WO2008067317A2

WO2008067317A2 - Method and apparatus for supporting body organs, urethra and bladder neck

Info

Publication number: WO2008067317A2
Application number: PCT/US2007/085647
Authority: WO
Inventors: Ashvin H. Desai; Neal Desai
Original assignee: ProSurg Inc
Current assignee: ProSurg Inc
Priority date: 2006-11-27
Filing date: 2007-11-27
Publication date: 2008-06-05
Anticipated expiration: 2009-05-27
Also published as: WO2008067317A3

Abstract

An apparatus and a surgical method for supporting body organs to treat urinary incontinence by supporting the urethra and bladder neck are described, including construction, material selection, introducer tools and surgical methods for self-anchoring urethral slings to support the urethra and bladder for treatment of female urinary incontinence. The device includes a modular, self-locking anchor for fixation of surgical mesh in target tissue. The apparatus is also useful for repair and reconstruction of prolapsed pelvic floor body organs.

Description

METHOD AND APPARATUS FOR SUPPORTING BODY ORGANS,

URETHRA AND BLADDER NECK

CROSS REFERENCE TO RELATED APPLICATIONS

[0001) This application claims priority from U.S. Provisional Patent Application No.

60/861 ,596 filed on November 27, 2006.

BACKGROUND

Field of the Invention

[0002] The present invention relates generally to devices and methods for supporting body organs, and more particularly to the treatment of urinary incontinence by supporting the urethra and bladder neck, pelvic floor reconstruction surgery, and repairs for bladder, vagina, rectum, bowel and uterine prolapse. More specifically, this invention relates to design, construction, material selection, and surgical methods for self-anchoring urethral slings, introducer tools, and tissue fixation methods. The surgical method involves urethral sling implantation using adjustable, self-anchoring fixation anchors to support the urethra and bladder neck for treatment of female urinary incontinence, and use of self-locking, modular, fixation anchors for repair and reconstructive surgery associated with prolapse of pelvic floor body organs.

Description of the Prior Art

[0003] Urinary incontinence is a common problem, especially in women. It is estimated that there are over 13 million individuals with urinary incontinence in the United States, of which about 85% are women. Stress urinary continence is a condition in which the patient leaks urine when a sudden increase in his or her abdominal pressure occurs. This increase in abdominal pressure can result from many routine daily activities such as laughing, sneezing, walking, or getting up from a chair. The increase in abdominal pressure causes an increase in pressure in the bladder. When the pressure in the bladder is sufficiently great, urethral sphincter leakage will occur.

[0004] Various treatments have been provided for stress urinary incontinence. For over 50 years, surgeons have used sub-urethral sling procedures to treat severe or refractory genuine stress incontinence. This procedure, sometimes referred to as pubo-vaginal or trans- obturator sling procedure, is used to treat urinary stress incontinence by creating a support to the urethra and bladder neck. Providing this support serves to increase the urethral closure pressure during stress to mitigate the involuntary loss of urine. See U.S. Patent Nos. 4,669,478; 4,880,002; 4,905,367; 4,920,986; 5,234,006; 5,362,294; 5,386,836; 5,562,689; 5,785,640; 5,840,01 1; 6,010,447; and 6,042,536. See also The Journal of Urology, JuI. 1996, "Female Stress Urinary Incontinence Due to Intrinsic Sphincteric Deficiency: Recognition and Management", Vol. 156, pp. 3-17, Haab et al.; Obstetrics & Gynecology, "Suburethral Sling Release", Oct. 1995, Vol. 86, No. 4, Part 2, pp. 686-688, Brubaker; Anatomy and Pathophysilogy of Pelvic Support. Chapter 5, pp. 57-72, Wahle, et al.; British Journal of Obstetrics and Gynecology, "A follow up of silastic sling for genuine stress incontinence", Feb. 1995, Vol. 102, pp. 143-147, Chin et al.; International Urogynecology Journal, "Pubovaginal Slings: Past, Present and Future", 1997, pp. 358-368, Sarver et al.

[0005] Traditionally, the materials used to create the urethral sling include rectus fascia and fascia lata from the patient or processed tissue. Recently, chemically treated cadaveric fascia lata and synthetic polymer materials have been used. These include woven sheets made of polypropylene, dacron, and other biocompatible materials. The surgical method for implanting a urethral sling consists of supporting the urethra by synthetic sling, which can be anchored in position using screws, sutures or other fixation devices attached to bones, skin or muscle of the patient. All of the current devices used for urethral support require surgical fixation or anchoring by the physician. None of the currently available urethral support devices are based on self-anchoring fixation mechanisms for supporting body organs including the urethra and bladder neck.

