Device and system for delivering a curable material into bone

Description of the invention

Background of the invention

[0001] The present invention relates to assemblies for stabilizing the bone structure. More particularly, it relates to assemblies and systems for delivering a curable stabilizing material to a bone structure.

[0002] Surgical intervention for damaged or weakened bone fragments has proved highly beneficial for patients, for example patients with back pain associated with vertebral damage.

[0003] The bones of the human skeleton contain mineralized tissue that can broadly be categorized into two morphological groups: bone cortex and spongy bone. The outer walls of all bones are composed of the cortical layer of bone, which has a dense, compact bone structure characterized by microscopic porosity. The spongy or trabecular bone forms the internal structure of the bone. Spongy bone is composed of a network of interconnected thin rods and plates, known as trabeculae.

[0004] When performing certain bone related procedures, spongy bone is replenished by injecting a palliative (or therapeutic) material used to stabilize the trabeculae. For example, the higher and lower vertebrae of the spine can advantageously be stabilized by injecting a suitable hardenable material (e.g. PMMA or other bone cement). In other procedures, percutaneous injection of a stabilizing material into a vertebral compression fracture using, for example, a transpedicular or parapedicular procedure, has proved beneficial in treating pain and stabilizing damaged bone fragments. Other skeletal bones (e.g. the femur) may be handled in a similar manner. Either way, bone in general, and spongy bone in particular, can be strengthened and stabilized by injecting a palliative bone compatible material.

[0005] A conventional technique for delivering bone stabilizing material involves the use of a simple access device or cannula whereby a piercing (or otherwise cut) is made through the cortex of bone to access a target site in the cancellous bone. The bone stabilizing material is then passed through the cannula to fill the portion of the cancellous bone at the target bone site. In order to minimize the invasiveness of this procedure, the cannula is typically a small diameter needle. WO 99/08616 describes the

- a tubular body including an internal bore to guide the flow of material to the bone. The tubular body includes a dispensing end having an opening in communication with the bore for discharging the flow of material.

[0006] With the foregoing in mind, when the needle cannula comes into contact with spongy bone and other soft tissue structures, there is an associated risk that upon initial puncture, the needle cannula may spinal or pierce other tissue and / or bone mass that would is repaired (at a site other than the puncture site). Therefore, during percutaneous vertebroplasty, great care should be taken to avoid puncture, spinal puncture or other disruption of the vertebral body. Similar concerns about a spinal puncture concern arise with other bone repair procedures. Therefore, in order to minimize the trauma and time required for the procedure, it is desirable that only a single puncture at a target point in the bone is performed. Unfortunately, for many procedures, the surgical target is not fully accessible for use with a conventional straight needle cannula. For example, in vertebroplasty, the closed and tight nature of the inner vertebral body often requires two or more punctures made with a straight needle cannula at different vertebral target points (bi-pedicle technique). It would be desirable to provide a bone stabilizing material delivery system that can more readily conform to the anatomical requirements of a particular administration target, for example, a system suitable for monopedicular vertebroplasty.

[0007] The instruments sold by Cook Medical under the name OSTEO-RX ™ for the entire product line use a curved needle to supply bone stabilizing material as part of vertebroplasty or the like. The curved needle apparently improves the surgeon's ability to locate and inject the stabilizing material at the appropriate target point. As with a conventional straight needle cannula, the curved needle discharges the curable material through a single axial opening at the farthest tip. However, this curved needle is used in conjunction with an outer cannula which assists substantially in accessing a bone target point as well as facilitating transdermal delivery of the needle to the delivery point (inside bone) in a desired manner. More specifically, the outer cannula accesses such a bone target point followed by advancement of the needle through the outer cannula. As the needle tip passes beyond the distal end of the outer cannula, the needle tip becomes "exposed" to a target point in bone. To avoid core puncture and thus potential tissue damage when inserting the distal end of the needle into a target point in bone, an additional wire component is required concentrically within the needle and extending beyond the distal tip. This coaxial tube must be removed prior to infusing the bone stabilizing material through the needle. Moreover, the needle can only discharge the stabilizing material through the axial opening at the distal needle tip, which may affect the surgeon's ability to infuse all desired infusions.

And / or requires the additional step of the procedure of "retracting" the needle tip from the desired destination of administration. Also, due to the fact that the needle tip and thus the axial opening can cause a bone defect (e.g. vertebral body disruption) to be treated, the stabilizing material can be injected directly into the lesion, with the risk that another possibility arises, namely that the stabilizing material will squeeze through and out of the lesion. This is clearly undesirable. The issues and concerns described above in the context of percutaneous vertebroplasty may also arise with similar surgical procedures at other bone targets.

[0008] The injection of palliative materials into damaged or weakened bone targets has proven to be highly beneficial for patients. However, known access and infusion techniques require multiple needle punctures and / or are associated with a risk of core perforation of bone or tissue. Therefore, there is a need for an improved device and system for delivering stabilizing material to damaged or weakened bone targets.

Summary of the invention

[0009] The benefits derived in connection with the essential features of the invention disclosed herein include a delivery cannula having a non-traumatic blunt distal end that minimizes the risk of core tissue perforation or bone or tissue puncture during endosseous procedures without the need for additional components (such as like a separate wire). Other advantages relate to a delivery cannula defining at least one side outlet adjacent the blunt distal end, the outlet opening (s) allowing the radial infusion of the curable material at the bone target, even when the distal end is in contact. with bone and / or tissue. Thus, a palliative bone procedure can be performed with a limited time in the operating room and with less interference by surgical instruments at the bone endpoint. For example, monopedicular vertebroplasty can be easily performed. Moreover, virtually any area within the target of the surgical procedure can be accessed. Also, the distal end of the delivery cannula may be positioned as close as necessary to a particular anatomical portion of the target point of the surgical procedure being performed (e.g., a fracture in a bone), without fear that later feed material will tear into or thereby fracture.

