Transvascular diaphragm pacing systems and methods of use

• US 9,776,005 B2
• Filed: 08/28/2015
• Issued: 10/03/2017
• 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:
  US14/839,432
• Publication Number:
  US 20150367127A1
• Time in Patent Office: 767 Days
• Field of Search: 12820024, 12820213, 12820216
• 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 method of stimulating a diaphragm to provide a diaphragm assist level, comprising:

(a) obtaining an attribute of a breath cycle of a patient, wherein the patient receives respiratory assistance from a ventilator during the breath cycle;

(b) based on a stimulation parameter, the attribute of the breath cycle, and a desired value of a breath parameter, transmitting a first stimulation signal to a first electrode positioned within a blood vessel of the patient such that the electrode recruits a phrenic nerve of the patient;

(c) after transmitting the first stimulation signal, determining an actual value of the breath parameter from a breath;

(d) comparing the actual value of the breath parameter to the desired value of the breath parameter; and

(e) either (1) maintaining the stimulation parameter if the actual value of the breath parameter is within a selected range of the desired value of the breath parameter;

or (2) modifying the stimulation parameter if the actual value of the breath parameter is not within the selected range of the desired value of the breath parameter; and

(f) repeating steps (b)-(e),

wherein the method further includes transmitting a second stimulation signal to a second electrode to recruit the phrenic nerve, and wherein transmitting the first stimulation signal to the first electrode occurs at a different time as transmitting the second stimulation signal to the second electrode.

2. The method of claim 1, wherein the first stimulation signal includes at least one pulse, and the stimulation parameter includes at least one of a rate, a duration, a pulse width, a frequency, or an amplitude.

3. The method of claim 1, wherein the blood vessel is at least one of a left jugular vein or a left subclavian vein, the phrenic nerve is a left phrenic nerve, and the method further includes transmitting a stimulation signal to a third electrode positioned in a superior vena cava such that the third electrode recruits a right phrenic nerve of the patient.

4. The method of claim 1, wherein the blood vessel is at least one of a left jugular vein or a left subclavian vein, the phrenic nerve is a left phrenic nerve, and the method further includes transmitting stimulation signals to a third electrode and a fourth electrode positioned in the superior vena cava such that the third and fourth electrodes recruit a right phrenic nerve of the patient.

5. The method of claim 4, wherein transmitting the stimulation signal to the third electrode occurs at a different time as transmitting the stimulation signal to the fourth electrode.

6. The method of claim 1, wherein each of (a) the step of obtaining the attribute of the breath cycle of the patient, and (b) the step of determining the actual value of the breath parameter from the prior breath includes detecting with a sensor at least one of airflow, volume, pressure, motion, or electrical signals.

7. The method of claim 1, wherein the step of comparing the actual value of the breath parameter to the desired value of the breath parameter includes calculating at least one of a change in pressure or a change in tidal volume.

8. The method of claim 1, wherein, if the actual value of the breath parameter is not within the selected range of the desired value of the breath parameter, the method further includes:

determining a cause of a difference between the actual and desired values of the breath parameter, wherein the cause is at least one of;

a displacement of an electrode;

a change in respiratory mechanics;

or diaphragm fatigue; and

based on the cause, modifying at least one of the stimulation parameter, a position of the first electrode, or a selection of an electrode to receive the stimulation signal.

9. The method of claim 1, wherein transmitting the first stimulation and transmitting the second stimulation signal occur during the breath cycle.

10. The method of claim 1, wherein, during at least one breath cycle of a plurality of breath cycles of the same diaphragm stimulation treatment, the assist level provided by the ventilator is zero.

11. The method of claim 1, wherein during at least one breath cycle of a plurality of breath cycles of the same diaphragm stimulation treatment, the stimulation signal is not transmitted to the first electrode.

12. A method of stimulating a diaphragm of a patient to provide a diaphragm assist level, comprising:

obtaining an attribute of a breath cycle of a patient receiving respiratory assistance from a ventilator; and

during a breath cycle that includes respiratory assistance from the ventilator, transmitting a stimulation signal to at least one electrode positioned within a blood vessel of the patient such that the electrode recruits a phrenic nerve of the patient,

wherein the stimulation signal is based on a stimulation parameter, the attribute of the breath cycle, and a desired value of a breath parameter, wherein the breath parameter is at least one of a tidal volume or a pressure; and

wherein at least one of the stimulation signal and the respiratory assistance is adjusted between breath cycles of a same diaphragm stimulation treatment.

13. The method of claim 12, wherein the attribute of a breath cycle includes a start or a duration of at least one of an inspiration phase, an end-inspiratory pause, an expiration phase, or an end-expiratory pause.

14. The method of claim 12, wherein the stimulation signal includes at least one pulse;

the stimulation parameter includes at least one of a rate, a duration, a pulse width, a frequency, or an amplitude; and

the method further comprises calculating the stimulation parameter.

15. The method of claim 12, further comprising adjusting the desired breath parameter.

16. The method of claim 12, wherein, during a breath, expansion of the patient'"'"'s lungs from the ventilator and transmission of the stimulation signal produces an actual value of a breath parameter within a preselected range of the desired value of the breath parameter.

17. The method of claim 12, further comprising (a) measuring an actual value of a breath parameter of a prior breath, and (b) adjusting the at least one stimulation parameter based on the actual value.

18. The method of claim 12, further comprising (a) determining a functional characteristic of the diaphragm from a prior breath, and (b) based on the functional characteristic, determining whether to stop respiratory assistance from the ventilator.

19. The method of claim 12, wherein, during at least one breath cycle of a plurality of breath cycles of the same diaphragm stimulation treatment, the assist level provided by the ventilator is zero.

20. A method of stimulating a diaphragm to provide a diaphragm assist level, comprising:

(a) obtaining an attribute of a breath cycle of a patient, wherein the patient receives respiratory assistance from a ventilator during the breath cycle;

(b) based on a stimulation parameter, the attribute of the breath cycle, and a desired value of a breath parameter, transmitting a stimulation signal to an electrode positioned within a blood vessel of the patient such that the electrode recruits a phrenic nerve of the patient, wherein the breath parameter is at least one of a tidal volume or a pressure;

(c) after transmitting the stimulation signal, determining an actual value of the breath parameter from a breath;

(d) comparing the actual value of the breath parameter to the desired value of the breath parameter; and

(e) either (1) maintaining the stimulation parameter if the actual value of the breath parameter is within a selected range of the desired value of the breath parameter;

or (2) modifying the stimulation parameter if the actual value of the breath parameter is not within the selected range of the desired value of the breath parameter; and

(f) repeating steps (b)-(e),

wherein the blood vessel is at least one of a left jugular vein or a left subclavian vein, the phrenic nerve is a left phrenic nerve, and the method further includes transmitting a stimulation signal to a second electrode positioned within at least one of the left jugular vein or the left subclavian vein such that the second electrode recruits the left phrenic nerve, and transmitting stimulation signals to a third electrode and a fourth electrode positioned in the superior vena cava such that the third and fourth electrodes recruit a right phrenic nerve of the patient; and

wherein transmitting the stimulation signal to the first electrode occurs at a different time as transmitting the stimulation signal to the second electrode, and transmitting the stimulation signal to the third electrode occurs at a different time as transmitting the stimulation signal to the fourth electrode.