CN101444441B - Support type artificial venous blood vessel with valve - Google Patents
Support type artificial venous blood vessel with valve Download PDFInfo
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- CN101444441B CN101444441B CN2008102429919A CN200810242991A CN101444441B CN 101444441 B CN101444441 B CN 101444441B CN 2008102429919 A CN2008102429919 A CN 2008102429919A CN 200810242991 A CN200810242991 A CN 200810242991A CN 101444441 B CN101444441 B CN 101444441B
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- blood vessel
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Abstract
The invention relates to the technical field of medical appliances, in particular to a support type artificial venous blood vessel with valve for treating venous reflux diseases and venous return obstruction diseases. The artificial venous blood vessel comprises artificial valve (1) inside the artificial blood vessel, a metal support (2) attached to the outer wall of the artificial blood vessel to support the artificial blood vessel, a metal ring (3) attached to the metal support to support the valve and an artificial blood vessel (4) beyond the range of the support. The artificial venous blood vessel is produced according to the normal vessel valve structure of the human body, the vessel valve can be opened and closed freely, the supporting strength of the support is proper, and the supporting metal ring can maintain the normal state of the vessel valve. The artificial venous blood vessel has the advantages of reasonable structure, low fabrication cost and good histocompatibility, and can be used for valve repair operation for lower limb deep vein, valve repair operation for upper limb deep vein and main vein return obstruction disease of four limbs (especially occlusive diseases) After the vein of the pathologic section is resected, the support type artificial venous blood vessel with the valve is stitched on the normal vein, the operation is simple, and the operative wound is small.
Description
Technical field
The present invention relates to a kind of medical apparatus and instruments, especially a kind ofly can be used to thoroughly effect a radical cure the vein blood vessel disease medical artificial blood vessel of (comprising vein refluence disease and venous return obstacle disease), specifically a kind of band valve bracket type artificial venous blood vessel.
Background technology
As everyone knows, lower limb disease mainly is divided into two classes: veins of lower extremity adverse current disease, as the lower limb chronic venous insufficiency; Veins of lower extremity backflow obstacle disease is as losing syndrome behind the deep venous thrombosis of lower limbs based on obturation.The most common lower limb chronic venous insufficiency (chronic venousinsufficiency, CVI) be the clinical common disease that a class flows owing to the valvular function obstacle causes blood reflux, the caused venous system of lower extremity persistence high pressure of alluvial is a feature, China shows that investigation in 1993 its sickness rate is 8.8%.The lower extremity swelling and distension that is caused, pigmentation, dermatitis and prolonged serious symptoms such as skin ulcer of not healing affect patient's routine work and life thus.
The method of treatment veins of lower extremity valve disease roughly has 2 classes at present, and a class is a valve repair, promptly by direct or indirect method, repairs the valve of lax or incompetence, recovers the function of its unidirectional opening.Another kind of is that valve substitutes, and promptly uses from body, allogeneic, heterogenous allosome or non-biological material and replaces the veins of lower extremity valve that has lost function.
Though the method for valve repair has obtained curative effect preferably, but its operation indication is narrow, only be applicable to that the complete and valve of valve itself is lax or because the chap of vein caliber valvular insufficiency thes occur person, can not be used for that valve lacks as and the destructive patient of valve of deep venous thrombosis sequela.At present, mainly take operating mode to treat this type of disease clinically, operation is mostly handled at vein valve, corrects venous system of lower extremity persistence high pressure, to reach the purpose that promotes that blood refluxes.The surgical intervention of vein valve is wished to accomplish: 1. select suitable operation plan according to different anti-stream reasons and anti-flow process degree.2. make patient possess the physiological structure of meeting and hemodynamic valve again.3. prevention of postoperative thrombosis.4. keep secular curative effect.But still do not have a kind of surgical intervention method at present both at home and abroad and can possess above 4 points simultaneously.
The alternate method of valve is exactly that the valve of pathological changes is replaced with the valve of better function.The kind of the valve substitute in the research mainly contains at present: 1. all or part of of wall of vein formed a valve spline structure to the intracavity upset.2. utilize rustless steel, platinum etc., the manufacture of intraocular valve.3. design regular compressing venous device outside tube wall, simulation vein valve function.4. utilize tissue engineering technique to make up valve bracket, insert the venous endothelial cell of cultivation.These methods are all also at the experimental stage at present, and its short run effect is often satisfactory, but have problems such as long-term implantation back thrombosis, endotheliosis, implant wear out.
