IP Library › Granted Patent US 7,613,516
Granted Patent B2
US 7,613,516 · App. 10/497,397 · Granted Nov 3, 2009

Pelvic disorder treatment device

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Quick Facts
Patent No.
US 7,613,516
App. No.
10/497,397
Granted
Nov 3, 2009
Kind
B2
Abstract

A device ( 20 ) for treating a medical condition is provided, and a surgical procedure for implanting the device is disclosed. The device ( 20 ) includes a sensor ( 44 ), which is adapted to generate a signal responsive to a state of a patient, and at least one electrode ( 27 ), which is adapted to be coupled to a pelvic site of the patient. A control unit ( 22 ) is adapted to receive the signal, to analyze the signal so as to distinguish between an imminent stress incontinence event and an imminent urge event, and, responsive to analyzing the signal, to apply an electrical waveform to the at least one electrode ( 27 ). In various configurations, the device ( 20 ) may be used alternatively or additionally to treat fecal incontinence, interstitial cystitis, chronic pelvic pain, or urine retention.

Claims (66)

1. A device, comprising:

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

a control unit, which is adapted to drive the at least one electrode to apply to the muscle an electrical waveform configured to treat a neurogenic bladder condition of the patient responsive to an amount of time elapsed since the patient last voided his or her bladder.

2. A device, comprising:

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

a control unit, which is adapted to drive the at least one electrode to apply to the muscle an electrical waveform configured to treat an urgency frequency symptom of the patient responsive to an amount of time elapsed since the patient last voided his or her bladder.

3. A device according to claim 1 , wherein the control unit is adapted to receive an input from the patient and to apply the waveform responsive to the input.

4. A device according to claim 1 , wherein the at least one electrode comprises a single monopolar electrode.

5. A device according to claim 1 , wherein the at least one electrode comprises a pair of bipolar electrodes.

6. A device according to claim 1 , wherein the at least one electrode comprises a flexible intra-muscular electrode.

7. 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.

8. A device according to claim 1 , wherein the control unit is adapted to configure the waveform so as to induce relaxation of a bladder muscle of the patient.

9. A device according to claim 8 , wherein the control unit is adapted to configure the waveform to have a frequency component between about 5 and 15 Hz.

10. A device according to claim 8 , wherein the control unit is adapted to configure the waveform to have an amplitude between about 1 and 4 V.

11. A device according to claim 8 , wherein the control unit is adapted to configure the waveform to include a series of pulses having widths between about 0.05 and 0.2 ms.

12. A device according to claim 8 , wherein the control unit is adapted to configure the waveform to have a duration of about 10-30 minutes.

13. A device according to claim 8 , wherein the control unit is adapted to configure the waveform to include a rise time lasting between about 1 second and 3 minutes prior to attaining a designated waveform application voltage.

14. A device according to claim 8 , wherein the control unit is adapted to configure the waveform to include a decay time lasting between about 1 second and 3 minutes, prior to returning to a baseline voltage.

15. A device according to claim 8 , wherein the control unit is adapted to configure the waveform to have a duty cycle between about 6% and about 50%.

16. A device according to claim 8 , wherein the control unit is adapted to configure the waveform to have a duty cycle of between about 2 and about 10 seconds on, and between about 10 and about 30 seconds off.

17. A device according to claim 2 , wherein the control unit is adapted to receive an input from the patient and to apply the waveform responsive to the input.

18. A device according to claim 2 , wherein the at least one electrode comprises a single monopolar electrode.

19. A device according to claim 2 , wherein the at least one electrode comprises a pair of bipolar electrodes.

20. A device according to claim 2 , wherein the at least one electrode comprises a flexible intra-muscular electrode.

21. A device according to claim 2 , wherein the at least one electrode and the control unit are adapted to be implanted in the body of the patient.

22. A device according to claim 2 , wherein the control unit is adapted to configure the waveform so as to induce relaxation of a bladder muscle of the patient.

23. A device according to claim 22 , wherein the control unit is adapted to configure the waveform to have a frequency component between about 5 and 15 Hz.

24. A device according to claim 22 , wherein the control unit is adapted to configure the waveform to have an amplitude between about 1 and 4 V.

25. A device according to claim 22 , wherein the control unit is adapted to configure the waveform to include a series of pulses having widths between about 0.05 and 0.2 ms.

26. A device according to claim 22 , wherein the control unit is adapted to configure the waveform to have a duration of about 10-30 minutes.

27. A device according to claim 22 , wherein the control unit is adapted to configure the waveform to include a rise time lasting between about 1 second and 3 minutes prior to attaining a designated waveform application voltage.

28. A device according to claim 22 , wherein the control unit is adapted to configure the waveform to include a decay time lasting between about 1 second and 3 minutes, prior to returning to a baseline voltage.

29. A device according to claim 22 , wherein the control unit is adapted to configure the waveform to have a duty cycle between about 6% and about 50%.

30. A device according to claim 22 , wherein the control unit is adapted to configure the waveform to have a duty cycle of between about 2 and about 10 seconds on, and between about 10 and about 30 seconds off.

