Delivery devices and methods for heart valve repair

• US 9,949,829 B2
• Filed: 02/19/2015
• Issued: 04/24/2018
• Est. Priority Date: 06/13/2002
• Status: Expired due to Term

• Current Assignee: Ancora Heart, Inc.
• Original Assignee: Ancora Heart, Inc.
• Inventors: Starksen, Niel F., To, John, Fabro, Mariel, Wei, Michael F., Morales, Rodolfo A.
• Primary Examiner(s): YABUT, DIANE D
• Application Number:
  US14/626,826
• Publication Number:
  US 20150164639A1
• Time in Patent Office: 1,160 Days
• 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 17/0643 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 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 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• 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 catheter assembly comprising:

a guide sheath having a guide sheath axis and a distal end, wherein the guide sheath is configured to position the distal end in a subannular space;

an elongate device slidably extendable within the guide sheath, the elongate device having an elongate device axis, a distal portion, a distal end, and a plurality of openings corresponding to a plurality of distinct anchor delivery sites located along the distal portion;

the guide sheath comprising a sheath orientation portion having a pre-shaped non-linear configuration; and

the elongate device comprising a device orientation portion having a pre-shaped non-linear configuration that corresponds with the pre-shaped non-linear configuration of the sheath orientation portion and located proximal to the distal portion, wherein the pre-shaped non-linear configuration of the sheath orientation portion and the pre-shaped non-linear configuration of the device orientation portion are determined prior to positioning the guide sheath in the subannular space;

wherein registration of the pre-shaped non-linear configuration of the sheath orientation portion and the pre-shaped non-linear configuration of the device orientation portion axially and rotationally aligns the guide sheath and the elongate device such that the distal end of the elongate device is at a selected orientation.

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

3. The catheter assembly according to claim 2 wherein the pre-shaped non-linear configuration of the sheath orientation portion and the pre-shaped non-linear configuration of the device orientation portion each comprise 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.

4. The catheter assembly according to claim 1 wherein the pre-shaped non-linear configuration of the sheath orientation portion and the pre-shaped non-linear configuration of the device orientation portion each comprise 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.

5. The catheter assembly according to claim 1 wherein the pre-shaped non-linear configuration of the sheath orientation portion and the pre-shaped non-linear configuration of the device orientation portion are configured to cause the sheath orientation portion and device orientation portion to form a complementary interfit when the sheath orientation portion and device orientation portion are axially and rotationally aligned.

6. A method for orienting a catheter assembly comprising:

selecting a catheter assembly comprising;

selecting a guide sheath having a guide sheath axis and a distal end, wherein the guide sheath is configured to position the distal end in a subannular space;

selecting an elongate device slidably extendable within the guide sheath, the elongate device having an elongate device axis, a distal portion, a distal end, and a plurality of openings corresponding to a plurality of distinct anchor delivery sites located along the distal portion;

wherein the guide sheath comprises a sheath orientation portion, the sheath orientation portion having a pre-shaped non-linear configuration; and

the elongate device comprises a device orientation portion, the device orientation portion having a pre-shaped non-linear configuration that corresponds with the pre-shaped non-linear configuration of the sheath orientation portion and located proximal to the distal portion, and wherein the pre-shaped non-linear configuration of the sheath orientation portion and the pre-shaped non-linear configuration of the device orientation portion are determined prior to positioning the guide sheath at a chosen location;

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

registering the sheath orientation portion and the device orientation portion so that the guide sheath and elongate device are axially and rotationally aligned such that the distal end of the elongate device is at a selected orientation.