Leads for implantable medical device that affects pressures within the intrathoracic cavity through diaphragmatic stimulation

• US 10,369,361 B2
• Filed: 04/26/2017
• Issued: 08/06/2019
• Est. Priority Date: 04/29/2016
• Status: Active Grant

• Current Assignee: Viscardia, Inc.
• Original Assignee: Viscardia, Inc.
• Inventors: Bauer, Peter T., Chinchoy, Edward, Snell, Jay
• Primary Examiner(s): Wehrheim, Lindsey G
• Application Number:
  US15/498,303
• Publication Number:
  US 20170312507A1
• Time in Patent Office: 832 Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2562/0204 Acoustic sensors
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1102 Ballistocardiography
• CPC Class Codes: A61B 5/113 occurring during breathing
• CPC Class Codes: A61B 5/1135 by monitoring thoracic expansion
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/3601 : of respiratory organs
• 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 1/36585 : controlled by two or more physical parameters
• CPC Class Codes: A61N 1/37217 : characterised by the communication link, e.g. acoustic or tactile

Abstract

A lead for placement on a diaphragm includes a sensor assembly, a connector, and a lead body. The sensor assembly includes a housing having a first end surface and a second end surface opposite the first end surface. The first end surface is intended to contact the diaphragm. The sensor assembly includes at least one fixation structure also associated with the first end surface. The fixation structure is configured to preserve the hermetic integrity of the intrathoracic cavity. The fixation structure may extend through the diaphragm and transition to a state that forms a seal between itself and tissue of the diaphragm. Alternatively, the fixation structure may surround the sensor assembly and form a seal between itself and the surface of the diaphragm.

Claims

1. A lead configured for implant on a surface of a biological membrane forming part of a hermetically sealed biological cavity, the lead comprising:

a sensor assembly at a distal end of the lead, and comprising;

a housing having a first end surface and a second end surface opposite the first end surface;

a sensor structure associated with the first end surface, and comprising at least one sensor; and

at least one fixation structure associated with the first end surface and comprising a projecting structure that extends away from the first end surface of the housing, and configured to preserve the hermetic integrity of the biological cavity after implant of the lead;

a connector at a proximal end of the lead, and comprising at least one conductor pin; and

a lead body extending between the sensor assembly and the connector, and comprising at least one conductor that electrically couples the at least one sensor to the at least one conductor pin,

wherein the projecting structure comprises a wire and at least a portion of the wire is configured to actively transition from a first state, wherein the portion of the wire has a first diameter, and a second state, wherein the portion of the wire has a second diameter greater than the first diameter.

2. The lead of claim 1, wherein at least one sensor comprises an electrode.

3. The lead of claim 2, wherein the electrode is in a form of one of a flat surface electrode, or a ring electrode.

4. The lead of claim 1, wherein sensor structure comprises a plurality of sensors, and the plurality of sensors comprises at least one electrode and at least one motion sensor.

5. The lead of claim 1, wherein the sensor structure comprises a ring having a circumference, and comprises a plurality of sensors spaced apart around the circumference.

6. The lead of claim 1, wherein the projecting structure is characterized by a protruding length defined as a length between the surface of the sensor structure and a distal tip of the projecting structure.

7. The lead of claim 1, wherein the projecting structure comprises a proximal section end near the first end surface of the housing and a distal section opposite the proximal end, and only the distal section is configured to transition from the first state to the second state.

8. A lead configured for implant on a surface of a biological membrane forming part of a hermetically sealed biological cavity, the lead comprising:

a sensor assembly at a distal end of the lead, and comprising;

a housing having a first end surface and a second end surface opposite the first end surface;

a sensor structure associated with the first end surface, and comprising at least one sensor; and

at least one fixation structure comprising a projecting structure in the form of a helix that extends away from the first end surface of the housing, and configured to preserve the hermetic integrity of the biological cavity after implant of the lead;

a connector at a proximal end of the lead, and comprising at least one conductor pin; and

a lead body extending between the sensor assembly and the connector, and comprising at least one conductor that electrically couples the at least one sensor to the at least one conductor pin,

wherein the projecting structure comprises a middle section between a proximal section and a distal section, wherein a wire forming the middle section has a diameter that is less than the diameter of a wire forming the proximal section and a wire forming the distal section.

9. The lead of claim 8, wherein the projecting structure comprises a sensor.

10. The lead of claim 8, wherein the at least one fixation structure further comprises an extension member surrounding the projecting structure and having a maximum diameter greater than a maximum diameter of the housing.

11. The lead of claim 10, wherein the extension member is formed of a material configured to form a seal with the surface of the biological membrane.

12. The lead of claim 10, wherein the extension member comprises an adhesive configured to form a seal with the surface of the biological membrane.

13. A lead configured for implant on a surface of a biological membrane forming part of a hermetically sealed biological cavity, the lead comprising:

a sensor assembly at a distal end of the lead, and comprising;

a housing having a first end surface and a second end surface opposite the first end surface;

a sensor structure associated with the first end surface, and comprising a ring having a circumference and one or more electrodes and one or more motion sensors located on the ring and spaced apart around the circumference; and

at least one fixation structure comprising a projecting structure configured to extend through the biological membrane, and an extension member surrounding the projecting structure and configured to form a hermetic seal with the surface of the biological membrane, which formed seal surrounds an area where the projecting structure extends through the biological membrane to thereby preserve the hermetic integrity of the biological cavity;

a connector at a proximal end of the lead, and comprising a plurality of conductor pins; and

a lead body extending between the sensor assembly and the connector, and comprising a plurality of conductors that electrically couple the one or more electrodes and the one or more motion sensors to the plurality of conductor pins.

14. The lead of claim 13, wherein the projecting structure comprises a helix extending away from the first end surface of the housing.

15. The lead of claim 13, wherein:

the sensor assembly is characterized by a central axis extending through the housing,

the lead body is characterized by a longitudinal axis that extends between a distal end of the lead body and a proximal end of the lead body, and

the longitudinal axis of the lead body and the central axis of the sensor assembly are offset from each other.

16. The lead of claim 15, further comprising a grip structure extending from the second end surface in the direction of the central axis, and configured to be received by a gripping structure of an implant tool.

17. The lead of claim 13, wherein the projecting structure comprises a sensor.

18. The lead of claim 13, wherein the extension member has a maximum diameter greater than a maximum diameter of the housing.

19. The lead of claim 13, wherein the extension member is formed of a material configured to form a seal with the surface of the biological membrane.

20. The lead of claim 13, wherein the extension member comprises an adhesive configured to form a seal with the surface of the biological membrane.