Delivery devices and methods for heart valve repair

• US 20050065550A1
• Filed: 07/27/2004
• Published: 03/24/2005
• Est. Priority Date: 02/06/2003
• Status: Active Grant

• Current Assignee: Ancora Heart, Inc.
• Original Assignee: Guided Delivery Systems, Inc.
• Inventors: Starksen, Niel F., To, John, Morales, Rodolfo A.
• Granted Patent: US 7,758,637 B2
• Time in Patent Office: Days
• US Class Current: 606/219
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 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 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/07221 curved
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

Devices, systems and methods facilitate positioning of a cardiac valve annulus treatment device, thus enhancing treatment of the annulus. Methods generally involve advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting the anchor delivery device with a length of the valve annulus, delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus, and drawing the anchors together to circumferentially tighten the valve annulus. Devices generally include an elongate catheter having at least one tensioning member and at least one tensioning actuator for deforming a distal portion of the catheter to help it conform to a valve annulus. The catheter device may be used to navigate a subannular space below a mitral valve to facilitate positioning of an anchor delivery device.

Claims

1. A method for advancing an operational device into a left ventricle of a heart to contact the mitral valve annulus comprising:

advancing an operational device into a left ventricle and along at least a portion of a mitral valve annulus of a heart;

urging the operational device radially outwardly to seat the operational device against the mitral valve annulus; and

acting on the mitral valve annulus by the operational device.

2. The method according to claim 1, wherein the advancing step is carried out in a retrograde manner into the left ventricle.

3. The method according to claim 2 wherein the advancing step comprises passing the operational device through the aorta.

4. The method according to claim 1 wherein the urging step is carried out by radially outwardly expanding an expansible element associated with the operational device.

5. The method according to claim 4 wherein the urging step is carried out with an expansible element having a radius larger than the radius of the operational device.

6. The method according to claim 1 wherein the urging step is carried out by radially outwardly expanding a balloon associated with the operational device.

7. The method according to claim 1 wherein the urging step is carried out:

with an operational device having a length; and

to seat the entire length of the operational device against the mitral valve annulus.

8. The method according to claim 1 wherein the urging step is carried out by magnetically urging the operational device towards the mitral valve annulus.

9. The method according to claim 1 wherein the operational device advancing step is carried out using a steerable operational device.

10. The method according to claim 1 wherein the operational device advancing step is carried out using a steerable guide catheter.

11. The method according to claim 1 wherein the acting on step comprises:

securing a series of anchors of the operational device to the mitral valve annulus, the series of anchors comprising a proximal anchor coupled to a tether and a distal anchor secured to the tether; and

pulling on the tether to reduce the distance between the proximal and distal anchors.

12. The method according to claim 11 wherein the securing step is carried out using self-forming anchors.

13. The method according to claim 1 wherein:

the advancing step is carried out using an operational device comprising;

an elongate housing having a longitudinal axis and an open interior;

self-forming tissue-engageable anchors within the open interior of the housing;

each anchor having a first part and a second part, the second part having a tissue-piercing tip;

the housing having side wall openings sized for passage of the anchors tip-first generally radially outwardly through the openings;

each anchor placeable in a relatively straight, undeployed state generally parallel to the longitudinal axis within the housing; and

the acting on step comprises driving the anchors tip-first through the openings with each anchor naturally assuming a curved, tissue-engaging deployed state after passing through the opening in the housing.

14. The method according to claim 13 wherein the advancing step is carried out using an anchor comprising said first part and two of said second parts extending from the first part.

15. The method according to claim 14 wherein the first part is looped when the anchor is in the deployed state.

16. The method according to claim 14 wherein the second parts extend in directions generally opposite one another when in the deployed state.

17. The method according to claim 16 wherein the second parts extend outwardly, away from one another when in the deployed state.

18. The method according to claim 14 wherein the second parts have generally circular or semicircular shapes when in the deployed state.

19. The method according to claim 13 wherein the anchor is oriented generally perpendicular to the longitudinal axis when in the deployed state.

20. The method according to claim 13 wherein the anchor has a generally circular or semicircular shape when in the deployed state.

21. The method according to claim 13 wherein:

the advancing step is carried out using an operational device comprising;

a series of the anchors, the anchors comprising a distal anchor and a proximal anchor; and

a tether serially coupling the anchors to one another with the proximal anchor coupled to the tether and the distal anchor secured to the tether; and

the acting on step comprises;

securing the series of anchors to the mitral valve annulus; and

pulling on the tether to reduce the distance between the proximal and distal anchors.

