CN1468080A - Distally narrowed vascular grafts - Google Patents

Abstract

Graft (10) has a first end (20) adapted for insertion into a blood receiving vessel site and a second end (30) adapted for attachment to an artery site. Graft (10) is preferably made of a material having a generally uniform thickness, and graft (10) defines a lumen (11) having the same shape as the external surface of the graft (10). In graft (10), distal end (20) defines oriface (21) and proximal end (30) defines oriface (31). The portion of the lumen (11) defined by section (23), also referred to as a ''stepped'' or a ''taper'' section, has a generally gradually decreasing diameter from a longitudinal point adjacent section (40).

Description

The blood vessel graft that far-end narrows down

The cross-reference of related application

The application requires to enjoy the excellent power of following application: the U.S. Provisional Application N0.60/224 that is entitled as " arteriovenous graft and implantation method thereof " that on August 10th, 2000 filed an application, 392; The U. S. application No.09/704 that is entitled as " arteriovenous graft and implantation method thereof " that on November 1st, 2000 filed an application, 083; The U.S. Provisional Application No.60/297 that file an application June 8 calendar year 2001 is entitled as " being used for blood vessel graft and using method thereof that far-end that tremulous pulse is connected tremulous pulse vein and tremulous pulse narrows down ", 088 and the U.S. Provisional Application No.60/297 that is entitled as " arteriovenous graft and relevant apparatus and using method thereof " that files an application June 8 calendar year 2001,226, above-mentioned application all is incorporated herein by reference.

Background of invention

The present invention relates to blood vessel graft and implantation method thereof.The present invention relates to blood vessel graft with diminishing far-end in every respect, have one be convenient to graft be fixed on the cover on the target blood blood vessel graft, be used for electrical connector and the method relevant that the end connects the end graft with them.In each embodiment of the present invention, this blood vessel graft can be used for carrying out tremulous pulse vein connection (being called arteriovenous graft herein) or tremulous pulse is connected tremulous pulse.

Carry out the background of tremulous pulse as being used to, it is reported that annual nearly 40,000 new patients begin hemodialysis the blood vessel graft of vein connection.This number rises with about 10% speed continuation every year.Once report that also the doctor and the hospital expenses that increased and kept hemodialysis access in 1998 newly are about 800,000,000 dollars.Term " inlet " indicates in patient's blood circulation special in to the dialysis machine blood supply with accept the position at the position of the blood that returns from dialysis machine.If patient's conditions permit, preferred entry mode is graft or fistula, the both is the subcutaneous device that is communicated with patient's blood circulation fluid, wherein can repeatedly insert syringe needle, so that blood imported dialysis machine during dialysis treatment or return from dialysis machine.

The common cause that hospital accepts dialysis patient is the problem relevant with inlet, and the setback that expense and inlet lost efficacy expection will continue to rise, up to seeing clearly Chu and setting up the solution of current inlet problem.Even in view of this huge demand, the major progress of hemodialysis access does not appear in nearest 30 years yet.Hakim and Himmelfarb are entitled as in the paper of " hemodialysis access lost efficacy: call action " conclusion at it and say, " enter the mouth as for [hemodialysis]; we can not continue to do same thing (considerably less really), same method again ..., and wish that [end-stage renal disease] patient's life will reduce expense better or the inlet treatment." (hakimR, HimmelfarbJ. " hemodialysis access lost efficacy: call action ", " international kidney magazine ",, 54 volumes, 1029-1040 page or leaf in 1998.If) inlet take up rate and can double, will save multi-billion dollar every year so, and can then the sensing nephropathy transplanting project or treatment.In addition, dialysis patient, particularly end-stage renal disease (" ESRD ") patient can enjoy health that production capacity is more arranged and happy life.

For the first time arteriovenous fistula (AVF) is that preferred effect one price of hemodialysis patient is than best long-term inlet.AVF is the artificial directly connection between tremulous pulse and vein.High blood flow by this connection makes vein become wall much bigger and that qualification is thicker, more as a radicular arteries.Therefore AVF provides one to be used for the blood circulation inlet to carry out the high blood flow position of hemodialysis.For each dialysis, two big vent needles (being generally 14-16 number) insert AVF by dialysis patient skin, and one in " tremulous pulse " end, and another root is in " vein " end.In the time of in needle point is inserted in inlet suitably, the blood post enters the pipe end that is attached on the every pin.Before the beginning dialysis treatment, remove pipe cap from each needle tubing, make blood be full of needle tubing thus, then by each needle tubing and saline syringe of pin injection.With sebific duct two pins are connected in the inflow (tremulous pulse) and outflow (vein) pipeline of dialysis machine then, thereby begin dialysis.

Unfortunately, even carry out careful physical examination and/or use doppler ultrasound or venography to discern suitable vein, be reported that also the patient of about 40-50% is not enough to produce the vascular anatomy feature of AVF for the first time.In addition, many dialysis of using AVF to fail previously have experience person also no longer can consider to adopt fistula for the first time.

Selecting as the next one of long-term inlet is to settle an arteriovenous graft (" AVG ").An AVG is the plastic tube of certain-length, uses porous politef (" PTFE ") to make usually, is placed under the skin with surgical operation, and fluid is communicated with a radicular arteries and a radicular vein.In case settled a graft, just can be by inserting a needle into this graft and this pin being connected on the dialysis machine (as above in the face of AVF general description) and the dialysis machine fluid being connected on patient's the blood circulation with pipe.But when an AVG was discussed, term " long-term inlet " was a misnomer, because taking up rate of report is very low, usually reports 1 year and takes up rate and have only 40%.Even adopt graft supervision and sufficient preventive measure to prevent that tampon limits, take up rate also still very low with the second time for the first time; And the extra charge of causing is also too high unreasonably.

Though many factors work to the finite lifetime of PTFE graft, the dead enemy be have that venous anastomosis narrows down and subsequently graft limit thrombosis neointimal hyperplasia (NIH) carry out sexual development.The graft of qualification thrombosis can be with surgical operation or is percutaneously removed clot, and fixedly film shaping hands is continuous perhaps can to utilize meticulous arthrectomy device, angioplasty or Si Tante; But NIH still in advance insight take place again.Also can finish the repairing that has near the transplanting that coincide, but find that this repairing also is highly susceptible to failure.Therefore press for and improve taking up rate of AVG, with the reduction expense with improve patient's quality of the life.

Neointimal hyperplasia is considered to owing to many factors produce, and for example comprises the turbulent flow at the damage that has the endothelium that growth factor discharges, anastomotic position place, to the cause of disease of vibration force, shearing force, uremia or other hypothesis of coincideing.Multinomial studies show that, NIH is development as one man lastingly and all the time at the venous anastomosis position.

The doctor has used diminishing and graft taper, and this graft has the diameter that increases gradually along its part or along its whole length from the arterial end to the vein end, and its terminal point at vein end has a hole at a point with graft maximum gauge.Fig. 1 illustrates the example of the taper graft of a diameter with continuous increase, and wherein the diameter in the chamber of vein end 1 is greater than the diameter of arterial end 2.

Among the medical professional the general conviction of wide-scale distribution be that the development of NIH can prevent by the size of further increase venous anastomosis or delay.In a kind of test that prolongs the AVG operating period, used to have " graft of the prominent hat of band " that coincide than large vein.Fig. 2 illustrates a kind of representative example (Venaflo, Impra company) of the prominent graft of being preced with of band of prior art, and wherein vein end 3 has one " prominent hat " configuration.But the report use is not a kind of like this has the graft of prominent hat can produce significant the improvement.In fact find that in some cases, the Venaflo graft than the diminishing graft of standard obturation takes place earlier.Secondly, have been found that make graft up with thrombectomy surgery or nonsurgical test difficulty finish, thereby take up rate the second time that causes lacking.

When a graft be used for by fluid connect two radicular arterieses and from a radicular arteries to another radicular arteries shunting blood or when coming bypass one radicular arteries a part of by two diverse locations that a graft fluid are connected in an independent radicular arteries, may produce same difficulty.For example, when the part of a radicular arteries is stopped up or is damaged, perhaps when because other blood flow infringement or other are former thereby need or when wishing to make blood flow bypass one radicular arteries a part of, may use a kind of like this graft.But the arrangement that is appreciated that the artery bypass grafting thing usually causes the infringement of natural blood flow in the tremulous pulse, therefore also follows neointimal hyperplasia (NIH), far-end to coincide to narrow down and graft subsequently limits the remarkable risk of thrombosis.

