WO2009064866A1 - Adjustable tissue support member - Google Patents
Adjustable tissue support member Download PDFInfo
- Publication number
- WO2009064866A1 WO2009064866A1 PCT/US2008/083381 US2008083381W WO2009064866A1 WO 2009064866 A1 WO2009064866 A1 WO 2009064866A1 US 2008083381 W US2008083381 W US 2008083381W WO 2009064866 A1 WO2009064866 A1 WO 2009064866A1
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- WO
- WIPO (PCT)
- Prior art keywords
- tissue
- anchor
- tissue support
- support system
- implant
- Prior art date
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Classifications
-
- 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, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—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, 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
- A61B17/06066—Needles, e.g. needle tip configurations
- A61B17/06109—Big needles, either gripped by hand or connectable to a handle
-
- 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
- A61B17/0401—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, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—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
- 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
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0427—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 anchoring barbs or pins extending outwardly from the anchor body
-
- 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
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0427—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 anchoring barbs or pins extending outwardly from the anchor body
- A61B2017/0437—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 anchoring barbs or pins extending outwardly from the anchor body the barbs being resilient or spring-like
-
- 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
- A61B17/0401—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
-
- 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
- A61B17/0401—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
-
- 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
- A61B17/0401—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
- 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
- A61B17/06004—Means for attaching suture to needle
- A61B2017/06009—Means for attaching suture to needle having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
-
- 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
- A61B17/06004—Means for attaching suture to needle
- A61B2017/06042—Means for attaching suture to needle located close to needle tip
Definitions
- sling suspension procedures involve the placement of a sling member beneath a patient's urethra.
- the sling member is suitably implanted in the patient's tissue with an introducer needle, which helps draw the sling into position.
- Slings have been made of numerous materials, synthetic and natural, and are generally in the form of a mesh.
- a traditional sling procedure involves placing a strip of implant material (natural tissue, synthetic mesh, or a combination of the two) under the urethra and securing it to the rectus fascia or other portions of the patient's anatomy with sutures to hold the implant in position during the healing process.
- Improved techniques have been developed that speed the implant process by reducing the number of incisions made and by altering the pathways by which the implant is introduced into the body. These improvements, which employ specialized instrumentation, help to reduce operative time and have made the procedure less invasive.
- the improved techniques generally require that an implant be joined to an introducer needle. The implant is then inserted into, and pulled through, the body. Subsequently, the implant is detached from the introducer needle.
- Such procedures may require long needle passes and substantial tissue dissection, such as in the case of a retropubic or suprapubic procedure.
- Long needle passes increase the likelihood of an unintended perforation of a body structure (e.g.. the bladder).
- the procedures typically require not only at least one vaginal incision, but also two external incisions at the locus of the obturator foramina in the case of a transobturator approach, and above the pubic bone in the retro- and suprapubic approaches.
- a mesh sling has to exert an appropriate amount of tension on the urethra. Excessive tension can result in kinking of the urethra and/or undue tissue erosion, whereas insufficient tension can result in an ineffective sling. It might be desirable to be able to adjust the tension of the sling after both ends of the sling have been anchored in tissue, but before the tension is fixed and surgery is concluded. In addition, it could be desirable to provide bi-directional adjustment and not just adjustment in a single direction. Features that further the achievement of at least one of the foregoing goals could be desirable.
- each end of the implanted minimally invasive sling terminates in a tissue anchor.
- the length of the sling (and the tension exerted by the sling on the urethra) is configured for adjustment once at least one of the tissue anchors has been implanted.
- a tissue support system comprising an implantable tissue support member, wherein the implantable tissue support member comprises a tissue support portion having a length and a width, a first arm disposed at one end of the tissue support portion, and a second ami disposed at an opposite end of the tissue support portion, a first tissue anchor connected to the first ami. and a second tissue anchor connected to the second arm. wherein the second tissue anchor is slideable along a length of said second arm.
