WO2020247717A1 - System and method for paraurethral support restoration to treat stress incontinence - Google Patents
System and method for paraurethral support restoration to treat stress incontinence Download PDFInfo
- Publication number
- WO2020247717A1 WO2020247717A1 PCT/US2020/036266 US2020036266W WO2020247717A1 WO 2020247717 A1 WO2020247717 A1 WO 2020247717A1 US 2020036266 W US2020036266 W US 2020036266W WO 2020247717 A1 WO2020247717 A1 WO 2020247717A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- introducer
- trocar
- distal end
- suture
- lumen portion
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0482—Needle or suture guides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0483—Hand-held instruments for holding sutures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00805—Treatment of female stress urinary incontinence
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06166—Sutures
- A61B2017/06176—Sutures with protrusions, e.g. barbs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0807—Indication means
- A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
- A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
- A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
- A61F2/0045—Support slings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
- A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
Definitions
- the present invention is directed to treatments and devices for incontinence. More specifically, disclosed are devices and methods for treatment of female stress incontinence through restoration of paraurethral support.
- This paraurethral support maintains urethral length and kinking at the bladder neck during strain maneuvers such as coughing. With the vaginal delivery process and repetitive life-long increases in intra-abdominal pressure, the paraurethral support mechanism becomes attenuated resulting in impaired urethral support, excess urethral mobility, and the development of stress urinary incontinence.
- the object of the present invention is to restore bilateral longitudinal parallel paraurethral support in order to restore continence in women with stress incontinence due to loss of paraurethral support.
- the present invention provides a system, and a method of use to implement a novel treatment to restore bilateral longitudinal parallel paraurethral support, the system comprising at least one rigid trocar, at least one flexible introducer, and one or more flexible barbed suture-type devices. These components are used cooperatively to implant the one or more barbed suture-type devices in the patient bilaterally parallel to the urethra and attached to suprapubic support structures including fascia and ligaments. Once properly implanted the barbed suture-type devices provide sufficient paraurethral support to restore continence in the patient.
- FIG. 1 illustrates a trocar component in accordance with one embodiment the present invention.
- FIG. 2 illustrates an introducer component in accordance with one embodiment the present invention.
- FIG. 3 illustrates a barbed suture-type device component in accordance with one embodiment the present invention.
- FIG. 4 illustrates a cross sectional view of the female urethra showing the general target placement for the barbed suture components in accordance with one embodiment of the present invention
- FIGS. 5A and 5B illustrate, respectively, frontal and sagittal views of the bladder with barbed suture components in place bilaterally in accordance with one embodiment of the present invention.
- FIG. 6 illustrates a sagittal view of the top of the urethra with barbed suture-type device components in place bilaterally in accordance with one embodiment of the present invention.
- the component devices of the system of the present invention comprise at least one trocar (100), at least one introducer (200); and at least one barbed suture-type device (300). Because in almost all situations the barbed suture-type device (300) will be implanted bilaterally to the urethra, at least two barbed suture-type devices (300) will be required in most cases. However, it is not beyond the scope of the present invention to utilize a single barbed suture- type device (300) applied unilaterally. Moreover, where additional support is required, multiple barbed suture-type devices (300) may be implanted on either, or both, sides of the urethra. Therefore, it is also possible for the system to comprise more than two barbed suture-type devices (300).
- the purpose of the trocar (100) and introducer (200) is to aid in the implanting of the barbed suture-type device (300) along the urethral length to restore physiologic paraurethral support.
- the trocar (100) comprises a lumen portion (101) having proximal and distal ends (102,103) as well as proximal and distal openings (104,105).
- the lumen portion (101) may be straight or curved to accommodate anatomical variations.
- a handle (106) attached near the proximal end (102) is adapted to permit manipulation of the trocar (100) during use.
- the tip of the distal end (103) of the lumen portion (101) may be sharpened to ease introduction.
- the bore of the lumen portion (100) is large enough to accommodate the outside diameter of introducer (200) (e.g. 14G) and is adapted to be inserted on either side of the urethral meatus.
- introducer (200) comprises a substantially elongated hollow cylindrical body (201) having proximal and distal ends (202,203), as well as distal and proximal openings (204,205) disposed therein.
- the body is of sufficient length to traverse the entire length of the lumen portion (101) of the trocar (100).
- the outer diameter of the body (201) must be small enough to fit within the lumen portion (101).
- the inner diameter of the body (201) must be large enough to permit at least one barbed suture-type device (300) fit within it.
- the distal end (203) of the introducer (200) may optionally be curved to facilitate placement of the barbed suture-type device (300) during the procedure and to prevent bladder wall perforation.
- the introducer (200) may optionally also include indicia (not shown) on the proximal end (202) to indicate the orientation of the curved distal end (203).
- the construction of the introducer (200) is substantially flexible but resilient.
