Soft Tissue Repair Device and Method

• US 20100087857A1
• Filed: 09/30/2009
• Published: 04/08/2010
• Est. Priority Date: 11/05/2004
• Status: Active Grant

• Current Assignee: Biomet Sports Medicine LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Sports Medicine LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Slater, Nicholas R., Butters, Joshua A., Berelsman, Brian K., Stone, Kevin T., Sautter, Nathan M., Arnett, Jeffery D., Hushka, Dylan M.
• Granted Patent: US 8,303,604 B2
• Time in Patent Office: Days
• US Class Current: 606/232
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/042 plastically deformed during insertion
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/2923 Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument

Abstract

A soft tissue repair device can include a housing having a handle, a deployment system having an actuation member, and an insertion system having an inserter and a slider. The slider can be coupled to the actuation member and movable relative to the inserter between deployed and retracted positions. First and second anchors can be carried on an external surface of the slider such that the anchors are spaced apart and portions of the anchors are coaxial with the slider and each other. A flexible strand can couple the anchors. The insertion system can cooperate with the deployment system to move the slider to the deployed position to deploy the first anchor upon activating the actuation member a first time, and to move the slider to the deployed position from the retracted position to deploy the second anchor upon actuating the actuation member a second time after the first time.

Claims

1. A soft tissue repair device comprising:

a housing including a handle;

a deployment system including an actuation member;

an insertion system including an inserter and a slider, the slider coupled to the actuation member and movable relative to the inserter between deployed and retracted positions;

a first anchor, at least a portion of the first anchor carried on an external surface of the slider in a first position;

a second anchor, at least a portion of the second anchor carried on the external surface of the slider in a second position longitudinally spaced apart from the first anchor such that the portions of the first and second anchors are co-axial with the slider and each other; and

a flexible strand coupling the first and second anchors;

wherein the insertion system is operable to cooperate with the deployment system to move the slider from the retracted position to the deployed position to deploy the first anchor upon actuating the actuation member at a first time, and to move the slider from the retracted position to the deployed position to deploy the second anchor upon actuating the actuation member a second time after the first time.

2. The soft tissue repair device of claim 1, wherein the handle comprises a pistol grip handle and the actuation member comprises a trigger protruding from the handle and being adapted for engagement by a user.

3. The soft tissue repair device of claim 1, wherein the deployment system further comprises a cam and a cam follower, the cam coupled to the actuation member and the cam follower, the cam follower attached to the slider at a proximal end thereof, and wherein actuating the actuation member pivots the cam thereby causing the cam follower to translate the slider from the retracted position to the deployed position.

4. The soft tissue repair device of claim 3, wherein the deployment system further comprises a biasing member configured to bias the actuation member to the retracted position.

5. The soft tissue repair device of claim 3, wherein the insertion system further comprises a positioning member, the positioning member having a longitudinal axis and a through bore extending between proximal and distal ends thereof, the positioning member being slidably disposed over the slider so as to be coaxial therewith, and wherein the positioning member is positioned such that the distal end is configured to engage the second anchor and the proximal end is configured to engage the cam follower.

6. The soft tissue repair device of claim 5, wherein the slider and the positioning member are received within a through bore of the inserter, the slider and the positioning member being independently movable relative to each other and the inserter.

7. The soft tissue repair device of claim 6, wherein actuating the actuation member the first time causes the cam follower to engage and translate the positioning member such that the distal end of the positioning member engages and translates the second anchor to a third position proximate a distal end of the inserter, the positioning member including a longitudinal length such that the third position of the second anchor is adjacent to or beyond an engagement portion on a distal end of the slider when the slider is in the retracted position.

8. The soft tissue repair device of claim 7, wherein the positioning member further comprises an engagement member extending from a proximal end thereof, the engagement member configured to engage the housing upon translating the second anchor to the third position such that when the slider is translated to the retracted position, the positioning member remains stationary and maintains the second anchor in the third position.

9. The soft tissue repair device of claim 5, further comprising an outer cannula adjustably extending from the housing;

wherein the slider, positioning member and inserter are slidably received within said outer cannula, and wherein the outer cannula is coupled at a proximal end to an adjustment mechanism substantially disposed within the housing and operable to adjust a distal end of the outer cannula relative to a distal end of the inserter such that the distal end of the inserter extends a predetermined distance beyond the distal end of the outer cannula.

