Sling And Method Of Forming Same

Abstract

A medical sling for supporting an anatomical feature having ends that are tapered using a folding fixture and then thermoset. The thermoset ends hold the bunched or folded shape thus allowing the ends to be removed from the fixture and placed into a mold assembly where anchors are molded over the ends.

Claims

1. A method of forming a medical sling device comprising: providing a strip of material, wherein the strip of material includes a first end portion, a second end portion, and a body between the first end portion and the second end portion; tapering the first end portion without removing any material therefrom by passing the strip of material through a fixture assembly such that a terminus of the first end portion has a smaller width than an intersection between the first end portion and the body; thermosetting the first end portion such that the smaller width of the first end portion remains unchanged when unconstrained; placing the first end portion in a mold; and forming an anchor around the terminus of the first end portion.

2. The method of claim 1, wherein the fixture assembly includes a tapered circular end.

3. The method of claim 2, wherein the tapered circular end comprises a wave-form opening.

4. The method of claim 1, wherein passing the strip of material through the fixture assembly comprises pulling the strip of material through the fixture assembly.

5. The method of claim 1, wherein tapering the first end portion comprises bunching the strip of the material.

6. The method of claim 1, further comprising forming a waveform at the terminus of the first end portion.

7. The method of claim 6, further comprising pulling the waveform through a heat shrink tube over a shaping rod and heat-shrinking the waveform into a crescent shape.

8. The method of claim 1, wherein the fixture assembly comprises: a fixture bottom having a groove with a wide end and a narrow end, the narrow end having a curved form with gaps on either side of the curved form; and a fixture top having a groove with a wide end and a narrow end, the narrow end having a center fin and a curved form on either side of the center fin.

9. The method of claim 8, wherein when the fixture top is placed on the fixture bottom and aligned therewith, the center fin points down toward the curved form, thereby creating a wave-like gap through which the strip of material is pulled to create the smaller width in the first end portion.

10. The method of claim 8, wherein the fixture assembly further comprises a shaping rod extending from the narrow end of the groove.

11. The method of claim 1, wherein the strip of material comprises an elongated rectangular strip of material.

12. A method of forming a medical sling device comprising: providing a strip of material, wherein the strip of material includes a pair of end portions and a body between the pair of end portions; tapering at least one of the pair of end portions without removing any material therefrom by creating a wave-like configuration such that a terminus of the at least one of the pair of end portions has a smaller width than an intersection between the at least one of the pair of end portions and the body, wherein tapering at least one of the pair of end portions further comprises passing the strip of material through a fixture assembly; placing the at least one of the pair of end portions in a mold; and forming an anchor around the terminus.

13. The method of claim 12, wherein the fixture assembly includes a tapered circular end comprising a wave-form opening.

14. The method of claim 12, further comprising thermosetting the at least one of the pair of end portions before placing the at least one of the pair of end portions in the mold.

15. The method of claim 12, wherein the fixture assembly comprises: a fixture bottom having a groove with a wide end and a narrow end, wherein the narrow end has a curved form with gaps on either side of the curved form; and, a fixture top having a groove with a wide end and a narrow end, wherein the narrow end has a center fin and a curved form on either side of the center fin.

16. The method of claim 15, wherein when the fixture top is placed on the fixture bottom and aligned therewith, the center fin points down toward the curved form, thereby creating a wave-like gap through which the strip may be pulled to create the wave-like configuration in the at least one of the pair of end portions.

17. The method of claim 12, further comprising thermosetting the at least one of the pair of end portions such that the smaller width of the at least one of the pair of end portions remains unchanged when unconstrained.

18. The method of claim 17, further comprising wrapping the at least one of the pair of end portions around a shaping rod within a heat shrink tube and exposing the at least one of the pair of end portions to thermosetting conditions to form a crescent-shaped end.

19. The method of claim 12, wherein passing the strip of material through the fixture assembly comprises pulling the strip of material through the fixture assembly.