- a tissue support system comprising an implantable tissue support member, wherein the implantable tissue support member comprises a tissue support portion having a first end and a second end. a first arm having a first end and a second end. wherein the first end is joined to the first end of the tissue support portion, a second ami having a first end and a second end. wherein the first end is joined to the second end of the tissue support portion, a first tissue anchor fixed to the second end of the first arm. and a second tissue anchor having an aperture therein, wherein the aperture is configured to at least partially enclose a portion of the second arm.
- a method for providing support to body tissue comprising making an incision in the vaginal wall. inserting an introducer needle having a first tissue anchor at the distal end thereof into the incision in the direction of the obturator membrane, wherein the first introducer needle is connected to an implant, ejecting the first tissue anchor from the introducer needle. withdrawing the introducer needle from the incision, and inserting a second tissue anchor in the distal end thereof wherein the second tissue anchor is connected to an implant. re-inserting the introducer needle into the incision in the direction of the contra-lateral obturator membrane, ejecting the second tissue anchor from the introducer needle, and applying traction to the implant until the desired amount of tissue support is obtained.
- a medical device configured for implantation in tissue, comprising a lumen formed from a flexible material, at least one tissue anchor having at least one aperture therein, said at least one aperture configured to receive said lumen formed from a flexible material, and an anchor stop disposed in said lumen, wherein said anchor stop is configured to resist movement when urged in one direction within said lumen.
- FIG. 1 illustrates one aspect of a tissue support system in accordance with the present disclosure.
- FIG. 2 illustrates an aspect of an implantable tissue support member and an introducer needle.
- FIG. 3 illustrates a tissue anchor being released from an introducer needle.
- FIG. 4 illustrates a stylet being urged into a lumen.
- FIG. 5 illustrates a view of a tissue support member.
- FIG. 6 illustrates an exploded view of a tissue support member.
- FIG. 7 illustrates a view of one aspect of a tissue support member.
- FIG. 8 illustrates an exploded view of an introducer needle.
- FIGS. 9A-9B illustrate cut-away views of exemplary tissue anchors.
- FIG. 10 illustrates an embodiment of a tissue support system.
- FIG. 11 illustrates cut-away views of exemplary tissue anchors.
- FIGS. 12A-12B illustrate bottom and side views of an exemplary tissue anchor.
- FIG. 1 illustrates a tissue support system 10 according to various aspects of the present disclosure.
- the system includes an implantable tissue support member 100. a stylet 185. and an introducer needle 200.
- the tissue support member comprises a tissue support portion 130 having ends 132 and 134 connected to arms 120 and 160. and orienting indicia 140.
- the arm 129 has ends 121 and 122. and arm 160 has ends 162 and 164.
- the orienting indicator 140 can comprise, by way of non-limiting example, a dyed centerline. or a colored thread woven into the center portion of the implant. According to one embodiment, the indicator is colored midline indicator in the form of a blue polypropylene thread woven through the middle of tissue support portion 130.
- the implantable support member 100 further comprises a first tissue anchor 110. and a second tissue anchor 150.
- Tissue anchor 150 is configured to be connected to. but moveable along (i.e.. slidably attached to), a length of arm 160.
- tissue anchor 150 slides along a length of arm 160.
- tissue anchor 150 has an aperture therein, through which ami 160 is received.
- anchor 110 is fixed to end 121 of ami 120.
- anchor 110 is configured to be connected to. but moveable along, a length of arm 120.
- tissue support portion 130 is a flat, single layer of mesh, and arms 120 and 160 are tubular mesh constructs.
- the tubular knit pattern allows for bi-directional adjustability of the implant once the tissue anchors 110 and 150 are in place.
- the amis are joined to the support feature via any suitable means, including by stitching, adhesive, sonic welding, and heat-staking.
- each of the amis is sewn to the tissue support portion 130 using the same type and size of polypropylene fiber from which the tissue support portion 130 and amis 120 and 160 are constructed.
- tissue support portion 130 and amis 120 and 160 are constructed from a unitary tubular member having a single lumen miming longitudinally therethrough.
- the diameter of the arms transition at 162 and 122 to form the tissue support portion 130.
- the tubular mesh is smooth, providing a slight "ratcheting" effect during adjustment to give tactile feedback to the user.
- tubular mesh implants can be prepared by a number of known methods.
