Implantable medical device delivery system with integrated sensor

• US 10,758,724 B2
• Filed: 10/25/2017
• Issued: 09/01/2020
• Est. Priority Date: 10/27/2016
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Koop, Brendan Early, Yu, Yinghong, An, Qi, Maile, Keith R., Thakur, Pramodsingh Hirasingh, Mi, Bin, Stahmann, Jeffrey E., Averina, Viktoria A., Siejko, Krzysztof Z., Kane, Michael J., Shuros, Allan Charles, Sharma, Arjun D., Soltis, Brian
• Primary Examiner(s): Piateski, Erin M
• Application Number:
  US15/793,149
• Publication Number:
  US 20180117304A1
• Time in Patent Office: 1,042 Days
• Field of Search: 600 31
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A delivery and deployment device may include a handle assembly and a shaft extending distally from the handle assembly. A device containment housing may be coupled to a distal region of the shaft and may extend distally therefrom. The distal containment housing may be configured to accommodate at least a portion of the IMD therein. The IMD may, for example, be a leadless pacemaker, a lead, a neurostimulation device, a sensor or any other suitable IMD. A plurality of electrodes may be distributed about an exterior surface of the device containment housing such that at least some of the plurality of electrodes may be positioned to test a potential IMD deployment location before deploying the IMD.

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 at least part of the IMD therein;

a plurality of electrodes distributed about an exterior surface of the device containment housing such that at least some of the plurality of electrodes may be positioned to test a potential IMD deployment location defined by the device containment housing before deploying the IMD; and

a plurality of electrical conductors operably coupled with the plurality of electrodes and extending proximally back along the shaft toward the handle assembly, the plurality of electrical conductors having proximal ends configured to be operably coupled to a testing device, wherein the testing device is configured to deliver electrical stimulation pulses to the at least some of the plurality of electrodes to test the potential IMD deployment location defined by the device containment housing before deploying the IMD.

2. The delivery and deployment device of claim 1, wherein the plurality of electrodes include at least some electrodes that are radially disposed about the exterior surface of the device containment housing.

3. The delivery and deployment device of claim 1, wherein the plurality of electrodes comprise at least four electrodes spaced axially along the exterior surface of the device containment housing, the at least four electrodes including a first electrode, a second electrode, a third electrode and a fourth electrode;

the first electrode and the fourth electrode spaced apart a first distance to form a stimulation dipole providing a potential difference;

the second electrode and the third electrode spaced apart a second distance less than the first distance to provide a conductivity measurement by measuring a voltage between the second electrode and the third electrode resulting from the potential difference applied by the first electrode and the second electrode; and

the second electrode and the third electrode disposed between the first electrode and the fourth electrode.

4. The delivery and deployment device of claim 1, wherein the plurality of electrodes comprise a first electrode and a second electrode disposed on an exterior surface of the device containment housing to form a stimulation bipole.

5. The delivery and deployment device of claim 4, further comprising a pressure sensor configured to obtain an indication of pressure in the chamber of the patient'"'"'s heart in response to a stimulating electrical pulse delivered via the first electrode and the second electrode.

6. The delivery and deployment device of claim 5, wherein the pressure sensor is disposed at or near a proximal end of the device containment housing.

7. The delivery and deployment device of claim 4, further comprising:

a first pressure sensor configured to obtain an indication of pressure in the chamber of the patient'"'"'s heart; and

a second pressure sensor configured to obtain an indication of pressure in a different chamber of the patient'"'"'s heart.

8. The delivery and deployment device of claim 4, further comprising an accelerometer and/or a gyroscope operatively fixed to the device containment housing, the accelerometer and/or the gyroscope are configured to output a signal to the testing device representative of cardiac performance.

9. The delivery and deployment device of claim 1, wherein at least some of the plurality of electrodes are disposed on an expandable assembly movably secured about an exterior of the device containment housing, the expandable assembly movable to a deployed configuration in which at least some of the plurality of electrodes contact cardiac tissue for endocardial mapping of at least part of the chamber of the patient'"'"'s heart prior to IMD deployment.

10. The delivery and deployment device of claim 1, further comprising one or more magnet tracking sensor fixed relative to the device containment housing for tracking purposes.

11. An IMD implantation device configured to deliver an implantable medical device (IMD) to a chamber of a patient'"'"'s heart and deploy the IMD therein, the IMD implantation 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 at least part of the IMD therein;

a deployment member extending through the shaft, the deployment member configured to apply a deployment force to the IMD in order to move the IMD from the device containment housing to deploy the IMD in the patient'"'"'s heart;

a plurality of electrodes distributed about an exterior surface of the device containment housing such that at least some of the plurality of electrodes may be positioned to test a potential IMD deployment location defined by the device containment housing before deploying the IMD; and

a plurality of electrical conductors operably coupled with the plurality of electrodes and extending proximally back along the shaft toward the handle assembly, the plurality of electrical conductors having proximal ends configured to be operably coupled to a testing device, wherein the testing device is configured to deliver electrical stimulation pulses to the at least some of the plurality of electrodes to test the potential IMD deployment location defined by the device containment housing before deploying the IMD.

12. The IMD implantation device of claim 11, wherein the deployment member is a push tube, and wherein the IMD implantation device further comprises:

a tether extending distally through the push tube and coupled to the IMD, the tether configured to be used to retrieve the IMD back into the device containment housing if an alternate deployment location is desired.

13. The IMD implantation device of claim 12, wherein the plurality of electrodes comprise at least four electrodes spaced axially along the device containment housing, the at least four electrodes including a first electrode, a second electrode, a third electrode and a fourth electrode;

the first electrode and the fourth electrode are spaced apart a first distance to form a stimulation dipole providing a potential difference, wherein the fourth electrode extends to a distal end of the device containment housing;

the second electrode and the third electrode are spaced apart a second distance less than the first distance to provide a conductivity measurement by measuring a voltage between the second electrode and the third electrode resulting from the potential difference applied by the first electrode and the second electrode; and

the second electrode and the third electrode disposed between the first electrode and the fourth electrode.

14. The IMD implantation device of claim 11, wherein the plurality of electrodes comprise a first electrode and a second electrode disposed on an exterior surface of the device containment housing to form a stimulation bipole.

15. The IMD implantation device of claim 14, further comprising a pressure sensor configured to obtain an indication of pressure in the chamber of the patient'"'"'s heart in response to a stimulating electrical pulse delivered via the first electrode and the second electrode.

16. The IMD implantation device of claim 15, wherein the pressure sensor is disposed at or near a proximal end of the device containment housing.

17. The IMD implantation device of claim 14, further comprising an accelerometer and/or a gyroscope fixed relative to the device containment housing.