IP Library Granted Patent US 6,896,651
Granted Patent B2
US 6,896,651 · App. 10/047,135 · Granted May 24, 2005

Mechanical and electrical sensing for incontinence treatment

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Quick Facts
Patent No.
US 6,896,651
App. No.
10/047,135
Granted
May 24, 2005
Kind
B2
Abstract

A device and method for treatment of urinary stress incontinence. At least one electrode is implanted in a pelvic muscle of a patient. A control unit receives signals indicative of abdominal stress in the patient and responsive thereto applies an electrical waveform to the electrode which stimulates the muscle to contract, so as to inhibit involuntary urine flow through the patient's urethra due to the stress.

Claims (43)

1. A device for treatment of urinary stress incontinence, comprising:

at least one electrode, which is adapted to be implanted in pelvic muscle of a patient; and

a control unit, which receives signals indicative of abdominal pressure or strain in the patient and further comprises a processor which analyzes the signals and determines when an involuntary urine flow is likely, and when the analyzed signals exceed a predetermined threshold indicative of abdominal pressure or strain, applies an electrical waveform to the electrode which stimulates the muscle to contract, so as to inhibit involuntary urine flow through the patient's urethra due to stress.

2. A device according to claim 1 , wherein the signals comprise electromyographic signals received from the at least one electrode.

3. A device according to claim 1 , wherein the processor is programmable to vary one or more parameters associated with the application of the waveform.

4. A device according to claim 3 , and comprising a wireless receiver, which receives data for programming the processor from a programming unit outside the patient's body.

5. A device according to claim 1 , wherein the at least one electrode and the control unit are adapted to be implanted in the body of the patient, and wherein the control unit comprises a rechargeable power source.

6. A device according to claim 5 , wherein the power source is recharged by inductive energy transfer, substantially without electrical contact between the control unit and any object outside the patient's body.

7. A device according to claim 1 , wherein the pelvic muscle comprises the levator ani muscle.

8. A device according to claim 1 , wherein the pelvic muscle comprises the urethral sphincter muscle.

9. A device according to claim 1 , wherein the pelvic muscle is adjacent to the urethral sphincter muscle.

10. A method for treatment of urinary stress incontinence of a patient, comprising:

implanting an electrode in a pelvic muscle of the patient;

receiving a signal from the patient's body indicative of abdominal pressure or strain;

analyzing the received signal using a processor; and

responsive to the analyzed signal, applying an electrical waveform to the electrode, which stimulates the muscle to contract so as to inhibit involuntary urine flow.

11. A method according to 10 , wherein the pelvic muscle comprises the levator ani muscle.

12. A method according to claim 10 , wherein the pelvic muscle comprises the urethral sphincter muscle.

13. A method according to claim 10 , wherein implanting the electrode comprises implanting an electrode in proximity to the urethral sphincter muscle.

14. A method according to claim 10 , wherein receiving the signal comprises receiving an electromyographic signal.

15. A device for inhibiting involuntary urine flow, comprising:

at least one electrode, which is adapted to be implanted in a pelvic muscle of a patient;

sensor, which senses a change in pressure of an abdomen or a urinary bladder of the patient and generates a signal responsive thereto; and

a control unit, which receives the signal, analyzes the signal to determine a level of abdominal stress of the patient, and, responsive thereto, applies an electrical waveform to the electrode which stimulates the muscle to contract and inhibit involuntary urine flow through the patient's urethra due to stress,

wherein the control unit comprises a processor which analyzes the signals and determines when an involuntary urine flow is likely, whereupon the waveform is applied, and

wherein the processor is programmable to vary one or more parameters associated with the application of the waveform.

16. A device according to claim 15 , and comprising a wireless receiver, which is adapted to receive data for programming the processor from a programming unit outside the patient's body.