- the tubular mesh can be manufactured by circular knitting, either single- ended or double-ended for added strength to provide a stable knit, uniform cross section, and smooth profile.
- the mesh can be manufactured by weft knitting via a "glove" style knitting machine to make smooth chain link stitches, which can allow diameter variation over a given length.
- the tubular mesh is a double warp knit, providing a high strength, multi-end knit using two flat mesh warp knits that are joined on the sides to make a tube mesh.
- the tubular mesh is made from a flat knitting machine, such as a Shimatronic ® flat knitting machine sold by Shima Seiki Mfg.. Ltd. of Wakayama. JP.
- the mesh portions of implant 100 can have a single-strand or double-strand construction.
- the tissue support portion 130 is a flat mesh comprising a knitted, open porosity, monofilament, polypropylene mesh strip.
- the open porosity of the mesh design and large pore sizes allow for macrophage penetration and the creation of an inert scaffold for tissue ingrowth to create a permanent support for the urethra.
- the pore sizes can be of any suitable diameter to allow tissue ingrowth.
- the tissue support portion 130 of implant 100 can have smaller pores ranging in diameter from 0.4mm to 1.1mm. for example 0.5mm to 1.0mm. such as 0.6 to 0.9mm.
- the mesh can additionally have larger pores ranging in diameter from 0.8mm to 1.3mm. for example 1.0mm to 1.2mm.
- the mesh is a polypropylene knit made from a small diameter fiber to create a soft and pliable material.
- the mesh is constructed so as to avoid, or at least minimize, curling of the implant upon application of a tensile force in the lengthwise direction.
- the mesh implant is a single-knit, double-stranded construction.
- the fibers can be of any suitable diameter.
- the fibers can have a diameter ranging from 0.0015" to 0.100". for example 0.002". 0.0025". 0.003" or 0.004".
- the implants disclosed herein can be constructed from different types of mesh.
- One suitable non-limiting example is a knitted polypropylene monofilament mesh fabric, such as BARD MESH from C. R. Bard. Inc.
- Other materials include SOFT TISSUE PATCH (microporous ePTFE - available from W. L. Gore & Associates. Inc.); SURGIPRO (available from US Surgical. Inc.); TRELEX (available from Meadox Medical); PROLENE and MERSILENE (available from Ethicon. Inc.); and other mesh materials (e.g.. available from Atrium Medical Corporation).
- the mesh fabric may be formed from multifilament yams and that any suitable method, such as knitting, weaving, braiding, molding, and the like, may be employed to form the prosthetic mesh material.
- the mesh may also be constructed from absorbable materials, such as polylactic acid.
- the mesh implants disclosed herein are manufactured via a knitting machine, such as a computerized Jacquard flat knitting machine.
- the implants disclosed herein can include, or be constructed entirely from, a natural material.
- the natural material can be disposed over at least one surface of the tissue support members disclosed herein.
- the natural material can be any suitable material including, but not limited to. biologically derived materials, such as cadaveric (human) or xenograft tissue (particularly of porcine or bovine origin) - for example dermis processed to make an acellular collagen scaffold or intestinal submucosa or other biological material and/or bioengineered materials.
- Collagen materials can be obtained from various sources, such as that available from Cook Biomedical. Inc. under the name COOK SURGISIS soft tissue graft.
- the natural material comprises a cross-linked porcine dermal collagen material, such as COLLAMEND surgical implant from Davol (R.I.).
- Other suitable bioengineered materials may be employed as the present disclosure is not limited in this respect.
- the amis 120 and 160 can have any width sufficient for the implant's intended memepose.
- the amis can have a width ranging from 0.5 to 5.0mm. including lmm to 5 mm. for example 2.0mm to 4mm. or 2.5mm to 3.5mm.
- the amis can have a length ranging from 10mm to 100mm. for example 20mm to 60mm. including 30mm to 50mm.
- tissue support portion 130 has a length ranging from about 30mm to about 100mm. for example about 40mm to about 80mm. including 65mm.
- the support portion 130 can have any width sufficient to provide support to a body tissue.