In view of the foregoing, press for the alternative that treatment hemodialysis patient and treatment need other patient of arrangement blood vessel graft such as artery bypass grafting thing.Particularly, press for the method that hemodialysis access graft and new artery bypass grafting thing and surgery are settled these grafts.The present invention just satisfies these needs.

Brief summary of the invention

The present invention settles the method for this graft to solve the problem relevant with other blood vessel graft with the hemodialysis access graft well known in the prior art by novel graft is provided with surgery.Various embodiments of the present invention show many superior characteristics.

A kind of form of the present invention is the blood vessel graft with uniqueness of diminishing far-end.This distal portions can comprise the common constant section of the diameter of vicinity one a diminishing section, the contiguous again common constant section that diameter is bigger of this diminishing section.This diminishing section promptly has the diameter that dwindles along the direction of far-end along the direction of blood flow by graft.Perhaps, this diminishing section with the diameter that dwindles can be from the bigger adjacent segments of a diameter to this remote extension.The length of this diminishing section and the gradient can change, and its diameter can dwindle or non-linearly dwindle substantially linearly.Another form of the present invention is a kind of blood vessel graft that a diminishing near-end is arranged simultaneously.In certain embodiments, graft of the present invention comprises can be from the labelling such as the radio opaque markers of external detection, and this is marked with the identification that is beneficial to subsequently and settles graft, and therefore helps the supervision or the operative therapy of graft.

Another kind of form is a kind ofly to have one to be placed in a blood vessel graft from the uniqueness that is used for fixing the cover on the target vessel wall of far-end preset distance.This cover limits a groove, is used for holding a pocket mouth stitching thread in blood vessel wall.This cover can be an independent mechanism that is fixed on the graft outer surface, perhaps can comprise a plurality of mechanisms.In one embodiment, this cover is included in two rings that a spaced-apart precalculated position centers on the periphery of this graft, thereby limits a groove between two rings, to hold this stitching thread and blood vessel wall.In another embodiment, at least a portion of this cover such as one or two ring comprise that one can be from the labelling such as the radio opaque markers of external detection, so that identification subsequently and settle anastomotic position, and be convenient to supervision or the operative therapy that graft may need thus.

Another form of the present invention comprises a kind of method of transplanting one blood vessel graft, be included in and do otch in the target vessel wall, the far-end of graft of the present invention is inserted blood vessel, make this far-end be placed in the downstream of cutting part, and graft is fixed on the blood vessel wall.Have among the embodiment of cover graft a use, this fixedly comprises the pocket mouth stitching in the groove that embeds cover.In certain embodiments, this method also comprises the middle part of removing graft and shortens this graft thus.For example, can be by cutting the middle part that this graft is removed this graft at two predetermined points that equal the distance of the length that will remove of being separated by, thereby the end of two cuttings is provided, and connects the end of these two cuttings, so that the graft of a shortening to be provided.

In another form of the present invention, a kind of electrical connector is provided, this device helps helping to connect the end of a plurality of conduits such as blood vessel, graft etc., for example, in an embodiment who connects two conduits, this adapter comprises that its shape can insert first section and its shape of the end of a conduit and can insert second section of the end of another conduit.In certain embodiments, this device also comprises a central section, is used for the end of these two cuttings is held in a kind of spaced apart relation.

An object of the present invention is to provide novel blood vessel graft and implantation method thereof, they provide a kind of alternative for the not satisfied graft of prior art and method.

Another object of the present invention provides and is used for by remove the method and apparatus that pars intermedia assigns to shorten a blood vessel graft from graft.

Can know other form of the present invention, embodiment, purpose, advantage, benefit, aspect and characteristics from accompanying drawing and the detailed description of this paper.

The accompanying drawing summary

Though in claims, will particularly point out characteristic feature of the present invention, come with reference to following description the present invention may be better understood and the mode of making and using itself in conjunction with the accompanying drawing that limits a part of the present invention.

Fig. 1 represents a kind of standard taper graft with prior art of 1 diameter that increases gradually from near-end 2 to far-end.

Fig. 2 represents a kind of graft that prominent hat is arranged of prior art.

Fig. 3 is the side view according to the embodiment of a kind of blood vessel graft of the present invention.

Fig. 4 is the side view according to another embodiment of a kind of blood vessel graft of the present invention.

Fig. 5 is the side view according to another embodiment of a kind of blood vessel graft of the present invention.

Fig. 6 is the side view according to another embodiment of a kind of blood vessel graft of the present invention.

Fig. 7 is the side view that the part of the signal of graft of the present invention after it is transplanted is saved.

Fig. 8 is the side view according to the embodiment of a kind of cover of the present invention.

Fig. 9 is the side view according to another embodiment of a kind of blood vessel graft of the present invention.

Figure 10 is the side view according to another embodiment of a kind of blood vessel graft of the present invention.

Figure 11 is the side view that the part of the signal of graft of the present invention after it is transplanted is saved.

Figure 12 is the perspective view according to the embodiment of a kind of electrical connector of the present invention.

Figure 13 is the perspective view of electrical connector of representing Figure 12 of connected graft section simultaneously.

Figure 14 is the perspective view of the electrical connector of expression Figure 12 of being positioned to the device that connects two graft sections.

Figure 15 is the perspective view according to another embodiment of a kind of electrical connector of the present invention.

Figure 16 is the perspective view of the electrical connector of this device of expression Figure 15 of being used to connect the graft section.

Figure 17 is the perspective view according to another embodiment of a kind of electrical connector of the present invention.

Figure 18 is the perspective view according to another embodiment of a kind of electrical connector of the present invention.

Figure 19 is the perspective view according to another embodiment of a kind of electrical connector of the present invention.

Figure 20 is the perspective view according to another embodiment of a kind of electrical connector of the present invention.

Figure 21 is the perspective view of electrical connector of Figure 12 of the far-end of the expression graft of representing to be placed in the connection in the blood vessel when being positioned to the device that connects two graft sections.

Preferred embodiment is described

For the ease of understanding principle of the present invention, with reference now to preferred embodiment and use professional language that it is described.Yet be not appreciated that therefore to limit the scope of the invention,, can normally consider the further application of variation of the present invention and the further modification and the principle of the invention described herein for the Technology professional under the present invention.

The present invention provides a kind of blood vessel graft prosthese (after this being called " graft ") on the one hand, and this graft comprises a piped substantially conduit, this conduit limit one by blood the chamber and a far-end taper or that progressively reduce is arranged.The shape of this far-end is made and is used for inserting in the target blood by an otch, leaves cutting part and provides more with the guiding blood flow to enter vein or tremulous pulse from the next stratiform blood flow of the far-end of graft, thereby reduce the turbulent flow at anastomotic position place.

With reference to Fig. 3 of illustration one embodiment of the invention, graft 10 has first end 20 (" far-end " that after this be called graft) and that is suitable for inserting the vascular of accepting blood to be suitable for being fixed on selected next second end 30 (" near-end " that after this be called graft) on the tremulous pulse position of graft blood supply.Ordinary professionals of the technology are appreciated that blood passes through the blood vessel graft one-way flow.As used herein, term " near-end " and " far-end " self-consistentency ground use, with the identification graft with respect to the two ends of blood flow direction wherein.Used herein as these terms, blood is mobile along the direction from the near-end to the far-end.In other words, blood feeds the near-end of graft from the tremulous pulse position, flows by the far-end of graft towards graft, the downstream position of the same tremulous pulse that is fixed thereon with flowing into the vascular of accepting blood such as vein, second tremulous pulse or this near-end fluid then.

The most handy a kind of thickness of graft 10 substantially uniformly material make, so graft 10 limits a chamber 11 that has substantially as this graft outer surface shape.In graft 10, far-end 20 limiting holes 21 and near-end 30 limiting holes 31.The part in hole 21 and the graft chamber that limited by the section 22 of graft 10 has a constant substantially diameter, the diameter of the part in the graft chamber that this diameter limits less than hole 31 with by the section 40 of graft 10.The part (being also referred to as " progressively reducing " section or " taper " section herein) that is limited by section 23 in mobile thing chamber 11 has a diameter that reduces gradually substantially from the axial point of adjacent segments 40 to the axial point of adjacent segments 22, also is described as successive substantially taper herein.