22. The method according to claim 13 further comprising selecting an operational device comprising a housing having a diametrical dimension d and an anchor having a diametrical dimension D in the deployed state, and wherein the ratio of D to d is at least 3.5.

23. The method according to claim 13 further comprising selecting an operational device comprising a housing having a diametrical dimension d and an anchor having a diametrical dimension D in the deployed state, and wherein the ratio of D to d is at least 4.4.

24. The method according to claim 13 further comprising selecting an operational device comprising a housing having a diametrical dimension d and an anchor having a diametrical dimension D in the deployed state, and wherein the ratio of D to d is at least 7.

25. The method according to claim 13 further comprising selecting an operational device comprising a housing having a diametrical dimension d and an anchor having a diametrical dimension D in the deployed state, and wherein the ratio of D to d is at least 8.8.

26. The method according to claim 1 wherein the acting on step comprises delivering anchors from a housing of the operational device into tissue at the mitral valve annulus.

27. The method according to claim 26 wherein the anchors delivering step is carried out using a series of tethered anchors, comprising a tether and said anchors, and the acting on step further comprises circumferentially tightening the mitral valve annulus by placing the tether in tension.

28. The method according to claim 26 wherein the anchors delivering step comprises driving at least one of the anchors through a biocompatible material thereby attaching the biocompatible material to the mitral valve annulus.

29. The method according to claim 28 wherein the anchor delivering step is carried out using a strip of the biocompatible material and the anchors driving step comprises driving a plurality of the anchors through the strip of biocompatible material.

30. The method according to claim 1 wherein the advancing step comprises advancing the operational device through a guide sheath.

31. The method according to claim 30 wherein the acting on step comprises delivering anchors from a housing of the operational device, through a distal portion of the guide sheath and into tissue at the mitral valve annulus thereby attaching the distal portion of the guide sheath to the mitral valve annulus.

32. The method according to claim 31 further comprising detaching the distal portion of the guide sheath from a proximal portion of the guide sheath.

33. A method for advancing an operational device into a left ventricle of a heart to contact and circumferentially tighten the mitral valve annulus comprising:

selecting an operational device comprising an elongate housing having a diametrical dimension d and anchors having a diametrical dimension D in a deployed state, and wherein the ratio of D to d is at least 3.5.

advancing the operational device through an aorta and into a left ventricle and along at least a portion of a mitral valve annulus of a heart of a patient, the advancing step being carried out using an operational device comprising;

an elongate housing having a longitudinal axis and an open interior;

a series of self-forming tissue-engageable anchors, the anchors comprising a distal anchor and a proximal anchor within the open interior of the housing;

the anchor having a first part and at least two second parts extending from the first part, the second parts each having a tissue-piercing tip, the second parts having generally circular or semicircular shapes when in the deployed state;

a tether serially coupling the anchors to one another with the proximal anchor coupled to the tether and the distal anchor secured to the tether;

the housing having openings sized for passage of the anchors tip-first through the openings; and

each of the anchors placeable in a relatively straight, undeployed state generally parallel to the longitudinal axis within the housing;

urging the operational device radially outwardly to seat the operational device against the mitral valve annulus;

securing the series of anchors to the mitral valve annulus by;

driving the anchors tip-first through the openings with the anchors naturally assuming curved, tissue-engaging deployed states after passing through the openings in the housing, the anchors oriented generally perpendicular to the longitudinal axis when in the deployed state; and

pulling on the tether to reduce the circumferential distance between the proximal and distal anchors and circumferentially tighten the mitral valve annulus.

34. A method for advancing an operational device into a left ventricle of a heart to contact the mitral valve annulus comprising:

advancing a guide catheter into a left ventricle and along at least a portion of a mitral valve annulus of a heart;

passing a flexible guide sheath over the guide catheter and along at least a portion of the mitral valve annulus;

advancing an operational device through the guide sheath;

urging the operational device radially outwardly to seat the operational device against the mitral valve annulus; and

acting on the mitral valve annulus by the operational device.

35. The method according to claim 34 wherein the advancing step is carried out using a steerable guide catheter.

36. The method according to claim 34 further comprising withdrawing the guide catheter from the guide sheath before the operational device advancing step.

37. The method according to claim 34 further comprising removing the guide sheath from the heart before the acting on step.