17. A method for inhibiting involuntary urine flow of a patient, comprising:

implanting an electrode in a pelvic muscle of the patient;

receiving a pressure-measurement signal indicative of abdominal stress; and

responsive to the signal, applying an electrical waveform to the electrode, which stimulates the muscle to contract so as to inhibit involuntary urine flow.

18. A method according to 17 , wherein implanting the electrode in the pelvic muscle comprises implanting the electrode in the levator ani muscle.

19. A method according to claim 17 , wherein implanting the electrode in the pelvic muscle comprises implanting the electrode in the urethral sphincter muscle.

20. A method according to claim 17 , wherein implanting the electrode comprises implanting the electrode in proximity to the urethral sphincter muscle.

21. A method according to claim 17 , wherein applying the waveform comprises applying the waveform responsive to an electromyographic signal.

22. A method for inhibiting involuntary urine flow of a patient, comprising:

implanting an electrode in a pelvic muscle of the patient;

receiving a strain-measurement signal indicative of abdominal stress; and

responsive to the signal, applying an electrical waveform to the electrode, which stimulates the muscle to contract so as to inhibit involuntary urine flow.

23. A method according to 22 , wherein implanting the electrode in the pelvic muscle comprises implanting the electrode in the levator ani muscle.

24. A method according to claim 22 , wherein implanting the electrode in the pelvic muscle comprises implanting the electrode in the urethral sphincter muscle.

25. A method according to claim 22 , wherein implanting the electrode comprises implanting the electrode in proximity to the urethral sphincter muscle.

26. A method according to claim 22 , wherein applying the waveform comprises applying the waveform responsive to an electromyographic signal.

