JP2007260343A - Blood vessel prosthetic device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a blood vessel prosthetic device to be used for a complicated blood vessel lesion treatment. <P>SOLUTION: The blood vessel prosthetic device includes: a main tube having a comparatively large diameter; and a branch tube which is joined to the side part of the main tube and has a diameter smaller than that of the main tube. The main tube and the branch tube are different in material. When polyester is used for the material of the main tube and PTFE is used for that of the branch tube, for example, the properties of the respective materials are utilized so as to cope with a complicated lesion. Furthermore, not only suture thread but a non-absorbent synthetic polymer, wherein permanent elongation is ≤2% in a test based on JIS K6401, are used in joining the main tube to the branch tube, so that the leak of blood in a joint part is prevented. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

The present invention relates to a vascular prosthesis such as an artificial blood vessel and a stent graft.

Even in recent years when medical development is remarkable, deaths due to heart disease or aortic disease tend to increase year by year.

In particular, in the United States, many people die from coronary artery disease among heart diseases, and most of them are said to be due to squeezing of the coronary arteries. For stenosis or occlusion of the coronary artery, aorta-coronary artery bypass surgery or the like is performed by collecting the patient's own artery or vein from another site.

In addition to coronary artery disease, the number of patients with concurrent lesions such as heart valves and aorta is increasing, and simultaneous surgery such as valvuloplasty and aortic reconstruction is being performed to save these people. .

In addition to these surgical treatments, advances in treatment technology have provided minimally invasive treatments using catheters, balloons, stents, stent grafts, etc., but simple lesions can be treated easily. However, in complicated lesion treatment that requires treatment for multiple vascular lesions at the same time, there are many risks such as a tendency to prolong the operation time and the risk of bleeding, etc. This is the current situation.

US Patent Publication 6,770,090

An object of the present invention is to provide a vascular prosthesis that can be used for treating complicated vascular lesions.

Such an object is achieved by the present inventions (1) to (5) below.
(1) A vascular prosthesis in which a main tube portion having an end portion having a diameter of 1 mm to 50 mm and a branch tube portion having one or more branched end portions having a diameter of 1 mm to 50 mm are integrated. The vascular prosthesis is characterized in that the main pipe part and at least one branch pipe part are made of different materials.

(2) The main pipe portion is made of a polyester fiber knitted fabric or a structure containing a polyester fiber knitted fabric, and the branch pipe portion is a structure containing a stretched fibrillated fluororesin ( The blood vessel prosthesis described in 1).

(3) The material constituting the main pipe portion is formed of a polyester fiber knitted fabric or a structure including a polyester fiber knitted fabric, and the branch pipe portion includes other porous synthetic polymer resin excluding polyester. The vascular prosthesis according to (1), comprising a structure.

(4) The material constituting the main pipe part is composed of a structure containing a stretched fibrillated fluororesin, and at least one of the branch pipe parts is composed of a polyester fiber knitted fabric or a structure containing polyester. The vascular prosthesis described in (1).

(5) In the joining of the main pipe part and the branch pipe part, the diameter of the end part of the branch pipe part joined to the main pipe part is 1.2 times or more than the diameter of the remaining end part of the branch pipe part, The vascular prosthesis according to (1), wherein a non-absorbable synthetic polymer and a suture that have a permanent elongation of 2% or less in a test based on JIS K6301 are present in a caliber portion of 1.2 times or more.

According to the present invention, in complex vascular lesion treatment, it is possible to perform vascular treatment of a plurality of sites safely, easily, and in a short time, and to deal with complicated lesion blood vessel size variations. Become.

Hereinafter, the vascular prosthesis of the present invention will be described in detail based on preferred embodiments.

As an example of complex lesion treatment to which the vascular prosthesis of the present invention is applied, a case in which a thoracic aortic aneurysm and coronary stenosis simultaneously have a lesion will be described.

Aortic-coronary artery bypass surgery is generally performed for coronary artery stenosis. Currently, the patient's saphenous vein and internal thoracic artery are used as bypass blood vessels.

In addition, patients with coronary artery stenosis usually have to bypass two or three branches.

For thoracic aortic aneurysms, replacement using an artificial blood vessel or endovascular treatment using a stent graft is generally performed.

As described above, the treatment for simultaneous multiple lesions requires multiple sites and multiple prosthetic devices at the same time, has a high degree of invasiveness to the patient itself, and has collected or prepared a plurality of prosthetic devices in advance. They are used together.

