MINIMALLY INVASIVE REPAIR OF A VALVE LEAFLET IN A BEATING HEART

• US 20090105751A1
• Filed: 10/20/2008
• Published: 04/23/2009
• Est. Priority Date: 10/18/2007
• Status: Active Grant

• Current Assignee: NeoChord, Inc.
• Original Assignee: NeoChord, Inc.
• Inventors: Zentgraf, John
• Granted Patent: US 8,758,393 B2
• Time in Patent Office: Days
• US Class Current: 606/206
• 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 tendinae 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 adapted to be extended into a chest cavity of the patient and an actuator mechanism positioned proximate a proximal end of the handle assembly, the shaft having a diameter and a generally circular cross-section along a longitudinal axis at a distal portion of the shaft that is adapted to pass through an incision in the beating heart;

a capture assembly extending from the distal portion of the shaft and adapted to be positioned within the beating heart, the capture assembly having a distal portion including a clamping mechanism adapted to grasp and release the valve leaflet and a proximal portion operably connected to the shaft, the distal portion of the capture assembly having a maximum diameter of an asymmetric cross section transverse to the longitudinal axis of the capture assembly that is greater than the diameter of the shaft, wherein one of a first clamping jaw or a second clamping jaw of the clamping mechanism is selectively positionable along a longitudinal axis of the capture assembly in response to actuation of the actuator mechanism to create a space between interior surfaces of the first clamping jaw and the second clamping jaw having an asymmetric perimeter; and

a needle head slidably positionable within the capture assembly to engage a suture at least partially carried by the capture assembly in response to selective activation of a needle by the actuator mechanism as the needle penetrates the valve leaflet,

such that an area of the interior surfaces is increased relative to an interior surface area of a circular clamping jaw having a diameter equal to the diameter of the shaft and the capture assembly is rotatable within the heart with reduced blood loss relative to blood loss of rotation of the asymmetric perimeter of the first clamping jaw and the second clamping jaw in the incision of the heart.

2. The device of claim 1, wherein the first clamping jaw and the second clamping jaw are separable along a bifurcation plane, the bifurcation plane forming a bifurcation angle with the longitudinal axis of the capture assembly, the bifurcation angle being between approximately forty-five degrees and ninety degrees.

3. The device of claim 2, wherein the bifurcation angle is between approximately fifty-five degrees and approximately sixty-five degrees.

4. The device of claim 1, wherein the area of the interior surfaces is increased relative to the interior surface area of a circular clamping jaw having a diameter equal to the diameter of the shaft by between 20% and 100%.

5. The device of claim 4, wherein the area of the interior surfaces is increased relative to the interior surface area of a circular clamping jaw having a diameter equal to the diameter of the shaft by between 30% and 50%.

6. The device of claim 1, wherein the diameter of the shaft is less than 9 mm.

7. The device of claim 1, wherein the space between interior surfaces of the first clamping jaw and the second clamping jaw of the distal tip portion when positioned in an open position provides a distance along the longitudinal axis of the capture assembly between interior surfaces of the first clamping jaw and the second clamping jaw of between 1 and 5 cm.

8. The device of claim 7, wherein the distance along the longitudinal axis of the capture assembly between interior surfaces of the first clamping jaw and the second clamping jaw is between 2 and 3 cm.

9. The device of claim 1, wherein the capture assembly is configured to penetrate the valve leaflet with the needle head from a distance of between approximately one millimeter and four millimeters from a leading edge of the valve leaflet.

10. The device of claim 1, wherein the distal portion of the shaft is isodiametric and the proximal portion of the capture assembly includes a tapered region having cross sections that transition from a substantially circular cross section of the distal portion of the shaft to the asymmetric perimeter of the first clamping jaw and the second clamping jaw.

11. The device of claim 2, wherein the distal portion of the capture assembly has a generally oblong asymmetric egg three dimensional shape, with the bifurcation angle approximately 60 degrees and the asymmetric perimeter of the first clamping jaw and the second clamping jaw generally loaf shaped cross section.

38. A method of repairing a valve leaflet in a beating heart of a patient by using any of the devices of claims 1-37.

39. A method of providing instruments and instructions for repairing a valve leaflet comprising:

providing the devices of claims 1-37; and

providing instructions for operating the devices of claims 1-37 to repair the valve leaflet.

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

a shaft having a proximal end outside the patient and a distal end adapted for insertion into the beating heart of the patient;

a handle with an actuator operably connected to the proximal end of the shaft;

a capture assembly adapted to penetrate the beating heart, the capture assembly being operably coupled to the distal end of the shaft and including a bifurcated tip adapted to grasp the valve leaflet in response to selective actuation of the actuator; and

a needle slidably positionable within the capture assembly to penetrate the valve leaflet;

wherein the shaft is generally isodiametric and the capture assembly has a cross sectional perimeter that is asymmetric at the bifurcated tip and a maximum diameter of the cross sectional perimeter at the bifurcated tip that is greater than a diameter of a portion of the shaft adapted to be positioned proximate a wall of the beating heart.

13. The device of claim 12, wherein the handle includes a first actuator extending generally outwardly the handle for lateral operation and a second actuator generally axially along the handle for inline operation.

14. The device of claim 13, wherein the first actuator extending is operably connected to the needle assembly and the second actuator is operably connected to the capture assembly.

15. The device of claim 12, wherein the handle defines a first and second spaced-apart aperture and the actuator defines a third aperture, the first, second, and third apertures being adapted to receive fingers of an operator.

16. The device of claim 12, wherein the handle and the actuator are adapted for robotic control.

17. The device of claim 16, wherein the robotic control is performed by a multi-axis control system.

18. The device of claim 17, wherein the capture assembly includes a pivot joint, the pivot joint being operably controllable by the multi-axis control system.