- the optional curved tip can be straightened for introduction into, and advancement through the lumen portion (101) of the trocar (100) but will immediately spring back to its curved shape when it emerges from the distal opening (105) of the trocar (100).
- Introducer (200) may be made up from aa number of different surgically suited flexible materials including nitinol, polycarbonates, metals, and the like.
- barbed suture-type device (300) comprises a central elongated suture-type thread (301), having a proximal end (302) and a distal end (303), and a plurality of short barbs (304) extending from the thread (301).
- the barbs (304) may extend in the direction of the proximal end (302) or in the direction of the distal end (303).
- Barbs (304) extending in the direction of the proximal end
- the amount of resistance to movement, and thus the level of support, provided by the barbed suture-type device, can be adjusted by varying the flexibility of the barb material, or by changing the density of the barbs (304) within the thread.
- barb (304) flexibility, density, direction, and placement may vary along the length of the thread (301) to provide various levels of resistance along the length of the device.
- the barbed suture-type device (300) comprises a semi-rigid but bendable material, such as polypropylene, and the like.
- the barbed suture-type device (300) is of a size adapted to be loaded into the introducer (200) and advanced through the trocar (200) (e.g. size A #1 to #3 sutures) to be positioned along the length of the urethra from the top of the pubic bone, with attachment of the abdominal wall fascia, to the external urethral meatus.
- Proximal end (302) of the barbed suture-type device (300) may optionally comprise a needle tip, soft tissue anchor, or dart (not shown) adapted to penetrate through the ipsilateral Cooper’s ligament.
- the procedure of the present invention may be performed in the doctor’s office or in the surgical suite. A diagnosis of stress urinary incontinence is made. Urethral mobility is assessed.
- the patient is placed in stirrups and a Foley catheter is placed in the bladder.
- a rigid catheter guide can optionally be placed into the foley catheter lumen in order to clearly identify the location of the urethra during the surgical procedure.
- Local anesthetic e.g. 1% lidocaine
- 1% lidocaine is injected along the length of the urethra to the bladder neck and suprapubic lower abdominal wall bilaterally.
- the trocar (100) is inserted a few millimeters lateral the urethral meatus (see FIG. 4, locations 401 and 402) and advanced along the urethra to the top of the pubic bone and until it indents the abdominal fascia and is palpable through the abdominal wall skin.
- the trocar can be directed towards the medial portion of the ipsilateral Cooper’s ligament. This is performed bilaterally.
- Cystoscopy is performed with a 70 scope to confirm bladder wall integrity. If the bladder was perforated, the trocar (100) is repositioned, and cystoscopy repeated.
- the barbed suture-type device (300) is loaded onto the introducer (200) by inserting the distal end (303) of the barbed suture-type device (300) into the proximal opening (204) of the introducer (200).
- the barbed suture-type device (300) is pushed through the introducer (200) until the distal end (303) of the barbed suture- type device (300) emerges out of the distal opening (205) of the introducer (200).
- the distal end (203) of the suture-loaded introducer (200) is then inserted into the proximal opening (104) of the trocar (100) and advanced along the lumen portion (101) of the trocar (100) until the distal end (203) of the introducer (200) is palpable along the anterior abdominal wall.
- the introducer (200) is advanced until it is positioned at the desired position, possibly through Cooper’s ligament and even full thickness through the abdominal wall skin and held in place, The trocar (100) is then removed.
- the barb (304) direction on the barbed suture-type device (300) can vary depending on support needs. For example, facing proximally at one end and distally at the other.
- barbed suture-type device (300) More than one barbed suture-type device (300) per side of the urethra may be required to enhance support.
- the distal and/or proximal end (302,302) of barbed suture-type device (300) may require a higher density of polypropylene and type of barbs in order to enhance support.
- the barbed suture-type device (300) may be advanced over top of pubic bone or into Cooper’s ligament (using a curved tip introducer (200)) or simply towards abdominal wall (using a straight tip introducer (not shown)).
- a soft tissue anchor may be optionally used at the distal end of barbed suture-type device (300) to enhance support.
- FIGS. 5A and 5B Shown in FIGS. 5A and 5B respectively, are frontal and sagittal views of the bladder with barbed suture-type devices (300) in place bilaterally after placement using the above-described method.