20. A method of forming a medical sling device comprising: providing a strip of material having two end portions and an elongate body between the two end portions; tapering at least one of the two end portions without removing the material therefrom by pulling the strip of material through a fixture assembly having a tapered circular end comprising a wave-form opening such that a terminus of the at least one of the two portions has a smaller width than an intersection between the at least one end portion and the elongate body; thermosetting the at least one end portion such that the at least one end portion maintains the smaller width when unconstrained; placing the at least one end portion in a mold; and forming an anchor around the terminus.

Description

BRIEF DESCRIPTION OF FIGURES

[0022] FIG. 1 is a transparent perspective view of an embodiment of a fixture of the invention;

[0023] FIG. 2 is a partial perspective view of an embodiment of a bottom portion of a fixture of the invention;

[0024] FIG. 3 is a partial perspective view of an embodiment of a top portion of a fixture of the invention;

[0025] FIG. 4 is a perspective view of an embodiment of a bottom portion of a fixture of the invention;

[0026] FIG. 5 is a perspective view of an embodiment of a top portion of a fixture of the invention;

[0027] FIG. 6 is a partial front elevation of an embodiment of a fixture of the invention;

[0028] FIG. 7 is a partial perspective view of an embodiment of a fixture of the invention in which the top is depicted as transparent to show internal detail;

[0029] FIGS. 8a-8g depict a sequence of end views of configurations of a mesh strip being pulled through an embodiment of a fixture of the invention;

[0030] FIG. 9a is a right-side perspective view of an embodiment of a shaping rod of the invention;

[0031] FIG. 9b is a perspective view of an embodiment of a shaping rod of the invention;

[0032] FIG. 9c is a left-side perspective view of an embodiment of a shaping rod of the invention;

[0033] FIG. 10 is a perspective view of one end of an embodiment of a sling of the invention;

[0034] FIG. 11 is a transparent perspective view of an embodiment of a mold assembly of the invention;

[0035] FIG. 12 is a perspective view of an embodiment of a lower half of a mold assembly of the invention;

[0036] FIG. 13 is a partial plan view of an embodiment of a lower half of a mold assembly of the invention;

[0037] FIG. 14 is a bottom plan view of an embodiment of an upper half of a mold assembly of the invention;

[0038] FIG. 15 is a perspective view of an embodiment of an upper half of a mold assembly of the invention;

[0039] FIG. 16 is a perspective view of an embodiment of a core pin of the invention;

[0040] FIG. 17 is an elevation of an embodiment of an anchor of the invention with a core pin;

[0041] FIG. 18 is a perspective view of an embodiment of an anchor of the invention;

[0042] FIG. 19 is a perspective view of an embodiment of an anchor of the invention;

[0043] FIG. 20 is a perspective view of an embodiment of an anchor of the invention;

[0044] FIG. 21 is a perspective view of an embodiment of an anchor of the invention;

[0045] FIG. 22 is a side elevation of an embodiment of an anchor of the invention;

[0046] FIG. 23 is a section view of the embodiment of the anchor of FIG. 22 taken along section lines D-D;

[0047] FIG. 24 is a plan view of an embodiment of an anchor of the invention;

[0048] FIG. 25 is a section view of the embodiment of the anchor of FIG. 24 taken along section lines F-F;

[0049] FIG. 26 is a section view of the embodiment of the anchor of FIG. 22 taken along section lines E-E;

[0050] FIG. 27 is a plan view of an embodiment of a sling of the invention;

[0051] FIG. 28 is a perspective view of an embodiment of a sling of the invention;

[0052] FIG. 29 is a plan view of an embodiment of a sling of the invention;

[0053] FIG. 30 is a side elevation of an embodiment of a sling of the invention;

[0054] FIG. 31 is a partial perspective view of an embodiment of an anchor of the invention;

[0055] FIG. 32 is a partial perspective view of an embodiment of an anchor of the invention;

