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WO2025081172A1 - Systèmes et méthodes pour traiter l'incontinence urinaire d'effort - Google Patents

Systèmes et méthodes pour traiter l'incontinence urinaire d'effort Download PDF

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Publication number
WO2025081172A1
WO2025081172A1 PCT/US2024/051302 US2024051302W WO2025081172A1 WO 2025081172 A1 WO2025081172 A1 WO 2025081172A1 US 2024051302 W US2024051302 W US 2024051302W WO 2025081172 A1 WO2025081172 A1 WO 2025081172A1
Authority
WO
WIPO (PCT)
Prior art keywords
anchor
vaginal
tether
tissue
housing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/051302
Other languages
English (en)
Inventor
Jon I. EINARSSON
James Bleck
John Aho
Jonathan Towle
Gerald I. Brecher
Aidan Linton
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Freyja Healthcare LLC
Brigham and Womens Hospital Inc
Original Assignee
Freyja Healthcare LLC
Brigham and Womens Hospital Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US18/525,687 external-priority patent/US12336897B2/en
Application filed by Freyja Healthcare LLC, Brigham and Womens Hospital Inc filed Critical Freyja Healthcare LLC
Publication of WO2025081172A1 publication Critical patent/WO2025081172A1/fr
Priority to US19/224,766 priority Critical patent/US20250288324A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00535—Surgical instruments, devices or methods pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409—Instruments for applying suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0414—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0417—T-fasteners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0445—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors cannulated, e.g. with a longitudinal through-hole for passage of an instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0448—Additional elements on or within the anchor
    • A61B2017/045—Additional elements on or within the anchor snug fit within the anchor
    • A—HUMAN NECESSITIES
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    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods 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
    • A61B2017/06052—Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods 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
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320044—Blunt dissectors
    • 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
    • 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
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • 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
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/92—Identification means for patients or instruments, e.g. tags coded with colour
    • 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
    • A61F2/005—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 with pressure applied to urethra by an element placed in the vagina

