CN104274218A - Implant apparatus for treatment of fistula - Google Patents

Implant apparatus for treatment of fistula Download PDF

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Publication number
CN104274218A
CN104274218A CN201410513579.1A CN201410513579A CN104274218A CN 104274218 A CN104274218 A CN 104274218A CN 201410513579 A CN201410513579 A CN 201410513579A CN 104274218 A CN104274218 A CN 104274218A
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China
Prior art keywords
fistula
cytoskeleton
protective cover
treatment
implant device
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Chinese (zh)
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王亮
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SHAANXI RUISHENG BIOLOGICAL SCIENCE AND TECHNOLOGY Co Ltd
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SHAANXI RUISHENG BIOLOGICAL SCIENCE AND TECHNOLOGY Co Ltd
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Priority claimed from CN201410179821.6A external-priority patent/CN103961144A/en
Application filed by SHAANXI RUISHENG BIOLOGICAL SCIENCE AND TECHNOLOGY Co Ltd filed Critical SHAANXI RUISHENG BIOLOGICAL SCIENCE AND TECHNOLOGY Co Ltd
Priority to CN201410513579.1A priority Critical patent/CN104274218A/en
Publication of CN104274218A publication Critical patent/CN104274218A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004(bio)absorbable, (bio)resorbable, resorptive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00641Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closing fistulae, e.g. anorectal fistulae

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The invention relates to an implant apparatus for treatment of fistula, comprising a protective cover (1) and at least two tractive members (2); at least one of the tractive members (2) is directly connected with the protective cove (1) The implant apparatus for treatment of fistula has the advantages that the apparatus is applicable to clinical treatment of complex rectal fistula with multiple tracts affected, a cell growth direction is parallel to a cell attachment wall, and tissue in-growth is favored; the protective cover in the spherical shape has the effect of preventing intestinal excrement from accumulating in the inner rectal opening with fistula and enabling less rectal excrement to enter the fistulous tracts; a cell stent membrane can freely slide on flexible silk members, the shape of a 'foot' can be adjusted according to the actual shape of one fistulous tract, and sufficient filling of the fistulous tract and remediation of tissues are achieved.

Description

A kind of implant device for the treatment of fistula
Technical field
The present invention relates to the technology of medical apparatus and instruments, specifically a kind of implant device repaired for human body soft tissue.
Background technology
Can there is fistula in tissue, cause the reason of fistula and comprise birth defect, wound, tissue infection and Crow grace disease (Chron ' s disease).In many fistulas, anorectal fistula clinical onset rate is high---and in China, its prevalence accounts for 1.67% ~ 3.6% of anal and intestinal disease, and occupy second in the anal and intestinal disease sickness rate of the European and American developed countries such as abroad, its sickness rate is 8% ~ 25%.Anorectal fistula, is also referred to as anal fistula, and the perianal tissue's abscess how to cause because anus body of gland infects, usually cannot spontaneous recovery.Abscess can be passed through operative drainage or naturally flows out, and form passage at place of infected tissue, be called as fistula road, the opening of fistula road on anorectal wall is foramen primum, is commonly referred to as internal orifice, and the opening that fistula road produces in perianal tissue is secondary mouth, is commonly referred to as collar extension.
Anal fistula can be divided into simple anal fistula (single fistula road) and complex anal fistula (Duo Lou road) due to the complexity in its fistula road.In traditional therapy, general simple anal fistula adopts the treatment of drain thread-drawing therapy, and complex anal fistula adopts rectal mucosa lobe to pass art treatment, though clinically there is certain curative effect, but owing to can cause damage to anal sphincter in operation process, cause higher postoperative incontinence risk, relapse rate is higher.
The another kind of technology of Treatment of Anal Fistula is anal fistula bolt technology, and its Therapy characteristics without the risk of postoperative incontinence, but because its structure is only for simple Treatment of Anal Fistula, cannot be applicable to the treatment of complex anal fistula.
