Penetration depth limiter for tissue repair devices

Abstract

A penetration depth limiter for use with a meniscal repair device is described that has a built-in self-stop feature to prevent the limiter from dislodging from the device housing. The self-stop feature is a cantilevered flexure on the bottom surface of the limiter that biases it as it is moved through the housing. Once the flexure passes the edge of the recess in the housing, it returns to its original shape, thereby trapping the flexure within the recess and preventing further distal movement of the limiter / depth tube. A connecting feature on the limiter advantageously provides increased resistance to pullout of the depth tube from the limiter.

Description

[Background technology]

[0001] Fibrous tissue wounds, such as muscle, ligament, and meniscal tears, may be repaired arthroscopically using sutures. To close fibrous tissue wounds, surgeons often insert the needle of a tissue repair device into the tissue to sequentially place two anchors attached to the same suture on either side of the wound, shortening the length of suture between the two anchors to close the side of the wound. Many of these tissue repair devices use a finger-engageable sliding limiter that moves the depth tube to control the penetration depth of the delivery needle. However, there is currently no feature to stop the limiter from being inadvertently removed from the device housing. When pushed or pulled out of the device housing, the surgeon must manually reinsert the limiter into the housing, with the risk of extending the surgery time. Furthermore, it can be difficult to couple the limiter to the depth tube due to high surface friction of the mating features. Thus, a secondary action is often required to increase the inner diameter of the depth tube before the limiter can be coupled to the depth tube. Summary of the Invention

[0002] Described herein is a penetration depth limiter for use with a meniscal repair device that has a built-in self-stop feature to prevent the limiter from dislodging from the device housing. The self-stop feature is a cantilever flexure on the bottom surface of the limiter that biases it as it is moved through the housing. Once the flexure clears the edge of the recess in the housing, it returns to its original shape, thus trapping the flexure within the recess and preventing further distal movement of the limiter / depth tube. Additionally, the connection feature on the limiter advantageously provides increased resistance to pullout of the depth tube from the limiter.

[0003] Further embodiments of the tissue repair device of the present disclosure may include one or more of the following, in any suitable combination:

[0004] In embodiments, a tissue repair device of the present disclosure includes a handle having a proximal end and a distal end, and a needle assembly at least partially disposed within a channel extending through the handle. A depth tube including a cannula insert is configured to receive at least a portion of the needle assembly therein. The restrictor member includes a housing disposed within the handle and a shaft extending from a distal end of the handle. The shaft is configured to engage the cannula insert of the depth tube. The restrictor member has a finger-engageable actuator for permitting axial movement of the depth tube relative to the needle assembly. The housing of the restrictor member includes a flexure configured to engage a recess in the housing to limit distal movement of the restrictor member relative to the housing.

[0005] In further embodiments, the proximal side of the flexure includes a cantilever surface configured to allow proximal movement of the restrictor member relative to the housing. In embodiments, the outer surface of the restrictor member shaft has at least one connection feature for increasing pull-out resistance between the restrictor member shaft and the cannulated portion of the depth tube. In embodiments, the at least one connection feature is at least one circumferential rib formed by a conical section of the restrictor member shaft. In other embodiments, the at least one connection feature is a plurality of barbs on the outer surface of the restrictor member shaft. In embodiments, the handle has a hub coupled to a distal end of a tube extending through the handle, and the restrictor member housing is disposed within the hub. In embodiments, a top portion of the housing extends through an open slot in the hub. In embodiments, the proximal portion of the depth tube and the distal end of the needle assembly include coordinating marks for indicating a tissue penetration depth of the needle assembly. In embodiments, the depth tube is made of a flexible material and the proximal end of the depth tube is configured to extend around the outer surface of the restrictor member shaft. In an embodiment, the restrictor member includes a tab for continuously engaging a groove in the handle upon longitudinal movement of the restrictor member within the handle.

[0006] A further example of a tissue repair device of the present device includes a handle having a proximal end and a distal end and a needle assembly at least partially disposed within a channel extending through the handle. A depth tube including a cannula insert is configured to receive at least a portion of the needle assembly therein. The restrictor member includes a housing disposed within the handle and a shaft extending from a distal end of the handle. The shaft is configured to engage with the cannula insert of the depth tube. The restrictor member has a finger-engageable actuator for enabling axial movement of the depth tube relative to the needle assembly. An outer surface of the shaft of the restrictor member includes at least one connection feature for increasing pull-out resistance between the shaft of the restrictor member and the cannula insert of the depth tube.