Definitions

  • Stress urinary incontinence affects around 15-60% of women during their lifetime. Urine leakage happens when the person laughs, coughs, sneezes, lifts things, or during exercise.
  • the current standard of care for surgical treatment of stress urinary incontinence is the polypropylene mesh vaginal sling procedure. This has the highest efficacy as well as the highest improvement in quality of life of any SUI procedure.
  • polypropylene mesh has recently come under severe scrutiny due to risks such as infection and erosion, and the use of vaginal mesh has been largely abandoned for the surgical treatment of pelvic organ prolapse.
  • Fig. IB The autologous sling procedure is illustrated in Fig. IB.
  • a harvested strip of rectus fascia is placed transvaginally at the level of the proximal urethra.
  • the fascial strip is secured superiorly to the rectus fascia (rectus abdominus muscle) with permanent sutures. This forms a sling underneath the urethra close to the bladder neck. This in turn helps to elevate and stabilize the bladder neck and the urethra.
  • the disclosure provides methods and devices for treating stress urinary incontinence (SUI).
  • SUI stress urinary incontinence
  • the system can further include at least one pull wire coupled to the actuator and to the tissue anchor, wherein pulling the at least one pull wire byway of the actuator causes the tissue anchor to separate from the elongate shaft.
  • the system can further include at least one push rod coupled to a further actuator, wherein the at least one push rod is configured to be advanced distally to change the orientation of the tissue anchor after the tissue anchor has been separated from the elongate shaft.
  • the elongate shaft can define at least one lumen along its length. Each of the pull wire and the push rod can traverse at least part of the length of the elongate shaft from the housing to the tissue anchor.
  • the tissue anchor can form a leading end of the system and includes a tissue dissection tip.
  • the tether can pass through an opening defined in the anchor. The first and second ends of the tether can be coupled to the housing.
  • the method can include delivering a tether along a first pathway from a location inside the vagina to a location proximate to the rectus abdominus, wherein the first pathway is laterally offset from the urethra, deploy ing a fascial anchor anterior to the rectus abdominus attached to a first end of the tether, coupling a vaginal anchor to a second end of the tether inside the vaginal canal, and applying tension to the tether and raising the vaginal anchor to lift the anterior wall of the vaginal canal.
  • At least one of the first pathway and second pathway can pass near the mid-urethra.
  • the other of the first pathway and second pathway can pass near the bladder neck.
  • a first tether can be connected to a first vaginal anchor inside the vaginal canal, and a second tether can be connected to a second vaginal anchor inside the vaginal canal.
  • any system as described herein can further include matrix material to induce scarring in the region of the procedure.
  • the matrix material can be coupled to the tether.
  • the matrix material can be made at least in part from a bioresorbable material.
  • the bioresorbable material can include at least one of Poly polydioxanone (PDS), Poly(lactic acid), Poly D Lactic Acid, and Poly L Lactic Acid.
  • PDS Poly polydioxanone
  • the matrix material can be integrally formed with the tether.
  • Fig. IB illustrates an example of an autologous sling procedure, as is known in the art.
  • Fig. 13B is a further isometric cross-sectional view of the vaginal anchor Figs. 6A-6B showing internal components of the anchor holding the suture in place in a fully locked position.
  • Fig. 14 is an upper isometric view of a representative embodiment of a delivery system in accordance with the present disclosure.
  • Figs. 19A-19C present upper isometric, proximal isometric, and lower isometric views of a first portion of a housing of the delivery system of Fig. 14.
  • Figs. 22-24 are a partial isometric exploded views of a portion of the delivery system of Fig. 14 illustrating aspects of retainer blocks of the system and guide and alignment plates of the delivery system.
  • Figs. 27A-27C are various isometric views of a distal portion of the delivery system of Fig. 14 that couples to the fascia anchor of the system of Fig. 14.
  • Figs. 29A-29B are isometric views of the fascia anchor and a distal end portion component of the delivery system of Fig. 14.
  • Fig. 32-35 are closeup isometric views of a proximal end portion of a handle portion of the delivery system of Fig. 14.
  • Figs. 83A-83C are views of the vaginal anchor adjustment tool of Fig. 79A showing the tool engaged with the vaginal anchor with the vaginal anchor in a locked position against the sutures.
  • Fig. 87 is an isometric view of the vaginal anchor adjustment tool disengaged from the vaginal anchor.
  • an illustrative procedure begins by first placing a urinary catheter, such as a conventional Foley -ty pe catheter, into the urethra and into the bladder and inflated at its distal end to hold it in place (not shown). The bladder is drained by way of the urinary catheter.
  • a catheter as described in U.S. Patent Application Serial No. 63/012,056, filed April 17, 2020, which is incorporated by reference herein in its entirety 7 , can be used instead.
  • the sutures 30 can be unfastened, the vaginal anchor can be raised to reduce the distance between the fascial anchor 20 and the vaginal anchor 40, and the sutures 30 can then be refastened.
  • the patient will typically realize that either condition has occurred within a couple of days, long before the repair has had time to scar in place.
  • the anchor can be engaged or disengaged with the suture, as appropriate, by way of depressing an actuator or a friction lock incorporated into the suture path, or by toggling a mechanical switch that, in a first position, locks the suture in place, and in a second position, lets the suture slide through the vaginal anchor.