[0056] FIG. 33 is a partial perspective view of an embodiment of an anchor of the invention;

[0057] FIG. 34 is a partial perspective view of an embodiment of an anchor of the invention;

[0058] FIG. 35 is a partial perspective view of an embodiment of an anchor of the invention;

[0059] FIG. 36 is a partial perspective view of an embodiment of an anchor of the invention;

[0060] FIG. 37 is a plan view of an embodiment of an introducer of the invention;

[0061] FIG. 38 is a side elevation of an embodiment of an introducer of the invention;

[0062] FIG. 39 is a front elevation of an embodiment of an introducer of the invention;

[0063] FIG. 40 is an exploded view of an embodiment of an introducer of the invention;

[0064] FIG. 41 is a perspective view of an embodiment of an introducer of the invention with a top half of the handle separated to show interior detail

[0065] FIG. 42 is a perspective view of an embodiment of an end piece of the invention;

[0066] FIG. 43 is a plan view of an embodiment of an end piece of the invention;

[0067] FIG. 44 is a back elevation of an embodiment of an end piece of the invention;

[0068] FIG. 45 is a sectional view of the embodiment of the end piece of FIG. 44 taken along lines B-B;

[0069] FIG. 46 is a side elevation of an embodiment of an end piece of the invention;

[0070] FIG. 47 is a sectional view of the embodiment of the end piece of FIG. 46 taken along lines A-A; and,

[0071] FIG. 48 is a distal elevation of an embodiment of an end piece of the invention.

DESCRIPTION OF EMBODIMENTS

[0072] Specific embodiments of the invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements.

[0073] In the present application, the sling is designed in such a way that the mesh is reduced in width, rolled, folded, and/or bunched into a small cross-section that can be contained within the plastic anchor. The method of reducing the width of the mesh is done with a fixture assembly that allows smooth transition with a simple pulling of the mesh. Subsequently, the mesh is thermally treated to retain the small cross-sectional shape prior to over-molding inside the anchor.

[0074] FIG. 1 describes a fixture assembly 10 which is used for rolling the sling mesh into a smaller cross-sectional profile. The fixture assembly comprises two major parts, including, a fixture bottom 20 and a fixture top 60. FIG. 2 demonstrates the fixture bottom part 20 and FIG. 3 demonstrates the fixture top part 60. Each of the fixture bottom 20 and the fixture top 60 define grooves 22 and 62, respectively, and the grooves 22, 62 of the fixture bottom and fixture top taper into a smaller cross-sectional area at the terminal ends forming a semicircular pattern. As seen in FIGS. 2 and 4, the groove 22 tapers from a wide end 24 to a narrow end 26. The narrow end 26 includes a crescent-shaped, semi-circular or curved form 28 that includes gaps 30 on either side, the function of which will be explained below.

[0075] FIGS. 3 and 5 show the detail of the groove 62 of the fixture top 60. The groove 62 also tapers from a wide end 64 to a narrow end 66. The narrow end 66 includes a center fin 68 that results in two curved forms 70, one on either side of the fin 68.

[0076] As seen in FIGS. 6 and 7, when assembled, the fixture bottom and fixture top align with each other such that the tapered ends 26 and 66 of mating grooves 22 and 62 form a tapered circular end. FIG. 6 demonstrates a front view of this tapered circular end of the fixture assembly in an assembled state. FIG. 7 is another view of the fixture assembly in an assembled state showing holes 32 (bottom) and 72 (top) through which locking pins are employed or inserted to keep the fixture bottom and fixture top securely connected and to prevent accidental disengagement. The sling mesh is pulled through this groove of tapered circular end.

[0077] Hereafter, the applicant discloses the method of securing mesh within the plastic anchors at both ends to form the Single Incision Sling. The method involves three steps.