10. The soft tissue repair device of claim 1, wherein the insertion system further includes a depth positioning system comprising:

an outer cannula having a proximal end disposed within said housing and a distal end extending from said housing;

a translation member fixed at one end to the proximal end of said outer cannula;

a cam member coupled to the housing so as to be rotatable and translatable relative thereto, the cam member engaging a proximal end of the translating member; and

a biasing member configured to bias the translation member into engagement with the cam member;

wherein the cam member is operable to adjust a position of the distal end of the outer cannula relative to a distal end of the slider such that the distal end of the slider extends beyond the distal end of the outer cannula by one of a plurality of predetermined distances, the predetermined distances corresponding to an insertion depth of the inserter.

11. The soft tissue repair device of claim 10, wherein the cam member further comprises an outer periphery and a cam surface, the outer periphery having a toothed portion configured to engage the housing, each tooth of the toothed portion corresponding to one of the plurality of predetermined distances and being configured to maintain the outer cannula in one of the predetermined distances relative to the slider, and the cam surface being configured to cooperate with the proximal end of the translation member such that rotational motion of the cam member causes translational motion of the translating member.

12. The soft tissue repair device of claim 11, wherein the depth positioning system further comprises:

a locked position where the distal end of the outer cannula extends at least to the distal end of the inserter and the outer periphery of the cam member engages the proximal end of the translation member, and

an unlocked position where the proximal end of the translation member engages the cam surface, the cam surface being spaced apart from the outer periphery.

13. The soft tissue repair device of claim 12, wherein the actuation member further comprises a flange configured to engage a corresponding flange of the translation member such that when the depth positioning system is in the locked position the flanges engage one another and prevent the actuation member from being activated.

14. The soft tissue repair device of claim 10, wherein the cam member is disposed with the housing such that a portion of the periphery of the cam member protrudes beyond an exterior surface of the housing, the protruding portion being adapted for engagement by a user.

15. The soft tissue repair device of claim 10, wherein the cam member includes a projection extending from a central axis, and wherein the housing includes a longitudinal channel having a width substantially mating with a diameter of the projection, the channel configured to cooperate with the projection to provide for translation and rotation of the cam member relative to the housing.

16. The soft tissue repair device of claim 10, wherein the translation member further comprises a position indication member extending transverse to the translation member and protruding through an aperture on the housing, the position indication member configured to align with one of a first plurality of indicia indicative of a distance of one of the predetermined distances that the distal end of the inserter extends beyond the distal end of the outer cannula.

17. The soft tissue repair device of claim 15, wherein the inserter further includes a second plurality of indicia indicative of a distance the distal end of the inserter extends beyond the distal end of the outer cannula, the first plurality of indicia configured to correspond to the second plurality of indicia.

18. The soft tissue repair device of claim 10, wherein the distal end of the outer cannula further comprises a chamfered terminal end and an at least one aperture proximate the terminal end.

19. The soft tissue repair device of claim 1, wherein the inserter includes a tubular member defining an internal longitudinal bore extending from a proximal end towards a distal end, and a trough section having a semi-circular cross-section extending from a distal end and mating with the internal bore, the trough section carrying the first and second anchors in the respective first and second positions preloaded on the slider.

20. The soft tissue repair device of claim 19, wherein the distal end of the inserter further includes an inclined portion angled relative to a longitudinal axis of the longitudinal bore.

21. The soft tissue repair device of claim 1, wherein the slider includes an engagement portion proximate a distal end thereof, the engagement portion including a barb configured to engage the first and second anchors when the slider translates in a first direction from the retracted position to the deployed position, and slide relative to the second anchor when translating in a second, opposite direction.

22. The soft tissue repair device of claim 21, wherein the engagement portion further comprises:

a flattened area having a recess that partially defines the barb, the flattened area having a first width on a first side of the barb in a direction towards the distal end, and a second width on a second side of the slider in a direction towards the proximal end of the slider, the second width being greater than the first width.

23. The soft tissue repair device of claim 1, wherein the flexible strand passes through a portion of the first and second anchors and forms an adjustable knotless loop.

