US20040249396A1 - Sling adjustment and tensioning accessory - Google Patents

Abstract

An anatomical support adjustment and tension control article for use in applying a tensioning force to anatomical support material disposed therein. The tension control article preferably comprises a base member disposing a plurality of tensioning members extending therefrom. The tensioning members create a tortuous pathway thereby providing a tensioning force to anatomical support material positioned therebetween. Additionally, at least one of the plurality of tensioning members may be removed from the device to alter the supportive tension applied by the device. The anatomical support material may be disposed between the plurality of tensioning members in a number of ways, thereby resulting in varying amounts of supportive tension being applied by the device.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• The present application claims priority to U.S. Provisional Application Ser. No. 60/238,771, filed Oct. 6, 2000 (the entire contents of which are fully incorporated herein by reference).[0001]
BACKGROUND
• Urinary incontinence, or the inability to control urination, is a major and debilitating problem affecting millions of people, especially women. The female's natural support system for the urethra is a hammock-like supportive layer composed of endopelvic fascia, the anterior vaginal wall, and a distal attachment to the pubic bone. Weakening and elongation of the pubourethral ligaments and the arcus tendineus fascia pelvis, weakening of the endopelvic fascia and pubourethral prolapse of the anterior vaginal wall are some common characteristics of a patient with urinary incontinence.[0002]
• Many procedures have been devised to treat urinary incontinence. Some have the goal of elevating the neck of the bladder to return it to a higher retropubic position. Many pubovaginal sling procedures have been developed to treat urinary incontinence. Some of these procedures involve positioning anatomical sling material under the urethra to provide elevation and support of the urethra and/or the bladder neck. Examples of attachment sites for the sling include the anterior or superior portion of the pubis (e.g. with bone anchors and associated sutures), Cooper's ligament, or rectus abdominus fascia. Examples of procedures for treating incontinence are disclosed in U.S. Pat. Nos. 5,112,344; 5,611,515; 5,842,478; 5,860,425; 5,899,909; 6,039,686, 6,042,534 and 6,110,101.[0003]
• Slings used for pubovaginal procedures differ in the type of implantable material and anchoring methods. In some cases, the sling is placed under the bladder neck and secured via suspension sutures to a point of attachment (e.g. bone) through an abdominal and/or vaginal incision.[0004]
• Complications associated with procedures for treating incontinence include urinary retention, bladder instability and erosion of an implanted article into surrounding tissue. See Spencer et al,[0005]A Comparison of Endoscopic Suspension of the Vesical Neck With Suprapubic Vesicourethropexy for Treatment of Stress Urinary Incontinence,J. Urol. 137: 411, (1987); Araki et al,The Loop Loosening Procedure for Urination Difficulties After Stamey Suspension of the Vesical Neck,J. Urol., 144; (1990); and Webster et al.,Voiding Dysfunction Following Cystourethropexy: Its Evaluation and Management,J. Urol., 144; (1990).
• With respect to sling procedures, if the sling mesh is too loosely associated with its intended physiological environment, the mesh may be ineffective in supporting the urethra and treating incontinence. Several complications can arise from a mesh that is too tightly placed including retention, sling erosion and other damage to surrounding tissue such as the urethra and vagina.[0006]
• The TVT Tension-free Vaginal Tape procedure utilizes a knitted Prolene™ nonabsorbable, polypropylene mesh. The mesh is a substantially flat, rectangular woven article. The mesh includes a plurality of holes that are sized to allow tissue ingrowth to help avoid infection. A removable plastic sheath surrounds the mesh and is used during insertion of the mesh. The sling is positioned near the urethra without the use of bone anchors. Once the sheath is removed from the mesh of the TVT product, friction between the mesh and tissue keeps the mesh in position and it becomes very difficult to subsequently adjust the position of the mesh relative to tissue. Attempts to move the sling once the sheath is removed may damage the sling or adjacent tissue such as the urethra or vagina.[0007]
• Proper tension of a sling is an important factor for a successful surgical procedure. Surgical approaches to applying tension or slack in a sling procedure vary widely. See Decter,[0008]Use of the Fascial Sling for Neurogenic Incontinence: Lessons Learned,The Journal of Urology, Vol. 150, 683-686 (1993). While the TVT procedure suggests using a scissors or hemostat placed between the sling and urethra to set the looseness of the TVT mesh sling, a flat blunt surgical instrument is placed between the sling and urethra in other procedures. See Moir et al.,The Gauze-Hammock Operation,The Journal of Obstetrics and Gynaecology of the British Commonwealth, Vol. 75, No. 1 (January 1968) Pps. 1-9.
• The TVT sling procedure instructs users to place a scissors or hemostat between the urethra and the sling to ensure ample looseness of the sling. There are several problems associated with this approach. First, the type of scissors or hemostat used to tension the sling may differ in size, potentially causing application of different amounts of looseness for the sling. For example, one surgeon may use a Mayo scissors while another surgeon may use a hemostat or flat, blunt instrument. It is believed that the use of different instruments with different sizes inherently leads to inconsistency in the amount of slack or looseness provided in a sling. This inconsistency could lead to inconsistent therapeutic results, misleading medical data and other clinical errors. Second, even if the same surgical instrument is used, the precise portion of the surgical instrument used to set the looseness of the sling may vary along the length instrument. For example, some surgeons use the tips of closed Mayo scissors to tension a sling. Mayo scissors are curved and the precise thickness of a scissors along its length varies significantly. See FIG. 5 of Rackley et al.,[0009]Tension-free Vaginal Tape and Percutaneous Vaginal Tape Sling Procedures,Techniques in Urology, Vol. 7, No. 2, pp. 90-100 (2001). Depending upon how far the Mayo scissors tips are inserted between the sling and the urethra, the actual amount of looseness provided can vary significantly.
• Other prior art sling procedures use bone anchors or other methods of securing a sling. A difficulty that contributes to the unnatural positioning of the urethra is that some attachment sites, such as the rectus abdominus fascia or the top of the pubic bone, require very long sutures. Long sutures increase the difficulty in achieving the proper tension in the sutures and sling and increase the chances that intervening anatomical structures may interfere with proper tension. Improper sling tension or sling suture tension can result in increased lateral movement and momentum of the support structures or mesh sling when they are moved due to intra-abdominal pressures.[0010]
• U.S. Pat. No. 5,863,315 discloses a method of tensioning a suspended tissue mass. The method utilizes a suture tensioner comprising a handle, a main body and an annular recess.[0011]
