IMPLANTABLE MEDICAL DEVICE FIXATION TESTING

• US 20120172891A1
• Filed: 03/29/2011
• Published: 07/05/2012
• Est. Priority Date: 12/29/2010
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Lee, Nathan T.
• Application Number:
  US13/074,948
• Publication Number:
  US 20120172891A1
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2205/18 with alarm
• 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

Abstract

In one example, this disclosure includes a kit for implanting an implantable medical device within a patient. The kit comprises a delivery catheter including an inner member and an outer member. The kit further comprises the implantable medical device. The implantable medical device is adjacent the inner member and constrained by the outer member. The kit further comprises a force sensor in mechanical communication with the implantable medical device via the inner member. The force sensor collects force feedback data representing force applied by the inner member on the implantable medical device. The kit further comprises a user communication module configured to deliver force feedback information corresponding to the force feedback data collected by the force sensor to a user.

Claims

1. A kit for implanting an implantable medical device within a patient, the kit comprising:

a delivery catheter including an inner member and an outer member;

the implantable medical device, wherein the implantable medical device is adjacent the inner member and constrained by the outer member;

a force sensor in mechanical communication with the implantable medical device via the inner member, wherein the force sensor collects force feedback data representing force applied by the inner member on the implantable medical device; and

a user communication module configured to deliver force feedback information corresponding to the force feedback data collected by the force sensor to a user.

2. The kit of claim 1, wherein the implantable medical device is releasably attached to the inner member.

3. The kit of claim 1, wherein the force feedback information delivered to the user allows the user to evaluate whether the implantable medical device is adequately fixated within the patient prior to fully releasing the implantable medical device from the delivery catheter.

4. The kit of claim 1, wherein the force feedback information includes an indication that a holding force of the implantable medical device at least meets a predetermined threshold level.

5. The kit of claim 1, wherein the implantable medical device includes an expandable fixation mechanism deployable from a collapsed position to an expanded position, the expanded position suitable to secure the implantable medical device within a vascular structure of a patient.

6. The kit of claim 5, wherein the implantable medical device is configured for implantation within a pulmonary artery of the patient.

7. The kit of claim 1, wherein the implantable medical device includes a pressure sensor.

8. The kit of claim 1, wherein the implantable medical device includes an active fixation mechanism configured to secure the implantable medical device component to a patient tissue.

9. The kit of claim 8, wherein the active fixation mechanism includes a set of active fixation tines that are deployable from a spring-loaded position in which distal ends of the active fixation tines point away from a implantable medical device housing to a hooked position in which the active fixation tines bend back towards the implantable medical device housing.

10. The kit of claim 1, wherein the implantable medical device is a leadless pacemaker.

11. The kit of claim 1, wherein the force feedback information delivered to the user represents a pushing force of the inner member on the implantable medical device as the user attempts to deploy the implantable medical device from the catheter.

12. The kit of claim 1, wherein the force sensor includes at least one from a group consisting of:

a strain gauge; and

a fiber optic force sensor.

13. The kit of claim 1, wherein the implantable medical device includes at least one sensor selected from a group consisting of:

an electrocardiogram sensor;

a fluid flow sensor;

an oxygen sensor;

an accelerometer;

a glucose sensor;

a potassium sensor; and

a thermometer.

14. A catheter for implanting an implantable medical device within a patient, the catheter comprising:

an inner member configured to apply a force to the implantable medical device;

an outer member configured to constrain the implantable medical device;

a force sensor configured to collect force feedback data representing force applied by the inner member on the implantable medical device; and

a user communication module configured to deliver force feedback information corresponding to the force feedback data collected by the force sensor to a user.

15. The catheter of claim 14, wherein the inner member configured to releasably attach to the implantable medical device.

16. The catheter of claim 14, wherein the force feedback information delivered to the user allows the user to evaluate whether the implantable medical device is adequately fixated within a patient prior to fully releasing the implantable medical device from the inner member.

17. The catheter of claim 14, wherein the force feedback information includes an indication that a holding force of the implantable medical device at least meets a predetermined threshold level.

18. The catheter of claim 14,

wherein the inner member includes a tether and a deployment element,

wherein the force sensor is located on the tether.

19. The catheter of claim 14,

wherein the implantable medical device is configured for implantation to a location within the patient selected from a group consisting of:

a pulmonary artery of the patient; and

a right ventricle of the patient,

wherein the catheter is configured to deliver the implantable medical device to the location.

20. The catheter of claim 14, wherein the force feedback information delivered to the user represents a pushing force of the inner member on the implantable medical device as the user attempts to deploy the implantable medical device from the catheter.

21. The catheter of claim 14, wherein the force sensor includes at least one from a group consisting of:

a strain gauge; and

a fiber optic force sensor.

22. The catheter of claim 14, wherein the user communication module includes at least one from a group consisting of:

an audible alert;

a visible alert;

a digital readout providing a real-time representation of the force feedback data; and

a graphical user interface display of force versus time.

23. A method of implanting an implantable medical device within a patient comprising:

deploying the implantable medical device from a catheter to a location within the patient, the catheter including a force sensor in mechanical communication with the implantable medical device;

receiving an indication of a holding force of the implantable medical device, wherein the indication of the holding force corresponds to force feedback data collected by the force sensor; and

fully releasing the implantable medical device from the catheter at the location within the patient after determining the implantable medical device is adequately fixated at the location within the patient,

wherein determining the implantable medical device is adequately fixated at the location within the patient comprises evaluating whether the implantable medical device is adequately fixated at the location within the patient based on the indication of the holding force of the implantable medical device.

24. The method of claim 23, further comprising:

determining the implantable medical device is inadequately fixated within the patient; and

after determining the implantable medical device is inadequately fixated within the patient, recapturing the implantable medical device using the catheter prior to fully releasing the implantable medical device within the patient.

25. The method of claim 23, further comprising:

applying an axial force to the deployed implantable medical device via a user-controlled portion of the catheter,

wherein the indication of the holding force of the implantable medical device is a representation of the axial force applied to the deployed implantable medical device via the user-controlled portion of the catheter.

26. The method of claim 23, wherein the location is within a vasculature of the patient.

27. The method of claim 23, wherein the location is within a pulmonary artery of the patient.

28. The method of claim 23, wherein the location is within a right ventricle of the patient,

29. The method of claim 23, wherein the implantable medical device is a leadless pacemaker.