Delivery devices and methods for heart valve repair

• US 20060025750A1
• Filed: 07/27/2004
• Published: 02/02/2006
• Est. Priority Date: 06/13/2002
• Status: Active Grant

• Current Assignee: Ancora Heart, Inc.
• Original Assignee: Guided Delivery Systems, Inc.
• Inventors: Starksen, Niel F., To, John, Morales, Rodolfo A., Fabro, Mariel, Wei, Michael F.
• Granted Patent: US 7,753,858 B2
• Time in Patent Office: Days
• US Class Current: 604/510
• 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• 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
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• 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 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/07221 curved
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61M 2025/0096 : being laterally outward extensions or tools, e.g. hooks or fibres

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 catheter assembly comprising:

a guide sheath having a guide sheath axis;

an elongate device slidably extendable within the guide sheath, the elongate device having an elongate device axis;

the guide sheath comprising a sheath orientation portion placeable in a chosen shape; and

the elongate device comprising a device orientation portion placeable in said chosen shape;

whereby the chosen shape of the sheath and device orientation portions tend to cause the sheath and device orientation portions to assume complementary rotary orientations when the sheath and device orientation portions are axially aligned.

2. The catheter assembly according to claim 1 wherein at least a chosen one of the guide sheath and elongate device are steerable.

3. The catheter assembly according to claim 1 wherein the sheath orientation portion is located at a distal end of the guide sheath.

4. The catheter assembly according to claim 1 wherein the device orientation portion is located at a position spaced apart from a distal end of the elongate device.

5. The catheter assembly according to claim 1 wherein said chosen shape comprises a first curved portion and a second curved portion.

6. The catheter assembly according to claim 1 wherein said chosen shape comprises a first curved portion in a first plane and a second curved portion in a second plane.

7. The catheter assembly according to claim 1 wherein said chosen shape comprises a first curved portion in a first plane and a second curved portion in a second plane, said first and second planes being different planes.

8. The catheter assembly according to claim 1 wherein the sheath orientation portion assumes the chosen shape when in a relaxed state.

9. The catheter assembly according to claim 1 wherein the sheath and device orientation portions each assume the chosen shape when in a relaxed state.

10. A method for creating a catheter assembly having orientation-seeking inner and outer members comprising:

selecting a first chosen location for a sheath orientation portion of a sheath;

selecting a second chosen location for an elongate device orientation portion of an elongate device, the elongate device slidably extendable within the guide sheath;

creating the sheath orientation portion at the first chosen location of the sheath, the sheath orientation portion placeable in a chosen shape; and

creating the elongate device orientation portion at the second chosen location of the sheath, the device orientation portion placeable in said chosen shape, whereby the chosen shape of the sheath and device orientation portions tend to cause the sheath and device orientation portions to assume complementary rotary orientations when the sheath and device orientation portions are axially aligned.

11. The method according to claim 10 wherein the first chosen location selecting step comprises selecting the distal end of the guide sheath as the first chosen location.

12. The method according to claim 10 wherein the second chosen location selecting step comprises selecting a position spaced apart from a distal end of the elongate device as the second chosen location.

13. The method according to claim 10 wherein the sheath orientation portion creating step comprises forming a first curved portion and a second curved portion.

14. The method according to claim 10 wherein the sheath orientation portion creating step comprises forming a first curved portion in a first plane and a second curved portion in a second plane.

15. The method according to claim 14 wherein the forming step is carried out with said first and second planes being different planes.

16. The method according to claim 10 wherein the sheath orientation portion creating step is carried out with the sheath orientation portion naturally assuming the chosen shape when in a relaxed state.

17. A method for orienting the inner and outer members of a catheter assembly comprising:

selecting a catheter assembly comprising;

a guide sheath having a guide sheath axis and a distal end;

an elongate device slidably extendable within the guide sheath, the elongate device having an elongate device axis;

the guide sheath comprising a sheath orientation portion, the sheath orientation portion placeable in a chosen shape; and

the elongate device comprising a device orientation portion, the device orientation portion placeable in said chosen shape;

placing the distal end of the guide sheath at a chosen location;

axially aligning the sheath and device orientation portions so that the guide sheath and elongate device are at a chosen axial orientation; and

axially repositioning, as necessary, the guide sheath and elongate device away from and back into the chosen axial orientation until the sheath and device orientation portions to assume complementary rotary orientations.

18. The method according to claim 17 wherein the catheter assembly selecting step is carried out with the first chosen location at the distal end of the guide sheath.

19. The method according to claim 17 wherein the axially aligning step is carried out with the distal end of the elongate device at a position distal of the distal end of the guide sheath.