- the width can range from 5mm to 20mm. for example 7mm to 15mm. including 10mm to 14mm.
- the width of tissue support portion 130 ranges from 5mm to 15mm. for example 10mm to 12mm.
- amis 120 and 160 have the same length, or substantially the same length.
- amis 120 and 160 have different lengths.
- ami 120 is 5mm to 20mm long, for example 80mm to 15mm long
- ami 160 is 80mm to 200mm. for example 100mm to 150mm in length.
- a tissue anchor can be fixed, either directly or indirectly (i.e.. via a connector) to one or both of arms 120 and 160.
- Any anchor suitable for anchoring an implant to tissue such as soft tissue, for example muscle tissue, a ligament, a tendon, or a membrane, such as the transobturator membrane, will suffice.
- the anchor may be fixed to the arms via any suitable means, including mechanically, by adhesive, friction fit. ultrasonic welding, solvent bonding, and heat staking.
- a first tissue anchor 110 is configured to move freely along a length of ami 120. and a second anchor 150 is also configured to move freely along a length of ami 160. Once the anchors are implanted and the desired tension is obtained, both anchors can be fixed in position to arms 120 and 160.
- a first tissue anchor 110 is permanently fixed to the terminal end 121 of arm 120. and a second anchor 150 is configured to move freely along a length of ami 160. This facilitates the adjustment feature of the implant, such that once the first anchor and then the second anchor are implanted, the tension exerted on the urethra by the sling is adjusted by manipulating ami 160 in either direction relative to the anchor 150. The manipulation is via gripping feature 180. disposed at end 164 of ami 160. Once the desired tension is reached, the ami 160 is fixed in position to the anchor.
- At least one of the tissue anchors such as tissue anchor 150. contains an aperture that is normal to the longitudinal axis of the anchor. This is illustrated in FIGS. 9A-9B and FIG. 11.
- FIG. 9A illustrates anchor 150a having barbs 151a. and aperture 152a configured to receive mesh ami 160.
- the aperture 151a and mesh arm 160 are respectively sized so that movement of ami 160 therethrough is restricted. The degree of restriction will depend on the fit between the ami and the edges of the aperture.
- the ami 160 and aperture 152a are relatively sized so that a slippage resistance in an amount of force ranging from 4 ounces to 6 pounds, for example 2 to 6 pounds, or 1 to 2 pounds, is required to pull lcni of the ami through the anchor aperture.
- FIG. 9B illustrates tissue anchor 150b having a triangularly-shaped aperture 152b. Arm 160 is received in aperture 152b. and exemplary feature 153b (the distal end of aperture 152b) assists in resisting movement of the arm. Additional exemplary tissue anchors are illustrated in FIG. 11.
- FIG. 12A illustrates a bottom view of an exemplary tissue anchor 150 according to the present disclosure.
- the tissue anchor has a longitudinal axis defined by a lumen.
- the lumen is configured to receive a pin that can pierce, and thereby anchor into position, ami 160.
- FIG. 12B illustrates a side view of tissue anchor 150.
- FIG. 10 illustrates another embodiment in accordance with the present disclosure.
- a tissue support portion 130 is disposed underneath urethra 310 to assist in managing the flow of urine from bladder 300.
- Anchors HOa and 150a having barbs I l ia and 151a. respectively, are anchored in the two obturator membranes 330a and 330b. respectively.
- a first adjustment suture 410 is attached to ami 160 at location 412. The distal end of first adjustment suture 410 is attached to tab 414.
- a second adjustment suture 416 is attached to tissue support portion 130 at location 418. The distal end of adjustment suture 416 is attached to tab 420.
- Both adjustment sutures 416 and 410 are configured to be disposed outside vaginal incision 320. According to various embodiments, and like the tissue anchors and the tissue support system, the adjustment sutures can be bioabsorbable.
- the surgeon may adjust the amount of tension exerted by tissue support portion 130 on urethra 310.
- the tension may be decreased by pulling suture 416 via tab 420.
- tension may be increased by pulling on suture 410 via tab 414.
- the adjustment sutures 410 and 416 may be differently colored to aid in identification.