SUMMARY OF THE INVENTION

[0006] The present device provides support for body organs, including the urethra and bladder neck. The material selection, support structure, and self-anchoring fixation ends are designed to approximate tissue surrounding the body organ. The flexibility and elastic properties of the support structure accommodate the normal up and down movements of the body organs including the urethra and bladder neck, without pinching or compressing the urethra to avoid urinary retention.

[0007J The urethral support device consists of a central section of knitted / woven mesh constructed from biocompatible polymers such as polypropylene monofilaments. The self-anchoring fixation ends are constructed from bioabsorbable polymers and are bonded or attached to the polypropylene mesh using fixed, adjustable or modular "snap-on" anchors. The self-anchoring fixation ends attached to the mesh structure also minimize the elongation of the support structure and descent of the urethra and bladder neck under stress, while providing adequate support. Under stress, the bladder neck can drop and if not controlled, cause urine leakage due to the hypermobility of the bladder neck. The present invention provides controlled elongation of the urethral support structure, prevents excessive bladder neck descent, and minimizes urine leakage, without causing urinary retention.

[0008] The present invention can reduce clinical adverse events including sling extrusions, urethral erosion, and bladder perforation, which are associated with current sling products and surgical procedures. The biocompatible polymer mesh structure combined with a self-anchoring bioabsorbable / non-absorbable fixation ends provides flexible and elastic support to the urethra and bladder neck, while preventing urethral erosion and extrusion. The micro-invasive procedure involves a small vaginal incision to introduce the urethral support sling around the urethra in fibro-muscular tissue, using an introducer tool that reduces the risk of damage to surrounding body organs, such as bladder and bowel perforation. The introducer tool which has a notched tip for quick connect and disconnect of the sling fixation ends, which allows controlled delivery and secure positioning into fibro-muscular tissue surrounding the urethra, such as pubo-urethral tissue in the retro pubic tissue space.

[0009] One embodiment of the present invention includes a central portion of the support structure made of biocompatible polymers such as polypropylene mesh with self- anchoring fixation means made of a nonabsorbable polymer such as polypropylene (PP) or a bioabsorbable polymer material such as polyglycolide (PEG), polylactide (PLA- PLLA, DPLA), poly-lacide-co-glycolide (PLG), polycaprolactone (PCL), poly dioxanone (POD), or a combination of bioabsorbable and nonabsorbable co-polymer materials. The polymer sling surface can be coated with a variety of treatment agents including antibiotics, anti-microbial agents, biological tissue, pharmaceutical drugs, lubricants, tissue growth agents, or antiinflammatory agents to provide added utility and localized delivery of agents to body organs.

[0010] One embodiment of the present invention includes a central portion of the support structure made of materials including biocompatible polymers, processed tissue, tissue derivatives / byproducts or a combination thereof to approximate characteristics of natural tissue surrounding target body organs. Furthermore, the support structure can be impregnated with treatment agents and pharmaceutical drugs for selective localized delivery to a target tissue/organ, without affecting surrounding body organs. [0011] Another embodiment of the present invention includes a self-anchoring fixation means with spikes or saw-tooth protrusions along the length and the surface of the anchor for fixation in the tissue. The protrusions are designed to be on at least one side or surface of the anchoring means. The protrusions can be also be designed to be on three, four or more sides and surfaces, located at an angle to the central axis of the anchoring means. Additionally, the self-anchoring fixation means can be designed to be adjustable to facilitate urethral sling adjustment from one or both ends during surgery.

(0012] Another embodiment of the self-anchoring means is a device with a shape memory to facilitate fixation in the tissue. The anchoring means can be made from memory metal or polymer material, which can be transformed to its original shape and configuration by application of external stimuli including heat, cold, ultrasound, pH, or microwave, RF, electrical, thermal or electromagnetic energy.

[0013| Another embodiment of the self-anchoring means uses biomaterials that can be injected in the tissue to form an anchor for the support structure. The injectable biomaterial can be polymer, organic material, metal particle suspension, or a combination thereof, in liquid, semi-liquid, gel, paste, semi-solid, suspension or other material forms, suitable for injection in the tissue. The injectable agents, once injected into the tissue, can solidify to foπn an anchor on their own or through application of external stimuli including heat, cold, ultrasound, pH, or microwave, RF, electrical, thermal or electromagnetic energy.

