Tricuspid valve repair using tension

• US 8,475,525 B2
• Filed: 01/22/2010
• Issued: 07/02/2013
• Est. Priority Date: 01/22/2010
• Status: Active Grant

• Current Assignee: 4Tech Inc.
• Original Assignee: 4Tech Inc.
• Inventors: Maisano, Francesco, Vanermen, Hugo, Perevalov, Valery, Hof, Repheal
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US12/692,061
• Publication Number:
  US 20110184510A1
• Time in Patent Office: 1,257 Days
• Field of Search: 623/2.36, 623/2.37, 623/1.36, 600/37
• US Class Current: 623/2.37
• 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 tricuspid valve of a patient;

implanting at least a second tissue-engaging element in a portion of a blood vessel selected from the group of blood vessels consisting of;

a superior vena cava and an inferior vena cava; and

drawing at least a first leaflet of the tricuspid valve toward at least a second leaflet of the tricuspid valve by performing a tensioning method selected from the group consisting of;

(a) adjusting a distance between the portion of the blood vessel and the first tissue portion, and maintaining the adjusted distance using tension applied to the first tissue-engaging element and the second tissue-engaging element by a longitudinal member that connects the first and the second tissue-engaging elements, and

(b) adjusting the distance between the portion of the blood vessel and the first tissue portion by applying tension to the first tissue-engaging element and the second tissue-engaging element using the longitudinal member.

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

3. The method according to claim 1, further comprising monitoring repair of the tricuspid valve in conjunction with the adjusting the distance between the portion of the blood vessel and the first tissue portion.

4. The method according to claim 1, wherein adjusting the distance between the portion of the blood vessel and the first tissue portion of tissue comprises pulling the first tissue-engaging element toward the portion of the blood vessel.

5. The method according to claim 1, wherein adjusting the distance between the portion of the blood vessel and the first tissue portion comprises achieving bicuspidization of the tricuspid valve.

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

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

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

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

9. The method according to claim 8, wherein:

the first tissue portion includes a portion of tissue of that is opposite the portion of the blood vessel of the patient,

engaging the first tissue portion 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 tricuspid valve toward the second leaflet of the tricuspid 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.

10. The method according to claim 8, wherein the first tissue portion includes a portion of tissue of a wall of a right atrium of the heart above an annulus of the tricuspid valve, and wherein engaging the first tissue portion comprises engaging the portion of tissue of the wall of the right atrium.

11. The method according to claim 8, wherein the first tissue portion includes a portion of tissue of an annulus of the valve, and wherein engaging the first tissue portion comprises engaging the portion of tissue of the annulus of the valve.

12. The method according to claim 11, 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.

13. The method according to claim 1, wherein performing the tensioning method comprises adjusting the distance between the portion of the blood vessel and the first tissue portion, and maintaining the adjusted distance using the tension applied to the first tissue-engaging element and the second tissue-engaging element by the longitudinal member.

14. The method according to claim 1, wherein performing the tensioning method comprises adjusting the distance between the portion of the blood vessel and the first tissue portion by applying tension to the first tissue-engaging element and the second tissue-engaging element using the longitudinal member.

15. The method according to claim 1, wherein implanting the first tissue-engagement element comprises advancing a catheter through vasculature of the patient to the vicinity of the tricuspid valve, and deploying the first tissue-engaging element from the catheter.

16. The method according to claim 2, wherein pulling the longitudinal member comprises pulling the longitudinal member prior to implanting the second tissue-engaging element.

17. The method according to claim 2, wherein adjusting the distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the tricuspid valve comprises pulling on the second tissue-engaging element in order to pull the longitudinal member.

18. The method according to claim 3, wherein monitoring the repair of the tricuspid valve comprises monitoring the drawing together of the first and the second leaflets of the tricuspid valve.

19. The method according to claim 3, wherein monitoring the repair of the tricuspid valve comprises monitoring a level of regurgitation of the tricuspid valve in conjunction with the adjusting the distance.

20. The method according to claim 7, wherein expanding the stent comprises expanding the stent in the portion of the blood vessel so as to allow free flow of blood through the stent throughout a cardiac cycle of the patient.