Controlled steering functionality for implant-delivery tool

• US 9,949,828 B2
• Filed: 10/23/2013
• Issued: 04/24/2018
• Est. Priority Date: 10/23/2012
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Sheps, Tal, Hammer, Tal, Reich, Tal, Iflah, Ehud, Gross, Amir, Herman, Yaron, Koifman, Alexei, Zipory, Yuval
• Primary Examiner(s): TANNER, JOCELIN C
• Application Number:
  US14/437,373
• Publication Number:
  US 20150272734A1
• Time in Patent Office: 1,644 Days
• 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 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00044 Sensing electrocardiography, i.e. ECG
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/00327 with actuating members moving in opposite directions
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00455 Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/066 for measuring torque
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61M 2025/015 : Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 2025/0681 : Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0133 : Tip steering devices
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/06 : Body-piercing guide needles or the like
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: A61M 29/00 : Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: Y02E 60/36 : Hydrogen production from non-carbon containing sources, e.g. by water electrolysis

Abstract

A catheter (14), advanced toward an anatomical site, has a proximal end and a steerable distal end. An anchor (32, 2332) is advanced through the catheter. An anchor driver (36) drives the anchor out of the catheter'"'"'s distal end (104), anchoring the anchor at the site. A first constraining member (1602, 1652) engages tissue, and inhibits, after the anchor has been driven out of the catheter and before the anchoring, movement of at least the anchor driver'"'"'s distal end, on a first axis between the anchor driver'"'"'s distal end and a site at which the first constraining member engages the tissue. A second constraining member (26) inhibits, after the anchor has been driven out of the catheter and before the anchoring, movement of at least the anchor driver'"'"'s distal end, on a second axis. Other embodiments are also described.

Claims

1. Apparatus, comprising:

a catheter, transluminally advanceable to a valve of a heart of a subject;

an implant;

configured to be advanced distally through the catheter such that a distal end of the implant is placeable against tissue of the valve while a proximal end of the implant is disposed within the catheter, and

having a longitudinal axis between the distal end of the implant and the proximal end of the implant, and a lateral surface that circumscribes the longitudinal axis to define a lumen along the longitudinal axis;

a guidewire;

configured to be advanced distally through the catheter,

coupled to the implant such that at least a distal portion of the guidewire extends distally from a hole in the lateral surface of the implant, the distal portion of the guidewire being configured to be advanced between leaflets of the valve,

the apparatus being configured to mechanically bias placement of the distal end of the implant against the tissue of the valve at least in part dependently on a distance along the longitudinal axis between the distal end of the implant and the hole;

a tissue anchor; and

an anchor driver, configured such that the tissue anchor can be advanced through the catheter, into the lumen, and along the lumen to the distal end of the implant, and subsequently anchor the distal end of the implant to the tissue of the valve, by driving the tissue anchor through the lateral surface proximate the distal end of the implant and into the tissue of the valve.

2. The apparatus according to claim 1, wherein the apparatus is configured to bias the placement of the distal end of the implant against the tissue at least in part dependently on a stiffness of the guidewire.

3. The apparatus according to claim 1, wherein the guidewire is configured to engage a commissure of the valve, and the apparatus is configured, when the guidewire engages the commissure, to inhibit movement, on a plane of the valve, of the distal end of the implant outside of an arc centered on the commissure.

4. The apparatus according to claim 1, wherein the guidewire is coupled to the implant such that the guidewire extends proximally from the hole and out of a body of the subject.

5. The apparatus according to claim 4, wherein the guidewire extends proximally from the hole, exits from a point in the lateral surface of the implant, and extends proximally through the catheter along the outside of the implant.

6. The apparatus according to claim 1, wherein the guidewire is retractable through the hole and decouplable from the implant.

7. A method for using the apparatus of claim 1, the method comprising:

transluminally advancing a distal end of the catheter toward an anatomical site of the subject;

advancing the implant through at least part of the catheter while the distal portion of the guidewire extends out of the lateral surface of the implant;

implanting the implant at the anatomical site; and

removing the guidewire from the subject.