Granted Patent
B2
US 12,263,006 · App. 17/129,526 · Granted Apr 1, 2025
Treatment of male urinary incontinence and sexual dysfunction
Assignee:
Axena Health, Inc.
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Abstract
Methods and devices to diagnose and treat male urinary incontinence and sexual dysfunction are provided. A multiple sensor-enabled catheter for rectal insertion in a male patient allows for the visualization and manipulation or positioning of the bladder. A multiple sensor-enabled catheter for rectal insertion in a male patient allows for the visualization and implementation of efficient and effective exercises to strengthen pelvic floor muscles.
Claims (13)
1. A method for diagnosing or treating urinary incontinence in a subject comprising:
a) inserting into a rectum of the subject a device comprising a handle and a probe configured to enter the rectum, wherein the probe comprises microelectromechanical (MEM) accelerometers positioned along a length of the probe and wherein the device lacks accelerometers in the handle,
b) determining and visualizing on a graphical user interface a position of the accelerometers of the probe as a representation of an anatomical position of a bladder, bladder neck, or urethra of the subject in real-time, and
c) manipulating the anatomical position of the bladder, bladder neck, or urethra relative to at least one fixed anatomical reference point selected from the group consisting of a pubic bone, a coccyx, a bladder, a urethra, a prostate, and a rectum, thereby diagnosing or relieving the incontinence.
2. The method of claim 1 , wherein the anatomical position of the subject is transmitted in real-time as wireless data to the graphical user interface.
3. The method of claim 1 , wherein the anatomical position of the bladder neck and the urethra is transmitted in real-time as wireless data to the graphical user interface.
4. The method of claim 1 , wherein the method further comprises determining a muscular function of a bladder sphincter, a rectal sphincter, or a pelvic floor muscle of the subject.
5. The method of claim 4 , wherein the muscular function is determined by having the subject manipulate the pelvic floor muscle.
6. The method of claim 1 , wherein the device is a catheter.
7. The method of claim 1 , wherein the manipulating comprises having the subject perform a pelvic floor muscle exercise.
8. The method of claim 7 , wherein the pelvic floor muscle exercise is repeated one or more times.
9. The method of claim 1 , wherein the manipulating comprises performing an exercise that strengthens a sphincter of the subject.
10. The method of claim 1 , wherein the device further comprises one or more pressure sensors.
Assignments (5)
SECURITY INTEREST
Recorded Dec 23, 2025
From: AXENA HEALTH, INC.
To: ANKURA TRUST COMPANY, LLC, ADMINISTRATIVE AND COLLATERAL AGENT
Reel/Frame 073305/0470 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Aug 18, 2023
From: REMENDIUM LABS LLC
To: RENOVIA INC.
Reel/Frame 064632/0669 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Aug 18, 2023
From: RENOVIA INC.
To: AXENA HEALTH, INC.
Reel/Frame 064632/0786 →
CORRECTIVE ASSIGNMENT TO CORRECT THE RECEIVING PARTY'S ADDRESS PREVIOUSLY RECORDED AT REEL: 056009 FRAME: 0832. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT .
Recorded Sep 28, 2021
From: IGLESIAS, RAMON JOSE
To: REMENDIUM LABS LLC
Reel/Frame 057632/0602 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 22, 2021
From: IGLESIAS, RAMON JOSE
To: REMENDIUM LABS LLC
Reel/Frame 056009/0832 →
Continuity (5)
Continuation In Part
14359890
Provisional Application
61563889
· Nov 28, 2011
References Cited (305)
US 2830582A
· Ljung
· 1958
[cited by applicant]
US 3854476A
· Dickinson, III et al.
· 1974
[cited by applicant]
US 4669478A
· Robertson
· 1987
[cited by applicant]
US 4873990A
· Holmes et al.
· 1989
[cited by applicant]
US D309866S
· Fukuda et al.
· 1990
[cited by applicant]
US D310275S
· Su
· 1990
[cited by applicant]
US 5049132A
· Shaffer et al.
