CN111867516A - 用于内窥镜疝修补术的自膨胀网状内置假体 - Google Patents
用于内窥镜疝修补术的自膨胀网状内置假体 Download PDFInfo
- Publication number
- CN111867516A CN111867516A CN201880091173.5A CN201880091173A CN111867516A CN 111867516 A CN111867516 A CN 111867516A CN 201880091173 A CN201880091173 A CN 201880091173A CN 111867516 A CN111867516 A CN 111867516A
- Authority
- CN
- China
- Prior art keywords
- self
- mesh
- endoprosthesis
- expanding
- titanium
- 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.)
- Granted
Links
- 206010019909 Hernia Diseases 0.000 title claims abstract description 20
- 230000008439 repair process Effects 0.000 title claims abstract description 13
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims abstract description 35
- 239000010936 titanium Substances 0.000 claims abstract description 17
- 229910052719 titanium Inorganic materials 0.000 claims abstract description 17
- 239000004744 fabric Substances 0.000 claims description 23
- 239000000463 material Substances 0.000 claims description 14
- 229910045601 alloy Inorganic materials 0.000 claims description 4
- 239000000956 alloy Substances 0.000 claims description 4
- 238000001356 surgical procedure Methods 0.000 abstract description 10
- 230000000694 effects Effects 0.000 abstract description 8
- 208000014674 injury Diseases 0.000 abstract description 8
- 238000000034 method Methods 0.000 abstract description 8
- 230000008733 trauma Effects 0.000 abstract description 7
- 238000011084 recovery Methods 0.000 abstract description 3
- 238000005516 engineering process Methods 0.000 abstract description 2
- 208000027418 Wounds and injury Diseases 0.000 description 11
- 206010052428 Wound Diseases 0.000 description 10
- 238000011282 treatment Methods 0.000 description 10
- PXHVJJICTQNCMI-UHFFFAOYSA-N Nickel Chemical compound [Ni] PXHVJJICTQNCMI-UHFFFAOYSA-N 0.000 description 8
- 210000001519 tissue Anatomy 0.000 description 8
- 230000007547 defect Effects 0.000 description 7
- 229910052751 metal Inorganic materials 0.000 description 5
- 239000002184 metal Substances 0.000 description 5
- 229910001000 nickel titanium Inorganic materials 0.000 description 5
- 241001465754 Metazoa Species 0.000 description 4
- 208000002847 Surgical Wound Diseases 0.000 description 4
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 description 4
- 210000003815 abdominal wall Anatomy 0.000 description 4
- 229910052759 nickel Inorganic materials 0.000 description 4
- 230000002980 postoperative effect Effects 0.000 description 4
- 231100000241 scar Toxicity 0.000 description 4
- 210000004872 soft tissue Anatomy 0.000 description 4
- 229910001069 Ti alloy Inorganic materials 0.000 description 3
- 210000000683 abdominal cavity Anatomy 0.000 description 3
- 238000003486 chemical etching Methods 0.000 description 3
- 210000002808 connective tissue Anatomy 0.000 description 3
- 239000007943 implant Substances 0.000 description 3
