Delivery system with force sensor for leadless cardiac device

• US 10,350,423 B2
• Filed: 02/02/2017
• Issued: 07/16/2019
• Est. Priority Date: 02/04/2016
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Shuros, Allan Charles, Shome, Shibaji, Soltis, Brian, Schmidt, Brian L., Stalsberg, Kevin John
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US15/423,078
• Publication Number:
  US 20170224997A1
• Time in Patent Office: 894 Days
• Field of Search: 607122
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 2001/058 Fixing tools

Abstract

A device configured to deliver and deploy an implantable medical device (IMD) includes a handle assembly and a shaft extending distally therefrom. A device containment housing configured to accommodate the IMD is coupled to the distal region of the shaft. At least one of the shaft and device containment housing includes a compressible region that is configured to compress by an amount that is related to an applied force. The device may include a first position indicator and a second position indicator. An applied force causes the compressible region to compress by an amount that is related to the applied force, causing a change in distance between the first position indicator and the second position indicator and thus providing an indication of the applied force.

Claims

1. A delivery and deployment device configured to deliver an implantable medical device (IMD) to a chamber of a patient'"'"'s heart and deploy the IMD therein, the delivery and deployment device comprising:

a handle assembly;

a shaft extending distally from the handle assembly, the shaft including a distal region;

a device containment housing coupled to the distal region of the shaft and extending distally therefrom, the device containment housing configured to accommodate the IMD therein;

at least one of the shaft and the device containment housing including a compressible region, wherein;

when the shaft includes the compressible region, the compressible region comprises a portion of a wall of the shaft that compresses by an amount that is related to an applied force; and

when the device containment housing includes the compressible region, the compressible region comprises a portion of a wall of the device containment housing that compresses by an amount that is related to an applied force;

a first position indicator and a second position indicator, wherein at least part of the compressible region is situated between the first position indicator and the second position indicator; and

wherein a force applied to the device containment housing causes the compressible region to compress by an amount that is related to the applied force, which causes a change in distance between the first position indicator and the second position indicator, which provides an indication of the applied force.

2. The delivery and deployment device of claim 1, wherein the compressible region comprises a portion of the device containment housing.

3. The delivery and deployment device of claim 1, wherein the compressible region is configured to shorten in length in response to the applied force.

4. The delivery and deployment device of claim 1, wherein the first position indicator comprises a first radiopaque marker band and the second position indicator comprises a second radiopaque marker band, and the change in distance between the first position indicator and the second position indicator is visible via fluoroscopy.

5. The delivery and deployment device of claim 1, wherein the first position indicator comprises a first electrode and the second position indicator comprises a second electrode, and the change in distance between the first electrode and the second electrode is indicated via a change in impedance between the first electrode and the second electrode.

6. The delivery and deployment device of claim 5, wherein the first electrode comprises a ring electrode.

7. The delivery and deployment device of claim 5, wherein the first electrode comprises one of a plurality of electrodes that are disposed radially about a distal end of the device containment housing and alignable with each of a plurality of talons of the IMD.

8. The delivery and deployment device of claim 5, wherein the second electrode comprises a ring electrode.

9. The delivery and deployment device of claim 1, further comprising a force sensor arranged and configured to provide an indication of a force applied to the IMD during implantation.

10. The delivery and deployment device of claim 1, further comprising a force sensor arranged and configured to provide an indication of a force applied to an IMD during a tug test after deployment of the IMD.