In some cases, the two-branch bypass and the three-branch bypass must be stitched twice in two locations.

Therefore, since the same operation must be repeated twice and three times, double and triple labor is required, which increases the burden on the patient.

In addition, a considerable portion of the ascending aorta is occupied with an anastomosis, or bleeding from the suture site extends the operation time, and in some cases, the patient is at risk of bleeding death.

In the case of an even thinner transplanted blood vessel, the suturing technique is difficult and the possibility of thrombus and stenosis occurring due to inadequate suturing increases.

In order to solve these problems, the present inventor has made various studies to develop a vascular prosthesis that is easy for the operator to handle, reduces the burden on the patient, and causes less trouble after transplantation. did.

The number of the branch pipes of the present invention is at least one, preferably 1 to 4, more preferably 2 or 3.

In the vascular prosthesis of the present invention, the main tube portion has a diameter of 1 mm to 50 mm, preferably 8 mm to 50 mm, and more preferably 20 mm to 40 mm.

In the vascular prosthesis of the present invention, the branch tube portion has a diameter of 1 mm to 50 mm, preferably 2 mm to 30 mm, and more preferably 2 mm to 10 mm.

The prosthetic branch according to the present invention may taper substantially uniformly over the entire length, may continue to a relatively large diameter up to a certain length, taper from the middle, or taper to any location. You may have.

In addition, the branch tube of the present invention can be used as a composite connected to veins and arteries collected from a patient.

Non-absorbent resins present in the main pipe and branch pipe joints are thermoplastic elastomers under the trade name Kraton G-1650, 1652, 2705, plasticized oils such as paraffin oil, stiffeners such as polypropylene, and Non-degrading agents can be mixed and used.

Kraton G-1650 and 1652 are trade names of styrene-ethylene-butylene-styrene block copolymer (SEBS), and Kraton G-2705 is a trade name of SEBS containing naphtha oil and a non-decomposition agent.

Further, SEBS can be used by mixing silicone oil and polypropylene.

Specific examples include SEBS, which is a trade name of Lavalon (Mitsubishi Oil Chemical Co., Ltd.), which is a blend of SEBS with polypropylene.

If necessary, a lubricant such as silicone oil and oleic amide, an antioxidant such as dibutylhydroxytoluene, a filler such as talc, and the like can be added.

In addition, thermosetting resins such as silicon and rubber, which are general plastics, or thermally crosslinkable resins can be used, but it is important that the permanent elongation is 2% or less.

Specific examples of the non-absorbing resin as a base include, for example, polyesters such as polyethylene terephthalate and polybutylene terephthalate, polyester elastomers using these as hard segments, polyolefins such as polyethylene and polypropylene, polyolefin elastomers, and metallocene catalysts. Copolymer polyolefins used, vinyl polymers such as polyvinyl chloride, polyvinylidene chloride (PVDC), polyvinylidene fluoride (PVDF), polyamide and polyamide elastomer (PAE) including nylon, polyimide, polystyrene, styrene ethylene butylene styrene block Copolymer (SEBS) resin, polyurethane, polyurethane elastomer, ABS resin, acrylic resin, polyarylate, polycar Nate, polyoxymethylene (POM), polyvinyl alcohol (PVA), fluororesin (ETFE, PFA, PTFE), ethylene-vinyl acetate saponified product, ethylene vinyl alcohol copolymer, ethylene vinyl acetate, carboxymethyl cellulose, methyl cellulose, cellulose acetate, etc. Various thermoplastic resins and polymer derivatives such as cellulose plastic, vinyl polysulfone, liquid crystal polymer (LCP), polyethersulfone (PES), polyetheretherketone (PEEK), polyphenylene oxide (PPO), polyphenylene sulfide (PPS) In addition to these, thermosetting resins or heat crosslinkable resins such as vulcanized rubber, silicon resin, epoxy resin, and two-component reactive polyurethane resin can be used.

A polymer alloy containing any one of the above thermoplastic resins and thermosetting / crosslinking resins can also be used. Among these, polyurethane, polyurethane elastomer, polyester elastomer, SEBS resin, silicon, and olefin are preferable.

Permanent elongation (%) means that a sheet-like or tube-shaped specimen is stretched by 300%, held for 10 minutes, then released, and after 60 minutes, the full length was measured. The value obtained by subtracting the length is divided by the original length and multiplied by 100.