• More than a year prior to the filing date of the present application, Vesica Sling Kits were sold (by Boston Scientific, Microvasive, USA) in the United States that included a Suture Spacer. Surgeons were instructed to place the Suture Spacer on the top of the pubic tubercle (which is a location remote from the sling and remote from the urethra, vagina and bladder neck). The surgeon then places a suture about the Suture Spacer and ties a knot. As a knot is tied, the Suture Spacer is pulled downward onto the top of the pubic bone. Six or seven additional throws are tied and the Suture Spacer is withdrawn.[0012]
• U.S. Pat. No. 5,474,518 discloses a device for cofrecting urinary incontinence by use of vesical suspension. The device includes a box that houses a drum with a toothed wheel that engages a worm gear.[0013]
• U.S. Pat. Nos. 4,938,760 and 4,969,892 disclose a method of suspending the urethrovesical junction in females. An anchoring means for anchoring a suture in tissue is disclosed. The anchoring means comprises a rotating spool, a driving gear and an adjusting means.[0014]
• PCT International Pub. No. WO 01/39670 discloses an implantable support sheet for providing suburethral stabilization for female patients. A clip is disclosed that inhibits folding of a central part of the sheet about its longitudinal axis.[0015]
• U.S. Pat. No. 6,106,545 discloses a suture tensioning and fixation device for attachment of tendon to muscle or reattachment of ligaments to bone. The device includes a retaining element and suture thread engaging portions.[0016]
• U.S. Pat. No. 6,117,067 discloses a device for the height-adjustable fixing and support of internal organs. The device includes a sling, threads, tube, small capsule and chamber. A needle is used to introduce or extract liquid.[0017]
• U.S. Pat. No. 6,068,591 discloses an apparatus for treatment of female stress urinary incontinence with a support harness. The patent discloses an adjustable setting and Carter pin.[0018]
BRIEF SUMMARY
• The present invention is directed to an article useful in surgical procedures. The article assists surgeons in providing consistent, repeatable relationships between implantable materials such as slings, and target tissue such as urethra tissue. In use with a plurality of different surgeons and a plurality of different patients, the present invention can contribute to consistent, repeatable medical results, more reliable medical data and improved medical decisions.[0019]
• The article comprises a portion adapted to be grasped, and at least one tensioning member that is sized and shaped to afford predetermined looseness of an anatomical support material, such as a sling, relative to anatomical tissue, such as a urethra.[0020]
• A variety of procedures are contemplated, including, for example, pubovaginal sling procedures. The present invention is particularly suitable for use in a sling procedure that places a sling in a therapeutically effective position. Preferably, the sling is placed to control the pressure applied to the urethra to obtain or restore normal anatomy and continence.[0021]
• In a preferred embodiment, the article comprises a plurality of tensioning members. In one embodiment the article includes movement means for moving at least one tensioning member between an open position for receiving the anatomical support material and a closed position that associates the article with the anatomical support material. Preferably, the movement means comprises means for affording substantial parallel movement between tensioning members to resist wrinkling of the anatomical support material.[0022]
• In another preferred embodiment, the plurality of tensioning members are arranged to afford a plurality of tortuous paths of different lengths, and the anatomical support material may be associated with the article along one of the tortuous paths.[0023]
• In another embodiment, the article includes means for moving at least one of the tensioning members relative to another tensioning member to change the length of a tortuous path.[0024]
• In another aspect, the present invention comprises a device for applying tension to a surgical sling.[0025]
• In another aspect, the invention comprises a tensioning device comprises a base member having a plurality of tensioning members extending outwardly from the base member, thereby creating a tortuous pathway for sling material positioned thereon. When the sling material is used in a pubovaginal sling procedure, the tensioning device provides additional tensioning support to the urethral body, the bladder neck, or both.[0026]
• The tensioning device of the present invention may have a number of different configurations. For example, in one embodiment, the base member is arcuate. In an alternate embodiment, the base member is rectangular. Additionally, the base member may include a directional indicator to aid the user in applying the device. In yet another embodiment, the base member may include an integral or detachable grasping member. The base member may further include at least one sling material locking member having an open position which allows removal of the sling material from the device, and a closed position to the retain sling material within the device.[0027]
• The tensioning members of the present invention may comprise a plurality of configurations, including circular members, oval members, or other shaped members capable of retaining material disposed therein. Similarly, the tensioning members may be manufactured from a plurality of materials including, without limitation, silicone elastomer, acetate, acetal polyurethane, acrylic, elastomer, stainless steel, polysulfone, nylon, polycarbonate, polyethermide, acetal, ABS, bioresorbable materials or other biologically-compatible materialsf or temporary or permanent implantation.[0028]
• In another form, the device remains implanted and can be adjusted in the subsequent post operative period by removing all or some of the tensioning members or by constructing the tensioning members of a bioresorbable material.[0029]
• Additionally, the tensioning members may be constructed so that they indicate the preload on the sling through a deflection or alignment of the tensioning members.[0030]
• The present invention may further include various methods of using the tensioning device for creating and using a tortuous pathway to apply tensioning force to a material disposed therein.[0031]
• In another aspect, the present invention comprises a method of providing a uniform distance between the urethra and a sling comprising: providing a sling and tensioning article, associating the tensioning article with the sling, implanting the sling and associated tensioning article in a position substantially adjacent or, alternatively, just touching the urethra, and then removing the tensioning article. Optionally, the step of providing a sling and tensioning article includes the step of providing an insertion sheath surrounding the sling; and the step of associating the tensioning article with the sling includes the step of associating the sling and sheath combination with the tensioning article.[0032]
• In another aspect, the present invention comprises a method of treating incontinence comprising the steps of: (i) providing a support material with at least a portion that is elastically deformable, (ii) elastically deforming at least a portion of the support material to tension the support material; (iii) providing a tensioning article, (iv) applying the tensioning article to the tensioned support material to retain at least a portion of the support material in an elastically deformed condition; (v) implanting the support material with applied tensioning article in a patient; removing the tensioning article to increase the tension provided by the support material.[0033]
