IMPLANT PLACEMENT SYSTEMS AND ONE-HANDED METHODS FOR TISSUE FIXATION USING SAME

• US 20160367357A1
• Filed: 09/06/2016
• Published: 12/22/2016
• 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.
• Granted Patent: US 9,782,250 B2
• Time in Patent Office: 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 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/0088 ceramic
• 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 2017/044 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: 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. Particularly preferred embodiments allow for the one-handed operation. To that end, embodiments in which relative axial movement between the inner tensioning device and outer driver device is optionally physically constrained, for example by means of cooperating and/or compressive elements disposed in the respective hub and handle portions, are described herein.

Claims

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

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

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; and

c. an axial control assembly having a first constrained configuration and a second free configuration;

wherein;

i. said insertion device is slidably received within said at least one lumen of said driver device and the proximal end of said driver device handle portion is engaged to the distal end of said insertion device hub portion;

ii. when said axial control assembly is in said first constrained configuration, the distal end of said insertion device extends 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 and relative axial movement between said driver device and said insertion device is precluded; and

iii. when said axial control assembly is in said second free configuration, the driver device and implant move axially in a distal direction along the length of said rigid distal portion of said insertion device to thereby drive said implant into said socket while the insertion device is maintained in a fixed position.

2. The implant placement system of claim 1, wherein said axial control assembly includes a longitudinal spring contained within said proximal hub portion.

3. The implant placement system of claim 2, wherein said longitudinal spring is held in a compressed configuration by one or more slidable control elements.

4. The implant placement system of claim 3, wherein said slidable control element includes extends through a lateral wall of said proximal hub portion and is transversely oriented to the longitudinal axis.

5. The implant placement system of claim 1, wherein said implant comprises an interference plug-type anchor.

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

7. The implant placement system of claim 1, wherein said implant comprises a cannulated knotless suture anchor fabricated from a high strength ceramic material selected from the group consisting of alumina and zirconia.

8. The implant placement system of claim 1, wherein the distal end of said driver device and a proximal end of said implant are provided with mating features that enable secure attachment of said implant to said driver device.

9. The implant placement system of claim 8, wherein both the implant and at least the mating features of said cannulated driver device are shaped by Ceramic Injection Molding (CIM).

10. The implant placement system of claim 1, 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.

11. 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.

12. The implant placement system of claim 1, wherein said elongate insertion device further comprises an open proximal end, an open distal end, and at least one insertion lumen extending from open proximal end to said open distal end.

13. The implant placement system of claim 12, wherein said system further comprises an elongate element formed from a suitably elastic metallic or polymeric material and having a first configuration characterized by first and second free proximal ends and distal end in the form of a suture capturing loop 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 driver lumen such that rigid distal portion extends out of the open distal end of said driver device and distally past the distal end of said suture anchor when coupled to said driver device; and

ii. said elongate element in said first configuration is slidably received within said at least one insertion lumen such that the suture capturing loop extends out of and distally past the open distal end of said insertion device so as to enable said suture capturing loop to receive said suture first ends.

14. 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 with the proximal end of said driver device handle portion engaged to the distal end of said insertion device hub portion and the axial control assembly in said first constrained configuration, whereby relative 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. shifting said axial control assembly to said second free configuration; 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.

15. The method of claim 14, further comprising step (i) of withdrawing the implant placement system after step (h).

16. The method of claim 14, further comprising step (j) of trimming the free end of said suture after step (i).

17. The method of claim 14, further comprising repeating steps (b) through (h) as required.

18. The method of claim 14, 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.

19. The method of claim 14, 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.