24. The soft tissue repair device of claim 23, wherein the flexible strand is a braided strand having first and second ends and defining a longitudinal passage, and wherein the knotless loop is formed by passing one of the first or second ends through a portion of the longitudinal passage of the flexible strand, and further wherein the first and second anchors are flexible sleeves formed from woven material, each flexible anchor having first and second ends and defining a longitudinal bore therethrough for receiving the slider therein.

25. The soft tissue repair device of claim 24, wherein the flexible strand passes through a portion of the longitudinal bore between first and second openings of each sleeve communicating with the bore, the first and second openings intermediate the first and second ends of each of the first and second anchors, and wherein portions of each flexible anchor between the first and second ends and the first and second openings of the corresponding anchor define leg portions.

26. A soft tissue repair device for deploying an anchor, comprising:

a housing including a pistol grip handle;

an actuation member in the form of a trigger protruding from said handle and moveable relative thereto; and

an insertion system including an inserter and a slider, the slider movable relative to the inserter between a deployed position and a retracted position upon activation of the trigger;

wherein upon activating the trigger, the insertion system is configured to cooperate with the trigger to move the slider from the retracted position to the deployed position to deliver the anchor.

27. The soft tissue repair device of claim 26, further comprising a cam and a cam follower, the cam coupled to the trigger and including an arcuate portion having a first plurality of teeth, the cam follower fixed to a proximal end of the slider and having a second plurality of teeth in meshing engagement with the first plurality of teeth;

wherein depressing the trigger causes the cam to rotate which in turn drives the cam follower and translates the slider from the retracted position to the deployed position.

28. The soft tissue repair device of claim 26, wherein the slider includes an engagement portion proximate a distal end thereof, the engagement portion including a flattened area having a barb configured to engage the anchor when the slider translates in a first direction from the retracted position to the deployed position, and slide relative to the anchor when translating in a second, opposite direction.

29. A soft tissue repair device comprising:

a housing including a pistol grip handle;

a deployment system including an actuation member protruding from said handle and adapted for engagement by a user;

an insertion system including an inserter, a slider, and a positioning member, the inserter including a distal end extending from the housing and defining a longitudinal passage therethrough, the slider positioned coaxially within the inserter and coupled to the actuation member so as to be movable relative to the inserter between deployed and retracted positions, the positioning member coaxially disposed within the inserter such that the slider extends through an internal passage of the positioning member, the positioning member having a length less than a length of the inserter and the slider;

a depth positioning system including an outer cannula having a distal end extending from said housing and a depth adjustment mechanism, wherein at least a portion of the slider, positioning member and inserter are disposed coaxially within the outer cannula, and wherein the depth adjustment mechanism is operable to adjust a position of a distal end of the outer cannula relative to the distal end of the inserter;

a first flexible anchor, at least a portion of the first anchor carried on an external surface of the slider in a first position on a distal side of an engagement portion of the slider;

a second flexible anchor, at least a portion of the second anchor carried on the external surface of the slider in a second position longitudinally spaced apart from the first anchor and on a proximal side of the engagement portion such that at least the portions of the first and second anchors are co-axial with each other and the slider, wherein the positioning member includes a distal end configured to engage the second anchor; and

a flexible strand coupling the first and second anchors and forming an adjustable knotless loop;

wherein the insertion system is operable to cooperate with the deployment system to move the slider from the retracted position to the deployed position to deploy the first anchor upon actuating the actuation member at a first time, and to move the slider from the retracted position to the deployed position to have the engagement portion engage and deploy the second anchor upon actuating the actuation member a second time after the first time.

30. The soft tissue repair device of claim 29, wherein the deployment system further comprises a cam and a cam follower, the cam coupled to the actuation member and the cam follower, the cam follower attached to the slider at a proximal end thereof, wherein actuating the actuation member pivots the cam thereby causing the cam follower to translate the slider from the retracted position to the deployed position.

31. The soft tissue repair device of claim 30, wherein the positioning member further comprises a body portion at a proximal end thereof, the body portion configured to engage the cam follower when the cam follower is translated forward upon activating the actuation member the first time such that a distal end of the positioning member engages the second anchor and translates the second anchor forward to a third position, the body portion configured to engage the housing upon the cam follower being translated to the deployed position so as to prevent the second anchor from moving rearward toward a proximal end of the inserter upon retraction of the slider.