Utilize artificial valve treatment lower limb disease mostly by interventional therapy personnel invention and operation at present, as application number is 01126981.2, the patent of invention that name is called " leg type lower limb artificial vein valve " is a comparatively ideal at present treatment medical apparatus and instruments, and it is had the artificial vein of artificial valve and be attached to the artificial vein outer wall by inwall the passive metal rack of artificial vein is formed.But prove that through a large amount of clinical practices there is following limitation in it:
1, can not be applied to venous return disorder disease (especially occlusive disease).Because venous occlusion causes intervention can't pass through with seal wire, and can't finish intervene operation subsequently.
2, total vein of lower limb thigh and superficial femoral vein tube chamber are thinner, only about 10mm is with interior (" in femoral triangle; the about 3～4cm external diameter of femoral artery The initial segment is thicker; can reach 9.0mm; the femoral vein external diameter is slightly thicker than femoral artery ", referring to: Liu Zhengjin, Chen Eryu. clinical anatomy book series [M]. the 1st edition. Beijing: the People's Health Publisher, 1989.274-277.)." leg type lower limb artificial vein valve " is positioned at the pathological changes vein segment, and diameter must be less than pathological changes section diameter, and the moulding of the expansion of support and valve is restricted, and the function of valve also may be restricted.If be applied to the axillary vein of the more tiny upper limb of diameter or brachial veins then more difficult.
In sum: the lower limb chronic venous insufficiency is the sickness rate height not only, and has severe complications and sequela, has had a strong impact on broad masses of the people's quality of life, though the method for valve repair has obtained curative effect preferably, its operation indication is narrow; And the alternate method of valve is also at the experimental stage.Therefore there is not effective Therapeutic Method at present in the world.So, study a kind of new, effectively therapeutic device is treated this type of disease so that reach easily and fast the thoroughly purpose of radical cure, reducing postoperative complication and recurrence is the task of top priority of being engaged in venous disease treatment medical worker.
Summary of the invention
The objective of the invention is at big, few, the easy recurrence of indication of vein lesions treatment product limitation, the problem that operating difficulty is big, design a kind of simple in structure, the band valve bracket type artificial venous blood vessel that indication is wide, operation is simple, wound is little and complication is few.
Technical scheme of the present invention is:
A kind of band valve bracket type artificial venous blood vessel, comprise artificial blood vessel body 4 that matches with human vein and the artificial valve that matches 1 that is arranged in artificial blood vessel body 4, it is characterized in that suit is positioned with resistance to compression sheath 2 on the described artificial blood vessel body 4, the outside of the inboard of resistance to compression sheath 2 or the outside, artificial blood vessel body 4 is equipped with is convenient to the artificial valve location and the rapid reductive becket 3 in back that is squeezed, and the periphery of artificial valve 1 is made on the tube wall that is fixed on artificial blood vessel body 4 by the stitching thread that passes artificial blood vessel body 4 tube walls and link to each other with becket 3.
Described resistance to compression sheath 2 is Z-shaped, Z-shaped latticed, network shape or network of triangle trellis Nitinol metal rack, and described becket 3 is positioned at the place, centre position of resistance to compression sheath 2 axial lengths.
Described artificial valve 1 is two lobe valves.
Described resistance to compression sheath 2 is made on the outer surface that is positioned artificial blood vessel body 4 by the stitching thread that passes artificial blood vessel body 4 tube walls and resistance to compression sheath 2.
Beneficial effect of the present invention:
1, the present invention coincide with the support type artificial venous blood vessel and the normal vein segment of closing on of band valve by excision pathological changes vein segment, and operation is simple, and wound is little.
2, the present invention not only can be used for treating veins of lower extremity refluence disease, also can be used for extremity trunk venous return disorder disease (especially occlusive disease).Only need the excision of pathological changes section vein, blood vessel of the present invention gets final product in the stitching.
3, the present invention also can be used for the pathological changes that the axillary vein of the total vein of lower limb thigh and superficial femoral vein, upper limb or brachial veins etc. are located, employed blood vessel diameter can with want alternate vein segment same diameter, also can suitably increase the diameter of artificial blood vessel, be beneficial to the moulding and blood flow increasing of support expansion, valve.Therefore, the present invention not only helps the long-term stability performance of valvular function, also helps the unobstructed of blood flow.
4, the edge of valve of the present invention be sewn to be attached on the metal rack on the passive becket of valve, can keep for a long time vein valve normal morphology and the distortion after fast quick-recovery, help the performance of valvular function.