19. The device of claim 18, wherein the capture assembly is pivotable about at least two axes of rotation.

20. 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 adapted to be extended into a chest cavity of the patient and an actuator mechanism positioned proximate a proximal end of the handle assembly;

a capture assembly extending from the distal portion of the shaft and adapted to be positioned within the beating heart, the capture assembly having a distal portion including a clamping mechanism adapted to grasp and release the valve leaflet and a proximal portion operably connected to the shaft, wherein one of a first clamping jaw or a second clamping jaw of the clamping mechanism is selectively positionable along a longitudinal axis of the capture assembly in response to actuation of the actuator mechanism to create a space between interior surfaces of the first clamping jaw and the second clamping jaw having an asymmetric perimeter, the capture assembly further including a plurality of pairs of fiber optic fibers, each pair of fibers having a transmission fiber and a return fiber terminated on a distal end at an interior surface of the clamping mechanism where the fiber extends through the shaft and out of the handle assembly to a proximal end beyond the handle assembly; and

a needle head slidably positionable within the capture assembly to engage a suture at least partially carried by the capture assembly in response to selective activation of a needle by the actuator mechanism as the needle penetrates the valve leaflet, and

a capture confirmation system that verifies capture of the valve leaflet in the space between the interior surfaces of the first clamping jaw and the second clamping jaw, the capture confirmation system including a housing separate from the handle assembly that contains a battery powered optical light source in optical communication with a proximal end of each transmission fiber and at least one lens visible from an exterior surface of the housing and in optical communication with a proximal end of each return fiber to display light received from the space between the interior surfaces of the first clamping jaw and the second clamping jaw corresponding to the distal end of each return fiber as an indication of whether there is capture of the valve leaflet by the capture assembly.

21. The device of claim 20, wherein the capture confirmation system provides a binary indication of whether the valve leaflet is grasped between the interior surfaces of the first clamping jaw and the second clamping jaw by displaying a first color when a surface of the valve leaflet confronts the fiber optic pairs at the interior surfaces and a second color when the valve leaflet does not confront the fiber optic pairs at the interior surfaces.

22. The device of claim 21, wherein the first color is indicative of blood and the second color is indicative of valve leaflet.

23. The device of claim 20, wherein the optical light source is a light-emitting diode (LED), and wherein the proximal end of the transmission fiber is positioned less than 0.5 cm from the LED.

24. The device of claim 23, wherein the proximal end of the transmission fiber is positioned 0.1 cm and 0.2 cm from the LED

25. The device of claim 20, wherein each lens has a thickness of between approximately 0.2 cm and 0.5 cm.

26. The device of claim 25, wherein the thickness of each lens is between 0.3 cm and 0.35 cm.

27. The device of claim 20, wherein the proximal end of each return fiber is positioned within approximately three millimeters of the corresponding lens.

28. The device of claim 27, wherein the proximal end of each return fiber is position within approximately 1.5 to 2.0 millimeters of the corresponding lens.

29. The device of claim 20, wherein the shaft defines a needle lumen adapted to receive the needle and the pairs of fiber optic fibers are carried by the shaft outside the needle lumen.

30. The device of claim 20, wherein each pair of fiber optic fibers includes at least 1 m of length external to the handle such that the housing of the capture confirmation system is positionable proximal a separate patient display apparatus after insertion of the device into the chest cavity of the patient.

31. 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 first channel adapted to receive a suture and a second channel adapted to receive a needle, the handle assembly including an actuator mechanism and a suture retention mechanism;

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 distal portion including a clamping mechanism adapted to grasp and release the valve leaflet and a proximal portion operably connected to the shaft; and

a needle head slidably positionable within the capture assembly to engage the suture at least partially carried by the capture assembly in response to selective activation of the needle by the actuator mechanism as the needle penetrates the valve leaflet, wherein the suture retention mechanism selectively tensions the suture across a path of travel of the needle through the needle head prior to engagement by the needle.

32. The device of claim 31, wherein the capture assembly defines a needle detent, the suture being substantially taught across the needle detent.

33. The device of claim 32, wherein the needle head presents a hook adapted to receive the suture.

34. 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 adapted to be extended into a chest cavity of the patient and an actuator mechanism positioned proximate a proximal end of the handle assembly;

a capture assembly extending from the distal portion of the shaft and adapted to be positioned within the beating heart, the capture assembly having a distal portion including a clamping mechanism adapted to grasp and release the valve leaflet and a proximal portion operably connected to the shaft, wherein one of a first clamping jaw or a second clamping jaw of the clamping mechanism is selectively positionable along a longitudinal axis of the capture assembly in response to actuation of the actuator mechanism to create a space between interior surfaces of the first clamping jaw and the second clamping jaw; and

a needle head slidably positionable within the capture assembly to engage a suture at least partially carried by the capture assembly in response to selective activation of a needle by the actuator mechanism as the needle penetrates the valve leaflet,

wherein at least one of the handle assembly or the capture assembly includes a biasing member adapted to bias at least one of the first clamping jaw and the second clamping jaw with respect to one another such that selective actuation of the actuator mechanism overcomes the biasing member before the space is created or closed between the interior surfaces of the first clamping jaw and the second clamping jaw.

35. The device of claim 34, wherein the first clamping jaw and the second clamping jaw are biased toward a closed position.

36. The device of claim 34, wherein the biasing member exerts a force of between approximately one pounds per square-inch and ten pounds per square-inch.

37. The device of claim 36, wherein the biasing member exerts a force of approximately five pounds per square-inch.