[0007] In further embodiments, the housing of the restrictor member includes a flexure configured to engage a recess in the housing to limit distal movement of the restrictor member relative to the housing. In embodiments, a proximal side of the flexure includes a cantilever surface configured to allow proximal movement of the restrictor member relative to the housing. In embodiments, the at least one connection feature is at least one circumferential rib formed by a conical section of the shaft of the restrictor member. In other embodiments, the at least one connection feature is a plurality of barbs on an outer surface of the shaft of the restrictor member. In embodiments, the handle includes a hub coupled to a distal end of a tube extending through the handle, and the housing of the restrictor member is disposed within the hub. In embodiments, a top portion of the housing extends through an open slot in the hub. In embodiments, a proximal portion of the depth tube and a distal end of the needle assembly include coordinating marks to indicate a tissue penetration depth of the needle assembly. In embodiments, the depth tube is made of a flexible material, and the proximal end of the depth tube is configured to extend around an outer surface of the shaft of the restrictor member. In an embodiment, the restrictor member includes a tab for continuously engaging a groove in the handle upon longitudinal movement of the restrictor member within the handle.

[0008] These and other features and advantages will be apparent from a consideration of the following detailed description and the associated drawings. It is to be understood that both the foregoing general description and the following detailed description are intended to be illustrative and not restrictive of aspects of the claimed subject matter. [Brief description of the drawings]

[0009] The present disclosure will become more fully understood by reference to the detailed description in conjunction with the following figures.

[0010] [Figure 1] 1 illustrates a perspective view of a tissue repair device including a penetration depth limiter of the present disclosure. [Figure 2A] FIG. 2 is a detailed view of the hub of the tissue repair device of FIG. 1. [Figure 2B] FIG. 2 is a detailed view of the hub of the tissue repair device of FIG. 1. [Figure 2C] FIG. 2 is a detailed view of the hub of the tissue repair device of FIG. 1. [Figure 3A] 1 illustrates a depth tube for attachment to a penetration depth limiter of the present disclosure. [Figure 3B] 1 illustrates a depth tube for attachment to a penetration depth limiter of the present disclosure. [Figure 4A] 1 illustrates an example of a penetration depth limiter of the present disclosure. [Figure 4B] 1 illustrates an example of a penetration depth limiter of the present disclosure. [Figure 4C] 1 illustrates an example of a penetration depth limiter of the present disclosure. [Figure 4D] 4A-C coupled to the hub of a tissue repair device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] In the following description, identical components are given the same reference numerals, whether shown in different examples. In order to illustrate the examples in a clear and concise manner, the drawings may not necessarily be to scale and certain features may be shown in some schematic form. Features described and / or illustrated with respect to one embodiment may be used in the same or similar manner in one or more other embodiments and / or in combination with or instead of features of the other embodiments.

[0012] As used herein and in the claims, for the purposes of describing and defining the present invention, the terms "about" and "substantially" are used to represent the inherent degree of uncertainty that may result from any quantitative comparison, value, measurement, or other representation. The terms "about" and "substantially" are also used herein to represent the degree to which a quantitative representation may vary from a specified reference without resulting in a change in the basic functionality of the subject matter in question. The plural forms of "comprises," "includes," and / or each are open-ended and include the recited parts and may include additional parts that are not recited. "And / or" is open-ended and includes one or more recited parts and combinations of recited parts. The use of the terms "above," "below," and the like, is intended only to aid in the clarity of the disclosure and is not intended to limit in any manner the structure, positioning, and / or operation of the tissue repair device.

[0013] 1, an example of a tissue repair device 100 including a penetration depth limiter 400 of the present disclosure is shown in an assembled view. The device 100 generally includes a handle 110, a knob 120 coupled to the handle 110, a tube 130 disposed within the knob 120 and the handle 110, and a hub 170 coupled to the tube 130. The penetration depth limiter 400 of the present disclosure is disposed within the hub 170 and coupled to a depth tube 300, as described further below. A needle assembly 180 extends through the depth tube 300 and houses at least one suture anchor (not shown) for deployment from the needle assembly 180 into tissue. Other non-limiting examples of the handle 110, knob 120, tube 130, hub 170, and needle assembly 180 are disclosed in U.S. Patent No. 8,888,798 to Bourque et al., which is incorporated herein by reference in its entirety.