  • the suture path can include a wedge-shaped lock that can include teeth or undulations, for example, that slides into a keyed slot that when fully inserted j ams the suture in place, and when partially retracted, permits the suture to move freely or under a detectable amount of physical resistance.
  • Fig. 4 presents a schematic of one example of a vaginal anchor 40 in accordance with the present disclosure.
  • the anchor 40 can be bounded by an atraumatic low profile lozengelike body 42 and includes first and second suture entrances for receiving sutures 30 (SI and S2) on an upper side of the anchor, and a suture exit port that can be directed toward the vaginal entrance that can include a mechanical lock 46, such as a wedge lock that is received by an interference fit inside of the lock body.
  • the wedge body of the lock 46 can be disengaged, for example, by a suitably configured hand tool (not shown).
  • Fig. 5 presents a schematic depicting aspects of a further embodiment of a vaginal anchor in accordance with the present disclosure.
  • a suture 30 with barbs 32 facing in opposing directions is provided that is directed through the fascia as described above wherein the barbs prevent the suture from backing out.
  • a second portion of the suture has opposing faced barbs to pass through the vaginal anchor.
  • the barbs can be collapsed by advancing a tubular tool or hollow needle over the suture to permit the anchor to be loosened. Tightening the anchor can be accomplished by simply advancing the anchor over the barbs of the barbed suture.
  • housing component 144 includes a pair of spaced apart generally parallel plates 145 that define a cavity 7 145a therebetween through which sutures 130 pass, as well as through openings 146 in the sidewall 144a of component 144.
  • the plates 145 are generally tongue-shaped, and each said plate 145 is received by a corresponding canty 142a (Fig. 12B) of housing component 142.
  • Each plate 145 extends outwardly from the peripheral wall 144a of the housing component 144.
  • Housing component 142 defines two outwardly extending arms having barbs 141 thereon that slide into corresponding cavities, or tracks 141a within housing component 144.
  • Housing component 142 further defines an outward projection 147 that is slidably received within cavity 145a of housing component 144 that urges against sutures 130 to hold them in place within housing component 144.
  • FIGs. 25A-26B are enlarged isometric views of a distal portion of the system of Fig. 14 illustrating aspects of a fascial anchor portion of the system.
  • Anchor assembly 120 is formed from two portions, a first, proximal portion 124 that is attached to the distal end of the tubular member, and a second, distal portion 122 that is removably attached to proximal portion 124 by a pull wire 126.
  • Pull wire 126 traverses passages through both components to hold the components in alignment as they are being advanced through tissue.
  • the components 124, 122 are further held together by a keyed arrangement wherein, when the push or pull rod 126 is in place, the components 122, 124 cannot separate along an axial, lateral or rotational direction.
  • Figs. 27A-27C are various isometric views of the proximal portion 124 of the anchor assembly 120 that couples to the distal removable section 122 of the anchor assembly.
  • Component 124 includes a proximal end that begins in a crescent shaped sleeve 124f that is received by a lumen of tubular member 112 and coupled thereto by any suitable technique (adhesive, welding, and the like).
  • the main body of component 124 is generally cylindrical and elongate, includes a scalloped or recessed section 124r between its ends, and includes a rounded or fist-shaped, rounded distal end 124b.
  • the wire 126 is withdrawn by removing tape 166 (or other retainer) and proximally advancing block 1 15 that is attached to wire 126.
  • This causes the wire 126 to retreat out of the distal anchor 122, freeing the anchor from the mechanism except for tension applied to the tether or suture 130, which is routed through the opening 122a of component 122.
  • pushrod or push tube 128 is pushed distally by removing tape 164 from the housing 110, permitting block 114, which is attached to the proximal end of the wire or tube or rod 128, to be advanced distally out through opening 128a, and into surface 128c.
  • the balloon 480 can be deflated, the device can be withdrawn proximally slightly (e.g., several centimeters), and the balloon 480 can be re-inflated to dissect additional tissue. After the procedure is completed, the dissected tissue will be located along the path of the tether(s) 430. Disturbing the tissue via blunt dissection can enhance the formation of scar tissue to hold the repair in place that is provided by the procedure.
  • Tether(s) 430 are directed through an opening 422a in a lower side of fascial anchor 422, also discussed in further detail below.
  • Fig. 49 provides a slightly enlarged view of a distal portion of device 400 compared to Fig. 48. Visible is a top window 425 in fascial anchor 422 not discussed above. Window 425, and a lower window’ in component 424 permits direct visualization of wire 426 when coupling the fascial anchor 422 to mount 424 to ensure alignment.
  • Fig. 50 presents a view similar to Fig. 49 but along a proximal-distal direction.
  • tether 430 passes through passage 422a in anchor 422.
  • the anchor 422 can rotate about curved distal end 424b of component 424.
  • Fig. 58 depicts a cutaway view of the distal region of device 400 in the region of crimp 412c.
  • outer tubular member includes a continuous annular crimp (or could include one or more discrete crimps) that effectively clamp outer tubular member 412c to inner tubular member 420.
  • a portion of fluid flow passage 421 defined between an inner cylindrical surface of outer tubular member 412 and an outer surface of inner tubular member 420.
