Fixation device and method for installing same

• US 5,843,127 A
• Filed: 04/21/1995
• Issued: 12/01/1998
• Est. Priority Date: 08/22/1994
• Status: Expired due to Term

• Current Assignee: Linvatec Corporation (Jefferies Financial Group, Inc.)
• Original Assignee: Le Medical Technologies Incorporated
• Inventors: Li, Lehmann K.
• Primary Examiner(s): SCHMIDT, JEFFREY
• Application Number:
  US08/426,715
• Time in Patent Office: 1,320 Days
• Field of Search: 606/232, 606/75, 606/68, 606/104, 606/73, 606/187, 623/13, 411/60.54, 24/453
• 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 17/2909 Handles
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/0403 Dowels
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/042 plastically deformed during insertion
• CPC Class Codes: A61B 2017/0424 the separate member staying in the anchor after placement
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0453 threaded elements, e.g. set screws
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• 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 2/30723 Plugs or restrictors for sealing a cement-receiving space tools for inserting plugs A61F2/4614; sealing collars for use during cementing A61B17/8808
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2002/0835 with deformation of anchor parts, e.g. expansion of dowel by set screw
• CPC Class Codes: A61F 2002/0864 Fixation of tendon or ligament between anchor elements, e.g. by additional screws in the anchor, anchor crimped around tendon
• CPC Class Codes: A61F 2002/0882 Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone
• CPC Class Codes: F16B 13/08 : with separate or non-separate gripping parts moved into their final position in relation to the body of the device without further manual operation
• CPC Class Codes: Y10S 606/916 : Tool for installing or removing orthopedic fastener
• CPC Class Codes: Y10T 24/42 : Independent, headed, aperture pass-through fastener

Abstract

A fixation device and apparatus for inserting the fixation device securely into a bore in an element, e.g. bone. The apparatus is a hand held device having an actuating mechanism and a longitudinally extending member coupled to the hand held device adapted to hold the fixation device at a distal end. The fixation device has a plurality of engaging members adapted to be moved outwardly when the fixation device is inserted into the bore to secure the fixation device in the bore. The extending member has an operating member coupled to the fixation device for exerting a force on the fixation device tending to cause the engaging members to extend outwardly to engage the wall of the bore. The operating member is releasably coupled to the fixation device so that once the fixation device is installed, the hand-held insertion apparatus can be removed. In one embodiment, the fixation device is releasably held by a forceps of the hand held device. In another embodiment, the fixation device is releasably held by a coupling member having a frangible connection adapted to break upon experiencing a preset tensile stress.

Claims

1. Apparatus including a fixation device and a device for inserting the fixation device securely into a bore in an element, the apparatus comprising:

a hand held device having an actuating mechanism;

a longitudinally extending member coupled to the hand held device adapted to hold the fixation device at a distal end;

a fixation device having a plurality of longitudinally extending engaging members adapted to be moved outwardly when the fixation device is inserted into the bore to secure the fixation device in the bore;

the extending member having an operating member adapted to be coupled to the fixation device for exerting a force on the fixation device tending to cause the engaging members to extend outwardly to engage the wall of the bore;

the operating member being releasably coupled to the fixation device;

the extending member comprising a cylinder and the operating member comprising a shaft disposed concentrically in the cylinder, the operating member being coupled to the fixation device for exerting an axial force on the fixation device without rotation of the operating member to cause the engaging members of the fixation device to extend outwardly;

the fixation device further comprising two parts, each having engaging members extending in one of two opposite directions, one of said parts being in engagement with an abutment surface of the cylinder to prevent movement of the part, the engaging members of the two parts being interdigitated but not necessarily on a one-to-one ratio of interdigitated engaging members and the other part being acted on by said operating member, each part having cam surfaces thereon for causing opposed engaging members of the other part to extend outwardly in response to the force applied by the operating member.

2. The apparatus of claim 1, wherein the operating member terminates in a forceps, the forceps releasably grasping the fixation device.

3. The apparatus of claim 2, wherein the cylinder is in slidable engagement with a surface of the forceps to keep the forceps in engagement with the fixation device and the cylinder is movable with respect to the forceps to cause the forceps to release the fixation device after the engaging members of the fixation device have extended outwardly to secure the fixation device in the bore.

4. The apparatus of claim 3, wherein the forceps comprise two opposed members for engaging the fixation device with a spring disposed therebetween to bias the opposed members away from each other to release the fixation device.

5. The apparatus of claim 4, wherein the shaft is adapted to move the forceps a preset longitudinal distance and the cylinder comprises a section slidably in contact with a corresponding portion of the forceps to hold the forceps in a state of engaging the fixation device, the cylinder being thereafter movable longitudinally so that the section in slidable contact with the forceps moves off the corresponding portion of the forceps thereby to release the forceps from engaging the fixation device.

6. The apparatus of claim 5, wherein the fixation device comprises a center member having an engagement point for engagement by the forceps.

7. The apparatus of claim 6, wherein the engagement point comprises an opening in the center member.

8. The apparatus of claim 6, wherein the center member is integral with at least a portion of the fixation device.

9. The apparatus of claim 7, wherein the center member is a separate part from a fixation device portion having the engaging members.

10. The apparatus of claim 1, wherein at least one of the engaging members is of a different length than the other engaging members.

11. The apparatus of claim 1, wherein the engaging members are equiangularly spaced about the circumference of the fixation device.

12. The apparatus of claim 1, wherein the engaging members are not equiangularly spaced about the circumference of the fixation device.