· 1991
[cited by applicant]
US 5328077A
· Lou
· 1994
[cited by applicant]
US 5386836A
· Biswas
· 1995
[cited by applicant]
US 5406961A
· Artal
· 1995
[cited by applicant]
US 5562717A
· Tippey et al.
· 1996
[cited by applicant]
US 5603685A
· Tutrone, Jr.
· 1997
[cited by applicant]
US 5674238A
· Sample et al.
· 1997
[cited by applicant]
US 5924984A
· Rao
· 1999
[cited by applicant]
US 6001060A
· Churchill et al.
· 1999
[cited by applicant]
US 6021781A
· Thompson et al.
· 2000
[cited by applicant]
US 6039701A
· Sliwa et al.
· 2000
[cited by applicant]
US 6056699A
· Sohn et al.
· 2000
[cited by applicant]
US 6080118A
· Blythe
· 2000
[cited by applicant]
US 6086549A
· Neese et al.
· 2000
[cited by applicant]
US 6264582B1
· Remes
· 2001
[cited by applicant]
US 6272371B1
· Shlomo
· 2001
[cited by applicant]
US D458681S
· Sherlock et al.
· 2002
[cited by applicant]
US 6413206B2
· Biswas
· 2002
[cited by applicant]
US 6432037B1
· Eini et al.
· 2002
[cited by applicant]
US 6511427B1
· Sliwa, Jr. et al.
· 2003
[cited by applicant]
US 6652565B1
· Shimada et al.
· 2003
[cited by applicant]
US 6672996B2
· Ross et al.
· 2004
[cited by applicant]
US 6679854B2
· Honda et al.
· 2004
[cited by applicant]
US 6741895B1
· Gafni et al.
· 2004
[cited by applicant]
US D491079S
· Lim
· 2004
[cited by applicant]
US D491274S
· Dubniczki et al.
· 2004
[cited by applicant]
US 6816744B2
· Garfield et al.
· 2004
[cited by applicant]
US 7079882B1
· Schmidt
· 2006
[cited by applicant]
US 7104950B2
· Levy
· 2006
[cited by applicant]
US D535203S
· Chen
· 2007
[cited by applicant]
US D548359S
· Illein et al.
· 2007
[cited by applicant]
US 7577476B2
· Hochman et al.
· 2009
[cited by applicant]
US 7608037B2
· Levy
· 2009
[cited by applicant]
US 7628744B2
· Hoffman et al.
· 2009
[cited by applicant]
US 7645220B2
· Hoffman et al.
· 2010
[cited by applicant]
US 7736298B2
· Guerquin et al.
· 2010
[cited by applicant]
US 7837682B2
· Ostrovsky et al.
· 2010
[cited by applicant]
US 7892179B2
· Rieth
· 2011
[cited by applicant]
US 7955241B2
· Hoffman et al.
· 2011
[cited by applicant]
US 7957794B2
· Hochman et al.
· 2011
[cited by applicant]
US D651531S
· Rothman
· 2012
[cited by applicant]
US 8147429B2
· Mittal et al.
· 2012
[cited by applicant]
US 8360954B2
· Kim
· 2013
[cited by applicant]
US 8623004B2
· Johnson et al.
· 2014
[cited by applicant]
US 8715204B2
· Webster et al.
· 2014
[cited by applicant]
US 8728140B2
· Feemster et al.
· 2014
[cited by applicant]
US 8740767B2
· Rosen et al.
· 2014
[cited by applicant]
US 8751003B2
· DiUbaldi et al.
· 2014
[cited by applicant]
US 8805472B2
· Iglesias
· 2014
[cited by applicant]
US 8821407B2
· Kirsner
· 2014
[cited by applicant]
US 8914111B2
· Haessler
· 2014
[cited by applicant]
US 8983627B2
· Pelger et al.
· 2015
[cited by applicant]
US 9155885B2
· Wei et al.
· 2015
[cited by applicant]
US 9248285B2
· Haessler
· 2016
[cited by applicant]
US D759813S
· Newman et al.
· 2016
[cited by applicant]
US D759814S
· Newman et al.
· 2016
[cited by applicant]
US 9381351B2
· Haessler
· 2016
[cited by applicant]
US 9408685B2
· Hou et al.