5, the present invention has eliminated the adverse effect (as restriction expand and bring out thrombosis etc.) of pathological changes section vein to artificial blood vessel of the present invention by excision pathological changes section vein.
6, the present invention compares with existing implanted artificial valve, has better indication and therapeutic effect, sees following table for details:
| Project | Prior art (leg type lower limb artificial vein valve, the patent No. 01126981.2) | Band valve bracket type artificial blood vessel (the application) |
| The treatment approach | Interventional method | Operation method |
| Design concept | Keep the pathological changes vein | Excision pathological changes vein |
| Than former pathological changes vein diameter | Little | Identical or can suitably increase |
| Can treat the venous return obstacle disease | Not | Energy |
| The non-deformability of valve | Stronger (outer support ring is arranged) | |
| Moulding of cusp margin gone and firm degree | Higher (outer support ring is arranged) | |
| Sutures | Medical thin silk thread (easily repel, easily form thrombosis, leakiness blood) | Double needle CV ePTFE suture (anti-thrombogenic capacity By force, fit tightly with the expanded PTFE blood vessel, do not leak blood) |
| Have ManuallyAngiectopia? | Have | Do not have |
7, the present invention is the summary and the raising of a large amount of surgical clinical practical experiences, it has found a kind of brand-new Therapeutic Method and apparatus for the disease of Deep Vein Valve Insufficiency of Lower Extremity and venous occlusive disease, adopt the vein segment of infringement of surgical excision valve or pathological changes, the two ends of support type artificial valve vein blood vessel are sewn between the normal vein, and the function of utilizing the support type artificial valve is with treatment Deep Vein Valve Insufficiency of Lower Extremity or vein segment obturation.
The present invention is used for the treatment of Deep Vein Valve Insufficiency of Lower Extremity or the vein segment obturation has better prospect, mainly based on the following aspects:
1. belt supporting frame support type: make artificial valve possess crush resistance, can recover original form rapidly after the extruding, thereby do not influence the functional of valve; The design of support jacket-type has kept the slickness of artificial vein inwall.
2. valve material adopts the ePTFE material, and it is strong that this material has anti-thrombogenic capacity, and self-lubricating property is fine, and coefficient of friction is very little, has characteristics such as better elastic and intensity, is the material of at present domestic and international surgery vascular field widespread usage.
3. artificial valve size of the present invention can be selected consistent with corresponding vein size, compare with artificial valve with intervention, thereby the constraint of avoiding being subjected to duct of Arantius has been avoided the risk of liner valve because of the change of pressurized form with the valve size decreases; And fully according to bionics principle, copy the normal vein valve structure of human body, make vein valve opening and closure freely.
4. two ends of the present invention can with the vein myometrial suture, convenient, practical, avoided the risk of displacement.
5. use double needle CV ePTFE suture, sew up ePTFE valve and ePTFE blood vessel, pin hole does not leak blood.
8, the present invention also has rational in infrastructurely, and cost is low, the advantage that histocompatibility is good.
Description of drawings
Fig. 1 is the structural representation of user mode of the present invention.
Fig. 2 is the sectional structure sketch map of Fig. 1.
The specific embodiment
The present invention is further illustrated below in conjunction with drawings and Examples.
As shown in Figure 1, 2.
A kind of band valve bracket type artificial venous blood vessel, comprise that artificial blood vessel body 4 (material can be ePTFE) that matches with human vein 5 and the artificial valve that matches 1 that is arranged in artificial blood vessel body 4 (can adopt two lobes or three valve structures, be the best wherein with two valve structures, material is ePTFE), as shown in Figure 2.Suit is positioned with resistance to compression sheath 2 on the described artificial blood vessel body 4, resistance to compression sheath 2 can be Z-shaped support, also can be a kind of in Z-shaped latticed, network shape of Weaving type or the network of triangle trellis Nitinol metal rack, it is sewed up with artificial blood vessel body 4 by stitching thread 6 and links to each other.In the inboard of resistance to compression sheath 2 or the outside of the outside, artificial blood vessel body 4 be equipped with and be convenient to the artificial valve location and the rapid reductive becket 3 in back that is squeezed (can adopt nickel titanium alloy, should have certain elasticity and rigidity), the periphery of artificial valve 1 is made on the tube wall that is fixed on artificial blood vessel body 4 by the stitching thread that passes artificial blood vessel body 4 tube walls and link to each other with becket 3, available double needle CV ePTFE suture, sew up ePTFE valve and ePTFE blood vessel, pin hole does not leak blood, as Fig. 1.
