Implantable medical device with pressure sensor

• US 10,765,871 B2
• Filed: 10/23/2017
• Issued: 09/08/2020
• 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: Kane, Michael J., Haasl, Benjamin J., Maile, Keith R.
• Primary Examiner(s): Piateski, Erin M
• Application Number:
  US15/791,311
• Publication Number:
  US 20180117341A1
• Time in Patent Office: 1,051 Days
• Field of Search: 607 18
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61B 7/00 Instruments for auscultation
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

An implantable medical device (IMD) is configured with a pressure sensor. The IMD includes a housing, a pressure sensor and a fluid filled cavity. The housing has a diaphragm that is exposed to the environment outside of the housing. The pressure sensor has a pressure sensor diaphragm that is responsive to a pressure applied to the pressure sensor diaphragm and provides a pressure sensor output signal that is representative of the pressure applied to the pressure sensor diaphragm. The fluid filled cavity is in fluid communication with both the diaphragm of the housing and the pressure sensor diaphragm of the pressure sensor. The fluid filled cavity is configured to communicate a measure related to the pressure applied by the environment to the diaphragm of the housing to the pressure sensor diaphragm of the pressure sensor.

Claims

1. A leadless cardiac pacemaker (LCP) configured to sense cardiac activity and to pace a patient'"'"'s heart, the LCP comprising:

a housing having a proximal end and a distal end;

a fixation member configured for fixing the housing to an inner wall of the patient'"'"'s heart such that both the proximal end and the distal end of the housing are located inside of a chamber of the patient'"'"'s heart, the fixation member comprising a plurality of hooks or tines extending distally from the distal end of the housing and into the patient'"'"'s heart to anchor the distal end of the housing to the patient'"'"'s heart;

a first electrode secured relative to the housing and exposed to the environment outside of the housing;

a second electrode secured relative to the housing and exposed to the environment outside of the housing;

the housing having a diaphragm that is exposed to the environment outside of the housing, the diaphragm is positioned on the proximal end of the housing and is responsive to a pressure applied to the diaphragm by the environment outside the proximal end of the housing;

a pressure sensor within the housing, the pressure sensor having a pressure sensor diaphragm that is responsive to a pressure applied to the pressure sensor diaphragm and provides a pressure sensor output signal that is representative of the pressure applied to the pressure sensor diaphragm;

a fluid filled cavity in fluid communication with both the diaphragm of the housing and the pressure sensor diaphragm of the pressure sensor, the fluid filled cavity is configured to communicate a measure related to the pressure applied by the environment to the diaphragm of the housing to the pressure sensor diaphragm of the pressure sensor; and

circuitry in the housing in operative communication with the pressure sensor, the circuitry configured to determine a pressure exterior to the housing based on the pressure sensor output signal, and further configured to provide a plurality of pacing pulses via the first and second electrodes, wherein a timing of at least some of the plurality of pacing pulses is based at least in part on the pressure sensor output signal.

2. The LCP of claim 1, wherein the circuitry is further operatively coupled to the first electrode and the second electrode, and is further configured to:

use one or more cardiac signals sensed by the first electrode and the second electrode to determine when the patient'"'"'s heart is in a first phase of a cardiac cycle; and

determine a pressure exterior to the housing based at least in part on the pressure sensor output signal taken during the first phase of a cardiac cycle.

3. The LCP of claim 2, wherein the first phase of a cardiac cycle is systole.

4. The LCP of claim 2, wherein the first phase of a cardiac cycle is diastole.

5. The LCP of claim 1, wherein the circuitry is configured to detect heart sounds of the patient'"'"'s heart based at least in part on the pressure sensor output signal.

6. The LCP of claim 1, wherein the diaphragm of the housing comprises a localized thinning of a housing wall on the proximal end of the housing.

7. The LCP of claim 1, wherein the diaphragm of the housing comprises a region comprising a compliant material.

8. The LCP of claim 1, wherein the diaphragm of the housing comprises one or more bellows.

9. The LCP of claim 1, wherein the housing includes an elongated body with a distal end surface facing distally and a proximal end surface facing proximally, wherein the diaphragm of the housing is situated on the proximal end surface of the housing.

10. The LCP of claim 1, wherein the housing has a plurality of diaphragms that are exposed to the environment outside of the proximal end of the housing, each of the plurality of diaphragms are responsive to the pressure applied to the corresponding diaphragm by the environment outside of the housing.