· 2016
[cited by applicant]
US 9656067B2
· Pelger et al.
· 2017
[cited by applicant]
US D800898S
· Sanders et al.
· 2017
[cited by applicant]
US 9861316B2
· Egorov
· 2018
[cited by applicant]
US 9970923B2
· Sturman et al.
· 2018
[cited by applicant]
US 9974635B2
· Rosen et al.
· 2018
[cited by applicant]
US D832437S
· Zeltwanger et al.
· 2018
[cited by applicant]
US D841155S
· McMenamin et al.
· 2019
[cited by applicant]
US D845478S
· Luke
· 2019
[cited by applicant]
US D846120S
· Wallis et al.
· 2019
[cited by applicant]
US D852069S
· Fu
· 2019
[cited by applicant]
US D853035S
· Moretti
· 2019
[cited by applicant]
US D855825S
· Parsons et al.
· 2019
[cited by applicant]
US D877895S
· Sanders et al.
· 2020
[cited by applicant]
US D888949S
· Beer et al.
· 2020
[cited by applicant]
US D889649S
· Beer et al.
· 2020
[cited by applicant]
US D893026S
· Leather
· 2020
[cited by applicant]
US D896958S
· Beer et al.
· 2020
[cited by applicant]
US D896959S
· Beer et al.
· 2020
[cited by applicant]
US D897530S
· Beer et al.
· 2020
[cited by applicant]
US D898911S
· Beer et al.
· 2020
[cited by applicant]
US D899593S
· Beer et al.
· 2020
[cited by applicant]
US D903853S
· Wiegerinck
· 2020
[cited by applicant]
US D903896S
· Tianhao et al.
· 2020
[cited by applicant]
US D908160S
· Sun
· 2021
[cited by applicant]
US D909679S
· Chen
· 2021
[cited by applicant]
US D910851S
· Lagrange et al.
· 2021
[cited by applicant]
US D918390S
· Ollivier
· 2021
[cited by applicant]
US D919083S
· Lee
· 2021
[cited by applicant]
US D923806S
· Bunger von Wurmb et al.
· 2021
[cited by applicant]
US D923876S
· Hasegawa
· 2021
[cited by applicant]
US D938581S
· Floyd et al.
· 2021
[cited by applicant]
US D956229S
· Beer et al.
· 2022
[cited by applicant]
US D958987S
· Beer et al.
· 2022
[cited by applicant]
US 20010001125A1
· Schulman et al.
· 2001
[cited by applicant]
US 20010047132A1
· Johnson et al.
· 2001
[cited by applicant]
US 20020022836A1
· Goble et al.
· 2002
[cited by applicant]
US 20020111586A1
· Mosel et al.
· 2002
[cited by applicant]
US 20020143275A1
· Sarvazyan
· 2002
[cited by examiner]
US 20030028180A1
· Franco
· 2003
[cited by applicant]
US 20030087734A1
· Kring et al.
· 2003
[cited by applicant]
US 20040260207A1
· Eini et al.
· 2004
[cited by applicant]
US 20050148447A1
· Nady
· 2005
[cited by applicant]
US 20050177067A1
· Tracey et al.
· 2005
[cited by applicant]
US 20060084848A1
· Mitchnick
· 2006
[cited by applicant]
US 20060211911A1
· Jao et al.
· 2006
[cited by applicant]
US 20070066880A1
· Lee et al.
· 2007
[cited by applicant]
US 20070265675A1
· Lund et al.
· 2007
[cited by applicant]
US 20070270686A1
· Ritter et al.
· 2007
[cited by applicant]
US 20080077053A1
· Epstein et al.
· 2008
[cited by applicant]
US 20080146941A1
· Dala-Krishna
· 2008
[cited by applicant]
US 20080154131A1
· Lee et al.
· 2008
[cited by applicant]
US 20080171950A1
· Franco
· 2008
[cited by applicant]
US 20090024001A1
· Parks et al.
· 2009
[cited by applicant]
US 20090306509A1
· Pedersen et al.
· 2009
[cited by applicant]
US 20100069784A1
· Blaivas
· 2010
[cited by applicant]
US 20100174218A1
· Shim
· 2010
[cited by applicant]
US 20100222708A1
· Hitchcock et al.
