CN1217628C - Tectorial membrane rack for aorta without inner leakage - Google Patents
Tectorial membrane rack for aorta without inner leakage Download PDFInfo
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- CN1217628C CN1217628C CN 02138385 CN02138385A CN1217628C CN 1217628 C CN1217628 C CN 1217628C CN 02138385 CN02138385 CN 02138385 CN 02138385 A CN02138385 A CN 02138385A CN 1217628 C CN1217628 C CN 1217628C
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Abstract
The present invention relates to a tectorial membrane rack for the aorta without inner leakage, which is mainly composed of a pipeline network-shaped rack matched with the blood vessels of the aorta and a tectorial membrane layer coated on the surface of the blood vessel rack. The present invention is characterized in that high-water-absorption polymer materials with biocompatibility or prepolymer materials are wrapped or sewn on the end of the tectorial membrane to form a sealing ring similar to a collar or a tyre and gaps between the blood vessels and the ends of the rack are filled in a water-absorption expansion way. In order to decelerate the water-absorption expansion of the water-absorption materials, a biodegradable coating membrane or a micropore coating membrane is coated outside the high-water-absorption materials in the scheme, wherein the water-absorption materials contain acrylic acid, acrylic ester, acrylamide, polyvinyl alcohol, cellulose, etc. Pointing to the mechanism of I type inner leakage, the present invention positively solves problems from roots, and therefore, the present invention has the advantages of obvious effect, no injury and side effect on the human blood vessels, high isolation operation success ratio in the aortic aneurysm cavity, high operation safety and good therapeutic effect, and is an ideal blocking way.
Description
Technical field
The invention belongs to a kind of medical apparatus and instruments, be specifically related to a kind of overlay film frame of human aortic tumor.This aorta overlay film frame can effectively prevent the internal hemorrhage due to trauma at support two ends.
Background technology
Aortic aneurysm is modal aneurysm, and 90% aortic aneurysm is due to the atherosclerosis, and frequently-occurring disease is after 40 years old, and M-F is 10: 1, sickness rate about 5%.The final final result of aortic aneurysm is to break, and as for antetheca breaks, its mortality rate is up to 90%.Aortic aneurysm is common clinically and comparatively dangerous a kind of angiopathy.According to relevant medical journal, the aortic aneurysm patient, if untimely treatment, its 5 years survival rates only are about 17%, and wherein 63% patient dies from aortic aneurysm and breaks.Therefore, to suffering from the patient of aortic aneurysm,, should in time treat once discovery.Traditional Therapeutic Method is that the excision aneurysm is rebuild the ventral aorta blood vessel simultaneously, though it is effective, but operation wound is big, particularly for the patient at advanced age who merges important organ illness such as the heart, brain, lung, kidney, its average of operation periods mortality rate surpasses 20%, in many sick and the gerontal patient that deposits, operative mortality is higher, reaches more than 60%.
Along with the continuous development of modern medicine technology, interventional therapy just constantly is applied in the various difficult miscellaneous diseases as a kind of emerging treatment means, and wherein modal is aortic aneurysm endovascular graft exclusion.This operation is after at first being applied to the abdominal aortic aneurysm treatment in 1991 and succeeing by Parodi doctor, abdominal aortic aneurysm endovascular graft (Endovascular Exclusion of Abdominal AorticAneurysm) has become the optimum selection of treatment aortic aneurysm.Compare with traditional operation, endovascular graft has characteristics such as the operation wound degree is little, and blood loss is little, and the hospital stays is short, after it has reduced traditional aneurysmectomy, and the incidence rate of important organ complication such as the common heart, brain, lung, kidney.The ultimate principle of aortic aneurysm endovascular graft exclusion is: under the DSA dynamic monitoring, with one section suitable artificial blood vessel inner support in femoral artery imports aorta, artificial blood vessel is fixed on the normal tremulous pulse inwall with inner support at the nearly far-end of aortic aneurysm, in lumen of vessels that aortic aneurysm wall and blood flow is isolated, reach the elimination aneurysm wall and bear the blood flow impact and keep the unobstructed purpose of aortic flow.Though aortic aneurysm endovascular graft exclusion have traditional operation incomparable advantage, remain at present at some flaws, as internal hemorrhage due to trauma (Endoleak), displacement (Migration) etc., therefore how overcoming these deficiencies is problems that those skilled in the art pay close attention to.
