CN101534746A - Surgical articles and methods for treating pelvic conditions - Google Patents

Surgical articles and methods for treating pelvic conditions Download PDF

Info

Publication number
CN101534746A
CN101534746A CNA2007800279342A CN200780027934A CN101534746A CN 101534746 A CN101534746 A CN 101534746A CN A2007800279342 A CNA2007800279342 A CN A2007800279342A CN 200780027934 A CN200780027934 A CN 200780027934A CN 101534746 A CN101534746 A CN 101534746A
Authority
CN
China
Prior art keywords
tissue
implant
elevator
zone
support section
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CNA2007800279342A
Other languages
Chinese (zh)
Inventor
K·P·蒙特皮蒂特
R·C·卡利塔
J·A·卡兹米尔科斯基
K·A·开普曼
K·A·安德尔森
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
AMS Research LLC
Original Assignee
AMS Research LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by AMS Research LLC filed Critical AMS Research LLC
Publication of CN101534746A publication Critical patent/CN101534746A/en
Pending legal-status Critical Current

Links

Images

Abstract

Described are pelvic implants and methods of surgically placing pelvic implants, that provide treatment for pelvic floor disorders by support of the levator. A pelvic implant (100, 102) may comprise a tissue support portion (104) to be placed in contact with tissue to be supported, extension portions (106, 110) that extend from the tissue support portion to provide additional support, and tissue fasteners (108, 112) to attach extension portions to supportive tissue.