- FIG. 6 illustrates a sagittal view of the top of the urethra with barbed suture-type devices (300) in place bilaterally in accordance with the present invention.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Molecular Biology (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pathology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Prostheses (AREA)
- Surgical Instruments (AREA)
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA3142732A CA3142732A1 (en) | 2019-06-06 | 2020-06-05 | System and method for paraurethral support restoration to treat stress incontinence |
EP20817811.1A EP3979920A4 (en) | 2019-06-06 | 2020-06-05 | System and method for paraurethral support restoration to treat stress incontinence |
AU2020287355A AU2020287355A1 (en) | 2019-06-06 | 2020-06-05 | System and method for paraurethral support restoration to treat stress incontinence |
US17/435,932 US11376041B2 (en) | 2019-06-06 | 2020-06-05 | System and method for paraurethral support restoration to treat stress incontinence |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201962857918P | 2019-06-06 | 2019-06-06 | |
US62/857,918 | 2019-06-06 |
Publications (1)
Publication Number | Publication Date |
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WO2020247717A1 true WO2020247717A1 (en) | 2020-12-10 |
Family
ID=73652273
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2020/036266 WO2020247717A1 (en) | 2019-06-06 | 2020-06-05 | System and method for paraurethral support restoration to treat stress incontinence |
Country Status (5)
Country | Link |
---|---|
US (1) | US11376041B2 (en) |
EP (1) | EP3979920A4 (en) |
AU (1) | AU2020287355A1 (en) |
CA (1) | CA3142732A1 (en) |
WO (1) | WO2020247717A1 (en) |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6068591A (en) * | 1998-02-17 | 2000-05-30 | Bruckner; Norman I. | Pubo-urethral support harness apparatus for percutaneous treatment of female stress urinary incontinence |
US6752814B2 (en) * | 1997-02-13 | 2004-06-22 | Scimed Life Systems, Inc. | Devices for minimally invasive pelvic surgery |
US20060173468A1 (en) * | 2005-01-28 | 2006-08-03 | Marc Simmon | Obturator introducer with snare |
US8467875B2 (en) * | 2004-02-12 | 2013-06-18 | Medtronic, Inc. | Stimulation of dorsal genital nerves to treat urologic dysfunctions |
US8944990B2 (en) * | 2008-10-27 | 2015-02-03 | Ams Research Corporation | Surgical needle and anchor system with retractable features |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
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US7758594B2 (en) * | 2005-05-20 | 2010-07-20 | Neotract, Inc. | Devices, systems and methods for treating benign prostatic hyperplasia and other conditions |
AU2007253683B2 (en) * | 2006-05-19 | 2012-12-06 | Boston Scientific Scimed, Inc. | Method and articles for treatment of stress urinary incontinence |
US9282958B2 (en) * | 2007-12-28 | 2016-03-15 | Boston Scientific Scimed, Inc. | Devices and method for treating pelvic dysfunctions |
US9955963B2 (en) * | 2011-07-08 | 2018-05-01 | Smith & Nephew, Inc. | Soft tissue repair |
US9414903B2 (en) * | 2011-07-22 | 2016-08-16 | Astora Women's Health, Llc | Pelvic implant system and method |
US9826972B2 (en) * | 2011-10-24 | 2017-11-28 | C.R. Bard, Inc. | Instruments for delivering transfascial sutures, transfascial suture assemblies and methods of transfascial suturing |
WO2018191661A1 (en) * | 2017-04-14 | 2018-10-18 | The Research Foundation For The State University Of New York | Suturing device and methods of use thereof |
KR101878258B1 (en) * | 2018-01-11 | 2018-08-17 | 주식회사 오브이월드 | Medical suture material insertion tool |
-
2020
- 2020-06-05 CA CA3142732A patent/CA3142732A1/en active Pending
- 2020-06-05 EP EP20817811.1A patent/EP3979920A4/en active Pending
- 2020-06-05 WO PCT/US2020/036266 patent/WO2020247717A1/en active Application Filing
- 2020-06-05 AU AU2020287355A patent/AU2020287355A1/en active Pending
- 2020-06-05 US US17/435,932 patent/US11376041B2/en active Active
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6752814B2 (en) * | 1997-02-13 | 2004-06-22 | Scimed Life Systems, Inc. | Devices for minimally invasive pelvic surgery |
US6068591A (en) * | 1998-02-17 | 2000-05-30 | Bruckner; Norman I. | Pubo-urethral support harness apparatus for percutaneous treatment of female stress urinary incontinence |
US8467875B2 (en) * | 2004-02-12 | 2013-06-18 | Medtronic, Inc. | Stimulation of dorsal genital nerves to treat urologic dysfunctions |
US20060173468A1 (en) * | 2005-01-28 | 2006-08-03 | Marc Simmon | Obturator introducer with snare |
US8944990B2 (en) * | 2008-10-27 | 2015-02-03 | Ams Research Corporation | Surgical needle and anchor system with retractable features |
Non-Patent Citations (1)
Title |
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See also references of EP3979920A4 * |
Also Published As
Publication number | Publication date |
---|---|
CA3142732A1 (en) | 2020-12-10 |
EP3979920A1 (en) | 2022-04-13 |
US20220125481A1 (en) | 2022-04-28 |
US11376041B2 (en) | 2022-07-05 |
AU2020287355A1 (en) | 2021-12-23 |
EP3979920A4 (en) | 2023-07-05 |
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