[0014] Another embodiment of the self-anchoring tissue fixation means is a modular,

"snap-on" type of self-locking anchor that can be attached or assembled to the urethral sling, surgical mesh or biological mesh by the physician during surgery to facilitate anchoring into surrounding tissue. The introducer tool of the present invention can be used to deliver and secure the sling or surgical mesh, pre-loaded with the modular anchor, into the target tissue. [0015] Another embodiment uses polymer or biological surgical mesh with modular, snap-on type, self-locking, and bioabsorbable polymer tissue anchors (fixed or adjustable) for repair and reconstruction surgery of pelvic floor organ prolapse including vaginal vault prolapse, bladder prolapse (cystocele), or rectal prolapse (rectocele), uterine prolapse, small bowel prolapse (enterocele), by supporting the urethra, bladder neck, vagina, bladder, rectum, uterus or small bowel.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] FIG. l(a) shows a self-anchoring urethral support sling.

|0017] FIG. l(b) is a detailed profile of a self-anchoring fixation end tab for the sling.

|0018] FIG. l (c) shows detailed profiles of other embodiments of the self-anchoring fixation end tab for the sling.

[0019] FIG. l (d) shows a profile of an adjustable self-anchoring fixation end tab for the sling.

[0020] FIG. l(e) shows a profile of an another embodiment of an adjustable self-anchoring fixation end tab for the sling.

|0021] FIGS. 2(a) and 2(b) shows details of the support mesh structure with a mid-line marking for proper positioning and smooth, rounded edges to prevent fold over and erosion.

|0022J FIG. 3(a) shows another embodiment of a self-anchoring fixation anchor for supporting body organs.

[0023] FIG. 3(b) shows another embodiment of a support sling structure with a modular self-anchoring fixation anchor for supporting body organs.

[0024] FIG. 3(c) shows another embodiment of a modular, support sling structure with an adjustable, modular fixation anchor for supporting body organs.

|0025] FIGS. 4(a) and 4(b) illustrate embodiments of the support sling structure with an injectable anchoring means. [0026] FIG. 5(a) illustrates an embodiment using a biocompatible polymer or biological surgical mesh to support, repair or reconstruct pelvic floor organs, including vaginal vault prolapse, bladder prolapse (cystocele), rectal prolapse (rectocele), and uterine proplapse, using an injectable anchoring means.

[0027] FIG. 5(b) illustrates an embodiment of a polymer or biological surgical mesh with modular self-locking anchors, used to support, repair or reconstruct pelvic floor organs including vaginal vault prolapse, bladder prolapse (cystocele), rectal prolapse (rectocele), and uterine prolapse, using modular fixed or adjustable absorbable polymer tissue anchors.

[0028] FIGS. 5(c) - 5(f) illustrate various embodiments of fixed and adjustable modular, self-locking, self-anchoring, snap-on bioabsorbable polymer fixation anchors.

[0029] FIG. 6 is a flow chart outlining the urethral sling implantation surgical procedure.

[0030] FIG. 7(a) shows an introducer tool used to deliver the urethral sling. The introducer tool can have a straight or curved profile to deliver the support sling structure in the hammock position or U position around the urethra.

[0031] FIGS. 7(b) and 7(c) illustrate introducer tools to deliver a support sling and surgical mesh assembly. The introducer tool is designed to deliver the support sling and surgical mesh with pre-assembled, modular, snap-on anchors (fixed or adjustable) in the soft tissue close to a target body organ.

[0032[ FIG. 8 illustrates details of a notched design of the introducer tip for quick connect/disconnect of the fixation anchor. [0033] FIGS. 9(a) and 9(b) illustrate assembly of a support sling structure with an introducer tool tip, prior to insertion in the target tissue via vaginal incision.

[0034) FIGS. 10(a) and 10(b) show a central section of an implanted urethral sling with self anchoring fixation ends surrounding the urethra and bladder neck in hammock and U positions.

