Meniscus Repair Delivery Device

The push-pull mechanism with a compliant nitinol pusher rod and bifurcated suture loop addresses the issues of unreliable retraction and user discomfort in current tissue repair devices, enabling efficient and comfortable implant deployment and tensioning.

JP7785681B2Active Publication Date: 2025-12-15SMITH & NEPHEW INC +2
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Patent Information

Application Number
JP2022554175
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-04-08
Filing Date
2021-04-05
Publication Date
2025-12-15
Estimated Expiration
2041-04-05

AI Technical Summary

Technical Problem

Current tissue repair devices face issues with pusher rods that do not retract reliably due to excessive force, are not optimized for curved needle tips, and require manual tensioning of sutures, leading to user discomfort and potential failure.

Method used

A push-pull mechanism with a compliant pusher rod made of martensitic nitinol and a bifurcated suture loop for tensioning, along with a ratchet system for reliable implant deployment and suture tensioning.

Benefits of technology

The solution provides reliable implant deployment through curved needles and reduces user discomfort during suture tensioning, ensuring consistent and efficient tissue repair.

✦ Generated by Eureka AI based on patent content.

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Abstract

The tissue repair device includes an advancement assembly including an advancement member having a rod portion configured to advance through the needle and eject the first and second implants from the needle, a ratchet coupled to a proximal section of the rod portion and configured to advance the rod through the needle by axial and rotational movements, and a linear advancement axis including a first bore connected to a second bore. The diameter of the first bore is smaller than the diameter of the second bore, such that the first and second bores include stops. The rod portion has mechanical properties optimized to conform to the curvature of the needle and to provide sufficient compressive strength to eject the implants from the device.
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Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to devices and methods for tissue repair. [Background technology]

[0002] Areas of the body where tissue can be surgically reattached to bone or surgically repaired when a tear forms in the tissue include, but are not limited to, the biceps tendon, the lateral collateral ligament of the knee, the medial collateral ligament of the knee, the meniscus of the knee, and the popliteal ligament of the leg. Fibrous tissue injuries, such as muscle, ligament, and meniscus tears, can be repaired arthroscopically using sutures. Traditionally, to close a fibrous tissue injury, a surgeon would insert two suture needles with sutures attached into the tissue, thread the sutures through the injury, and then tie a knot in the tissue to secure the free ends of the sutures.

[0003] To simplify wound healing and improve fixation, various types of devices and tools have been developed for use in device delivery. For example, some current meniscus repair devices utilize a curved, rigid needle tip to aid in reaching the appropriate area of ​​the damaged meniscus. Two implants, connected together using sutures, are held by the needle. Upon reaching the desired meniscus repair location, the needle is pushed through the meniscus, and the first implant is deployed using a push-and-release delivery mechanism. The needle is then retracted from the meniscus, repositioned on the opposite side of the tear, and pushed through the meniscus. The second implant is then deployed. The device is then removed, leaving a length of suture tied in such a way that, when pulled, it closes the distance between the two implants. The knot is tightened by pulling the length of suture, and the suture is cut adjacent to the knot.

[0004] Typical repair devices use a user-operated pusher mechanism to move a first implant distally (in the push-out direction) from the needle tip, followed by a passive retraction step to position the pusher mechanism behind a second implant and then move the second implant distally (in the push-out direction). These devices lack a means for retracting (pulling) the user-operated pusher mechanism. For example, some all-inside meniscus repair devices use a pusher delivery mechanism including a pusher rod. The pusher rod is connected to a user-operated knob or trigger that moves the pusher rod distally to push the first implant out. The pusher rod must then be retracted to a position proximal to the second implant when the knob or trigger is moved so that the implant can subsequently be pushed out. Means for retracting the pusher rod include a compression spring, a torsion spring, a constant force spring, etc. When certain forces, such as friction in the pusher mechanism, exceed the spring force, the pusher rod cannot retract to a position suitable for deploying the second implant.