Description

The surgical articles and the method that are used for the treatment of pelvic conditions
Prioity claim
The application requires the rights and interests of following application: on July 25th, 2006 submitted to, title is the U.S. Provisional Application 60/820,306 of " METHOD AND DEVICE FOR SUPPORTING PELVIC FLOOR AND LEVATOR ANIMUSCLES "; On July 27th, 2006 submitted to, title is the U.S. Provisional Application 60/820,564 of " METHOD AND DEVICE FOR SUPPORTING PELVIC FLOOR AND LEVATORAN1 MUSCLES "; On August 29th, 2006 submitted to, title is the U.S. Provisional Application 60/823,858 of " PERINEAL BODY REPAIR WITH TISSUE ANCHORS AND LEVATORBALLOONING CONCEPTS "; On October 26th, 2006 submitted to, title is the U.S. Provisional Application 60/863,049 of " MESH IMPLANTS FOR THE TREATMENT OF LEVATORAN1 MUSCLE DEFECTS AND FECAL INCONTINENCE "; With the title of the unallocated serial number of submitting on June 29th, 2007 be the U.S. Provisional Application of " PELVIC FLOOR TREATMENTS AND ASSOCIATED IMPLANTS "; Described application is all incorporated into this paper as a reference in full.
Invention field
The present invention relates to be used for treat the apparatus and method of pelvic conditions by the pelvic implant that use is used to support pelvic tissue.Pelvic conditions comprises women or male's the anatomy patient's condition, and comprises particularly and relate to the treatment of supporting elevator, so that treatment women or male's fecal incontinence and other patient's condition.
Background technology
The pelvic cavity health of masculinity and femininity is the medical domain that importance increases day by day, this to small part be because the aging of population.The example of common pelvic disease comprises incontinence (fecal incontinence and urinary incontinence) and pelvic tissue prolapsus (for example, vagina is deviate from).Urinary incontinence can further be categorized as and comprise different types, for example stress urinary incontinence (SUI), impulsive type urinary incontinence, mixed type urinary incontinence, and other type.Other pelvic floor disease comprises bladder hernia, proctoptosis, enterocele and prolapsus (for example procidentia of anus, uterine prolapse and vaginal vault prolapse).Bladder hernia is a kind of hernia of bladder, and normally bulging is in vagina and vaginal orifice.Can come from the reduction or the damage of normal pelvic cavity support system such as these pelvic cavity disease.
Introduced pelvic implant, be sometimes referred to as sling, suspender belt, for implantation into pelvic conditions for example prolapses and the incontinence patient's condition so that treat in the health.Referring to, for example common United States Patent (USP) 6,382,214,6,641,524,6,652,450 and 6,911,003, and publication of wherein quoting and patent.The implantation of these implants relate to use to produce transvaginal, through exposing on obturatorius, the pubis or behind the pubis or the implanting instrument of passage.Also comprise and be used for the sling end is connected to the end of elongated insertion instrument so that with the dilatory delivery system by anatomic passages in sling extension.The syringe needle that instrument is inserted in the right side of describing in 2005/0043580 patent disclosure of above-mentioned reference and left side has radian and more generally corresponding to by AmericanMedical Systems in single plane, Inc. sells has the BioArc that prolongs the urethra sling TMSP and SPARC TMSingle sling implanting instrument.
A wound that the specific region is a pelvic floor of pelvic cavity health, for example, the wound of elevator (levator ani m.) or coccygeus (being referred to as the wound of pelvic floor).Pelvic floor is made up of elevator and coccygeus, and elevator is by comprising that puborectalis, pubococcygeus and iliococcygeus form.For various reasons, reduction or damage can take place in elevator, can produce multiple symptom like this, other patient's condition of for example prolapsus, incontinence and pelvis.
Summary of the invention
The present invention relates to treat the method for pelvic conditions, particularly organize and treat pelvic conditions by the support elevator.Elevator defective (reduction or damage) can influence any part of elevator, and especially can be common in the pubis part of levator ani m., comprises pubococcygeus and puborectalis.This defective is to be common in relatively for example to see the women that vagina is deviate from.This defective also may reside in the iliococcygeus place.Other defective can be the form of the other defective of vagina, and for example the middle and lower part of levator ani m. (inferiomedial aspects) from the avulsion of pelvic cavity sidewall, this avulsion can be tissue from the pubis disengaging, and the prolapsus situation can take place subsequently.Another kind of elevator defective is the elevator flatulence, and this is meant the expansion of elevator.
A kind of different elevator defective is the elevator ceasma, and it can reduce the stability of pelvic floor and may cause sexual disorder, defecation dysfunction, proctoptosis and fecal incontinence.The elevator ceasma also is considered to play an important role in the progress of prolapsus.The embodiment of the inventive method can solve above-mentioned any patient's condition and the relevant patient's condition and symptom.
Present patent application has been described and has been used for supporting implant and the method that pelvic conditions is treated in elevator by treatment pelvic floor (coccygeus or elevator) defective (for example reduction or damage) or by other mode.Useful method can comprise that the implant (for example, graft) of forms such as can using the suspender belt that is used to strengthen impaired, reduction or weak elevator muscular tissue, sling recovers the anatomical method of pelvic floor and the implant of nature.Described elevator muscular tissue or " levator ani m. " can comprise puborectalis, pubococcygeus, iliococcygeus.
The embodiment that can be used for implant of the present invention can have size and the shape that is used to solve the target pelvic floor patient's condition, is generally to meet the elevator tissue, randomly in addition connect or support the size and the shape of other tissue (for example anal sphincter, rectum, perineal body etc.) in pelvic cavity zone.Implant can be one chip or multiple-piece, and it is configured as the part of coupling elevator on the whole, for example, is the ring-type of the combination that comprises straight, oblique and curved edge, oval trapezoidal, rectangle etc.Implant can comprise segmentation connection or independent, and it combines in order on pelvic cavity architectural feature next door such as rectum, anus, vagina or extend on every side for example, randomly in order to be connected in this architectural feature.
Implant (for example, defecation sling) can be continuous or discontinuous sling, and can comprise one or more parts or segmentation, for example, and for the successive implant of integral body or be sectional set.Successive implant can be for successive in fact between the edge, in order to place the elevator tissue in fact continuously or the surf zone of level.Discontinuous implant can comprise gap or otch, it allows most of implant to be placed on the level or continuous surface of elevator tissue, and some part forms around organizational structure and extends and for example organize from elevator that anus, rectum etc. stretch out or stretch to the elevator tissue.
Implant can comprise the support section of organizing that is connected with the elevator tissue at least in part.Randomly, implant can comprise one or more extensions in addition, and it extends beyond the tissue of organizing support section and being fixed in the pelvic cavity zone, in order to the supporting tissue support section.
Randomly, the extension for example can comprise for example architectural feature such as stitching thread, guiding mechanism of tissue fastener (for example, fixing certainly tip, soft tissue anchor, bone anchor etc.), sheath, tension mechanism.
Comprise that the implant of organizing support section and the extension of choosing wantonly, tissue fastener etc. can randomly scribble antimicrobial coatings or the coating in order to encourage inwardly growth or to suppress to repel in order to prevention infection.For organizing support section and extension, considered biocompatible materials, for example the corium of pig or have the net of somatomedin.
The patient's condition in pelvic cavity zone can be improved or treat to described herein method, for example any described pelvic conditions.This method can support the elevator tissue, is used for the treatment of prolapsus; Fecal incontinence; Elevator is torn, is weakened or impaired (being meant any part of elevator); The processing of elevator avulsion, elevator flatulence, support perineal body; The method that perineal body is repaired; By straining or reduce the method for the size treatment elevator ceasma of elevator ceasma; And one or more the combination in these.This method can also be more general, and as the treatment of the more common patient's condition, for example urinary continence is that it is considered to be caused by the elevator reduction or relevant with it.
This method needs on can be preventative or medical.But preventative processing can be for not having now the contingent possible disease or the preventative processing of the patient's condition.For example, preventative processing can be used for one-level or secondary prolapsus, is used for the enhancing that current prolapsus is repaired, or is used for puerperal enhancing.The method that needs in the medical treatment can be carried out under the situation that disease has existed and needs are treated immediately, for example in the situation of current prolapsus reparation of perineum depression, fecal incontinence, enhancing and proctoptosis.
Implant can be placed to contact pelvic tissue as required, be used for for example elevator tissue of supporting tissue, and can randomly be fixed in the tissue that is supported by for example sewing up.Implant can be fixed in the tissue in pelvic cavity zone in addition so that obtain other support, this for example organizing: sacrotuberous ligament; Sacrospinous ligament, anococcygeal ligament (symington's bodies ligament); The hole week (periostium) of the pubis zone of ischial tuberosity (for example); Pubourethral ligament; Ischial spine (for example, in the ischial spine zone); Ischial tuberosity; Arcus tendineus (it is a synonym with term " white line " in this article), for example, by the tissue access between levator ani m. and the obturator internus and be connected in arcus tendineus; Obturator internus.Perhaps, the extension of implant can extend through the tissue access of leading to external undercut, and for example: the tissue by closed pore is so that the external undercut by femoribus internus; Above pubis by so that leave at the pubis upper cut; Backward directions are led to rectum week or all external undercuts of anus, for example, pass through coccyx.As another possibility, the extension of implant or implant can be connected in bone or its fascia, for example rumpbone or pubis or its fascia.
According to exemplary method, can introduce implant by otch, described otch allows to enter the elevator tissue, randomly carries out a certain amount of incision.Described otch can provide any of this multiple otch that enters, and all otch of little outside rectum of the tissue access from all incision extensions of outside rectum to the elevator tissue for example can be provided; Outside pubis upper cut; Can be used for making the part of implant by the intermediary external undercut of closed pore, subrectal Kraske otch; The otch of perineum; Otch with vagina.The part of implant or implant can be utilized otch to enter and locate, in order to support the tissue of elevator.Preferably, can place implant by cutting the incision plane or the zone that comprise ischiorectal fossa open.The anatomy distinguishing mark that is included in this cut-out region can comprise ischial spine, obturator internus, arcus tendineus.
An embodiment of implant can be to have the synthetic or biological implant of organizing support section.Organize support section can have in order to support the size and the shape of elevator tissue.Definite form can depend on the patient's condition type that will treat.Organize some embodiment of support section can randomly comprise segmentation or the supporter that is used to solve elevator ceasma opening, perineum depression, proctoptosis, fecal incontinence etc.
Implant can be randomly but is optionally comprised the extension that extends to other tissue, for example, other tissue in the pelvic cavity zone, it is sometimes referred to as " supportive tissue ", and it can fix this extension in the mode that allows extension supporting tissue support section.Randomly, the end of extension can comprise fixation of tissue mechanism, for example from fixing most advanced and sophisticated, it can be fixed in the interior tissue in pelvic cavity zone, other local describes in this article for example, it includes but not limited to undertissue: zone, ischial tuberosity, pubourethral ligament, anococcygeal ligament and the arcus tendineus of the hole week of sacrotuberous ligament, sacrospinous ligament, pubis (for example, in the zone of ischial tuberosity), ischial spine; Perhaps be attached to arcus tendineus or or obturatorius tissue (for example, obturator internus), the perhaps tissue by closed pore by the tissue access between levator ani m. and the obturator internus and with the extension.
The present invention has considered to support the several different methods of elevator tissue.Exemplary method comprises the steps, comprises producing single otch placed in the middle (transvaginal otch or perineal incision) or near the otch rectum, anus or perineum; With in incision plane that comprises ischiorectal fossa or zone, cut open.Implant can be inserted into required zone, so that connect the tissue of elevator.Randomly, implant can be one chip or multiple-piece or a plurality of part, and can comprise one or more tissue fasteners that can be fixed in the tissue in the pelvic cavity zone.Implant can comprise following material or parts, for example be used for those of SPARC and Monarc system (deriving from AmericanMedical Systems), the connector that comprises the engagement between the far-end of the syringe needle that is used to the instrument that inserts and extension, and spiral helicine, straight and crooked pin.