[0010] Some aspects of the present invention pertain to a delivery cannula for delivering a curable material to bone. The device includes a delivery cannula and a hub defining a fluid port. The delivery cannula defines a proximal end, a deflectable segment, a distal end, a channel, and at least one side outlet located and dimensioned as defined in claim 1. The proximal end is axially open to the channel. The tilt segment is formed against the proximal end and ends at the distal end, which is otherwise axially behind.

-4 closed. Moreover, the distal end has a blunt tip. The conduit extends from the proximal end and is in fluid communication with the side outlet (s). For this purpose, a side outlet opening (s) is formed adjacent and also at a slight distance from the distal end. Finally, the deflectable segment forms a longitudinally curved shape and has shape memory properties. With this configuration, the deflectable segment can be biased into a substantially upright shape and will revert to a curved shape when the force is removed. The cup is fluidly coupled to the proximal end and the lead catheter. With such a construction, and in use, the distal end will not damage or puncture the core tissue upon insertion at the delivery target point within the bone, due to its blunt tip. Moreover, the side exit (s) introduces the possibility of injecting the curable material whether or not the distal end is located on the body material, and also allows a more fine distribution to be achieved.

[0011] 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 target point within bone. The system includes a delivery cannula and hub as described in the previous paragraph, including a guide cannula. The delivery cannula and the guide cannula are dimensioned such that the delivery cannula is able to slide within the guide cannula. To this end, the deflectable segment is configured to deflect into a substantially upright shape when inserted into the guide cannula and to revert to a curved shape as it extends further beyond the guide cannula to deliver the curable material. In one embodiment, the guide cannula and the delivery cannula are sized to perform the vertebroplasty procedure.

[0012] Yet 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. The distal end of the guide cannula is positioned within the bone structure. The delivery cannula is inserted into the interior of the guide cannula. In this regard, the deflectable segment deflects into a substantially straight shape within the guide cannula. The delivery cannula is advanced further away from the guide cannula such that the distal end and at least a portion of the pivoting delivery cannula extend beyond the distal end of the guide cannula. To this end, a part of the segment that can be deflected further beyond the distal tip of the guiding cannula naturally reverts to a curved shape. The distal end of the delivery cannula is located adjacent to the delivery target point within the bone structure. The curable material is injected into the channel. The injected curable material is led to the delivery destination via the side exit port (s). After delivery, the curable material may solidify into such

- a way to stabilize the bone structure. In one embodiment, the method further comprises rotating the delivery cannula relative to the guide cannula to change the spatial position of the side outlet (s) and thus provide for the ability to inject the curable material in different planes.

Brief description of the drawings

[0013] The drawings accompanying this description are included for a deeper understanding of the present invention, and are incorporated into and form part of the description herein. Other embodiments of the present invention, and the many advantages of the present invention, will be readily apparent as they become more readily understood by referring to the following detailed description. The elements in the drawings are not always shown to the same scale to each other. Like reference numerals indicate like parts.

Fig. 1 illustrates an intraosseous delivery system for curable material in accordance with the essential features of the present invention;

Fig. 2A is an exploded cross-sectional view of a delivery cannula device component of the arrangement of Fig. 1;

Fig. 2B is a front view of the delivery cannula portion and socket of the device of Fig. 2A;

Fig. 3A is an enlarged plan view of the distal portion of the delivery cannula of Fig. 2A;

Fig. 3B is a cross-sectional view of the delivery cannula of Fig. 3A;

Fig. 4 is a cross-sectional view of the delivery cannula device of Fig. 2A when finally assembled;

Fig. 5 is a side plan view of an alternative delivery cannula device not falling within the scope of the claims;

Fig. 6A is a simplified plan view through an intraosseous curable material delivery system used in a palliative bone procedure in accordance with the essential features of the present invention;

Fig. 6B is a cross-sectional view of a portion of the arrangement of Fig. 6A;

Fig. 6C illustrates the last step of the procedure performed by the system of Fig. 6A;

Fig. 6D is a cross-sectional view of the vertebral body in combination with part of the system of Fig. 6A, illustrating the injection of a hardenable material;

Fig. 6E is a cross-sectional view of the vertebral body illustrating different access direction positions for vertebroplasty, in accordance with the essential features of the present invention;

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

Figures 8A and 8B are simplified side views of the vertebral body illustrating the use of the system in accordance with the essential features of the present invention.

Detailed description

[0014] Fig. 1 illustrates components of an intraosseous curable material delivery system 20 in accordance with the essential features of the present invention. The system 20 includes an outer guide cannula 22 and a delivery cannula assembly 26 (generally indicated). Details of the various components are set out below. In general terms, however, a portion of the delivery cannula assembly 26 is dimensioned such that it can be slidably placed within the guide cannula 22 which further serves to create and / or position a desired delivery target point within bone. Once positioned, delivery cannula assembly 26 is used to inject the curable bone stabilizing material to the point of delivery. System 20 may be used for a number of other procedures, such as vertebroplasty and other bone augmentation procedures, in which curable material is delivered to a target point within bone, as well as for removing or aspirating material from a target point within bone.

The system 20, and in particular the delivery cannula assembly 26, is highly useful for delivering a curable material in the form of bone cement material. The term "curable material" in the context of the substance that is fed through the system / assembly of this invention and described herein is intended to refer to materials (e.g. composites, polymers, and the like) that have a fluid or flowable state or phase and a cured, solid or bonded state or phase. Curable materials include, but are not limited to, injectable polymethylmethacrylate (PMMA) bone cement, which has a flowable state where it can be delivered (e.g., injected) through a cannula to a target point and then set into cured cement. . Other materials such as calcium phosphate, bone-growing material, antibiotics, proteins, etc., may be used in place of or in addition to PMMA (but have no effect on the excess characteristics of the resulting flowable composition and cured, solid or solidified state) . This enables the body to re-absorb the cement or to improve the clinical effect according to the implanted filler material. With this in mind, and in one embodiment, system 20 further includes a source (not shown) of curable material in fluid communication with the delivery cannula assembly 26.