[0005] Furthermore, typical repair devices use rigid pusher rods that cannot easily adapt to the geometry of a curved needle tip. The pusher rod is typically connected to a user-operated knob or trigger that moves the pusher rod distally to eject one or more implants. Pusher rods are typically fabricated from austenitic stainless steel, precipitation-hardened stainless steel, or nickel-titanium alloys such as Nitinol. These materials offer the necessary compressive strength to withstand the compressive loads required to eject the implants. However, the mechanical properties of typical pusher rod materials are not optimized to accommodate the needle curvature. Often, the needle curvature is altered during use, either by manually bending the device before entering the joint space or by applying a force that bends the needle tip while in the joint space. This altered needle curvature can cause failure of the pusher delivery mechanism. Failure occurs due to excessive ejection force or the pusher rod portion of the pusher mechanism breaking through the needle slot where the implant resides. Failure can also result from the inability to retract the pusher rod when the knob is advanced forward to subsequently push out the second implant. The mechanical properties of typical pusher rod materials are not optimized to maintain low friction through added curvature or tortuous paths.

[0006] Furthermore, current techniques for tensioning sutures to close the distance between two implants involve wrapping the free suture ends around a user's finger, hand, or a surgical instrument, such as a pair of forceps. The suture is then pulled until the desired tension in the repair is achieved. Depending on the force required to tension the repair, tensioning the sutures can be difficult for the user and can even cause pain, as the sutures may tighten around the user's fingers beyond comfort. Furthermore, given the high lubricity of the materials typically used to construct sutures, the sutures may slip during reduction when wrapped around wet, gloved fingers. Summary of the Invention

[0007] Described herein is a tissue repair device that provides a push-pull delivery mechanism that facilitates retraction of a pusher rod independent of a spring force on the rod. The device includes a handle having a longitudinal axis, an elongated needle defining an axial bore extending from the handle, a first implant and a second implant connected by a suture and at least partially disposed within the axial bore of the needle, the second implant disposed proximal to the first implant, and an advancement assembly. The advancement assembly includes a rod portion configured to advance through the needle to eject the first and second implants, a ratchet coupled to a proximal section of the rod portion and configured to advance the rod through the needle by axial and rotational movement, and an advancement member having a linear advancement axis including a first bore connected to the second bore. The diameter of the first bore is smaller than the diameter of the second bore, such that the first and second bores include stops. The push-pull mechanism has mechanical properties optimized to conform to the curvature of the needle and provide sufficient compressive strength to expel the implant from the device. The present disclosure also provides a compliant pusher rod, or portion of the pusher rod, that allows for more reliable implant deployment through needles with varying degrees of curvature. Finally, the present disclosure also provides a suture with a bifurcated section that serves as a finger loop to facilitate tensioning the suture.

[0008] In one aspect, the present disclosure relates to a tissue repair device. The device may include a handle having a longitudinal axis and an elongated needle defining an axial bore extending from the handle. The needle may include a proximal end and a distal end. The device further includes a first implant and a second implant connected by a suture and at least partially disposed within the axial bore of the needle, the second implant disposed proximal to the first implant. The device may further include an advancement assembly. The advancement assembly may include a rod portion configured to advance through the needle and eject the first and second implants from the distal end of the needle, and a ratchet coupled to a proximal section of the rod portion and configured to advance the rod through the needle by axial and rotational movement. The advancement assembly may include an advancement member coupled to the ratchet member, the advancement member having a linear advancement axis including a first bore connected to a second bore. The diameter of the first hole is smaller than the diameter of the second hole, such that the first hole and the second hole define a stop. The push-pull mechanism may include a push-pull mechanism that moves on a linear axis of advancement, the push-pull mechanism including a mating rod. A first bore in the advancement member may receive a section of the mating rod. The mating rod may have a stop member including a barb on a distal end. In a first position, the push-pull mechanism engages the stop, and in a second position, the push-pull mechanism is proximal to the stop.

[0009] In some embodiments, the rod comprises nitinol. In some embodiments, the nitinol is martensitic phase nitinol. In some embodiments, the tensile strain of the nitinol is about 50 ksi.