The present invention has considered to be used for the treatment of the embodiment of the method and apparatus of pelvic conditions in addition, and it comprises that implant wherein is not by another skin incision single otch of leaving of abdominal part or shank otch for example.
In one aspect, the present invention relates to support the method for pelvic floor tissue, described pelvic floor tissue comprises the combination of elevator tissue, coccygeus tissue and these tissues.Described method comprises: produce the otch that allows near pelvic floor lower set tissue region, provide and comprise the pelvic implant of organizing support section, make implant by otch and will organize support section to be placed on pelvic floor lower set tissue region and will organize support section to be positioned at pelvic floor lower set tissue region in the mode that allows to organize support section to support the elevator tissue.
In one aspect of the method, () pelvic implant for example, the combination of elevator tissue, coccygeus tissue or these tissues is with relevant surgery systems and external member to the present invention relates to be used to support the pelvic floor tissue.Described implant comprises organizes support section, and it has following feature: can extend to the anterior side of inboard pelvic floor tissue regions from the front area in pelvic cavity zone, described front area is selected from closed pore zone, arcus tendineus zone and puborectalis zone; Can extend to the rear portion side in inboard pelvic floor zone from the Background Region in pelvic cavity zone, described Background Region is selected from ischial spine zone, ischial tuberosity zone, sacrospinous ligament sacrotuberous ligament zone, zone and sacrum area; With the lateral end that can extend to described Background Region from described front area.Described zone of organizing support section can be positioned at the elevator tissue.
In one aspect of the method, the present invention relates to organize the method for the treatment of the pelvic cavity situation by supporting pelvic floor.Described method comprises: provide to comprise the implant of organizing support section and tissue fastener, produce the otch that allows near the pelvic floor tissue, will organize support section to be placed as and connect the pelvic floor tissue and described tissue fastener is fixed in pelvic cavity regional organization.
Description of drawings
In conjunction with the accompanying drawings, along with following explanation, can see other features and advantages of the present invention to particular.Accompanying drawing is not schematically and not proportionally.
Fig. 1 illustrates an embodiment of described implant.
Fig. 2 illustrates an embodiment of described implant.
Fig. 3 illustrates an embodiment of described implant.
Fig. 4 illustrates an embodiment of described implant.
Fig. 5 illustrates the embodiment of the external member that comprises the described implant and the instrument of insertion.
Fig. 5 A illustrates the embodiment of the external member that comprises the described implant and the instrument of insertion.
Fig. 6 illustrates the anatomy in pelvic cavity zone.
Fig. 7 illustrates an embodiment of described tissue access.
Fig. 8,8A, 8B and 8C illustrate the embodiment of described otch.
Fig. 8 illustrates an embodiment of described otch.
Detailed Description Of The Invention
Below explanation is intended to illustrative and nonrestrictive. After considering this specification, Other embodiment of the present invention it will be apparent to those skilled in the art that.
The present invention relates to be used for the treatment of operation device, assembly and the implantable system of illness at the bottom of the pelvis Product, illness for example prolapses, the patient's condition of incontinence (being urinary and fecal inconvenience), perineal body, carries at the bottom of the described pelvis The patient's condition of flesh (for example part of elevator), the patient's condition of elevator ceasma and two kinds in these Or multiple combination. According to multiple embodiments, surgery implant can be used for disposing pelvic conditions, Wherein said method comprises supporting the mode of organizing at the bottom of the pelvis of sex and places implantation Thing, tissue comprises one or more in elevator and the coccygeus at the bottom of the described pelvis. Of the present invention each Individual aspect is presented as following characteristics: surgery implant is used for implant and is used for mounting implant Operation tool, surgery systems, operation external member and operation method.
Defective at the bottom of the pelvis, for example elevator expansion or inflatable may to the perineal body depression and acute, The possible imminent or following pelvic cavity prolapsus, and the prolapsus recurrence has important impact. One embodiment of the invention comprise can be in order to support rib pelvic floor tissue (for example, elevator, coccyx Flesh) reduce the method for this expansion. This embodiment comprises near elevator or coccygeus subcutaneous Place various materials; Described placement can be undertaken by any otch and incision approach, but special Fixed method is included in the otch of rectum week, anus week and perineal region and not necessarily utilizes warp The otch of vagina. (according to other embodiment, implant can be placed through vagina).
According to certain embodiments of the present invention, can come the support rib pelvic floor tissue by implant, Described implant is and the urinary incontinence, prolapsus, the stool that were used for the treatment of in the past such as masculinity and femininity Some similar nets in those of the pelvic conditions such as incontinence or biology sling, suspender belt etc. Form.
Also can use other possible supporting mechanism, it is different from the pelvic cavity of this routine plants Enter like the phase those, can be considered to " static ". Other supporting construction (that is, " is implanted Thing ") example comprise dynamic but not static structure. Dynamic implant can be able to permitted Show the ability of variation after being permitted to realize dynamic function for example the mode of dynamic support being implanted. The degree of support can change in the different phase of disease or the patient's condition or adjust to some extent.
The example of optional supporting mechanism (static or non-static state) includes but not limited to: fill Agent (collagen, salt solution, siloxanes etc.); The spacer of expandable foam/packing volume; Be full of The pillow thing of salt solution, siloxanes etc., or it can dwindle and swell to help the analog of defecation; Can be combined with growth factor to promote inwardly growth or the sponge of using along packing space.
The embodiment that does not comprise the method that vagina cuts can carry out easilier and reduce suffering from Person's danger and minimizing tissue injury. This reparation can be at the bottom of carrying out pelvis other treatment Carry out in the process or afterwards, so that the treatment vagina is deviate from (for example, fornix prolapsus, enterocele, rectum Bulging, Cystocele etc.), can reduce recurrence rate that vagina deviates from (for example, by for example Apogee from American Medical SystemsTMAnd PerigeeTMProlapsus product and class Solve like product), and repairing with other prolapsus restorative procedure combination or in other prolapsus Can provide whole improvement when using after the method. Perhaps, method of the present invention can be prevented The property use, prevent following prolapsus. Described method can be before uterectomy, afterwards, Or carry out simultaneously with it so that possibly prevention subsequently prolapsus or reduce its possibility or serious Degree. In other embodiments, described method can be used for prostatectomy or bladder be cut Except (because cancer) afterwards, also be for prevention possibly subsequently pelvic conditions or reduce it can Can property or the order of severity.
Many aspects of the present invention relate to Operation, thereby reduce elevator to support the elevator tissue Expand or otherwise repair the implant (for example, polypropylene mesh thing) of elevator tissue Use. Described technology can comprise the tissue that implant (for example, net) is delivered to elevator And the location that is fixed is in order to support the elevator tissue. These method and apparatus comprise near elevator Subcutaneous placement implant (that is, below elevator or bottom). This can carry out through vagina, still Also can be at (sex is anatomical) perineal region, perirectal region territory or other otch The external undercut of position carries out.
In certain embodiments, also can make implant (tissue support section or extension) Be fixed in other tissue in pelvic cavity zone, that is, " supportive tissue " is in order to support described group Knit support section. Exemplary supportive tissue is described in herein in Fig. 6 for example with relevant Body part in, and describe to some extent in the other parts of this specification. Supportive tissue bag Draw together at the tissue of the forward position of for example closed pore or arcus tendineus or in for example rear in ischial spine zone The tissue of putting or at the tissue at ligamentum sacrospinosum place.
Implant can directly or utilize tissue fastener (for example, for example bone anchor, soft group of anchor Knit anchor, self-retaining tip, tissue clamp etc.) be connected in this supportive tissue. Organize fastening What part can be connected in implant organizes support section or extension, and can be directly or logical Cross the connectivity suture and be connected in these tissues any. According to the latter, can tissue is tight The firmware location is then along the suture guiding implant as the track that will be positioned or guiding The material of (for example, net).
The embodiment of some implant can be and other treatment that is generally used for the pelvic cavity zone The same or analogous material and design of implant. Implant can comprise and can be used for supporting the pelvic cavity group That knits organizes support section (or " support section "), in particular for supporting the elevator tissue. In the use procedure, organize support section typically to be placed as supported for example the organizing of contact, carry Muscular tissue, and randomly, contact in addition surrounding tissue for example rectal tissue, perineal body tissue, External sphincter muscle of anus is in order to support one or more in these. In addition, randomly, tissue Support section can be connected in this tissue, such as using suture, biology adhesive etc. to carry out Connect.
The embodiment of implant can comprise randomly that one or more being connected in organize the support portion The extension (sometimes being also referred to as " end parts " or " arm ") of dividing. The extension is the multi-disc material Material, elongated material piece for example, it is from organizing support section to stretch out and being connected in or passable Be connected in and organize support section, and can be used for being connected in or tying by the dissection in the pelvic cavity zone The structure characteristic is so that for organizing support section and supported tissue to provide support. Can prop up from tissue The support part branch stretches out one or more (for example, one, two or four) extension, as Elongated " end ", " arm " or " extension " can be used for for example described logical herein Cross and extend through the tissue access of leading to inner anchor point and be connected in tissue in the pelvic cavity zone. Randomly, according to alternative embodiment of the present invention, what the extension can be by the pelvic cavity zone Tissue and lead to external undercut.
As discussing herein, the embodiment of spendable exemplary implant can comprise Organize support section and do not have the extension. Other embodiment can comprise one, two, Three or the more extension of organizing support section that is connected in. An exemplary urethra Sling can be unitary mesh bar or the suspender belt with supportive part, and it comprises or substantially On comprise support section and the zero, one or two extensions of central authorities.
Implant can comprise part or fragment (for example, the pig of synthetic material or biologic material , corpse etc.), and can be can absorb again or can not be resorbent. The extension can The net of for example synthesizing, polypropylene mesh thing for example. It can be synthetic organizing support section Material (for example, polypropylene mesh thing) or biologic material.
Implant, comprise organize one of support section or extension or its two, can comprise Have different flexible different braiding order numbers, for example have high resiliency with fair circumanal Permitted the net that ight soil passes through.
Some examples of commercially available material can comprise can be from Bard of Covington, the MarleX that RI obtainsTM(polypropylene), the Prolene (polypropylene) and Mersilene (PETG) the Hernia Mesh that obtain from the Ethicon of New Jersey, from W.L.Gore and the Phoenix that forms a partnership, the Gore-TeX that Arizona obtainsTM(polytetrafluoroethylene (PTFE) of expansion), and from Minnetonka, the American MedicalSystems of Minnesota., the SPARC that Inc. obtainsTMThe sling system. The commercial embodiments of absorbable material comprises From Danbury, the DexonX that the Davisand Geck of Connecticut obtainsTM(polyglycolic acid) and the Vicryl that obtains from EthiconTM。
