Minimally invasive annuloplasty procedure and apparatus

• US 20030074012A1
• Filed: 04/10/2002
• Published: 04/17/2003
• Est. Priority Date: 10/10/2000
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Coalescent Surgical Inc. (Medtronic Plc)
• Inventors: Nguyen, John D., Schaller, Laurent, Hill, Arthur
• Granted Patent: US 6,921,407 B2
• Time in Patent Office: Days
• US Class Current: 606/139
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

Clips of a self-closing type are used in annuloplasty procedures. Each 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 naturally closed configuration if the constraint is removed. A plurality of such clips in open configurations penetrate the tissue around the annulus circumferentially and then the constraint keeping them in the open configuration is removed such that they pull the tissue together between their two end points and this tends to reduce the diameter of the annulus. Such clips may be deployed each in the form of a clip assembly, having at least one of its end points connected to a needle through a flexible member and a release mechanism by which the clip can be easily released. The needle is caused to penetrate the tissue at one position and to come out therefrom at another circumferentially separated positions. Alternatively, a clip delivery device may be used with a plurality of such clips loaded to a clip-holder serving to keep them in open configurations. A pusher pushes the loaded clips out of the device one at a time. Self-closing clips can be used efficiently also in ring annuloplasty and valve replacement procedures.

Claims

1. An annuloplasty method comprising:

providing clips each 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 said end points when in said open configuration; and

placing said clips around an annulus by causing both of the two end points of each of said clips in said open configuration to penetrate tissue of said annulus at two circumferentially separated positions, whereby said clips reduce diameter of said annulus.

2. The method of claim 1 wherein one of said two end points of each of said clips is connected through a flexible member to a tissue-piercing needle and said clips are placed around the annulus each by causing the associated one of the needles connected thereto to penetrate the tissue at one position and to come out thereof at another position which is circumferentially separated from said one position.

3. The method of claim 1 wherein said clips are loaded in a clip delivery device, a specified number of said clips being pushed out of said delivery device at a time, each of said clips having both end points thereof to penetrate said tissue simultaneously.

4. The method of claim 1 wherein said clips are each generally U-shaped when in said open configuration, comprising a wire of a shape memory material.

5. A clip delivery device for annuloplasty, said device comprising:

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

a clip-holder supporting said clips in said open configuration; and

a pusher for pushing a specified number of said clips at a time by causing said two end points thereof to leave said device simultaneously together.

6. The device of claim 5 further comprising an outer tube extending in a longitudinal direction and having an elongated slit at one end, said pusher being elongated and adapted to slide in said longitudinal direction inside said outer tube and to thereby push said specified number of clips at a time through said slit.

7. The device of claim 6 wherein said clip-holder comprises:

a pair of cylindrical cartridges coaxially disposed with a gap therebetween and adjacent said slit, said clips being mounted in said open configuration to said cartridges, said gap being wide enough to allow only said specified number of said clips to pass therethrough at a time to be pushed out of said device together; and

a pair of springs for pushing said clips over and along said cartridges towards said gap.

8. The device of claim 5 wherein said clips are each generally U-shaped when in said open configuration, comprising a wire of a shape memory material.

9. A mitral valve repair method comprising:

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

placing an annuloplasty ring about an annulus; and

attaching said ring around said annulus by causing said clips to pass through said ring and annulus and moving the clips toward said closed configuration.

10. The repair method of claim 9 wherein said clips are attached to said ring in circumferential directions along said ring.

11. The repair method of claim 9 wherein each of said clips has a tissue-penetrating needle releasably attached through a flexible member to one of said two end points thereof and said step of attaching said ring comprises the steps of:

causing the needle associated with said each clip to penetrate and pass through said ring and tissue of said annulus; and

thereafter pulling said flexible member to position said each clip so as to hold said ring to said tissue.

12. The repair method of claim 11 wherein said needle is caused to pass through said ring at two positions separated by a shorter distance, to penetrate said tissue at one position and to come out therefrom at another position separated from said one position by a larger distance than said shorter distance.

13. The repair method of claim 9 wherein said clips are each generally U-shaped when in said open configuration, comprising a wire of a shape memory material.

14. The repair method of claim 9 wherein each of said clips has a tissue-penetrating needle releasably attached through a flexible member to each of said two end points thereof and attaching said ring comprises:

causing each of the needles of each of said clips to penetrate and come out of the annulus and to pass through said ring; and

thereafter pulling the flexible members to position said each clip so as to hold said ring to said tissue.

19. The method of claim 9 wherein each of said clips is passed through said ring and annulus in a radial direction.

15. A mitral valve replacement method comprising:

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

removing mitral valve portions to be replaced;

placing a prosthesis sewing cuff therefor where said valve portions have been removed;

attaching said prosthesis sewing cuff to a tissue around said removed valve portions by causing said clips to penetrate both said prosthesis sewing cuff and said tissue.

16. The replacement method of claim 15 wherein each of said clips has a tissue-penetrating needle releasably attached through a flexible member to one of said two end points thereof and attaching said prosthesis sewing cuff comprises:

causing the needle associated with said each clip to penetrate and pass through said prosthesis sewing cuff and tissue of said annulus; and

thereafter pulling said flexible member to position said each clip so as to hold said prosthesis sewing cuff to said tissue.

17. The replacement method of claim 15 wherein each of said clips has a tissue-penetrating needle releasably attached through a flexible member to each of said two end points thereof and attaching said prosthesis sewing cuff comprises:

causing the needle associated with said each clip to penetrate and pass through said prosthesis sewing cuff and tissue of said annulus; and

thereafter pulling said flexible member to position said each clip so as to hold said prosthesis sewing cuff to said tissue.

18. The replacement method of claim 15 wherein said clips are each generally U-shaped when in said open configuration, comprising a wire of a shape memory material.