Internal hemorrhage due to trauma is the modal problem of intracavitary therapy aortic aneurysm.1996, the comparatively strict definition of having leaked down in White gives: relevant with the endoluminal vascular graft, outside the graft chamber and in the phenomenon that the persistence blood flow appears in the aneurysm cavity of being treated by this graft and adjacent blood vessel intracavity, be called internal hemorrhage due to trauma.Concrete form according to internal hemorrhage due to trauma can be divided into four types: first kind is support two ends internal hemorrhage due to trauma (Attachment leak) (representing with I among the figure); Second kind is branch's internal hemorrhage due to trauma (Branch Flow) (representing with II among the figure); The third is support defective or stake body division internal hemorrhage due to trauma (Defect in graft or Modular disconnection) (representing with III among the figure); The 4th kind is the excessive internal hemorrhage due to trauma of stake body material hole (Fabic porosity) (representing with IV among the figure), referring to shown in Figure 1.
In above-mentioned four kinds of internal hemorrhage due to trauma, III, IV type internal hemorrhage due to trauma are main relevant with timbering material, often by reasonably selecting material just can solve the generation of this two classes internal hemorrhage due to trauma preferably.The cause more complicated of I, II type internal hemorrhage due to trauma, adherent property is bad but its basic reason is support and blood vessel, thereby causes producing on end position between support and the blood vessel slit or space.The incidence rate of these two kinds of internal hemorrhage due to trauma accounts for more than 90% of internal hemorrhage due to trauma sum.Lasting internal hemorrhage due to trauma can cause hemangioma to increase, the blood vessel wall attenuate, so that break, finally cause patient death.According to the related data statistics, in the operation of aortic aneurysm inner cavity insulation, the internal hemorrhage due to trauma incidence rate accounts for 24~42% of sum.Therefore, how to improve that to resolve the internal hemorrhage due to trauma problem extremely urgent.
For I type internal hemorrhage due to trauma, the main in the world at present repairing method that adopts has following several:
1, adjusts the position that support discharges,, itself and blood vessel wall are pasted such as suitable runing rest;
2, carry out balloon expandable, promptly use sacculus that the aortic stents two ends are expanded once more, make it press close to blood vessel wall more;
3, additional bare bracket is overlapping, promptly places a small rack again at the aortic stents port, allows it support the aortic stents two ends, makes it press close to blood vessel wall;
4, secondary is repaired or balloon expandable, leaks even once more, just with the sacculus expandable stent second time;
5, surgical operation.
Though said method has reduced the incidence rate of internal hemorrhage due to trauma to a certain extent, these measures are from being passive in nature, and at the mechanism of internal hemorrhage due to trauma, aggressive tackling the problem at its root not this shows that their effect is not very good yet.Such as adopting sacculus to expand, be artificial external force expansion, once after removing external force, support can produce resilience, so its effective time is very short, after a period of time, have the internal hemorrhage due to trauma phenomenon again and take place.
The purpose of this invention is to provide a kind of aorta overlay film frame that can effectively prevent I type internal hemorrhage due to trauma.
Summary of the invention
For achieving the above object, the technical solution used in the present invention is: a kind of aorta overlay film frame that prevents internal hemorrhage due to trauma, mainly constitute with aortic blood tube shape grid shape stent that matches and the overlay film layer that is coated on the intravascular stent surface by one, a kind of high water absorbency polymer or prepolymer material with biocompatibility wrapped up or made at the overlay film port, form a kind of sealing ring, fill the gap of blood vessel and support port in the imbibition mode.