[0016] Considering the above, the outer guide cannula 22 generally allows the delivery cannula assembly 26 to access a suitable bone target, and thus may take one of a wide variety of forms. In general outline, however, the guide cannula 22 is sized to slideably receive a portion of the delivery cannula assembly 26, ending with an open distal.

- tip 28. The distal tip 28 may further be adapted to facilitate core drilling of bone tissue, such as when a guide cannula 22 is used to create a target delivery point within bone. To assist in achieving proper engagement between the guide cannula 22 and a portion of the delivery cannula assembly 26, except that it is slidingly inserted into the guide cannula 22 during use (as described below), in one embodiment, the inner diameter surface of the guide cannula 22 it is highly smoothed to a matte or mirror finish (i.e. RMS range of 4 - 16). Regardless of this, and in some embodiments, the guide cannula 22 may further be attached, at its proximal end, to the handle 30 to improve the surgeon's manipulation of the system 20. Alternatively, the handle 30 can be eliminated.

[0017] The delivery cannula assembly 26 is shown in more detail in Fig. 2A, and generally includes a handle assembly 32 (generally designated), a hub 34, and a delivery cannula 36. The socket port 34 defines a fluid port and is in fluid communication with the delivery cannula 36. the gripping assembly 32 stops the socket 34 from connecting to the delivery cannula 36. As described in more detail later, the delivery cannula 36 is sized to be coaxially received and slid inside the guide cannula 22 (Fig. 1), and is adapted to deliver the curable material injected therein via the socket 34.

The handle assembly 32 includes, in one embodiment, a handle 40 and a retention member 42. The handle 40 is adapted to receive the hub 34, the retention member 42 securing the hub 34 (and thus also the delivery cannula 36) to the handle 40. .

The handle 40, in one embodiment, includes a first section 44 and a second section 46. This first section 44 is adapted to snap onto the second section 46, such as by a complementary annular protrusion (s) 48 and grooves. 50. Independently, the first section 44 forms a central passage 52 extending inwardly from its outer surface 54.

[0020] The second section 46 defines an inner aperture 56 which, when finally assembled into the handle 40, aligns with the central passage 52. The aperture 56 may take a variety of shapes sized to receive the socket 34 in a socket fashion. Such a socket connection between the handle 40 and the socket 34 is preferably arranged such that the socket 34 cannot rotate with respect to the handle 40 when finally assembled (i.e., the connection of the socket 34 and the socket 40 resists a torque acting on one of the compartments in such a way). a manner that rotation of the handle 40 results in identical rotation of the hub 34 and delivery cannula 36, even when the delivery cannula 36 is inserted within a restricted surgical target). Therefore, in one embodiment, aperture 56 and cup 34 (as described below) have corresponding unsymmetrical or non-spherical shapes in cross-section. With respect to the section view

In Fig. 2A, such a non-circular shape of the aperture 56 is characterized in that the aperture 56 is defined by a side wall 58 having a projection 60 corresponding to the shape of the socket 34 as described in more detail below. Alternatively, sidewall 58 may take any of a variety of other configurations. Regardless of this, and in one embodiment, the second section 46 forms an external thread 62.

The retention member 42 is configured to attach the hub 34 and delivery cannula 36 to the handle 40 and defines a central opening 64 defining a proximal portion 66 and a distal portion 68. The proximal portion 66 defines a central opening 64 slightly larger than the diameter. socket 34, including an internal thread 70 sized to engage the external thread 62 of the handle 40. The distal portion 68 defines an opening 64 having a diameter approximately similar to the outer diameter of the delivery cannula 36 to provide a more rigid connection between the gripping assembly 32 and the socket 34 and delivery cannula 36. Alternatively, the gripping assembly 32 may take any of a variety of other shapes, and in some cases In some embodiments, it can be completely eliminated.

[0022] In one embodiment, socket 34 has a conventional fluid port structure and defines a fluid passage 71 and an external thread 72 at its proximal end 74. In one embodiment, thread 72 is a two-thread right-hand Luer thread with a pitch of 5 mm. however, other thread configurations and pitch size are also acceptable. Regardless of previously mentioned, in one embodiment, socket 34 is configured to be pivotally "locked" with respect to handle assembly 32 when finally assembled. Therefore, in one embodiment, the socket body 34 forms a substantially cylindrical surface 76, a portion of which is flattened in an area 78, as shown in Fig. 2B. The size and shape of this flattened area 78 corresponds to the side wall 58 of the aperture (Fig. 2A) provided with the handle 40 (Fig. 2A).

[0023] The cup 34 is formed, in one embodiment, from a sterilizable polymeric material. By way of example, cup 34 may be fabricated from polylac 717C acrylonitrile butadiene styrene (ABS), although other sterilizable polymers and / or copolymers are also acceptable.

Returning to Fig. 2A, the delivery cannula 36 defines a proximal end 80 and a distal end 82, and defines one or more side exit holes 84 adjacent the distal end 80 and in fluid communication with the inner passage 86. Further, delivery cannula 36 includes a deflectable segment 88 (indicated generally) defining a predetermined curve or fold 90. As described below, the deflect segment 88, and in particular the fold 90, includes or extends from the distal end 82 and has shape memory characteristics, wherein the deflect segment 88 can be pushed from a curved shape (shown in Fig. 2A) to a curved shape (shown in Fig. 2A). a substantially upright shape and will naturally revert to a curved shape upon cessation of force.

