TRICUSPID VALVE REPAIR USING TENSION

• US 20110184510A1
• Filed: 01/22/2010
• Published: 07/28/2011
• Est. Priority Date: 01/22/2010
• Status: Active Grant

• Current Assignee: 4Tech Inc.
• Original Assignee: 4tech SARL
• Inventors: PEREVALOV, Valery, MAISANO, Francesco, VANERMEN, Hugo, HOF, Repheal
• Granted Patent: US 8,475,525 B2
• Time in Patent Office: Days
• US Class Current: 623/1.24
• 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 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00407 Ratchet means
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• 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 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2/848 : having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/90 : characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/915 : with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/8483 : Barbs
• CPC Class Codes: A61F 2002/8486 : provided on at least one of the ends
• CPC Class Codes: A61F 2220/0008 : Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 : V-shaped

Abstract

A method is provided, including implanting at least a first tissue-engaging element in a first portion of tissue in a vicinity of a heart valve of a patient, implanting at least a second tissue-engaging element in a portion of a blood vessel that is in contact with an atrium of a heart of the patient, and drawing at least a first leaflet of the valve toward at least a second leaflet of the valve by adjusting a distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve of the patient. Other applications are also described.

Claims

1. A method, comprising:

implanting at least a first tissue-engaging element in a first portion of tissue in a vicinity of a heart valve of a patient;

implanting at least a second tissue-engaging element in a portion of a blood vessel that is in contact with an atrium of a heart of the patient; and

drawing at least a first leaflet of the valve toward at least a second leaflet of the valve by adjusting a distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve of the patient.

2. The method according to claim 1, wherein adjusting the distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve of the patient comprises pulling a longitudinal member that connects the first and second tissue-engaging elements.

3. The method according to claim 1, wherein adjusting the distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve of the patient comprises applying tension to one or more elements selected from the group consisting of the first tissue-engaging element and the second tissue-engaging element.

4. The method according to claim 1, further comprising monitoring a level of regurgitation of the heart valve in conjunction with the adjusting the distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve of the patient.

5. The method according to claim 1, wherein adjusting the distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve of the patient comprises pulling the first tissue-engaging element toward the portion of the blood vessel.

6. The method according to claim 1, wherein the heart valve includes a tricuspid valve, and wherein adjusting the distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve of the patient comprises achieving bicuspidization of the tricuspid valve of the heart.

7. The method according to claim 1, wherein adjusting the distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve of the patient comprises actuating an adjusting mechanism that is coupled to a portion of a longitudinal member that connects the first and second tissue-engaging elements.

8. The method according to claim 1, wherein implanting the second tissue-engaging element in the portion of the blood vessel comprises expanding a stent in the portion of the blood vessel.

9. The method according to claim 8, further comprising:

implanting a third tissue-engaging element in a second portion of tissue of the heart, the third tissue-engaging element bring connected at a proximal end thereof to a distal end of a longitudinal member; and

engaging a proximal end portion of the longitudinal member with the stent.

10. The method according to claim 9, further comprising applying tension to the third tissue-engaging element.

11. The method according to claim 1, wherein implanting the first tissue-engaging element in the first portion of tissue in the vicinity of the heart valve of the patient comprises engaging the first portion of tissue by performing one or more actions selected from the group consisting of:

puncturing and squeezing the first portion of tissue and advancing at least a portion of the first tissue-engaging element into the first portion of tissue.

12. The method according to claim 11, wherein:

the first portion of tissue in the vicinity of the heart valve includes a portion of tissue of that is opposite the portion of the blood vessel of the patient,

engaging the first portion of tissue comprises engaging the portion of tissue that is opposite the portion of the blood vessel of the patient, and

drawing the first leaflet of the valve toward the second leaflet of the valve comprises adjusting a distance between the portion of the blood vessel of the patient and the portion of tissue that is opposite the portion of the blood vessel of the patient.

13. The method according to claim 11, wherein the first portion of tissue in the vicinity of the heart valve includes a portion of tissue of a wall of the atrium of the heart above an annulus of the valve, and wherein engaging the first portion of tissue comprises engaging the portion of tissue of the wall of the atrium.

14. The method according to claim 11, wherein the first portion of tissue in the vicinity of the heart valve includes a portion of tissue of an annulus of the valve, and wherein engaging the first portion of tissue comprises engaging the portion of tissue of the annulus of the valve.

15. The method according to claim 14, wherein the portion of tissue of the annulus of the valve includes a portion of tissue that is between a middle portion of an anterior leaflet of the valve and a middle portion of a posterior leaflet of the valve.