The size of implant can be random, and can be used for any concrete installation procedure, treatment, Patient's anatomy is in order to support specific tissue or types of organization and to prop up in order to extend to inside The precalculated position of support sex organization or external undercut. Exemplary size can be enough to allow tissue to prop up The tissues such as contact elevator, coccygeus, rectum, external sphincter muscle of anus are divided in the support part, perhaps in these One or more any required parts. Randomly, one or more extensions can be arranged From organizing support section to extend to inside or the outside anatomical location of expectation, extend in order to allow Part is fixed on the anatomical structure in pelvic cavity zone, in order to the supporting tissue support section.
According to the present invention, the size of extension can allow the extension being placed as support Tissue organizes support section (being connected in the end of organizing support section in the extension) at the bottom of the pelvis And the far-end of extension is connected between the position of pelvic tissue and extends, perhaps can be randomly Otch by the outside.
Implant can be one chip or multiple-piece, and it is configured as the part of coupling elevator on the whole, For example, be ring-type wholly or in part, trapezoidal (asymmetric or symmetrical), rectangle, tiltedly square Shape etc. Implant can be multiple-piece, in order to be engaged in pelvic cavity architectural feature for example rectum or anus Door next door or on every side. Perhaps, implant can be irregular (although randomly for symmetrical), To affect the zones of different of elevator.
In order to be contacted with the pelvic floor tissue, implant (for example, the defecation sling) can be continuous or discontinuous sling, and can be one chip or multiple-piece.Successive implant can be for successive in fact between the edge, in order to the top in the horizontal surface zone that places the elevator tissue.Discontinuous implant can comprise gap or otch, it allows most of implant to be placed on the horizontal surface of elevator tissue, and some part forms around organizational structure and extends and for example organize from elevator that anus, rectum etc. stretch out or stretch to the elevator tissue.
The embodiment of discontinuous sling can be designed as covering or is contacted with elevator, coccygeus or its both zone, and extends around so that the rear portion side of contact rectum or external anal sphincter.For example, the part of implant can be connected in the lateral sides of external anal sphincter and extend towards closed pore, perhaps is connected in any other suspended structure (for example, the supportive tissue), but does not need the engage tissue of direct and closed pore.In this embodiment, do not need implant organize support section one fix on anus under the correcting action of fecal incontinence is provided.The advantage of this method is to allow anus to expand without restriction, so that promote normal rectum function, and can provide leverage required support for one or more levator plate.
The embodiment of implant can comprise and be positioned at the forward segmentation of anus, for example contacts with elevator tissue or perineal body tissue in that anus is anterior.Optionally implant can be designed as the upper part that replaces perineum muscle or be connected in external sphincter.The various embodiments of Pi Luing also are applicable to the male in this article, and can implant (referring to accompanying drawing) by the otch of perineum bottom.
Implant can, for example, organize support section or, randomly comprise the tissue fastener that is connected in pelvic cavity regional organization at the far-end of extension.Described tissue fastener for example can be, soft tissue anchor, fixing most advanced and sophisticated certainly, biology binding agent, tissue clamp, at the relative male and female connector element that is being pushed firm engagement when lumping together or be fixed in any other device of pelvic cavity regional organization in order to far-end with the extension.Exemplary tissue fastener is for example, discuss among the PCT/SU2007/014120 that on June 15th, 2007 submitted to, " Surgical Implants, Tools; and Methods for Treating Pelvic Conditions ", its full content is merged in this paper as a reference.Implant can also have the extension that does not comprise tissue fastener at its far-end, for example, is used for being fixed in tissue by other method (for example, sew up) or is intended to by tissue access externally in the situation of otch termination in remote design.
Any desired tissue that the extension can be connected in the pelvic cavity zone perhaps leads to external undercut by the desirable tissue path.In order to make the extension be connected in tissue, can be randomly at the far-end conjunctive tissue securing member of extension.In settling the implant process, tissue fastener can be connected in any desired tissue, for example, the supportive tissue, its many examples are as described herein.The supportive tissue can be a fibrous tissue, for example muscle (for example, closed pore, especially obturator internus; Obturator externus, ligament, for example sacrotuberous ligament, sacrospinous ligament or surrounding tissue; Tendon, for example arcus tendineus or surrounding tissue; Or ischial spine or near the tissue (that is, tissue) it, for example ischial tuberosity in the ischial spine zone.
The length of extension (extending through any tissue access) can be randomly fixed or adjustable, allows before implanting, in the process or changed the length of extension afterwards by the surgeon.On the other hand, also can be from the embodiment of implant or from concrete extension (for example, be connected in the top extension of closed pore or place extension) to outside incision extension in tissue access get rid of guiding mechanism and tension mechanism.
The length of extension can be enough to allow far-end to arrive within the pelvic cavity zone or outside expectation tissue, for example, about 1 centimetre (cm) arrives about 5 centimetres.The width of extension can be random, for example is in about 1 to the 1.5 centimetre scope.
" fixing certainly most advanced and sophisticated " can be the structure that is connected in the extension far-end usually, and it can be implanted in the tissue with the mode that supports the implant that is connected to keep fixing certainly most advanced and sophisticated location.Exemplary certainly fixedly the tip can be designed for engagement insertion instrument () end for example, elongated pin, elongated pipe etc. makes that the insertion instrument can be used for promoting most advanced and sophisticatedly implanting by tissue from fixing.As required, certainly fixedly the tip can be at fixing most advanced and sophisticated certainly place, inner passage, cylindrical base place or for example, position externally at the portion's of extending laterally engagement insertion instrument.Exemplary certainly fixedly the tip for example be described in, the PCT/US2007/004015 that on February 16th, 2007 submitted to, in " Surgical Articles and Methods for Treating Pelvic Conditions ", its full content is merged in this paper as a reference.
Can be from fixing tip by any useful manufacture of materials, generally including can be molded or be configured as desired structure and be connected in the material of end of the extension of implant.Useful material can comprise for example material of polyethylene, polypropylene and other thermoplasticity or thermoformable of plastics, and the biocompatible and optional biology of metal, pottery and other type can absorb or biology can resorbent material.Exemplary bioabsorbable material for example comprises, the copolymer of polyglycolic acid (PGA), polyactide (PLA), PGA and PLA.
Can be to be inserted in the tissue in pelvic cavity zone and can be maintained at any form in the tissue subsequently from fixing tip.Exemplary certainly fixedly the tip can comprise one or more portions that extend laterally, it increases from tissue after can be in being inserted into tissue remove from fixing most advanced and sophisticated needed power, just " withdrawal force ".Simultaneously, the portion of extending laterally can be designed as to show and reduces or low relatively " insertion force ", its be used for certainly fixedly the tip be inserted into the required power of tissue.Can be designed as when being inserted in the tissue basically location for good and all from fixing tip, unique exception is, if absolute demand provides the desired locations from fixing most advanced and sophisticated or the implant that connects, can in the implant procedure process, will remove by the surgeon from fixing tip.From fixing most advanced and sophisticated and fixing certainly all most advanced and sophisticated parts can be form and the size that makes up, so that produce these functional characteristics.
According to exemplary embodiment, fixedly the tip can have the structure that comprises pedestal certainly, and described pedestal has nearly base ends and base ends far away.Nearly base ends can (directly or indirectly, for example by the connection suture) be connected in the far-end of extension, perhaps is directly connected in the support section of organizing of implant.Described pedestal extends to base ends far away from nearly base ends, and can randomly comprise from nearly base ends, at least in part along a segment base seat, to inner passage that base ends far away is extended.The far-end that optional inner passage can be designed as and inserted instrument interacts (that is, engagement), with allow the insertion instrument be used for certainly fixedly the tip be placed on position in patient's the pelvic tissue.
Alternative embodiment from fixing tip does not need and can get rid of the inner passage that is used to mesh the insertion instrument.These alternative embodiment can be solid, there is not the inner passage, and if desired can be by arbitrarily optional engagement system engagement insertion instrument, such as for example, contact from fixing most advanced and sophisticated insertion instrument to extension by the base portion of holding (on a side of nearly base ends or surface) or by contact side by using externally the position.
From fixing most advanced and sophisticated embodiment also comprise from base portion side to (for example, radially) one or more portions that extend laterally of Yan Shening, for example from the position between near-end and the far-end, from the position of base ends far away, or extend laterally from the position of nearly base ends.
Can be connected in implant in the extension of for example implant from fixing tip, perhaps directly be connected in by any bindiny mechanism by any way and organize support section, perhaps for example by syndeton for example suture connect indirectly.Connection can be based on frame for movement, by binding agent, by connecting suture or the monoblock type connection by for example described injection molding of U.S. Patent Publication 2006-0260618-A1 or " insertion " molded (being also referred to as " over-molded "), described document is merged in this paper as a reference.According to foregoing description, can for example, be molded directly on the net with thermoplasticity or heat fixation polymeric material inserted mode system or injection-molded at the end of the netted extension of implant.By this method, molded polymer can form at the end of extension from fixing most advanced and sophisticated.Can for example comprise the portion of extending laterally and inner passage as described herein from fixing tip.
An example of implant as shown in fig. 1.Comprising that the implant 2 of organizing support section 10 is generally symmetric trapezoid form (adding extension 12), but alternatively, can be symmetric rectangle, rhombus, square, asymmetric trapezoidal, oblong rectangle etc.Two extensions 12 are positioned at the corner of wide terminal 4 contact sides 6.Side 6 extends and stops at narrow terminal 8 places.The tissue fastener (not shown) can be placed on 12 places, extension.In use, the extension can be connected in the tissue in pelvic cavity zone; For example, a tissue of organizing extension 12 can be connected in rear positions, for example zone of ischial spine, sacrospinous ligament, ischiorectal fossa or iliococcygeus; Another extension can be connected in the forward position, the tissue of closed pore for example, for example, near the obturator internus of bottom pubic branch, the tissue of arcus tendineus etc.This makes long terminal 4 to be in lateral position.Organize support section 10 to organize centered beneath extension and short terminal 8 to be in inner side in elevator.Short terminal 8 for example can be positioned at below the rectum.When being in such position, implant is extended to closed pore or arcus tendineus zone from lateral position between ischial spine or the sacrospinous ligament zone, organizes support section 10 to be contacted with the elevator tissue, short terminal 8 are in inner side, for example, near rectum, randomly below anococcygeal ligament.
Length terminal and side can be random, so that be fit to these positions.For example, length L 1 can be 6-12 centimetre scope, for example 7-10 centimetre.Wide terminal 4 length L 2 (not comprising extension 12) can be for example 3-5 centimetre.Narrow terminal 8 length L 3 can be for example 2-3 centimetre.
The method according to this invention, implant 2 can be inserted by otch placed in the middle, for example at the otch placed in the middle at perineum place, and is positioned at as described below the elevator tissue.Implant 2 is placed on the side of pelvic floor, so that support side in fact of elevator or half.Can place second implant according to identical method, so that support the side of offside with same design.In this embodiment of implant and method, use two independent implants, below each of elevator is lateral, there is one, short end extends to the middle position.Preferably, implant also is positioned at the superficial transverse muscle of perineum below.Short end can be each other or is overlapping or fixing with organizing of pelvic cavity zone, and for example, by suture or other fixing means, for example binding agent, bail etc. fix.