DETAILED DESCRIPTION

[0035] A preferred embodiment of the present invention is illustrated in Fig 1 (a). A sling device 192 with overall length L₃ for supporting a body organ such as the urethra and bladder neck consists of central section length L₅ of knitted or woven mesh structure made from polypropylene monofilament and self-anchoring fixation end tabs 194 and 200 with spikes or saw toothed protrusions 204 along lengths L₄ and L_O. Alternatively, the central section of sling device can be made from biological tissue or a composite biomaterial and tissue matrix. The fixation anchor spikes protrude at an angle from the axis of the sling so that they can be securely anchored into surrounding tissue. The angle of the spikes can be straight, upward or downward as shown in Figs. l(b) - l(c). The fixation anchors can be adjustable along the length of the sling to provide necessary length and tension adjustment of the elongated member for urethral support as shown in Figs. l(d) and l(e). The length adjustment can be made by pulling the sling at the mid-line away from the first, second, or both fixations anchors. The angular spikes or saw-toothed fixation means resist movement of the anchors in the downward direction, thus providing self-anchoring capability and sling adjustment up to approximately one centimeter. The fixation end tabs are made from nonabsorbable or bioabsorbable polymer materials with a minimum three to six weeks of degradation life. Within days and weeks after implantation, a fibrosis process begins and provides additional tissue support around the fixation anchors. Fig. l(b) provides a detailed view of the profile and angle of a spike structure. The fixation anchor also contains an opening 201 to facilitate quick connect and disconnect of the support sling from an introducer tool tip used to deliver the sling into target tissue. The introducer tool can be made of a variety of materials including metal, semi-rigid thermoplastic, or a combination thereof. An introducer tool made with a stainless steel tip and shaft portion with an ergonomically designed ABS / polycarbonate handle is one preferred embodiment.

[0036] Figs. 2(a) and 2(b) illustrate details of a urethral sling or surgical mesh structure with smooth, rounded edges to prevent fold over and urethral erosion. The figures also show a mid-line reference marking for proper positioning around a body organ. The mid-line reference marking on the central section of the sling serves as a guideline for a physician to position the sling along the centerline of urethra or other body organs. The central section of the sling or mesh structure can be made from polypropylene with knitted or woven monofilament to provide flexibility and elasticity. The exposed monofilament edges of polypropylene mesh can be sealed together to minimize potential fold over or fraying by application of a temperature controlled thermal process, using laser, RF, heat and other energy sources. The lateral elongation of the support sling can also be minimized by heat sealing the ends with fixation anchors. The support sling can also be constructed with an accordion profile or wave form along the length or width to provide additional flexibility and elasticity. The polypropylene mesh structure can be coated with color, anti-bacterial agents, treatment substances, tissue growth factors, tissue derivatives, tissue byproducts, lubricating agents, electromagnetic enhancement materials, pharmaceutical agents and drugs, chemical agents, or other biomaterials to provide additional utility and enhancement.

[0037] Fig. 3(a) illustrates another embodiment of a sling structure with self-anchoring fixation means for supporting body organs. The central section of the support sling consists of knitted or woven mesh structure made from polypropylene monofilaments attached to self anchoring fixation end tabs. The fixation end tabs 195, made of bioabsorbable or non-absorbable polymer material, consist of series of triangular spikes 206 at an angle to the axis of sling. The fixation end tab also contains a small pocket (207) to facilitate quick connect and disconnect from the introducer tool tip that delivers the support sling into the target tissue. The profile, dimensions and configuration of fixation anchors can vary depending on the target body tissue structure and location of body organ.

[0038] Fig. 3(b) illustrates another embodiment of a support sling structure with modular self-anchoring fixation anchors for supporting body organs. The self-locking, snap- on fixation anchors can be attached to the end or side of the biomaterial mesh or biological tissue section using mechanical assembly or thermal means.

[0039] Fig. 3(c) illustrates another embodiment of a modular support sling structure with an adjustable modular fixation anchor for supporting body organs. The adjustable self- locking fixation anchors can be attached to the end or side of the biomaterial mesh or biological tissue section using mechanical assembly or thermal means.

[0040] Figs. 4(a) and 4(b) illustrate an injectable anchoring means for a sling structure for supporting body organs. The central section of the support sling consists of a knitted or woven mesh structure made from polypropylene monofilaments. The central section of the support sling can be secured in the target tissue by flowable biomaterials which can be injected in the tissue to form anchoring means for the support structure. The injectable biomaterial can be polymer, organic material, metal or a combination thereof in liquid, semi- liquid, gel, paste, semi-solid or suspension or other material forms, suitable for injection in the tissue. The injectable agents, once injected in the tissue can solidify to form anchoring means on their own or by application of external stimuli including heat, cold, ultrasound, pH, or microwave, RF, electrical, thermal, sound, magnetic or electromagnetic energy. The injectable anchoring agent can be used by itself or in combination with the self-anchoring end tabs described above.