• In another method, the present invention comprises a method of reducing the looseness of an implanted sling comprising the steps of: providing a tensioning article, and associating the tensioning article with the sling in vivo to tighten the sling.[0034]
• In another method, the tensioning member remains implanted and provides an elastic stress relieving component to the sling in the immediate or long term post operative period. This is particularly useful when the sling is made of an elastic material such as a silicone elastomer.[0035]
• In another aspect, the present invention comprises a kit for treating incontinence. The kit comprises surgical articles for implanting a surgical sling, and a tensioning article.[0036]
• Other features and advantages of the present invention will become apparent from a consideration of the following detailed description.[0037]
BRIEF DESCRIPTION OF THE DRAWINGS
• Other features and advantages of the present invention will be seen as the following description of particular embodiments progresses in conjunction with the drawings, in which:[0038]
• FIG. 1 shows a perspective view of an embodiment of tensioning device of the present invention;[0039]
• FIG. 2[0040]ais a perspective view of the tensioning device of FIG. 1 engaging sling material positioned thereon;
• FIG. 2[0041]bis a perspective view of an alternate embodiment of the tensioning device of the present invention engaging sling material positioned therein;
• FIG. 3 shows a perspective view of an embodiment of tensioning device of the present invention having an orientation indicator positioned thereon;[0042]
• FIG. 4[0043]ashows a perspective view of another embodiment of tensioning device of the present invention having a grasping structure disposed on the base member;
• FIG. 4[0044]bshows a perspective view of an alternate embodiment of the tensioning device of the present invention having a grasping member disposing a directional indicator thereon positioned on the base member;
• FIG. 5[0045]ashows a perspective view of another embodiment of tensioning device of the present invention having a locking member positioned thereon;
• FIG. 5[0046]bshows a perspective view of an alternate embodiment of the tensioning device of the present invention having another embodiment of locking member positioned thereon;
• FIG. 6 shows a perspective view of an alternate embodiment of the tension device of the present invention wherein at least one tensioning member is oval;[0047]
• FIG. 7 is another embodiment of tensioning device according to the present invention that includes a securement member;[0048]
• FIGS. 8[0049]a-8dare views of an alternative embodiment of the present invention wherein:
• FIG. 8[0050]ashows an end view of an alternative embodiment of tensioning device shown in a closed position;
• FIG. 8[0051]bshows a side view of the device of FIG. 8a;
• FIG. 8[0052]cis an end view of the device of FIG. 8ashown in an open position;
• FIG. 8[0053]dis a side view of the device of FIG. 8c;
• FIGS. 9[0054]a-9dare views of an alternative embodiment of the present invention wherein:
• FIG. 9[0055]ashows an end view of an alternative embodiment of tensioning device shown in a closed position;
• FIG. 9[0056]bshows a side view of the device of FIG. 9a;
• FIG. 9[0057]cis an end view of the device of FIG. 9ashown in an open position;
• FIG. 9[0058]dis a side view of the device of FIG. 9c;
• FIGS. 10[0059]a-10dare views of an alternative embodiment of the present invention wherein:
• FIG. 10[0060]ashows an end view of an alternative embodiment of tensioning device shown in an open position;
• FIG. 10[0061]bshows a side view of the device of FIG. 10a;
• FIG. 10[0062]cis an end view of the device of FIG. 10ashown in a closed position;
• FIG. 10[0063]dis a side view of the device of FIG. 10c;
• FIG. 11[0064]ais an end view of another embodiment of tensioning article and sling according to the present invention with tensioning indicia located thereon, which tensioning article is shown in an open position;
• FIG. 11[0065]billustrates the assembly of FIG. 11ain a closed position;
• FIG. 12 is a perspective view of another embodiment according to the present invention which embodiment includes an adjustment feature;[0066]
• FIG. 13 is a perspective view of another embodiment of tensioning device according to the present invention;[0067]
• FIG. 14 is an end view of the article of FIG. 13 with a sling threaded through the article in a first orientation;[0068]
• FIG. 15 is another end view of the article of FIG. 13 with a sling threaded through the article in a second orientation;[0069]
• FIG. 16[0070]ais a side view of another embodiment of surgical article according to the present invention;
• FIG. 16[0071]bis an end view of the article of FIG. 16;
• FIG. 17[0072]ais a side view of another embodiment of tensioning device according to the present invention;
• FIG. 17[0073]bis a side view of the tensioning device of FIG. 17awith a sling inserted therebetween;
• FIG. 18[0074]ais a side view of another embodiment of tensioning device according to the present invention shown in a closed position;
• FIG. 18[0075]bis a side view of another embodiment of tensioning device according to the present invention shown in an open position;
• FIG. 18[0076]cis a view of the tensioning device of FIGS. 18aand18bwith a sling placed therein;
• FIG. 19 is a flow chart showing a surgical procedure according to the present invention;[0077]
• FIG. 20 is a schematic view of a tensioning article, sling and selected portions of the anatomy of a patient, which view illustrates removal of the tensioning article after it sets sling tension;[0078]
• FIG. 21 is a schematic view of a tensioning article, sling and selected portions of the anatomy of a patient, which view illustrates implantation of the tensioning article to increase the tension of the sling; and[0079]
• FIG. 22 is a flowchart showing an example of a method according to the present invention.[0080]
DETAILED DESCRIPTION
• Disclosed herein is a detailed description of various illustrated embodiments of the invention. This description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention. The section titles and overall organization of the present detailed description are for the purpose of convenience only and are not intended to limit the present invention.[0081]
• The present invention comprises an article, preferably a tension control article, for use in conjunction with an implantable article such as a sling. In a preferred embodiment, the tension control article is utilized in conjunction with a sling for treating urinary incontinence. The tension control article may be used in conjunction with a wide variety of slings and other surgical procedures. For example, the present invention may be utilized in conjunction with the slings and procedures described in U.S. Pat. Nos. 5,520,700; 5,611,515; 5,842,478; 5,860,425; 5,972,000; 6,039,686, 6,042,534 and 6,110,101 (the entire contents of which are herein incorporated by reference in their entirety) and U.S. patent application Ser. No. 09/917,562 (entitled: Implantable Article and Method) and Ser. No. 09/917,443 (entitled: Sling Delivery System and Method of Use); and Ser. No. 09/917,445 (entitled: Surgical Instrument and Method); both filed Jul. 27, 2001 (the entire contents of each of which are herein incorporated by reference. Commercial examples of slings, instructions for use and kits that may be modified to incorporate the present invention include the In-Fast Sling System and the SPARC Sling System available from American Medical Systems of Minnetonka, Minn., and the transvaginal TVT Sling System available from Ethicon (a division of Johnson & Johnson).[0082]