· 2010
[cited by applicant]
US 20100249576A1
· Askarinya et al.
· 2010
[cited by applicant]
US 20100262049A1
· Novak et al.
· 2010
[cited by applicant]
US 20110144458A1
· Gauta
· 2011
[cited by applicant]
US 20110190580A1
· Bennett et al.
· 2011
[cited by applicant]
US 20130035611A1
· White
· 2013
[cited by applicant]
US 20130130871A1
· McCoy et al.
· 2013
[cited by applicant]
US 20130184567A1
· Xie et al.
· 2013
[cited by applicant]
US 20130324380A1
· Horsley
· 2013
[cited by applicant]
US 20140073879A1
· Cantor et al.
· 2014
[cited by applicant]
US 20140213927A1
· Webster et al.
· 2014
[cited by applicant]
US 20140288612A1
· Addington et al.
· 2014
[cited by applicant]
US 20140296705A1
· Iglesias
· 2014
[cited by applicant]
US 20140309550A1
· Iglesias
· 2014
[cited by applicant]
US 20150112230A1
· Iglesias
· 2015
[cited by applicant]
US 20150112231A1
· Iglesias
· 2015
[cited by applicant]
US 20160022198A1
· De Laat
· 2016
[cited by applicant]
US 20160051354A1
· Patankar et al.
· 2016
[cited by applicant]
US 20170281072A1
· Iglesias
· 2017
[cited by applicant]
US 20170281299A1
· Iglesias
· 2017
[cited by applicant]
US 20170291012A1
· Iglesias
· 2017
[cited by applicant]
US 20180199816A1
· Kalt et al.
· 2018
[cited by applicant]
US 20190133738A1
· Rosen et al.
· 2019
[cited by applicant]
US 20200069161A1
· Schentag et al.
· 2020
[cited by applicant]
US 20200146800A1
· Iglesias
· 2020
[cited by applicant]
US 20200405142A1
· Whitaker
· 2020
[cited by applicant]
US 20210106787A1
· Iglesias
· 2021
[cited by applicant]
US 20230201660A1
· Bohorquez et al.
· 2023
[cited by applicant]
US 20230225847A1
· Iglesias
· 2023
[cited by applicant]
CA 2625428A1
· 2007
[cited by applicant]
CA 2862928A1
· 2013
[cited by applicant]
CN 103622710A
· 2014
[cited by applicant]
CN 204839545U
· 2015
[cited by applicant]
DE 10345282B3
· 2005
[cited by applicant]
DE 202018103016U1
· 2018
[cited by applicant]
EP 0268972A2
· 1988
[cited by applicant]
EP 1105040A1
· 2001
[cited by applicant]
EP 1231859A1
· 2002
[cited by applicant]
EP 2429626A2
· 2012
[cited by applicant]
EP 2689724A1
· 2014
[cited by applicant]
EP 2809231A4
· 2015
[cited by applicant]
EP 3366212A1
· 2018
[cited by applicant]
GB 2492754A
· 2013
[cited by applicant]
JP 2002143133A
· 2002
[cited by applicant]
JP 2008532578A
· 2008
[cited by applicant]
JP 2009538176A
· 2009
[cited by applicant]
JP 2011183167A
· 2011
[cited by applicant]
RU 2307636C1
· 2007
[cited by applicant]
WO WO9605768A1
· 1996
[cited by applicant]
WO WO9905963A1
· 1999
[cited by applicant]
WO WO0009013A1
· 2000
[cited by applicant]
WO WO0023030A1
· 2000
[cited by applicant]
WO WO0137732A1
· 2001
[cited by applicant]
WO WO0217987A2
· 2002
[cited by applicant]
WO WO2006107930A2
· 2006
[cited by applicant]
WO WO2007136266A1
· 2007
[cited by applicant]
WO WO2010131252A2
· 2010
[cited by applicant]
WO WO2011050252A1
· 2011
[cited by applicant]
WO WO2011121591A2
· 2011
[cited by applicant]
WO WO2011159906A2
· 2011
[cited by applicant]
WO WO2012079127A1
· 2012
[cited by applicant]
WO WO2012138232A1
· 2012
[cited by applicant]
WO WO2013082006A1
· 2013
[cited by applicant]
WO WO2013115310A1
· 2013
[cited by applicant]