Chinese patent application 200680023018.7 and 201110158543.2, discloses a kind of graft adopting plastic material to roll and is used for the treatment of fistula.Plastic material can be the submucous layer of small intestine material of extracellular matrix class, roll the spiral layers cone graft adopting flaky material to wind up, there is multiple limitation in disclosed mechanotherapy anal fistula: one of its deficiency, be configuration of implant be single cone-shaped structure, be not suitable for the treatment of complex anal fistula; Its less than two, that graft adopts flaky material spiral to wind up to form, after implanting, autologous tissue grows into, and to attach face (material wall) vertical for direction and recipient cell, be unfavorable for that the initial stage organizes initial stage liquid infiltration and cell to creep and moves into, cause regeneration and restoration poor effect, treatment cell density heterogeneity; Its less than three, be the upper structure without preventing from deviating from of graft structure design, in Treatment of Anal Fistula, graft has the risk of deviating from.
Chinese patent application 200980119365.3 is improved on basis before, improves to be included in graft end and to add lid-like, for reducing the risk that graft in Treatment of Anal Fistula is deviate from.But do not improve less than one with less than two above described so far.
Chinese patent application 201110350823.3, is disclosed a kind of contour structures of anal fistula bolt, is found by mechanical analysis, although it can reduce the risk come off after apparatus is implanted, is not suitable for the treatment of complex anal fistula.
Summary of the invention
The object of this invention is to provide one to be applicable to simple anal fistula and complex anal fistula, can to prevent from and to intercept intestinal dirt, meanwhile, be convenient to tissue fluid infiltration and cell is moved into, is conducive to the implant device being used for the treatment of fistula of tissue repair.
One aspect of the present invention relates to a kind of implant device for the treatment of fistula, and the implant device of described treatment fistula comprises protective cover 1 and at least two traction pieces 2, and traction piece 2 described at least one is directly connected with described protective cover 1.
Specifically, can be that all traction pieces 2 are all directly connected with protective cover 1, also can be that part traction piece 2 is directly connected with protective cover 1, and part traction piece 2 is by being indirectly connected with protective cover 1 with the traction piece 2 that protective cover 1 is directly connected.Certainly, part traction piece 2 can also be had to be by being indirectly connected with protective cover 1 with the traction piece 2 that protective cover 1 is connected indirectly.
More specifically, can also be that a traction piece 2 is directly connected with protective cover 1, all the other traction pieces 2 be by being indirectly connected with protective cover 1 with the traction piece 2 that protective cover 1 is directly connected.
As instantiation, the implant device of this treatment fistula, comprise protective cover and be arranged on the traction piece inside this protective cover, traction piece is multiple; This traction piece is formed by flexible filament thing with through the cytoskeleton diaphragm group that multiple cytoskeleton diaphragms that this flexible filament thing is cascaded form; The outer end of flexible filament thing connects with protective cover, and it is inner through described cytoskeleton diaphragm group formation traction end.
Protective cover comprise be convenient to be attached to horizontal plane on intestinal tube wall and from this horizontal plane lateral surface edge outwardly with the jut preventing intestinal dirt from piling up around protective cover;
Flexible filament beyond the region of objective existence end connects with the medial surface of described horizontal plane.
Multiple traction piece is the inner side that divergent shape is arranged at protective cover;
Or one of them is fixed on the central point inside protective cover as main traction piece, remaining traction piece is connected with the main flexible filament thing of main traction piece by the attached flexible filament thing on it as attached traction piece.
Attached traction piece from described main traction piece outer end to inner, circumferentially set gradually.
Flexible filament thing is sutures: the silk thread of titanium silk thread, titanium alloy, can be used in organic plastics silk, nonabsorable sutures and Absorbable rod sutures that human body implants any one.
The outer end of flexible filament thing is sewed up or is binded or be cast on protective cover.
The shape of cytoskeleton diaphragm group is cylindrical, cube shaped, pyramid, taper shape or the circular cone bench-type corresponding with fistula road shape.
It is highly 5 ~ 9cm that the heap of cytoskeleton diaphragm group is built.
Protective cover is made up of any one in polylactic acid, poly-sour lactone, polyglycolic acid and poly butyric fat, and its thickness is between 0.1 ~ 0.5cm, and surface area is at 0.25 ~ 2.00cm 2between.