The related content and the change interpretation of technique scheme are as follows:
1, in the such scheme, described " grid shape stent that matches with the aortic blood tube shape " its implication is that the structure and the face shaping of support is consistent with the aortic blood tube shape of human body rest, therefore support may be a straight barrel type, also may be fork type structure, specifically can be referring to shown in the accompanying drawing.Sealing ring can be located at an end of overlay film when support is the straight barrel type structure, also can be located at the two ends of overlay film respectively; Sealing ring can only be located at total port when support is fork type structure, also can be located at total port and fork port respectively
2, in the such scheme, the form of described sealing ring mainly comprises two kinds:
(1), sealing ring is annular pouch, in the bag powder or graininess high water absorbency polymer or prepolymer material is housed, annular pouch adopts parcel or the mode of making to be placed in support overlay film port, forms a kind of sealing ring that is similar to collar or tire-like.
(2), sealing ring is fabric strip, fabric strip is made by high water absorbency polymer or prepolymer material, fabric strip adopts parcel or the mode of making to be placed in support overlay film port, forms a kind of sealing ring that is similar to collar or tire-like.
Described " wrap up or make " is two kinds of different fixing modes, and wherein parcel is meant and adopts a kind of thin material to be fixed on support overlay film port by canoe; Make and be meant that adopting suture will be made part is fixed on support overlay film port.
3, in the such scheme, described high water absorbency polymer or prepolymer material have a variety of, specifically can be divided into following type, and therefrom select a kind of the use:
(1), acrylic acid, propylene fat and acrylic amide
Specifically comprise: the copolymerization of polyacrylic acid, starch-propylene fat is saponified, hydrolyzed copolymer, methacrylate, cross-linked polyacrylamide and the hydrolysate thereof of saponified copolymer, propylene fat or the acrylamide of the copolymer of starch-acrylic, vinyl acetate resin-acrylate.
(2), polyvinyl alcohol
Specifically comprise: polyvinyl alcohol, polyvinyl alcohol and copolymer-maleic anhydride.
(3), cellulose family
Specifically comprise: the cross linked polymer of methylcellulose, carboxymethyl cellulose, hydroxyethyl-cellulose, hydroxypropyl emthylcellulose.
(4), other class
Specifically comprise: saponified, the isobutene. of the crosslinked body of acetate ethylene copolymer and the crosslinked body of horse rice acid anhydride copolymer, the plain derivant of crospolyvinylpyrrolidone, cyclodextrin, gelfoam.
4, in the such scheme,, operation is normally carried out, a kind of biodegradable film or a kind of micropore is filmed of coating high water absorbency polymer or prepolymer outside in order to slow down the imbibition speed of high absorbency material.
Described biodegradable polymeric comprises: PLA (Polylactic acid-PLA), aliphatic polyester (aliphatic polyesters), polyamino acid poly (amino acids), copolymerization (ether-ester) copoly (ether-esters), polyolefin oxalates (polyalkylenes oxalates), polyamide (polyamides), poly-iminocarbonic acid salt poly (iminocarbonates), positive polyester (polyorthoesters), polyether ester (polyoxaesters), polyesteramide (polyamidoesters), the polyether ester (polyoxaesters containing amido groups) that band is amino, polyanhydride poly (anhydrides), poly phosphate (polyphosphazenes) etc.
The polymeric material of described micropore comprises: PLA (Polylactic acid-PLA), aliphatic polyester (aliphatic polyesters), polyamino acid poly (amino acids), copolymerization (ether-ester) copoly (ether-esters), polyolefin oxalates (polyalkylenes oxalates), polyamide (polyamides), poly-iminocarbonic acid salt poly (iminocarbonates), positive polyester (polyorthoesters), polyether ester (polyoxaesters), polyesteramide (polyamidoesters), the polyether ester (polyoxaesters containing amido groups) that band is amino, polyanhydride poly (anhydrides), poly phosphate (polyphosphazenes), polyurethane (Polyurethanes-PU), silicones (silicones), polymethacrylates (poly (meth) acrylates), polyesters (polyester), polyalkyl oxides (polyethylene oxide) poly(ethylene oxide), polyvinyl alcohol (polyvinylalcohols), polyethylene glycols (Polyethylene Glycol) and polyvinyl pyrrolidone (polyvinylpyrrolidone), glutin (gelatin), polysiloxanes (Polysiloxane) etc.
