Implant placement systems, devices and methods

• US 9,566,060 B2
• Filed: 02/01/2016
• Issued: 02/14/2017
• Est. Priority Date: 03/03/2014
• Status: Active Grant

• Current Assignee: Tenjin, LLC
• Original Assignee: Tenjin, LLC
• Inventors: Dougherty, Christopher P., Heisler, Gary R., Van Wyk, Robert A.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US15/012,060
• Publication Number:
  US 20160157852A1
• Time in Patent Office: 379 Days
• US Class Current: 1/1
• 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 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 2017/00358 Snares for grasping
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/0053 Loading magazines or sutures into applying tools
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• 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
• CPC Class Codes: A61F 2/0805 Implements for inserting tendons or ligaments
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2002/0841 Longitudinal channel for insertion tool running through the whole tendon anchor, e.g. for accommodating bone drill, guidewire
• CPC Class Codes: A61F 2002/0858 Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
• CPC Class Codes: A61F 2002/0888 Anchor in or on a blind hole or on the bone surface without formation of a tunnel

Abstract

Described herein is a simplified placement system and method for a tissue graft anchor by which a surgeon may introduce one or more sutures into a hole in a boney tissue, apply a precise amount of tension to the sutures to advance a soft tissue graft to a desired location, and then advance the anchor into the bone, preferably while maintaining the requisite pre-determined suture tension and without introducing spin to the suture.

Claims

1. An implant placement system for affixing a soft tissue graft to a prepared socket in a boney surface via an anchoring implant, said system comprising:

a. a cannulated driver device comprising an open proximal end, a proximal handle portion, an elongate tubular distal portion that defines the longitudinal axis of the system, an open distal end configured to receive said implant, and at least one lumen extending from said proximal to distal end; and

b. an elongate insertion device comprising a proximal hub portion and a rigid distal portion configured to receive the first ends of one or more elongate sutures, wherein;

i. said insertion device is slidably received within said at least one lumen of said driver device;

ii. the proximal end of said driver device handle portion may be releasably engaged to and disengaged from the distal end of said insertion device hub portion, such that when said driver device handle portion and said insertion device hub portion are engaged, relative rotational and axial movement between said driver device and insertion device is precluded and when said driver device handle portion and said insertion device hub portion are disengaged, relative rotational and axial movement between said driver device and insertion device is enabled;

iii. when said insertion device and said driver device are engaged as set forth in (ii), the distal end of said insertion device is configured to extend distally past the distal end of said implant when coupled to said driver device so as to enable said insertion device distal end to receive said suture first ends.

2. The implant placement system of claim 1, wherein said anchoring implant comprises a cannulated interference plug-type anchor.

3. The implant placement system of claim 2, wherein the distal end of said driver device and a proximal end of said cannulated interference plug-type anchor are provided with mating features that enable secure attachment of said anchor to said driver device.

4. The implant placement system of claim 1, wherein said anchoring implant comprises a threaded anchor.

5. The implant placement system of claim 4, wherein the distal end of said driver device includes torque transmitting features that, together with complementary torque receiving features formed in a proximal portion of the anchor, allow the transmission of torque to said anchor necessary to drive said anchor into said prepared socket.

6. The implant placement system of claim 1, wherein said insertion device has an open proximal end, an open distal end, and at least one lumen extending therebetween, further wherein said one or more first ends of said one or more elongate sutures received by said elongate distal portion of said insertion device may be threaded through said at least one lumen and out said proximal opening.

7. The implant placement system of claim 6, further comprising an elongate wire element having a pull tab at its proximal end and a suture loading loop at its distal end, wherein said elongate wire element is slidably received within the at least one lumen of said insertion device, such that said proximal end pull tab engages with the proximal end of said insertion device hub portion and said distal end suture loading loop extends distally past the distal end of said insertion device.

8. The implant placement system of claim 6, wherein said insertion device hub portion further comprises a laterally projecting flange comprising a plurality of narrow slots configured to securably receive the first ends of said one or more sutures.

9. The implant placement system of claim 8, wherein said flange is further provided with a central slot configured to securably receive the proximal end pull tab of said elongate wire element.

10. The implant placement system of claim 6, wherein the proximal end of said insertion device hub portion is provided with a plurality of narrow slots disposed about the periphery of said proximal end that serve to cleat said first ends of said one or more sutures to said insertion hub portion.

11. The implant placement system of claim 6, wherein said insertion device hub portion further comprises a laterally projecting flange comprising a plurality of narrow slots configured to securably receive the first ends of one or more sutures.

12. The implant placement system of claim 1, wherein said rigid distal portion of said insertion device has at its distal end a sharpened fork portion characterized by two or more axially extending tines spaced apart to define one or more channels therebetween in which said one or more first ends of said one or more elongate sutures may be slidably received.