• Preferably, the tension control article is associated with an implantable material (e.g. a sling). Suitable implantable materials associated with the present invention include synthetic and non-synthetic materials. Suitable non-synthetic implantable materials include human fascia lata, treated animal (e.g. bovine or porcine or equine pericardium) tissue, autologous tissue, cadaver tissue, homografts, xenografts, heterografts, allografts and combinations of such materials. Suitable synthetic materials include knitted polypropylene slings alone, such slings with surrounding sheaths, or silicone coated polymer slings, such as those described in U.S. patent application Ser. No. 09/939,098 (entitled Coated Sling Material), filed Aug. 24, 2001 (the entire contents of which are herein incorporated by reference). Alternatively, the tension control article may be associated with sutures associated with slings. Such sutures typically extend from an implanted bone anchor on the pubic bone, or from the rectus abdominus fascia. These sutures hold the sling in place in the body.[0083]
• The present invention may also be used in conjunction with surgical procedures other than those designed to strictly address incontinence. For example, the present invention may be used in conjunction with a sacral colpopexy procedure designed to treat vaginal prolapse.[0084]
• The tension control article of the present invention, when used with transvaginal or suprapubic surgical anatomical support material (e.g. a sling) or sutures, is designed to provide an adjustable tensioning or spacing mechanism as an objective aid for surgeons in associating the sling or suture with a therapeutically effective position. The article of the present invention assists surgeons in consistently and repeatably associating a sling with its intended physiological environment (e.g. the bladder neck or urethra, or both).[0085]
• The tension control article is preferably positioned on a portion of anatomical support material. In one embodiment, the tension control article has a plurality of tensioning members that are sized and shaped to provide a tortuous pathway for the sling material. When the tension control article is associated with the sling material and the sling material is placed at its intended anatomical location, the tension control article results in an increase in the supportive tension that is applied by the sling to anatomical structures relative to that supportive tension that would be applied to the anatomical structures in the absence of the tension control article.[0086]
• In one embodiment, the size and shape of the tensioning members are selected to provide a predetermined slack in the sling material once the article is removed from the sling material. For example, for a tension free surgical sling procedure for treating incontinence, the tension control article may be associated with the sling and the sling/tension control article combination may be implanted to just touch the urethra of a patient. In this example, once this penultimate orientation of the sling and urethra is achieved, the tension control article may then be removed to ensure a consistent, uniform amount of slack is provided between the sling and the urethra. Providing a uniform, consistent, repeatable amount of looseness in each surgical procedure reduces the chances that patient data is corrupted by the vagaries associated with a particular surgeon's preferences or lack of training or experience. As a result, it is believed that the present invention can lead to more consistent medical results.[0087]
• The tension control article of the present invention may be constructed of a wide variety of materials. Suitable materials include those that may be permanently implanted in the body, temporarily implanted, and/or completely removed prior to the end of the surgical procedure. The material used to construct the tension control article should be biocompatible and may comprise bioresorbable materials or permanent, biocompatible materials or combinations thereof.[0088]
• FIG. 1 shows an embodiment of the anatomical support adjustment and[0089]tension control article10 for use with suspension sutures, surgical slings, or other anatomical supports. In this embodiment, the present invention includes abase member12 and three tensioningmembers14,16, and18 attached thereto. Optionally, more than three tensioning members may be positioned on the base member. Thebase member12 is preferably arcuate and includes beveled edges to reduce or eliminate damage to the surrounding tissue and anatomical support material disposed thereon. In an alternate embodiment, thebody member12 may form any other configuration which facilitates support of the urethra and which minimizes damage to the surrounding tissue and anatomical structures. Thedevice10 may be manufactured in a plurality of sizes to accommodate the physiological or anatomical constraints of the patient and the location of use. The configuration of thedevice10 enables a user to adjust the length of anatomical support material positioned therein and adjustably control the supportive tension applied to tissue.
• The[0090]device10 may be constructed of a plurality of materials, including, for example, titanium, stainless steel, nylon, polycarbonate, polysulfone, ABS, ultem, polyetherimide, and polyacetate or combinations thereof, thereby providing a relatively rigid device. In an alternate embodiment of the present invention, thedevice10 may be manufactured from moderately flexible materials, such as acetal, or soft flexible materials, such as silicon elastomer or polyurethane, should a more flexible support mechanism be desired. In yet another embodiment, thedevice10 may be manufactured from biodegradable materials or polymers. Thedevice10 may further include or be manufactured from materials having distinct radio opacities or echogenic properties, thereby enabling location of thedevice10 in post-surgical procedures. In yet another embodiment, the present invention may be manufactured from materials having distinct optical properties, wherein the application of force todevice10 alters the visual appearance of, or light transmission through, thedevice10. Furthermore, it is considered within the scope of the claimed invention to construct thedevice10 from multiple materials. For example, thedevice10 may comprise abase member12 constructed of polyacetate, or a similar rigid material, and thetensioning members14,16, and18, respectively, constructed of a flexible material. Other biocompatible materials and material combinations not specifically listed herein, may also be used to fabricate thedevice10 and are included within the scope of the claimed invention.
• The[0091]members14,16 and18 may be integrally molded with the base portion. Alternatively, they could be releasably attached to the base portion to afford adjustment of the sling. For example, themembers14,16 and18 may be constructed to be separable from the base portion by use of a remotely actuated device (e.g. a device that utilizes electromagnetic energy). In particular, a magnetic attachment of one or more of themembers14,16 and18 and thebase portion12 may be provided. This magnetic attachment may be eliminated by a remotely activated device. This embodiment affords adjustment in the tension of a sling post operatively without requiring a subsequent incision.
• FIGS. 2[0092]aand2bshow alternative methods of positioning the present invention on a portion of anatomical support material. FIG. 2ashows one method of using thetensioning device10 to engage a portion ofanatomical support material20, wherein thematerial20 is positioned within a tortuous pathway formed by the plurality oftensioning members14,16, and18 respectively. FIG. 2bshows an another method of using thetensioning device10, wherein theanatomical support material20 traverses an alternate tortuous pathway formed by the plurality oftensioning members14,16, and18.