[0010] In some embodiments, the advancement assembly includes a plunger that a user can engage with a push-pull mechanism to advance the first implant and the second implant from the distal end of the needle.

[0011] In some embodiments, the distal end of the needle includes a slot. In some embodiments, at least one of the first implant and the second implant includes a body having a cross-section that approximates the axial bore of the needle and a protrusion that mates with the slot to prevent rotation of the implant within the needle.

[0012] In some embodiments, the device further includes a depth tube that limits the depth to which the needle can be inserted into tissue. In some embodiments, the depth tube has a depth tube lock for locking the linear position of the depth tube. In some embodiments, the depth tube includes a tapered distal portion.

[0013] In some embodiments, the device further includes a needle housing coupled to the handle. In some embodiments, the depth tube lock is operably coupled to the needle housing.

[0014] In some embodiments, the distal end of the needle has a curved geometry. In some embodiments, the curvature of the curved geometry is coincident with the slot in the distal end of the needle. In some embodiments, the curvature of the curved geometry is away from the slot in the distal end of the needle.

[0015] In some embodiments, the device further includes one or more stops configured to limit advancement of the ratchet member in predefined increments.

[0016] In some embodiments, the ratchet member is configured to return to a final position that is proximally aligned with the starting position of the ratchet member after expelling at least one of the first implant and the second implant.

[0017] In some embodiments, the suture comprises a sliding knot.

[0018] In some embodiments, the interior surface of the advancement member includes a plurality of teeth configured to engage with the ratchet member.

[0019] In some embodiments, the ratchet member includes two radially extending tabs configured to alternately engage and disengage with a plurality of channels positioned in the advancement member.

[0020] In some embodiments, the barb includes a lead-in portion configured to facilitate press-fitting into the first bore of the advancement member.

[0021] In another aspect, the present disclosure relates to a method of tissue repair. The method may include inserting a first anchor into tissue, the tissue including a tear, the first anchor inserted into the tissue on a first side of the tear. The method may also include inserting a second anchor on a second side of the tear, the second anchor connected to the first anchor via a knotted flexible member having a finger-engageable bifurcated portion. The method may also include using the bifurcated portion to tension the flexible member to reduce the length of the flexible member between the first anchor and the second anchor to close the first and second sides of the tear. In some embodiments, the size of the bifurcated portion is fixed. [Brief explanation of the drawings]

[0022] Various aspects of at least one embodiment of the present disclosure are discussed below with reference to the accompanying drawings. It will be appreciated that for simplicity and clarity of illustration, elements shown in the drawings have not necessarily been drawn accurately or to scale. For example, the dimensions of some elements may be exaggerated relative to other elements for clarity, or several physical components may be included in a single functional block or element. Furthermore, where considered appropriate, reference numerals may be repeated among the drawings to indicate corresponding or similar elements. For clarity, not every component may be labeled in every drawing. The drawings are provided for purposes of illustration and description and are not intended to define the limits of the invention.

[0023] [Figure 1A]1 illustrates a system for tissue repair, according to certain embodiments. [Figure 1B] 1 illustrates a system for tissue repair, according to certain embodiments. [Figure 2A] 1 illustrates a ratchet mechanism of a tissue repair system, according to certain embodiments. [Figure 2B] 1 illustrates a ratchet mechanism of a tissue repair system, according to certain embodiments. [Figure 3] 1 illustrates a push-pull mechanism of a tissue repair system, according to certain embodiments. [Figure 4] 1 illustrates a push-pull mechanism of a tissue repair system, according to certain embodiments. [Figure 5A] 10 further illustrates a push-pull mechanism of the tissue repair system, according to certain embodiments. [Figure 5B] 10 further illustrates a push-pull mechanism of the tissue repair system, according to certain embodiments. [Figure 5C] 10 further illustrates a push-pull mechanism of the tissue repair system, according to certain embodiments. [Figure 6A] 1 illustrates another system for tissue repair, according to certain embodiments. [Figure 6B] 1 illustrates another system for tissue repair, according to certain embodiments. [Figure 7] 1 illustrates a suture for use with a system for tissue repair, according to certain embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0024] In the following detailed description, numerous specific details are set forth to provide a thorough understanding of the embodiments of the present disclosure. Those skilled in the art will understand that these embodiments may be practiced without some of these specific details. In other instances, well-known methods, procedures, components, and structures may not be described in detail so as not to obscure the described embodiments.