- 230000001954 sterilising effect Effects 0.000 description 3
- 238000004659 sterilization and disinfection Methods 0.000 description 3
- 208000032544 Cicatrix Diseases 0.000 description 2
- 206010061218 Inflammation Diseases 0.000 description 2
- 241000283973 Oryctolagus cuniculus Species 0.000 description 2
- 238000010171 animal model Methods 0.000 description 2
- 239000013060 biological fluid Substances 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 238000009792 diffusion process Methods 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 210000000416 exudates and transudate Anatomy 0.000 description 2
- 239000000835 fiber Substances 0.000 description 2
- 210000002950 fibroblast Anatomy 0.000 description 2
- 230000004054 inflammatory process Effects 0.000 description 2
- 238000009940 knitting Methods 0.000 description 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 2
- 230000004660 morphological change Effects 0.000 description 2
- 210000004877 mucosa Anatomy 0.000 description 2
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 description 2
- 238000005498 polishing Methods 0.000 description 2
- -1 polypropylene Polymers 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 230000037387 scars Effects 0.000 description 2
- 206010060954 Abdominal Hernia Diseases 0.000 description 1
- 208000021970 Abdominal wall defect Diseases 0.000 description 1
- 206010002091 Anaesthesia Diseases 0.000 description 1
- 208000030453 Drug-Related Side Effects and Adverse reaction Diseases 0.000 description 1
- 102000009123 Fibrin Human genes 0.000 description 1
- 108010073385 Fibrin Proteins 0.000 description 1
- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin monomer Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 206010072170 Skin wound Diseases 0.000 description 1
- 208000036950 Surgical Wound Dehiscence Diseases 0.000 description 1
- 229910000883 Ti6Al4V Inorganic materials 0.000 description 1
- 208000035091 Ventral Hernia Diseases 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 208000026935 allergic disease Diseases 0.000 description 1
- 230000007815 allergy Effects 0.000 description 1
- 230000037005 anaesthesia Effects 0.000 description 1
- 210000003484 anatomy Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 230000007797 corrosion Effects 0.000 description 1
- 238000005260 corrosion Methods 0.000 description 1
- 125000004122 cyclic group Chemical group 0.000 description 1
- 238000009713 electroplating Methods 0.000 description 1
- 229950003499 fibrin Drugs 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000002695 general anesthesia Methods 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 235000014655 lactic acid Nutrition 0.000 description 1