In one embodiment, the diameter of the part that is limited by section 40 in graft chamber 11 goes out about 20% greatly than the diameter of the part that is limited by section 22 at least.In another embodiment, the diameter of the part that is limited by section 40 in graft chamber 11 goes out about 30% greatly than the diameter of the part that is limited by section 22 at least.In another embodiment, the diameter of the part that is limited by section 40 in graft chamber 11 goes out about 40% greatly than the diameter of the section that is limited by section 22 at least.In another embodiment, the diameter of the part that is limited by section 40 in graft chamber 11 goes out about 50% greatly than the diameter of the section that is limited by section 22 at least.

In one embodiment, the internal diameter of the part that is limited by section 22 in chamber 11 is not more than about 6 millimeters.In another embodiment, the internal diameter of the part that is limited by section 22 in chamber 11 is not more than about 5 millimeters.In another embodiment, the internal diameter of the part that is limited by section 22 in chamber 11 is about 3 to about 6 millimeters, and the internal diameter of the part that is limited by section 40 in chamber 11 is about 4 to about 8 millimeters.In another embodiment, the internal diameter of the part that is limited by section 22 in chamber 11 is about 3.5 to about 4.5 millimeters, and the internal diameter of the part that is limited by section 40 in chamber 11 is about 5.5 to about 7.0 millimeters.

In one embodiment, the extension of section 23 only accounts for a quite short length of graft 10, for example less than about 2 centimetres.In such an embodiment, section 23 preferably from far-end 20 about 1 to about 10 centimetres.In another embodiment, section 23 from far-end 20 about 1 to about 8 centimetres, and in another embodiment, section 23 from far-end 20 about 1 to about 6 centimetres.In another embodiment, the extension of section 23 accounts for a bigger length of graft, as greater than about 2 centimetres, limits the littler taper of a gradient thus.In one embodiment, section 23 extends about 1 to about 10 centimetres along the length of graft.

Among another embodiment shown in Figure 4, graft 110 does not comprise the section corresponding to section among Fig. 3 22, and tapered segment 123 is the successive substantially tapers from the section 140 of maximum gauge to far-end 120.In one embodiment, section 123 along the longitudinal axis of graft 110 from stretching out from the longitudinal axis point of far-end 120 at least about 2 centimetres.In another embodiment, section 123 is from stretching out from the longitudinal axis point of far-end 120 at least about 4 centimetres.In another embodiment, section 123 is from about 2 centimetres away from far-end 120 stretching out to about 15 centimetres longitudinal axis point be.In another embodiment, section 123 is from about 4 centimetres away from far-end 120 stretching out to about 15 centimetres longitudinal axis point be.In another embodiment, section 123 is from about 2 centimetres away from far-end 120 stretching out to about 10 centimetres longitudinal axis point be.In another embodiment, section 123 is from stretching out from far-end 120 about 4 centimetres to 10 centimetres longitudinal axis points.

Referring now to Fig. 5, in another embodiment of the present invention, except a distal portions that progressively reduces was arranged, graft 210 also had a proximal part that progressively reduces.Graft 210 has a first end 220 that is suitable for inserting the vascular of accepting blood and one to be suitable for being fixed on selectedly to come to provide the second end 230 on the tremulous pulse position of blood to this graft.In graft 210, far-end 220 limiting holes 221, and near-end 230 limiting holes 231.The part in the graft chamber that is limited by section 222 of hole 221 and graft 210 has a constant substantially diameter, and this diameter is less than the diameter of the part in the graft chamber that is limited by section 240 of graft 210.In addition, the part in the graft chamber that is limited by section 232 of hole 231 and graft 210 has a constant substantially diameter, and this diameter is less than the diameter of the part in the graft chamber that is limited by section 240 of graft 210.The part (being also referred to as " progressively dwindling " section or " taper " section herein) that is limited by section 223 in graft chamber 211 has a diminishing substantially diameter from the longitudinal axis point of adjacent segments 240 to the longitudinal axis point of adjacent segments 222, also is described as successive substantially taper herein.Equally, the part (being also referred to as " progressively dwindling " section or " taper " section herein) that is limited by section 233 in graft chamber 211 has a diameter that evenly increases substantially from the longitudinal axis point of adjacent segments 232 to the longitudinal axis point of adjacent segments 240.

In one embodiment, the diameter of the part that is limited by section 240 in graft chamber 211 goes out about 20% greatly than the diameter of the part that is limited by section 222 or section 232 at least.In another embodiment, the diameter of the part that is limited by section 240 in graft chamber 211 goes out about 30% greatly than the diameter of the part that is limited by section 222 or section 232 at least.In another embodiment, the diameter of the part that is limited by section 240 in graft chamber 211 goes out about 40% greatly than the diameter of the part that is limited by section 222 or section 232 at least.In another embodiment, the diameter of the part that is limited by section 240 in graft chamber 211 goes out about 50% greatly than the diameter of the part that is limited by section 222 or section 232 at least.In another embodiment, the length of the part that is limited by section 240 in graft chamber 211 is at least about 50% of graft length.In another embodiment, the length of the part that is limited by section 240 in graft chamber 211 is at least about 60% of graft length.In another embodiment, the length of the part that is limited by section 240 in graft chamber 211 is at least about 70% of graft length.In another embodiment, the length of the part that is limited by section 240 in graft chamber 211 is at least about 80% of graft length.In another embodiment, the length of the part that is limited by section 240 in graft chamber 211 is at least about 90% of graft length.In another embodiment, the length of the part that is limited by section 240 in graft chamber 211 is at least about 95% of graft length.

In one embodiment, the internal diameter of the part that is limited by section 222 in chamber 211 is not more than about 6 millimeters.In another embodiment, the internal diameter of the part that is limited by section 222 in chamber 211 is not more than about 5 millimeters.In another embodiment, the internal diameter of the part that is limited by section 232 in chamber 211 is not more than about 6 millimeters.In another embodiment, the internal diameter of the part that is limited by section 232 in chamber 211 is not more than about 5 millimeters.In another embodiment, the internal diameter by in section 222 and the section 232 or the part that both limit in chamber 211 is about 3.5 to about 6 millimeters, and the internal diameter of the part that is limited by section 240 in chamber 211 is about 4 to about 8 millimeters.In another embodiment, the internal diameter by in section 222 and the section 232 or the part that both limit in chamber 211 is about 3.5 to about 4.5 millimeters, and the internal diameter of the part that is limited by section 240 in chamber 211 is about 5.5 to about 7.5 millimeters.In another embodiment, the internal diameter by in section 222 and the section 232 or the part that both limit in chamber 211 is about 3.5 to about 4.5 millimeters, and the internal diameter of the part that is limited by section 240 in chamber 211 is 5.5 to about 6.5 millimeters.In another embodiment, the internal diameter of the part that is limited by section 222 and section 232 in chamber 211 is about 4 millimeters, and the internal diameter of the part that is limited by section 240 in chamber 211 is about 6 millimeters.

Section 223 and 233 can extend one of graft 210 quite short length, as each less than about 2 centimetres.In such an embodiment, section 223 preferably is positioned at from far-end 220 about 1 to about 10 centimeters, and section 233 preferably is positioned at from near-end 230 about 1 to about 10 centimeters.In another embodiment, section 223 is positioned at from far-end 220 about 1 to about 8 centimeters, and section 233 is positioned at from near-end 230 about 1 to about 8 centimeters.In yet another embodiment, section 223 is positioned at from far-end 220 about 1 to about 6 centimeters, and section 233 is positioned at from near-end 230 about 1 to about 6 centimeters.Be appreciated that section 223 can have the length that identical length can be different with 233.Or section 223 and 233 can each extend bigger length as greater than about 2 centimetres along graft, limits the littler taper of a gradient thus.In one embodiment, section 223 and 233 each extend about 2 to about 10 centimetres along the length of graft.

In another embodiment shown in Fig. 6, graft 310 does not comprise the section corresponding to section among Fig. 5 222 and 233.On the contrary, diameter reduction is to far-end 320 gradually substantially from the bigger section 340 of diameter for tapered segment 323, and the characteristics of tapered segment 333 expressions are diameters that increase continuously substantially that a section bigger from near-end 330 to diameter 340 is arranged.Section 323 and 333 one or both preferably extend to from two ends 320 and 330 at least about 2 centimetres longitudinal axis point along the longitudinal axis of graft 310.In another embodiment, section 323 and 333 one or both extend to from two ends 320 and 330 at least about 4 centimetres longitudinal axis point.In another embodiment, section 323 and 333 one or both extend to from two ends 320 and 330 about 2 centimetres to about 15 centimetres longitudinal axis point.In another embodiment, section 323 and 333 one or both extend to from two ends 320 and 330 about 4 centimetres to about 15 centimetres longitudinal axis point.In another embodiment, section 313 and 333 one or both extend to from two ends 320 and 330 about 2 centimetres to about 10 centimetres longitudinal axis point.In another embodiment, section 323 and 333 one or both extend to from two ends 320 and 330 about 4 centimetres to about 10 centimetres longitudinal axis point.

