. In said modality, the swivel connector 29 allows a doctor to rotate the sending cannula 26, and thus rotate the curved end of the sending cannula 26 inside the implantation field, without requiring the source of curable material to be disconnected from the cannula 26 or rotated with respect to the cannula. In a preferred modality, the swivel connector 29 is operable to rotate the delivery cannula 26 preferably by about 90 degrees and more preferably by about 360 degrees.

In more general terms, during the palliative bone procedure, a physician operating the intraosseous system 150 extends a portion of the preset curve 90 within the sending field 192 otherwise defined within the bone. In one embodiment, a subsequent rotation of the sending cannula 36 rotates the spatial position of the lateral orifice 84 with respect to the sending field 192, thus accessing multiple planes of the sending field 192 with only the sting of the external guide cannula 22. Thus, by a combination of retraction of the cannula 36 inside the outer guide cannula 22, distally advancing the cannula 36 with respect to the outer cannula 22, and by rotating the cannula 36, ​​multiple planes and multiple regions of the bone field of interest can be evaluated by the sending cannula 36 with a single approach of the external guide cannula 22. Thus, for example, a unipedicular vertebroplasty can be performed with the 150 system. Figures 7A to 8B in general illustrate (figures 7A and 7B from an anterior perspective; figures 8A and 8B from a left side perspective) several planes / regions of a vertebral body 182 accessible with rotation and / or advancement of the sending cannula 36 with respect to the guide cannula 22 (again with the guide cannula 22 remaining stationary). Notably, in the drawings of figures 7A to 8B, the fold direction defined by the sending cannula 36 is not necessarily perpendicular to the plane of the page, so that the fold may not be completely evident in each view.

With reference to figures 9 to 10, another preferred method for sending curable material is illustrated. In this preferred embodiment, a physician creates voids 210 in the soft-bodied material 200 (e.g., spongy bone, blood, marrow, and other soft tissue) within a bone sending field by manipulating the curved end 90 of the sending cannula. 36. Voids 210 can then be filled with curable material. It has been observed that when voids are created, curable material sent to the shipping field will generally flow into voids 210 instead of soft-bodied material 200. As a result, a doctor can create a void 210 in a relatively small desired area, and mainly fill only that area with curable material.

According to a preferred embodiment, voids can be created through a combination of retracting the sending cannula 36 inside the outer guide cannula 22 and distally advancing the sending cannula 36 with respect to the outer guide cannula 22, thus moving the curved end 90 alternately. The alternating action causes the curved end 90 to grind the soft-bodied fabric and create a channel 212 within the soft-bodied material. In addition, by retracting the sending cannula 36 inside the outer guide cannula 22 and rotating the sending cannula 36 so that the curved end 90 advances distally within the sending field in a different orientation, the curved end 90 can create multiple channels

212 inside the soft-bodied fabric 200. In addition, the curved end 90 of the delivery cannula 36 can be distally advanced only partially within the delivery field and then removed to create shorter channels 212 within the implantation field where desired.

According to another preferred embodiment shown in figure 10, the sending cannula 36 can be rotated or rotated after the curved end 90 has been introduced into the implantation field. Rotating or rotating the delivery cannula 36 causes the curved end 90 to rotate or rotate within the shipping field and scrape through the soft body fabric 200 to create a cone-shaped void 214 in the soft fabric 200 inside the shipping field. Cone-shaped voids 214 of various sizes can be created by only partially inserting the curved end 90 into the implantation field and rotating the sending cannula 36.

Voids 210 inside the soft-bodied fabric of various sizes and shapes can be created by using a combination of the methods described above. According to a preferred method, a physician can introduce the curable material into the implantation field as he is creating the voids within the implantation field. Thus, voids can be created and filled at the same time.

One skilled in the art will observe that if voids are first created and then filled, or curable material is sent in a cloud-like pattern without first creating voids; the delivery cannula of the present invention can be manipulated to deliver small deposits of curable material to specific desired areas within a cavity.

In one embodiment, curable material can be sent to different planes to form structures of curable material within the cavity to stabilize the end plates of a vertebral body, as illustrated in figures 11A and 11B. In a preferred embodiment, curable material 232a and 232b is deposited proximal to the end plates 230a and 230b of a vertebral body so that the curable material substantially interfaces with the end plates 230a and 230b and provides structural support. According to a preferred embodiment, the procedure leaves a region between the deposits of curable material 232a and 232b that contain substantially no curable material. Curable material can thus be deposited only in a particular region or regions of the cavity.

Referring to figure 11C, in another preferred embodiment the deposits of curable material 232a and 232b can be connected by arranging the curable material between the deposits of curable material 232a and 232b to form a curing column of curable material 234. In said embodiment, deposits of curable material 232a and 232b are first created to stabilize the end plates of a vertebral body. A curable material stabilization column 234 is then created between the curable material deposits 232a and 232b to connect the curable material deposits and forms a curable material structure within a vertebral body. By first stabilizing the end plates, deformities created due to compression fractures can be stabilized. By stabilizing both end plates and then creating a column-like structure between the end plates, the stiffness of the vertebral body can be significantly improved in this way by minimizing the overall strength items of a vertebral body. It has been observed that when depositing curable material with known methods of depositing material in the center of a vertebral body, as typically created by a chifoplasty procedure, or dispersed through a vertebral body, as typically created by a vertebroplasty procedure, no uniformly strengthens a vertebral body. Because the cement is concentrated in regional areas, there is only minimal stabilization of the end plates. By stabilizing both end plates and then providing a structure to fix them together, the stiffness of the repaired vertebral body will be closer to the normal stiffness of an unbroken vertebral body when compared to the known procedures of vertebroplasty or chipoplasty. In another preferred embodiment, if the compression fracture is more pronounced on an end plate, stabilization of only said end plate may be required and only a deposit of curable material will be created proximal to the vertebral end plate. In said embodiment, a support structure can be created to connect the deposit of curable material and the vertebral end plate opposite the vertebral end plate being repaired.

Referring to figure 12, another preferred method for sending curable material is illustrated. In this preferred modality, the sending field is the sacrum 220. In that modality, the curable material is sent to the sacrum

220 to repair fragments or fractures of bone in the sacrum. According to a preferred method of the present invention, the curable material is sent to multiple regions within the sacrum through a single access point. Preferably, the guide cannula 22 is generally inserted in the middle portion of the sacrum. As described above, a curved needle is inserted into and advanced with respect to the guide cannula 22. The delivery cannula 36 is preferably oriented so that the curved end 90 between proximal to a first region 221 of sacrum 220. Curable material is then sent to the first region

221 of the sacrum 220. After the curable material is sent to the first region 221, the physician can then partially or completely retract the curved end 90 inside the guide cannula and then reorient the sending cannula 36 and curved end 90. As far as the sending cannula 36 is again advanced with respect to the guide cannula 22, the curved end 90 enters proximal to a second region 222 inside the sacrum 220. Curable material is then sent to the second region 222 of the sacrum 220. The process can be repeated for additional regions. Although the implantation field described above is the sacrum, fractures in other bones can be repaired by sending the curable material to multiple regions through the same access point using the methods described above.

Although specific modalities have been illustrated and described here, it will be appreciated by those skilled in the art that a variety of alternative and / or equivalent implementations can be substituted for the specific modalities shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations in the specific modalities discussed here. Therefore, it is intended that the present invention is limited only by the claims and equivalents thereof. For example, although specific reference has been made to the vertebroplasty procedure, the devices, systems, and methods in accordance with the principles of the present invention are equally applicable to the delivery of curable material within multiple other bones of a patient.