[0025] Before describing at least one embodiment in detail, it is to be understood that the claims are not limited in their application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description only and should not be regarded as limiting.

[0026] FIG. 1a illustrates, in an assembled view, one example of a tissue repair device 100 of the present disclosure. Device 100 generally includes a handle 110, a knobbed plunger 120 coupled to handle 110, a stationary housing 130 disposed within knobbed plunger 120 and handle 110, and a needle housing 170 coupled to stationary housing 130. A depth tube lock 140 is disposed within needle housing 170 and coupled to depth tube 150. Needle 180 extends through depth tube 150 and receives a first implant 182 and a second implant 184, connected by suture 186, within axial bore 188 ( FIG. 1b ) for deployment from needle 180 into tissue. Suture 186 includes a sliding knot 187 to facilitate reducing the length of suture 186 between implants 182 and 184. The two implants 182, 184 reside within the distal portion of the needle 180 prior to deployment. The depth tube may include a tapered distal portion to facilitate easy entry into the tissue entry portal. The depth tube 150 and depth tube lock 140 provide a means for limiting needle 180 penetration. The interface between the knobbed plunger 120 and the handle 110 is a slip fit, as is the fit between the implants 182, 184 and the needle 180. During use, the user will typically hold the device 100 by the handle 110 or needle housing 170, which are positioned on either side of the knobbed plunger 120. The user pushes the knobbed plunger 120 forward to deploy the first implant 182 from the distal tip of the needle 180. After repositioning the needle on the opposite side of the tear, a second user operation of the knobbed plunger 120 is required to deploy the second implant 184. The suture 186 is then pulled or otherwise tensioned to reduce the length of the suture 186 between the implants 182 and 184, thereby closing the tear.Other non-limiting examples of the handle 110, knobbed plunger 120, mounting housing 130, depth tube lock 140, depth tube 150, needle housing 170, needle 180, and implants 182, 184 are disclosed in U.S. Patent No. 8,888,798 to Smith & Nephew, Inc. and U.S. Publication No. 2018 / 0116654, the entire contents of which are incorporated herein by reference.

[0027] FIG. 2a illustrates a portion of the tissue repair device 100 of FIG. 1 in cross-section. As shown in FIG. 2a, the interior surface of the knobbed plunger 120 includes a plurality of teeth 122. The teeth 122 are configured to sequentially engage a ratchet member 124 that is rotationally and axially coupled to a pusher mechanism 126 to sequentially deploy implants 182, 184. A cylindrical rod portion 128 of the pusher mechanism 126 is contained within the needle 180. A compression spring 160 provides a linear force intended to maintain contact between the ratchet member 124 and the teeth 122 of the knobbed plunger 120. The spring 160 also provides a retraction force to the pusher mechanism 126 after implant deployment. The spring 160 further facilitates rotation of the ratchet member 124 relative to the teeth 122 of the knobbed plunger 120. The engagement of the ratchet member 124 with each successive tooth 122, together with the engagement between the side walls of the tabs 125 of the ratchet member 124 and the channel walls of the stationary housing 130, provides a tactile and audible indication of the deployment of the corresponding first implant 182 or second implant 184.

[0028] As shown in FIG. 2b, the ratchet member 124 includes two radially extending tabs 125 that alternately engage and disengage with several radially positioned channels in the wall of the mounting housing 130 during forward deployment. The tabs 125 of the ratchet member 124 slide along the axis of the mounting housing 130 within the internal channels, providing radial alignment prior to deployment of each implant 182, 184. The pusher mechanism 126 moves distally along the advancement axis A when the user retracts the knobbed plunger 120. The distal tip of the pusher mechanism 126 is linearly extended until the tabs 125 of the ratchet member 124 contact a first discrete stop member 136 of the mounting housing 130, resulting in deployment of the first implant 182. The discrete stop is radially aligned with the internal channels of the mounting housing 130 to prevent the pusher mechanism 126 from advancing during deployment of the implants 182, 184.