  • the components are welded or bonded with adhesive as appropriate.
  • the balloon 480 can be bonded to the tubular member 412 by an adhesive such as cyanoacrylate of the like.
  • Figs. 59-63 present various cutaway central views (similar to the prior figures) along a vertical direction through handle component 410 and strain relief section 416.
  • handle component 410 is comprised of an upper housing section 410a that interfits with a lower housing section 410b.
  • strain relief section 416 surrounds a proximal region of tubular member 412, and can be coupled thereto via an interference fit, and/or adhesive that can be deposited into openings 416a.
  • Tubular member 420 is contained concentrically within tubular member 412.
  • Wire 426 is further disposed within an inner lumen defined along the length of tubular member 420.
  • the fluid opening and passage 490a traverses the body of component 490 until it intersects a second fluid passage 490b oriented along the centerline of tubular sections 412, 420.
  • Tubular member 420 passes through passage 490b through body 490, and tubular member 412, which concentrically surrounds tubular member 420, is received by interference fit within a distal seal or o-ring 423a that is lodged within an entrance of passage 490b.
  • One or more passages are defined through the wall of member 412 to place bore 490a in fluid communication with annular flow’ passage 421.
  • Figs. 76A-87 depict aspects of a further implementation of a vaginal anchor in accordance wi th the present disclosure, and its manner of use alone and with respect to an adjustment tool that can lock and unlock the vaginal anchor in place on a tether.
  • Fig. 81 A and 8 IB depict opposing side isometric view's of the inner body or plunger 510 of tool 500.
  • the inner body 510 includes a handle 512 at its proximal end and includes a distally extending shaft 516 that terminates in a distal end portion 514.
  • the shaft 516 defines a rectangular or square cross sectional portion that is received by a corresponding and matching portion of the cavity within housing 520 to prevent relative rotation of the plunger 510 and housing 520 when those components are in an assembled condition.
  • a protrusion 519 can be provided on one or both sides of the shaft 516 to be received within a corresponding opening 529 of handle 525 of housing 520 (Fig. 83A).
  • Fig. 82A is an isometric view of an outer portion or housing 520 of the tool 500 of Fig. 79A.
  • Figs. 82B and 82C are isometric end views of the outer portion of the housing 520 of the tool 500showing each side of the distal end portion 524 of the tool 500 which is essentially symmetrical.
  • Fig. 82D is a view of the distal end portion of the tool showing hidden structures in dashed lines.
  • housing 520 of tool 500 includes a tubular body that defines a passageway along its length that may have a round and/or square crosssection.
  • Housing 520 is elongate and includes a proximal handle portion 525 and grip surfaces 527, 528, wherein a user can insert their fingers between surfaces 527, 528 to hold tool 500.
  • the proximal handle 525 is defined by two parallel surfaces that each include an opening 529 therethrough to receive boss 519 of the plunger 510.
  • the openings 529 are generally rectangular with a narrowed center region that the boss 519 needs to slide over to place the anchor 540 into a locked or unlocked condition as described below.
  • Indicia 523 A, 523B (Fig. 83A) are provided to indicate to a user when the anchor is locked or unlocked when in the device.
  • Figs. 83A-83C are views of the vaginal anchor adjustment tool 500 of Fig. 79A showing the tool 500 engaged with the vaginal anchor 540 with the vaginal anchor 540 in a locked position against the sutures.
  • the tool can be used to loosen the anchor from the sutures after the procedure has initially been performed, resulting in the locking of the vaginal anchors 540 by the doctor.
  • the sutures or tethers 430 are introduced into the device by first inserting the lock pin 542 and anchor body 544 into the cavity at the end of the tool 540 until the head 542A of the lock pin 542 is inserted into the cavity 518A of the plunger 510.
  • the anchor 540 is still fully locked together, evidenced by the pin 519 residing in the distal lobe of the slot 529.
  • the relative axial position of the anchor body 544 is held in registration with the housing 520 because the sutures 430 that pass through the anchor body 544 are trapped in place along an axial direction by slots 526B in the distal end region 524 of the housing 520.
  • the plunger 510 which can be pulled proximally with respect to housing 520, is axially coupled to the head 542A of the lock pin 542.
  • Figs. 86A and 86B show opposing longitudinal cutaway views of the distal portion of the vaginal anchor adjustment tool 500 wherein the lock pin 542 is pulled proximally by the plunger 510 to permit movement of the vaginal anchor 540 along the sutures 430.
  • Fig. 86C shows the inner portion 510 of the adjustment tool 500 advanced distally to engage the lock pin 542 with the body 540 of the anchor to lock the sutures 430 into place.
  • the anchor 540 can be relocked onto the sutures 430 by moving the plunger510 of the tool distally with respect to the housing 520. This pushes lock pin 542 back into the anchor body 544, locking the sutures in place once again.
  • the tool 500 can then be removed from the anchor and sutures, by rotating the tool in an opposite direction to permit the sutures to rotate out of the slots 526B, and the head 542A of the anchor pin 542 to once again realign with opening 518 at the distal end of the plunger 510. This permits the tool 500 to be pulled in a proximal direction off of the anchor 540 and sutures 430 as depicted in Fig. 87.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Urology & Nephrology (AREA)
  • Molecular Biology (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Rheumatology (AREA)
  • Surgical Instruments (AREA)