Multiple cytoskeleton diaphragm is arranged in turn and adjacent cytoskeleton diaphragm 4-0 is together bonded to each other, described flexible filament thing runs through described cytoskeleton diaphragm group and it is inner, all tie a knot outward in the two ends end face of this cytoskeleton diaphragm group in outer end, form a spacing zone, can not deviate to ensure certain thickness cytoskeleton diaphragm group can slide on flexible filament thing;
Or described flexible filament thing continuous looper button thus form multiple latch closure knot thereon, thus form multiple spacing zone, each cytoskeleton diaphragm is then fixed between adjacent latch closure knot, namely in a spacing zone;
Or described flexible filament thing continuous looper button thus formed thereon multiple latch closure knot, multiple cytoskeleton diaphragms of composition cytoskeleton diaphragm group, segmentation forms multiple spacing zone, comprise latch closure section and laminating section, described latch closure section comprises three latch closures knot be connected at least in turn, and is at least fixed with a cytoskeleton diaphragm in these three latch closures knots, between adjacent two latch closures knots; Laminating section is made up of the cytoskeleton diaphragm that at least two fit together; This latch closure section and the adjacent or alternate setting of laminating section.
Cytoskeleton diaphragm is cell epimatrix material or high molecular synthetic material.
Cell epimatrix material is by any one cell epimatrix material manufactured in mammalian small intestine tela submucosa, mammal pericardium, peritoneum, skin histology and muscular tissue.
Cell epimatrix material is the cell epimatrix material removing cell component completely;
Or do not remove the cell epimatrix material of cell component completely;
Or remain the cell epimatrix material of cell component completely.
Cell epimatrix material is by cross-linking agent or adopts UV-crosslinked or that heat cross-linking mode is crosslinked cell epimatrix material; Or uncrosslinked cell epimatrix material; Cross-linking agent is any one in glutaraldehyde reagent, genipin reagent, 1-(3-dimethylamino-propyl)-3-ethyl-carbodiimide hydrochloride (EDC) and epoxies reagent.
High molecular synthetic material is by polylactic acid, poly-sour lactone, poly butyric fat, any one high molecular synthetic material made in polyglycolic acid, poly terephthalic acid second fat, polyesters organic plastic material and expanded polytetrafluoroethylsealing.
Cell epimatrix material is dried forms or hydrated form.
Cytoskeleton diaphragm is compounded with the antimicrobial DP finish that can be used for human body.
Antimicrobial DP finish is the mixture of any one or more in gentamycin, tetracycline antibiotics, streptomycin, nitroimidazole antibiotics, sulfa antibiotics, Moxifloxacin, ciprofloxacin, oxytetracycline.
Protective cover is hemispherical or rectangle.
Compared with the graft for the treatment of for implant device and the existing fistula of fistula treatment of the present invention, it is advantageous that:
The technical scheme of many " foot " (i.e. traction piece) of the present invention, go for the treatment of the complex anal fistula in Duo Lou road clinically, fills up the vacancy of currently reported Treatment of Anal Fistula graft therapeutic domain.
Treatment of Anal Fistula implant device of the present invention, cell is grown into direction and cell attachment wall level, contributes to the migration of creeping of recipient cell, is beneficial to tissue and grows into.And currently reported its cell of Treatment of Anal Fistula graft is grown into, direction is vertical with cell attachment wall, and its material hinders recipient cell growing into fistula road.
The present invention is spherical protective cover, the Treatment of Anal Fistula graft that its airflow design comparatively has been reported, and has and effectively prevents intestinal Excreta from piling up at anal fistula internal orifice, reduces the possibility that intestinal dirt enters fistula road.
The cytoskeleton diaphragm of the present invention, can be free to slide on flexible filament thing, the shape of implant device shape " foot " can be regulated as cylindrical, cube shaped, pyramid, taper shape or the circular cone bench-type etc. corresponding with fistula road shape according to fistula road true form, play and fully fill fistula road, the effect of tissue repair.
Below in conjunction with drawings and Examples, the present invention will be further described, but be not used for limiting the scope of the invention.