- tabs 414 and 420 are differently shaped, differently colored, and/or marked to aid in distinguishing one suture from the other.
- sutures 410 and 416 are each in the form of a loop (not shown) that freely passes through respective points 412 and 418. That way. when the loops are cut following final tensioning of the implant, the entire length of suture is removed from the body.
- sutured 410 and 416 are cut and removed, and incision 320 is sutured closed.
- the implant is initially tensioned. and the incision is temporarily sutured and/or packed. The patient returns to the surgeon after 12 to 72 hours, and the patient's degree of continence or retention is reviewed. A final adjustment is made to the implant via tabs 414 and/or 420. the sutures 410 and 416 are cut and removed, and incision 320 is sutured closed.
- the tissue anchors disclosed herein may be constructed from any biocompatible material, including stainless steel, polypropylene, and absorbable materials, including but not limited to polylactic acid, polyglactin. and polyglycolic acid, or other materials commonly used in absorbable surgical materials.
- the anchors disclosed herein can be of any dimension suitable to withstand particular pulling forces.
- the anchors can range in length from, for example. 5mm to 20mm. for example 10mm to 15mm. such as 10.1. 10.2. 10.3. 10.4. or 10.5mm.
- the anchors have a thickness ranging from lmm to 5mm. for example 2mm to 3mm thick.
- the anchors have a base of approximately 2.5 mm. for example 2.2mm to 2.3mm.
- the tissue support system 10 may further include stylet 185.
- Stylet 185 is configured for insertion into gripping feature 180. and then into the lumen 166 of ami 160.
- Stylet 185 includes a shaft 190 having a proximal end 194 and distal end 192. gripping feature 196. and a distal end 198.
- Stylet 185 can range in length from, for example. 12cm to 25cm. including 18cm to 22cm. such as 21 cm.
- the tissue support system may further comprise introducer needle 200 having a handle 210.
- collet 240 configured to releasably secure a tissue anchor, and manually operable actuator 230.
- the actuator 230 is configured to secure a tissue anchor to the collet 240 when in position 231 (FIG. 2). and release the tissue anchor when moved to position 232 (FIG. 3).
- the illustrated introducer needle 200 has a curved shaft 220. where the curve is in substantially the same plane as the handle. With reference to FIG. 2.
- shaft 220 can have a length 213 ranging from 3cm to 7cm. such as 4cm to 6cm. for example 5cm.
- Shaft 220 can have a length 214 ranging from 3.5cm to 5.5cm. for example 4cm to 5cm. and 4.5cm.
- shaft 220 is sized and shaped so that it snugly rotates around the ischiopubic ramus when an anchor is inserted in the region of the obturator foramen.
- the shaft has a helical shape.
- the system may be provided to a clinician with two helically-shaped needles, one for each side of a patient's anatomy.
- FIGS. 1-6 illustrate locking member 170 disposed in lumen 166 in accordance with the present disclosure.
- the locking member 170 is constructed from polypropylene.
- the locking member 170 can have any size suitable for its intended memepose.
- the locking member has a diameter ranging from lmm to 2mm. for example 1.2mm to 1.8 mm. a width ranging from 1.5mm to 2.5mm. and a length ranging from 2.5mm to 5.5 mm. for example 4.5mm.
- the locking member 170 is configured to be initially disposed within the lumen 166 of ami 160 at a location proximal to grasping feature 180. After anchor 150 is set in a desired tissue location, ami 160 is fixed in position relative to the locking feature until it abuts anchor 150. The sliding can be accomplished by insertion of flexible stylet 185 through lumen 182 in grasping feature 185. which lumen is in fluid communication with lumen 166 in arm 160. The distal end 198 of stylet 185 contacts locking member 170. and urges the locking member in the direction of anchor 150. Movement of the locking member in the reverse direction, i.e.. towards end 164 of ami 160. is arrested by the prongs 172. When the anchor stop is urged towards the end 164. the prongs 170 will tend to anchor into the mesh, thus arresting further movement.
- FIG. 5 illustrates another view of the implantable tissue support member 100.
- FIG. 6 illustrates a partially exploded view of the tissue support member.