- 239000004310 lactic acid Substances 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 230000003278 mimic effect Effects 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 210000000963 osteoblast Anatomy 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 231100000572 poisoning Toxicity 0.000 description 1
- 230000000607 poisoning effect Effects 0.000 description 1
- 229920000747 poly(lactic acid) Polymers 0.000 description 1
- 239000004626 polylactic acid Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 230000008092 positive effect Effects 0.000 description 1
- 239000011241 protective layer Substances 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 229920006395 saturated elastomer Polymers 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 238000004381 surface treatment Methods 0.000 description 1
- 239000003356 suture material Substances 0.000 description 1
- 238000009210 therapy by ultrasound Methods 0.000 description 1
- 230000009424 thromboembolic effect Effects 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
- 206010045458 umbilical hernia Diseases 0.000 description 1
- PAPBSGBWRJIAAV-UHFFFAOYSA-N ε-Caprolactone Chemical compound O=C1CCCCCO1 PAPBSGBWRJIAAV-UHFFFAOYSA-N 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
- A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
- A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
- A61L27/06—Titanium or titanium alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/02—Inorganic materials
- A61L31/022—Metals or alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
- A61L31/082—Inorganic materials
- A61L31/088—Other specific inorganic materials not covered by A61L31/084 or A61L31/086
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
- A61F2002/0068—Implantable repair or support meshes, e.g. hernia meshes having a special mesh pattern
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/16—Materials with shape-memory or superelastic properties
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/18—Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/34—Materials or treatment for tissue regeneration for soft tissue reconstruction
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Vascular Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Chemical & Material Sciences (AREA)
- Cardiology (AREA)
- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Epidemiology (AREA)
- Surgery (AREA)
- Urology & Nephrology (AREA)
- Dermatology (AREA)
- Medicinal Chemistry (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Abstract
本发明涉及医学和医疗技术的领域,目的在于改善用于疝气外科治疗的内置假体的技术性能。用于内窥镜疝修补术的自膨胀网状内置假体包括线制成的网状织物和包含在网状织物中的自膨胀系统,其中自膨胀系统由位于内置假体结构中并沿着其轮廓的多丝钛线制成,并且,其中网状织物的钛线以凹凸表面制成。技术效果包括提高进行腹腔镜疝修补术操作的效率,提高可塑性,降低网状结构中线断裂的风险,简化穿过和放置内置假体的外科技术,减少外科手术的创伤和持续时间,并相应地加速患者康复。
Description
技术领域
本发明涉及医学和医疗技术的领域,目的在于改善用于疝气外科治疗的内置假体(endoprostheses)的技术性能。
背景技术
现有技术中有已知的方案(RU 2199968 C2,公开日2003年03月10日,“疝孔封闭器”),其涉及外科技术,能够用于灵活覆盖前腹壁缺损(疝孔、肌肉分离)。封闭器是基于钛镍线制成的网状植入物而制成的。