Accompanying drawing explanation
Fig. 1 is 5 " foot " divergent shape implant device structural representation;
Fig. 2 is 4 " foot " dendroid implant device structural representation;
Fig. 3 is that 3 " foot " divergent shape implant device anal fistula repairs schematic diagram;
Fig. 4 is that 3 " foot " dendroid implant device anal fistula repairs schematic diagram.
Description of reference numerals: 1, protective cover; 2, traction piece; 3, flexible filament thing; 4, cytoskeleton diaphragm group; 5, anorectal wall; 6, anal fistula foramen primum; 7, anal fistula secondary openings; 8, fistula road; 9, sphincter; 1-0, horizontal plane; 1-1, jut; 2-0, main traction piece; 2-1, attached traction piece; 3-0, traction end; 3-1; 3-2; 4-0, cytoskeleton diaphragm.
Detailed description of the invention
Figure 1 shows that a kind of implant device for the treatment of fistula, the traction piece 2 (in following examples, image is referred to as " foot ") comprising protective cover 1 and be arranged on inside this protective cover 1, figure is not difficult to find out thus, and traction piece 2 is multiple, is applicable to the Treatment of Anal Fistula of multiple secondary openings.And scheme high-visible thus, traction piece 2 is formed by flexible filament thing 3 with through the cytoskeleton diaphragm group 4 that multiple cytoskeleton diaphragm 4-0 that this flexible filament thing 3 is cascaded form; The outer end of flexible filament thing 3 connects with protective cover 1, and its inner cytoskeleton diaphragm group 4 of passing forms traction end 3-0.
Be not difficult to find out thus, the implant device of this treatment fistula prevents deviating from of graft in Treatment of Anal Fistula by protective cover 1, the most important thing is, the cytoskeleton diaphragm group 4 that the multiple cytoskeleton diaphragm 4-0 be cascaded by flexible filament thing 3 are formed, ensures that cell is grown into direction and cell attachment wall level, contributes to the initial stage to organize initial stage liquid infiltration and cell to creep to move into, be beneficial to tissue to grow into, contribute to the Regeneration and Repair of tissue, ensure that therapeutic effect, cell density is even.
And, protective cover 1 comprise be convenient to be attached to horizontal plane 1-0 on intestinal tube wall and from this horizontal plane 1-0 lateral surface edge outwardly with the jut 1-1 preventing intestinal dirt from piling up around protective cover 1, for this reason, the profile of protective cover 1 recommends to select the hemispherical shown in Fig. 1, also can select rectangle.
Select sutures if any one in the silk thread of titanium silk thread, titanium alloy, the organic plastics silk that can be used for human body implantation and Absorbable rod sutures is as flexible filament thing 3 herein, flexible filament thing 3 outer end is sewed up or is binded or be cast on protective cover 1, specifically connects with the medial surface of horizontal plane 1-0.
Specifically arranging of traction piece 2 can be the traction piece of 5 shown in Fig. 12, the inner side being arranged at protective cover 1 in divergent shape is that (one end towards the side of protective cover 1 is called outer end for the outer end of each traction piece 2, according in use, this one end is placed in outside fistula road or outer edge, and its other end enters fistula road as traction end);
Or as shown in Figure 2, be fixed on the central point inside protective cover 1 as main traction piece 2-0 one of in 5 traction pieces 2, remaining traction piece 2 is connected with the main flexible filament thing 3-2 of main traction piece 2-0 by the attached flexible filament thing 3-1 on it as attached traction piece 2-1, attached traction piece 2-1 autonomous traction piece 2-0 outer end to inner, circumferentially set gradually, around main traction piece 2-0.This kind of structure, is applicable to the more and treatment that the is complex anal fistula of distribution (namely continuous and multiple fistula roads of branch) in dendroid of secondary openings.
In order to strengthen the suitability of the implant device for the treatment of fistula, it is made not to be only applicable to the treatment of simple anal fistula, and be applicable to the treatment of complex anal fistula, special the shape (monnolithic cases of the multiple cytoskeleton diaphragm 4-0 be namely cascaded) of cytoskeleton diaphragm group 4 is made cylindrical, cube shaped, pyramid, taper shape or can be corresponding with fistula road shape circular cone bench-type.