The main design principle of the present invention is: with a kind of biocompatibility high water absorbency polymer or prepolymer material parcel or make in the port of support overlay film preferably, thereby form a kind of ring structure that is similar to collar or tire-like at the support two ends.After overlay film frame discharged, in the regular hour, the slit between support two ends and the blood vessel was filled in this polymer imbibition, has realized closely pasting of support two ends and blood vessel, has stopped I type internal hemorrhage due to trauma phenomenon and has taken place.
In order to slow down the imbibition speed of water absorbing material, this programme coats a kind of biodegradable film or a kind of micropore is filmed outside high water absorbency polymer or prepolymer, its objective is in order to control the speed of expansion of high absorbency material, make it not influence operation technique.Biodegradable filming is can be by the degradable polymer of blood hydrolysis, its degradation time is between 2Hr to 24Hr (in 37 ℃ of water), after this coating film hydrolysis, above-mentioned water absorbing material begins imbibition (swelling reaction) and the space between support two ends and the blood vessel wall is clogged.
Because the technique scheme utilization, the present invention compared with prior art has following advantage:
1, the present invention improves existing aorta overlay film frame from the angle that prevents I type internal hemorrhage due to trauma, and its measure of taking actively deal with problems from root, so effect is remarkable at the mechanism of I type internal hemorrhage due to trauma.This is compared with the prior art has essential distinction.
2, the present invention adopt biocompatibility preferably high water absorbency polymer as encapsulant, after the imbibition automatically, the slit between filling bracket two ends and the blood vessel slowly, to human vas both not damaged, have no side effect again, be a kind of comparatively ideal leak stopping mode.
3, the present invention is contained in powder or particle-shape water-absorbing material and makes then in the annular pouch in the overlay film port, perhaps the fabric strip of directly water absorbing material being made coats or makes the port at the support overlay film, this mode is not only easy but also flexible, its design is very ingenious, demonstrates fully to send out the innovation part of the present invention.
4, the present invention is in order to slow down the water absorbing material speed of expansion, coats biodegradable film or a kind of micropore is filmed in that water absorbing material is outer.This mode and water absorbing material combination back are obvious to control imbibition speed effect, and when especially the water absorbing material speed of expansion was very fast, such combination was very necessary.
In a word, the present invention has improved the success rate of aortic aneurysm endovascular graft exclusion from having reduced the incidence rate of I type internal hemorrhage due to trauma largely, also further improves the safety and the therapeutic effect of such operation.
Description of drawings
Accompanying drawing 1 is the concrete form sketch map of aorta overlay film frame internal hemorrhage due to trauma;
Accompanying drawing 2 is the aorta overlay film frame figure of the present invention at two ends coating water-absorbent material;
Accompanying drawing 3 is the partial enlarged drawing of Fig. 2;
Accompanying drawing 4~Fig. 5 is the anti-internal hemorrhage due to trauma aorta overlay film frame figure of the exposed type of an end;
Accompanying drawing 6~Fig. 9 is the anti-internal hemorrhage due to trauma aorta overlay film frame figure of the exposed type in two ends;
Accompanying drawing 10~Figure 13 is the anti-internal hemorrhage due to trauma aorta overlay film frame figure of first kind fork type;
Accompanying drawing 14~Figure 17 is the anti-internal hemorrhage due to trauma aorta overlay film frame figure of the second class fork type;
Accompanying drawing 18~Figure 21 is the anti-internal hemorrhage due to trauma aorta overlay film frame figure of the 3rd class fork type.