该产品的缺点是使用钛镍(NiTi)合金作为基体;当NiTi植入体内时,会发生镍向周围组织扩散。Ni2+离子形式的该金属对机体细胞具有明显毒性作用。各种方法的NiTi表面处理:(机械或电化学处理,化学蚀刻),有助于提高材料的耐腐蚀性,然而保护层的破坏增加了镍扩散的速率。钛镍的特定属性使其需谨慎用作植入物材料。
回弹式HRD装置(WO 2007087146 A2,公开日2007年08月02日)应被认为是最接近的类似物(原型),具有完备的自膨胀功能。该装置是聚丙烯、超薄、轻质打孔网状物,具有钛镍制成的自膨胀网架。镍钛合金丝厚度是2至2.5mm。网状物具有250μm的线厚度和52g/m2的表面密度,将其置于一类轻型内置假体。回弹式HRD网状物通过腹腔镜安装或通过小切口以切口手术安装。
回弹式HRD的缺点是网状物基于聚丙烯结构,其生物稳定性较低。还应牢记的是,植入物受循环荷载影响,造成使用时金属疲劳。在这种情况下,使用金属丝会造成材料断裂;直径2.0-2.5mm的镍钛合金线是附近器官创伤或甚至穿孔的原因,随后会发展成可怕的并发症。此外,钛镍在相变过程是镍释放至组织的来源。所述的缺点降低了腹腔镜疝修补术的有效性,增加了创伤几率,并使穿过与放置内置假体的操作技术变得复杂,这些会对促进患者康复产生不利影响。
本发明能够基本上克服原型内在所述缺点。
发明内容
提出的技术方案解决的技术问题是研发基于钛线的自膨胀内置假体,增强腹腔镜疝修补术操作过程中部件的有效使用。
技术效果包括提高进行腹腔镜疝修补术操作的效率,简化穿过和放置内置假体的外科技术,提高可塑性,降低线断裂的风险,减少外科手术的创伤和持续时间,并相应地加速患者康复。
技术效果得以实现,归因于如下事实:内窥镜疝修补术的自膨胀网状内置假体包括线制成的网状织物和网状织物中包括的自膨胀系统,其中自膨胀系统由多丝钛线制成,多丝钛线位于内置假体的结构中并沿着内置假体的轮廓,其中网状织物的钛线以凹凸(relief)表面制成。
自膨胀系统的钛线采用5级合金制成。
网状织物钛线的表面凹凸以从0.00025mm开始波动的不均匀钛线直径制成。
将氧化膜应用于网状织物钛线的凹凸表面。
自膨胀系统的多丝线由直径60-200μm的单丝线制成。
自膨胀系统中多丝线的直径不超过600μm。
沿着内置假体的轮廓,自膨胀系统的多丝钛线被可吸收材料的壳包围。
附图说明
图1.具有自膨胀系统的内置假体的图案;
图2.三根单丝制成的多丝线的横截面的示意图;
图3.七根单丝制成的多丝线的横截面的示意图;
图4a.以凹凸的线制成的网状结构中交叉环系列的状态;
图4b.无凹凸的线制成的网状结构中交叉环系列的状态;
图5.编织的网状的零抗拉刚度的图表;
图6a.化学蚀刻之后线表面凹凸的实例;
图6b.离子处理之后线表面凹凸的实例;
图7a.处理之前有纵向尖锐缺陷的线的横截面;
图7b.处理之后有平滑的纵向缺陷的线的横截面。
具体实施方式
本发明的基础是自膨胀系统3,由多丝线组成,包围在内置假体1的网状结构2中。
多丝线由七根单丝线(单线)组成,线的数目可以是3至24。单丝线的直径是60-200μm,整根多丝线的直径可达到600μm。单丝线由5级钛合金(俄罗斯的型号VT6)制成。使用的5级合金钛线的弹簧特性提供了膨胀系统3的自膨胀性和高弹性。
自膨胀系统3(由钛多丝线组成)整合入了网状织物2的结构中。系统的钛多丝线穿过,与网状结构2交织在一起。自膨胀系统3在其卷起以穿过内窥镜之后提供材料的膨胀。多丝线的弹性能够在宽范围内变化,这一方面实现了回弹性,另一方面避免了软组织创伤。
当使用不同数目和不同结构的多丝线得到材料时,回弹性可以是不同的。例如,当多丝线由单丝线直径60μm的三根单丝线制成时,对软组织的压力最小,而当多丝线由单丝线直径200μm的七根单丝线制成时,对软组织的压力最大。用于自膨胀系统的多丝线越多,其膨胀的回弹性越大。
根据经验来选择获得弹性多丝线的最佳尺寸。在折叠时,比600μm厚的多丝线占据了1.2mm以上,当穿过直径8-10mm的内窥镜时其(除了网状之外还)占据了很大空间。在该范围内,系统具有适中的回弹性,不会对软组织施加过大压力。
单丝线直径小于60μm,会减弱多丝线的回弹性,产生小于3N的膨胀力,不会使网状织物完全膨胀。直径大于200μm会产生大于10N的超压,这对附近组织会产生影响并可能进一步对患者造成不适。采用例如130μm的直径,会产生6N的膨胀力,这足以产生膨胀但不会为对组织的过度压力制造条件。
钛多丝线可位于内置假体1的结构(中心区域)中并可沿着其轮廓(边缘),而它们的数目(单丝线最小直径是60μm)可达到49。
沿着内置假体1的边缘,钛多丝线可被包围在可吸收材料制成的壳中,这排除了单丝线对机体精密结构的穿孔。乳酸基聚合物,诸如聚乳酸、己内酯和它们的同分异构体,可用作可吸收材料。
网状织物2,形成自膨胀内置假体的基础,由纬编(filling-knit)或经编(warp-knitting)金属织物制成,金属织物由单丝或多丝钛线(例如1级(型号VT1-00)的钛合金)制成。网状织物抵抗生物体液;抵抗由消毒、灭菌前清洗和灭菌构成的处理循环,对组织有优良的生物相容性,在植入过程中不会造成中毒、过敏或其它副反应。
网状织物2的钛线以凹凸表面来制造,凹凸表面可通过例如功率超声处理、化学蚀刻、电化学抛光、离子处理等来获得。这些处理方法将网状织物的钛线直径减小了初始直径的10-35%,同时减小了交叉环(interloop)接触面积。结果是,获得了“伸缩效应”:环和线穿过环之间进入临近环的区域,显示于图4a。在未处理的线上没有观察到该效应(图4b)。在图4a和图4b中,箭头和直线突出了在一个环系列中环和线穿过环之间在环内相互穿透;图4a中的相互穿透更强。
伸缩效应和交叉环接触区域中阻力的减小是消除“弹簧”特性的主要原因。通过测量材料的机械性证实了该事实。
因此,当拉伸编织的网状物时,有零刚性(zero rigidity)Z时期,其中Z aten是具有凹凸线的网状织物(张力编织金属织物)的零刚性,Z nat是具有无凹凸线的网状织物(天然编织金属织物)的零刚性,即网状织物无阻力拉伸时图上的面积(图5)。将相同编织类型和线厚度的常规网状织物和处理的网状织物进行比较时,可以确定的是,凹凸线制成的处理的网状织物的零刚性区域比无凹凸的线制成的未处理的网状织物的区域大了20%或更多。
作为工艺流程的结果,凹凸出现在钛线表面:位置无规律的凹下和碰撞(图6a和6b)。
此外,对位于编织的网状织物结构中的线表面进行处理的过程中(例如,采用了电化学抛光),拉拔线造成的纵向尖锐缺陷(图7a)得以平滑。处理之后缺陷平滑显示于图7b。平滑的纵向缺陷(这是内应力的集中区域)补偿了线本身的残余应力并且减小了网状织物破损的风险。
处理的结果还表现为钛线直径不均匀,长度从0.00025mm开始波动,这也造成了交叉环空隙的额外自由度。