WO WO2013116310A1
· 2013
[cited by applicant]
WO WO2015103629A1
· 2015
[cited by applicant]
WO WO2016026914A2
· 2016
[cited by applicant]
WO WO2016042310A1
· 2016
[cited by applicant]
WO WO2016067023A1
· 2016
[cited by applicant]
WO WO2016119002A1
· 2016
[cited by applicant]
WO WO2016203485A1
· 2016
[cited by applicant]
WO WO2017149688A1
· 2017
[cited by applicant]
WO WO2018023037A1
· 2018
[cited by applicant]
WO WO2019084468A1
· 2019
[cited by applicant]
WO WO2019084469A1
· 2019
[cited by applicant]
WO WO2019200222A1
· 2019
[cited by applicant]
WO WO2019210204A1
· 2019
[cited by applicant]
WO WO2020092343A1
· 2020
[cited by applicant]
Glazer et al., “Pelvic floor muscle biofeedback in the treatment of urinary incontinence: A literature review,” Appl Psychophysiol Biofeedback. 31(3):187-201 (2006) (Abstract only).
[cited by applicant]
[cited by applicant]
Kandadai et al., “Correct Performance of Pelvic Muscle Exercises in Women Reporting Prior Knowledge,” Female Pelvic Med Reconstr Surg. 21(3):135-40 (2015).
[cited by applicant]
Malcovati et al., Interface Circuitry and Microsystems.
[cited by applicant]
Moen et al., “Pelvic floor muscle function in women presenting with pelvic floor disorders,” Int Urogynecol J Pelvic Floor Dysfunct. 20(7):843-6 (2009).
[cited by applicant]
Nygaard et al., “Efficacy of pelvic floor muscle exercises in women with stress, urge, and mixed urinary incontinence,” Am J Obstet Gynecol. 174(1 Pt 1):120-125 (1996) (Abstract only).
[cited by applicant]
Parekh et al., “The role of pelvic floor exercises on post-prostatectomy incontinence,” J Urol. 170(1):130-33 (2003) (Abstract Only) (2 pages).
[cited by applicant]
Rosenbaum, “Pelvic floor involvement in male and female sexual dysfunction and the role of pelvic floor rehabilitation in treatment: a literature review,” J Sex Med. 4(1):4-13 (2007) (Abstract only) (2 pages).
[cited by applicant]
Rosenbaum et al., “The Role of Pelvic Floor Physical Therapy in the Treatment of Pelvic and Genital Pain-Related Sexual Dysfunction,” J Sex Med. 5(3): 513-23 (2008).
[cited by applicant]
Rosenblatt et al., “Evaluation of an accelerometer-based digital health system for the treatment of female urinary incontinence: A pilot study,” Neurourol Urodyn. 38(7): 1944-1952 (2019).
[cited by applicant]
Rosenblatt et al., “Interactive Pelvic Floor Muscle Training for Female Urinary Incontinence,” Renovia, Inc., retrieved Apr. 30, 2019 from <renoviainc.com/wp-content/uploads/2018/04/REN005.01-White-Paper-12Apr18-FINAL.p…
[cited by applicant]
[cited by applicant]
First Examination Report for Australian Patent Application No. 2017245476, dated Sep. 12, 2018 (3 pages).
[cited by applicant]
First Office Action for Mexican Patent Application No. MX/a/2014/006219, dated Jul. 31, 2017 (7 pages).
[cited by applicant]
Examination Report for Canadian Patent Application No. 2,856,724, dated Oct. 18, 2018 (3 pages).
[cited by applicant]
Extended European Search Report for European Patent Application No. 17203166.8, dated Jul. 31, 2018 (10 pages).
[cited by applicant]
Communication pursuant to Article 94(3) EPC for European Patent Application No. 12852598.7, dated Jun. 6, 2018 (4 pages).