[0014] 2A-C, an example of a hub 170 is shown in detailed view. FIG. 2A shows an assembled hub 170 having a first part 171 (FIG. 2B) and a second part 172 (FIG. 2C). When assembled, the first part 171 and the second part 172 define a cannula insert 176 that extends through the hub 170. Both the first part 171 and the second part 172 include a first section 171a, 172a and a second section 171b, 172b. An open slot 173 extends between the first sections 171a and 172a that communicates with the cannula insert 176. The first sections 171a, 172a also include front portions 171a', 172a' and grooves 171a", 172a", the purpose of which will be explained in more detail below. Each part 171, 172 also includes a tab 171d, 172d located on an outer surface of the second section 171b, 172b. The second sections 171b, 172b are received within the tube 130 (FIG. 1) such that the tabs 171d, 172d are disposed within the holes 132 of the tube 130, thereby coupling the hub 170 to the tube 130.

[0015] 3A, an example of depth tube 300 is shown in detail. Depth tube 300 includes a distal portion 300a, a proximal portion 300b, and a cannulation portion 300c for passage of needle assembly 180. In an embodiment, proximal portion 300b of depth tube 300 includes markings 300d. Depth tube 300 may be made from a flexible material such that proximal portion 300b of depth tube 300 may be stretched around an outer surface of penetration depth limiter 400, as described further below.

[0016] 3B, the penetration depth limiter 400 of the present disclosure is coupled to the proximal portion 300b of the depth tube 300, while the needle assembly 180 extends from the distal portion 300a of the depth tube 300. The distal end of the needle assembly 180 also includes markings 182 to indicate the penetration depth of the needle assembly 180 during repair. In use, as the depth tube 300 is moved longitudinally along the needle assembly 180, the front portions 171a', 172a' of the hub 170 and the front portion 300a' of the depth tube 300 can remain aligned with their respective markings 300d, 182 such that the marks 300d, 182 with which the front portions 171a', 172a', 300a' can each be aligned are equivalent to one another. For example, if front portions 171a', 172a' are aligned with mark 300d corresponding to 1 mm, then front portion 300a' is also aligned with mark 182 corresponding to 1 mm.

[0017] 4A and 4B, a penetration depth limiter 400 of the present disclosure is shown in a side view (FIG. 4A) and an isometric view (FIG. 4B). The penetration depth limiter 400 includes a shaft 401, a housing 402 coupled to the shaft 401, and a cannulated portion 403 for passage of the needle assembly 180 and / or actuator 184 (FIG. 4D). In an embodiment, a flexure 409 is coupled to an inner surface of the cannulated portion 403 such that the flexure extends below the housing 402, the purpose of which will be explained in more detail below. The shaft 401 includes a connection feature 407 configured to connect the shaft 401 to a proximal portion 300b of the depth tube 300. In an embodiment, the connection feature 407 is one or more circumferential ribs 404 defined by a cone-shaped section 405 of the shaft 401. 4C, the connection feature 407 is a plurality of barbs 406 disposed around the circumference of the shaft 401. In embodiments, the cross-section of the barbs 406 can be cylindrical, mirror symmetric, rectangular, triangular, pentagonal, star-shaped, etc. The connection feature 407 is configured to provide sufficient assembly force as well as increase resistance to pull-out of the depth tube 300 from the shaft 401. The depth tube 300 can be assembled to the shaft 401 by stretching the proximal portion 300b of the depth tube 300 around the connection feature 407 and relaxing the depth tube 300 around the surface of the shaft 401.

[0018] Further embodiments (not shown) of the depth tube 300 and / or the connection feature 407 are provided by the present disclosure. For example, the depth tube 300 may include a window that serves as a hook to the connection feature 407. Similarly, there may be a number of hooks on the depth tube 300 that act as ratchet pawl style features with the connection feature 407 of the shaft 401. In other embodiments, the surface roughness, material combinations, and various other surface parameters may be tailored on the depth tube 300 and / or the shaft 401 to achieve the design intent. In other embodiments, the connection feature 407 may be an asymmetrical "mini-barb" that requires more force to remove from the depth tube 300 than to assemble to the depth tube 300. In further embodiments, a round cross section of one of the depth tube 300 or the shaft 401 may be mated to a square cross section of the other of the depth tube 300 or the shaft 401. In other embodiments, the shaft 401 and the depth tube 300 may be screwed together utilizing a helical interface. In a further embodiment, the mating surfaces between the depth tube 300 and the shaft 401 may be the inner diameter of a boss on the shaft 401 and the outer diameter of the depth tube 300 .