[0078] The first step is forming the sling 100. FIGS. 8a-g demonstrate how the reduced width form of the sling mesh is formed. For clarity, only the resulting shape of the sling 100 is shown at various points as it is pulled through the mated grooves 22 and 62. FIG. 8a thus represents the shape of the sling 100 near the wide ends 24 and 64. FIGS. 8b-8f show the gradual progression in the wave-like M-shape formed in the sling as it is pulled toward and, in FIG. 8g, through the narrow ends 26 and 66. In FIG. 8a, the sling mesh is manipulated into a smaller cross-section by gently pulling one end of a mesh through the tapered circular end of the fixture assembly. The M-shape results in a smaller cross-sectional area and is created by the configuration of the forms 28 and 70, the fin 68, and the gaps 30.

[0079] The second step is thermally forming or setting the wave-like M-shaped end of the mesh. In this step, the wave-like M-shaped smaller cross-sectional end of the sling 100 is pulled through a portion of heat shrink tube 82 and over a shaping rod 80. FIGS. 1 and 9 show a shaping rod 80 which is protruded from the fixture assembly. The M-shaped smaller cross-sectional end of the sling, within the shrink tube, is wrapped around the shaping rod, and the M-shaped end is exposed to thermosetting conditions to form a C-shaped end thermoformed mesh end. The thermoset mesh end is cooled, the shaping rod 80 is withdrawn, the shrink tube 82 removed, and the shaped mesh end 102 is trimmed to the desired length, shown in FIG. 10.

[0080] FIG. 10 shows a sling 100 having mesh body 103 which has undergone the second step, resulting in thermosetting to form a crescent-shaped terminal end or terminus 102. The mesh of the sling is made of, for example, polyethylene or polypropylene and after exposing to the elevated temperature of the thermosetting condition the mesh is reshaped to a thermoset form which retains the crescent-shape of the terminal end. The terminal end 102 shape can also be described as C-shaped, semi-circular, arced, curved, etc.

[0081] The mesh body 103 begins as a strip, possibly a rectangular strip, and is formed through the methods described herein to have at least one, preferably two tapered end portions 104. The tapered end portions 104 meet the body 103 at intersections 105, though it is to be clear that the end portions 104 are a continuous extension of the mesh body 103 and are distinguished therefrom by the shaping methods described herein. It is also to be understood that the mesh construct of the mesh body 103 may differ from that of the tapered end portions. However, the taper created in the tapered end portions 104 results from the methods described herein and does not arise from removal of material from the elongate strip.

[0082] The third step of the inventive sling-forming method is the over-molding process in which the crescent-shaped end 102 of the mesh is affixed within the smaller diameter of a plastic anchor 200. Alternatively stated, the anchor 200 is formed over and incorporates the crescent-shaped end 102 of the mesh.

[0083] Referring now to FIG. 11, the over-molding process involves a mold assembly 300 which generally includes three parts, the upper half 320, the lower half 310 and the core pin 330. FIG. 11 shows the mold assembly comprising the upper half 320, lower half 310 and core pin 330, in an assembled state.

[0084] FIGS. 12 and 13 demonstrate different views of the lower half 310 of the mold assembly employing a mesh placement cavity 312 in which the sling 100 with the crescent-shaped terminal end 102 is placed; a core pin channel 331; and a material injection gate 314 through which plastic to form the anchors flows into an anchor mold portion 316 of the mold assembly.

[0085] FIGS. 14 and 15 demonstrate different views of the upper half 320 of the mold assembly employing a channel 322 through which plastic flows to gate 314 to form the anchor. The upper half includes an upper mold portion 340, which complements the anchor mold portion 316 of the lower half 310 in order to form a complete anchor. The details of the anchor are discussed below. The upper half 320 also includes a core pin channel 341, which complements the core pin channel 331 of the lower half 310.

[0086] FIG. 16 shows the core pin 330 of the mold assembly 300. FIG. 17 shows a partial cross-sectional view of the core pin 330 positioned through the anchor 200 formed over the mesh with crescent-shaped terminal end 102, e.g. after formation of the anchor 200 over the mesh with the crescent-shaped terminal end 102 and removal of the sling 100 and core pin 330 from the mold assembly 300.

