HEART VALVE CHORDAE REPLACEMENT METHODS AND APPARATUS

• US 20130253639A1
• Filed: 09/20/2012
• Published: 09/26/2013
• 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.
• Granted Patent: US 10,271,947 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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, as well as 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 having a proximal end and a distal end;

first and second jaw surfaces near the distal end of the shaft, the jaw surfaces being 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; and

a leaflet stabilization structure deployable from the shaft distal of the jaw surfaces for at least partly restraining movement of the leaflet.

2. The apparatus as claimed in claim 1, wherein the leaflet stabilization structure includes a resiliently expandable wire mesh structure.

3. The apparatus as claimed in claim 1, wherein the leaflet stabilization structure includes an inflatable balloon.

4. The apparatus as claimed in claim 1, wherein the shaft includes a lumen extending along a longitudinal axis of the shaft from the proximal end to the distal end, the apparatus further comprising

a control mechanism disposed in the lumen and operable to control deployment of the leaflet stabilization structure.

5. The apparatus as claimed in claim 4, wherein the control mechanism is operable to control retraction of the leaflet stabilization structure.

6. The apparatus as claimed in claim 1, wherein the leaflet stabilization structure is deployable from an aperture in the distal end of the shaft.

7. The apparatus as claimed in claim 6, wherein the shaft includes a lumen extending along a longitudinal axis of the shaft from the proximal end to the distal end, and the aperture is the distal end of the lumen.

8. 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 insertable through an aperture in the wall of the patient'"'"'s heart, the shaft having a proximal end and a distal end;

first and second jaw surfaces near the distal end of the shaft, the jaw surfaces being 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; and

an annular sealing structure disposed concentrically around the shaft proximally of the jaw surfaces for resiliently bearing against an outer surface of the wall of the heart annularly around the aperture when the shaft is inserted through the aperture to reduce blood leakage through the aperture.

9. The apparatus as claimed in claim 8, wherein the sealing structure is slidable along the length of the shaft.

10. The apparatus as claimed in claim 9, wherein the sealing structure is resiliently biased to slide in a distal direction along the length of the shaft.

11. 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 having a proximal end and a distal end;

first and second jaw surfaces near the distal end of the shaft, the jaw surfaces being 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; and

a lumen extending through the shaft from the proximal end to a point distal of the jaw surfaces, the lumen being sized to receive a guide wire.

12. The apparatus as claimed in claim 11, wherein the lumen extends through the shaft.

13. 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 having a proximal end and a distal end;

first and second jaw surfaces near the distal end of the shaft, the jaw surfaces being 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;

an elongated, laterally flexible needle insertable longitudinally into and along the shaft; and

a tether attached to the needle;

the shaft being configured to guide the needle distally past the jaw surfaces and then back proximally past the jaw surfaces, the needle passing at least once through tissue clamped between the jaw surfaces as it passes the jaw surfaces in order to pull the tether through the tissue.

14. 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 having a proximal end and a distal end;

first and second jaw surfaces near the distal end of the shaft, the jaw surfaces being 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 resiliently expandable tissue anchor disposed in the shaft adjacent one of the jaw surfaces;

a tether attached to the tissue anchor; and

means for driving the tissue anchor through tissue clamped between the jaw surfaces.

15. 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 having a proximal end and a distal end, and a lumen extending along a longitudinal axis of the shaft;

first and second jaw surfaces near the distal end of the shaft, the jaw surfaces being 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 tissue clip disposed in a substantially straight configuration in the lumen of the shaft, the clip being deformable from the substantially straight configuration to a coiled configuration;

a tether attached to the clip; and

means for pushing the clip distally from the lumen through tissue clamped between the jaw surfaces, whereupon the clip deforms to the coiled configuration and thereby clips onto the tissue.

16. 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 having a proximal end and a distal end;

first and second jaw surfaces near the distal end of the shaft, the jaw surfaces being 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 deformable tissue clip having first and second arms respectively adjacent the first and second jaw surfaces, the arms being movable from a spaced apart condition for admitting the tissue between the arms to a clamping condition for clamping the tissue between the arms.

17. The apparatus as claimed in claim 16, wherein the arms are resiliently biased to move from the spaced apart condition to the clamping condition.

18. The apparatus as claimed in claim 16, wherein each of the arms is releasably secured to one of the jaw surfaces.

19. Apparatus for temporarily reducing motion of at least one leaflet in a heart valve in a patient'"'"'s beating heart, comprising:

an elongated structure insertable into the patient to a location adjacent the heart valve, the elongated structure including a leaflet stabilization structure deployable into contact with the at least one leaflet, the leaflet stabilization structure including a mesh of wires resiliently biased to expand into contact with the at least one leaflet when deployed to apply mechanical pressure to the at least one leaflet while allowing blood to flow through the mesh.

20. The apparatus as claimed in claim 19, wherein the heart valve includes at least two leaflets, and the mesh of wires is deployable between the at least two leaflets.

21. The apparatus as claimed in claim 20, wherein the mesh of wires is resiliently expandable to push the at least two leaflets apart while allowing blood to flow through the valve through the mesh of wires.

22. The apparatus as claimed in claim 19, wherein the mesh of wires is collapsible for removal from the patient.