In the above accompanying drawing: 1, support; 2, overlay film; 3, sealing ring; 4, inner membrance; 5, double-layer outer membrane.
The specific embodiment
Below in conjunction with drawings and Examples the present invention is further described:
Embodiment one: referring to accompanying drawing 2 and shown in Figure 3, a kind of aorta overlay film frame that prevents internal hemorrhage due to trauma is made of a straight barrel type pipe network support 1 and the overlay film 2 that is coated on rack surface.In order to prevent internal hemorrhage due to trauma, with a kind of characteristic with high water absorbency polymer material of biocompatibility by its suction, get in the middle of the interlayer of double-layer outer membrane 5 that appropriate amount places support 1 two-end part, form a kind of sealing ring in the parcel mode, after this water absorbing material begins imbibition, the space between support two ends and the blood vessel wall is clogged.Described high absorbency material can be selected in the above range, such as polyacrylic acid, and polyvinyl alcohol etc.
Embodiment two: referring to accompanying drawing 4 and shown in Figure 5, a kind of aorta overlay film frame that prevents internal hemorrhage due to trauma is made of a straight barrel type pipe network support 1 and the overlay film 2 that is coated on rack surface.In order to prevent internal hemorrhage due to trauma, a kind of high water absorbency polymer material with biocompatibility is made port at overlay film 2 one ends, form a kind of sealing ring 3 that is similar to collar or tire-like, fill the gap of blood vessel and support port in the imbibition mode.Described sealing ring 3 is annular pouch, in the bag powder or graininess high water absorbency polymer material is housed, and annular pouch adopts the mode of making to be placed in support overlay film port.Sealing ring 3 among Fig. 4 is located at support upper end overlay film port and upwards erects similar collar shape.Sealing ring 3 is located at support upper end overlay film port and turns over similar tire-like downwards among Fig. 5.
Embodiment three: referring to accompanying drawing 6~shown in Figure 9, a kind of aorta overlay film frame that prevents internal hemorrhage due to trauma, be made of a straight barrel type pipe network support 1 and the overlay film 2 that is coated on rack surface.In order to prevent internal hemorrhage due to trauma, a kind of high water absorbency polymer material with biocompatibility is made port at overlay film 2 one ends, form a kind of sealing ring 3 that is similar to collar or tire-like, fill the gap of blood vessel and support port in the imbibition mode.Described sealing ring 3 is a fabric strip, and fabric strip is directly made by cellulose family high water absorbency polymer material, and fabric strip adopts the mode of making to be placed in support overlay film port.The sealing ring 3 of Fig. 6 in being is located at support upper end overlay film port and upwards erects similar collar shape.Sealing ring 3 is located at support upper end overlay film port and turns over similar tire-like downwards among Fig. 7.Sealing ring 3 is in the port setting at overlay film 2 two ends among Fig. 8, and is the collar shape.Sealing ring 3 is in the port setting at overlay film 2 two ends among Fig. 9, and wherein Shang Duan sealing ring 3 is a tire-like, and the sealing ring 3 of lower end is the collar shape.
Embodiment four: referring to accompanying drawing 10~shown in Figure 21, a kind of aorta overlay film frame that prevents internal hemorrhage due to trauma, be made of a fork type pipe network support 1 and the overlay film 2 that is coated on rack surface.Its anti-internal hemorrhage due to trauma structure and material can adopt the scheme of embodiment two or embodiment three.
The fork support that Figure 10~Figure 13 represents is long for left side trouble, and right trouble is short, and wherein sealing ring 3 is located at total port, top among Figure 10, and is the collar shape.Sealing ring 3 is located at total port, top among Figure 11, and is tire-like.Sealing ring 3 is located at two forks of total port in top and bottom port respectively among Figure 12, and is the collar shape.Sealing ring 3 is located at two forks of total port in top and bottom port respectively among Figure 13, and wherein total port is a tire-like, and the fork port is the collar shape.
The fork support that Figure 14~Figure 17 represents is short for left side trouble, You Chachang, and other is the same.
