Heart valve chordae replacement methods and apparatus

• US 8,303,622 B2
• Filed: 03/04/2008
• Issued: 11/06/2012
• Est. Priority Date: 03/14/2007
• Status: Active Grant

• Current Assignee: St Jude Medical LLC (Abbott Laboratories)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Alkhatib, Yousef F.
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): MASHACK, MARK F
• Application Number:
  US12/074,586
• Publication Number:
  US 20080228223A1
• Time in Patent Office: 1,708 Days
• Field of Search: 600102-104, 600/117, 600/308, 600/553, 600562-567, 606139-148, 606/151, 606205-209, 2271751-1821
• US Class Current: 606/205
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses

Abstract

Apparatus for attaching a prosthetic tether between a leaflet of a patient'"'"'s heart valve and another portion of the patient'"'"'s heart to help prevent prolapse of the leaflet and/or to otherwise improve leaflet function. The apparatus can be used with relatively low invasiveness of the patient'"'"'s body. The apparatus releasably clamps the leaflet during attachment of the tether to the leaflet. The apparatus may include an integrated display for indicating how extensively the leaflet is being clamped. The apparatus may include structure for stabilizing the leaflet for better clamping. The apparatus may enter the heart through an aperture in the wall of the heart, and may include structure for helping to reduce blood leakage from that aperture. The apparatus may be able to enter the heart by following a guide wire. The apparatus may include various means for attaching the tether to the leaflet.

Claims

1. Apparatus for attaching a tether between a leaflet of a patient'"'"'s heart valve and another portion of the patient'"'"'s heart, comprising:

an elongated shaft structure insertable into the patient'"'"'s heart from outside of the patient'"'"'s body, the shaft structure including first and second jaw surfaces near a distal end of the shaft structure that are movable relative to one another to admit tissue of the leaflet between the jaw surfaces and to releasably clamp the tissue between the jaw surfaces;

a handle attached to a proximal portion of the shaft structure and configured to remain outside the patient'"'"'s body at all times, the handle including an actuator for controlling motion of the jaw surfaces relative to one another, and a display for indicating where the tissue is between the jaw surfaces, the display being integrated into the handle;

a sensor for detecting tissue between the jaw surfaces, the sensor including at least one pin that extends axially along an interior of the shaft structure from the handle to an aperture in the first jaw surface, the at least one pin having a free end, an extended condition in which the free end extends from the first jaw surface by at least a minimum distance, and a recessed condition in which the free end extends from the first jaw surface by less than the minimum distance; and

circuitry operable to detect whether the at least one pin has reached the extended condition and to indicate a result of the detection on the display.

2. The apparatus defined in claim 1, wherein the display is located more distally on the handle than the actuator.

3. The apparatus defined in claim 1, wherein the display is rotatable about a longitudinal axis of the shaft structure.

4. The apparatus defined in claim 1, further comprising:

means for communicating results of the determination to the display.

5. The apparatus defined in claim 1, wherein

the at least one pin comprises a plurality of pins that extend axially along an interior of the shaft structure from the handle to a plurality of apertures in the first jaw surface, each of the plurality of pins being resiliently biased to extend to the extended condition from a respective one of the apertures;

and

the circuitry is operable to detect whether each of the plurality of pins has reached the extended condition and to indicate a result of the detection on the display.

6. The apparatus defined in claim 1, wherein the handle further includes a grip configured to be held in a hand of an operator of the apparatus, the grip being attached to at least a portion of the shaft structure so that all rotational and translational motions applied to the grip by the hand of the operator are transferred to the portion of the shaft structure.

7. The apparatus defined in claim 1, further comprising a plurality of channels extending through the shaft structure from a proximal end of the shaft structure to the distal end of the shaft structure.

8. The apparatus defined in claim 1, wherein the handle includes a plurality of ports that respectively connect to lumens that pass through the handle into the shaft structure.

9. The apparatus defined in claim 8 wherein the lumens extend longitudinally through at least a portion of the length of the shaft structure.

10. The apparatus defined in claim 9 wherein at least one of the ports and the respective lumen are configured for use in introducing a fluid into the patient.

11. The apparatus defined in claim 9 wherein at least one of the ports and the respective lumen are configured for use in introducing a wire into the patient.

12. The apparatus defined in claim 9 wherein at least one of the ports and the respective lumen are configured for use in introducing a length of suture into the patient.

13. The apparatus defined in claim 9 wherein at least one of the ports and the respective lumen are configured for use in introducing a temporary leaflet stabilization structure into the patient.

14. The apparatus defined in claim 9 wherein at least one of the ports and a respective first lumen are configured for use in introducing a needle into the patient.

15. The apparatus defined in claim 14 wherein another of the ports and a respective second lumen are configured for use in removing the needle from the patient after the needle has curved back inside the patient from the first lumen to the second lumen.

16. The apparatus defined in claim 1, wherein the at least one pin is resiliently biased to extend to the extended condition.

17. Apparatus for attaching a tether between a leaflet of a patient'"'"'s heart valve and another portion of the patient'"'"'s heart, comprising:

an elongated shaft structure insertable into the patient'"'"'s heart from outside the patient'"'"'s body, the shaft structure including first and second jaw surfaces near a distal end of the shaft structure that are movable relative to one another to admit tissue of the leaflet between the jaw surfaces and to releasably clamp the tissue between the jaw surfaces;

a handle attached to a proximal portion of the shaft structure and configured to remain outside the patient'"'"'s body at all times, the handle including an actuator for controlling motion of the jaw surfaces relative to one another, and a display integrated into the handle;

a sensor for detecting tissue between the jaw surfaces, the sensor including at least one pin that extends axially along an interior of the shaft structure from the handle to an aperture in the first jaw surface, the at least one pin having a free end, an extended condition in which the free end extends from the first jaw surface by at least a minimum distance, and a recessed condition in which the free end extends from the first jaw surface by less than the minimum distance;

circuitry operable to detect whether the at least one pin has reached the extended condition; and

means for coupling the sensor to the display so that the display can display results of the detection.