32. The soft tissue repair device of claim 29, wherein the depth positioning system further comprises:

a translation member disposed with the housing and coupled to a proximal end of the outer cannula;

a cam member having a portion disposed within said housing and a portion protruding from the housing and adapted to be engageable by a user, the cam member in cooperating engagement with a proximal end of the translation member and operable to adjust a position of the distal end of the outer cannula relative to the distal end of the inserter such that the distal end of the inserter extends beyond the distal end of the outer cannula by one of a plurality of predetermined distances.

33. The soft tissue repair device of claim 29, wherein the inserter is fixed to the housing and the slider, positioning member and outer cannula are independently moveable relative to each other and the inserter.

34. A method for repairing a tear in soft tissue, comprising:

coupling first and second flexible anchors with a flexible strand;

providing an insertion device having a housing with a pistol grip handle, an inserter and a slider carried in the inserter, wherein the inserter and the slider each have a distal end extending from the housing;

loading the first and second coupled anchors on an external surface of the slider;

inserting the inserter through the soft tissue at a first position from a first side of the tear to a second side of the tear;

actuating an actuation member protruding from the pistol grip handle at a first time to translate a distal end of the slider beyond a distal end of the inserter;

deploying the first anchor;

releasing the actuation member after deploying the first anchor;

inserting the inserter through the soft tissue for a second time in a second position;

actuating the actuation member a second time after the first time to extend the distal end of the slider beyond the distal end of the inserter and deploy the second anchor;

removing the inserter from the soft tissue;

tensioning the flexible strand; and

reducing the tear.

35. The method of claim 34, wherein coupling first and second anchors includes forming an adjustable knotless loop with the flexible strand, the loop passing through a portion of each flexible anchor;

and

wherein loading the first and second flexible anchors includes positioning an internal longitudinal bore of the first and second flexible anchors coupled with the adjustable knotless loop over the external surface of the slider such that at least a portion of the first and second anchors are coaxial with the slider and each other.

36. The method of claim 35, wherein forming an adjustable knotless loop includes passing a first end of the flexible strand through a longitudinal passage defined by a portion of the flexible strand.

37. The method of claim 35, further comprising positioning the first and second anchors on the slider such that the first anchor is on a distal side of an engagement portion of the slider, and the second anchor is on a proximal side of the engagement portion.

38. The method of claim 34, wherein providing an insertion device further includes providing an insertion device with an outer cannula having a distal end extending from the housing and a proximal end coupled to an adjustment mechanism, the slider and the inserter being positioned in a longitudinal passage extending through the outer cannula.

39. The method of claim 38, further comprising adjusting a distal end of the outer cannula relative to the distal end of the inserter such that the distal end of the inserter extends beyond the distal end of the outer cannula so as to establish an insertion depth of the inserter;

and

wherein inserting the inserter through the soft tissue includes inserting the extending distal end of the inserter through the soft tissue until the distal end of the outer cannula abuts an exterior surface of the soft tissue.

40. The method of claim 34, wherein depressing an actuation member further includes translating a positioning member disposed coaxially around the slider and inside the inserter to translate the second anchor forward towards the distal end of the inserter.

41. The method of claim 40, wherein releasing the actuation member further includes retracting the slider to a retracted position such that an engagement portion of the slider is positioned adjacent to or beyond the translated second anchor;

and

wherein depressing the actuation member a second time includes depressing the actuation member a second time after releasing the actuation member and translating the second anchor to the third position such that the engagement portion of the slider engages the second anchor and moves the second anchor beyond the distal end of the inserter.

42. The method of claim 34, wherein tensioning the flexible strand includes self-locking the adjustable loop.

43. The method of claim 42, wherein loading the first and second flexible anchors includes loading the first and second flexible anchors in a substantially linear first shape on an external surface of the slider;

and

wherein tensioning the flexible strand further includes changing the shape of each flexible anchor from the first shape to a second deformed shape that is suitable for securely lodging each flexible anchor relative to the soft tissue.

44. The method of claim 35, wherein loading the first and second coupled anchors further includes positioning only a portion of the internal bores of the first and second coupled anchors over the external surface of the slider such that a first portion of each anchor is coaxial with the slider and a second tail portion of each anchor extends at an angle relative to the slider, and

wherein the second tail portion is configured to engage the soft tissue when the actuation member is released and the slider is retracted from being translated beyond the distal end of the inserter.