The fork support that Figure 18~Figure 21 represents is that Zuo Cha is identical with right trouble length, and other is the same.
Claims (9)
1, a kind of aorta overlay film frame that prevents internal hemorrhage due to trauma, mainly constitute with aortic blood tube shape grid shape stent that matches and the overlay film layer that is coated on the intravascular stent surface by one, it is characterized in that: a kind of high water absorbency polymer or prepolymer material with biocompatibility wrapped up or made at the overlay film port, form a kind of sealing ring, fill the gap of blood vessel and support port in the imbibition mode.
2, aorta overlay film frame according to claim 1, it is characterized in that: described sealing ring is annular pouch, in the bag powder or graininess high water absorbency polymer or prepolymer material are housed, the annular pouch adopts parcel or the mode of making to be placed in support overlay film port, forms a kind of sealing ring that is similar to collar or tire-like.
3, aorta overlay film frame according to claim 1, it is characterized in that: described sealing ring is a fabric strip, fabric strip is made by high water absorbency polymer or prepolymer material, fabric strip adopts parcel or the mode of making to be placed in support overlay film port, forms a kind of sealing ring that is similar to collar or tire-like.
4, aorta overlay film frame according to claim 1, it is characterized in that: described high water absorbency polymer or prepolymer material are selected one of following material: the copolymerization of polyacrylic acid, starch-propylene fat is saponified, hydrolyzed copolymer, methacrylate, cross-linked polyacrylamide and the hydrolysate thereof of saponified copolymer, propylene fat or the acrylamide of the copolymer of starch-acrylic, vinyl acetate resin-acrylate.
5, aorta overlay film frame according to claim 1, it is characterized in that: described high water absorbency polymer or prepolymer material are selected one of following material: polyvinyl alcohol, polyvinyl alcohol and copolymer-maleic anhydride.
6, aorta overlay film frame according to claim 1, it is characterized in that: described high water absorbency polymer or prepolymer material are selected one of following material: the cross linked polymer of methylcellulose, carboxymethyl cellulose, hydroxyethyl-cellulose, hydroxypropyl emthylcellulose.
7, aorta overlay film frame according to claim 1, it is characterized in that: described high water absorbency polymer or prepolymer material are selected one of following material: saponified, the isobutene. of the crosslinked body of acetate ethylene copolymer and the crosslinked body of horse rice acid anhydride copolymer, the plain derivant of crospolyvinylpyrrolidone, cyclodextrin, gelfoam.
8, aorta overlay film frame according to claim 1, it is characterized in that: outside described high water absorbency polymer or prepolymer, coat a kind of biodegradable film or a kind of micropore is filmed, to slow down high water absorbency polymer or prepolymer imbibition speed.
9, aorta overlay film frame according to claim 8, it is characterized in that: described biodegradable polymeric is selected one of following material: PLA, aliphatic polyester, polyamino acid, copolymerization ether-ester, polyolefin oxalates, polyamide, poly-iminocarbonic acid salt, positive polyester, polyether ester, polyesteramide, the polyether ester of band amino, polyanhydride, poly phosphate; The polymeric material of described micropore is selected one of following material: PLA, aliphatic polyester, polyamino acid, copolymerization ether-ester, polyolefin oxalates, polyamide, poly-iminocarbonic acid salt, positive polyester, polyether ester, polyesteramide, polyether ester, polyanhydride, poly phosphate, polyurethane, silicones, polymethacrylates, polyester, poly(ethylene oxide), polyvinyl alcohol, Polyethylene Glycol and the polyvinylpyrrolidone of band amino, glutin, polysiloxanes.
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CN 02138385 CN1217628C (en) | 2002-09-28 | 2002-09-28 | Tectorial membrane rack for aorta without inner leakage |
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CN 02138385 CN1217628C (en) | 2002-09-28 | 2002-09-28 | Tectorial membrane rack for aorta without inner leakage |
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Families Citing this family (22)
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