ES2594429T3 - Implants for pelvic floor repair - Google Patents

Abstract

An implant for pelvic floor repair comprising: a central body portion (101) having a leading edge (110), a trailing edge (111), and a first and 2nd edge of the lateral sides (112, 113), a first and a second extension portions similar to belts (102, 103) extending outward towards the first (104) and the 2nd (105) distal ends from the first and 2nd regions of the ends of the trailing edge of the central body portion, wherein said first and 2nd extension portions similar to belts extend outward at an angle such that an implant substantially in the form of a "Y" is formed in combination with the central body portion; It is characterized in that the leading edge of the central body portion has a hole (120) that extends inwardly from the leading edge and is placed substantially in the center along the leading edge, and where the trailing edge has an element flange type (115) extending outwardly from the trailing edge and located substantially in the center along the trailing edge; And to a first (106) and a 2nd (107) compartments located at the first and 2nd distal ends of the first and the 2nd extensions similar to belts, respectively, where the first and the 2nd compartments each have a closed end (130, 131) substantially adjacent to the distal end of the belt-like extension, and having an open end (136, 137) close to them and opening towards the central body portion.

Description

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DESCRIPTION

Implants for pelvic floor repair

BACKGROUND OF THE INVENTION

1. Area of the invention

[0001] This invention relates to implants suitable for use for the repair of various pelvic floor prolapse conditions, and more specifically, to meshes having specific applications for the front and / or posterior repair of the pelvic floor.

2. Presentation of the Background

[0002] Each year in the United States of America, approximately 200,000 women undergo surgery for pelvic organ prolapse. Pelvic organ prolapse usually involves the descent of one or more of the uterus, bladder or rectum along with the vagina into (or extreme cases in which the prolapse extends beyond) the introite. Women of advanced years, or those who have given birth to some children are the people who most frequently suffer a pelvic organ prolapse. Traditional vaginal surgery that is used to address these conditions is associated with a high failure rate of between 30-40%. Complex and laborious abdominal, vaginal and laparoscopic procedures such as abdominal sacral colpopexla, sacroespinosa transvaginal ligament fixation, and laparoscopic sacral colpopexy have been developed to reduce the risk of recurrence of prolapses. Unfortunately, these procedures require a high level of specialized surgical knowledge and are only available for a small number of medical specialists and, therefore, for a small number of patients. Details of several procedures that are currently being used are described in Boyles SH., Weber AM, Meyn L. "Procedures for pelvic organ prolapse in the United States" (1979, Procedures for the Prolapse of Pelvic Organs in the United States ”), 1979 -1997, American Journal of Obstetric Gynecology 2003,188; 108-115.

[0003] Recently there has been a trend towards the use of reinforcement materials to support vaginal walls damaged by prolapse. Prosthetic materials such as donor fascination, pig dermis and various types of synthetic meshes have been used with varying levels of success. These materials are generally placed adjacent to, or in contact with, the vaginal wall or walls and are sutured or secured by straps, in their corresponding position.

[0004] WO 2004/045457 presents a different method that uses a prosthetic material to repair the damaged pelvic tissue, and subsequently an intra-cervical splint is inserted. It is placed to the splint in the vagina, and works to reduce the mobility of the vaginal walls during the internal growth of the tissue. Repairs commonly involve dissection of the posterior wall of the vagina, the front wall of the vagina, or both. A graft of any synthetic material, such as a polypropylene mesh or other fabric, or an autologous or analogous material, is freely placed, without any fixation, in the area where the dissection was made between the vaginal wall and the organ with prolapse. The vaginal incision is then closed by a suture or other closure system, at which time, it is inserted into the vaginal splint into the vagina and fixed to both walls of the cervical clamp. The splint stabilizes the vagina, keeps it elongated in its anatomical position, and helps keep the graft in place by preventing it from sliding or being expelled. Eventually, the fasclal tissue on each side of the graft will seep into it, and therefore be incorporated into the body, and the splint can be subsequently moved. An implant according to the preamble of claim 1 was disclosed in WO-A-03/073960.

