Transvascular diaphragm pacing system and methods of use

• US 10,406,367 B2
• Filed: 08/24/2018
• Issued: 09/10/2019
• Est. Priority Date: 06/21/2013
• Status: Active Grant

• Current Assignee: Lungpacer Medical Inc.
• Original Assignee: Lungpacer Medical Inc.
• Inventors: Meyyappan, Ramasamy, Hoffer, Joaquin Andres, Baru, Marcelo, Coquinco, Bernard, Sandoval, Rodrigo Andres, Tang, Jessica Kit-Sum
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US16/111,644
• Publication Number:
  US 20180361148A1
• Time in Patent Office: 382 Days
• Field of Search: None
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61M 16/00 Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes stimulating the respiratory movement by mechanical, pneumatic or electrical means, iron lungs combined with gas breathing means A61H31/00
• CPC Class Codes: A61M 16/0069 the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• CPC Class Codes: A61M 16/026 specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
• CPC Class Codes: A61M 2016/0024 with an on-off output signal, e.g. from a switch
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/60 Muscle strain, i.e. measured on the user
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: H03M 9/00 Parallel/series conversion or vice versa digital stores in which the information is moved stepwise per se G11C19/00
• CPC Class Codes: H04J 3/0664 unidirectional timestamps
• CPC Class Codes: H04J 3/067 Details of the timestamp structure
• CPC Class Codes: H04J 3/0697 Synchronisation in a packet node
• CPC Class Codes: H04L 5/24 with start-stop synchronous converters

Abstract

Transvascular diaphragm pacing systems (TDPS) and methods are disclosed for providing respiratory therapy to a patient. The TDPS can provide rapid insertion and deployment of endovascular pacing electrodes in critically ill patients who require intubation and invasive PPMV in order to support the physiological requirements of the human ventilatory system. The systems and methods make best use of the contractile properties of the diaphragm muscle and prevent muscle disuse and muscle atrophy. This can be carried out by engaging the phrenic nerves using patterned functional electrical stimulation applied to endovascular electrodes that are temporarily and reversibly inserted in central veins of the patient, such as the left subclavian vein and the superior vena cava. The TDPS can be designed to seamlessly interface with any commercially available positive-pressure ventilatory assistance/support equipment such as is commonly in use in hospital intensive care units (ICU) for treating critically ill patients with breathing insufficiencies, pain, trauma, sepsis or neurological diseases or deficits.

Claims

1. A medical device, comprising:

a first electrode pair configured to be positioned proximate at least one phrenic nerve within a patient;

a stimulator coupled to the first electrode pair, the stimulator being configured to;

calculate a level of work to be expended during breathing by the patient;

calculate a desired electrical stimulation based on the calculated level of work; and

deliver the calculated desired electrical stimulation to the first electrode pair to at least partially activate the patient'"'"'s diaphragm; and

a sensor configured to provide a flow measurement to the stimulator;

wherein the stimulator is configured to determine when inspiration of a given breath is occurring based on the flow measurement from the sensor, and deliver the electrical stimulation during the determined inspiration; and

wherein the stimulator is configured to end the electrical stimulation before initiation of a subsequent breath.

2. The medical device of claim 1, wherein the stimulator is configured to end the electrical stimulation before initiation of expiration during the given breath.

3. The medical device of claim 1, wherein the stimulator is configured to end the electrical stimulation at initiation of expiration during the given breath.

4. The medical device of claim 1, wherein the stimulator is configured to end the electrical stimulation after initiation of expiration during the given breath.

5. The medical device of claim 1, wherein the medical device includes a plurality of pairs of electrodes, including the first electrode pair, and the stimulator is configured to deliver the electrical stimulation with one of the plurality of pairs of electrodes.

6. The medical device of claim 1, wherein the stimulator is in wired communication with the first electrode pair.

7. The medical device of claim 1, wherein the first electrode pair is disposed on a catheter.

8. The medical device of claim 7, wherein the electrodes of the first electrode pair are longitudinally spaced from one another on the catheter.

9. The medical device of claim 1, wherein the first electrode pair is configured to be placed within a blood vessel of the patient.

10. The medical device of claim 1, wherein the first electrode pair includes an anodal electrode and a cathodal electrode.

11. The medical device of claim 1, further including a second electrode pair, wherein the stimulator is configured to deliver electrical stimulation to the second electrode pair to at least partially activate the patient'"'"'s diaphragm.

12. The medical device of claim 1, wherein the sensor is configured to interface with a breathing circuit of a mechanical ventilator.

13. The medical device of claim 1, wherein the sensor is for coupling to a mechanical ventilator, and the sensor is external to the mechanical ventilator.

14. The medical device of claim 1, wherein the flow measurement includes inspired airflow and/or expired airflow.

15. The medical device of claim 1, wherein the stimulator is configured to deliver stimulation during the given breath, and not during the subsequent breath.

16. A medical device, comprising:

one or more electrodes configured to be positioned under skin of a patient proximate to at least one phrenic nerve within the patient;

a sensor configured to measure airflow into and out of the patient; and

a stimulator connected to the one or more electrodes and to the sensor, the stimulator configured to;

determine when inspiration of a given breath is occurring based on input from the sensor;

calculate a level of work to be expended during breathing by the patient;

calculate a desired electrical stimulation based on the calculated level of work;

deliver the calculated desired electrical stimulation to the one or more electrodes to at least partially activate the patient'"'"'s diaphragm during the determined inspiration; and

cease the electrical stimulation before initiation of expiration during the given breath.

17. The medical device of claim 16, wherein the one or more electrodes includes an anodal electrode and a cathodal electrode.