Abstract

La divulgation concerne des méthodes et des dispositifs améliorés pour créer un effet hamac afin de stabiliser l'urètre sans créer d'incision dans l'abdomen ou le vagin, et sans utiliser de treillis chirurgical. De telles mises en œuvre peuvent également ne laisser aucun matériau permanent dans le corps. La simplicité apportée par de telles interventions et méthodes permet le traitement de patients sur une base de soins ambulatoires, et évite les risques et les inconvénients associés à l'installation d'un treillis permanent.
PCT/US2024/051302 2020-06-30 2024-10-14 Systèmes et méthodes pour traiter l'incontinence urinaire d'effort Pending WO2025081172A1 (fr)

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US202363590280P 2023-10-13 2023-10-13
US63/590,280 2023-10-13
US18/525,687 2023-11-30
US18/525,687 US12336897B2 (en) 2020-06-30 2023-11-30 Systems and methods for treating stress urinary incontinence

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090140005A1 (en) * 2005-01-03 2009-06-04 Pressure Products, L.L.C. Pressurized fluid delivery system
US20170020540A1 (en) * 2015-07-24 2017-01-26 Route 92 Medical, Inc. Anchoring delivery system and methods
US20190117211A1 (en) * 2005-05-20 2019-04-25 Neotract, Inc. Devices, systems and methods for retracting, lifting, compressing, supporting or repositioning tissues or anatomical structures
WO2022006350A1 (fr) * 2020-06-30 2022-01-06 Einarsson Jon I Systèmes et méthodes pour traiter l'incontinence urinaire d'effort

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090140005A1 (en) * 2005-01-03 2009-06-04 Pressure Products, L.L.C. Pressurized fluid delivery system
US20190117211A1 (en) * 2005-05-20 2019-04-25 Neotract, Inc. Devices, systems and methods for retracting, lifting, compressing, supporting or repositioning tissues or anatomical structures
US20170020540A1 (en) * 2015-07-24 2017-01-26 Route 92 Medical, Inc. Anchoring delivery system and methods
WO2022006350A1 (fr) * 2020-06-30 2022-01-06 Einarsson Jon I Systèmes et méthodes pour traiter l'incontinence urinaire d'effort

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