[0025] The proximal end 80 is axially open to the channel 86 and, conversely, the distal end 82 is axially closed to the channel 86, i.e. the material cannot exit axially from the distal end 82 with respect to the axis of the channel 86). This means that material within channel 86 cannot be pushed further axially therefrom. Moreover, distal end 82 defines or includes a blunt tip 100. For example, in one embodiment, the dull tip defines or includes the surface of a hemisphere, although other dull (i.e., curved or curved) shapes and contours are also acceptable. The blunt tip surface 100 is adapted to provide a non-traumatic surface suitable for accessing, contacting and sampling bone or tissue while minimizing the risk of puncture and / or perforation of core tissue or bone damage. To improve the desired softness, the blunt tip 100 may vary in thickness compared to the remainder of the delivery cannula 36, ​​such as by sintering the distal end 82 to form a blunt tip 100 (when the delivery cannula 36 is initially provided with a continuous tube). Alternatively, a blunt tip 100 may be formed independently of the remainder of the delivery cannula 36 and then attached to the delivery cannula 36 to form a distal end 82 (e.g., the delivery cannula 36 may include a first tubular body formed for the hardened material together with a second solid body formed and more soft material, fixed (eg. welded) to the tubular body to form a distal end 82 and a blunt end 100).

With reference to Figures 2A and 2B, a side outlet (s) 84 is formed adjacent the distal end 82, extending through the thickness of the side wall of the delivery cannula 36. In one embodiment, a single outlet 84 is provided and it is situated "opposite" to the direction of the fold 90. In other words, with reference to the longitudinal section view in Fig. 2A, the fold direction 90 serves to form the delivery cannula 36 to define the inner folded side 102 and the outer folded side 104. As noted here, side outlet 84 is formed lengthwise and also opens correspondingly to the outer side of fold 104. It has been surprisingly found that by positioning the side outlet 84 "opposite" the fold 90, users will experience improved control of the direction in which the curable material is distributed from the delivery cannula 36 as well as improved safety. Alternatively, a plurality of side outlets 84 may or may not be circumferentially aligned. Generally, the side outlet 84 is offset by at least a distance D1 from the distal end 82. In one embodiment, the distance D1 is between 0.13 cm (0.05 inch) and 1.27 cm (0.5 inch), and preferably, the distance D1 is between 0.25 cm (0.1 inch) and 0.64 cm (0.25 inch). With this configuration, even when the blunt tip 100 is pressed against tissue or bone, the side exit port (s) 84 is "open" and thus available for dispensing (or suction) material. Moreover, the side outlet (side openings

The outlet 84 allow for the radial discharge or flow direction with respect to the longitudinal axis of the delivery cannula 36.

[0027] The side outlet (s) 84 may take any of a variety of shapes and sizes (relative to the outer surface of the delivery cannula 36). For example, the side outlet (s) 84 may be oval, circular, curved, etc. In one embodiment, and with reference to Fig. 3A, a chamfered area 106 may be formed about side exit 84 to eliminate sharp edges along the outer portion of supply catheter 36 as well as to aid a consistent flow of curable material from side exit 84 (by expanding the size of exit hole provided by bevel area 106). ). In the case of embodiments where the side outlet 84 is non-circular, the length L and the width W of the outlet are defined. Therefore, the length L is greater than 0.13 cm (0.050 inch), preferably greater than 0.19 cm (0.075 inch), even more preferably greater than 0.25 cm (0.100 inch). While the width W of the side outlet 84 may or may not be less than the length L (e.g. of 0.11 cm (0.042 inch) in one embodiment), the side outlet 84 is correctly characterized as relatively large, especially when compared to conventional bone cement supply needles which otherwise only have an axial outlet or distal tip orifice .

[0028] More specifically, and with further reference to Fig. 3B (otherwise illustrating a cross sectional view of a delivery cannula 36 taken through a side outlet 84), the delivery cannula 36 defines an inner diameter ID (i.e., the diameter of channel 86). Side outlet 84 is fluidly connected to channel 86 and extends radially. Bearing these assumptions in view, in one embodiment, the length L of the side outlet 84 is greater than the inside diameter ID of the delivery cannula 36. Therefore, at least one linear dimension of the side outlet 84 is greater than any size of the outlet that would otherwise be otherwise be obtained if the outlet opening is to be formed at the distal end 82 (i.e., an axially extending outlet opening). That is, the outlet opening made at the distal end 82 of the delivery cannula 82 (as conventionally used in the field of bone cement delivery needles) is limited in size (i.e. diameter) by the ID inside diameter of the delivery cannula 36. In contrast, the side outlet 84 in accordance with the essential features of the present invention is much larger, with different advantages when a low viscosity fluid (a curable material such as bone cement) is attempted to pass therethrough.

Returning to Fig. 2A, in one embodiment, the delivery cannula 36 defines a continuous length between the proximal end 80 and the distal end 82, with a deflectable segment 88, and more particularly a bend 90, extending approximately 25% of the length from the distal end. 82 (where the "length" of the cannula in the case of the delivery cannula 36 is the length from the hub 34 when finally assembled). In other places

- 11 embodiments suitable for other surgical procedures for the tiltable segment

88, and more particularly, bend 90 extends along between 10% -50% of the length of the delivery cannula 36 as measured from the distal end 82.

[0030] To aid in bringing the curable material (e.g., bone cement) to a restricted target point inside bone (such as in a vertebroplasty procedure), the deflection segment 88 may be shaped to define a bend 90 at a predetermined radius of curvature R suitable for given procedure. In one embodiment, fold 90 is J-shaped (approximately a bend of at least 90 degrees) and defines a radius of curvature R to be less than 1.5 inches (3.8 cm), preferably in the range of 0.64-3 .81 cm (0.25 - 1.5 inch). In one preferred embodiment, fold 90 defines the radius of curvature R to be approximately 1 inch (2.54 cm). Alternatively, as described in more detail below, the radius of curvature R may be greater or less depending upon the particular procedure for which the delivery cannula 36 is to be used.