[0005] This invention presents an implant for use in procedures such as those described above that have a configuration and construction particularly suitable for those applications.

SUMMARY OF THE INVENTION

[0006] An implant is presented to repair the pelvic floor that has a central coiporal portion that has a leading edge, a trailing edge, and a first and a 2nd edge of the lateral sides. The leading edge has a hole that extends inwardly from the leading edge and is located substantially in the center along the leading edge, and the trailing edge has a flange-like element that extends outwardly from the trailing edge and is located substantially in the center along the trailing edge. The first and second portions of belt-like extensions extend outward toward the first and the 2nd distal end from the first and 2nd regions of the ends of the posterior edge of the central coiporal pordón. The first and 2nd extension portions similar to belts extend outwardly at an angle that substantially forms an implant in

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"Y" shape in combination with the central body portion. A first and 2nd compartments are located at the first and 2nd extreme ends of the first and 2nd extensions similar to belts, respectively. Each has a closed end that is substantially adjacent to the extension end similar to a belt, and to an open end near it and to an opening that opens toward the central body portion.

[0007] In an implementation, the leading edge has a length that is less than the length of the trailing edge. The Implant can be made in addition to a non-absorbent biocompatible material, and in one implementation the implant is made of polypropylene. In alternate implementations, the implant is an implanted mesh made of woven polypropylene filaments, or is made of a material selected from a group consisting of, an absorbing polymer, a non-absorbing polymer, and a natural material. It could also be made of a combination of absorbable and non-absorbable materials.

[0008] In another implementation, the general shape of the implant is suitable for subsequent and forward repairs.

[0009] An implant is also presented for pelvic floor repair that includes a central body portion having a leading edge, a trailing edge, and a first and a 2nd edge of the lateral sides, and a first and a 2nd extension portions similar to belts that extend outward towards the first and 2nd distal ends from the first and the 2nd regions of the ends of the posterior edge of the central body portion. The first and 2nd extension portions similar to belts extend outwardly at an angle to form an implant substantially in the form of a "Y" in combination with the central body portion. The first and the 2nd compartments are located at the first and the 2nd distal ends of the first and the 2nd belt-like extensions, respectively, where each has a closed end that is substantially adjacent to the distal end of the similar extension. to a belt, and that has an open end close to them and that opens the central body portion.

BRIEF DESCRIPTION OF THE SCHEMES

[0010]

Figure 1 is a perspective from above of an implant according to this invention;

Figures 2a and 2b are perspective views from above and lateral, respectively, of an instrument specifically suitable for supporting the implant of the part of Figure 1.

Figures 3a-3d illustrate the orientation of the instrument of Figures 2a-2b when used to aid the implant of the part of figure one;

Figures 4a-4d illustrate several aspects of a method for implanting the part of Figure 1 for a front repair;

Figures 5a-5d illustrate several aspects of a method for implanting the part of Figure 1 for a rear repair;

Figures 6a and 6b illustrate the placement of the implants for a repair of a front / rear combination; Y

Figures 7 and 8 illustrate an example vaginal splint and its placement which can be used in connection with the implants of this invention.

DETAILED DESCRIPTION OF THE INVENTION

[0011] Referring now to Figure 1, an implant 100 is presented which has a specific application for the repair of front, posterior and / or apical vaginal defects. The implant could be formed of any suitable biocompatible material, absorbed or non-absorbable, synthetic or natural or one of its combinations. Preferably, the implant is a mesh-like material, and in a preferred section, it is constructed of woven filaments or extruded polypropylene, such as that manufactured and sold by Ethicon, Inc. of Somerville, NJ under the name of GYNEMESH PS.

[0012] The implant 100 has a central body pordon 101 that has a leading edge and a trailing edge 110, 111, and a first and a 2nd edge of the lateral sides 112, 113 that can be slightly arched as indicated above. . The leading edge 110 has a hole 120 that extends inwardly from there and the trailing edge has a flange-like element 115 that extends outwardly from there. The hole and the flange type element are located substantially in the center along the front and rear edges respectively, as shown above to help properly position the implant. Additionally, the flange-like element 115 supplies adidonal material for adhesion to the uterus, if this were

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wanted. The central coiporal portion is preferably made of a size and a foima to be placed between the urinary bladder and the upper 2 thirds of the vagina, or between the rectum and the upper 2 thirds of the vagina, such as It will be described in greater detail below.