13. A method for affixing an elongate soft tissue graft to a target boney surface, the method comprising the steps of:

a. providing the implant placement system of claim 12, wherein the proximal end of said driver device handle portion is engaged to the distal end of said insertion device hub portion such that relative rotational and axial movement between said driver device and said insertion device is precluded;

b. positioning an anchoring implant on the distal end of said driver device;

c. piercing and releasably retaining a proximal portion of said elongate soft tissue graft with said sharpened fork portion of said rigid distal portion of said insertion device so as to allow positioning of said proximal portion of said graft;

d. drawing said proximal portion of said elongate graft to a suitably configured socket disposed in said target boney surface;

e. inserting said distal portion of said tensioning device and said proximal portion of said graft retained thereto into said socket; and

f. distally advancing said driver device so as to drive the implant in the socket, whereby said implant serves to anchor said elongate tissue graft to said target boney surface.

14. The method of claim 13, wherein the anchoring of step (f) arising in the absence of one or more sutures.

15. The implant placement system of claim 1, wherein said driver device handle portion and said insertion device hub portion are provided with complementary mating features that enable secure engagement.

16. The implant placement system of claim 15, wherein said complementary mating features comprise (a) one or more off-axis lateral hole(s) disposed near the proximal end of the proximal handle portion of said driver device and (b) one or more off-axis lateral groove(s) disposed near the distal end of the proximal hub portion of said insertion device, wherein said placement system further comprises a key element comprised of a proximal portion having one or more cylindrical projections extending therefrom, whereby said cylindrical projection(s) extend through said off-axis lateral hole(s) and engage said off-axis lateral groove(s) to lock said insertion device to said driver device and preclude relative rotational and axial movement therebetween.

17. The implant placement system of claim 1, wherein the proximal portion of said insertion device further includes a handle portion comprising an assembly of first and second rigid elements with an elastic element positioned therebetween, whereby the application of a distal force to said first rigid element of the handle portion causes deflection of the elastic element proportional to the tension on the one or more elongate sutures received by the distal end of said insertion device.

18. A method for affixing a soft tissue graft to a target boney surface, the method comprising the steps of:

a. providing the implant placement system of claim 1, wherein the proximal end of said driver device handle portion is engaged to the distal end of said insertion device hub portion such that relative rotational and axial movement between said driver device and said insertion device is precluded;

b. positioning an anchoring implant to the distal end of said driver device;

c. providing one or more elongate sutures, each of which has a first free end and a second end attached to said soft tissue graft;

d. receiving said first free ends in the distal end of said insertion device;

e. inserting the distal end of the insertion device into a suitably configured socket disposed in said target boney surface;

f. applying tension to the suture to draw the soft tissue graft to a desired position;

g. disengaging said driver device handle portion from said insertion device hub portion so as to enable relative rotational and axial movement between said driver device and said insertion device; and

h. distally advancing said driver device so as to drive the implant in the socket, whereby said implant serves to anchor said soft tissue graft to said target boney surface.

19. The method of claim 18, further comprising step (i) of withdrawing the implant placement system after step (h).

20. The method of claim 18, further comprising step (j) of trimming the free end of said suture after step (i).

21. The method of claim 18, further comprising repeating steps (b) through (h) as required.

22. The method of claim 18, wherein said anchoring implant comprises an interference plug-type anchor, further wherein the distal end of said driver device and a proximal end of said interference plug-type anchor are provided with mating features that enable secure attachment of said anchor to said driver device.

23. The method of claim 18, wherein said anchoring implant comprises a threaded anchor, further wherein the distal end of said driver device includes torque transmitting features that, together with complementary torque receiving features formed in a proximal portion of the anchor, allow the transmission of torque to said anchor.

24. The method of claim 18, wherein the proximal end of said insertion device hub portion is provided with a plurality of narrow slots disposed about the periphery of said proximal end that serve to cleat said first end of said suture to said insertion hub portion, such that said tensioning step (f) terminates with the step of securing said first free ends of said one of more sutures to said longitudinal cleats.

25. The method of claim 18, wherein said insertion device hub portion further comprises a laterally projecting flange comprising a plurality of narrow slots configured to securably cleat the first ends of a plurality sutures, such that said tensioning step (f) terminates with the step of securing each of said first free ends of said one of more sutures a separate cleat.

26. The method of claim 18, wherein said implant placement system further comprises an elongate wire element having a pull tab at its proximal end and a suture loading loop at its distal end, wherein said elongate wire element is slidably received within a lumen of said insertion device, such that said proximal end pull tab engages with the proximal end of said insertion device hub portion and said distal end suture loading loop extends distally past the distal end of said insertion device, such that said threading step (d) includes the step of passing said first free ends of said one of more sutures through said suture loading loop and proximally retracting said elongate wire element until said first free ends are advanced through said proximal end opening of said insertion device.

27. The method of claim 18, wherein said driver device handle portion and said insertion device hub portion are provided with complementary mating features that enable secure engagement, said complementary mating features comprising (a) one or more off-axis lateral hole(s) disposed near the proximal end of the proximal handle portion of said driver device and (b) one or more off-axis lateral groove(s) disposed near the distal end of the proximal hub portion of said insertion device, wherein said implant placement system further comprises a key element comprised of a proximal portion having one or more cylindrical projections extending therefrom, wherein step (a) further comprises the step of extending said cylindrical portion(s) through said off-axis lateral hole(s) so as to engage said off-axis lateral groove(s) and thereby lock said insertion device to said driver device and preclude relative rotational and axial movement therebetween.