11. The LCP of claim 1, wherein the fluid filled cavity is filled with an incompressible fluid.

12. The LCP of claim 11, wherein the incompressible fluid is a dielectric fluid.

13. The LCP of claim 1, further comprising an anti-thrombogenic coating disposed over the diaphragm of the housing.

14. The LCP of claim 1, wherein the diaphragm of the housing has a first surface area and the pressure sensor diaphragm of the pressure sensor has a second surface area, wherein a ratio of the first surface area to the second surface area is at least 5 to 1.

15. A leadless cardiac pacemaker (LCP) configured to sense cardiac activity and to pace a patient'"'"'s heart, the LCP comprising:

a housing having an elongated body with a proximal end having a proximal end surface facing proximally and a distal end having a distal end surface facing distally;

a first electrode secured relative to the housing and exposed to the environment outside of the housing;

a second electrode secured relative to the housing and exposed to the environment outside of the housing;

a fixation member at the distal end of the housing configured for fixing the distal end of the housing to an inner wall of a chamber of the patient'"'"'s heart with the proximal end of the housing extending away from the inner wall and into the chamber of the patient'"'"'s heart, the fixation member comprising a plurality of hooks or tines extending distally from the distal end of the housing and into the patient'"'"'s heart to anchor the distal end of the housing to the patient'"'"'s heart;

the housing having a diaphragm that is exposed to the environment outside of the housing, the diaphragm is responsive to a pressure applied to the diaphragm by the environment outside of the housing, wherein the pressure is a pressure inside of the chamber of the heart;

one or more sensors coupled to the diaphragm of the housing for detecting a stress in the diaphragm of the housing, wherein the stress in the diaphragm is representative of the pressure applied to the diaphragm by the environment outside of the housing;

circuitry in the housing in operative communication with the one or more sensors for determining a pressure exterior to the housing based at least in part on the detected stress in the diaphragm of the housing; and

wherein the diaphragm of the housing is situated on the proximal end surface of the housing.

16. The LCP of claim 15, wherein the diaphragm of the housing comprises a localized thinning of a housing wall of the housing.

17. The LCP of claim 16, wherein the localized thinning of the housing wall comprises a transition from a first thicker wall thickness to a second thinner wall thickness.

18. The LCP of claim 17, wherein the one or more sensors comprises a piezo resistor, and wherein the stress in the diaphragm comprises one or more of compression and stretching.

19. A leadless cardiac pacemaker (LCP) comprising:

a housing having a proximal end and a distal end;

a first electrode secured relative to the housing and exposed to the environment outside of the housing;

a second electrode secured relative to the housing and exposed to the environment outside of the housing;

the housing having a diaphragm that is exposed to the environment outside of the housing, the diaphragm is responsive to a pressure applied to the diaphragm by the environment outside of the housing;

a pressure sensor within the housing, the pressure sensor having a pressure sensor diaphragm that is responsive to a pressure applied to the pressure sensor diaphragm and provides a pressure sensor output signal that is representative of the pressure applied to the pressure sensor diaphragm;

a sealed fluid filled cavity extending between the diaphragm of the housing and the pressure sensor diaphragm, the sealed fluid filled cavity including a fluid that is in fluid communication with both the diaphragm of the housing and the pressure sensor diaphragm of the pressure sensor, the sealed fluid filled cavity is configured to communicate a measure related to the pressure applied by the environment to the diaphragm of the housing to the pressure sensor diaphragm of the pressure sensor;

a component cavity in the housing defined by a component cavity inner wall, the component cavity fluidly isolated from the sealed fluid filled cavity;

circuitry mounted in the component cavity in the housing with at least part of the circuitry spaced from the component cavity inner wall, the circuitry in operative communication with the pressure sensor, the circuitry configured to determine a pressure exterior to the housing based on the pressure sensor output signal, and further configured to communicate with another device via the first and second electrodes;

a battery mounted in the component cavity in the housing for providing power to the circuitry;

the battery and the circuitry both fluidly isolated from the fluid in the sealed fluid filled cavity; and

the circuitry configured to provide a plurality of pacing pulses via the first and second electrodes, wherein a timing of at least some of the plurality of pacing pulses is based at least in part on the pressure sensor output signal.