为了进一步提高可塑性,厚度1至3μm、滑动摩擦系数低并且使环相对于彼此容易地滑动(这对材料的延展性有积极作用)的氧化膜可应用于网状织物的凹凸钛线的表面。表面氧化膜减小了编织的环之间的摩擦和伴随的负面属性:当膨胀材料时破损,等。通过将凹凸线制成的网状织物浸泡于充满了必要溶液的电镀槽中(电流恒定)一定时间来获得氧化膜。取决于时间和选择的电压,钛线表面形成厚度1-3μm的氧化膜。在这种情况下,线本身的厚度并不增加。
使用内置假体1的技术如下:在全身麻醉下,导管(套管针)通过前腹壁的皮肤切口插入患者腹腔中,然后通过它们插入内窥镜仪器。圆柱形式卷起的自膨胀钛网状内置假体1应该是通过10mm套管针插入腹腔。用仪器轻微牵引内置假体1的边缘,它在手术区膨胀(打开),封闭疝缺损。同时,内置假体1的重要特点是一方面,它的边缘达到伤口边缘,另一方面,它不会在其上施加过大压力。
内置假体1置于疝缺损区域,与其边缘重叠3-5厘米。在拉伸时,网状2的弹性边缘临近伤口边缘并在伤口自固定一点。由于自固定,内置假体1保留在组织上不发生移动,这有利于其进一步固定。使用间断缝合或疝切除器(herniostepler)进行内置假体1的进一步固定。完成手术的同时,内置假体1位于解剖区域,封闭疝孔。由于其边缘临近手术区的边界,内置假体1还固定在手术区。
在控制手术伤口状态之后,从腹腔移除仪器和套管针。缝合前腹壁的皮肤伤口。另一积极特点是钛线的辐射不能穿透性质,这使得在手术之后在患者有生之年可用肉眼观察内置假体1的位置。
网状织物的高可塑性使弹簧特性最小化,降低了组织和粘膜之间生物力学排斥的可能性,并且能够将材料置于粘膜下而不会有损伤风险。网状内置假体在外科伤口表面自由膨胀,易于呈现和保持给定形状,如有必要,可通过拉伸来模拟外科伤口的形状。
高孔隙率提高了生物体液向内置假体的渗透率,加速了成纤维细胞和成骨细胞定殖过程,并改善了材料的生物整合。
由钛线制成表面凹凸的网状织物一旦与伤口表面接触,即可会浸透血液和伤口渗液,其展示了对伤口表面显著的附着能力,提供了暂时的自固定,使外科医生不必使用其它固定元件。对伤口表面的高附着能力能够将钛网放置组织下或覆盖内置假体而不需张力,防止如外科伤口裂开的频繁并发症。
同时,高孔隙度结构不会保留伤口渗液,排除了液体渗漏与进一步感染的可能。
线表面的凹凸显著改善了其上纤维蛋白纤维的固定,从而有利于吸引成纤维细胞作为新形成的结缔组织的来源。
与类似物形成对照,当使用要求保护的内置假体时,外科医生需要做一个更小的切口,放置与矫正内置假体的动作和时间更少,从而减少了外科手术的创伤和持续时间。它还需要更少的缝合材料和更少的内部缝合,外科伤口保持打开的时间更少,微生物污染的机会和范围也更少。结果是,麻醉持续时间更短,血栓栓塞并发症和药物副作用的风险更低。
实施例1
在三个实验室动物(兔,4个月大)得到前腹壁外侧上腹疝的模型;通过内窥镜安装网状内置假体,其包括钛合金制成的3根多丝线膨胀系统,每根由单丝线直径60μm的三根单丝线组成。术后伤口按预期愈合。1个月后,动物退出实验。当研究形态学变化时,在网状内置假体的整个表面发现了白色疤痕;当进行显微镜检测时,有序的结缔组织纤维代表术后疤痕结构,没有无菌性炎症的迹象。
实施例2
在三个实验室动物(兔,4个月大)得到前腹壁外侧上脐疝的模型;通过内窥镜安装网状内置假体,其包括钛合金制成的7根多丝线膨胀系统,每根由单丝线直径70μm的三根单丝线组成。术后伤口按预期愈合。2个月后,动物退出实验。当研究形态学变化时,在网状内置假体的整个表面发现了白色疤痕;当进行显微镜检测时,有序的结缔组织纤维代表术后疤痕结构,没有无菌性炎症的迹象。
要求保护的内置假体含有多丝钛线制成的自膨胀系统,多丝钛线位于网状结构的内置假体的结构中并沿着其轮廓,并且网状结构线带凹凸,使得要求保护的内置假体能够提高腹腔镜疝修补术的效率,提高可塑性并降低网状结构中线断裂的风险,简化穿过与放置内置假体的外科技术,减少外科手术的创伤和持续时间,这些能够使患者快速康复。
Claims (7)
1.一种用于内窥镜疝修补术的自膨胀网状内置假体,包括线制成的网状织物和包围在网状织物中的包含的自膨胀系统,其中所述自膨胀系统由位于内置假体结构中并沿着其轮廓的多丝钛线制成,并且,其中网状织物的钛线以凹凸表面制成。
2.根据权利要求1所述的用于内窥镜疝修补术的自膨胀网状内置假体,其中所述自膨胀系统的钛线由5级合金制成。
3.根据权利要求1所述的用于内窥镜疝修补术的自膨胀网状内置假体,其中网状织物钛线的表面凹凸以从0.00025mm开始波动的不均匀钛线直径制成。
4.根据权利要求1所述的用于内窥镜疝修补术的自膨胀网状内置假体,其中将氧化膜应用于网状织物钛线的凹凸表面。
5.根据权利要求1所述的用于内窥镜疝修补术的自膨胀网状内置假体,其中所述自膨胀系统的多丝线由直径60-200μm的单丝线制成。
6.根据权利要求1所述的用于内窥镜疝修补术的自膨胀网状内置假体,其中所述自膨胀系统的多丝线的直径不超过600μm。
7.根据权利要求1所述的用于内窥镜疝修补术的自膨胀网状内置假体,其中沿着内置假体的轮廓,所述自膨胀系统的多丝钛线被可吸收材料的壳包围。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/RU2018/000048 WO2019151885A1 (ru) | 2018-01-31 | 2018-01-31 | Саморасправляющийся сетчатый эндопротез для эндоскопической герниопластики |
Publications (2)
Publication Number | Publication Date |
---|---|
CN111867516A true CN111867516A (zh) | 2020-10-30 |
CN111867516B CN111867516B (zh) | 2023-12-29 |
Family
ID=67479410
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201880091173.5A Active CN111867516B (zh) | 2018-01-31 | 2018-01-31 | 用于内窥镜疝修补术的自膨胀网状内置假体 |
Country Status (9)
Country | Link |
---|---|
US (1) | US11950993B2 (zh) |
EP (1) | EP3747398B1 (zh) |
KR (1) | KR102459873B1 (zh) |
CN (1) | CN111867516B (zh) |
BR (1) | BR112020015640A8 (zh) |
CA (1) | CA3091614C (zh) |