[0031] Moreover, to facilitate proper deflection of the deflection segment 88 from a curved shape to a substantially upright shape (such as when the delivery cannula 36 is inserted into the outer guide cannula 22 (Fig. 1)) and to restore it to a curved shape, the delivery cannula 36, ​​or at least the deflectable segment 88, is made of a shape memory metal. In one embodiment, the delivery cannula 36 comprises Nitinol (TM), a known shape-memory alloy of nickel (Ni) and titanium (Ti). In one embodiment, a bend 90 is made in the delivery cannula 36 by deforming the straight fluid delivery cannula on exposure to extreme heat for a predetermined period of time to establish a curved shape in the delivery cannula 36.

[0032] In another embodiment, such predetermined curvature or fold 90 is created in the initially straight cannula by cold-working the straight cannula and applying a mechanical stress. Cold working permanently locks the crystal structure (e.g., a partial martensite crystal structure) to a portion (i.e., deflect segment 88) of the cannula, while the unstressed portion remains with e.g. the austenitic structure.

[0033] In addition to Nitinol, other materials exhibiting this shape memory behavior may be used, including superelastic and pseudoelastic copper alloys such as copper, aluminum, and nickel alloys, as well as copper, aluminum, and zinc alloys, and copper alloys. and zinc. Regardless, deflectable segment 88 is formed resilient and naturally adopts the correct radius of curvature R. Thus, after the delivery cannula 36, ​​and in particular deflection segment 88, is bent into a substantially erect shape (not shown), upon subsequent release, deflect segment 88 "remembers" the predetermined curved shape and reversibly released or released. goes back to fold 90 as described in more detail below.

[0034] The above selection of material, in conjunction with the delivery of the curable fluid through one or more relatively large side outlets (otherwise located near the distal end 82) and the blunt tip 100 has been found to surprisingly allow the delivery cannula 36 to be made smaller. and thinner than conventional bone cement delivery needles (i.e. having an outer diameter of approximately 0.125 inches; yet, sufficient structural integrity is still provided to perform all appropriate procedures for bringing the curable material to a target point within bone or removing such material therefrom. More in detail, as best shown in Fig. 3B, the delivery cannula 36 defines an inside diameter (ID) and an outside diameter (OD). In one embodiment, the inside diameter ID is in the range 0.10-0.23 cm (0.040-0.090 inch), preferably in the range 0.13-0.20 cm (0.050-0.080 inch), and more preferably in the range 0.12-0.17 cm (0.047-0.067 inch). The outer diameter OD is selected appropriately to allow the delivery cannula 36 to be received coaxially by the outer guide cannula 22 (Fig. 1). With this in mind, and in one embodiment, the outer diameter OD is in the range 0.08cm-0.25cm (0.030-0.10 inch), preferably no more than 0.23cm (0.090 inch). more preferably in the range of 0.15-0.23 cm (0.060-0.090 inch), and more preferably in the range 0.18-0.21 cm (0.072-0.082 inch). Therefore, in one embodiment, the delivery cannula 36 has a reduced outer diameter and thickness compared to available bone cement delivery needles (e.g., the curved needle available with the OSTEO-RX ™ product line has an outer diameter of 0.23 cm (0.092 inch) and a wall thickness of 0.07 cm (0.027 inch). By way of example, but not thereby limiting, an exemplary delivery catheter is constructed in accordance with the essential features of the present invention and has an outer diameter of approximately 0.077 inch (0.20 cm) and a wall thickness of 0.04 cm (0.015 inch). and also proved to be highly suitable for performing vertebroplasty procedures. It is a completely different improvement previously unknown to surgeons.

[0035] An additional feature of the delivery cannula 36 according to one embodiment is best shown in plan view in Fig. 1. More specifically, the delivery cannula 36 includes the indicia 110 (indicated generally) adjacent the proximal end 80. The indicia 110 indicate the location of the distal end 82 relative to the distal end 28 of the guide cannula 22 after insertion of the delivery cannula 36 into the guide cannula 22. For example, the tokens 110 may include first, second, and third depth indications 10a, 11b, 11c. The longitudinal positioning of the depth marks 110a relative to the distal end 82 (when the delivery cannula 36 is pushed to a substantially erect state) is appropriate for the length of the guide cannula 22 in conjunction with the handle 30 (when used). That is, the first depth mark 110a is positioned some linear distance from the distal end 82 such that when the delivery cannula 36 is inserted into the guide cannula 22 (in addition to pushing the delivery cannula 36 into a substantially erect state), the distal end 82 located next to or even next to the horse

13 of the distal tip 28 of the guide cannula 22, the first depth mark HOa will approximately adjoin or be aligned with (and visible in relation to) the proximal end of the handle 30. Therefore, a user can quickly and easily obtain visual confirmation that distal end 82 is located inside the guide cannula 22. The second and third depth marks HOb, HOc are spaced a short distance from the first depth marks HOa at known intervals (e.g. 0.5 cm, 1.0 cm, etc.) which represent the distal extension length of the distal end 82 relative to the distal end 28. For example, in a situation where the second depth mark HOb is spaced longitudinally (spaced apart) by 0.5 cm from the first depth mark HOa and the third depth mark HOc is offset by 0.5 cm from the second depth mark HOb in use, when the delivery cannula 36 is inserted into the guide cannula 22 such that the second depth mark HOb aligns with the proximal side of the handle 30. the user can visually confirm (from a location farther from the surgical target and outside of the patient's body) that an approximately 0.5 cm length of delivery cannula 36 extends beyond the distal end 28 of the guide cannula 22. Likewise, when the third HOc mark is left aligned with the proximal side of handle 30, an approximately 1.0 cm section of the delivery cannula 36 is exposed beyond distal tip 28. The indicia 110 can take a wide variety of forms deviating from that shown in Fig. 1, and may be eliminated in some embodiments.