The most handy politef of graft described herein (" PTFE ") is made; But this does not also mean that the present invention is made the restriction of the material of graft.Can think this graft can be enough the far-ranging material that can bio-compatible with physical property such as acceptable flexible of known now or later development advantageously make.

The present invention provides the method with surgical graft graft of the present invention simultaneously.In order to settle a graft according to the present invention, in blood vessel, make an otch from a position of the next blood of graft selected acceptance, the far-end of graft introduced internal blood vessel at the cutting part place and be arranged to downstream part, and this graft is fixed on hermetically on the blood vessel wall at cutting part place from a preset distance of otch.This graft shown in Fig. 7 after arrangement with respect to the representative configuration of target vascular site, wherein the far-end 360 of graft 365 be placed in the target blood 370 with respect to natural blood flow in the blood vessel 370 from cutting part 380 location downstream.

In one embodiment, the distal portions of graft of the present invention is attached on the target vascular site reaches through the following steps: (1) makes a kerf in predetermined locations in target vessel wall; (2) far-end of graft of the present invention is retouched into blood vessel by this otch, made this first end lead to a point in otch downstream; (3) this graft is fixed on the blood vessel at the cutting part place; And (4) with this proximal anastomosis on a previously selected tremulous pulse position.In one embodiment, the far-end of graft can utilize pocket mouth stitching thread advantageously to be fixed on the target blood.In implementing a kind of mode of the present invention, pocket mouth stitching thread can insert in the wall of target blood before making otch.In another embodiment, inserting step comprises that the far-end with graft of the present invention inserts this blood vessel by this otch, makes this far-end lead to the otch downstream at least about a some place of 1 centimetre.In another embodiment, this inserting step comprises that the far-end with graft of the present invention inserts this blood vessel by this otch, makes this far-end lead to from the otch downstream about 1 to about 4 a centimetres some place.In another embodiment, this inserting step comprises that the far-end with graft of the present invention inserts this blood vessel by this otch, makes this far-end lead to from the otch downstream about 1 to about 3 a centimetres some place.Can guide blood flow to leave cutting part the far-end insertion blood vessel of graft, the blood that has therefore reduced the anastomotic position place fiercely flows.

An advantage of the invention is that the far-end of graft of the present invention can be placed in the blood vessel of accepting blood with wide variety of sizes, comprise and originally thinking because size restrictions and unaccommodated blood vessel.In implementing a kind of mode of the present invention, have at the blood vessel of accepting blood that is selected to the identical attached position of target and to be not more than 1.5 centimetres diameter.In another embodiment, the selected blood vessel of accepting blood at the attached position of target have about 0.4 centimetre to about 1.5 centimetres diameter.In another embodiment, the selected blood vessel of accepting blood at the attached position of target has and is not more than about 1.4 centimetres diameter.In another embodiment, the selected blood vessel of accepting blood at the attached position of target is not more than about 1.3 centimetres diameter.In another embodiment, the selected blood vessel of accepting blood at the attached position of target has and is not more than about 2 centimetres diameter.Can consider that also the present invention can be used for settling graft of the present invention at the blood vessel of a trunk such as patient upper leg.For example, in another embodiment, the selected blood vessel of accepting blood at the attached position of target has big to about 3 centimetres diameter.

On the other hand, the invention provides a kind of graft, this graft comprise one be placed in from one of graft far-end the distance of wanting and be suitable for during the graft surgery is settled, accepting the sutural cover of pocket mouth at the cutting part place, part isolation between the injured endothelium that makes the cutting part place thus and the blood vessel that coincide.In this respect, in one aspect of the invention, the graft that provides comprises a cover that is fixed on this graft outer surface, and this cover limits its shape and can hold identical with the sutural groove of pocket mouth.Be appreciated that it is with described herein to have novel graft taper or diminishing far-end and standard graft (graft that does not promptly have taper at far-end) and other graft related that the present invention considers to use such cover.

In one embodiment, the shape of this cover is made this groove and is positioned at one substantially on the plane perpendicular to the graft longitudinal axis.Can easily understand, use this each configuration, when this graft was sewn on the blood vessel wall, this graft will be substantially to become an angle of 90 degrees and to pass through blood vessel wall vein.In another embodiment, the shape of this cover is made this groove and is positioned on the longitudinal axis plane at angle to graft, as shown in Fig. 9 and 10.In a preferred embodiment, this groove is positioned on the plane of the longitudinal axis into about miter angle to graft, and still, the present invention also considers various angles.

In one embodiment, this cover comprises an independent structure that limits a groove.For example, Fig. 8 illustrates its shape and makes the cover 650 that is attached on the graft outer surface.Cover 650 limits a chamber 651, and its size is made the outer surface at a graft of want engagement position.Cover 650 also comprises around groove 655 of qualification between first ridge 652 of cover 650 extensions and second ridge, 653, two ridges.Cover 650 can be attached on the graft in want position with the adhesive of bio-compatible, also can whole qualification on graft.

In another embodiment, this cover can comprise two circuluses of extending around graft, limits a groove between the two.Referring now to Fig. 9 and 10, graft 410,510 comprises and being separately fixed at or Unitarily molded cover 450,550 on graft 410,510 outer surfaces.Each comprises two circuluses 452,453,552,553 cover 450,550, and each limits a groove 455,555, and the shape of groove is made and can be held a pocket mouth stitching thread that is used for vein or arterial anastomosis.

In one embodiment, the position of this groove from far-end at least about 1 centimetre.In another embodiment, the position of this groove is be about 1 centimetre to about 5 centimetres away from far-end.In another embodiment, the position of this groove is be about 1 centimetre to 3 centimetres away from far-end.Can easily understand, graft rests on the length in the target blood after the distance affects graft transplantation formality of far-end is finished.For example, in one embodiment, settle a cover, make the groove that limits by this cover be positioned at from graft far-end about 1 to about 3 centimetres.In another embodiment, settle a cover, make the groove that limits by this cover be positioned at from graft far-end about 1.5 to about 2.5 centimetres.In another embodiment, wherein this cover comprises two circuluses as shown in Fig. 9 and 10, and ring is positioned at be about 1.75 centimetres away from graft far-end, and another ring is positioned at be about 2.25 centimetres away from graft far-end, limits this groove between two rings.

In another embodiment of the present invention, at least a portion of graft has applied and/or has flooded a kind of material of antithrombotic qualification.In one embodiment, the graft surface that contacts with blood has applied and/or has flooded the material of antithrombotic qualification.The material that exists antithrombotic to limit on graft surface has and prevents to contact this surperficial blood coagulation and/or attached to lip-deep advantageous effects.According to some embodiment of the present invention, the surface that can advantageously apply or flood the material of antithrombotic qualification comprises the surface in graft chamber, the distal portions that is inserted into the target blood of accepting blood is arranged (for the graft that a cover is arranged, the graft part between this cover and this far-end just) outer surface, and, when having a cover, the remaining of this cover is placed in the outer surface (part of the most close graft far-end of this cover just) of the part of target blood intracavity.The material that the suitable antithrombotic that soaks graft surface limits be can be used to apply and/or steep and (for example) carbon, heparin and silicone comprised.

In another embodiment, comprise can be from the labelling such as the radio opaque markers of external detection at least a portion of this cover.A kind of like this existence of labelling makes and can utilize radiation or other means to come from the position of external measurement this cover, measures the graft diameter position that locate and/or graft intravasation place that changes thereby can be enclosed within relative position on the graft according to this.This kind information helps supervision or the operative therapy after the arrangement that a graft may need.In some preferred embodiment, one or two ridge of this cover or ring comprise can be from the labelling of external detection.In another embodiment, one or two end of graft comprise one can be from the labelling of external detection so that help being used for subsequently from the method for the position of one or more ends of outside identification graft.In a preferred embodiment, the vein end can be from the labelling marking of external detection with one.