[0013] The Implant also has a first and a second extension portions similar to belts 102, 103 extending outwardly from the central body portion to the first and 2nd distal ends 104, 105. The extension portions similar to Straps extend outwardly from the first and second regions of the ends 121, 122 of the rear edge 111 of the central body portion at an angle to substantially form a "Y" Implant in combination with the central body portion 101. In A preferred implementation, lines A and B that symmetrically bisect to an upper surface 123, 124 of the extension poles similar to belts, and line C that substantially bisects symmetrically to an upper surface 125 of the central body portion, are intercept within of the central body portion as shown in Figure 1.

[0014] Each of the first and 2nd extension portions similar to belts 102,103 each further includes a compartment 106, 107 at their respective distal ends. Each compartment has a closed end 130, 131 that is substantially adjacent to the distal ends 104, 105 of the extension strap similar to a belt, 2 closed sides, and an open end 136, 137 near the closed end, with an open end which opens towards the central body pordón 101 as shown above. Preferably, the first and the 2nd compartments and an underlying extension similar to a belt narrows inwardly from the open end to the closed end as shown in Figure 1.

[0015] In a preferred Implementation, the leading edge 110 has a length of approximately 30 mm, and the trailing edge 111 has a length b of approximately 80 mm. In addition, cortex-like extensions 102, 103 preferably have a length ci, 02 of approximately 40 mm, where the implant 100 has a width and a general length d, of approximately 10.5 centimeters and 9 cm, respectively.

[0016] The open end of the compartments is able to receive at the end of an implant instrument or device to facilitate implant placement as will be described in greater detail below. An Implantation device particularly suitable for Implantation for a front repair is illustrated in Figures 2a-2b, which are seen in upper and lateral perspectives, respectively. The instrument 300 includes a grip portion 310 properly configured to grip the instrument. The grip portion 310 has an upper side 301, a lower side 302, a first and a 2nd sides of the ends 303, 304, and a front side and a rear side 305, 306. The grip is preferably made of polycarbonate or any biocompatible plastic, and could include one or more grip regions 311 configured to receive a finger from the user to facilitate handling of the instrument.

[0017] The instrument 300 further includes a first substantially rigid extension arm 330 extending laterally outwardly from the first side of the end 303 of the gripping portion, and a 2nd substantially rigid extension arm 331 which is extends laterally outward from the 2nd side of end 304 of the grip portion. The arms can be made of any suitable biocompatible material that has sufficient rigidity for implantation procedures as will be described later, such as, for example, stainless steel. Although the first and 2nd extension arms are described herein as extending outwardly from the first and 2nd sides of the gripping portion, it should be understood that the first and 2nd extension arms could be a unit structure that extends along the grip portion (ie, a polymeric grip portion formed around a central portion of the unit structure), and a reference to the "first and second" extension arms should not be considered as a requirement of 2 separate extension arms that are secured separately to the grip portion, although this could be so. Each of the first and 2nd extension arms extends outwardly along the first and 2nd longitudinal axes, which for purposes of this application are defined as a line that extends along the length of the arm of extension and are located substantially in the center in relation to the cross section of the extension arm, as shown with dotted lines AA and BB in Figure 2b.

[0018] Each of the first and second extension arms further includes a substantially straight portion 335, 336 and a distal portion 339, 340. The substantially straight portions 335, 336 are close to the first and 2nd sides of the ends 303, 304 of the grip. Within the first and second substantially straight portions 335, 336, the extension arms lie substantially within an individual foreground which is the same for these. The distal portions 339, 340 extend from substantially straight poles to the first and 2nd distal ends 343, 344, respectively. Within the first distal portion 339 of the first extension arm, the extension arm extends upward in the opposite direction to the foreground, and also rotates against the clockwise hands around the longitudinal axis AA as shown by the arrow C in Figure 2b. Within the distal opening 340 of the 2nd extension arm, the extension arm extends downwards in the opposite direction to the foreground, and also rotates against the clockwise hands around the longitudinal axis BB, as shown by the arrow D in figure 2b. Preferably, the first and the 2nd distal ends are not sharp, and have a substantially flat edge.