[0036] With reference to Fig. 4, the arrangement of the delivery cannula assembly 26 includes a first attachment of a hub 34 to a delivery cannula 36. In one embodiment, the hub 34 is formed on the delivery cannula 36. To provide improved tensile strength at the connection of the hub 34 to the delivery cannula 36, ​​in one embodiment, the support body 112 is secured to the delivery cannula 36 adjacent the proximal end 80 (generally indicated) prior to being molded or cast-molded 34. support 112 is preferably a rigid material suitable for attachment to the delivery cannula 36 material (e.g. when the delivery cannula 36 is made of Nitinol material, support body 112 may also be made of Nitinol material and thus easily welded to delivery cannula 36). The support body 112 can take many different shapes and sizes, but in one embodiment it is rectangular (0.09 cm (0.035 inch) thick, 0.05 inch (0.13 cm) wide, and a row length is 0.51 cm (0.2 inch), although other dimensions are also acceptable), therefore, when applied to an otherwise circular (cross-sectionally) delivery cannula 36, ​​this support body 112 provides flat surfaces. on which the socket 34 is formed by overspreading. Such a connection in a flat surface area in turn clearly resists the "sliding" of the socket 34 relative to the delivery cannula 36 and vice versa in response to forces applied tensing, compressing and / or torsionally on one of these component elements. For example, in cases where the distal end 82 of the delivery cannula 36 is inserted or positioned within the material

The body (e.g. bone or tissue) at the surgical target and the force is applied to pull the cup 34 (e.g. via the handle 40), the delivery cannula 36 will not detach from the cup 34 even if the distal end 82 will "resist" direct displacement (due to the location inside the body material). Likewise, a force exerted in rotation or torsion on the hub 34 will therefore be transmitted to the delivery cannula 36 via the coupling of the hub 34 to the support member 112, whether or not the distal end 82 "resists rotational displacement due to interaction with the surgical target. . Alternatively, however, support body 112 may be omitted and is not a necessary component.

[0037] After the hub 34 is attached to the delivery cannula 36, ​​the hub 34 is mounted within the handle assembly 32 as previously described. For example, the hub 34 is seating within aperture 56 in the handle 40, and the retention member 42 is coaxial over the hub 34 with the delivery cannula 36 and is attached (e.g., threadedly engaged) to the handle 40. To this end, and in one embodiment, the hub 34 is oriented with respect to the delivery cannula 36 such that the flattened area 78 of the hub 34 "faces" towards the spatial fold 90 direction. The previously described configuration of the gripping unit 32 results in a in that, when the socket 34 and handle 40 are assembled, the fold 90 will also extend in some known spatial direction with respect to handle 40. Alternatively, the spatial direction of fold 90 with respect to handle 40 may be visually inspected after socket 34 has been mounted thereto. Regardless of one embodiment, and as best shown in Fig. 1, handle assembly 32 further includes directional indicia 114 (indicated generally). along the exterior of handle 40 to indicate to the user the direction of fold 90 relative to handle 40. For example, in one embodiment, such directional indicia 114 include an arrow 114a "indicating" the direction of fold 90. With this configuration, the user can readily ascertain the spatial position of fold 90 relative to handle 40 as fold 90 is inserted into the interior. limited space of the surgical target (and thus no longer visible to the user). These directional indicia 114 can be applied at various locations along the length of the handle 40, such as on both major surfaces (one of which is shown in Fig. 1) as well as at their proximal ends, and can take many different forms. In other embodiments, the directional indicia 114 may be eliminated. Regardless, after mounting the hub 34 to the handle assembly 32, the delivery cannula assembly 26 may be used to deliver the curable material to the bone.

[0038] While the delivery cannula assembly 26 has been described as including the delivery cannula 36 while otherwise forming a single side outlet 84, many other configurations are possible. For example, two circumferentially aligned side outlet openings may be provided. Moreover, Fig. 5 shows portions of another embodiment of a delivery cannula assembly 120 that was not left

- 15 within the scope of the reservations. The delivery cannula assembly 120 includes a delivery cannula 122 that extends between the proximal end 124 and distal end 126, and a hub 128 coupled to the proximal end 124. The delivery cannula 122 is similar to the delivery cannula 36 (Fig. 2A) described above (including a blunt tip), but defines a series of longitudinally aligned side outlets 130 extending along the length of the delivery cannula 122 and in fluid communication with the inner lumen (not shown). Moreover, the delivery cannula 122 includes a deflectable segment 132 that defines a predetermined curve 134 as in the previous embodiments.

[0039] The distal side outlet 130a is offset by a distance D1 from the distal end 116. In this case also, the distance D1 is, in one embodiment, in the range 0.13-1.27 cm (0.05-0.5 cm). inch), preferably in the range 0.25-0.64 cm (0.1-0.25 inch). The longitudinal distance between the remaining side side openings 130 adjacent to the farthest side outlet 130a may be different. Preferably, however, the second side outlet 13Rb defines an orifice smaller in size compared to the most distal side outlet 130a, and the third side outlet 130c is smaller than the second side outlet 130b. This reduction in size of the side outlet port near distal end 126 helps to evenly distribute the curable material that is pushed through the delivery cannula 122.

[0040] While the three side outlets 130 are illustrated, other configurations are also possible. For example, a plurality of side outlets (i.e., more than three side outlets) may be formed longitudinally along the length of the delivery cannula 122, and in addition, such side outlets 130 may include more than one longitudinally aligned series of side outlets. In one embodiment, the side outlets 130 which are shown in Fig. 5 have their respective columns of longitudinally aligned side outlets formed on the opposite side of the delivery cannula 122 (thus not visible in the view in Fig. 5). Aspects of the present invention provide that the side outlets 130 define circular side outlets, non-circular side outlets, or a set of circular and non-circular side outlets.