31. A device, comprising:

a sensor, which is adapted to generate a signal responsive to a state of a patient;

at least one electrode, which is adapted to be coupled to a pelvic site of the patient; and

a control unit, which is adapted to receive the signal, to analyze the signal so as to distinguish between an imminent stress incontinence event and an imminent urge event, and, responsive to analyzing the signal, to apply an electrical waveform to the at least one electrode,

wherein the control unit is adapted to configure the waveform so as to induce relaxation of a bladder muscle responsive to analyzing the signal and determining that an urge event is imminent, and

wherein the control unit is adapted to configure the waveform to have a duty cycle between about 6% and about 50%.

32. A device, comprising:

a sensor, which is adapted to generate a signal responsive to a state of a patient;

at least one electrode, which is adapted to be coupled to a pelvic site of the patient; and

a control unit, which is adapted to receive the signal, to analyze the signal so as to distinguish between an imminent stress incontinence event and an imminent urge event, and, responsive to analyzing the signal, to apply an electrical waveform to the at least one electrode,

wherein the control unit is adapted to configure the waveform so as to induce relaxation of a bladder muscle responsive to analyzing the signal and determining that an urge event is imminent, and

wherein the control unit is adapted to configure the waveform to have a duty cycle of between about 2 and about 10 seconds on, and between about 10 and about 30 seconds off.

33. A device, comprising:

a sensor, which is adapted to generate a signal responsive to a state of a patient;

at least one electrode, which is adapted to be coupled to an anatomical site of the patient; and

a control unit, which is adapted to receive the signal, to analyze the signal so as to determine a likelihood of imminent patient pain due to interstitial cystitis, and, responsive to analyzing the signal, to apply to the at least one electrode an electrical waveform configured to reduce patient pain due to interstitial cystitis,

wherein the control unit is adapted to configure the waveform to have a duty cycle between about 6% and about 50%.

34. A device, comprising:

a sensor, which is adapted to generate a signal responsive to a state of a patient;

at least one electrode, which is adapted to be coupled to an anatomical site of the patient; and

a control unit, which is adapted to receive the signal, to analyze the signal so as to determine a likelihood of imminent patient pain due to interstitial cystitis, and, responsive to analyzing the signal, to apply to the at least one electrode an electrical waveform configured to reduce patient pain due to interstitial cystitis,

wherein the control unit is adapted to configure the waveform to have a duty cycle of between about 2 and about 10 seconds on, and between about 10 and about 30 seconds off.

35. A device, comprising:

a sensor, which is adapted to generate a signal responsive to a state of a patient;

at least one electrode, which is adapted to be coupled to an anatomical site of the patient; and

a control unit, which is adapted to receive the signal, to analyze the signal so as to determine a likelihood of patient pelvic pain, and, responsive to analyzing the signal, to apply to the at least one electrode an electrical waveform configured to reduce the patient pelvic pain,

wherein the control unit is adapted to configure the waveform to have a duty cycle between about 6% and about 50%.

36. A device, comprising:

a sensor, which is adapted to generate a signal responsive to a state of a patient;

at least one electrode, which is adapted to be coupled to an anatomical site of the patient; and

a control unit, which is adapted to receive the signal, to analyze the signal so as to determine a likelihood of patient pelvic pain, and, responsive to analyzing the signal, to apply to the at least one electrode an electrical waveform configured to reduce the patient pelvic pain,

wherein the control unit is adapted to configure the waveform to have a duty cycle of between about 2 and about 10 seconds on, and between about 10 and about 30 seconds off.

Assignments (23)
SECURITY INTEREST Recorded Jul 22, 2024
From: ENDO BIOLOGICS LIMITED; ENDO OPERATIONS LIMITED
To: COMPUTERSHARE TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 068469/0001 →
SECURITY INTEREST Recorded Jul 19, 2024
From: ENDO BIOLOGICS LIMITED; ENDO OPERATIONS LIMITED
To: GOLDMAN SACHS BANK USA
Reel/Frame 068461/0692 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 27, 2024
From: ENDO USA, INC.
To: ENDO OPERATIONS LIMITED
Reel/Frame 067245/0492 →
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 23, 2024
From: ASTORA WOMEN’S HEALTH, LLC
To: ENDO USA, INC.
Reel/Frame 067202/0768 →
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 →
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 Jan 11, 2016
From: APHRODITE WOMEN'S HEALTH, LLC
To: ASTORA WOMEN'S HEALTH, LLC
Reel/Frame 037473/0535 →
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: AMERICAN MEDICAL SYSTEMS, INC.
Reel/Frame 032379/0501 →
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 21, 2011
From: AMERICAN MEDICAL SYSTEMS, INC.
To: MORGAN STANLEY SENIOR FUNDING, INC., AS ADMINISTRATIVE AGENT
Reel/Frame 026628/0260 →
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 Mar 7, 2008
From: BIOCONTROL MEDICAL LTD.
To: AMERICAN MEDICAL SYSTEMS, INC.
Reel/Frame 020618/0610 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 11, 2008
From: BIOCONTROL MEDICAL, LTD.
To: BIO CONTROL MEDICAL (B.C.M.) LTD.
Reel/Frame 020783/0199 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 23, 2005
From: COHEN, EHUD; GROSS, YOSSI; NISSENKORN, ISRAEL
To: BIOCONTROL MEDICAL LTD.
Reel/Frame 015950/0488 →