[0029] As shown in FIG. 3 , the pusher mechanism 126 shares a common linear axis of travel A with the knobbed plunger 120. The knobbed plunger 120 has an inner bore 132 configured to receive the rod portion 128 of the pusher mechanism 126. The inner bore 132 of the knobbed plunger 120 maintains alignment of the pusher mechanism 126 with a distal bore of the needle 180 ( FIG. 1 ). The pusher mechanism 126 also includes a stop feature, such as an annular barb 134. The inner bore 132 of the knobbed plunger 120 includes a proximal first portion 132a having an inner diameter selected to be larger than a distal second portion 132b, creating a counterbore 138 between the first and second portions 132a and 132b. The outer diameter of the barb 134 is selected to be larger than the second portion 132b of the inner bore 132 but smaller than the outer diameter of the first portion 132a. When assembled, the linear position of the barb 134 is proximal to the linear position of the counterbore 138 in the knobbed plunger 120 such that a gap 142 exists between the barb 134 and the counterbore 138 .

[0030] 4 shows the device 100 after the first implant 182 has been deployed by pushing the knobbed plunger 120 distally until the tab 125 of the ratchet member 124 contacts the first discrete stop member 136. The spring 160 creates enough retraction force to slightly retract the pusher mechanism 126. This small amount of retraction allows the ratchet member 124 to rotate and position the pusher mechanism 126 in an intermediate rest position. However, if the combined forces of friction and bending between the rod portion 128 of the pusher mechanism 126 and the inner bore 188 of the needle 180 exceed the spring force, the pusher mechanism 126 will not retract. This prevents radial alignment of the ratchet member 124 and prevents the pusher mechanism 126 from advancing distally to deploy the second implant 184.

[0031] 5A and 5B illustrate the relative positions of the pusher mechanism 126 and the knobbed plunger 120 as a user retracts the knobbed plunger 120. As shown, retraction of the knobbed plunger 120 causes contact between the mating axial wall of the barb 134 in the pusher mechanism 126 and the annular counterbore 138 of the knobbed plunger 120. Thus, the pusher mechanism 126 retracts with the knobbed plunger 120, restoring device functionality that may have been impaired by a use-related error. As shown in FIG. 5C, the barb 134 of the pusher mechanism 126 includes a lead-in portion 134a to facilitate press-fitting into the inner bore 132 of the knobbed plunger 120. The annular feature 134b on the barb 134 provides sufficient structural strength to resist forces that would impede proximal axial movement of the pusher mechanism 126. The amount of diametric interference is sufficient to resist axial forces that would prevent proximal axial movement, but not so high as to prevent assembly of the two components. During retraction, the normal operating gap 142 between the barb 134 and the counterbore 138 of the pusher mechanism 126 decreases until the mating surfaces contact. After contact is made, the pusher mechanism 126 moves proximally along the advancement axis A as the user advances the knobbed plunger 120. The pusher mechanism 126 will retract with the knobbed plunger 120 until the knobbed plunger 120 reaches a proximal stop. Thus, the delivery device of the present disclosure provides an alternative means by which the pusher mechanism 126 can be retracted and the ratchet member 124 can be rotated to a radial position suitable for deployment of the second implant 184 when spring force alone is insufficient to retract the pusher mechanism 126.

[0032] Although not shown, in some embodiments, an annular interlocking feature may be created in knobbed plunger 120 with a corresponding undercut in push-out mechanism 126. Interlocking features for multiple components may also serve an equivalent function. For example, a retaining ring may be pressed onto push-out mechanism 126 after assembly of knobbed plunger 120 into bore 132.