[0041] As a reference point, the predetermined curvature 134 is deviated from the centerline C of the delivery cannula 122 such that the curvature of the predetermined curvature 134 is less than the radius of curvature R of the previously set curvature 90 (FIG. 2A) previously described. thus, a further embodiment according to the basic features of the present invention is illustrated. In addition, while the side outlets 130 are illustrated as formed along a predetermined curve 134, in another embodiment at least one of the side outlets 130 is formed near a predetermined curve 134.

Regardless of the particular configuration, an integrated delivery cannula assembly (such as the delivery cannula assembly 26 of Fig. 4), in accordance with the essential features of the present invention, is highly useful for performing a variety of bone stabilization procedures as part of an overall system. feed of the curable material. Therefore, in Fig. 6A illustrates an intraosseally curable material delivery system 150 according to one embodiment of the present invention used to perform a vertebroplasty procedure. The system 150 includes an outer guide cannula 22, a delivery cannula assembly 26, a source 152 of curable material, fluidly coupled to the delivery cannula assembly 26, and a controller 154 coupled to the at least one source 152 of curable material.

[0043] The source 152 of curable material includes, in one embodiment, a reservoir 160 containing curable material as previously described, and a tubing 164 extending from the reservoir 160 to the gripping assembly 30 of the delivery cannula assembly 26. Accordingly, the tubular conduit 164 terminates at a connecting member 166 configured to be removably attached to the socket 34. More specifically, connecting member 166 is configured to fit within corridor 52 of handle 40 and releasably engage socket 34. In one embodiment, connecting member 166 is threaded onto the Luer thread defined by socket 34. In another embodiment, the connecting member 166 is threaded onto the Luer thread defined by socket 34. In another embodiment, In the exemplary embodiment, this connecting member 166 snaps onto the socket 34. Alternatively, a number of other mounting configurations are also possible.

[0044] The controller 154 may take any form known in the art and is coupled to a source 152 of curable material. In one embodiment, controller 154 controls the mass flow and the mass flow rate (i.e., fluid delivery rate) of the curable material from reservoir 160 to delivery cannula assembly 26. The controller 154 may include various actuators (e.g. switches, foot pedal, etc.), enabling the user to remotely control the flow of fluid into the delivery cannula 36. Alternatively, manual control may be provided such that the controller 154 can be eliminated.

[0045] When performing a palliative bone procedure, when the delivery cannula 36 has been partially retracted inward, or has been completely removed, the outer guide cannula 22, the outer guide cannula 22 is positioned at the appropriate target administration site within the bone. For example, for a vertebroplasty procedure, the outer guide cannula 22 is inserted into 180, preferably at the stalk 182. and thus, vertebra 180 includes a vertebral body 184 defining a vertebral wall 186 surrounding the body material (e.g., spongy bone, marrow, and other soft tissue) 188. This peduncle 182 extends from the vertebral body 184 and surrounds the spinal canal 190. More specifically, the peduncle 182 is attached further to the vertebral body 184 and together they form the vertebrae 180 and form the walls of the spinal canal 190. As a reference, this endosseous system 150 is capable of accessing various bone targets. Therefore, although vertebra 180 is illustrated here, it should be understood that

- 17 that other bone targets can be accessed with system 150 (i.e., femur, long bones, ribs, sacrum, etc.).

[0046] The outer guide cannula 22 forms an access path to the delivery destination 192 (or forms the delivery destination 192) through the stem 182 into the body material 188. Therefore, as shown, the outer guide cannula 22 has been guided through the stem 182. using the transpedicular access route. This transpedicular access path places the outer guide cannula 22 between the pectoral process and the accessory lumbar process of the peduncle 182. In this way, the outer guide cannula 22 allows access to the delivery target 192 with the distal tip 28 open. For other procedures, the outer guide cannula 22 may similarly perform a core-drilling operation to create a hanged hole within the bone.

[0047] Once the outer guide cannula 22 has been formed or otherwise positioned inside bone at a suitable delivery destination 192, the delivery cannula 36 is slidably inserted and advanced within this outer guide cannula 22. As shown generally in Fig. 6A, the distal end 82 of the delivery cannula 36 points towards the distal tip 28 of the outer guide cannula 22. Approximately aligning the first depth mark HOa with the handle 30 provides the user with visual confirmation (at a point outside the body of the patient) of the position of the distal end 82 relative to the distal end 28 of the outer guide cannula 22. Before further advancement, the delivery cannula 36 is fully positioned inside the outer guide cannula 22 in such that the deflectable segment 88 (Fig. 2A) of the delivery cannula 36 is locked (i.e., fixed) in a substantially upright shape that substantially conforms to the shape of the outer guide cannula 22. This relationship is shown more clearly in Fig. 6B, with some force being effectively applied by the guide cannula 22 on deflectable segment 88, due to the radius of curvature R (Fig. 2A) defined by this deflectable segment 88 in the "natural" state and which is larger than the inside diameter of the guide cannula 22. This interaction substantially "removes" the predetermined curvature of the fold 90 (Fig. 2A), forcing or giving this deflection segment 88 a substantially upright shape (it being understood that the inside diameter of the guide cannula 22 is greater than the outside diameter of the delivery cannula 36, ​​while the deflectable segment 88 will still have a slight curvature within the guide cannula 22; hence the term "Substantially upright" with respect to the delivery cannula 36 (which is substantially, but not necessarily, completely linear). Therefore, prior to acting on the delivery target 192 (FIG. 6A), the delivery cannula 36 is flexed in a substantially straight, non-curved orientation within the outer guide cannula 22.

[0048] The delivery cannula assembly 26, especially the delivery cannula 36, ​​is then advanced within the guide cannula 22 as shown in Fig. 6C. More specifically, the delivery cannula 36 is routed like this

A manner that at least a portion of the deflectable segment 88 extends beyond the open end 28 of the guide cannula 22 and into the target delivery point 192. The now unrestricted portion of deflection segment 88 naturally deflects laterally (from the substantially straight shape described above) upon exiting guide catheter 22, returning to the predetermined curvature of fold 90 as previously described due to shape memory characteristics. The user can visually obtain confirmation of the extension length of the distal delivery catheter 36 from the guide catheter 22 via the longitudinal position of the indicia 11b or IlOc (where the features IlOc are shown in Fig. 6C) relative to the handle 30. Moreover, these directional indicia 114 indicate to the user (at a point outside the patient's body) the spatial direction of fold 90 within the target delivery point 192 relative to the spatial position of handle 40.