It is highly 5 ~ 9cm that the heap of cytoskeleton diaphragm group 4 is built.Protective cover 1 is made up of any one in polylactic acid, poly-sour lactone, polyglycolic acid and poly butyric fat, and its thickness is between 0.1 ~ 0.5cm, and surface area is at 0.25 ~ 2.00cm 2between.
Multiple cytoskeleton diaphragm 4-0 has three kinds by flexible filament thing 3 mode forming cytoskeleton diaphragm group 4 together of connecting:
Attaching type: multiple cytoskeleton diaphragm 4-0 arranges in turn and adjacent cytoskeleton diaphragm 4-0 is together bonded to each other, flexible filament thing 3 runs through cytoskeleton diaphragm group 4, and its (flexible filament thing 3) is inner, all tie a knot outward in the two ends end face of this cytoskeleton diaphragm group 4 in outer end, can not deviate to ensure certain thickness cytoskeleton diaphragm group 4 can slide on flexible filament thing 3;
Latch closure eliminant: flexible filament thing 3 continuously looper button thus form multiple latch closure knot its (flexible filament thing 3) is upper, each cytoskeleton diaphragm 4-0 is then fixed between adjacent latch closure knot;
Hybrid (attaching type mixes fixed form with latch closure eliminant): flexible filament thing 3 continuously looper button thus form multiple latch closure thereon and tie, multiple cytoskeleton diaphragm 4-0 of composition cytoskeleton diaphragm group 4, segmentation forms latch closure section and laminating section; Latch closure section comprises three latch closures knot be connected at least in turn, and is at least fixed with a cytoskeleton diaphragm 4-0 in these three latch closures knots, between adjacent two latch closures knots; Laminating section is made up of the cytoskeleton diaphragm 4-0 that at least two fit together; This latch closure section and the adjacent or alternate setting of laminating section.
Above-mentioned cytoskeleton diaphragm 4-0 is cell epimatrix material or high molecular synthetic material, and cell epimatrix material can be by any one cell epimatrix material manufactured in mammalian small intestine tela submucosa, mammal pericardium, peritoneum, skin histology and muscular tissue;
Cell epimatrix material can for removing the cell epimatrix material of cell component completely; Or do not remove the cell epimatrix material of cell component completely; Or remain the cell epimatrix material of cell component completely, the power that its difference can cause recipient immune to react after being to implant receptor.
Cell epimatrix material is by cross-linking agent or adopts UV-crosslinked or that heat cross-linking mode is crosslinked cell epimatrix material; Or uncrosslinked cell epimatrix material; Cross-linking agent is any one in glutaraldehyde reagent, genipin reagent and epoxies reagent.
Above-mentioned high molecular synthetic material can be by polylactic acid, poly-sour lactone, poly butyric fat, any one high molecular synthetic material made in polyglycolic acid, poly terephthalic acid second fat, polyesters organic plastic material and expanded polytetrafluoroethylsealing.
Cell epimatrix material can be dried forms, also can be hydrated form, and when it is dried forms, the drying mode that can adopt is be no more than the drying mode of 60 DEG C, includes but not limited to lyophilization, and laminar flow is dry, vacuum drying and naturally drying.
Cytoskeleton diaphragm 4-0 can be used as the support of recipient cell, is convenient to tissue repair and reconstruction; Cytoskeleton diaphragm also by directly being smeared by the medicine with certain function, and (or) be infiltrated on wherein, can become a kind of medicine carrying body simultaneously, is convenient to treatment.During as medicine carrying body, cytoskeleton diaphragm 4-0 is compounded with the antimicrobial DP finish that can be used for human body, and antimicrobial DP finish is the mixture of any one or more in gentamycin, tetracycline antibiotics, streptomycin, nitroimidazole antibiotics, sulfa antibiotics, Moxifloxacin, ciprofloxacin, oxytetracycline.