[0019] 4D, in a further embodiment of the penetration depth limiter 400 of the present disclosure, the housing 402 has a top portion 402a for extending through the slot 173 in the hub 170 (FIG. 3B) and a bottom portion 402b connected to the shaft 401. The top portion 402a includes an upper tab 408. The housing 402 is positioned within the hub 170 such that the upper tab 408 is positioned within the grooves 171a", 172a" of the hub 170. The cannulation portion 403 is configured to allow passage of the actuator 184 for deploying the anchors from the needle assembly 180. Longitudinal movement of the depth tube 300 occurs by pushing the top portion 402a of the housing 402 in a direction toward the bottom portion 402b to remove the upper tab 408 from one of the grooves 171a", 172a". Thus, the housing 402 may be moved longitudinally and then the top portion 402a may be released such that the upper tab 408 is deposited into the other one of the grooves 171 a″, 172 a″. Meanwhile, the flexure 409 deforms within the hub 170 and slides along the bottom surface 178 of the cannulated portion 176 of the hub 170. However, once the upper tab 408 reaches the distal-most groove 171 a″, 172 a″, the flexure 409 engages with the recess 174 in the bottom surface 178 of the hub 170 and is configured to return to its original shape and prevent further distal movement of the housing 402 relative to the hub 170. In particular, the proximal side 409a of the flexure 409 is cantilevered such that proximal movement of the housing 402 causes the flexure 409 to slide out of the recess 174, allowing proximal movement of the depth tube 300. The cantilever on the proximal side 409a also distributes stress evenly along the length of the cantilever.

[0020] Additional embodiments (not shown) of the penetration depth limiter 400 are contemplated by the present disclosure. In an embodiment, the recess 174 may be on the depth tube 300 while the flexure 409 is on the needle assembly 180. In other embodiments, a limiting strap may allow movement of the penetration depth limiter 400 over a defined distance, but stop movement when extended beyond the reach of the strap. In a further embodiment, a flexure catch may be incorporated into this flexure 409.

[0021] Those skilled in the art will appreciate that the present disclosure may be embodied in other specific forms without departing from its concept or essential characteristics.The above examples are therefore to be considered in all respects as illustrative and not limiting of the disclosure described herein.The scope of the present disclosure is therefore indicated by the appended claims, rather than the above description, and therefore all changes that come within the meaning and range of equivalency of the claims are intended to be embraced therein. [Additional note 1] 1. A tissue repair device comprising: a handle having a proximal end and a distal end; a needle assembly at least partially disposed within a channel extending through the handle; a depth tube including a cannula insert configured to receive at least a portion of the needle assembly therein; a restrictor member comprising a housing disposed within the handle and a shaft extending from the distal end of the handle, the shaft configured to engage the cannula insert of the depth tube, the restrictor member having a finger-engageable actuator for permitting axial movement of the depth tube relative to the needle assembly; A tissue repair device, wherein the housing of the restrictor member comprises a flexure configured to engage a recess in the housing to limit distal movement of the restrictor member relative to the housing. [Additional note 2] 2. The tissue repair device of claim 1, wherein the proximal side of the flexure includes a cantilever surface configured to allow proximal movement of the restrictor member relative to the housing. [Additional note 3] 2. The tissue repair device of claim 1, wherein an outer surface of the shaft of the restrictor member comprises at least one connection feature for increasing pull-out resistance between the shaft of the restrictor member and the cannulated portion of the depth tube. [Additional note 4] 4. The tissue repair device of clause 3, wherein the at least one connecting feature is at least one circumferential rib formed by a conical section of the shaft of the restrictor member. [Additional note 5] The tissue repair device of clause 3, wherein the at least one connecting feature is a plurality of barbs on an outer surface of the shaft of the restrictor member. [Additional note 6] 2. The tissue repair device of claim 1, wherein the handle comprises a hub coupled to a distal end of a tube extending through the handle, and the housing of the restrictor member is disposed within the hub. [Additional note 7] The tissue repair device of claim 6, wherein a top portion of the housing extends through an open slot in the hub. [Additional note 8] 2. The tissue repair device of claim 1, wherein the proximal portion of the depth tube and the distal end of the needle assembly include coordinating markings to indicate the tissue penetration depth of the needle assembly. [Additional note 9] 2. The tissue repair device of claim 1, wherein the depth tube is made of a flexible material and the proximal end of the depth tube is configured to extend around an outer surface of the shaft of the restrictor member. [Additional Note 10] 2. The tissue repair device of claim 1, wherein the restrictor member comprises tabs for continuous engagement with grooves in the handle upon longitudinal movement of the restrictor member within the handle. [Additional Note 11] 1. A tissue repair device comprising: a handle having a proximal end and a distal end; a needle assembly at least partially disposed within a channel extending through the handle; a depth tube including a cannula insert configured to receive at least a portion of the needle assembly therein; a restrictor member comprising a housing disposed within the handle and a shaft extending from the distal end of the handle, the shaft configured to engage the cannula insert of the depth tube, the restrictor member having a finger-engageable actuator for permitting axial movement of the depth tube relative to the needle assembly; A tissue repair device, wherein an outer surface of the shaft of the restrictor member comprises at least one connection feature for increasing pull-out resistance between the shaft of the restrictor member and the cannulation portion of the depth tube. [Additional Note 12] 12. The tissue repair device of claim 11, wherein the housing of the restrictor member comprises a flexure configured to engage a recess in the housing to limit distal movement of the restrictor member relative to the housing. [Additional Note 13] 13. The tissue repair device of claim 12, wherein a proximal side of the flexure includes a cantilever surface configured to allow proximal movement of the restrictor member relative to the housing. [Additional Note 14] 12. The tissue repair device of clause 11, wherein the at least one connecting feature is at least one circumferential rib formed by a conical section of the shaft of the restrictor member. [Additional Note 15] 12. The tissue repair device of clause 11, wherein the at least one connecting feature is a plurality of barbs on an outer surface of the shaft of the restrictor member. [Additional Note 16] 12. The tissue repair device of claim 11, wherein the handle comprises a hub coupled to a distal end of a tube extending through the handle, and the housing of the restrictor member is disposed within the hub. [Additional Note 17] 17. The tissue repair device of claim 16, wherein a top portion of the housing extends through an open slot in the hub. [Additional Note 18] 12. The tissue repair device of claim 11, wherein the proximal portion of the depth tube and the distal end of the needle assembly include coordinating markings to indicate the tissue penetration depth of the needle assembly. [Additional Note 19] 12. The tissue repair device of claim 11, wherein the depth tube is made of a flexible material and the proximal end of the depth tube is configured to extend around an outer surface of the shaft of the restrictor member. [Additional Note 20] 12. The tissue repair device of clause 11, wherein the restrictor member comprises tabs for successively engaging grooves in the handle upon longitudinal movement of the restrictor member within the handle.