[0019] As indicated above, the implant of this invention is intended to be used in several

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pelvic floor repair procedures, and could be used in connection with an intravaginal splint of the type described in detail in US patent applications with serial numbers 11 / 258,441, 11 / 334,966 and 10 / 534,930.

[0020] An example of that splint 800 is illustrated in Figure 8. Example procedures for placing the implant will now be described in detail.

[0021] The implant, as described and illustrated in this document, has a specific application for the repair of front, posterior and / or apical vaginal defects. When only the front vaginal wall reinforcement is needed, for a front repair, the implant 100 is intended to be placed between the urinary bladder 500 and the upper 2 thirds of the vagina 501 (refer to Figure 4d), with the central body portion that extends laterally to approximately the level of the tendonic arch of the pelvic fascia (ATFP - arcus tendineus fascia pelvis), approximate position which is illustrated with the reference number 521 in Figure 4c. The front vaginal epithelium is dissected and removed first from the bladder, dissecting the entire thickness of the vaginal wall and preventing its separation into 2 layers. Dissection continues to the pelvic lateral wall (also illustrated approximately 521) and to the depth of the ischial spine 522. Additional dissections are made to create channels for the placement of extensions similar to straps 102, 103 of implant 100, preferably placing these extensions directly against the pelvic lateral wall and the parietal fascia of the internal obturator muscle 523 (Figure 4b). The dissection of each side should create a leading and superior canal in relation to the ischulatic and superficial spine in relation to the ATFP, the internal obturator muscle and the parietal fascia.

[0022] After dissection, the implant 100 is placed on the pre-bladder tissue with the straps inserted to each right and left channel created by the front and upper dissection in relation to the ischulatic spine as described above. Implantation of the mesh and the extension portions similar to belts could be facilitated using the instrument 300 illustrated in Figures 2a-2b which is described herein. As shown in Figure 4a, the distal end 343 of the first extension arm 330 is inserted into the first compartment 106 of the implant, with the compartment facing upwards. Visual indicators 524, such as the arrows shown in Figures 3a and 3c, could be used to ensure proper orientation of the instrument. The instrument and the implant are then inserted through the channel described above (as shown in Figure 4b, which, for purposes of clarity, does not illustrate most of the tissue) on the right side of the patient's body until the Grip portion 301 comes into contact with the labia majora on the contralateral side. It is then lowered to the grip portion until it is approximately parallel to the floor, such that the distal edge is adjacent and in contact with the inner muscle. The instrument is removed, and the distal end 344 of the 2nd extension arm 331 which is inserted in the 2nd compartment 107, with the combination inserted in the 2nd channel formed on the left side of the patient's body. Figures 3a and 3b illustrate in greater detail the positioning of the instrument 300 during implantation on the right side of the body. For purposes of illustrative clarity, the implant or soft tissue structures are not shown. Figures 3c and 3d illustrate similarly a positioning of the instrument during implantation on the left side of the body. When the instrument is subsequently removed, the implant should be placed as illustrated in Figures 4c and 4d. The central coiporal portion 101 of the implant is placed in a loose form on the underlying vaginal tissue. It is then closed to the vaginal epithelium in a suitable way.

[0023] For subsequent repair (when only the vaginal wall reinforcement is needed), it is dissected first and the entire thickness of the posterior vaginal epithelium is removed from the pre-rectal tissue (rectum 520 illustrated in Figure 5d). The dissection, for the central body portion 101, continues laterally on each side of the anus lift muscle at the same depth as the level of the ischial spine and then channels are created through each of the rectal pillars (not shown) and in , but not through, each sacrospinous ligament 510. The dissected channels in which the extension portions similar to straps of the implant are placed will ultimately help secure the implant after internal tissue growth.