J00411 Fig. 5(a) shows an embodiment using biocompatible polymer surgical mesh for repair or reconstruction surgery associated with pelvic floor body organ prolapse, including vaginal vault prolapse, bladder prolapse (cystocele), rectal prolapse (rectocele), and uterine prolapse, using injectable anchoring means. The polymer surgical mesh can also be manufactured from polypropylene monofilament material. The polymer surgical mesh is a flat mesh support structure with variable dimensions based on the prolapsed body organ requiring support and the patient's anatomy. The injectable anchoring agent can be used by itself or in combination with the self-anchoring anchors described above.

[0042] Fig. 5(b) shows a modular, bioabsorbable, self-locking, snap-on fixation anchor for securing polymer mesh or biological material to provide support for a prolapsed body organ. The modular, fixed or adjustable self-locking fixation anchors can be attached to the end or side of the biomaterial mesh or biological tissue section, using mechanical or thermal means. The shapes, profile, materials and construction of self-locking fixation anchors can vary depending on the mesh material to be attached or its utility during surgical procedure.

[0043] Figs. 5(c) to 5(f) illustrate various embodiments of modular, bioabsorbable, self-locking, snap-on fixation anchors for securing polymer mesh or biological material used during repair or reconstruction of pelvic floor body organs. The modular, fixed or adjustable self-locking fixation anchors can be attached to the end or side of a biomaterial mesh or biological tissue section by the physician. The design of the self-locking fixation mechanism can vary from single snap, double snap, side snap, etc., for fixed or adjustable anchor means. (0044J Fig. 6 is a flow chart outlining the urethral sling implantation surgical procedure. The procedure consists of: (1) opening the vaginal canal using a speculum; (2) making a small incision to expose the urethra and isolating the urethra using blunt dissection; (3) attaching the self-anchoring end tab of the sling to the tip of an introducer tool and inserting the assembly through the vaginal incision around the urethra; (4) pushing the fixation end tab into fibro-muscular tissue using the introducer to the end stop, and releasing the sling into the surrounding tissue; (5) attaching the other end of the sling to the introducer tip and inserting the assembly on the other side of the urethra to the end stop, and then releasing it from introducer; (6) centering the position of the support sling around the urethra, using the mid-line reference marking as a guide, while maintaining appropriate tension to prevent urethral retention; (7) positioning the central section of the sling using the first, second, or both adjustable self-anchoring fixation means to maintain appropriate tension for urethral support, if necessary; and (8) closing up the vaginal incision and finishing the procedure.

[0045] Fig. 7(a) shows an introducer tool for delivering a support sling. The introducer tool can be made of stainless steel 222 with a notched distal end 226 to facilitate quick connect and disconnect of a self-anchoring end tab. The introducer handle 224 is ergonomically designed for easy and safe insertion with an end stop 225. The end stop is designed to insert the tip of the introducer to a predetermined depth for safe and secure placement of the self-anchoring end tabs. The distal tip of the introducer can vary, based on the configuration and profile of the self-anchoring end tabs. For injectable anchoring means, the design of introducer tool tip will depend on the delivery method of the polymer mesh structure, without pre-formed anchors. [0046] Figs.7(b) and 7(c) illustrate alternative embodiments introducer tools for delivering a support sling and surgical mesh assembly. The introducer tool is designed to deliver the support sling and surgical mesh with pre-assembled, modular, snap-on anchors (fixed or adjustable) to the soft tissue close to the target body organ.

[0047] Fig. 8 shows details of an introducer tip for "quick connect/disconnect" of fixation end tabs in a sling structure. The notched distal end 226 of the introducer tip is designed to engage the opening in the self-anchoring end tab for quick connect and disconnection. Alternatively, the introducer distal end can engage in the pocket 207 in the self-anchoring sling outlined in Fig 3(a) - 3(c).

[0048] Figs. 9(a) and 9(b) show the assembly of a support sling with an introducer tool tip, prior to insertion. The introducer handle is ergonomically designed for easy and safe insertion with an end stop. The end stop is designed to insert the tip of introducer to a predetermined depth for safe and secure placement of self-anchoring end tabs.