Be more than the basic introduction of the implant device to the treatment fistula shown in Fig. 1,2, now by reference to the accompanying drawings should being used as of implant device of this treatment fistula illustrated:
Embodiment 1, the implant device (hereinafter referred to as implant device) for the treatment of fistula repairs anorectal fistula (hereinafter referred to as anal fistula):
Verify fistula road shape by routine operation, as shown in Figure 3, fistula road is divergent shape at anal fistula foramen primum 6 place, through sphincter 9, generates 3 anal fistula secondary openings 7 at perianal.
3 shown in Fig. 3 " foot " (namely traction piece 2 is 4) divergent shape implant device is selected to repair above-mentioned complex anal fistula, the diaphragm that the cytoskeleton diaphragm of this implant device selects de-cell-adhesion matrix to manufacture, the heap of each cytoskeleton diaphragm group 4 is built and is highly respectively 8cm, 8cm, 8cm and 8cm, Absorbable rod sutures is adopted to connect multiple cytoskeleton diaphragm, the hemispherical stiff sheet that protective cover 1 adopts polylactic acid to manufacture, Absorbable rod sutures is sewed up fixing, " foot " of implant device is connected with protective cover 1.
First penetrated from anal fistula foramen primum 6 by Absorbable rod sutures during operation, pass from anal fistula secondary openings 7, " foot " of traction implant device enters debridement Hou Lou road, protective cover 1 and anorectal wall 5 are sewed up simultaneously, anal fistula secondary openings 7 is not sewed up, and gauze is wrapped up, and postoperatively imposes routine care.
In the present embodiment: protective cover 1 is polylactic acid; Flexible filament thing 3 is Absorbable rod sutures, being stitched together of its outer end and protective cover 1; Cytoskeleton diaphragm is the cell epimatrix material that mammalian small intestine tela submucosa is manufactured; This cell epimatrix material is the cell epimatrix material removing cell component completely, and cell epimatrix material carries out the drying mode of 50-60 DEG C; Cell epimatrix material adopts 25kGy irradiation sterilization before playing effect; Cell epimatrix material is by the crosslinked cell epimatrix material of cross-linking agent glutaraldehyde reagent.
The shape size of cytoskeleton diaphragm group 4 and the shape in fistula road adapt, and are circular cone bench-type, smear wherein during use by the medicine with certain function, become a kind of medicine carrying body.
Embodiment 2: implant device repairs anorectal fistula (hereinafter referred to as anal fistula)
Verify fistula road shape by routine operation, as shown in Figure 4, Zhu Lou road, at anal fistula foramen primum 6 place of anorectal wall 5, through sphincter 9, and generates an anal fistula secondary openings 7 at perianal, generates Liang Gefulou road simultaneously in dendroid, form complex anal fistula.
3 shown in Fig. 4 " foot " dendroid implant device is selected to repair above-mentioned complex anal fistula, the cytoskeleton diaphragm of this implant device selects the diaphragm of expanded polytetrafluoroethylsealing material, each cytoskeleton diaphragm group 4 heap builds height for being respectively 9cm, 6cm and 5cm, adopt titanium silk series connection cytoskeleton diaphragm, and pour into a mould fixing with the protective cover 1 of poly-sour lactone material.
During operation, " foot " of 6cm and 5cm is slided into appropriate location, ensure that cytoskeleton diaphragm group 4 is consistent to the length in its corresponding fistula road with anal fistula foramen primum 6 with the length of the flexible filament thing 3 between protective cover 1.Again titanium silk is penetrated from anal fistula foramen primum 6, pass from anal fistula secondary openings 7, " foot " that first draw Liang Gefulou road enters debridement Hou Lou road, " foot " that draw Zhu Lou road again enters debridement Hou Lou road, protective cover 1 and anorectal wall 5 are sewed up simultaneously, anal fistula secondary openings 7 is not sewed up, and gauze is wrapped up, and postoperatively imposes routine care.