• Generally, the longer the tortuous path, the greater the slack provided in the[0093]sling20 once thetension control article10 is removed. Also, the longer the tortuous path, the more slack is taken up in asling20 once thetension control article10 is associated with the sling. For thesame clip10, the length of the tortuous path in FIG. 2ais different than the length of the tortuous path in FIG. 2b.As a result, the same tension control article may be utilized to provide a plurality of different slacks in the anatomical support material (e.g. sling)20.
• A second embodiment of[0094]tension control article10A is illustrated in FIG. 3. Thetension control article10A hastensioning members14A,16A and18A, andbase member12A. Thetension control article10A further comprises adirectional indicator22A included on thebody member12A. Thedirectional indicator22A assists the user in properly applying thedevice10A to a portion of anatomical support material. As shown in FIG. 3, thedirectional indicator22A may comprise an arrow printed on, embossed or integrally disposed on a surface of thebase member12A. Alternatively, the directional indicator may include figures, shapes, letters, or other markings formed, printed, or otherwise included on thedevice10A. In another embodiment, thebase member12A may include a tension scale, enabling the user to determine the amount of load imposed on the tensioning members. Alternatively, displacement of flexible members may be used to indicate the applied load. For example, deflection or alignment of the tensioning members may be used to indicate the relative preload on thesling20.
• FIGS. 4[0095]aand4bshow additional embodiments of the present invention.Tension control article10B has tensioningmembers14B,16B and18B, andbase member12B.Tension control article10C hastensioning members14C,16C and18C, andbase member12C. As shown in FIG. 4b, thedevice10C may include a graspingmember24C disposed on or attachable to thebase member12C. In FIG. 4a,the graspingmember24B is integral with the base member and comprises an arcuate discontinuity in thebase member12B. Optionally, the free (unattached) ends of tensioningmembers14,16 and18 could include an enlarged portion or ledge that retains the sling material or sutures in place.
• The grasping[0096]member24C aids the user in applying, positioning, and removing thedevice10C from the anatomical support material20C. FIG. 4bshows the graspingmember24C further comprising adirectional indicator22C positioned thereon, thereby aiding the user in applying thedevice10C. In an alternative embodiment of the present invention, a detachable graspingmember24C is contemplated.
• Additional embodiments of the present invention are shown in FIGS. 5[0097]aand5b.Tension control article10D has tensioningmembers14D,16D and18D, andbase member12D.Tension control article10E hastensioning members14E,16E and18E, andbase member12E.Base member12D of thedevice10D includes at least onematerial locking member26D. The lockingmember26D has an open position permitting the movement of anatomical support material20 (see FIG. 2a) between thetensioning members14D,16D, and18D, respectively, and a closed position restricting the movement of theanatomical support material20 relative to thetension control article10D. The at least one locking member may be manufactured from a plurality of materials having sufficient structural rigidity to prevent material movement, thereby preventing accidental or unintentional adjustment of the tension applied by the anatomical support material. The lockingmember26E of FIG. 5bis located on the sides of thebase portion12E, as opposed to the ends (see FIG. 5a).
• In another embodiment, the article of the present invention may include a spring biased locking member that is biased toward the closed position. In the closed position, the locking position retains a portion of the[0098]sling20 in a pre-tensioned, elastically deformed condition. Placing the pretensioned sling and associated article in the patient and then subsequently removing the association between the article and the pre-tensioned sling can result in an increase in the tension encountered by a target anatomical structure such a urethra.
• The[0099]tensioning members14,16, and18 (and those to which a letter suffix has been added herein) may be manufactured from a plurality of materials. For example, thetensioning members14,16, and18 may be manufactured from a flexible material, thereby providing a dynamic tensioning device capable of absorbing temporary variations in supportive loading. If desired, in an alternative embodiment thetensioning members14,16, and18 may be manufactured from a rigid material, permitting the operator to forcibly remove a tensioning member if desired, thereby resulting in decreased support tension applied by the anatomical support material. In an alternate embodiment, the tensioning member may be manufactured from a pliable material, thereby permitting the user to easily position and apply thedevice10.
• The spacing and number of tensioning members may be adapted to adjust the tension of the anatomical support material disposed on the[0100]device10. For example, a greater number of tensioning members would provide a more tortuous pathway, resulting in greater anatomical support tension or spacing adjustment. The exterior of the tensioning members are preferably smooth. In another embodiment of the present invention, the exterior of at least one of the plurality of tensioning members may be textured to increase anatomical support material retention, or to increase stability within the body if the tension control article is permanently implanted, or to promote tissue ingrowth.
• FIG. 6 shows another embodiment of[0101]tension control article10F includingtensioning components14F,16F, and18F. In FIG. 6,tensioning member16F is oval. Thetensioning members14F,16F, and18F may be formed in a plurality of shapes and combinations thereof, including, without limitation, triangular, rectangular, oval, hexagonal, octagonal and diamond.
• FIG. 7 illustrates another embodiment of[0102]tension control article10G.Tension control article10G hastensioning members14G,16G and18G, andbase member12G. Aband25 may also be used in conjunction withtension control article10G to retain the association between thesling20 andtension control article10G. Theband25 is placed on thetension control article10G after the sling is associated with thetension control article10G so that theband25 prevents or blocks separation of thetension control article10G from thesupport material20.
• FIGS. 8[0103]a-8dshow another embodiment oftension control article20′ according to the present invention. Thetension control article20′ comprises abase portion22 withintegral tensioning member24, handle34, andmovable tensioning members27 and29.
• The[0104]tension control article20′ is movable between an open position (FIGS. 8cand8d) with thetensioning members27 and29 spaced frombase portion22 so that thetension control article20′ may readily receive a sling, and a closed position (FIGS. 8aand8b) with thetensioning members27,29 closer to thebase portion22 than in the open position.
• A[0105]spring32 biases thetension control article20′ toward the closed position. Manual pressure onhandle34 moves the tension control article from the closed toward the open position. Thehandle34 is preferably designed so that major surfaces of thebase portion22 andtensioning members27,29 remain substantially parallel between the open and closed positions. Substantial parallel movement resists binding or wrinkling of the sling when thetension members27 and29 clamp onto the sling.