[0049] Figs. 10(a) and 10(b) illustrate the position of the central section of a urethral sling relative to the urethra and bladder neck. The self-anchoring end tabs are positioned securely in the fϊbro-muscular tissue, around the urethra extending at least one inch from the urethra mid-line. The urethral support sling does not require any additional sutures, anchors, screws or other fixation devices. To obtain optimum clinical outcome, the urethral support sling can be positioned in a U shape configuration or hammock position, using a curved or straight introducer tool, depending on the patient's anatomy and the physician's preference.

[0050] While certain representative embodiments and details have been shown for purposes of illustrating the invention, it will be apparent to those skilled in the art that various changes in the methods and apparatus disclosed herein may be made without departing from the scope of the invention which is defined in the appended claims.

Claims

[0051] What is claimed is: CLAIMS

1. An apparatus for supporting a body organ comprising: (a) a central elongated section including a biocompatible material; and (b) a plurality of self-anchoring fixation tabs for anchoring the apparatus in tissue of a patient.

2. The apparatus of claim 1, wherein the apparatus is used for treatment of a condition selected from the group consisting of stress urinary incontinence (SUI), vaginal vault prolapse, bladder prolapse, rectal prolapse, uterine prolapse, and small bowel prolapse.

3. The apparatus of claim 1 , wherein the biocompatible material is selected from group consisting of polymer strip, knitted polymer mesh, woven polymer mesh, molded polymer mesh, cast polymer mesh, polymer ribbon with holes, polymer tape, polymer matrix, layered polymer composite with biological tissue, and biological tissue.

4. The apparatus of claim 1 , wherein the biocompatible material is selected from group consisting of non-absorbable polymers, bioabsorbable polymers, memory shape polymers, intelligent polymer gel, superelastic polymers, polymers with color dye, co- polymers, and composites.

5. The apparatus of claim 4, wherein the biocompatible material is selected from the group consisting of polypropylene, polyglycolide, polylactide, poly-lacide-co-glycolide, poly-e-caprolactone, and polydioxanone.

6. The apparatus of claim 1 , wherein the tabs include a plurality of protrusions along the length of the tabs to engage the tissue.

7. The apparatus of claim 1 , wherein the length of the apparatus is adjustable.

8. The apparatus of claim 7, wherein at least one tab provides adjustment of the length of the apparatus.

9. The apparatus of claim 1 , wherein the biocompatible material is coated or impregnated with a treatment substance selected from group consisting of antibiotics, anti-microbial agents, pharmaceutical drugs, lubricants, biological tissue matrix, tissue growth agents, and anti-inflammatory agents.

10. The apparatus of claim 1 , wherein the central elongated section has a reference marking to serve as a guideline for positioning the apparatus.

1 1. The apparatus of claim 1 , wherein the central elongated section has smooth edges.

12. The apparatus of claim 1 , wherein at least one tab is constructed from a memory material that can be transformed to a different shape.

13. The apparatus of claim 1 , wherein at least one tab is formed by injecting a flowable material that solidifies after injection.

14. The apparatus of claim 13, wherein the flowable material solidifies by the application of an external stimulus selected from the group consisting of cold, ultrasound, pH, and microwave, RF, electrical, thermal, magnetic, or electromagnetic energy.

15. The apparatus of claim 1, wherein at least one tab is a modular, snap-on fitting that can be attached to the central elongated section.

16. The apparatus of claim 1 , wherein at least one tab includes a bioabsorbable polymer.

17. The apparatus of claim 16, wherein the tabs include a plurality of protrusions along the length of the tabs to engage the tissue.

18. The apparatus of claim 17, wherein the length of the apparatus is adjustable.

19. The apparatus of claim 17, wherein at least one tab provides adjustment of the length of the apparatus.

20. The apparatus of claim 16, wherein the biocompatible material is coated or impregnated with a treatment substance selected from group consisting of antibiotics, anti-microbial agents, pharmaceutical drugs, lubricants, biological tissue matrix, tissue growth agents, and anti-inflammatory agents.

21. The apparatus of claim 16, wherein the central elongated section has a reference marking to serve as a guideline for positioning the apparatus.

22. The apparatus of claim 16, wherein the central elongated section has smooth edges.

23. The apparatus of claim 16, wherein at least one tab is a modular, snap-on fitting that can be attached to the central elongated section.