[0087] During formation of anchor 200 on the sling 100, the crescent-shaped terminal end 102 of the mesh is first situated within the mesh placement cavity 312 in the lower half 310 of the mold assembly and the core pin 330 is placed into the core pin channel 331. The upper half 320 of the mold assembly is secured to the lower half 310 and molten plastic is introduced through channel 322 and gate 314 and into anchor mold portion 316. The assembly is allowed to cool so as to solidify the formed anchor 200, the sling 100 is removed from the assembly 300, and the gate is cut from the anchor 200.

[0088] The gate 314 and the anchor mold portion 316 are designed to allow sufficient plastic material flow around the crescent-shaped terminal end 102 and the core pin 330 while minimizing the size of the anchor 200. After removal of the sling 100 from the assembly 300, the core pin 330 is withdrawn from the anchor 200 thereby leaving a cavity 210 formed through the anchor 200 for receipt of a distal end of a surgical tool for placement of the anchor within a patient. In certain embodiments, the exterior shape of the core pin 330 has features, e.g. asymmetric features and/or surfaces, that allow the anchor to be securely connected to the tool and prevent rotation or accidental disengagement.

[0089] FIG. 18 demonstrates a terminal end or terminus 102 of the sling 100 over-molded with the anchor 200 as described above. FIG. 19 shows an inside view of the cavity 210 of the anchor 200 which results from the placement of the core pin 330 inside the channel 331 during formation of the anchor and from which the core pin 330 is taken out after formation of the anchor.

[0090] FIGS. 20-26 show the anchor 200. The anchor 200 has a body 201 with a proximal end 204 and a distal end 202 and the cavity 210. Tissue-grabbing features 220 extend from the body 201, and are shown as being embodied by two wings 220 placed on opposite sides of the body 201. The tissue grabbing features 220 may be alternatively embodied as a single feature or a plurality of features. Additionally, instead of being shaped like wings, non-limiting examples of these features include a ridge or ridges extending partially or completely around the body, barbs, hooks, spikes, posts, fins, textured surfaces, adhesives, in-growth promoting surfaces, etc.

[0091] The embodiment of the wings 220 shown in the figures include a leading edge 222, a trailing edge 224 and a lateral edge 226. The leading edge sweeps from the body 201 proximally back to the trailing edge 224. The trailing edge 224 joins the leading edge 222 and the lateral edge 226. The lateral edge 226 joins the trailing edge 224 and the lateral edge 226.

[0092] The leading edge 222 is shown as tapering to a point or sharpened edge in order to aid in separating tissue as it is pushed therethrough. The leading edge 222 alternatively may be curved, flat, rounded, or comprise two concave surfaces joining together.

[0093] The trailing edge 224 results from a termination of the leading edge 222 and thus has the shape of a cross-section of the leading edge 222. The trailing edge 224 is shown as being swept proximally such that it extends further in a proximal direction than the lateral edge 226, which is shown as extending relatively perpendicularly to the body 201.

[0094] FIG. 21 is a view of the proximal end 204 of the anchor 200 with a portion of C-shaped terminal end 102 of the mesh extending therefrom.

[0095] FIGS. 27-30 show an assembled single incision sling 100 with two anchors 200 secured at the terminal ends 102 through an over-molding process. A radiopaque band 110 may be included to provide a centering reference to assist in installation. The radiopaque band may be of a radiopaque mesh material or may be a radiopaque coating applied over the mesh body 103.