• FIGS. 9[0106]a-9dshow another embodiment oftension control article40 according to the present invention. Thetension control article40 comprises abase portion42 withintegral tensioning member44, handle54, andmovable tensioning members47 and49.
• The[0107]tension control article40 is movable between an open position (FIGS. 9cand9d) with thetensioning members47 and49 spaced frombase portion42 so that thetension control article40 may readily receive a sling, and a closed position (FIGS. 9aand9b) with thetensioning members47,49 closer to thebase portion42 than in the open position.
• A[0108]spring52 biases thetension control article40 toward the closed position. Manual pressure onhandle54 moves the tension control article from the closed toward the open position. The movement between the open and closed positions is pivotal movement about a point on or substantiallyadjacent handle54.
• FIGS. 10[0109]a-10dshow another embodiment of tension control article60 according to the present invention. The tension control article60 comprises abase portion62 withintegral tensioning member64, handle76, andmovable tensioning members67 and69.
• The tension control article[0110]60 is movable between an open position (FIGS. 10cand10d) with thetensioning members67 and69 spaced frombase portion62 so that the tension control article60 may readily receive a sling, and a closed position (FIGS. 10aand10b) with thetensioning members67,69 closer to thebase portion62 than in the open position.
• A[0111]spring72 biases the tension control article60 toward the closed position. Manual pressure onhandle76 moves the tension control article from the closed toward the open position. The tension control article includes ahinge structure74 that is preferably designed so that major surfaces of thebase portion62 andtensioning members67,69 remain substantially parallel during movement between the open and closed positions. Parallel movement between these structures is believed to avoid sling material extruding out of the open end of the tension control article60 as the sling is being associated with the tension control article60.
• FIGS. 11[0112]a-11bshow another embodiment oftension control article80. The tension control article comprises abase portion82 withintegral tensioning member84, a handle, andmovable tensioning members87 and89. Thetension control article80 is movable between an open position (FIG. 11a) with thetensioning members87 and89 spaced frombase portion82 so that thetension control article80 may readily receive asling85′, and a closed position (FIG. 11b) with thetensioning members87,89 closer to thebase portion82 than in the open position.
• The[0113]tension control article80 includestension level indicators81,83 and85 on tensioningmember84. Theindicators81,83 and85 may comprise printing, molded in indicia or other forms of indicia.Members87 and89 may also include indicia thereon. The position of theindicators81,83 and85 relative to the indicia onmembers87 and89 provide an indication of the tension provided by thetension control article80.
• Preferably, the[0114]tension control article80 includes structure that releasably indexes thetension members87,89 between locationsadjacent indicators81,83 and85. A releasable detent and groove associated with a hinge provides suitable structure.Locations81,83 and85 correspond to predetermined positions between the open (FIG. 11a) and fully closed (FIG. 11b) positions. Generally, the closer thetension members87 and89 are to thebase portion82, the more slack will be provided insling85′ when thetension control article80 is removed.
• FIG. 12 illustrates another embodiment of[0115]tension control article100. Thetension control article100 comprises tensioningmembers102,104 and106,base member105, andadjustment member110. Thetensioning members102 and106 are located onarms112 and111 that are movable relative to tensioningmember104. By rotating ageared wheel110 that engages gears onarms111 and112, thetensioning members102 and106 may be moved away from or closer to tensioningmember104.Indicia109 may be printed on or embossed on thearms111 and112 to provide an indication of the preselected tension provided by thetension control article100. Adjustabletension control article100 allows the surgeon to preselect a tension to account for the vagaries in human anatomy sizes, surgical procedure requirements or personal preference.
• FIGS. 13-15 illustrate another embodiment of[0116]tension control article120 according to the present invention. Thetension control article120 includesmajor tensioning member124 andminor retention members122 and126. FIGS. 14 and 15 illustrate different tortuous paths associated withtension control article120.Sling127 is associated witharticle120 by being threaded withintension control article120 along one of the tortuous paths. The tortuous path of FIG. 14 is shorter than the tortuous path of FIG. 15. Generally, the longer the tortuous path, the more slack will be provided in thesling127 when thetension control article120 is removed. Also, the longer the tortuous path, the more slack is taken up in an implanted sling when thearticle120 is applied to the sling.
• FIGS. 16[0117]aand16billustrate another embodiment oftension control article130 according to the present invention. Thetension control article130 includesspacer jaws136 and138, hinge134, handles132 and over opening stops137 and139. Thetension control article130 is preferably a unitary structure with an inherent bias of the jaws toward a closed or clamped position.
• The[0118]hinge134 may comprise an integral or living hinge that biases thejaws136 and138 toward a closed position. In use, manual pressure is applied tohandles132 to open the jaws. A sling is placed in the open jaws and the handle is released. Upon release, the sling is clamped between thejaws136 and138. The sling is then placed next to the urethra withjaw136 located between the sling and the urethra. Thejaw136 is sized and shaped to provide a predetermined distance between the urethra and sling. Thetension control article130 is then removed. The predetermined distance or size of jaw146 assists the surgeon in providing a consistent, uniform and repeatable amount of looseness in a sling.
• Another embodiment of[0119]tension control article140 is shown in FIGS. 17aand17b.Tension control article140 includesjaws142 and144. Asling141 is shown placed within the jaws in FIG. 17b.Optionally,jaw142 may be constructed to be a different size thanjaw144 to afford two different spacing options for the surgeon.
• FIGS. 18[0120]athrough18cshow another embodiment oftension control article150 according to the present invention. Thetension control article150 includesjaws152 and154, a hinge and aspring151 for biasingjaws152 and154 toward a closed position.Sling151′ is shown placed betweenjaws152 and154 in FIG. 18C.
• The device according to the invention may be easily tailored to provide increased or decreased urethral support. Optionally, the tension control article may allow the surgeon to remove, or break the tensioning members during the surgical procedure or during a post operative period.[0121]
Method
• In another aspect, the present invention comprises a method of changing tension of an implantable article using an article according to the present invention. The article may be implanted in the body during a surgical procedure. Alternatively it may be removed prior to the end of a surgical procedure. The article of the present invention may be modified in a subsequent surgical procedure or by substantially non-invasive means.[0122]
• FIGS. 19 and 20 illustrate a method where the surgical article is removed prior to the end of the surgical procedure. FIG. 19 is a flowchart illustrating an embodiment of[0123]method200 according to the present invention.