In Fig. 1, implant 12 can be synthetic material or biologic material.Fig. 2 represents the example of the implant 20 of synthetic net.From fixing most advanced and sophisticated 22 corners that are positioned at implant (have or do not have extension).Equally, implant 20 is designed for the method for using two relative implants, and each is used to support each side of elevator.
Fig. 3 illustrates optional implant, and implant 30 comprises two relative trapezoidal portions of implant, and described relative part integrally links together in the centre by meshing narrow end.Implant 30 can unitary construction, perhaps from the implant preparation of two types shown in Figure 2.Implant 30 comprises that also it in use can be located from fixing tip 32 as described in for the extension 12 of implant 2.In use, the narrow mid portion 34 of implant 30 can be located between two parties, for example, and below rectum.Wide terminal 36 length can be for example 4-5 centimetre.The width of the implant 30 at narrow centering portions 34 places can be for example 2-3 centimetre.Total length (perpendicular to the direction of mid portion 34) can be for example 14-18 centimetre, for example, and 15-17 centimetre.
Another embodiment of implant is illustrated among Fig. 4.Comprise that the implant 40 of organizing support section 54 is generally asymmetric trapezoid form.Two extensions, anterior extension 44 and extension, rear portion 42 are positioned at and make side end 52 be connected in the corner of anterior side 46 and rear portion side 50.Anterior side 46 and rear portion side 50 extend to inside end 48 between two parties.The tissue fastener (not shown) can randomly be positioned at extension 42 and 44.In use, anterior extension 44 can be connected in the tissue in anterior pelvic cavity zone, and the tissue of closed pore for example for example, near the obturator internus of bottom pubic branch, or is connected in the tissue of arcus tendineus.Extension, rear portion 42 can be connected in the tissue in pelvic cavity zone, rear portion, and for example the zone of ischial spine for example, is connected in sacrospinous ligament, ischiorectal fossa or iliococcygeus.Sidepiece side 52 extends back with edgewise position in the past, and inside end 48 is positioned at middle position, for example below rectum.When being in such position, implant is extended from for example ischial spine zone and for example lateral position between the closed pore zone, organizes support section 54 contact elevator tissues, and the middle position of inside end 48, for example, near rectum, randomly below anococcygeal ligament.Generally speaking, this implant can provide lateral support and supports along ground, the more close center of pubococcygeus and puborectalis along iliococcygeus.
Length terminal and side can be random, so that allow this location.For example, lateral end 52 can be for example 5-7 centimetre.The length of anterior side 46 can be 5-10 centimetre, for example 6-9 centimetre.The length of rear portion side 50 can be slightly short, and for example 4-8 centimetre, perhaps 5-6 centimetre.The length of inside end 48 can be for example 2-3 centimetre.
In Fig. 4, implant 40 is synthetic nets, but can optionally be biologic material.
The method according to this invention, implant 40 can be passed through otch placed in the middle (for example, perineal incision) insertion, and are positioned at the below of pelvic floor tissue, for example coccygeus or elevator as described.Implant 40 is positioned at the lateral tissue of of pelvic floor below, in order to side in fact of supporting pelvic floor or half.Can place and have same design second implant of (but be the form of mirror image), in order to opposite flank according to identical method support pelvic floor.In this embodiment of implant and method, use two independent implants, be respectively applied for each side of supporting elevator, inside end extends to the middle position.Preferably, implant also is positioned at the superficial transverse muscle of perineum below.Inside end can overlap each other or be fixing, and for example, for example binding agent, bail etc. fix by suture or other fixing means.In optional embodiment, two implants, implant 40 and its mirror image can be in the inside end connections and as one implant.
Can use the insertion instrument that implant is installed.Known various types of insertion instrument, and the instrument of these types and variant thereof can be used to install implant according to the present invention.The example of useful instrument comprises the instrument of following those types, and it generally includes the thin elongated syringe needle that is connected in handle; Be connected in the hands handle of an end (near-end) of described syringe needle; And the far-end of syringe needle is suitable for engagement from fixing most advanced and sophisticated, and it allows syringe needle to promote from fixing most advanced and sophisticated by anatomic passages and will be inserted in the pelvic cavity regional organization from fixing tip.(in alternative embodiment, can use connector to replace from fixing most advanced and sophisticated, described connector can mesh the far-end of insertion instrument so that allow connector to be pushed or to spur by leading to the tissue access of outside organization's otch.) this class instrument can use fixing certainly most advanced and sophisticated (or the connector of other form) that comprises the inner passage that is designed for the far-end engagement by inserting instrument.
Also can use the insertion instrument of other universal class, but can mesh from fixing most advanced and sophisticated (or connector) not comprise from the mode of fixing most advanced and sophisticated inner passage.This alternative insertion instrument can for example not contact under the situation of the inner passage that base ends far away is extended or catching from fixing most advanced and sophisticated nearly base ends, for example by catching the outer surface of pedestal from nearly base ends.Optionally the insertion instrument can contact or catch pedestal the side, extend laterally portion or fixing any other parts of tip or pedestal certainly, make to allow the insertion instrument to keep inserting from fixing most advanced and sophisticated from the fixing most advanced and sophisticated and precalculated position in pelvic cavity regional organization.
Being used for the treatment of the exemplary insertion instrument that incontinence and vagina deviate from for example is described in, U.S. Patent application 10/834,943,10/306,179,11/347,553,11/398,368,10/840,646, in PCT application 2006/028828 and PCT application 2006/0260618 and other document.The instrument of describing in those patent documents is designed to implant is placed in the pelvic cavity zone, is used for the treatment of prolapsus, sex incontinence etc.The instrument of the patent document of above-mentioned reference can be straight or can two dimension or three-dimensional bending, and can comprise for example three-dimensional helical form part, tissue access is passed through in the extension that is used to place implant, described tissue access is passed through from mid-urethral zone, by closed pore, to the external undercut of groin or inside thigh areas.The insertion instrument of other description comprises two dimension or three-dimensional elongated syringe needle, and it allows the extension of user by external undercut placement implant, for example, is placed on position or anus week or periproctic position on the pubis.
Exemplary insertion instrument used according to the invention can be similar to the instrument described in the patent document of above-mentioned reference, perhaps can comprise its feature.For the use that comprises according to the wherein implant of described method herein from fixing most advanced and sophisticated embodiment, those insertion instruments can be modified, so that allow the insertion instrument to place from fixing most advanced and sophisticated by the tissue that the tissue access that does not extend to external undercut is used in the pelvic cavity zone.The insertion instrument can design, form and sizing is to comprise elongated insert or pin, it can be straight or can be two dimension or three-dimensional bending, it can pass through vaginal incision (for women's anatomical structure), passes through perineal incision (for the andranatomy structure) or pass through any insertion of described other otch herein, and to the pelvic tissue position, be used for placing from fixing most advanced and sophisticated from this incision extension.
Some embodiment of insertion instrument can be designed as by vaginal incision, perineal incision or other described otch; By the tissue access of inside, then by second external undercut, for example, inboard groin, thigh, abdomen area, suprapubic region territory or rectum week or anus week are regional.Optionally instrument can sizing or is formed at the interior location in pelvic cavity zone and place from fixing most advanced and sophisticated, and need not from the incision extension to the external undercut so long.Described length can just be enough to fix other most advanced and sophisticated position from vaginal incision or all incision extensions of rectum certainly to the zone of closed pore, ischial spine, the zone or the placement of sacrospinous ligament.Perhaps, this length can be to be enough to incision extension from expectation to different muscle or tissue, and for example levator ani m., coccygeus, iliococcygeus, arcus tendineus etc. are placed from fixing tip in order to locating at one of those tissues.
According to an aspect of the present invention, implant can organized the office, support portion or randomly comprise one or more from fixing most advanced and sophisticated in one or more ends of optional extension, and method for implantation can comprise and being placed in the tissue in pelvic cavity zone from fixing tip one or more, in order to supporting implant, and implant supports one type pelvic tissue.Described tissue can be a fibrous tissue, for example muscle (for example, closed pore, obturator internus, obturator externus, levator ani m., coccygeus, iliococcygeus), ligament (for example, sacrospinous ligament), tendon (arcus tendineus), or the like.In addition preferably, but be not essential condition of the present invention, fixedly the tip can be directed so that make the key dimension (being referred to herein as " width ") that extends laterally on not parallel with machine direction direction in fibrous tissue certainly.
In order to control Support Position and the degree of implant with respect to the tissue that will support with implant, from fixedly the tip can be in the expectation inlet point insertion with respect to total zone of organizing, and,, oneself fixedly can be inserted into selected depth in the tip for tissue with adequate thickness or degree of depth.
The single embodiment of the method according to this invention is the method for improving pelvic floor tissue or its a part of position or improving its support, by operation near the pelvic floor tissue (for example by permission, elevator tissue, coccygeus tissue) otch (for example implant implant, one, monoblock type, optional uniform braided polymer net bar), described otch is the otch or the described herein other otch of vaginal incision (for women's anatomical structure), perineum (for the sex anatomical structure) for example.Some embodiment of these methods can advantageously comprise and have only single otch (being vaginal incision, perhaps women or male's perineal incision among the women) and can be without any need for other otch.
In Fig. 5, represented to comprise the embodiment of the external member of the present invention of insertion instrument and implant.Implant 100 can be installed support the elevator tissue.Implant 100 is designed to support the part of elevator tissue, and implant 102 is designed to support the opposite side portion of elevator tissue.Each implant comprises organizes support section (104), anterior extension (106), described anterior extension (106) to comprise from the tissue fastener (108) of fixing most advanced and sophisticated form.Each implant also comprises extension, rear portion (110), and it comprises the tissue fastener (112) from fixing most advanced and sophisticated form.Side and end comprise: lateral end 136, and it can extend along the Outboard Sections of elevator, for example near the arcus tendineus between forward position and the rear positions; Extend to the anterior side 132 of anterior extension 106 from inside end 130; Extend to the rear portion side 134 of extension, rear portion 110 from inside end 130; With inside end 130.
Instrument 120 also is the part of external member.Instrument 120 comprises handle 122, and it is connected in the near-end of elongated syringe needle 124.Far-end 126 is configured to be used to mesh the inner passage of each tissue fastener 108 and 112 or 128 (being expressed as dotted line) of holing.Instrument 120 is expressed as has straight syringe needle part 124, but the syringe needle part can two dimension or three-dimensional bending.
Fig. 5 represents two implants, 102 and 100, and they are mirror images each other, all are asymmetric trapezoid forms, are the part of external member.Optionally external member can comprise the implant of two other shapes, for example, as discussing, comprises rectangle, symmetric trapezoidal, the square or general shape of any of these herein, and perhaps, if desired, one or more straight edges are arcual.In other optional external member, implant can be substantially connect in inside end 130 (for example, whole or by engaging mechanism for example suture connect) the form (referring to Fig. 5 A) of two implants.