[0033] As shown in FIG. 6A , another embodiment of a tissue repair device 200 of the present disclosure includes a needle 280 and a pusher mechanism 226 that share a common linear axis of advancement A. Two implants 282, 284 reside at the distal end of the needle 280. FIG. 6A also shows the needle 280 having a significant curvature. In the embodiment, the curvature of the needle 280 coincides with a slot 290 in the distal portion of the needle 280. The pusher mechanism 226 includes a rod portion 228 configured to advance through the needle 280 and eject the first implant 282 and the second implant 284 from the distal end of the needle 280. In the embodiment, the rod portion 228 is composed of martensitic phase nitinol at operating temperatures. Martensitic phase nitinol advantageously exhibits a lower modulus of elasticity than austenitic materials. For a given diameter of rod portion 228, a martensitic rod will maintain residual strain at a lower extrusion force than an austenitic rod having the same cross-sectional area and shape. If the material is mechanically loaded below the martensitic finish temperature (Mt) or is fully martensitic, the material will remain strained when subsequently unloaded. Heating above the austenitic finish temperature (At) will allow it to regain its original shape. In an example, the stress of Nitinol measured at 3% strain during tension loading is approximately 50 ksi.

[0034] FIG. 6b depicts the device 200 with a needle curvature (reverse curvature) in the direction opposite the slot 290. This curvature direction is challenging because the distal tip of the rod portion 228 is unsupported during distal advancement. Typical pusher rod materials exhibit sufficient mechanical rigidity to deform the slot 290 and break through the needle hole 288. If breakthrough occurs, the pusher rod 228 will not eject the implant 284. The rod portion 228 of the present disclosure conforms to the reverse needle curvature by having optimized mechanical properties and by deforming with a force lower than that required to break through the hole 288 of the needle 280 in the region of the slot 290. Proper function is maintained during distal advancement of the pusher mechanism 226 to eject the implant from the distal end of the needle 280. In an embodiment, at least one of the first implant 282 and the second implant 284 comprises a body 292 having a cross-section that approximates the axial bore 288 of the needle 280 and a protrusion 294 that mates with a slot 290 to prevent rotation of the implant 282, 284 within the needle 280.

[0035] In some embodiments, the push rod 228 can be fabricated with one or more sections having a lower bending modulus, achieved by heat treating a portion of the push rod 228 to achieve a desired bending strength. The multi-segment push rod 228 can include a distal tip section having a first diameter and a proximal rod section having a second diameter, the second diameter being smaller than the first diameter. The multi-component push rod 228 can have tip sections constructed from different materials to reduce friction. The push rod 228 can include a distal tip section with material removed (cut) to increase flexibility.

[0036] FIG. 7 shows a suture 386 having a proximal end 386a and a distal end 386b. The distal end 386b is configured to couple to a tissue repair device implant, such as the tissue repair devices 100, 200 described above. The proximal end 386a is configured to exit the joint space and includes a bifurcated section 386c and a tail 386d. The bifurcated section 386c serves as a loop through which a user can pass several fingers. In the bifurcated section 386c, half of the fiber strand used to create the suture 386 forms each segment of the loop, effectively creating divergence and convergence of the suture 386. The bifurcated section 386c is large enough to fit multiple fingers so that the user can tension the suture 386 to the desired repair tension. This bifurcated section 386c is of a fixed diameter and will not cause any user discomfort when under tension. In embodiments, curing techniques ensure that the bifurcated section 386c remains open when wet and is easily visible to the user. These curing techniques may include heat-setting or "shape-setting" the suture 386 by heating the suture 386 to its glass transition temperature and allowing it to cool around a mandrel of a particular shape and size. Other examples of curing techniques include providing each segment of the bifurcated section 386c with a monofilament core. Although not shown, in other embodiments, the suture 386 may include a complete loop instead of the bifurcated section 386c to maintain the same diameter along the entire length of the suture 386, not including the tail portion 386d. It is further contemplated that the suture 386 may include multiple bifurcated sections 386c of the same or different sizes along the length of the suture 386.

[0037] It is understood that certain features of the invention that are, for clarity, described in the context of separate embodiments, can also be provided in combination in a single embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, can also be provided separately or in any suitable subcombination.