As used herein, term " can from external detection " refers to that a kind of of material can comprise the performance that the long-range image device of cryptoscope equipment, X-ray equipment, CT equipment, MRI equipment, ultrasonic device and other form carries out imaging with medical image device.Various medical image devices can be used as commodity and have bought.As used herein, term " can from the external detection " material that comprises the radiopaque material and can enough medical image devices because it is different from the density of ambient substance or other character detect.For example, under the situation of radiopaque material, can utilize the cryptoscope method.Radiopaque material of selecting to use according to the present invention can be a kind of barium compound such as barium sulfate, metal ingredient such as tantalum or other radiopaque material.Select a kind of suitable radiopaque material to be used for the present invention, belong to fully within ordinary professionals of the technology's the field range.Or, can utilize MRI or ultrasonic examination to detect the material that a kind of its density is different from health or other ambient substance.

Can for example provide from the labelling of external detection with following method: with a kind of inert can be included in from the material of external detection be coated on this put its part goes up or the part such as coating or other coating on its end of this graft; With a kind of part that can make this cover or its part or this graft from the material of external detection; Perhaps with in a kind of polymer that can be included in an a kind of part that is used to make this cover or its part or this graft from the material of external detection.

The present invention also is provided for non-infringement ground monitoring in some aspects and has the patient's of a subcutaneous transplantation thing of the present invention method.In one embodiment, a kind of method comprises can be from the graft transplantation of the present invention of the characteristics of the material of external detection patient body with having, and by with noninvasive technology such as X ray or checking that with MRI or ultrasonic scanning this patient determines the position of this graft and/or open-minded with the cryptoscope imaging or under the situation of the different material of density under the situation of radiopaque material.

The present invention also is provided for transplanting the method that has as the graft of the present invention of cover described herein.In order to settle one according to the graft that a cover is arranged of the present invention, in target blood, do an otch, the far-end of this graft is introduced internal blood vessel, make the cover that wherein is provided with groove be positioned to and hold blood vessel wall, and this blood vessel wall is fixed on this graft at the cutting part place.Shown in Figure 11 one after arrangement with respect to the representative configuration of the graft that cover is arranged of target blood, wherein, the far-end 460 of graft 465 be placed in target blood 470 interior from cutting part leave in respect to blood vessel 470 the oral area position with respect to blood vessel 470 in natural blood flow location downstream.Cover 480 is positioned so that the groove of qualification holds blood vessel wall at the cutting part place thus.

In one embodiment, coincide and to finish through the following steps: (1) does an otch in the wall of previously selected target blood; (2) there is the far-end of the graft of cover to insert this blood vessel with one, makes this groove be positioned to and to hold this blood vessel wall and stitching thread by this otch; (3) this blood vessel wall being fixed on this puts; And (4) coincide this second end on a previously selected target arterial position.In one embodiment, the far-end of graft can advantageously be fixed on the vascular site of accepting blood with pocket mouth stitching thread.In implementing a kind of mode of the present invention, pocket mouth stitching thread can insert in the wall of target blood before making otch, and this fixing step comprises that with this pocket mouth stitching thread this blood vessel being fixed on this puts.Except the guiding blood flow leaves cutting part, reduces graft to the power of anastomotic position with blood flow is become the stratiform more, use of the present invention has also reduced by otch significantly and has sewed up the amount of damage to blood vessel endothelium that produces.Secondly, using a cover and pocket mouth stitching thread to coincide according to the present invention can make otch itself (being the cut edge of blood vessel wall) and internal blood vessel separate.Like this, graft can not contact cutting part with blood in the blood vessel.

Be appreciated that the present invention also considers to overlap with the standard graft and also promptly do not have the graft of taper to use at far-end.In addition, though describe and show the embodiment that comprises cover, the invention is not restricted to the graft of cover herein, in some aspects, as mentioned above, the present invention also provides the configuration that does not comprise cover.In the occasion that does not have cover, this graft can coincide with known other technology in this technology and accept on the vascular site of blood, and this graft can selectively comprise other structure that is used to as known in the art be attached on the vascular site arbitrarily.

Forward another favourable characteristics of the present invention now to, ordinary professionals of the technology can easily understand, and graft is settled the variation that is usually directed to be placed graft length.For example, arteriovenous graft is made usually and is had the unnecessary length that can remove if desired.A reason of this unnecessary length provides a graft that can be used for the patient of all builds.In addition, when selecting from the target arterial position to settle to target vein position the suitable subcutaneous path of graft, this unnecessary length provides the degree of freedom of the fore-and-aft distance of settling graft to the doctor.Therefore, during settling an arteriovenous graft, usually by cut off the unnecessary part that is confirmed as that suitable length is removed graft from graft one end.In this respect, during settling an arteriovenous graft, this graft can be from a point near target venous anastomosis position at the subcutaneous point (vice versa) that buries near the arterial anastomosis position.Just cut off unnecessary length then if desired and be positioned to the two ends that are attached to the graft on the blood vessel separately suitably to provide from one or both ends.Settling tremulous pulse in the formality of the graft of tremulous pulse, use similar technology usually.

Obviously, above-mentioned formality extremely is not suitable for the graft that wherein is placed has specific required configuration (for example wherein using according to the proximal graft thing that has a taper or the far-end that progressively dwindles and taper aspect some or progressively dwindle of the present invention) at two ends graft and settles formality.When settling this graft, do not adopt by a end usually and cut off the length that a predetermined length shortens graft simply from graft.Therefore,, must remove a predetermined length, with the end end that the mode of end connects these two cuttings be limited a successive graft tubing then from the middle part of graft in order to shorten the length of graft.Except that above-mentioned, when the arteriovenous graft that must revise an existence, bypass graft and so on, also may need the end that ground, end is connected two sections grafts.This correction is usually directed to carry out end the end is connected of graft section.But, two sections PTFE grafts are stitched together, all may be time-consuming and trouble for an arteriovenous graft new or that revise, and may cause scabbing and/or the growth inside tissue at connecting portion.Like this, with the end mode of end is stitched together the graft section and may causes narrowly,, may cause thrombosis to limit or graft lost efficacy if this narrow enough serious.In addition, with the two ends of PTFE graft be stitched together may cause at anastomotic position hemorrhage, thereby further increase operating time and expense.

According to another aspect of the present invention, a kind of electrical connector is provided, this device can be advantageously used in the end that helps to connect the graft section.When hope maybe needs by removing the intermediate portion when assigning to shorten the length of arteriovenous graft, electrical connector of the present invention is particularly useful.In certain embodiments of the present invention, after removing mid portion, two cutting tips of graft connect with electrical connector of the present invention.Certainly the invention is not restricted to connect two cutting tips of an arterio-venous catheter.Electrical connector of the present invention can be used for the end mode of end being connected various conduits.

In an embodiment shown in Figure 12, adapter 710 is normally piped and limit a chamber 750, and the shape in chamber 750 is made and can be communicated with chamber 761,762 or other connected conduit 771,772 fluids of graft section, as shown in Figure 13 and 14.Adapter 710 comprises first end section 720, second section portion's section 740 and the bigger central section 730 of external diameter; the shape of section 720 is made in the end 773 that can be inserted into the first graft section or other conduit 771; the shape of section 740 is made in the end 774 that can be inserted into the second graft section or other conduit 772, and the shape of section 730 is made and protected graft section end 773,774 in spaced relation.

In other embodiments, adapter 710 also comprises and is used for mechanism that graft section 771,772 is attached on the adapter 710.For example, in one embodiment, on the outer surface of first end section 720 and the second end section 740, provide a kind of viscose glue to become to assign to and to be held in place with adapter 710 after graft section 771,772 contacts.In another embodiment shown in Figure 15, each limits a groove 781,782 first end section 720 and the second end 740, in order to hold a securing member such as jig, clip, to be silk etc.Figure 16 represents that it in the embedded groove 781,782 is the representative example that silk 791,792 is connected the adapter 710 on the graft section 771,772 that the usefulness according to this embodiment is positioned to.In another embodiment shown in Figure 17, limiting one or two groove around section 720 and/or 740 ridges that limit or between encircling 783,784,785,786.It will of course be appreciated that these ridges or ring are made limits a groove betwixt, but had better not be too big and cause and be difficult to this section is inserted graft.In another embodiment shown in Figure 180, first end section 720 and the second end section 740 one or each comprise an independent ridge or encircle 788,789, and its shape is made can mesh a securing member such as jig, clip, be silk etc.The adapter of this embodiment can be by being fixed on the graft end with making the graft end extend in section 720 and the 740 insertion graft ends on ridge 788 and 789, then a selected securing member is placed on one on the position of contiguous this ridge meshing this ridge, thereby prevents the landing on the end section of adapter of graft end.It will of course be appreciated that such as ordinary professionals of the technology meeting, adapter of the present invention can also be attached on the graft section with other method.