- FIG. 7 illustrates one embodiment of the fixation of anchor 110 to ami 120. End 121 of ami 120 is inserted into aperture 112 of anchor 110. Plug 111 is then inserted into lumen 166 and aperture 112. thereby providing a friction fit between the plug 112. the ami 120. and anchor 110.
- the tissue support system in accordance with the present disclosure can be used to restore correct support to various types of tissue.
- the system can be used to treat female and male urinary incontinence, for example stress incontinence.
- the system can be used to treat fecal incontinence.
- the system can be used for pelvic floor repair, such as pelvic organ prolapse, by fixing a tissue support portion to ligament and/or muscle for anterior, posterior, and apical vaginal vault repair.
- the tissue support system disclosed herein comprises a urethral sling.
- a procedure for implanting the urethral sling generally comprises making a niid-urethral incision and dissecting the vaginal tissue out laterally in the direction of the superior-medial aspect of the obturator foramen. The ends of the sling are then passed through the obturator intemus muscle/obturator membrane using an introducer device.
- two exit incisions are made in the groin to allow for exteriorization of the introducer needle and sling ends.
- exit incisions allow for adjustment of the sling tension under the urethra using the free amis of the mesh at the exit incisions.
- the urethral sling does not require any exit incisions because mesh adjustment can be done at the vaginal incision.
- tissue support system in accordance with the present disclosure may be used to treat female urinary incontinence.
- the patient is placed in a dorsal lithotomy position with hips in flexion at approximately 90 degrees and the buttocks even with the edge of the table.
- Standard operative preparation of the surgical site is completed, and the bladder is emptied with a Foley catheter.
- the mid-urethra is identified by first locating the external urethral meatus and then the bladder neck by identifying the Foley catheter bulb.
- Hydro-dissection is performed by injecting a solution (e.g.. 19c lidocaine with epinephrine) at the midline between the vaginal wall and urethra, thereby creating a urethro-vaginal space. Additional hydro-dissection can be performed by injecting solution laterally towards the cephalad aspect of the ischiopubic ramus in order to better identify the lateral sulci. Allis clamps are placed at the level of the mid-urethra on the anterior vaginal wall.
- a solution e.g.. 19c lidocaine with epinephrine
- a small (approximately 1.5 cm) incision is made in the anterior vaginal wall beginning approximately 1 cm under the urethral meatus. The depth of the incision may extend into the vaginal muscularis. The urethra is gently freed from the anterior vaginal wall. Next, dissection is made using scissors (e.g.. Metzenbaum scissors) laterally in a 45 degree angle until the tip of the scissors makes contact with the medial-cephalad aspect of the ischiopubic ramus (approximately 1-2 cm). This procedure is then repeated on the contralateral side.
- scissors e.g. Metzenbaum scissors
- the introducer needle 200 is loaded with anchor 110. as shown in FIG. 2.
- the introducer is then inserted into the vaginal dissection laterally through one of the dissected planes toward the cephalad aspect of the ischiopubic ramus.
- the introducer 200 is angled towards the superior-medial aspect of the obturator foramen.
- the handle 210 is pivoted to insert the anchor 110 through the obturator intemus muscle/membrane at the superior-medial aspect of the obturator foramen, such that the orienting indicia 140 is at or slightly past the midurethra (about 0.5 cm) in the direction of insertion. A distinctive pop may be heard, indicating perforation of the muscle/membrane.
- the anchor 110 is released by pushing the actuator 230 forward from position 231 to position 232 in the introducer handle 210. The introducer is then gently retracted by reversing through the insertion path.
- adjustable anchor 150 is loaded into the introducer and secured by retracting the manual actuator 230 on the handle 210 from position 232 to position 231. A slight “click” may be felt or heard, confirming secure loading. At this point in the procedure, care is taken to ensure the implant is not twisted. [0047] Next, it may be desirable to confirm at least 4 cm of adjustable mesh between the tissue support portion 130 and the anchor 150 prior to insertion.
- anchor 150 is inserted in the contralateral dissection plane, and the introducer needle 200 is oriented towards the superior-medial aspect of the obturator foramen.