Claims

1. 1. A tissue repair device comprising: a handle having a proximal end and a distal end; a needle assembly at least partially disposed within a channel extending through the handle and coupled to the handle; a depth tube including a cannula insert configured to receive at least a portion of the needle assembly therein; a restrictor member comprising a housing disposed within the handle and a shaft extending from the distal end of the handle, the shaft configured to engage the cannula insert of the depth tube, the restrictor member having a finger-engageable engagement member selectively engageable with the handle to permit axial movement of the depth tube relative to the needle assembly; Equipped with A tissue repair device, wherein the housing of the restrictor member comprises a flexure configured to engage a recess in the handle to limit distal movement of the restrictor member relative to the handle.

2. The tissue repair device of claim 1 , wherein a proximal side of the flexure includes a cantilever surface configured to allow proximal movement of the restrictor member relative to the handle.

3. The tissue repair device of claim 1 , wherein an outer surface of the shaft of the restrictor member comprises at least one connecting feature for increasing pull-out resistance between the shaft of the restrictor member and the cannulation portion of the depth tube.

4. The tissue repair device of claim 3, wherein the at least one connecting feature is at least one circumferential rib formed by a conical section of the shaft of the restrictor member.

5. The tissue repair device of claim 3, wherein the at least one connecting feature is a plurality of barbs on an outer surface of the shaft of the restrictor member.

6. The tissue repair device of claim 1 , wherein the handle comprises a hub coupled to a distal end of a tube extending through the handle, the housing of the restrictor member being disposed within the hub.

7. The tissue repair device of claim 6, wherein a top portion of the housing extends through an open slot in the hub.

8. The tissue repair device of claim 1 , wherein the proximal portion of the depth tube and the distal end of the needle assembly include coordinating markings to indicate the tissue penetration depth of the needle assembly.

9. The tissue repair device of claim 1 , wherein the depth tube is made of a flexible material and the proximal end of the depth tube is configured to extend around an outer surface of the shaft of the restrictor member.

10. The tissue repair device of claim 1, wherein the restrictor member includes tabs for successively engaging grooves in the handle upon longitudinal movement of the restrictor member within the handle.

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