In another embodiment of the present invention shown in Figure 19, do not have the bigger centre portion of external diameter, and adapter 710 comprises that its shape can insert first section 720 in first end of conduit and its shape and can insert second section 740 in second end of conduit.Adapter 710 limits groove 781,782, in order to hold securing member such as jig, clip, to be silk etc.

The most handy quite firm biomaterial of adapter of the present invention is made.The fastness of adapter of the present invention can change, but adapter is preferably enough firm, can bear that to pick and place, insert the graft section and be used for the graft section is fixed on the adapter be the power of silk, clip or other utensil.Certainly it is also important that adapter also can enough firmly prevent the twist and warping or the damage at connecting portion place.It is also important that the material that is used for making adapter is nonbiodegradable in the environment of its arrangement.For example, be used to connect arteriovenous graft or artery bypass grafting thing adapter must with a kind of under physiological condition when blood exists non-degradable suitable material make.Select suitable material to belong to fully within ordinary professionals of the technology's the field range, various suitable materials can be used as commodity and have bought.

The size of adapter of the present invention preferably can relevantly be packed in the end of conduit to be connected.Proper being equipped with helps prevent restriceted envelope or gap between adapter and each graft section, and is convenient to adapter is fixed on the graft end.Therefore be appreciated that when selecting to be used to connect the graft of different size, preferably select the adapter of different size for use.In some embodiment as shown in figure 20, adapter 710 comprises the end sections 721 and 741 of taper, so that with in the insertion graft end separately, adapter end.The taper of certainly best end does not reach after settling adapter can produce the significantly disorderly degree that blood flow passes through of filling or hinder in by the blood flow of graft and adapter.Selection reaches the taper dimensions that the present invention wants effect, belongs to fully within ordinary professionals of the technology's the range of views.If desired, before inserting, use salt water-wet adapter surface, also can help adapter of the present invention is inserted the graft end with lubricated adapter.It will of course be appreciated that the fluid that also can use other bio-compatible comes moistening and/or lubricated adapter, and ordinary professionals of the technology can select a kind of suitable fluid to reach this effect.

Expect that adapter of the present invention can be through being usually used in connecting the grafting device section with constant substantially internal diameter.In one embodiment of the invention, the external diameter of the external diameter of first end section and the second end section is almost equal.For example, the internal diameter of many arteriovenous graft is about 5 to about 8mm.Therefore, in a preferred embodiment, the external diameter of external diameter that the first end district is estimated and the second end section is about 5 to about 8mm.Certainly can understand, adapter of the present invention can be used for connecting the different graft section of internal diameter or other conduit.The adapter that is used to connect these graft sections certainly has its external diameter first end section different with the external diameter of the second end section.In a preferred embodiment, the diameter of the diameter of first end section and the second end section is respectively in about 0.5mm of the internal diameter of target graft section.

The chamber of adapter of the present invention and nonessential qualification straight tube as shown in the drawing.On the contrary, in certain embodiments, adapter of the present invention is crooked.

Therefore, clearly visible from this description, in one embodiment of the invention, provide a kind of blood vessel graft, this graft comprises: (1) far-end that is suitable for being placed in the blood vessel of accepting blood and is limited with first hole of one first diameter; (2) near-ends that are suitable for being attached on the tremulous pulse position; (3) first tubular sections between far-end and near-end, this first tubular section limits the part in the chamber with common constant second diameter bigger than first diameter; And (4) first tapered segment between first tubular section and far-end, this first tapered segment has along the diminishing substantially diameter of this section.In another embodiment, graft comprises second tubular section between the far-end and first tapered segment, and this second tubular section qualification has the part corresponding to the chamber of the constant substantially diameter of first diameter.

In another embodiment, the near-end of graft limits one second hole less than the 3rd diameter of second diameter, and graft comprises second tapered segment between this near-end and first tubular section, and this second tapered segment has a diameter that evenly increases substantially.In another embodiment, graft comprises the 3rd a tubulose section between the near-end and second tapered segment, and wherein the 3rd tubulose section limits the part have corresponding to the chamber of the constant substantially diameter of the 3rd diameter.

In another embodiment, cover is fixed on the outer surface of graft from far-end at least about 1 centimeters, and this cover limits its shape can hold a sutural groove of pocket mouth that is used to coincide.In another embodiment, this groove be positioned at substantially one with the longitudinal axis of graft plane into about miter angle.In one embodiment, this cover comprise one limit its size can engage the graft outer surface the chamber tubular part and extend and limit betwixt first and second ridges of this groove around these parts.In another embodiment, this cover comprises first ring component and second ring component that is fixed on the graft that are fixed on graft, wherein limits this groove between this first and second ring component.

In other embodiments, the other parts of this cover or graft comprise one can be from the labelling of external detection.In certain embodiments, this can be a radio opaque markers from the labelling of external detection, and in other embodiments, this can comprise that a kind of its density is different from the material of patient body density from the labelling of external detection.In certain embodiments, the other parts of this cover or graft scribble a kind of comprising can be from coating or other coating composition of the material of external detection.

Another form of the present invention is a kind of method, comprises that (1) do an otch in the wall of a previously selected target blood; (2) provide one according to blood vessel graft of the present invention; (3) far-end with this graft inserts in the blood vessel by this otch, makes this far-end lead to a point in otch downstream; (4) graft is fixed on the blood vessel wall; And (5) with the proximal anastomosis of graft on a previously selected target arterial position.

In another form of the present invention, this graft utilizes pocket mouth stitching thread to be fixed on the blood vessel.In another form of the present invention, this pocket mouth stitching thread inserted in the wall of target blood before doing otch.In another form of the present invention, this insertion comprises by this otch inserts blood vessel with far-end, makes this far-end lead to the otch downstream at least about a point of 1 centimetre.In another embodiment of the present invention, this graft comprises that one is being fixed on cover on the graft outer surface from this far-end at least about 1 centimeters, and this cover limits its shape can hold a sutural groove of pocket mouth that is used to coincide.In this embodiment, this insertion comprises by otch inserts blood vessel with the far-end of graft, makes this groove be positioned to and holds blood vessel wall, and should fixedly comprise blood vessel wall is fixed on and put.In implementing another mode of the present invention, a pocket mouth stitching thread inserted in the wall of target blood before doing otch, and this fixedly comprise this pocket mouth stitching thread is introduced in this groove.

In another form of the present invention, a kind of method is provided, this method comprises: (1) coincide the first end of a blood vessel graft on one first blood vessel; (2) the second end with this blood vessel graft coincide on one second blood vessel; (3) cut off the middle part that this graft is removed graft by two positions between this first end and the second end, thereby limit the first graft section and second a graft section that comprises this second end that comprises this first end; (4) provide a piped substantially electrical connector that wherein limits a chamber.This device has its shape can insert the second end section in the chamber that first end section in the chamber of this first graft section and its shape can insert this second graft section; And (5) are connected this first and second grafts section on first and second end section of this electrical connector.In certain embodiments, this electrical connector also comprises a central section, and its shape can be held in spaced apart relation with two graft section ends.In other embodiments, each first and second end section limits a groove or one or more ring, is used to hold jig, a clip, is silk etc., so that these sections are attached on this first and second grafts section.In another embodiment, this first and second end section applies a kind of gluing composition, so that these sections are attached on the first and second graft sections.In another embodiment, this connection is finished by following formality: (1) inserts this first in the chamber of the first graft section; (2) this first is fixed on the first graft section; (3) this second portion is inserted in the chamber of the second graft section; And (4) are fixed on this second portion on the second graft section.

According to another aspect of the present invention, a kind of piped substantially electrical connector that wherein limits a chamber is provided, this device comprises: (1) its shape is made the first end section in the chamber that can insert the first graft section; (2) its shapes are made the second end section in the chamber that can insert the second graft section; And (3) its shapes are made the central section that the end of these two transplanting portion sections can be held in spaced apart relation; Wherein, this first and second end section has been coated with a kind of gluing composition, so that these two sections are attached on the first and second graft sections.

The invention provides a kind of piped substantially electrical connector that wherein limits a chamber more on the one hand according to of the present invention, this device comprises: (1) its shape is made the first end section in the chamber that can insert the first graft section; And (2) its shapes are made the second end section in the chamber that can insert the second graft section; Wherein, each first and second end section limits a groove or one or more ring, to hold jig, a clip, to be silk etc., is used for these sections are attached at the first and second graft sections.