- Anchor 150 is pushed into the tissue slightly beyond the ischiopubic ramus, and handle 210 is pivoted to insert anchor 150 through the obturator internus muscle/membrane in the superior-medial aspect of the obturator foramen.
- Anchor 150 is released from collet 240 by pushing the actuator 230 from position 231 to position 232 in the introducer handle 210. Introducer needle 200 is retracted by reversing through the insertion path. After anchor 150 is released, gentle traction is applied on the tissue support system 100 to confirm secure fixation in the tissue.
- Grasping feature 180 is gently pulled to adjust the tension exerted by the tissue support portion 130 on the urethra.
- a finger is inserted vaginally to stabilize anchor 150 at the obturator internus muscle.
- the sling can also be loosened by using gentle counter-traction on the tissue support portion 130 on the side closest to anchor 150.
- a thin, blunt instrument (such as a hemostat) between the urethra and the sub-urethral sling may be used as a spacer to aid in setting the appropriate tension.
- a cough or mat test can also be employed to achieve the appropriate tension.
- the orienting indicia 140 should be visible at the midline, no more than lcm away from the urethra in either direction.
- stylet 185 is inserted into lumen 182 of gripping feature 180.
- the stylet 185 is inserted into lumen 166 to urge locking member 170 into place at anchor 150.
- the stylet 185 will bow. signifying that the locking member 170 is in the proper location and the tissue support member has been secured. Once anchor 150 is locked into position, additional tightening can be achieved using the gripping feature 180.
- Stylet 185 is removed after final securement of the tissue support member 100.
- ami 160 is cut between anchor 150 and end 164.
- the vaainal incision is then closed usina suture.
- the incision is temporarily closed and packed around arm 160. This would allow the clinician to post-operatively modify the amount tension exerted by the implant on the urethra.
- the anchor 150 can optionally be fixed to ami 160. and the remaining material can be cut and. in the case wherein the implant is constructed of non-bioabsorbable material, be removed from the body.
- a sheath can enclose at least a portion of the tissue support member disclosed herein to facilitate their passage into tissue.
- the tissue support member, or at least the support portion thereof is sandwiched between two sheaths.
- the sheath sides are suitably made out of a material with a low coefficient of friction, such as polytetrafluoroethylene (PTFE).
- PTFE polytetrafluoroethylene
- the tissue support member is implanted without a sheath.
Abstract
Description
Claims
Priority Applications (6)
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AU2008320999A AU2008320999A1 (en) | 2007-11-13 | 2008-11-13 | Adjustable tissue support member |
EP08849041.2A EP2211764A4 (en) | 2007-11-13 | 2008-11-13 | Adjustable tissue support member |
JP2010534163A JP2011502712A (en) | 2007-11-13 | 2008-11-13 | Adjustable tissue support member |
CA2703885A CA2703885A1 (en) | 2007-11-13 | 2008-11-13 | Adjustable tissue support member |
CN200880115957.3A CN101854883B (en) | 2007-11-13 | 2008-11-13 | Adjustable tissue support member |
MX2010005271A MX2010005271A (en) | 2007-11-13 | 2008-11-13 | Adjustable tissue support member. |
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US12/269,749 | 2008-11-12 | ||
US12/269,749 US8206280B2 (en) | 2007-11-13 | 2008-11-12 | Adjustable tissue support member |
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Also Published As
Publication number | Publication date |
---|---|
CA2703885A1 (en) | 2009-05-22 |
KR20100084543A (en) | 2010-07-26 |
US20090137862A1 (en) | 2009-05-28 |
AU2008320999A1 (en) | 2009-05-22 |
EP2211764A4 (en) | 2013-04-10 |
MX2010005271A (en) | 2010-06-01 |
JP2011502712A (en) | 2011-01-27 |
EP2211764A1 (en) | 2010-08-04 |
CN101854883B (en) | 2013-07-24 |
US8206280B2 (en) | 2012-06-26 |
CN101854883A (en) | 2010-10-06 |
US20120253110A1 (en) | 2012-10-04 |
US20140058193A1 (en) | 2014-02-27 |
US8574149B2 (en) | 2013-11-05 |
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