Minimally invasive valve repair procedure and apparatus

• US 7,914,544 B2
• Filed: 12/07/2004
• Issued: 03/29/2011
• Est. Priority Date: 10/10/2000
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Nguyen, John D., Hill, Art, Schaller, Laurent
• Primary Examiner(s): Woo; Julian W
• Assistant Examiner(s): Ou; Jing Rui
• Application Number:
  US11/007,825
• Publication Number:
  US 20050101975A1
• Time in Patent Office: 2,303 Days
• Field of Search: 606/151, 606/139, 606/142, 606/148, 606/213, 606/227, 606/228, 606/232
• US Class Current: 606/157
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/06009 having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve

Abstract

A clip of a self-closing type is used for valve repair. The clip is generally U-shaped with two end points separated from each other when constrained to be in an open configuration, but tends to coil up to assume its natural closed configuration if the constraint is removed. At least one end point is connected through a suture to a tissue-penetrating needle. A needle holder has an outer tube and an inner member which has a slit at the front and is slidable inside the outer tube. A double-arm clip assembly with each of the end points of the clip attached through a suture to a separate needle may be used for valve repair and may contain two of such clips mutually connected by a flexible connector whereby two leaflets are held together by the connector, with the two clips each anchored to a corresponding one of the leaflets.

Claims

1. Apparatus for minimally invasive valve repair, the apparatus comprising:

a tissue penetrating needle, a flexible member, and a clip, the tissue penetrating needle being connected through the flexible member to the clip, the clip having two end points which are separated from each other when the clip is in an open configuration and tending to return to a naturally closed configuration by reducing distance between the end points when in the open configuration;

a needle holder including an outer tube and an inner member which has a front end adapted to grab the needle and is slidable inside the outer tube;

a release mechanism attached to one of the end points of the clip to releasably connect the flexible member to the clip.

2. The apparatus of claim 1 wherein the clip is generally U-shaped when in the open configuration.

3. The apparatus of claim 1 wherein the clip comprises a wire made of shape memory material.

4. The apparatus of claim 1 wherein the clip in the closed configuration is looped by more than 360°

.

5. Apparatus for minimally invasive valve repair, the apparatus comprising:

a tissue penetrating needle, a flexible member, and a clip, the tissue penetrating needle being connected through the flexible member to the clip, the clip having two end points which are separated from each other when the clip is in an open configuration and tending to return to a naturally closed configuration by reducing distance between the end points when in the open configuration;

a needle holder including an outer tube and an inner member which has a front end adapted to grab the needle and is slidable inside the outer tube, the needle holder further including a spring which is disposed inside the outer tube and serves to apply a biasing force on the inner member backward away from the front end; and

a release mechanism attached to one of the end points of the clip to releasably connect the flexible member to the clip.

6. The apparatus of claim 5 wherein the front end of the inner member has a slit for accepting and grabbing the needle therein.

7. The apparatus of claim 6 wherein the outer tube, the inner member and the slit are designed such that the slit opens wide enough to accept the needle therein and to release the needle therefrom when the inner member is pushed forward against the biasing force and the slit becomes narrower and firmly grips the needle therein when the inner member is moved backward.

8. The apparatus of claim 5 wherein the clip is generally U-shaped when in the open configuration.

9. The apparatus of claim 5 wherein the clip comprises a wire made of shape memory material.

10. The apparatus of claim 5 including a second needle and a second flexible member coupled to the second needle, wherein each flexible member is connected to one of the two end points of the clip.

11. The apparatus of claim 10 including a second release mechanism to releasably connect the second flexible member to the clip.

12. Apparatus for minimally invasive valve repair, the apparatus comprising:

a tissue penetrating needle, a flexible member, and a clip, the tissue penetrating needle being connected through the flexible member to the clip, the clip having a first end point and a second end point which are separated from each other when the clip is in an open configuration and tending to return to a naturally closed configuration by reducing distance between the end points when in the open configuration, wherein the clip in the closed configuration is looped by more than 360°

; and

a needle holder including an outer tube and an inner member which has a front end adapted to grab the needle and is slidable inside the outer tube; and

a release mechanism attached to the first end point of the clip to releasably connect the flexible member to the clip.

13. The apparatus of claim 12 wherein the needle holder further includes a spring which is disposed inside the outer tube and serves to apply a biasing force on the inner member backward away from the front end.

14. The apparatus of claim 13 wherein the front end of the inner member has a slit for accepting and grabbing the needle therein.

15. The apparatus of claim 14 wherein the outer tube, the inner member and the slit are designed such that the slit opens wide enough to accept the needle therein and to release the needle therefrom when the inner member is pushed forward against the biasing force and the slit becomes narrower and firmly grips the needle therein when the inner member is moved backward.

16. The apparatus of claim 12 wherein the clip is generally U-shaped when in the open configuration.

17. The apparatus of claim 12 wherein the clip comprises a wire made of shape memory material.

18. The apparatus of claim 12 including a second needle and a second flexible member coupled to the second needle, wherein each flexible member is connected to one of the two end points of the clip.

19. The apparatus of claim 18 including a second release mechanism attached to the second end point of the clip to releasably connect the second flexible member to the clip.