According to another aspect of the present invention, the invention provides a kind of piped substantially electrical connector that wherein limits a chamber, this device comprises: (1) its shape is made the first end section in the chamber that can insert the first graft section; (2) its shapes are made the second end section in the chamber that can insert the second graft section; And (3) its shapes are made the centre portion that these two graft section ends can be held in spaced apart relation; Wherein, each first and second end section limits a groove or one or more ring, to hold jig, a clip, to be silk etc., is used for these two sections are attached at the first and second graft sections.In certain embodiments, the shape of this groove or ring is made and can be held a pocket mouth stitching thread.

In certain embodiments, the chamber of this electrical connector is straight basically, and in other embodiments, this adapter is not straight.

As mentioned above, an advantage of the invention is that using one has a graft taper or diminishing far-end, thus the size that can dwindle otch, and this expection can reduce the amount of endothelial injury and slow down the chain reaction that causes NIH.Secondly, comprise on graft among the embodiment of a cover that the sutural identical method of a kind of pocket mouth can be got rid of the endothelium of damage the part between the blood vessel that coincide.This cover can prevent that also meeting that the pocket tone is closed from causing the slip or the displacement of tangible catastrophic effect.Dwindle graft diameter in the exit, also can be used for slowing down turbulent flow and make blood flow laminarization more.

Though obviously, the taper of this far-end will be influential to the speed and the pressure of blood flow in the graft of the present invention, it is believed that graft of the present invention will show remarkable long-term flow behavior, show other clearly visible advantage from this paper describes simultaneously.Really, carry out graft and monitor that the researcher of research reported, the function AVG of high percent has greater than 50% anastomotic strictures of original diameter or other narrow.Other researcher was once said, " critical stenosis that thrombosis limits is approximately reduced 70% " (Hakim and Himme lfarb (1998)).Have from the graft of the present invention of 6 millimeters diminishing 4 millimeters far-ends of section at one, the far-end diameter reduces really, but only reduces 33%.In addition, in the embodiment of every end (being far-end and near-end) taper, can believe that by having a diminishing far-end, the rate of volume flow by graft can not change significantly.

Can expect, the resistance with blood flow that tapered distal end limits be caused flow rate reduces in the bigger part of graft diameter.Report was once arranged, and greater than the flow rate of 800ml/min anti-tampon being limited is critical (Hakim and Himmelfarb[1998]).Can believe that for above-mentioned reason, graft of the present invention will be owing to enough blood pressures and tremulous pulse influx and kept open-minded in period at an acceptable.Though certain probability that the thrombosis that reduces to cause owing to flow rate in the bigger part of graft diameter of the present invention limits may be a kind of concern in the use at graft of the present invention, but can expect that the increase trend (if present) that thrombosis limits can solve by using anticoagulant and/or antiplatelet drug.

In addition, Lumsden says, if the length that is in the section that has 4 mm dias on the diminishing graft at arterial anastomosis may be unfavorable for open-minded greater than 2 centimetres.Do not enumerate marked difference on the statistics; But this meets unanimity with the discovery with Poiseuille law and Hakim and the relevant flow rate of Himmelfarb.In the application of Hasan-Poiseaille law: $Q=\frac{{\mathrm{\ΠR}}^4\mathrm{\ΔP}}{8\mathrm{\ηL}}$

When other variable was constant, when the radius (R) of pipe when dwindling, rate of volume flow (Q) reduced, and is not linear.When (narrow zone) length (L) increased, flowing velocity (Q) was also dwindled.The discovery expection of Lumsden is equally applicable to far-end.Therefore, a preferred embodiment of the present invention comprises that its size (promptly dwindle gradually part radius and length) can not increase the diminishing distal portions of the danger that the thrombosis of graft limits significantly.In a preferred embodiment, the length sent out of this diminishing far-end total value is not more than about 3 centimetres.In another embodiment, the length of this diminishing distal portions is not more than about 2 centimetres.In another embodiment, the length of this diminishing distal portions is not more than about 1 centimetre.

As mentioned above, a kind of conviction widely and popular trend are to transplant the graft with sizable venous anastomosis.This conviction and trend are considered to come from a kind of like this viewpoint, exactly in a graft with big venous anastomosis, distal graft thing obturation will postpone to take place, because will need narrow largely making above the venous anastomosis of opening required critical dimension to narrow down.Ordinary professionals of the technology will find, need not to use the AVG with less far-end in the prior art, and really, ordinary professionals of the technology will reach a conclusion, the less critical stenosis and the inaccessible point that coincide and will cause an acceleration.Can believe the less development and a kind of more unexpected " critical stenosis " that have the thrombosis qualification that coincide and to cause NIH of traditional approach (end is to the side); But, the invention provides the apparatus and method of the uniqueness of the AVG that can settle a kind of far-end with diminishing or taper.

All that quote in this description or enumerate documents comprise publication, patent and patent application, all with reference to being incorporated in this, are pointed out specially and individually by with reference to merging with all to be set forth in this same just as every kind of independent documents.Outside inferior, the operation mechanism of Chen Shu any theory, proposition or discovery herein is intended to further deepen the understanding of the present invention, and and thinks by any way the present invention to be limited to the operation mechanism or the discovery of this kind theory, proposition.Though the present invention's quilt illustration and description at length in accompanying drawing and above-listed description; it is nonrestrictive but they are considered to just illustration; be appreciated that; just illustrate and described some preferred embodiments, and will protect all changes, equivalents and the modification that is in the spirit of the present invention that limits by following claims.

Claims (64)

1. blood vessel graft that limits the chamber that blood supply liquid passes through comprises:

A far-end that is adapted to pass through in the blood vessel that blood vessel wall is placed in containment blood, this far-end limits first hole with one first diameter;

A near-end that is suitable for being attached on the tremulous pulse position;

First tubular section between far-end and near-end, this first tubular section limit has the part greater than the chamber of the second constant substantially diameter of first diameter; And

One between described first tubular section and described far-end and have first tapered segment of the diameter that reduces gradually substantially along first tapered segment.

2. according to the described graft of claim 1, it is characterized in that this second diameter goes out about 20% at least greatly than first diameter.

3. according to the described graft of claim 1, it is characterized in that this second leading thread goes out about 30% at least greatly than first diameter.

4. according to the described graft of claim 1, it is characterized in that this first diameter is not more than about 6 millimeters.

5. according to the described graft of claim 1, it is characterized in that this first diameter is not more than about 5 millimeters.

6. according to the described graft of claim 1, it is characterized in that this first diameter is about 3.5 to about 4.5 millimeters, and this second diameter is about 5.5 to about 7.0 millimeters.

7. according to the described graft of claim 1, it is characterized in that, also comprise second tubular section between described far-end and described first tapered segment, described second tubular section qualification has the part corresponding to the chamber of the constant substantially diameter of first diameter.

8. according to the described graft of claim 7, it is characterized in that the longitudinal length of this first tapered segment is less than about 2 centimetres.

9. according to the described graft of claim 7, it is characterized in that, the position of this first tapered segment from described far-end about 1 to about 10 centimetres.

10. according to the described graft of claim 1, it is characterized in that the longitudinal length of this first tapered segment is about 2 to about 10 centimetres.

11. according to the described graft of claim 1, it is characterized in that, this first tapered segment from described remote extension to from the axial point of described far-end at least about 4 centimetres.

12., it is characterized in that this first tapered segment extends to described far-end from one from described far-end about 4 to about 15 centimetres axial point according to the described graft of claim 1.

13., it is characterized in that described near-end limits second hole through three diameters that has less than second diameter according to the described graft of claim 1; And described graft also comprises second tapered segment between described near-end and described first tubular section, and this second tapered segment has the diameter that evenly increases substantially.

14. according to the described graft of claim 13, it is characterized in that, also comprise the 3rd a tubulose section between described near-end and described second tapered segment, wherein, described the 3rd tubulose section qualification has the part corresponding to the chamber of the constant substantially diameter of the 3rd diameter.

15., it is characterized in that this second diameter goes out about 20% at least greatly than the 3rd diameter according to the described graft of claim 14.

16., it is characterized in that the 3rd diameter is not more than about 6 millimeters according to the described graft of claim 14.

17., it is characterized in that this first diameter is about 3.5 to about 4.5 millimeters according to the described graft of claim 14; Wherein, this second diameter is about 5.5 to about 6.5 millimeters; Wherein, the 3rd diameter is about 3.5 to about 4.5 millimeters.

18. according to the described graft of claim 13, it is characterized in that, the length of described first tubular section be this graft length at least about 60%.

