Systems and methods for delivering pulmonary therapy

• US 10,639,477 B2
• Filed: 01/14/2015
• Issued: 05/05/2020
• Est. Priority Date: 01/17/2014
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Franke, Manfred, Clark, Bryan Allen, Flanagan, Aiden, Hincapie Ordonez, Juan Gabriel, Ternes, David J.
• Primary Examiner(s): Wu, Eugene T
• Application Number:
  US14/597,131
• Publication Number:
  US 20150202437A1
• Time in Patent Office: 1,938 Days
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00595 Cauterization
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

An example of a system may include an electrode and a pulse generation system. The electrode may be configured to be implanted near a neural target that innervates airways. The pulse generation system may be configured to be operably connected to the electrode to deliver depletion block stimulation through the electrode to alleviate symptoms of pulmonary disease. The pulse generation system and the electrode may be configured to cooperate to capture axons in the neural target. The depletion block stimulation may include a series of pulses at a depletion pulse frequency.

Claims

1. A system for delivering depletion block stimulation to a neural target that innervates airways using an implantable electrode near the neural target where the depletion block stimulation at a measurable activation threshold (AT) begins to increase nerve activity with increasing current amplitude and the depletion block stimulation at a measurable saturation threshold is where all or nearly all nerve fibers propagate action potentials such that nerve activity does not significantly increase in response to further increases in current amplitude, the system comprising:

the electrode which is configured to be implanted near the neural target that innervates airways; and

a pulse generation system configured to be operably connected to the electrode and programmed to deliver through the electrode a full depletion block stimulation where a current amplitude is at or above the saturation threshold followed by a partial depletion block where a stimulation intensity is reduced to a level below the saturation threshold and above the activation threshold to alleviate symptoms of pulmonary disease, the programmed pulse generation system and the electrode configured to cooperate to capture only some of the axons in the neural target when the partial depletion block is delivered to cause those captured axons to propagate action potentials and to capture all or almost all of the axons in the neural target when the full depletion block stimulation is delivered to cause those captured axons to propagate action potentials wherein both the full depletion block stimulation and the partial depletion block stimulation include a series of pulses within a depletion frequency range between about 100 Hz to about 1 kHz such that the series of pulses generate action potentials in the captured axons but block communication across synaptic clefts.

2. The system of claim 1, further comprising an electrode device, the electrode device including the electrode and configured to be implanted in an airway operably proximate to the neural target.

3. The system of claim 2, wherein the pulse generation system includes a pulse generator, a controller and a power supply configured to cooperate to deliver the depletion block stimulation through the electrode.

4. The system of claim 1, wherein the electrode includes an expandable structure configured to be expanded within the airway to contact an interior surface of the airway structure, the expandable structure including a pacing surface, the pacing surface including:

a smooth surface configured to abut against an interior surface of a wall for the airway structure;

or

a surface with protrusions configured penetrate partially into or fully through the wall for the airway structure;

or

a surface with a non-penetrating surface texture.

5. The system of claim 1, further comprising a stimulation lead, the lead including the electrode, the lead configured to be implanted to position the electrode external to an airway proximate to the neural target.

6. The system of claim 5, wherein the stimulation lead is configured to wrap at least partially around the airway to position the electrode proximate to the neural target.

7. The system of claim 5, wherein the stimulation lead is configured to be advanced within the airway, configured with an end to puncture a wall of the airway, and configured to wrap at least partially around the airway to position the electrode proximate to the neural target.

8. The system of claim 1, wherein the electrode is configured to be implanted operably proximate to:

a first generation bronchi for use in stimulating a pulmonary nerve branch that traverses along the first generation bronchi;

or

a second generation bronchi for use in stimulating a pulmonary nerve branch that traverses along the second generation bronchi;

or

a third generation bronchi for use in stimulating a pulmonary nerve branch that traverses along the third generation bronchi.

9. The system of claim 1, wherein the electrode is configured to be implanted near a cervical vagus nerve.

10. The system of claim 1, further comprising at least one sensor configured to sense a parameter correlated to increased airway resistance, the pulse generation system operably connected to the at least one sensor to detect an increase in airway resistance and configured to automatically initiate delivery of the depletion block stimulation in response to the detected increase in airway resistance.

11. The system of claim 10, wherein the sensor includes an impedance sensor configured to sense a reduction in transthoracic impedance.

12. The system of claim 10, wherein the sensor includes a pressure sensor configured to sense a reduction in pleural pressure.

13. The system of claim 1, wherein the pulse generation system is configured to receive a human-initiated command, and is configured to automatically initiate delivery of the depletion block stimulation in response to the received command.