ES (1) | ES2961696T3 (zh) |
MX (1) | MX2020008067A (zh) |
WO (1) | WO2019151885A1 (zh) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
MX2020009106A (es) * | 2018-03-01 | 2023-01-09 | Titanium Textiles Ag | Tela tejida por urdimbre de metal de titanio libre de tensión para dar forma quirúrgicamente a tejidos blandos. |
Citations (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
RU2199968C2 (ru) * | 2000-04-25 | 2003-03-10 | Зотов Вадим Александрович | Обтуратор грыжевых ворот |
RU2284762C1 (ru) * | 2005-03-25 | 2006-10-10 | Андрей Анатольевич Радкевич | Способ хирургического лечения больших и гигантских грыж передней брюшной стенки |
CN101112335A (zh) * | 2006-07-28 | 2008-01-30 | 北京天助畅运医疗技术有限公司 | 一种可植入的多用途腹外疝修补片 |
RU2326581C1 (ru) * | 2006-12-22 | 2008-06-20 | Государственное образовательное учреждение дополнительного профессионального образования "Уральская государственная медицинская академия дополнительного образования Федерального агентства по здравоохранению и социальному развитию" | Способ лапароскопической герниопластики пупочных грыж и грыж белой линии живота |
JP2009095856A (ja) * | 2007-10-16 | 2009-05-07 | Hi-Lex Corporation | チタン繊維およびその製造法 |
CN101489502A (zh) * | 2006-05-10 | 2009-07-22 | 明尼苏达医药发展股份有限公司 | 制造疝补片的方法及其得到的产物 |
CN201379820Y (zh) * | 2009-04-27 | 2010-01-13 | 宋永春 | 胸骨关闭用生物活性涂层可植入高强度钛合金丝 |
CN102137634A (zh) * | 2008-09-03 | 2011-07-27 | 库克公司 | 具有可移除的弹性元件的疝气补片 |
CN202184970U (zh) * | 2011-07-25 | 2012-04-11 | 中国人民解放军第四军医大学 | 基化改性的壳聚糖涂层尿道支架 |
CN202714884U (zh) * | 2012-02-23 | 2013-02-06 | 上海交通大学医学院附属第三人民医院 | 一种医用自锁式钛丝缝合线 |
US20130253645A1 (en) * | 2012-03-26 | 2013-09-26 | Marshall Kerr | Biocompatible Mesh Implant |
US20140379007A1 (en) * | 2011-09-26 | 2014-12-25 | Bard Shannon Limited | Implantable hernia prosthesis with an uninterrupted ring |
CN204274719U (zh) * | 2014-11-17 | 2015-04-22 | 贾忠 | 自张开补片 |
RU160627U1 (ru) * | 2015-04-14 | 2016-03-27 | Федеральное государственное бюджетное учреждение здравоохранения Центральная клиническая больница Российской академии наук (ЦКБ РАН) | Сетчатый материал для герниопластики на основе титановых нитей с антиадгезивным биологически активным покрытием |
Family Cites Families (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH09215753A (ja) * | 1996-02-08 | 1997-08-19 | Schneider Usa Inc | チタン合金製自己拡張型ステント |
US5824082A (en) * | 1997-07-14 | 1998-10-20 | Brown; Roderick B. | Patch for endoscopic repair of hernias |
US6319264B1 (en) | 1998-04-03 | 2001-11-20 | Bionx Implants Oy | Hernia mesh |
DE10243132B4 (de) * | 2002-09-17 | 2006-09-14 | Biocer Entwicklungs Gmbh | Antiinfektiöse, biokompatible Titanoxid-Beschichtungen für Implantate sowie Verfahren zu deren Herstellung |
WO2007048094A2 (en) | 2005-10-18 | 2007-04-26 | Valspar Sourcing, Inc. | Coating compositions for containers and methods of coating |
JP2009523056A (ja) | 2006-01-12 | 2009-06-18 | ミネソタ メディカル ディベロップメント、インコーポレイテッド | ヘルニア・パッチ・フレーム |