[0038] Although many variations and modifications of the present disclosure will no doubt become apparent to those skilled in the art after reading the foregoing description, it should be understood that the specific embodiments shown and described by way of illustration are not intended to be considered limiting in any way. Moreover, while the subject matter has been described with reference to specific embodiments, those skilled in the art will envision variations within the spirit and scope of the present disclosure. It is noted that the foregoing examples are provided merely for illustrative purposes and are not to be construed as limiting the present disclosure in any way.

[0039] Although the present disclosure is described herein with reference to particular embodiments, the present disclosure is not intended to be limited to the particulars disclosed herein, but rather, the present disclosure extends to all functionally equivalent structures, methods, and uses, including within the scope of the claims.

Claims

1. 1. A tissue repair device comprising: a handle having a longitudinal axis; an elongated needle defining an axial bore extending from the handle, the needle including a proximal end and a distal end; a first implant and a second implant connected by a suture and at least partially disposed within the axial bore of the needle, the second implant disposed proximally of the first implant; an advancement assembly, the advancement assembly comprising: a rod portion configured to advance through the needle to eject the first implant and the second implant from the distal end of the needle; a ratchet member coupled to a proximal section of the rod portion and configured to advance the rod through the needle by axial and rotational movement; an advancement member coupled to the ratchet member, the advancement member having a linear travel axis including a first bore connected to a second bore, the diameter of the first bore being smaller than the diameter of the second bore such that the first bore and the second bore define a stop; and a push-pull mechanism that moves on the linear axis of advancement, the push-pull mechanism including a mating rod, the first bore of the advancement member receiving a section of the mating rod, the mating rod having a stop member including a barb on a distal end, wherein in a first position, the stop member of the push-pull mechanism engages the stop and in a second position, the stop member of the push-pull mechanism is proximal to the stop.

2. The tissue repair device of claim 1 , wherein the rod comprises nitinol.

3. The tissue repair device of claim 2 , wherein the nitinol is martensitic phase nitinol.

4. A tissue repair device as described in claim 3, wherein the stress of the nitinol measured at 3% strain during tensile loading is approximately 344.8 MPa.

5. 10. The tissue repair device of claim 1, wherein the advancement assembly comprises a plunger that a user can engage with the push-pull mechanism to advance the first and second implants from the distal end of the needle.

6. the distal end of the needle includes a slot; 2. The tissue repair device of claim 1, wherein at least one of the first implant and the second implant comprises a body having a cross-section approximating the axial bore of the needle and a protrusion that mates with the slot to prevent rotation of the implant within the needle.

7. The tissue repair device of claim 1 , further comprising a depth tube that limits the depth to which the needle can be inserted into tissue.

8. The tissue repair device of claim 7 , wherein the depth tube comprises a depth tube lock for locking the linear position of the depth tube.

9. The tissue repair device of claim 8, further comprising a needle housing coupled to the handle, the depth tube lock operably coupled to the needle housing.

10. The tissue repair device of claim 1 , wherein the distal end of the needle has a curved geometry.

11. The tissue repair device of claim 10, wherein the curvature of the curved geometry matches a slot in the distal end of the needle.

12. The tissue repair device of claim 10 , wherein the curvature of the curved geometry is away from the slot at the distal end of the needle.

13. The tissue repair device of claim 1, further comprising one or more stops configured to limit the advancement of the ratchet member in predefined increments.

14. 10. The tissue repair device of claim 1, wherein the ratchet member is configured to return to a final position that is proximally aligned with the starting position of the ratchet member after ejecting at least one of the first implant and the second implant.

15. The tissue repair device of claim 1 , wherein the suture comprises a sliding knot.

16. The tissue repair device of claim 1, wherein an interior surface of the first bore of the advancement member comprises a plurality of teeth configured to engage the ratchet member.

17. The tissue repair device of claim 1 , wherein the ratchet member includes two radially extending tabs configured to alternately engage and disengage with a plurality of channels positioned in the advancement member distal to the first bore.

18. The tissue repair device of claim 1 , wherein the barb comprises a lead-in portion configured to facilitate press-fitting the advancement member into the first bore.

Citation Information

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