19. according to the described graft of claim 13, it is characterized in that, the length of described first tubular section be this graft length at least about 70%.

20. according to the described graft of claim 13, it is characterized in that, the length of described first tubular section be this graft length at least about 80%.

21. according to the described graft of claim 13, it is characterized in that, the length of described first tubular section be this graft length at least about 95%.

22. according to the described graft of claim 1, it is characterized in that, also comprise on the outer surface that is fixed on this graft and from the cover of described far-end at least about 1 centimetre, this cover limits its shape can hold one in the blood vessel wall sutural groove of pocket mouth that is used to coincide.

23., it is characterized in that this groove is positioned at one substantially with respect to the longitudinal axis of this graft plane into about miter angle according to the described graft of claim 22.

24., it is characterized in that the position of described cover is from 1 to about 10 centimetres of described far-end according to the described graft of claim 22.

25. according to the described graft of claim 22, it is characterized in that, the position of described cover from described far-end about 1 to about 5 centimetres.

26., it is characterized in that described cover comprises according to the described graft of claim 22:

One limits the tubular part in chamber that a size can engage the outer surface of described graft; And

Extend and limit betwixt first and second ridges of this groove around described parts.

27., it is characterized in that described cover comprises according to the described graft of claim 22:

First ring component that is fixed on the described graft; And

Second ring component that is fixed on the described graft;

Wherein, this first and second ring component is limited to the groove between them.

28. according to the described graft of claim 27, it is characterized in that, this first the ring position from this far-end about 1.5 to about 2 centimetres, and this bicyclic position from this far-end about 2 to about 2.5 centimetres.

29., it is characterized in that position of this first ring about 1.75 centimetres away from this far-end, and this bicyclic position about 2.25 centimetres away from this far-end according to the described graft of claim 27 be.

30. a method comprises:

In the wall of a previously selected target blood, do an otch;

A blood vessel graft that limits the chamber that blood supply liquid passes through is provided, and this graft comprises:

One is adapted to pass through this otch and is placed in this blood vessel and limits one and has

The far-end in first hole of one diameter;

A near-end that is suitable for being attached on the radicular arteries;

First tubular section between this far-end and near-end, this first tubular section

Qualification has the part greater than the chamber of the second constant substantially diameter of first diameter;

And

One between described first tubular section and described far-end and have along this first the awl

First tapered segment of the diameter that the shape section reduces substantially gradually;

This far-end is inserted blood vessel by this otch, make this far-end lead to a point in this otch downstream;

This graft is fixed on the blood vessel wall; And

With the proximal anastomosis of this graft on the position of a previously selected target arterial.

31. in accordance with the method for claim 30, it is characterized in that this graft is to be fixed on the blood vessel wall with a pocket mouth stitching thread.

32., it is characterized in that this pocket mouth stitching thread is to be inserted in the wall of target blood according to the described method of claim 31 before doing this otch.

33. in accordance with the method for claim 30, it is characterized in that described inserting step comprises inserts blood vessel with this far-end by this otch, make this far-end lead to the otch downstream at least about a point of 1 centimetre.

34. in accordance with the method for claim 30, it is characterized in that the diameter of this blood vessel is less than about 1.5 centimetres.

35. in accordance with the method for claim 30, it is characterized in that the diameter of this blood vessel is not more than about 1.4 centimetres.

36. in accordance with the method for claim 30, it is characterized in that the diameter of this blood vessel is not more than about 1.3 centimetres.

37. in accordance with the method for claim 30, it is characterized in that the diameter of this blood vessel is greatly to about 3 centimetres.

38. according to the method for claim 30,

Wherein this graft comprises that one is fixed on the graft outer surface and from the cover of described far-end at least about 1 centimetre, this cover limits its shape can hold a sutural groove of pocket mouth that is used to coincide;

Wherein said inserting step comprises that the far-end with graft inserts blood vessel by this otch, makes the position of this groove can hold blood vessel wall; And

Wherein said fixing step comprises that blood vessel wall is fixed on this to put.

39., it is characterized in that this blood vessel wall is fixed on this with a pocket mouth stitching thread and puts according to the described method of claim 38.

40., it is characterized in that this pocket mouth stitching thread is to be inserted in the wall of target blood according to the described method of claim 39 before doing this otch, and wherein said fixing step comprises this pocket mouth stitching thread is introduced in this groove.

41. according to the described graft of claim 1, it is characterized in that, described graft comprise one can be from the labelling of external detection.

42. according to the described graft of claim 1, it is characterized in that, described cover comprise one can be from the labelling of external detection.

43., it is characterized in that this can be the labelling of a radip-opaque from the labelling of external detection according to the described graft of claim 41.

44., it is characterized in that this can comprise that a kind of its density is different from the density material of patient body from the labelling of external detection according to the described graft of claim 41.

45., it is characterized in that this can be that a kind of comprising can be from the coating or the coating of the material of external detection from the labelling of external detection according to the described graft of claim 41.

46. according to the described graft of claim 41, it is characterized in that, at least a portion of described cover comprise a kind of can be from the material of external detection.

47. in accordance with the method for claim 30, it is characterized in that, this graft comprise one can be from the labelling of external detection.

48. according to the described method of claim 38, it is characterized in that, this cover comprise one can be from the labelling of external detection.

49. a method comprises:

First end of a blood vessel graft is coincide on one first blood vessel;

Second end of this graft is coincide on one second blood vessel;

Cut off the middle part part that this graft is removed this graft by two positions between this first end and this second end, the first graft section and second a graft section that comprises this second end that comprises this first end is provided thus;

Provide one to limit the piped substantially electrical connector in chamber by therebetween, this device has shape can insert the second end section in the chamber that first end section in the chamber of this first graft section and shape can insert the second graft section; And

This first and second grafts section is connected on first and second parts of this electrical connector.

50., it is characterized in that this electrical connector also comprises a central section according to the described method of claim 49, its shape can make these graft section ends keep spaced relationship.

51., it is characterized in that one or two of first and second end section limits a groove according to the described method of claim 49, be used to hold jig, a clip or be silk, so that be attached on one or two of the first and second graft sections.

52., it is characterized in that one or two of first and second end section applies a kind of gluing composition according to the described method of claim 49, so that be attached on one or two of the first and second graft sections.

53. according to the described method of claim 49, it is characterized in that, one or two of first and second end section comprises two rings that limit a groove betwixt, is used to hold jig, a clip or is silk, so that be attached on one or two of the first and second graft sections.

54., it is characterized in that one or two of first and second end section comprises a ring according to the described method of claim 49, be used to hold jig, a clip or be silk, so that be attached on one or two of the first and second graft sections.

55., it is characterized in that one or two of first and second end section limits a tapered end part according to the described method of claim 49.

56. according to any one described method among the claim 49-55, it is characterized in that, describedly comprise continuously:

This first is inserted in the chamber of this first graft section;

This first is fixed on this first graft section;

This second portion is inserted in the chamber of this second graft section; And

This second portion is fixed on this second graft section.

57. one kind by limiting the piped substantially electrical connector in a chamber therebetween, this device comprises:

A first end section, its shape can insert in the chamber of one first graft section;

A second end section, its shape can insert in the chamber of one second graft section; And

A centre portion, its shape can keep spaced relationship with two graft section ends.

58., it is characterized in that one or two of this first and second end section applied a kind of gluing composition according to the described device of claim 57, so that these sections are attached on the first and second graft sections.

59., it is characterized in that one or two of this first and second end section limits a groove according to the described device of claim 57, be used to hold jig, a clip or be silk, so that be attached on one or two of the first and second graft sections.

60. according to the described device of claim 57, it is characterized in that one or two of this first and second end section comprises two rings, limit a groove between two rings, be used to hold jig, a clip or be silk, so that be attached on one or two of the first and second graft sections.

61., it is characterized in that one or two of this first and second end section comprises a ring according to the described device of claim 57, be used to hold jig, a clip or be silk, so that be attached on one or two of the first and second graft sections.

62., it is characterized in that one or two of this first and second end section limits a tapered end part according to the described device of claim 57.

63. a piped substantially electrical connector that limits a chamber betwixt, this device comprises:

A first end section, its shape can insert in the chamber of one first graft section; And

A second end section, its shape can insert in the chamber of one second graft section;

Wherein each first and second end section limits a groove, is used to hold a stitching thread, so that these sections are attached on the first and second graft sections.

64., it is characterized in that the chamber of this electrical connector is straight basically according to any one described device among the claim 57-63.

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