Connector device and method for surgically joining and securing flexible tissue repair members

• US 5,899,921 A
• Filed: 07/25/1997
• Issued: 05/04/1999
• Est. Priority Date: 07/25/1997
• Status: Expired due to Term

• Current Assignee: Innovasive Devices Inc. (Johnson & Johnson)
• Original Assignee: Innovasive Devices Inc. (Johnson & Johnson)
• Inventors: Chervitz, Alan, Justin, Daniel F., Fallin, Thomas Wade, Hart, Rickey D., Perkins, Daniel A., Caspari, Richard B.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US08/901,026
• Time in Patent Office: 648 Days
• Field of Search: 606/232, 606/151, 24/129 R, 24/130, 24/136 R, 24/136 L, 24/115 M
• US Class Current: 606/232
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/045 snug fit within the anchor
• CPC Class Codes: A61B 2017/0479 Packages or dispensers for MIS suturing instruments
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter

Abstract

A connector for joining sections of flexible material includes inner and outer members that snap fit together by passing the bore of the outer member over the inner member to capture and secure ends of flexible material such as sutures. The flexible material is fitted into a bore in the inner member and project out a side portal to pass between the shared or opposing inner and outer member surfaces. This serpentine pathway locks the flexible material in place. The invention further provides a delivery instrument to maintain the outer member in alignment with a receiving end of the inner member loaded with flexible material. The delivery instrument further includes cooperating elements for urging the outer member over the inner member to lock the flexible material in place.

Claims

1. A connector for affixing at least one piece of flexible, elongated material at a surgical site, the connector comprising:

an outer member having a longitudinal bore extending from a top end;

an inner member movable between an open position and a locked position in engagement with the outer member, the inner member having;

a central portion dimensioned to permit passage into the outer member bore;

a passage extending from a top end to an exit portal, the passage dimensioned to permit a piece of flexible material to pass therethrough, and a top portion having means for preventing a passage thereof into the outer member bore; and

means for retaining at least a portion of the inner member within the outer member bore when in the locked position, wherein an outer surface of the inner member and an inner surface of the outer member are closely opposed;

wherein in the locked position, the passage is at least partially in engagement with the outer member and a serpentine path is provided for the piece of material comprising an insertion through the inner member passage, a proceeding generally upward between the inner member outer surface and the outer member inner surface, and an exit between the inner member top end and the outer member top end;

the serpentine path, the retention of the inner member portion within the outer member bore, and the dimensioning adapted to retain the piece of material in a desired position.

2. The connector recited in claim 1, wherein the passage-preventing means of the inner member top portion comprises the top portion having a diameter greater than a diameter of the outer member bore.

3. The connector recited in claim 1, wherein the inner member has a distortable protrusion adjacent and beneath the central portion dimensioned larger than at least an upper section of the outer member bore in a relaxed state and forcible into the outer member bore upper section in a distorted state.

4. The connector recited in claim 3, wherein the protrusion tapers inwardly from a top to a bottom thereof, for facilitating an insertion of the protrusion into the outer member bore.

5. The connector recited in claim 4, wherein the inner member bottom portion meets the central portion at an outwardly extending ledge having a diameter greater than a diameter of the outer member bore, and the bottom portion diameter tapers inwardly toward a bottom end for facilitating an insertion of the bottom portion into the outer member bore.

6. The connector recited in claim 5, wherein the bottom portion describes a generally inverted conical shape.

7. The connector recited in claim 5, wherein the outer member bore further has a lower section having a diameter greater than the upper section, the lower section diameter sufficiently large to permit the inner member bottom portion to reside therein in the relaxed state, the retaining means thereby comprising the ledge abutting against the outer member bore upper section.

8. The connector recited in claim 5, wherein the outer member bore further has a lower section having a diameter greater than the upper section, the lower section meeting the upper section at a defined ledge, the lower section diameter sufficiently large to permit the inner member bottom portion to reside therein in the relaxed state, the retaining means thereby comprising the bottom portion ledge abutting against the outer member bore ledge.

9. The connector recited in claim 5, wherein:

the at least one piece of material comprises at least two pieces of material;

the portal comprises a first portal; and

the connector further comprises a second portal positioned beneath the top portion and extending from a side wall to the inner member bore, the second portal dimensioned to permit a passage of at least one piece of material, wherein in use a first piece of material passes through the first portal and a second piece of material passes through the second portal.

10. The connector recited in claim 9, wherein the two pieces of material comprise two ends of a loop of suture material.

11. The connector recited in claim 5, wherein the inner member and the outer member are slidable within a trocar cannula, thereby permitting use in endoscopic surgery.

