Ventilatory assist system and methods to improve respiratory function

• US 7,962,215 B2
• Filed: 03/09/2007
• Issued: 06/14/2011
• Est. Priority Date: 07/23/2004
• Status: Active Grant

• Current Assignee: Synapse Biomedical Inc.
• Original Assignee: Synapse Biomedical Inc.
• Inventors: Ignagni, Anthony R., Onders, Raymond P.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Kimball; Jeremiah T
• Application Number:
  US11/716,459
• Publication Number:
  US 20070265611A1
• Time in Patent Office: 1,558 Days
• Field of Search: 607/116
• US Class Current: 607/42
• 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 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/3601 of respiratory organs

Abstract

Systems and methods are provided to improve respiratory function. Systems include an external electrical stimulator coupled to electrodes that stimulates diaphragm contraction and may optionally include a positive pressure mechanical ventilator. The system further includes an electrode suitable for temporary implantation. Electrical stimulation is provided to specific portions of the diaphragm, such as one hemidiaphragm preferentially over another. By preferentially contracting one hemidiaphragm, a specific portion of a lung may be expanded, such as a posterior portion. By the provision of the negative intrathoracic pressure from diaphragm contraction, greater expansion of specific portion of lung is achieved in relationship to air pressure within the lung, thereby improving compliance. Supplementation of stimulated diaphragm contraction with positive pressure driven air flow from a PPMV directs the air flow to specific portions of the lung. Such portion may include a posterior portion of a lung, and may cause a clearing of atelectasis in that portion.

Claims

1. An electrode suitable for temporary placement in diaphragm tissue comprising:

a needle at a first end,

a central portion comprising a straight insulated lead, a helically wound insulated lead portion, and a deinsulated coiled portion, and

a deinsulated barb and a stop at a second end adjacent to the deinsulated coiled portion, wherein the stop is configured to hold the deinsulated barb and the deinsulated coiled portion at the surface of the diaphragm.

2. The electrode of claim 1 wherein the stop comprises soft silicone.

3. The electrode of claim 1 wherein the stop comprises an absorbable suture material thermally bonded to the deinsulated coiled portion.

4. The electrode of claim 1 wherein the needle is a break-away needle.

5. The electrode of claim 1 wherein the straight insulated lead and the helically wound insulated lead are joined at a junction, the electrode further comprising a bonding material disposed at the junction to form a bond configured to prevent the helically wound lead from unwinding.

6. A method of inserting an electrode suitable for temporary placement in a patient'"'"'s diaphragm, the electrode comprising a needle at a first end, a central portion comprising a straight insulated lead, a helically wound insulated lead portion, and a deinsulated coiled portion, and a deinsulated barb and a stop at a second end, the method comprising:

inserting the electrode into the diaphragm surface by the first end comprising the needle

pulling the electrode through the diaphragm until the second end comprising the stop is at the diaphragm surface; and

connecting the first end to an external electrical stimulator.

7. The method of claim 6 wherein the electrode stop comprises soft silicone.

8. The method of claim 6 wherein the electrode stop comprises an absorbable suture material thermally bonded to the deinsulated coiled portion.

9. The method of claim 6 wherein the electrode needle is a break-away needle.

10. The method of claim 6 wherein the electrode'"'"'s straight insulated lead and the helically wound insulated lead are joined at a junction, the electrode further comprising a bonding material disposed at the junction to form a bond configured to prevent the helically wound lead from unwinding.

11. The method of claim 6, further comprising coupling the first end of the electrode to an electrical connector.

12. The method of claim 6, further comprising pulling the needle thorough the patient'"'"'s skin until the insulated helically wound lead protrudes from the skin.

13. The method of claim 6, further comprising securing the junction of the helically wound insulated lead portion to the straight insulated lead to the patient to maintain the coiled configuration of the electrode.

14. The method of claim 6, wherein the step of connecting the first end to an external electrical stimulator comprises breaking away the needle from the first end and connecting the first end to the electrical stimulator.

15. The method of claim 6, wherein the step of connecting the first end to an external electrical stimulator comprises cutting the straight insulated lead and de-insulating at least a portion of the straight insulated lead and connecting the de-insulated portion to the electrical stimulator.

16. An electrode suitable for temporary placement in diaphragm tissue comprising:

a needle at a first end,

a central portion comprising a straight insulated lead adjacent to the needle, a helically wound insulated lead portion, and a deinsulated coiled portion adjacent to the second end, and

a deinsulated barb at the second end and a stop formed between the deinsulated barb and the deinsulated coiled portion, wherein the stop is configured to hold the deinsulated barb and the deinsulated coiled portion at the surface of the diaphragm.