Details are as follows:
Artificial blood vessel body and valve material: artificial blood vessel body and valve material all adopt ePTFE (expanded PTFE) material, and the shape of the valve in the shape of artificial valve 1 and the human body self vein blood vessel is identical or believe.The eFTFE artificial blood vessel has been widely used in the surgery vascular field at present at home and abroad.The ePTFE material is the best a kind of macromolecular material of internationally recognized biological property and stable chemical performance, is widely used in the surgery vascular field in the world, gains unanimous acceptance already.The ePTFE material is widely used in cardiovascular surgery at present as patching material, artificial pericardium, artificial blood vessel and artificial cords etc., and has obtained good and clinical curative effect.
Resistance to compression sheath 2 can adopt very ripe in the market and or directly buy or the support type support of customization, its material mostly is NiTi (Nitinol) alloy material greatly, NiTi (Nitinol) alloy is a kind of superelastic alloy, also is a kind of marmem.This material has been widely used in the blood vessel intervention support at present, as large artery trunks overlay film frame, peripheral blood vessel support etc.
The suture of the artificial valve 1 identical with artificial blood vessel body 4 materials by identical material is in the artificial blood vessel body 4 of ePTFE, the becket 3 that is with NiTi (Nitinol) is outward done support, in the anti-extrusion performance that guarantees valve, can bring into play its unidirectional opening and closed function again.
According to the pressure that can bear of superficial femoral vein valve, artificial valve adopts two lobe type structural designs, and from design angle, two lobes can bear the pressure bigger than three lobes, is more suitable for using in the displacement of superficial femoral vein valve.
Artificial vein body 4 is wherein made with the expanded PTFE material that the two lobe artificial valves 1 that are attached to the artificial vein inwall all can be used the bright medical treatment of shellfish (Shanghai) International Trading Company Ltd.Resistance to compression sheath 2 can design voluntarily, also can adopt NiTi (Nitinol) alloy produced by Weichuang Medical Equipment (Shanghai) Co., Ltd. to form a circle after folding, form hollow cylinder and be enclosed within on the artificial blood vessel body 4 the reuse stitching thread earlier and make on the outer surface that is positioned at artificial blood vessel 4 by " Z " type.Resistance to compression sheath 2 is placed in the outer wall of artificial vein body 4, and its diameter and artificial vein body diameter are complementary, with double needle CVePTFE suture sutured.Go in ring stitching the preceding paragraph Nitinol silk in the outside of resistance to compression sheath segment mid point as being convenient to the artificial valve location and the rapid reductive becket 3 in back that is squeezed.Becket 3 also can be positioned at the inboard of resistance to compression sheath 2 during concrete enforcement, and its position should be positioned at the place, centre position of resistance to compression sheath 2 and corresponding with the joining edge of artificial valve 1.The ePTFE artificial valve is positioned at the artificial blood pipeline section, and its periphery is fixing on the support metal ring with double needle CV ePTFE suture, and stitching thread should pass the tube wall of artificial blood vessel body.
During concrete enforcement, band valve bracket type artificial blood vessel external diameter and length are decided according to corresponding vein external diameter of patient's vein valve diseased region and length, and external diameter is 5～10mm usually, and length is generally 30mm.
When using artificial blood vessel of the present invention to carry out treating correlative diseases, the excision pathological changes of should performing the operation earlier vein segment, the support rack type artificial blood vessel of reuse band valve of the present invention makes to coincide with the special-purpose stitching thread of blood vessel with contiguous normal vein segment and gets final product, flow through behind the artificial blood vessel of the present invention effect of artificial valve that can be therein of limbs venous blood flow recovers normal blood flow direction down, operation is simple, and wound is little.
The support rack type artificial blood vessel of band valve of the present invention is a new exploration from surgery treatment vein pathological changes, provides a brand-new thinking for treating this type of disease.Can give treatment to the case that large quantities of the pasts are difficult to effective treatment thus, have tangible academic significance and economic results in society.
The part that the present invention does not relate to prior art that maybe can adopt all same as the prior art is realized.
Claims (4)
1. be with valve bracket type artificial venous blood vessel for one kind, comprise artificial blood vessel body (4) that matches with human vein and the artificial valve that matches (1) that is arranged in artificial blood vessel body (4), it is characterized in that the last suit of described artificial blood vessel body (4) is positioned with resistance to compression sheath (2), the inboard or the outside of resistance to compression sheath (2), the outside of artificial blood vessel body (4) is equipped with is convenient to the artificial valve location and the back rapid reductive becket (3) that is squeezed, and the periphery of artificial valve (1) is made on the tube wall that is fixed on artificial blood vessel body (4) by the stitching thread that passes artificial blood vessel body (4) tube wall and link to each other with becket (3); Described resistance to compression sheath (2) is Z-shaped, Z-shaped latticed, network shape or network of triangle trellis metal rack, and described becket (3) is positioned at the place, centre position of resistance to compression sheath (2) axial length.