In this embodiment, protective cover 1 is made by gathering sour lactone; Flexible filament thing 3 is silk threads of titanium or titanium alloy, can build or be bonded in the medial surface (one side that protective cover 1 and anorectal wall are fitted) of protective cover 1; Cytoskeleton diaphragm is the high molecular synthetic material that expanded polytetrafluoroethylsealing is manufactured; The shape size of cytoskeleton diaphragm group 4 and the shape in fistula road adapt---and be circular cone bench-type, implant adopts 30kGy irradiation sterilization before playing effect, smears wherein during use by the medicine with certain function, becomes a kind of medicine carrying body.
Embodiment 3: implant device repairs anorectal fistula (hereinafter referred to as anal fistula)
Fistula road shape is verified by routine operation, Zhu Lou road is at the anal fistula foramen primum place of anorectal wall, through sphincter, and generate anal fistula secondary openings at perianal, for simple anal fistula, select many " foot " dendroid implant shown in Fig. 2 or 4 to carry out anal fistula reparation, first " point foot " (the attached traction piece) of implant is cut, only retain " main foot " (main traction piece), carry out prosthesis.
The protective cover of this implant is polyglycolic acid; Flexible filament thing is the sutures of nonabsorable; The cell epimatrix material that cytoskeleton diaphragm selects cattle dermal matrix to manufacture, this cell epimatrix material is the cell epimatrix material removing cell component completely, and cell epimatrix material carries out cryodesiccated drying mode; The shape size of cytoskeleton diaphragm group and the shape in fistula road adapt, and are pyramid type, and implant adopts ethylene oxide sterilizing before performance effect.
Embodiment 4: implant device repairs anorectal fistula (hereinafter referred to as anal fistula)
Verify fistula road shape by routine operation, as shown in Figure 4, anal fistula foramen primum 6 place of Zhu Lou road on anorectal wall 5, through sphincter 9, and generates anal fistula secondary openings 7 at perianal, generates Liang Gefulou road simultaneously in dendroid, form complex anal fistula.5 " foot " dendroid implant device is selected to repair above-mentioned complex anal fistula, the cytoskeleton diaphragm of this implant device selects the diaphragm of pig intestinal mucosa host material, height is for being respectively 9cm, 8cm, 8cm, 6cm and 6cm, adopt titanium silk series connection cytoskeleton diaphragm, and sew up fixing with the protective cover of poly butyric fat material.
Will slidably during operation " foot " slide into appropriate location, ensure that cytoskeleton diaphragm group 4 is consistent with the length that anal fistula foramen primum 6 arrives its corresponding fistula road with the length of the flexible filament thing 3 between protective cover 1.Again titanium silk (i.e. flexible filament thing 3) is penetrated from anal fistula foramen primum 6, pass from anal fistula secondary openings 7, " foot " that first draw Liang Gefulou road enters debridement Hou Lou road, " foot " that draw Zhu Lou road again enters debridement Hou Lou road, protective cover and anorectal parietal suture are closed simultaneously, anal fistula secondary openings is not sewed up, and gauze is wrapped up, and postoperatively imposes routine care.
In this embodiment, protective cover is poly butyric fat; Flexible filament thing is titanium silk; Cytoskeleton diaphragm is the cell epimatrix material that pig intestinal mucosa substrate lower floor manufactures, cell epimatrix material, for part removes the cell epimatrix material of cell component, cell epimatrix material carries out the vacuum drying mode drying of 45 DEG C, cell epimatrix material, be by the crosslinked cell epimatrix material of cross-linking agent genipin reagent, and adopt 25kGy irradiation sterilization before playing effect; During use, the medicine with certain function is smeared wherein, become a kind of medicine carrying body, namely cytoskeleton diaphragm is compounded with the antimicrobial DP finish that can be used for human body, antimicrobial DP finish is the mixture of any one or more in gentamycin, tetracycline antibiotics, streptomycin, nitroimidazole antibiotics, sulfa antibiotics, Moxifloxacin, ciprofloxacin, oxytetracycline.
In sum, compared with the graft for the treatment of for implant device and the existing fistula of fistula treatment that above each embodiment provides, it is advantageous that:
The technical scheme of many " foot " (i.e. traction piece), goes for the treatment of the complex anal fistula in Duo Lou road clinically, fills up the vacancy of currently reported Treatment of Anal Fistula graft therapeutic domain.