[0096] In some embodiments, the present invention discloses a single incision sling wherein the terminal ends of the sling with larger widths are each affixed within a smaller width of the plastic anchor without compromising the strength of the sling. In some embodiments, the widths of the proximal and the distal ends of the sling mesh are about 11 mm and are secured inside the anchors at both ends where the anchors have diameters of about 2 mm. In certain embodiments, the present invention discloses a method of securing both ends of the sling within the plastic anchors to form the single incision sling. In some embodiments, this process involves thermosetting the sling end and over-molding the sling end to secure it inside the anchor.

[0097] FIGS. 31-36 show various methods for attaching the mesh sling 100 to the anchors. FIG. 31 shows the sling 100 attached to the anchor 200 via over-molding, as described above.

[0098] FIG. 32 shows a similar form of over-molding but includes an anchor 230 being molded to create a body 234 having a bridge 232 extending therefrom that defines a cavity 236 into which the sling is over-molded.

[0099] FIG. 33 shows an anchor 240 having surface features 242 in the form of bumps to increase the surface area available for adhesion. The sling mesh terminus may then be molded onto the features 242 or otherwise adhered to them.

[0100] FIG. 34 provides an anchor 250 having grooves 252 into which a terminus 102 may be pressed in order to attach the mesh to the anchor.

[0101] FIG. 35 shows an anchor 260 including a body 262. The mesh terminus 102 is attached to the body with a separate piece of material 264 which is then thermally joined to the body 262.

[0102] FIG. 36 shows a tubular anchor 270 with a terminus 102 attached to the body 272 with epoxy 274.

[0103] Turning now to FIGS. 37-47, an introducer 400 for use with the sling 100 is described. FIGS. 37-39 show a top plan view, a side elevation, and a front elevation, respectively, of the introducer 400, which includes a handle 420, a release mechanism 460 partially contained within the handle 420, a shaft 500 and an end piece 520.

[0104] FIG. 40 shows the introducer 400 in an exploded view. The handle 420 includes a top half 422 and a bottom half 424 and includes a plurality of internal molded features designed to keep the internal components of the release mechanism 460 in place. An end cap 426 fits over the matching distal ends of the top half 422 and bottom half 424 and aids in joining the top half 422 and bottom half 424.

[0105] The release mechanism 460 includes an actuator 462 that is ergonomically shaped for activation by a user. The actuator 462 is either attached to, or integral with, an extension 464, which links the actuator 462 to an internal slide block 466. The extension 464 is integral with the slide block 466.

[0106] The slide block 466 interacts with the internal features of the top and bottom halves 422 and 424 of the handle 420 and is limited thereby to fore and aft movements. The slide block acts against a spring 468, contained by the handle at a proximal end and biases the slide block distally. At a distal end, the slide block is connected to an engagement pin 470, which is slideably contained within a lumen of the shaft 500. The engagement pin 470 is shaped to fit within the lumen 210 of the anchor 200 and preferably includes at least one non-cylindrical feature that prevents the anchor 200 from rotating around the pin 470 when the pin 470 and the anchor are engaged.

[0107] FIG. 41 shows the introducer 400 partially assembled with only the handle top half 422 removed. This perspective view shows the interaction between the release mechanism 460 and the internal features of the bottom half 424 of the handle 420.

[0108] FIGS. 42-48 depict various views of the end piece 520. The end piece 520 includes a body 522, a pair of disengagement wings 540 extending distally from the body and creating a U-shaped cavity between the distal end of the body and the inside surfaces of the disengagement wings 540. In one embodiment, the disengagement wings 540 are integral with the body 522. The body 522 defines a lumen 524, which includes surface features 526 that are configured to accept the engagement pin 470. The disengagement wings 540 include distal surfaces 542 that, in some embodiments, engage the trailing edges 224 of the anchor wings 220, and are shaped to match.

[0109] In other embodiments, when the anchor 200 is mated with the introducer 400, the trailing edges 224 of the anchor wings 220 are slightly separated from each other. The gap between the edges 224 and the anchor wings 220, allow tissue to catch the outside of the trailing edge 224 of the anchor wings and assist in the separation of the anchor from the introducer when actuated.

[0110] Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.