12. The connector recited in claim 5, wherein prior to use the inner member is frangibly attached adjacent the bottom end to a top end of the outer member, and an axial pressure sufficient to move the inner member into the locked position is further sufficient to break the frangible attachment.

13. The connector recited in claim 12, further comprising a handle frangibly attached to the inner member top end for facilitating a forcing of the inner member bottom portion into the outer member bore and a breaking of the frangible attachment between the inner member and the outer member.

14. The connector recited in claim 3, wherein the outer member bore has a widened bottom portion dimensioned to permit the protrusion to reside therein in a relaxed state, the widened bore portion comprising the retaining means.

15. The connector recited in claim 1, wherein the passage comprises a generally longitudinal bore extending from the top end through to a bottom end of the inner member, and wherein the exit portal comprises at least one side portal extending radially inward from a side wall to communicate with the inner member bore.

16. The connector recited in claim 15, wherein the side portal comprises a pair of generally radially opposed side portals.

17. A device for affixing at least one piece of flexible, elongated material at a surgical site, the device comprising a connector and a rod, the connector comprising:

an outer member having a longitudinal bore extending from a top end;

an inner member movable between an open position and a locked position in engagement with the outer member, the inner member having;

a central portion dimensioned to permit passage into the outer member bore; and

a passage extending from a top end to an exit portal, the passage dimensioned to permit a piece of flexible material to pass therethrough; and

means for retaining at least a portion of the inner member within the outer member bore when in the locked position, wherein an outer surface of the inner member and an inner surface of the outer member are closely opposed;

wherein in the locked position a serpentine path is provided for the piece of material comprising an insertion through the inner member passage, a proceeding generally upward between the inner member outer surface and the outer member inner surface, and an exit between the inner member top end and the outer member top end;

the serpentine path, the retention of the inner member portion within the outer member bore, and the dimensioning adapted to retain the piece of material in a desired position;

the rod frangibly affixed to a bottom end of the inner member, the rod having a diameter adapted to slide within the outer member bore, the rod for retaining the inner member stationary while the outer member is moved upward to force the inner member into the locked position.

18. The device recited in claim 17, wherein the rod has a means for mating with a stationary portion of a driver.

19. The device recited in claim 18, wherein the mating means comprises a threaded screw section adjacent a bottom end adapted to mate with a correspondingly dimensioned grooved section on the stationary portion of a driver.

20. The device recited in claim 17, wherein the rod further has a groove extending from a top end, the groove in communication with the exit portal and dimensioned to permit the piece of material to reside therein, the groove for facilitating a loading of the piece of material onto the connector with the inner member in the open position.

21. The device recited in claim 17, wherein the rod has a diameter adapted to closely engage at least a portion of the outer member bore, for retaining the outer member in position adjacent the inner member bottom end prior to snap fit formation.

22. A device for affixing at least one piece of flexible, elongated material at a surgical site, the device comprising a connector, a rod, and a support member, the connector comprising:

an outer member having a longitudinal bore extending from a top end;

an inner member movable between an open position and a locked position in engagement with the outer member, the inner member having;

a central portion dimensioned to permit passage into the outer member bore; and

a passage extending from a top end to an exit portal, the passage dimensioned to permit a piece of flexible material to pass therethrough; and

means for retaining at least a portion of the inner member within the outer member bore when in the locked position, wherein an outer surface of the inner member and an inner surface of the outer member are closely opposed;

wherein in the locked position a serpentine path is provided for the piece of material comprising an insertion through the inner member passage, a proceeding generally upward between the inner member outer surface and the outer member inner surface, and an exit between the inner member top end and the outer member top end;

the serpentine path, the retention of the inner member portion within the outer member bore, and the dimensioning adapted to retain the piece of material in a desired position;

the rod frangibly affixed to a bottom end of the inner member, the rod having a diameter adapted to slide within the outer member bore, the rod for retaining the inner member stationary while the outer member is moved upward to place the inner member in the locked position;

the support member having;

a longitudinal bore extending from a top end to a bottom end and having a diameter dimensioned to permit the rod to slide therewithin;

means adjacent the top end for supporting the outer member in a fixed location relative thereto;

wherein a sliding of the support member upward relative to the rod achieves a movement of the inner member into the locked position.

23. The device recited in claim 22, wherein the support member further has means adjacent the bottom end for mating with a movable portion of a driver and the rod further has means adjacent a bottom end for mating with a stationary portion of a driver for permitting remote relative movement therebetween, for achieving the locking position.