• [0124]Step202 provides a tension control article (tension accessory) and a sling. Preferably, the tension control article (e.g.10) may be part of a surgical kit. The kit may be a surgical kit having tools for treating incontinence, such a sling kit. Alternatively, the tension control article, sling and the rest of the surgical articles may be independently provided to the surgeon. The latter case is desirable when the elements of the kit have drastically different shelf lives or storage condition requirements (e.g. refrigeration).
• Step[0125]204 associates the tension accessory (the tension control article) with the sling. Optionally, the manufacturer can conduct this step so that a sling/tension control article preassembly is provided to the surgeon in the kit. Alternatively, this step may be conducted by the surgeon or other healthcare professional prior to implanting the sling, especially if the tension control article provides a plurality of different tension options.
• Using[0126]tension control article10 as an example, to associate thearticle10 with a sling, the operator threads the sling along one of the tortuous paths provided by thearticle10. It is noted that, if the sling includes a surrounding, removable plastic sheath, the sling/sheath combination may be threaded along the tortuous path. Optionally, the sling/sheath combination may include a hiatus (e.g. a portion with no plastic sheath) at about the mid portion of the sling to allow the sling to be threaded between the tensioning members of thearticle10 without interference from the sheath.
• In[0127]step206, the sling is inserted in the body and adjusted to a predetermined position. For example, some sling procedures call for a tension free sling. For such a procedure, the sling/tension control article combination can be situated in a fully inserted position such that the sling and/or the tension control article are just adjacent or even slightly touching the urethra.
• FIG. 20 schematically illustrates article I[0128]0 in a fully inserted position with solid lines. Thearticle10 is justadjacent urethra304.Vaginal incision306,vagina302, and sling S are also shown. In step208 (FIG. 19), the surgeon verifies that the sling/tension control article combination are in this fully inserted position. If not, the surgeon continues to adjust207 the sling. If the combination is fully inserted, then the surgeon verifies the fully insertedposition209. Once the fully inserted position is verified, the surgeon may remove the tension control article instep210. This removal step is illustrated with an arrow and dotted lines in FIG. 20. Step210 may be conducted before or after any optional insertion sheath is removed from the sling, but it preferably occurs after any such optional insertion sheath is removed.
• Changing the tension of the sling S at a location substantially adjacent the[0129]urethra304 is more effective than attempting to modify the tension of a sling at a location remote from the urethra. This is particularly the case where a synthetic sling (a polypropylene sling with holes) and insertion sheath are used as, once the insertion sheath is removed, adjustment of the entire length of the sling is particularly difficult or problematic due to the interaction between tissue and the sling.
• FIG. 21 illustrates another embodiment of method according to the present invention. In this embodiment, the sling is excessively loose.[0130]Article10 is placed on the sling (see the arrow and solid lines) to take up excessive slack in the sling. In this instance,article10 is preferably left in the body after the surgical procedure. Preferably, by positioning the sling within the tortuous pathway formed by the plurality of tensioning members,article10 effectively increases the path length traversed by the support material, thereby resulting in a reduction or elimination of slack from the support material and an increase in supportive tension unless and until the tension control article is removed. As shown in FIGS. 2aand2b,multiple degrees of retentive force may be applied to anatomical support material by adevice10. For example, FIG. 2ashows one method of practice wherein thedevice10 provides a tortuous pathway for a section ofanatomical support material20 disposed thereon. An alternative method of practice is shown in FIG. 2b,wherein an alternate tortuous pathway is created. FIG. 12 illustrates an article with a feature that allows the surgeon to adjust the tension provided by the clip. In preferred embodiments, the present invention permits the user to vary the supportive tension applied to the anatomical support material disposed therein by altering the tortuous pathway traversed by the anatomical support material.
• It is also noted that removal of an article from its association with the sling can be exploited to increase the tension of the sling on the urethra. FIG. 22 is a flow chart illustrating a method of increasing the tension of a sling by removing a tension control article from its association with the sling.[0131]
• FIG. 22 illustrates a method of treating incontinence comprising the steps of: (i) providing a support material with at least a portion that is elastically deformable, (ii) elastically deforming at least a portion of the support material to tension the support material (see step[0132]462); (iii) providing a tensioning article, (iv) applying the tensioning article to the tensioned support material to retain at least a portion of the support material in an elastically deformed condition (see step464); (v) implanting the support material with applied tensioning article in a patient (466); and removing the tensioning article to increase the tension provided by thesupport material468. The tension control article used in this method is preferably one with a locking member (FIG. 5aor5b) or one that can clamp the sling between jaw members (e.g. FIGS. 10a-11b) so that the elastic deformation can be held in the sling material.
• The tension control article may be provided in a kit or provided independent of other surgical articles. One or more articles may be used during a surgical procedure. The tension control article may be positioned on a portion of anatomical support material at the time of manufacture, immediately prior to, or following the surgical implantation of the anatomical support. For example, one surgical urethral stabilization procedure comprises attaching anchors to an internal structure, for example, the posterior or inferior pubic bone, and affixing a mesh sling to said anchors, thereby resulting in supportive force being applied to the urethra. The[0133]tension control article10 may be applied to the anatomical support material according to FIG. 2aor2bshould the anatomical support fail to provide adequate support to the anatomical structure. Applying thetensioning device10 to the anatomical support material increases the pathway between the attaching anchors traversed by the anatomical support and increases the support tension applied by the device. The practitioner may easily vary the amount of supportive tension by applying more or fewer anatomical support tension control articles. Alternatively, the amount of supportive tension applied by the anatomical support tensioning device may be varied by applying tensioning device having more or fewer tensioning members disposed thereon.
• It is understood that the embodiments of the invention disclosed herein are illustrative of the principles of the invention. Other modifications may be employed which are within the scope of the invention; thus, by way of example but not of limitation, alternate base member shapes, alternative tensioning member shapes, and use with alternative anatomical support materials. Accordingly, the present invention is not limited to that precisely as shown and described in the present invention.[0134]

