IP Library Granted Patent US 7,962,215
Granted Patent B2
US 7,962,215 · App. 11/716,459 · Granted Jun 14, 2011

Ventilatory assist system and methods to improve respiratory function

Assignee: Synapse Biomedical, Inc.
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Quick Facts
Patent No.
US 7,962,215
App. No.
11/716,459
Granted
Jun 14, 2011
Kind
B2
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 (25)

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.

Assignments (3)
SECURITY INTEREST Recorded May 28, 2014
From: SYNAPSE BIOMEDICAL, INC.
To: THE DIRECTOR OF THE OHIO DEVELOPMENT SERVICES AGENCY
Reel/Frame 033037/0049 →
CORRECTIVE ASSIGNMENT: THE STATE OF INCORPORATION WAS CORRECTED TO DELAWARE INSIDE THE ASSIGNMENT. RECORDATION DATE: 07/19/2007, REEL 019590 FRAME 0404 Recorded Nov 11, 2008
From: IGNAGNI, ANTHONY R.; ONDERS, RAYMOND P.
To: SYNAPSE BIOMEDICAL, INC.
Reel/Frame 021880/0450 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 19, 2007
From: IGNAGNI, ANTHONY R.; ONDERS, RAYMOND P.
To: SYNAPSE BIOMEDICAL, INC.
Reel/Frame 019590/0404 →
Continuity (5)
Continuation In Part 10897685 · Jul 23, 2004
Provisional Application 60767201 · Mar 9, 2006
Provisional Application 60861568 · Nov 28, 2006
Provisional Application 60872265 · Dec 1, 2006
Related Publication 20070265611A1 · Nov 15, 2007