Due to the further advancement of the delivery cannula 36, ​​the blunt tip 100 of the distal end 82 is hemispherical (or some other blunt or blunt shape) and thus non-traumatic to tissue / bone contacting it. In this way, a blunt tip 100 can contact and / or sample the vertebral wall 186 with minimal risk of piercing or piercing the core body 184 of the vertebral body. In this way, this blunt tip 100 provides an advantage over conventional sharp-edged bone cement supply needles and therefore does not require a separate conduit to prevent core puncture, which is otherwise necessary with available curved needles.

[0050] The side outlet 84 is offset from the distal end 82, and thus is available for feeding the curable material and removing body material at the feed destination 192. More specifically, this side outlet can eject radially curable material and suck body material into and out of delivery cannula 36, ​​respectively, even though distal end 82 is pressed against a surface, such as in the case of the vertebral body inner wall 184.

With this in mind, in one embodiment, a fluid source 152 is then actuated (e.g., via controller 154) to supply curable material (not shown) to delivery cannula 36 via hub 34. Curable material entering into the delivery cannula 36 is pushed through the channel 86 (Fig. 2A) towards the side outlet 84. As shown in Fig. 6D, the curable material is then dispensed / injected from the delivery cannula 36 radially from the side outlet (s) 84 and to the delivery destination 192 in a cloud-like pattern 194. Alternatively or additionally, the delivery destination 192 may be aspirated. , by replacing the source 152 of the curable material (Fig. 6A) with a vacuum source (not shown).

Importantly, by injecting radially curable material from the side of the delivery cannula 36, ​​rather than axially from the farthest end (as is the case with conventional delivery needles), the system 150 (Fig. 6A) can be avoided.

Forcing the curable material to pass into a crack or other failure, which may in turn lead to undesirable leakage of the curable material through the fracture. By way of example, Fig. 6D shows a fracture 196 in the vertebral body wall 186. Vertebroplasty is a common solution for such vertebral fractures, and the generally accepted repair technique involves positioning the distal end 82 at or opposite fracture 196 to ensure that the curable material is fed in relatively close proximity. With the known delivery needles, this preferred access route causes the curable material to be injected directly into the fracture 196. In contrast, with the delivery catheter 36 of the present invention, distal end 82 is still "facing" toward the fracture 196, yet the cloud 194 of injected curable material is not being urged directly toward the fracture 196. Instead, the curable material cloud 194 indirectly reaches crack 196 while maintaining a minimum driving force, making the curable material cloud 194 unlikely to be pushed to "leak" through the crack 196. Nevertheless, the target point is The feed 192 is, as a whole, still filled with the curable material cloud 194 to effect the desired repair.

[0053] As shown in Fig. 6D, the entirety of the delivery target 192 is accessible to the delivery cannula 36. To that end, while the delivery cannula 22 has been inserted via the right distal side access path, system 150 can perform a vertebroplasty procedure. from a left lateral side access position or from a right or left front side access position as shown in Fig. 6E.

In one embodiment, and returning to Fig. 6C, the desired amount of curable material is delivered entirely through delivery cannula 36. In other embodiments, in accordance with the essential features of the present invention, after injecting a first volume of curable material by delivery cannula 36, ​​the delivery cannula 36 is disconnected from the source 152 of the curable material and removed from the guide cannula 22. The curable material source 152 is then fluidly connected to the guide cannula 22 (e.g., the connecting member 166 is fluidly connected to a corresponding fluid port / socket provided with a handle 30) and then actuated to inject a second volume of curable material to the target 192 through the guide cannula 22.

More generally, during a palliative bone procedure, a clinical worker serving this endosseous system 150 extends a portion of the predetermined curvature 90 to the delivery target 192, otherwise defined within the bone. In one embodiment, subsequent rotation of the delivery cannula 36 causes a portion of the side outlet 84 to rotate relative to the delivery destination 192, thereby accessing multiple planes of the delivery destination 192 with only one "mandrel: outer guide cannula".

Therefore, by combining retracting the delivery cannula 36 inside the outer guide cannula 22, further advancing the delivery cannula 36 relative to the outer guide cannula 22, and rotating the delivery cannula 36, ​​multiple planes and multiple areas of the respective target point can be accessed. in bone with delivery cannula 36 with only one insertion of outer guide cannula 22. Therefore, for example, unipedicular vertebroplasty can be performed with the system 150. Figures 7A-8B substantially illustrate (Figures 7A and 7B from a frontal perspective; Figures 8A and 8B from a left side perspective) different planes / regions of the vertebral body 182 spaced by rotating and / or moving the delivery cannula 36 relative to the guide cannula 22 (again with the guide cannula 22 stationary). It should be noted that in the drawing of Figures 7A-8B, the direction of the bend defined by the delivery cannula 36 need not necessarily be perpendicular to the plane of the page, so that the bend may not be completely visible in each view.

While particular embodiments are illustrated and described herein, it will be apparent to those of ordinary skill in the art that many different alternative and / or different implementation concepts may be used alternatively for the particular embodiments shown and described without prejudice to outside the scope of the present invention. This application is intended to cover any adaptations or variations of the specific embodiments discussed in this document. Therefore, it is intended that this invention be limited only by the claims and their equivalents. For example, while reference is made to vertebroplasty procedures, the devices, systems, and methods in accordance with the essential features of the present invention are equally applicable to delivering a curable material to many other bones in a patient's body.

She prepared and verified

Jolanta Gór czak

Patent Attorney