Minimally invasive valve repair procedure and apparatus

• US 7,744,611 B2
• Filed: 11/19/2003
• Issued: 06/29/2010
• Est. Priority Date: 10/10/2000
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Hill, Arthur, Nguyen, John D., Schaller, Laurent
• Primary Examiner(s): Woo; Julian W
• Application Number:
  US10/718,236
• Publication Number:
  US 20040111099A1
• Time in Patent Office: 2,414 Days
• Field of Search: 60410101-10203, 606/72, 606/75, 606/219, 606/220, 606/232, 606/233, 606/142, 606/224, 606/153, 623/1.47
• US Class Current: 606/151
• 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 it is 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. They are designed such that the slit can grab the needle tightly or release it as the inner member is moved backward or forward with respect to the outer tube. With the needle secured at the front, the needle holder is passed through a cannula inserted through an incision and the needle penetrates the leaflets such that the clip can be positioned with its end points hooked to the pair of leaflets to be stitched together. If the clip is released from the suture thereafter, it tends to coil up, reducing the distance between the end points and pulling the leaflets together. A double-arm clip assembly with each of the end points of the clip attached through a suture to a separate needle may be similarly used for valve repair. Such a double-arm clip assembly may contain two of such clips mutually connected by means of a flexible connector such that two leaflets are held together by the connector, with the two clips each anchored to a corresponding one of the leaflets.

Claims

1. A clip assembly comprising:

two clips each having two end points, a proximal end point and a distal end point, the proximal end point and the distal end point being separated from each other when said clip is held in an open configuration and tending to return to a naturally closed configuration wherein the distance between said proximal end point and said distal end point is reduced;

two tissue penetrating needles each releasably connected to one of said two end points of a corresponding one of said two clips through a flexible member; and

a flexible connector connecting the other end points of said two clips together.

2. The clip assembly of claim 1 wherein said clips comprise a wire made of a shape memory material.

3. The clip assembly of claim 1 further comprising releasing means for normally keeping the two clips in the open configuration and releasing each of the two clips to become separated from the associated flexible member to thereby allow the clips to begin returning to the closed configuration.

4. The clip assembly of claim 1 wherein each of said clips further comprise a stopper connected to one of said two end points of said clip.

5. The clip assembly of claim 1 wherein the flexible connector comprises a suture.

6. The clip assembly of claim 1 wherein the flexible connector comprises a metal wire.

7. A clip assembly comprising:

two clips each having two end points which are separated from each other when said clips are in an open configuration and tending to return to a naturally closed configuration by reducing distance between said end points when the clip is in said open configuration;

two tissue penetrating needles each connected to one of said two end points of a corresponding one of said two clips through a flexible member; and

a flexible connector connecting the other end points of said two clips together; and

releasing means for normally keeping said two clips in said open configuration and releasing each of said two clips to become separated from the associated flexible member to thereby allow said clips to begin returning to said closed configuration.

8. The clip assembly of claim 7 wherein the clips comprise a wire made of a shape memory material.

9. The clip assembly of claim 7 wherein each of said clips further comprise a stopper connected to one of said two end points of said clip.

10. The clip assembly of claim 7 wherein the flexible connector comprises a suture.

11. The clip assembly of claim 7 wherein the flexible connector comprises a metal wire.

12. A minimally invasive method of holding two tissue parts together, said method comprising the steps of:

providing a clip assembly which comprises two clips each having two end points which are separated from each other when said clips are in an open configuration and tending to return to a naturally closed configuration by reducing distance between said end points when the clip is in said open configuration, two tissue penetrating needles each releasably connected to one of said two end points of a corresponding one of said two clips through a flexible member, and a flexible connector connecting the other end points of said two clips together;

penetrating and completely pulling one of the needles through a tissue part and penetrating and completely pulling the other of the needles through an adjacent tissue part while said clips are each in said open configuration;

pulling the needles until each of said clips is hooked to a corresponding one of the tissue parts; and

allowing said clips to start to return to said naturally closed configuration, whereby said two tissue parts are held together by said flexible connector stretched between said clips.

13. The method of claim 12 wherein said clips comprise a wire made of a shape memory material.

14. The method of claim 12 wherein said flexible connector forms a loop when stretched between said clips.

15. A minimally invasive method of holding two tissue parts together, said method comprising the steps of:

providing a clip assembly which comprises two clips each having two end points which are separated from each other when said clips are in an open configuration and tending to return to a naturally closed configuration by reducing distance between said end points when the clip is in said open configuration, two tissue penetrating needles each connected to one of said two end points of a corresponding one of said two clips through a flexible member, and a flexible connector connecting the other end points of said two clips together;

penetrating and completely pulling one of the needles through a tissue part and penetrating and completely pulling the other of the needles through an adjacent tissue part while said clips are each in said open configuration;

pulling the needles until each of said clips is hooked to a corresponding one of the tissue parts; and

allowing said clips to start to return to said naturally closed configuration, whereby said two tissue parts are held together by said flexible connector stretched between said clips;

wherein said clip assembly further comprises releasing means for normally keeping said two clips in said open configuration and releasing each of said two clips to become separated from the associated flexible member to thereby allow said clips to begin returning to said closed configuration, and wherein said clips are allowed to start to return to said naturally closing configuration by separating said clips from said needles through said releasing means.

16. The method of claim 15 wherein said clips comprise a wire made of a shape memory material.

17. The method of claim 15 wherein said flexible connector forms a loop when stretched between said clips.