Claims (34)

1. An article for consistently controlling the relationship between an anatomical support material and an anatomical tissue, comprising:

a portion adapted to be grasped, and

at least one tensioning member that is sized and shaped to afford predetermined looseness of an anatomical support material, such as a sling, relative to anatomical tissue, such as a urethra.

2. An article according toclaim 1 comprising a plurality of tensioning members.

3. An article according toclaim 2 including movement means for moving at least one tensioning member between an open position for receiving the anatomical support material and a closed position that associates the article with the anatomical support material.

4. An article according toclaim 3 wherein the movement means comprises means for affording substantial parallel movement between tensioning members during movement from said open to said closed position to resist extrusion of the anatomical support material out of a position between the tensioning member.

5. An article according toclaim 2 wherein the plurality of tensioning members are arranged to afford a plurality of tortuous paths of different lengths, and the anatomical support material may be associated with the article along on of the tortuous paths.

6. An article according toclaim 5 further including means for moving at least one of the tensioning members relative to another tensioning member to change the length of a tortuous path.

7. An article according toclaim 6 further comprising means for indexing one of the tensioning members between a plurality of predetermined positions relative to another tensioning member to select the length of the tortuous path.

8. An article according toclaim 6 further comprising means for indexing one of the tensioning members between a plurality of predetermined positions relative to another tensioning member to select the distance between the sling and the urethra.

9. An article according toclaim 3 further including biasing means for biasing the tensioning member toward a closed position.

10. An article according toclaim 9 wherein, in the closed position, the article may retain at least a portion of the support material in an elastically deformed lengthened condition such that, upon implantation of the elastically lengthened support material within tissues of a patient and subsequent removal of the article from the support material, the support material may shorten to increase the tension provided by the support material.

11. A surgical article for adjusting an anatomical support material comprising:

A base member; and,

A plurality of tensioning members extending outwardly from said base member, wherein said plurality of tensioning members form a tortuous pathway for said anatomical support material.

12. The device ofclaim 11 wherein said base member is arcuate.

13. The device ofclaim 11 wherein said base member further comprises an orientation indicator.

14. The device ofclaim 11 wherein said base member further comprises a grasping member.

15. The device ofclaim 14 wherein said grasping member is integral to said base member.

16. The device ofclaim 14 wherein said grasping member is detachable from said base member.

17. The device ofclaim 11, wherein said base member further comprises at least one material locking member.

18. The device ofclaim 17 wherein said at least one material locking member comprises a movable arm, said arm having an open position, and a closed position.

19. The device ofclaim 11 wherein said plurality of tensioning members are laterally co-aligned.

20. The device ofclaim 11 wherein said plurality of tensioning members are co-aligned along an arc.

21. The device ofclaim 11 wherein said plurality of tensioning members are rigid.

22. The device ofclaim 11 wherein said plurality of tensioning member are pliable.

23. An tensioning device for an anatomical support comprising:

an arcuate base member having a first surface and a second surface;

a plurality of tensioning members in communication with and extending outwardly from said first surface; and,

a direction indicator disposed on said base member.

24. (Cancelled).

25. (Cancelled).

26. (Cancelled).

27. (Cancelled).

28. (Cancelled).

29. (Cancelled).

30. (Cancelled).

31. (Cancelled).

32. (Cancelled).

33. (Cancelled).

34. (Cancelled).

Images