Minimally invasive repair of a valve leaflet in a beating heart

• US 10,507,018 B2
• Filed: 06/20/2014
• Issued: 12/17/2019
• Est. Priority Date: 10/18/2007
• Status: Active Grant

• Current Assignee: NeoChord, Inc.
• Original Assignee: NeoChord, Inc.
• Inventors: Zentgraf, John
• Primary Examiner(s): Tanner, Jocelin C
• Application Number:
  US14/310,069
• Publication Number:
  US 20140364875A1
• Time in Patent Office: 2,006 Days
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/2926 Details of heads or jaws
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/3614 using optical fibre

Abstract

A device for performing minimally invasive repair of mitral valve leaflets in a beating heart through the delivery and implantation of artificial chordae tendineae includes a handle for positioning the device into a chest cavity of the patient, a capture assembly adapted to capture a valve leaflet between distal an proximal tip portions, a needle adapted to penetrate the valve leaflet, and a capture confirmation system for verifying capture of the valve leaflet between the distal and proximal tip portions.

Claims

1. A device for repairing a valve leaflet in a beating heart of a patient, comprising:

a handle assembly including a shaft extending from a distal end of the handle and adapted to be extended into a chest cavity of the patient, the shaft including a suture channel extending longitudinally through the shaft adapted to receive a suture and a needle channel extending longitudinally through the shaft generally axially parallel with the suture channel;

a capture assembly extending from a distal portion of the shaft and adapted to be positioned within the beating heart, the capture assembly having a clamping mechanism including a proximal clamping jaw defining a distally facing clamping surface and a distal clamping jaw movable with respect to the proximal clamping jaw and defining a proximally facing clamping surface; and

a needle adapted to be slidably positioned within the needle channel, the needle channel having a needle opening defined proximate where the needle channel terminates at the distally facing clamping surface defined by the proximal clamping jaw,

the distal clamping jaw including a jaw suture channel extending at least partially around the distal clamping jaw, a needle lumen extending into the proximally facing clamping surface and aligned with the needle opening, and a suture groove extending across the needle lumen,

such that when a suture is extended through the suture channel of the shaft, around the jaw suture channel of the distal clamping jaw and along the suture groove, the needle can be selectively advanced distally out of the needle opening at the proximal clamping jaw and past the suture positioned in the suture groove into the needle lumen without dislodging the suture from the suture groove and retracted proximally to engage the suture and remove the suture from the suture groove.

2. The device of claim 1, wherein the suture groove retains the suture in a substantially taut configuration across the needle lumen.

3. The device of claim 1, wherein the jaw suture channel of the distal clamping jaw intersects the suture groove at opposing ends of the suture groove.

4. The device of claim 1, wherein the needle includes a proximally facing hook for capturing the suture.

5. The device of claim 4, wherein the needle is adapted to be advanced past the suture without dislodging the suture from the suture groove and retracted proximally to capture the suture with the hook with the needle in a single rotational orientation.

6. The device of claim 1, wherein a distal portion of the needle presents an inclined ramp surface.

7. The device of claim 1, wherein a distal tip of the needle is generally blunted.

8. The device of claim 1, wherein the suture channel of the shaft is at least partially enclosable within the shaft.

9. A handheld suture deployment device adapted to deliver and manipulate a suture in a beating heart of a patient, comprising:

a shaft including a needle channel extending longitudinally through the shaft, wherein the shaft defines a proximal clamping jaw of a jaw assembly and the needle channel terminates at a clamping face of the proximal clamping jaw to define a needle opening at the clamping face;

a suture cartridge removably coupleable with the shaft, the suture cartridge including a suture channel adapted to receive a suture and generally axially parallel with the needle channel when the shaft is coupled with the suture cartridge, the suture cartridge further defining a distal clamping jaw of the jaw assembly having a clamping face that is longitudinally movable with respect to the proximal clamping jaw; and

a needle adapted to be slidably positioned within the needle channel, and wherein

the distal clamping jaw includes a jaw suture channel extending at least partially circumferentially around the distal clamping jaw, a needle lumen extending into the clamping face of the distal clamping jaw and aligned with the needle opening, and a suture groove extending across the needle lumen,

such that when a suture is extended through the suture channel of the suture cartridge, around the jaw suture channel of the distal clamping jaw and along the suture groove, the needle can be selectively advanced distally out of the needle opening of the shaft and past the suture positioned in suture groove into the needle lumen without dislodging the suture from the suture groove and retracted proximally to engage the suture and remove it from the suture groove.

10. The device of claim 9, wherein the suture groove retains the suture in a substantially taut configuration across the needle lumen.

11. The device of claim 9, wherein the jaw suture channel of the distal clamping jaw intersects the suture groove at opposing ends of the suture groove.

12. The device of claim 9, wherein the needle includes a proximally facing hook for capturing the suture.

13. The device of claim 12, wherein the needle is adapted to be advanced past the suture without dislodging the suture from the suture groove and retracted proximally to capture the suture with the hook with the needle in a single rotational orientation.

14. The device of claim 9, wherein a distal portion of the needle presents an inclined ramp surface.

15. The device of claim 9, wherein a distal tip of the needle is generally blunted.

16. The device of claim 9, wherein the suture channel of the suture cartridge is at least partially enclosable between the shaft and the suture cartridge.

17. A handheld suture deployment device adapted to deliver and manipulate a suture in a beating heart of a patient, comprising:

a device shaft including a needle channel extending longitudinally through the device shaft, wherein the device shaft defines a proximal clamping jaw of a jaw assembly and the needle channel terminates at a clamping face of the proximal clamping jaw to define a needle opening at the clamping face;

a suture cartridge having a suture shaft removably coupleable with the device shaft to be slideable with respect to the device shaft, the suture cartridge including a suture channel adapted to receive a suture that is generally axially parallel with the needle channel and at least partially enclosed by the device shaft when the device shaft is coupled with the suture cartridge, the suture cartridge further defining a distal clamping jaw of the jaw assembly having a clamping face that is longitudinally movable with respect to the proximal clamping jaw; and

a needle adapted to be slidably positioned within the needle channel, and wherein

the distal clamping jaw includes a needle lumen extending into the clamping face of the distal clamping jaw and aligned with the needle channel, the distal clamping jaw adapted to retain the suture in a substantially taut configuration across a path of travel of the needle from the needle opening in the clamping face of the device shaft to the needle lumen of the distal clamping jaw.

18. The device of claim 17, wherein the distal clamping jaw is configured to retain the suture as the needle is advanced past the suture into the needle lumen and to enable the suture to be grasped by the needle and removed from the distal clamping jaw when the needle is retracted proximally towards the needle channel in the device shaft.

19. The device of claim 18, wherein the needle includes a proximally facing hook for capturing the suture.

20. The device of claim 17, wherein a distal portion of the needle presents an inclined ramp surface.

21. The device of claim 17, wherein a distal end of the needle is generally blunted.