Assignments (16)
RELEASE OF SECURITY INTEREST Recorded Apr 26, 2024
From: WILMINGTON TRUST, NATIONAL ASSOCIATION
To: ACTIENT PHARMACEUTICALS LLC; ASTORA WOMEN’S HEALTH HOLDINGS, LLC; ASTORA WOMEN’S HEALTH LLC; AUXILIUM PHARMACEUTICALS, LLC; AUXILIUM US HOLDINGS, LLC; BIOSPECIFICS TECHNOLOGIES CORP.; BIOSPECIFICS TECHNOLOGIES LLC; DAVA INTERNATIONAL, LLC; DAVA PHARMACEUTICALS, LLC; ENDO GENERIC HOLDINGS, INC. (FORMERLY KNOWN AS PAR PHARMACEUTICALS COMPANIES, INC.); ENDO PHARMACEUTICALS INC.; ENDO PHARMACEUTICALS SOLUTIONS INC. (FORMERLY KNOWN AS INDEVUS PHARMACEUTICALS, INC.); GENERICS BIDCO I, LLC; GENERICS INTERNATIONAL (US), INC.; PAR PHARMACEUTICAL, INC.; PAR STERILE PRODUCTS, LLC (FORMERLY KNOWN AS JHP PHARMACEUTICALS, LLC); QUARTZ SPECIALTY PHARMACEUTICALS, LLC; SLATE PHARMACEUTICALS, LLC; VINTAGE PHARMACEUTICALS, LLC
Reel/Frame 067240/0001 →
RELEASE OF SECURITY INTEREST Recorded Apr 25, 2024
From: WILMINGTON TRUST, NATIONAL ASSOCIATION
To: ACTIENT PHARMACEUTICALS LLC; ASTORA WOMEN’S HEALTH LLC; AUXILIUM PHARMACEUTICALS, LLC; AUXILIUM US HOLDINGS, LLC; BIOSPECIFICS TECHNOLOGIES CORP.; BIOSPECIFICS TECHNOLOGIES LLC; DAVA INTERNATIONAL, LLC; DAVA PHARMACEUTICALS, LLC; ENDO PHARMACEUTICALS INC.; ENDO PHARMACEUTICALS SOLUTIONS INC. (FORMERLY KNOWN AS INDEVUS PHARMACEUTICALS, INC.); GENERICS BIDCO I, LLC; GENERICS INTERNATIONAL (US), INC.; PAR PHARMACEUTICAL, INC.; PAR PHARMACEUTICAL COMPANIES, INC.; PAR STERILE PRODUCTS, LLC (FORMERLY KNOWN AS JHP PHARMACEUTICALS, LLC); QUARTZ SPECIALTY PHARMACEUTICALS, LLC; SLATE PHARMACEUTICALS, LLC; VINTAGE PHARMACEUTICALS, LLC
Reel/Frame 067239/0491 →
CONFIRMATORY GRANT OF SECURITY INTEREST IN UNITED STATES PATENTS Recorded Sep 17, 2021
From: ASTORA WOMEN'S HEALTH LLC; ENDO PHARMACEUTICALS SOLUTIONS INC.; ENDO PHARMACEUTICALS INC.; PAR PHARMACEUTICAL, INC.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 057538/0978 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 18, 2018
From: BIOCONTROL ,EDICAL (B.C.M.) LTD
To: MEDTRONIC, INC.
Reel/Frame 046574/0208 →
SECURITY INTEREST Recorded Jun 8, 2017
From: ASTORA WOMEN'S HEALTH, LLC
To: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS COLLATERAL TRUSTEE
Reel/Frame 042743/0278 →
CORRECTIVE ASSIGNMENT TO CORRECT THE CONVEYING PARTY NAME PREVIOUSLY RECORDED AT REEL: 037300 FRAME: 0607. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Jan 11, 2016
From: AMS RESEARCH CORPORATION
To: AMS RESEARCH, LLC
Reel/Frame 037514/0402 →
CHANGE OF NAME Recorded Jan 11, 2016
From: APHRODITE WOMEN'S HEALTH, LLC
To: ASTORA WOMEN'S HEALTH, LLC
Reel/Frame 037473/0535 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 11, 2016
From: AMS RESEARCH, LLC
To: APHRODITE WOMEN'S HEALTH, LLC
Reel/Frame 037473/0425 →
CHANGE OF NAME Recorded Dec 15, 2015
From: AMS RESEARCH CORPATION
To: AMS RESEARCH, LLC
Reel/Frame 037300/0607 →
RELEASE OF SECURITY INTEREST Recorded Aug 6, 2015
From: DEUTSCHE BANK AG NEW YORK BRANCH
To: AMERICAN MEDICAL SYSTEMS, LLC; AMS RESEARCH, LLC; LASERSCOPE
Reel/Frame 036285/0146 →
GRANT OF SECURITY INTEREST IN PATENTS Recorded Mar 20, 2014
From: ENDO PHARMACEUTICALS SOLUTIONS, INC.; ENDO PHARMACEUTICALS, INC.; AMS RESEARCH CORPORATION; AMERICAN MEDICAL SYSTEMS, INC.; LASERSCOPE
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 032491/0440 →
RELEASE OF PATENT SECURITY INTEREST Recorded Mar 3, 2014
From: MORGAN STANLEY SENIOR FUNDING, INC., AS ADMINISTRATIVE AGENT
To: AMS RESEARCH CORPORATION
Reel/Frame 032380/0053 →
SECURITY AGREEMENT Recorded Jul 22, 2011
From: AMS RESEARCH CORPORATION
To: MORGAN STANLEY SENIOR FUNDING, INC., AS ADMINISTRATIVE AGENT
Reel/Frame 026632/0535 →
RELEASE OF SECURITY INTEREST IN PATENTS Recorded Apr 27, 2011
From: MEDTRONIC, INC.
To: BIO CONTROL MEDICAL (B.C.M.) LTD
Reel/Frame 026186/0580 →
SECURITY AGREEMENT Recorded May 20, 2010
From: BIO CONTROL MEDICAL (B.C.M.) LTD
To: MEDTRONIC, INC.
Reel/Frame 024411/0365 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 19, 2007
From: BIOCONTROL MEDICAL LTD.
To: AMS RESEARCH CORPORATION
Reel/Frame 019573/0906 →