US20090099409A1 (en) * | 2007-10-16 | 2009-04-16 | Luehrs Kirsten F | Medical sheet |
RU121735U1 (ru) * | 2011-11-29 | 2012-11-10 | Антон Анатольевич Казанцев | Сетчатый имплантат для реконструктивной хирургии (варианты) |
DE102013014295A1 (de) * | 2013-08-22 | 2015-02-26 | Johnson & Johnson Medical Gmbh | Chirurgisches Implantat |
DE102014000457B4 (de) | 2014-01-13 | 2018-03-29 | Harald Kobolla | Flächiges Implantat zur Hernienversorgung mit zwei Netzlagen und einer elastischen, selbstexpandierenden Expansionseinrichtung |
RU2551054C1 (ru) | 2014-02-11 | 2015-05-20 | Сергей Владимирович Шалашов | Устройство для пластики при паховых грыжах |
RU2578359C1 (ru) | 2015-01-16 | 2016-03-27 | Федеральное государственное бюджетное учреждение "Институт хирургии имени А.В. Вишневского" Министерства здравоохранения Российской Федерации (ФГБУ "НИИ хирургии им. А.В. Вишневского" Минздрава России) | Способ хирургического лечения послеоперационного стерномедиастинита |
US9693849B2 (en) * | 2015-02-25 | 2017-07-04 | Roderick B. Brown | Hernia patch frame incorporating bio-absorbable material |
-
2018
- 2018-01-31 ES ES18903710T patent/ES2961696T3/es active Active
- 2018-01-31 WO PCT/RU2018/000048 patent/WO2019151885A1/ru unknown
- 2018-01-31 BR BR112020015640A patent/BR112020015640A8/pt unknown
- 2018-01-31 CN CN201880091173.5A patent/CN111867516B/zh active Active
- 2018-01-31 US US16/966,663 patent/US11950993B2/en active Active
- 2018-01-31 KR KR1020207025090A patent/KR102459873B1/ko active IP Right Grant
- 2018-01-31 CA CA3091614A patent/CA3091614C/en active Active
- 2018-01-31 EP EP18903710.4A patent/EP3747398B1/en active Active
- 2018-01-31 MX MX2020008067A patent/MX2020008067A/es unknown
Patent Citations (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
RU2199968C2 (ru) * | 2000-04-25 | 2003-03-10 | Зотов Вадим Александрович | Обтуратор грыжевых ворот |
RU2284762C1 (ru) * | 2005-03-25 | 2006-10-10 | Андрей Анатольевич Радкевич | Способ хирургического лечения больших и гигантских грыж передней брюшной стенки |
CN101489502A (zh) * | 2006-05-10 | 2009-07-22 | 明尼苏达医药发展股份有限公司 | 制造疝补片的方法及其得到的产物 |
CN101112335A (zh) * | 2006-07-28 | 2008-01-30 | 北京天助畅运医疗技术有限公司 | 一种可植入的多用途腹外疝修补片 |
RU2326581C1 (ru) * | 2006-12-22 | 2008-06-20 | Государственное образовательное учреждение дополнительного профессионального образования "Уральская государственная медицинская академия дополнительного образования Федерального агентства по здравоохранению и социальному развитию" | Способ лапароскопической герниопластики пупочных грыж и грыж белой линии живота |
JP2009095856A (ja) * | 2007-10-16 | 2009-05-07 | Hi-Lex Corporation | チタン繊維およびその製造法 |
CN102137634A (zh) * | 2008-09-03 | 2011-07-27 | 库克公司 | 具有可移除的弹性元件的疝气补片 |
CN201379820Y (zh) * | 2009-04-27 | 2010-01-13 | 宋永春 | 胸骨关闭用生物活性涂层可植入高强度钛合金丝 |
CN202184970U (zh) * | 2011-07-25 | 2012-04-11 | 中国人民解放军第四军医大学 | 基化改性的壳聚糖涂层尿道支架 |