2. band valve bracket type artificial venous blood vessel according to claim 1 is characterized in that described artificial valve (1) is two lobe valves.
3. band valve bracket type artificial venous blood vessel according to claim 1 is characterized in that described resistance to compression sheath (2) makes on the outer surface that is positioned artificial blood vessel body (4) by the stitching thread that passes artificial blood vessel body (4) tube wall and resistance to compression sheath (2).
4. band valve bracket type artificial venous blood vessel according to claim 1 is characterized in that described artificial blood vessel body (4), artificial valve (1) and the employed material of stitching thread are expanded PTFE.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008102429919A CN101444441B (en) | 2008-12-31 | 2008-12-31 | Support type artificial venous blood vessel with valve |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008102429919A CN101444441B (en) | 2008-12-31 | 2008-12-31 | Support type artificial venous blood vessel with valve |
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| Publication Number | Publication Date |
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| CN101444441A CN101444441A (en) | 2009-06-03 |
| CN101444441B true CN101444441B (en) | 2011-06-29 |
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| CN2008102429919A Expired - Fee Related CN101444441B (en) | 2008-12-31 | 2008-12-31 | Support type artificial venous blood vessel with valve |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102670332B (en) * | 2012-05-24 | 2016-08-03 | 沛嘉医疗科技（上海）有限公司 | A kind of novel artificial heart valve |
| CN103598902B (en) * | 2013-11-14 | 2017-01-25 | 先健科技(深圳)有限公司 | Left aurcle plugging device |
| CN106236337B (en) * | 2016-08-31 | 2019-02-05 | 刘卫辉 | A kind of unidirectional valve formula stent drainage system |
| CN107411844B (en) * | 2016-09-14 | 2020-06-30 | 四川蓝光英诺生物科技股份有限公司 | Lumen tissue construct, and preparation method and preparation device thereof |
| CN107744413A (en) * | 2017-09-22 | 2018-03-02 | 南京市儿童医院 | The preparation method of new Valved allograft |
| CN109893294B (en) * | 2019-03-20 | 2021-06-22 | 武汉杨森生物技术有限公司 | Artificial blood vessel valved pipeline and manufacturing method thereof |
| CN109907860A (en) * | 2019-04-15 | 2019-06-21 | 黄欣 | Artificial Valved allograft |
| CN110522534A (en) * | 2019-09-21 | 2019-12-03 | 中山大学附属第一医院 | A kind of artificial blood vessel's pipeline and sewing method with skirt |
| CN115462934B (en) * | 2022-10-08 | 2023-07-14 | 浙江归创医疗科技有限公司 | Detachable venous valve |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5891195A (en) * | 1996-05-24 | 1999-04-06 | Sulzer Carbomedics Inc. | Combined prosthetic aortic heart valve and vascular graft with sealed sewing ring |
| CN1197531C (en) * | 2001-10-09 | 2005-04-20 | 中国人民解放军第二军医大学 | Leg type lower limb artificial vein valve |
| CN2817766Y (en) * | 2005-03-02 | 2006-09-20 | 郭伟 | Separated standing blood vessel for prosthesis of aorta ascendens and aortic arches cavity |
| CN201328893Y (en) * | 2008-12-31 | 2009-10-21 | 南京医科大学第一附属医院 | Bracket type artificial venous blood vessel with valve |
-
2008
- 2008-12-31 CN CN2008102429919A patent/CN101444441B/en not_active Expired - Fee Related
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5891195A (en) * | 1996-05-24 | 1999-04-06 | Sulzer Carbomedics Inc. | Combined prosthetic aortic heart valve and vascular graft with sealed sewing ring |
| CN1197531C (en) * | 2001-10-09 | 2005-04-20 | 中国人民解放军第二军医大学 | Leg type lower limb artificial vein valve |
| CN2817766Y (en) * | 2005-03-02 | 2006-09-20 | 郭伟 | Separated standing blood vessel for prosthesis of aorta ascendens and aortic arches cavity |
| CN201328893Y (en) * | 2008-12-31 | 2009-10-21 | 南京医科大学第一附属医院 | Bracket type artificial venous blood vessel with valve |
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