Randomly, according to various implant embodiments, implant 100 or 102 for example, the material that forms any part of sling 100 can comprise in the material that is incorporated into sling or be coated in one or more materials on the sling material.The example of material can include but not limited to medicine, hormone, antibiotic, antimicrobial material, dyestuff, elastomer silicone, polyurethane, radiopaque filament or material, position or Length Indication agent, antibacterium material, chemicals or reagent, comprises its any combination.Described material or material can be used to strengthen therapeutic effect, reduce of the repulsion of possible health to sling, reduce and organize erosive probability, allow or strengthen visual or monitoring position, the sling orientation of indicating correct, infection, or other effect of other expectation, useful or favourable effect is provided.
In addition, for any implant, for example implant 100,102 or optional embodiment can for example be strained suture by tension element and adjust sling tension force, and described tension suture for example is disclosed in the U.S. Patent Publication 6,652,450.Tension suture can be formed by nonvolatil or absorbable (that is, biology can be resorbent or biological absorbable) material structure.Strain component can for example be organized support section or extension along any part location of implant.
Reference support elevator tissue and coccygeus are organized and are described certain embodiments of the present invention.In addition, the present invention also can be used for more particularly treating the symptom that is caused by elevator or coccygeus structural weakness or damage of masculinity and femininity.For example, embodiment of the present invention are suitable for multiple pelvic floor repair or treatment, comprise pelvic organ prolapse reparation, elevator flatulence, for example elevator avulsion of the other defective of vagina, the reparation of elevator ceasma, fecal incontinence treatment, perineal body support, rectum support, elevator tissue repair etc.
Fig. 6 represents the anatomy relevant with the method and apparatus of embodiment of the present invention.With reference to figure 6, it is the view of the bottom tissue of the varying level in clear pelvic cavity zone for example, comprises gluteus maximus 200, levator ani m. 202 (it comprises iliococcygeus), sacrotuberous ligament 204, ischial tuberosity 206, superficial transverse muscle of perineum 208, pubococcygeus 210, puborectalis 212 and perineal body 214.Show epidermis 218 and coccyx 216 is used for reference.
According to illustrative methods of the present invention, the method that supports elevator or coccygeus can comprise that generation allows the step near the otch of bottom elevator or coccygeus tissue regions.When forming otch, a certain amount of incision of preferred or essential formation.For example, the placement of implant can be carried out under the situation of incision plane that will comprise ischiorectal fossa or zone incision.The anatomy distinguishing mark that is included in this cut-out region can comprise ischial spine, obturator internus, arcus tendineus.
Can be by the otch insertion or by the part of otch near implant or implant.Implant can be as herein or is described especially, for example in Fig. 1 any in Fig. 4, Fig. 5, Fig. 5 A, it comprises organizes support section, and randomly comprises one or more tissue fasteners that randomly are positioned at the corner of implant or are positioned at the far-end of optional extension.Implant can by this otch and will organize support section be placed in lower region thereof or downside (that is, below tissue or bottom) support elevator tissue, coccygeus tissue or its two.According to certain embodiments of the present invention, organize support section also can be positioned at the below (in its lower section) of superficial transverse muscle of perineum, so that also support these tissues.Can be randomly with organize support portion fixes in elevator tissue, superficial transverse muscle of perineum tissue or its two.Organize support section so that the mode of organizing support section to support the elevator tissue is positioned at the zone of bottom elevator tissue.Randomly, organize support section can be positioned at the rectum below, be connected in rectum or be connected in external anal sphincter.
With reference to figure 6, an embodiment of method can comprise for example to be organized the far-end of support section or extension to be placed as implant and is selected from following supportive tissue and contacts: the zone or the ischial tuberosity of the hole week of sacrotuberous ligament, pubis (not shown among Fig. 6), pubourethral ligament (also not shown, but urethra is connected in pubis), arcus tendineus (not shown), anococcygeal ligament (clearly not illustrating), sacrospinous ligament (not shown among Fig. 6), ischial spine.Optionally or additionally, can will organize support section or extension to be connected in the hole week of the pubis in the ischial tuberosity zone.Optionally or additionally, organize support section or extension can extend through the tissue access between levator ani m. and the obturator internus and be connected in arcus tendineus (white line), obturator membrane or extend through the external undercut that closed pore leads to femoribus internus.
Usually, for fecal incontinence sling and other pelvic floor and levator ani m. reparation, be used for tissue fastener and for example can comprise hole week of the horizontal grappling of sacrotuberous ligament or pubis-particularly pass through ischial tuberosity from the fixing anchor point of tip or bone anchor.In addition, the bone anchor can be placed on ischial tuberosity, sling is connected in the pelvic cavity intra-zone.Sling can laterally connect (for example, at the ischial tuberosity place) below external anal sphincter and on each side.According to a specific embodiment, can using certainly fixedly, the tip makes the sling location.In addition, sling and certainly fixedly the tip can be positioned between levator ani m. and the obturator internus, be connected in fascia white line or " arcus tendineus ".Randomly and preferably, sling can directly be positioned at the superficial transverse muscle of perineum top, increases the base support to pelvic floor.
In this embodiment, although be not wishing to be bound by theory, think that sling not only plays the function of recovering the anal orifice and rectal intestine angle, but also or optionally provide backstop (backstop) effect for elevator.More supports that this is provided for closure and keeps restraint for anus.The anchor point that recovers levator ani m. allows them more effectively to shrink and closes anal canal.
Optionally or additionally, sling can be connected in pubourethral ligament, it can recover the angle of rectum.So curing fecal incontinence to small part is owing to also recovered the point of leverage of levator plate and anus longitudinal muscle except any improvement owing to recovery anal orifice and rectal intestine angle.
The possible position of another of tissue fastener can be a rumpbone, for example uses the bone anchor by the conjunctive tissue securing member, perhaps at sacrospinous ligament or anococcygeal ligament place.
According to another embodiment, external undercut can be led to by the tissue access in the pelvic cavity zone in the extension of implant, for example: by extending to the tissue access of the external undercut in the abdominal part; By above pubis, extending to the tissue access of pubis upper cut; By extending through closed pore and leading to the tissue access of the external undercut of femoribus internus; The tissue access of leading to the external undercut adjacent by horizontal expansion by tailbone region with coccyx; Or the tissue access of the external undercut by extending to periproctic or all zones of anus.
Apparent from description of the present invention, can implant be installed by the combination of any one otch or otch, described otch can cause directly leading to elevator or coccygeus tissue or lead to the tissue access that extends to elevator or coccygeus tissue from external undercut.The example leads to the rectum week otch of pelvic floor tissue for allowing opening; Can allow the rectum week otch of tissue access from all incision extensions of the rectum of outside to the little outside of pelvic floor tissue; Can allow tissue access to extend to little external undercut the tailbone region of pelvic floor tissue from external undercut; Be included in the pubis upper cut of the little or big external undercut of position on the pubis; Can by from the external undercut of femoribus internus, by obturatorius, lead to be positioned in order to the placement implant extension of the implant that supports the pelvic floor tissue through the obturatorius method; Use the Kraske otch, for example, at subrectal otch; " improved Kraske " otch; Perineal incision; Vaginal incision.Some useful method can comprise and reducing based on using the interior tissue securing member for example from fixing tip implant to be fixed in the interior tissue in pelvic cavity zone the needs of external undercut and the elimination needs to the leading point of extension.
According to an exemplary tissue access, through closed pore muscular tissue path, the extension of implant can be stretched out from the support section of organizing of elevator tissue, above closed pore.The support that for example provides by pubis coccyx ligament can be provided passage by top (" closed pore top "), and tension elevator ceasma, and it can be repaired perineal body and recover the anal orifice and rectal intestine angle.Usually, being described in the title of submitting on February 3rd, 2006 through closed pore muscular tissue method is the pending application 11/347 of " Transobturator Methods for Installing Sling to TreatIncontinence; and Related Devices ", in 047, and the US patent disclosure of submitting on February 24th, 2,005 2005/0143618 (11/064,875) in, the full content of these documents is merged in this paper as a reference.
The example of method on the pubis (external undercut method) is in Fig. 7 illustrated.With reference to figure 7, relevant anatomical structure comprises coccyx 240, white line 242, rectum 244, vagina 246, urethra 248 and pubis 250.Insertion instrument 252 comprises the syringe needle that is connected in implant 254.Make a part of (not shown) location of implant 254, in order to contact elevator tissue and support elevator tissue, a part (illustrational) for example is connected in syringe needle and is pulled by lead to the tissue access of the external undercut in suprapubic region territory from elevator in extension (it randomly comprises the connector that is used for meshing the syringe needle end).
Usually, the otch in perineal region can be the otch in this position, for example, and between women's vagina and anus.The otch in perirectal region territory can be for example in 1-4 centimetre of anus.
Example (changing into machine-direction oriented) at Fig. 8 illustrated " improved " Kraske otch (260).Example at Fig. 8 A illustrated rectum week or anus week otch (262).Another example at Fig. 8 B illustrated rectum week or anus week otch (264).Example at Fig. 8 C illustrated perineal incision (266).The otch of all these types all allows near pelvic floor tissue, is used to implant one or two part (in the shade illustrated) of the sling that contacts with the elevator tissue.
The feature of various tissue access, relevant anatomical structure, implant material, implant (for example, connector, tensioner), insert the U.S. Patent Publication 2002/0161382 (10/106,086) that the case description of instrument was submitted in for example on March 25th, 2002; 2005/0250977 (10/840,646) that on May 7th, 2004 submitted to; With 2005/0245787 (10/834,943) of submitting on April 30th, 2004; 2005/0143618 (11/064,875) that on February 24th, 2005 submitted to; With the United States Patent (USP) of submitting on October 25th, 2,002 6,971,986 (10/280,341); 6,802,807 (09/917,445) that submit to July 27 calendar year 2001; 6,612,977 (09/917,443) that submit to July 27 calendar year 2001; 6,911,003 (10/377,101) that on March 3rd, 2003 submitted to; 7,070,556 (10/306,179) that on November 27th, 2002 submitted to; The title that on February 16th, 2007 submitted to is the PCT/US2007/004015 of " SurgicalArticles and Methods for Treating Pelvic Conditions "; The title that on June 15th, 2007 submitted to is " SurgicalImplants Tools and Methods for treating pelvic conditions " dePCT/US2007/014120; Each of these documents is all incorporated into this paper as a reference in full.
The specific embodiment
The embodiment elevator is expanded and is repaired
1. blunt dissection
A. make transverse incision, about 2cm under anus, long 3cm, similar to the Krasky otch,
I. can also select to cut open by anococcygeal ligament or at the shallow table of anococcygeal ligament herein.The shallow table of ligament cuts and can not make in its in tension or erosive danger for rectum provides backstop.Yet, for the fecal incontinence of serious symptom, or bigger if desired tension, also ligament can be cut open and place net in its back.
B. finger is inserted in the otch and the formation of the ischial spine on patient left side duct.Use blunt dissection to open the space of leading to sour jujube with finger.Finger is between elevator (inboard) and the fatty tissue (sidepiece).
C. swing with finger, between the closed pore rear part edge on ischial spine and the bottom pubic branch, between fat and muscle, set up a space.
D. at patient right side repeating step b and c.
2. place net with syringe needle
A. syringe needle is inserted through by the anchor on the net arm.
B. finger is placed near on the bottom pubic branch of closed pore, syringe needle is advanced along finger be advanced in the tissue, enter obturator internus up to the end that has anchor.
C. by from otch, extracting syringe needle is taken out.The pulling net has been fixed in tissue to guarantee anchor.Syringe needle is inserted in the anchor on another net arm.
D. finger is placed on the ischial spine, syringe needle is advanced along finger be advanced in the tissue, near the ischial spine in the elevator up to the end that has anchor.
E. take out syringe needle.
F. along the net swing, make the segment smoothing between the anchor, and swing subrectal tail end.
G. at offside repeating step a-f.
3. use the suture closure of incisions.
If a. ligament is broken away, then at the end that above net, meshes ligament before the closure of incisions again.