16. A method, comprising:

implanting at least a first tissue-engaging element in a first portion of tissue upstream of a tricuspid valve of a patient;

implanting at least a second tissue-engaging element in a second portion of tissue upstream of the tricuspid valve of the patient; and

altering a geometry of a wall of a right atrium of a heart of the patient by adjusting a distance between the first portion of tissue upstream of the tricuspid valve of the patient and the second portion of tissue upstream of the tricuspid valve of the patient.

17. The method according to claim 16, wherein adjusting the distance between the first portion of tissue upstream of the tricuspid valve of the patient and the second portion of tissue upstream of the tricuspid valve of the patient comprises adjusting a distance between the first tissue-engaging element and the second tissue-engaging element.

18. The method according to claim 16, wherein the first portion of tissue includes a first portion of the wall of the right atrium, and wherein implanting the first tissue-engaging element in the first portion of tissue upstream of the tricuspid valve of the patient comprises implanting the first tissue-engaging element in the first portion of the wall of the right atrium.

19. The method according to claim 16, wherein the second portion of tissue includes a second portion of the wall of the right atrium, and wherein implanting the second tissue-engaging element in the second portion of tissue upstream of the tricuspid valve of the patient comprises implanting the second tissue-engaging element in the second portion of the wall of the right atrium.

20. The method according to claim 16, further comprising monitoring a level of regurgitation of the tricuspid valve in conjunction with the altering the geometry of the wall of the right atrium.

21. The method according to claim 16, wherein adjusting the distance between the first portion of tissue upstream of the tricuspid valve of the patient and the second portion of tissue upstream of the tricuspid valve of the patient comprises pulling a longitudinal element that connects the first and second tissue-engaging elements.

22. The method according to claim 16, wherein adjusting the distance between the first portion of tissue upstream of the tricuspid valve of the patient and the second portion of tissue upstream of the tricuspid valve of the patient comprises actuating an adjusting mechanism that is coupled to a portion of a longitudinal element that connects the first and second tissue-engaging elements.

23. The method according to claim 16, wherein altering the geometry of the wall of the right atrium of the heart of the patient comprises drawing together at least a first leaflet of the tricuspid valve of the patient and at least a second leaflet of the tricuspid valve of the patient.

24. A method, comprising:

engaging at least a portion of at least a first tissue-engaging element in a portion of tissue of a wall of an inferior vena cava of a patient;

engaging at least a portion of at least a second tissue-engaging element in a portion of tissue of a wall of a superior vena cava of the patient;

drawing at least a first leaflet of a heart valve toward at least a second leaflet of the valve by applying tension to one or more portions of tissue selected from the group consisting of;

the portion of tissue of the wall of the inferior vena cava of the patient and the portion of tissue of the wall of the superior vena cava of the patient; and

monitoring a level of regurgitation of a heart valve of the patient in conjunction with the applying of the tension.

25. The method according to claim 24, wherein applying the tension comprises applying the tension following the engaging of the at least first tissue-engaging element and the engaging of the at least second tissue-engaging element.

26. The method according to claim 24, wherein applying the tension comprises adjusting a distance between the portion of tissue of the wall of the inferior vena cava of the patient and the portion of tissue of the wall of the superior vena cava of the patient.

27. The method according to claim 26, wherein adjusting the distance between the portion of tissue of the wall of the inferior vena cava of the patient and the portion of tissue of the wall of the superior vena cava of the patient comprises, by the applying of the tension, adjusting a distance between the first tissue-engaging element and the second tissue-engaging element.

28. The method according to claim 24, wherein engaging the portion of the at least first tissue-engaging element in the portion of tissue of the wall of the inferior vena cava of the patient comprises expanding a first stent member in the inferior vena cava and contacting at least a portion of the first stent member with the portion of the wall of the inferior vena cava.

29. The method according to claim 24, wherein engaging the portion of the at least second tissue-engaging element in the portion of tissue of the wall of the superior vena cava of the patient comprises expanding a second stent member in the inferior vena cava and contacting at least a portion of the first stent member with the portion of the wall of the inferior vena cava.

30. The method according to claim 24, wherein applying the tension comprises altering a geometry of a wall of an atrium of a heart of the patient.

31. The method according to claim 24, wherein applying the tension comprises pulling a longitudinal member that connects the at least first tissue-engaging element and the at least second tissue-engaging element.

32. The method according to claim 24, wherein applying the tension comprises actuating an adjusting mechanism that is coupled to a portion of a tensioning element that connects the first and second tissue-engaging elements.