[0024] The implant is then placed on the pre-rectal tissue with the belt-like elements 102, 103 inserted in each right and left channel created by dissection to each sacrospinous ligament 510. The belt-like elements could be inserted with the assistance of any surgical instrument 511 (the instrument 300 of the configuration shown in Figures 2a and 2b is not particularly suitable for the placement of a rear repair), one end of which is received within compartments 106, 107 of similar elements to belts in a manner similar to that described above. The ends of the belt-like elements are placed so that they collide with, but not penetrate, the sacrospinous ligaments 510. Optionally, either before or after the insertion of the belt-like elements, it can adhere to the type element tab 115 (by sutures or other adjustment element) at the apex of vagina 501a as shown in Figure 5d. Also, the implant could adhere to the pre-rectal tissue along the leading edge. The centrally located eyelash element and hole help the surgeon visually verify that the implant has been centrally aligned.

[0025] The central body 101 of the implant is loosely positioned on the underlying vaginal fascia, and care is taken to ensure that the belt-like extensions do not bend or twist. Depending

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of the vaginal dimensions, or the amount of lateral dissection, the central body may require cuts. It closes to the epithelium of the front vaginal wall on the implant, with a final implant placement as illustrated in Figure 5c and 5d.

[0026] If a reinforcement of the front and rear vaginal wall is needed, 2 implants of the type described herein could be used, with the first 600 placed as described above for front repair and the 2nd 601 placed as described above. For rear repair. The front repair should be done first. The final placement of the first and 2nd implants is shown in Figures 6a (hysterectomy) and 6b

(It is not a hysterectomy).

[0027] As previously indicated, implants already described in conjunction with a vaginal splint can be used to help maintain proper implant posidonation during initial internal tissue growth. A splint 800, such as the example splint shown in Figure 8, is inserted into the vagina 501 as shown in Figure 8, and as described in detail in co-pending US applications with Serial numbers 11 / 258,441.11 / 334,966 and 10 / 534,930.

[0028] After insertion, it expands to the balloon, and the splint is left in place for approximately 1-2 days, after which it can be deflated. The female can then remain in place for approximately 3-4 weeks to ensure proper internal tissue growth has occurred.

Claims (9)

5 10 fifteen twenty 25 30 35 40 Four. Five fifty 55 60 65 1. An implant for pelvic floor repair comprising: a central body portion (101) having a leading edge (110), a trailing edge (111), and a first and 2nd edge of the lateral sides (112,113), a first and a second extension portions similar to belts (102, 103) extending just outside the first (104) and the 2nd (105) distal ends from the first and second regions of the ends of the rear edge of the central body portion, wherein said first and 2nd extension portions similar to belts extend outwardly at an angle such that an implant substantially in the form of a "Y" is combined in combination with the central body portion; It is characterized in that the leading edge of the central body portion has a hole (120) that extends inwardly from the leading edge and is placed substantially in the center along the leading edge, and where the trailing edge has an element flange type (115) extending outwardly from the trailing edge and located substantially in the center along the rear boom; And to a first (106) and a 2nd (107) compartments located at the first and 2nd distal ends of the first and the 2nd extensions similar to belts, respectively, where the first and 2nd compartments have, each , to a closed end (130, 131) substantially adjacent to the distal end of the belt-like extension, and having an open end (136,137) close to these and which open towards the central body portion. 2. The implant according to claim 1, wherein the leading edge (110) has a length less than the rear edge length. 3. The implant according to claim 1, wherein the implant is made of an absorbable polymer or not absorbable, or one of its combinations. 4. The Implant according to claim 1, wherein the Implant is a mesh formed of woven polypropylene filaments. 5. The implant according to claim 1, wherein the Implant is made of a non-absorbable and biocompatible material. 6. The implant according to claim 5, wherein the Implant is made of polypropylene. 7. The implant according to claim 1, wherein the implant is formed of a selected material of a group consisting of an absorbable polymer, a non-absorbable polymer, and a natural material. 8. The implant according to claim 1, wherein the Implant is made from a combination of absorbable and non-absorbable materials. 9. The Implant according to claim 1, wherein the general shape of the implant is suitable for rear and front repairs.