[cited by applicant]
First Examination Report for Australian Patent Application No. 2018200715, dated Jun. 26, 2018 (4 pages).
[cited by applicant]
International Preliminary Report on Patentability for International Application No. PCT/US2017/044444, mailed Feb. 7, 2019 (14 pages).
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US17/44444, mailed Oct. 19, 2017 (21 pages).
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US18/57811, mailed Jan. 29, 2019 (18 pages).
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2019/029400, mailed Jul. 10, 2019 (17 pages).
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2019/027168, mailed Aug. 12, 2019 (39 pages).
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2012/066613, mailed Feb. 6, 2013 (5 pages).
[cited by applicant]
Second Examination Report for Canadian Patent Application No. 2,862,928, dated Nov. 20, 2018 (5 pages).
[cited by applicant]
Summons to attend oral proceedings pursuant to Rule 115(1) EPC, issued on Aug. 3, 2017 by the European Patent Office related to the European Patent Application No. 13743383.5 (10 pages).
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2019/058527, mailed Feb. 21, 2020 (18 pages).
[cited by applicant]
Office Action for Japanese Patent Application No. 2019-504938, dated May 18, 2021 (10 pages).
[cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2021/033155, mailed Aug. 25, 2021 (19 pages).
[cited by applicant]
Communication pursuant to Article 94(3) EPC for European Patent Application No. 15733078.8, dated Aug. 24, 2021 (8 pages).
[cited by applicant]
Office Action for Japanese Patent Application No. 2020-143711, dated Sep. 8, 2021 (4 pages).
[cited by applicant]
First Examination Report for Australian Patent Application No. 2020281099, dated Nov. 2, 2021 (6 pages).
[cited by applicant]
Office Action for Brazilian Patent Application No. BR112019001746-1, dated Dec. 10, 2021 (5 pages).
[cited by applicant]
Extended European Search Report for European Patent Application No. 19793343.5, dated Jan. 27, 2022 (7 pages).
[cited by applicant]
Notice of Preliminary Rejection for Korean Patent Application No. 10-2019-7005863, dated Jan. 26, 2022 (17 pages).
[cited by applicant]
Office Action for Chinese Patent Application No. 201780060078.4, issued Jan. 17, 2022 (20 pages).
[cited by applicant]
Office Action for Japanese Patent Application No. 2019-504938, dated Feb. 8, 2022 (13 pages).
[cited by applicant]
Office Action for Chinese Patent Application No. 201880083895.6, dated Feb. 8, 2022 (24 pages).
[cited by applicant]
Extended European Search Report for European Patent Application No. 19786241.0, dated Apr. 29, 2022 (10 pages).
[cited by applicant]
Notice of Reasons for Refusal for Japanese Patent Application No. 2020-143711, mailed May 9, 2022 (7 pages).
[cited by applicant]
Office Action for Chinese Patent Application No. 201780060078.4, issued Apr. 13, 2022 (19 pages).
[cited by applicant]
Extended European Search Report for European Patent Application No. 19878836.6, dated Jun. 1, 2022 (7 pages).
[cited by applicant]
Office Action for Canadian Patent Application No. 2,936,061, dated Jun. 23, 2022 (4 pages).
[cited by applicant]
Notice of Last Preliminary Rejection for Korean Patent Application No. 10-2019-7005863, dated Jul. 28, 2022 (4 pages).
[cited by applicant]
Office Action for Brazilian Patent Application No. BR112020008231-7, dated Sep. 7, 2022 (5 pages) (Informal translation of Office Action included).
[cited by applicant]
Extended European Search Report dated Aug. 16, 2017 issued in related EP Application No. 15733078.8 filed Aug. 2, 2016 (6 pages).
[cited by applicant]
International Search Report and Written Opinion, dated Mar. 26, 2015, issued in International Application No. PCT/US2015/010356, filed on Jan. 6, 2015 (5 pages).
[cited by applicant]
Office Action for Chinese Patent Application No. 201880083895.6 dated Oct. 25, 2022 (8 pages).
[cited by applicant]
Office Action for European Patent Application No. 17203166.8, dated Aug. 29, 2023 (6 pages).
[cited by applicant]
Cited By (1)