24. The device recited in claim 23, wherein the rod mating means comprises a threaded screw section adjacent the bottom end adapted to mate with a correspondingly dimensioned grooved section on the stationary portion of a driver.

25. The device recited in claim 24, wherein the support member mating means comprises a grooved section within the bore adjacent the bottom end adapted to mate with a correspondingly dimensioned threaded screw section on the movable portion of a driver.

26. The device recited in claim 22, wherein the support member bore has a widened section adjacent the top end dimensioned to permit the outer member to reside therein, the support means thereby comprising the bore widened section.

27. A method for affixing a piece of flexible material at a surgical site, the method comprising the steps of:

passing a piece of flexible material through a passage in a generally cylindrical inner member;

inserting the inner member into a bore of a generally cylindrical outer member, the inner member dimensioned to closely engage the outer member bore, the flexible material proceeding between the inner member outer surface and the outer member inner surface to form a serpentine pathway; and

retaining at least a portion of the inner member within the outer member bore to form a locked position therebetween.

28. The method recited in claim 27, wherein the inner member is frangibly affixed adjacent a bottom end to a rod, and further comprising the steps of:

supporting the inner member during the inserting step; and

breaking the rod away from the inner member following the inserting step.

29. The method recited in claim 28, further comprising the step of supporting the outer member during the inserting step within a recess at a top end of a generally cylindrical support member having a bore dimensioned to permit the rod to slide therewithin.

30. The method recited in claim 27, further comprising the step, following the retaining step, of releasing the connector from the locked position by pulling on an end of the flexible material to force the inner member out of the outer member bore.

31. A connector for affixing at least one piece of flexible, elongated material at a surgical site, the connector comprising:

a locking member;

an outer member having means for receiving an engagement portion of the locking member, the locking member movable between a disengaged position and a locked position in cooperation with the receiving means; and

means for causing a piece of flexible material to achieve a nonlinear path adjacent the locking member receiving means, wherein when the locking member is in the locked position the flexible material piece is retainable along the nonlinear path against movement between the locking member and the outer member, the causing means further adapted to permit a placement and a locking of the outer member and the locking member at a desired surgical site in a generally collinear fashion with the flexible material piece.

33. The connector recited in claim 31, wherein the locking member receiving means comprises at least a partial bore in the outer member.

34. The connector recited in claim 31, wherein the permitting means comprises means for engaging the flexible material piece with the locking member, and wherein the receiving means and the permitting means comprise means for changing an orientation of a portion of the flexible member piece into a nonlinear path during a movement of the locking member from the disengaged position to the locked position.

35. The connector recited in claim 31, wherein the permitting means comprises means for engaging the flexible material piece with the locking member, the engaging means adapted to permit a sliding of the locking member along the flexible piece to achieve the collinear placement.

32. A connector for affixing at least one piece of flexible, elongated material at a surgical site, the connector comprising:

a locking member;

an outer member having means for receiving an engagement portion of the locking member comprising a depression in the outer member adapted to receive a portion of the locking member in locking engagement therewith, the locking member movable between a disengaged position and a locked position in cooperation with the receiving means; and

means for causing a piece of flexible material to achieve a nonlinear path adjacent the locking member receiving means, wherein when the locking member is in the locked position the flexible material piece is retainable along the nonlinear path against movement between the locking member and the outer member, the causing means further adapted to permit a placement and a locking of the outer member and the locking member at a desired surgical site in a generally collinear fashion with the flexible material piece.

36. A connector for affixing at least one piece of flexible, elongated material at a surgical site, the connector comprising:

a locking member having an engagement portion and a top portion and further having a passage therethrough dimensioned for permitting a piece of flexible material to pass therethrough, the passage having an outlet at least partially within the engagement portion;

means for slidably engaging the flexible material piece with the locking member, for permitting a placement of the locking member at a desired surgical site in a generally collinear fashion with the flexible member piece; and

an outer member having means for receiving the engagement portion of the locking member and for preventing a passage of the locking member top portion thereinto, the locking member movable between a disengaged position and a locked position in cooperation with the receiving means, the receiving means further having means for changing an orientation of the flexible material piece, for tightening the flexible material piece when the locking member is moved to the locked position, such a movement causing the passage outlet to be at least partially in engagement with the outer member, thereby compressing a section of the flexible material piece emerging from the passage outlet between the locking member and the outer member to achieve retention of the flexible member piece against movement.

37. The connector recited in claim 36, wherein the flexible member section is reoriented during compression into a path noncollinear with an axis through the passage, thereby enhancing retention against disengagement.