Cell is grown into direction and cell attachment wall level, contributes to the migration of creeping of recipient cell, is beneficial to tissue and grows into.And currently reported its cell of Treatment of Anal Fistula graft is grown into, direction is vertical with cell attachment wall, and its material hinders recipient cell growing into fistula road.
Spherical protective cover, the Treatment of Anal Fistula graft that its airflow design comparatively has been reported, has and effectively prevents intestinal Excreta from piling up at anal fistula internal orifice, reduces the possibility that intestinal dirt enters fistula road.
Cytoskeleton diaphragm, can be free to slide on flexible filament thing, the shape of implant device shape " foot " can be regulated as cylindrical, cube shaped, pyramid, taper shape or the circular cone bench-type etc. corresponding with fistula road shape according to fistula road true form, play and fully fill fistula road, the effect of tissue repair.

Claims (11)

1. treat an implant device for fistula, it is characterized in that, comprise protective cover (1) and at least two traction pieces (2), wherein, at least one traction piece (2) is directly connected with protective cover (1).
2. treat the implant device of fistula described in claim 1, it is characterized in that, all traction pieces (2) are all directly connected with protective cover (1).
3. described in claim 1, treat the implant device of fistula, it is characterized in that, part traction piece (2) is directly connected with protective cover (1), and part traction piece (2) is by being indirectly connected with protective cover (1) with the traction piece (2) that protective cover (1) is directly connected.
4. described in claim 1-3 any one, treat the implant device of fistula, it is characterized in that, described traction piece (2) comprises flexible filament thing (3) and cytoskeleton diaphragm group (4), and described cytoskeleton diaphragm group (4) comprises the multiple cytoskeleton diaphragms (4-0) be cascaded by flexible filament thing (3); The outer end of described flexible filament thing (3) connects with protective cover (1), inner through described cytoskeleton diaphragm group (4) formation traction end (3-0).
5. the implant device for the treatment of fistula according to claim 1, it is characterized in that: described protective cover (1) comprises plane (1-0) and jut (1-1), described jut (1-1) from this plane (1-0) lateral surface edge to umbo; The outer end of described flexible filament thing (3) connects with the medial surface of plane (1-0).
6. the implant device for the treatment of fistula as claimed in claim 4, is characterized in that: described flexible filament thing (3) is sutures; The outer end of flexible filament thing (3) is sewed up or is binded or be cast on protective cover (1).
7. the implant device for the treatment of fistula according to claim 4, is characterized in that, described flexible filament thing (3) is provided with spacing zone, and described cytoskeleton diaphragm (4-0) is moved in spacing zone.
8. the implant device for the treatment of fistula according to claim 4, it is characterized in that: outer end and the inner segment of described flexible filament thing (3) are tied a knot respectively, form spacing zone, make multiple cytoskeleton diaphragms (4-0) of cytoskeleton diaphragm group (4) slide in spacing zone and can not deviate from.
9. the implant device for the treatment of fistula according to claim 4, it is characterized in that: the flexible filament thing (3) of described cytoskeleton diaphragm group (4) is tied a knot continuously, form multiple spacing zone, slide in a spacing zone to make at least one cytoskeleton diaphragm (4-0) and can not deviate from.
10. the implant device for the treatment of fistula according to claim 4, is characterized in that: described cytoskeleton diaphragm (4-0) is cell epimatrix material or high molecular synthetic material.
The implant device of 11. treatment fistulas according to claim 4, is characterized in that: described cytoskeleton diaphragm (4-0) is compounded with the antimicrobial DP finish that can be used for human body.
CN201410513579.1A 2014-04-30 2014-09-29 Implant apparatus for treatment of fistula Pending CN104274218A (en)

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CN201410179821.6A CN103961144A (en) 2014-04-30 2014-04-30 Implantation material device for fistula treatment
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CN204158424U (en) * 2014-04-30 2015-02-18 陕西瑞盛生物科技有限公司 A kind of implant device for the treatment of fistula
CN109350227A (en) * 2018-12-04 2019-02-19 武汉唯柯医疗科技有限公司 Implantable atrial septum ostomy appliance

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