US20140379007A1 (en) * | 2011-09-26 | 2014-12-25 | Bard Shannon Limited | Implantable hernia prosthesis with an uninterrupted ring |
CN202714884U (zh) * | 2012-02-23 | 2013-02-06 | 上海交通大学医学院附属第三人民医院 | 一种医用自锁式钛丝缝合线 |
US20130253645A1 (en) * | 2012-03-26 | 2013-09-26 | Marshall Kerr | Biocompatible Mesh Implant |
CN204274719U (zh) * | 2014-11-17 | 2015-04-22 | 贾忠 | 自张开补片 |
RU160627U1 (ru) * | 2015-04-14 | 2016-03-27 | Федеральное государственное бюджетное учреждение здравоохранения Центральная клиническая больница Российской академии наук (ЦКБ РАН) | Сетчатый материал для герниопластики на основе титановых нитей с антиадгезивным биологически активным покрытием |
Also Published As
Publication number | Publication date |
---|---|
BR112020015640A2 (pt) | 2021-01-05 |
CA3091614A1 (en) | 2019-08-08 |
EP3747398A1 (en) | 2020-12-09 |
EP3747398A4 (en) | 2021-08-11 |
US11950993B2 (en) | 2024-04-09 |
KR20200126379A (ko) | 2020-11-06 |
WO2019151885A1 (ru) | 2019-08-08 |
MX2020008067A (es) | 2020-12-11 |
CA3091614C (en) | 2022-12-13 |
BR112020015640A8 (pt) | 2023-04-11 |
US20210085832A1 (en) | 2021-03-25 |
KR102459873B1 (ko) | 2022-10-26 |
EP3747398B1 (en) | 2023-10-11 |
ES2961696T3 (es) | 2024-03-13 |
CN111867516B (zh) | 2023-12-29 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
JP5474970B2 (ja) | 閉塞性睡眠時無呼吸症を治療するための方法及び装置 | |
JP2007523672A (ja) | 伸張可能な組織支持部材および支持部材の形成方法 | |
RU121735U1 (ru) | Сетчатый имплантат для реконструктивной хирургии (варианты) | |
JP6932708B2 (ja) | 時間依存的生体組織足場 | |
CN111867516B (zh) | 用于内窥镜疝修补术的自膨胀网状内置假体 | |
RU2496431C1 (ru) | Способ хирургического лечения туберкулеза легких | |
RU2675316C2 (ru) | Способ изготовления облегченной четырехосной хирургической сетки | |
CN111867515B (zh) | 基于钛线和生物可吸收聚合物的自固定网状植入物 | |
CN112040995B (zh) | 外科整形软组织用无张力钛金属经编织物 | |
EP3250149A1 (en) | Resorbable and biocompatible graft in pga for implant following excision of the ipp plaque | |
RU166460U1 (ru) | Сетчатый имплант при пролапсах и при стресовом недержании мочи | |
RU195318U1 (ru) | Спейсер для саморасправляющегося сетчатого титанового эндопротеза для эндоскопической герниопластики | |
CN112040993B (zh) | 用于引导组织再生的基于无张力金属经编织物的钛基质 | |
EP3747473B1 (en) | Composite surgical suture material based on polyfilamentous titanium thread and bioresorbable polymers |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
PB01 | Publication | ||
PB01 | Publication | ||
SE01 | Entry into force of request for substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
TA01 | Transfer of patent application right |
Effective date of registration: 20220810 Address after: The application of German television Applicant after: Titanium Textiles Corporation Address before: Moscow, Russia Applicant before: Elastic titanium alloy implant Co.,Ltd. |
|
TA01 | Transfer of patent application right | ||
GR01 | Patent grant | ||
GR01 | Patent grant |