Claims (30)

1. support the method for pelvic floor tissue, described method comprises: produce the otch that allows near the pelvic floor tissue regions, provide and comprise the pelvic implant of organizing support section, make implant by otch and will organize support section to be placed on the pelvic floor tissue regions and so that the mode of organizing support section to support the pelvic floor tissue will organize support section to be positioned at the pelvic floor tissue regions.
2. the method for claim 1 comprises the bottom that support section is placed on superficial transverse muscle of perineum.
3. claim 1 or 2 method, wherein said method is selected from: the method for the method of the method for treatment fecal incontinence, the method that supports perineal body, perineal body reparation, treatment elevator avulsion, the method for treatment elevator flatulence, the method that supports levator ani m., the method for levator ani m. reparation, the method for straining or dwindling elevator ceasma size, method that the treatment vagina is deviate from and one or more the combination in these methods.
4. each method in the claim 1 to 3, wherein said implant comprises in addition from the extension of organizing support section to stretch out, and described method comprises extends so that the tissue in contact pelvic cavity zone the extension, make extension supporting tissue support section, and organize support section to support the elevator tissue.
5. each method in the claim 1 to 4, wherein implant comprises tissue fastener, and described method comprises the tissue that makes tissue fastener be fixed in the pelvic cavity zone.
6. each method in the claim 1 to 5 comprises implant is fixed in undertissue: the tissue and the arcus tendineus of the zone of the hole week of sacrotuberous ligament, sacrospinous ligament, pubis, pubourethral ligament, ischial spine, ischial tuberosity, obturatorius.
7. each method in the claim 1 to 5 comprises that the far-end that makes the extension is fixed in the hole week of the pubis in the ischial tuberosity zone.
8. each method in the claim 1 to 5 comprises that a part that makes implant connects the extension by the tissue access between levator ani m. and the obturator internus and at the arcus tendineus place.
9. each method in the claim 1 to 5, comprise that a part that makes implant extends through the tissue access between elevator and the external undercut, described external undercut is in and is selected from following position: the otch in pubis upper cut, rectum week otch, anus week otch, the tailbone region and wherein tissue access extend through the otch at the femoribus internus place of closed pore.
10. each method in the claim 1 to 9, wherein will organize support section be placed on external anal sphincter below, in order to support external anal sphincter.
11. be used to support the pelvic implant of elevator tissue, described implant comprises the support section of organizing with following feature:
Can extend to the anterior side of inboard elevator tissue regions from the front area in pelvic cavity zone, described front area is selected from closed pore zone, arcus tendineus zone and puborectalis zone,
Can extend to the rear portion side of inboard elevator tissue regions from the Background Region in pelvic cavity zone, described Background Region is selected from following zone: ischial spine zone, ischial tuberosity, sacrospinous ligament, sacrotuberous ligament zone and rumpbone and
Can extend to the lateral end of described Background Region from described front area,
Wherein organize support section to be positioned at the elevator tissue regions.
12. the implant of claim 11, the wherein said shape of organizing support section is essentially and is selected from square, rhombus, symmetric trapezoidal, asymmetric trapezoidal, symmetric rectangle and asymmetric orthogonal shape.
13. the implant of claim 11 or 12 comprises being positioned at one or two extension along the corner of side end of organizing support section.
14. each implant in the claim 11 to 14 comprises two relative support sections of organizing, each organizes support section to comprise
Can extend to the anterior side of inboard elevator tissue regions from the front area in pelvic cavity zone, described front area be selected from closed pore zone, arcus tendineus zone and puborectalis zone and
Can extend to the rear portion side of inboard elevator tissue regions from the Background Region in pelvic cavity zone, described Background Region be selected from the ischial spine zone zone, ischial tuberosity, sacrospinous ligament, sacrotuberous ligament zone and rumpbone and
Can extend to the lateral end of described Background Region from described front area.
15. an external member, it comprises in the claim 10 to 13 each two implants.
16. an external member, it comprises in the claim 10 to 13 each two implants, and described implant comprises from fixing most advanced and sophisticated, and described external member comprises that in addition engagement is described from fixing most advanced and sophisticated insertion instrument.
17. an external member, it comprises the implant of claim 14, and described implant comprises from fixing most advanced and sophisticated, and described external member comprises that in addition engagement is described from fixing most advanced and sophisticated insertion instrument.
18. the external member of claim 16 or 17, wherein the insertion instrument comprises elongated syringe needle, and described elongated syringe needle has and is selected from following shape: straight form, two dimension are crooked, three-dimensional bending and helically bent.
19. by supporting the method for pelvic floor tissue treatment pelvic conditions, described method comprises:
Provide to comprise the implant of organizing support section and tissue fastener,
Produce the otch that allows near the pelvic floor tissue,
To organize support section to be placed as to contact with the pelvic floor tissue and
Described tissue fastener is fixed in pelvic cavity regional organization.
20. the method for claim 19, wherein said implant are each implant in the claim 11 to 14, and implant comprises tissue fastener.
21. the method for claim 19 or 20, wherein said tissue fastener are from fixing most advanced and sophisticated.
22. each method in the claim 19 to 21 is wherein saidly organized support section to be placed as and is selected from following elevator tissue and contacts: the combination of two or more in puborectalis tissue, pubococcygeus tissue, perineum tissue, iliococcygeus tissue and these tissues.
23. each method in the claim 19 to 22, wherein said pelvic conditions is selected from: urinary incontinence, fecal incontinence, enterocele, bladder hernia, proctoptosis and vaginal vault prolapse.
24. each method in the claim 19 to 23, wherein said otch are the otch outside placed in the middle at perineum place.
25. each method in the claim 19 to 24 wherein organizes support section to be fixed in external anal sphincter in addition.
26. each method in the claim 19 to 24 comprises the following patient's condition for the treatment of the women: enterocele, bladder hernia, proctoptosis and vaginal vault prolapse.
27. each method in the claim 19 to 26, described method comprise with certainly fixedly the tip be placed on and be selected from the following fibrous tissue: sacrospinous ligament, sacrotuberous ligament, coccygeus, iliococcygeus, obturator internus, ischial spine zone.
28. each method in claim 1 to 10 and the claim 19 to 27, wherein said method comprises:
Formation is selected from following otch:
Can allow tissue access from the rectum of outside week incision extension to all otch of little outside rectum of elevator tissue,
Outside pubis upper cut,
By closed pore be connected in the elevator tissue the external undercut at the femoribus internus place,
Subrectal Kraske otch,
Perineal incision,
Vaginal incision and
Insert one or more in the part of insertion instrument, implant, implant by described otch.
29. comprising, each method in claim 1 to 10 and the claim 19 to 28, wherein said method cut incision plane or the cut-out region that comprises ischiorectal fossa.
30. each method in claim 1 to 10 and the claim 19 to 29, wherein said pelvic floor tissue is selected from: the combination of elevator tissue, coccygeus tissue and these tissues.
CNA2007800279342A 2006-07-25 2007-07-25 Surgical articles and methods for treating pelvic conditions Pending CN101534746A (en)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US82030606P 2006-07-25 2006-07-25
US60/820,306 2006-07-25
US60/820,564 2006-07-27
US60/823,858 2006-08-29
US60/863,049 2006-10-26
US60/947,044 2007-06-29