13. The apparatus of claim 1, wherein the operating member terminates in a coupling member coupling the operating member to the fixation device, the coupling member having a frangible connection whereby when a preset force in the coupling member is exceeded, the frangible connection breaks, releasing the fixation device from the operating member.

14. The apparatus of claim 13, wherein the frangible connection comprises a portion of said coupling member of weakened condition.

15. The apparatus of claim 14, wherein the frangible connection comprises an area of reduced thickness in said coupling member.

16. The apparatus of claim 15, wherein the area of reduced thickness comprises a groove or slit.

17. The apparatus of claim 13, wherein the coupling member is coupled to the shaft with a releasable connection.

18. The apparatus of claim 17, wherein the releasable connection comprises a bayonet connection.

19. The apparatus of claim 1, wherein the fixation device is adapted to connect to another member.

20. The apparatus of claim 19, wherein the fixation device includes a connector for attaching to another member.

21. Apparatus including a fixation device and a device for inserting the fixation device securely into a bore in an element, the apparatus comprising:

a hand held device having an actuating mechanism;

a longitudinally extending member coupled to the hand held device adapted to hold the fixation device at a distal end;

a fixation device having a plurality of longitudinally extending engaging members adapted to be moved outwardly when the fixation device is inserted into the bore to secure the fixation device in the bore;

the extending member having an operating member adapted to be coupled to the fixation device for exerting a force on the fixation device tending to cause the engaging members to extend outwardly to engage the wall of the bore;

the operating member being releasably coupled to the fixation device;

the extending member comprising a cylinder and the operating member comprising a shaft disposed concentrically in the cylinder, the operating member being coupled to the fixation device for exerting an axial force on the fixation device to cause the engaging members of the fixation device to extend outwardly;

the fixation device further comprising two parts, each having engaging members extending in one of two opposite directions, one of said parts being in engagement with an abutment surface of the cylinder to prevent movement of the part, the engaging members of the two parts being interdigitated but not necessarily on a one-to-one ratio of interdigitated engaging members and the other part being acted on by said operating member, each part having cam surfaces thereon for causing opposed engaging members of the other part to extend outwardly in response to the force applied by the operating member; and

further wherein the fixation device has a suture connected thereto.

22. A fixation device assembly for engagement by an insertion tool for inserting the fixation device assembly into a bore in a member, the assembly comprising:

a first member having a plurality of engaging members, the engaging members being adapted to be engaged by a cam surface to cause the engaging members to move outwardly to engage the bore in response to actuation by said insertion tool;

a second member extending longitudinally from the first member adapted to have a force releasably exerted thereon for causing the engaging members of the first member to engage the cam surface and move outwardly; and

further comprising a third member having a plurality of engaging members extending oppositely to the engaging members of said first member, the engaging members of the first and third members being interdigitated, the cam surface for causing each respective engaging member to extend outwardly comprising a surface of the respective first and third members disposed opposite each respective engaging member; and

wherein one of the first, second and third members has sutures connected thereto.

23. A fixation device assembly for engagement by an insertion tool for inserting the fixation device assembly into a bore in a member, the assembly comprising:

a first member having a plurality of engaging members, the engaging members being adapted to be engaged by a cam surface to cause the engaging members to move outwardly to engage the bore in response to actuation by said insertion tool;

a second member extending longitudinally from the first member adapted to have an axial force releasably exerted thereon for causing the engaging members of the first member to engage the cam surface and move outwardly;

a third member having a plurality of engaging members extending oppositely to the engaging members of said first member, the engaging members of the first and third members being interdigitated, the cam surface for causing each respective engaging member to extend outwardly comprising a surface of the respective first and third members disposed opposite each respective engaging member; and

further comprising a fourth member, the fourth member comprising a cylinder having a concentric shaft disposed therethrough, the concentric shaft non-rotationally providing the axial force to said second member, and further wherein the cylinder abuts one of said first and third members to prevent said one member from moving when said force is applied to the other of said first and third members.

24. The assembly of claim 23, wherein the concentric shaft has a snap-in end for removably attaching to the insertion tool.

25. Apparatus including a fixation device and a device for inserting the fixation device securely into a bore in an element, the apparatus comprising:

a hand held device having an actuating mechanism;

a longitudinally extending member coupled to the hand held device adapted to hold the fixation device at a distal end;

a fixation device comprising a generally cylindrical element having a plurality of longitudinally extending engaging members adapted to be moved generally radially outwardly when the fixation device is inserted into the bore to secure the fixation device in the bore;

the extending member having an operating member adapted to be coupled to the fixation device for exerting a force on the fixation device tending to cause the engaging members to extend generally radially outwardly to engage the wall of the bore;

the operating member being releasably coupled to the fixation device;

the extending member comprising a cylinder and the operating member comprising a shaft disposed concentrically in the cylinder, the operating member being coupled to the fixation device for exerting an axial force on the fixation device without rotation of the operating member to cause the engaging members of the fixation device to extend generally radially outwardly;

the engaging members of the cylindrical element of the fixation device having an initial undeployed position extending in a direction along the longitudinal axis of the longitudinally extending member, said cylindrical element being acted on by said operating member, said engaging members having proximal surfaces abutting against a cam surface on said cylinder for causing said engaging members to move to a deployed position wherein the engaging members extend generally radially outwardly at an angle to the longitudinal axis in response to the force applied by the operating member.

26. The apparatus of claim 25, further wherein the fixation device has a suture connected thereto.