Publications (1)

Publication Number Publication Date
CN101534746A true CN101534746A (en) 2009-09-16

Family

ID=41104952

Family Applications (1)

Application Number Title Priority Date Filing Date
CNA2007800279342A Pending CN101534746A (en) 2006-07-25 2007-07-25 Surgical articles and methods for treating pelvic conditions

Country Status (1)

Country Link
CN (1) CN101534746A (en)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102686184A (en) * 2009-09-30 2012-09-19 科洛普拉斯特公司 Body implantable fabric and a method of implanting a fabric to repair a pelvic floor
CN102740797A (en) * 2009-12-30 2012-10-17 Ams研究股份有限公司 Elongate implant system and method for treating pelvic conditions
CN102770080A (en) * 2009-12-30 2012-11-07 Ams研究公司 Systems, implants, tools, and methods for treatments of pelvic conditions
CN103561681A (en) * 2011-03-03 2014-02-05 远藤制药公司 Systems and methods for treating urinary incontinence
CN103957839A (en) * 2011-09-22 2014-07-30 Ams研究股份有限公司 Pelvic implant and treatment method
US9078729B2 (en) 2009-09-30 2015-07-14 Coloplast A/S Body implantable fabric
CN105395296A (en) * 2009-11-23 2016-03-16 Ams研究股份有限公司 Patterned implant and method
US9848970B2 (en) 2009-11-23 2017-12-26 Boston Scientific Scimed, Inc. Patterned sling implant and method

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9078729B2 (en) 2009-09-30 2015-07-14 Coloplast A/S Body implantable fabric
CN102686184A (en) * 2009-09-30 2012-09-19 科洛普拉斯特公司 Body implantable fabric and a method of implanting a fabric to repair a pelvic floor
US9848970B2 (en) 2009-11-23 2017-12-26 Boston Scientific Scimed, Inc. Patterned sling implant and method
CN105395296A (en) * 2009-11-23 2016-03-16 Ams研究股份有限公司 Patterned implant and method
CN105395296B (en) * 2009-11-23 2017-09-22 Ams研究股份有限公司 Pattern implant and method
US10028817B2 (en) 2009-11-23 2018-07-24 Boston Scientific Scimed, Inc. Patterned implant and method
US11116618B2 (en) 2009-11-23 2021-09-14 Boston Scientific Scimed, Inc. Patterned sling implant and method
CN102770080A (en) * 2009-12-30 2012-11-07 Ams研究公司 Systems, implants, tools, and methods for treatments of pelvic conditions
CN102770080B (en) * 2009-12-30 2016-08-03 Ams研究公司 For treating the system of pelvic disease, implant, instrument
CN102740797A (en) * 2009-12-30 2012-10-17 Ams研究股份有限公司 Elongate implant system and method for treating pelvic conditions
US10470861B2 (en) 2009-12-30 2019-11-12 Boston Scientific Scimed, Inc. Elongate implant system and method for treating pelvic conditions
CN103561681A (en) * 2011-03-03 2014-02-05 远藤制药公司 Systems and methods for treating urinary incontinence
CN103957839A (en) * 2011-09-22 2014-07-30 Ams研究股份有限公司 Pelvic implant and treatment method

Similar Documents

Publication Publication Date Title
CN101600402B (en) Surgical articles and methods for treating pelvic conditions
CN101801310B (en) Surgical articles and methods for treating pelvic conditions
AU2007277194B2 (en) Surgical articles and methods for treating pelvic conditions
US7811222B2 (en) Method and apparatus for treating pelvic organ prolapse
US20100261956A1 (en) Apparatus and Method for Pelvic Floor Repair in the Human Female
CN101534746A (en) Surgical articles and methods for treating pelvic conditions
WO2001045588A2 (en) Mesh pubovaginal sling
AU2009251827B2 (en) Minimally invasive levator avulsion repair
US20110011407A1 (en) Apparatus and method for pelvic floor repair in the human female
US20100261954A1 (en) Apparatus and Method for Pelvic Floor Repair in the Human Female
US20100261953A1 (en) Apparatus and method for pelvic floor repair in the human female
AU2015202101B2 (en) Surgical articles and methods for treating pelvic conditions
AU2007318079B2 (en) Surgical articles and methods for treating pelvic conditions

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
C12 Rejection of a patent application after its publication
RJ01 Rejection of invention patent application after publication

Application publication date: 20090916