EXAMPLES Hereinafter, although an Example and a comparative example are given and this invention is demonstrated concretely, this invention is not limited to these Examples.

A tube made of polyester weave with an inner diameter of 20 mm and a length of 30 cm was prepared, and the main tube was cut into two circular shapes with an inner diameter of 10 mm and 7 mm with a scalpel.

Next, a stretched fibrillated fluororesin tube having an inner diameter of 10 mm and a length of 20 cm and a stretched fibrillated fluororesin tube having an inner diameter of 6 mm and a length of 20 cm are prepared, and a stainless steel mandrel having an outer diameter of 11 mm and 7 mm is formed from one end. It was inserted and heat-treated in an oven at 150 ° C. for 120 minutes to expand one end.

Next, two circular holes made in the main pipe, and an oil-added thermoplastic elastomer with a permanent elongation of 1.8% with a width of 5 mm and a thickness of 0.3 mm are attached to the entire circumference, and 150 ° C. in an oven. After 20 minutes of heat treatment, the two branch tubes with one end expanded were joined with a surgical suture (Goretex). Thereafter, the artificial blood vessel A was obtained by further heat treatment at 180 ° C. for 90 minutes.
[Example 2]

A tube made of polyester weave with an inner diameter of 20 mm and a length of 30 cm was prepared, and the main tube was cut into two circular shapes with an inner diameter of 10 mm and 7 mm with a scalpel.

Next, a tube made of polyurethane having an inner diameter of 10 mm, a length of 20 cm, an inner diameter of 6 mm, and a length of 20 cm was prepared, and a stainless steel mandrel having an outer diameter of 11 mm and 7 mm was inserted from one end, followed by heat treatment at 150 ° C. for 120 minutes in an oven. One end was expanded by leaving it for one day.

Next, two circular holes made in the main pipe, and an oil-added thermoplastic elastomer with a width of 5mm and a thickness of 0.3mm with a permanent elongation of 1.5% are attached to the entire circumference, and the two branches are surgically operated. The artificial blood vessel B was obtained by bonding with a suture thread (Gore-Tex) and heat treatment at 150 ° C. for 120 minutes.

(Comparative Example 1)
A tube made of polyester weave with an inner diameter of 20 mm and a length of 30 cm was prepared, and the main tube was cut into two circular shapes with an inner diameter of 10 mm and 7 mm with a scalpel.

Next, a polyester knitted tube having an inner diameter of 10 mm, a length of 20 cm, an inner diameter of 6 mm, and a length of 20 cm is prepared, and a stainless steel mandrel having an outer diameter of 7 mm and 11 mm is inserted from one end, and heated in an oven at 180 ° C. for 120 minutes. One end was expanded.

Next, two circular holes made in the main pipe, and an oil-added thermoplastic elastomer with a permanent elongation of 1.8% with a width of 5 mm and a thickness of 0.3 mm are attached to the entire circumference, and 150 ° C. in an oven. After 20 minutes of heat treatment, the two branch tubes with one end expanded were joined with a surgical suture (Goretex). Thereafter, the artificial blood vessel C was obtained by further heat treatment at 180 ° C. for 90 minutes.

(Comparative Example 2)
A tube made of polyester weave with an inner diameter of 20 mm and a length of 30 cm was prepared, and the main tube was cut into two circular shapes with an inner diameter of 10 mm and 7 mm with a scalpel.

Next, a polyester knitted tube having an inner diameter of 10 mm, a length of 20 cm, an inner diameter of 6 mm, and a length of 20 cm was prepared and joined with a surgical suture (Gore-Tex) to obtain an artificial blood vessel E.
<Test Example 1 Blood compatibility test and blood leakage test>

When the specimens obtained in Examples 1 and 2 and Comparative Examples 1 and 2 were connected to the carotid artery-venous shunt circuit and circulated for 10 minutes, the degree of blood leakage from the main and branch joints and the circulation After the completion, the amount of thrombus attached to the inner surface of the tube was compared. The results are shown below.

In Examples 1 and 2, it was clarified that blood leakage at the junction was not observed and thrombus adhesion was not observed in the branch pipe.

On the other hand, in Comparative Example 1, thrombus adhesion was prominently observed in the branch canal, and in Comparative Example 2, leakage from the junction and thrombus adhesion were remarkably recognized.

Claims (5)

In the vascular prosthesis in which a main tube portion having an end portion having a diameter of 1 mm to 50 mm and a branch tube portion having one or more branched end portions having a diameter of 1 mm to 50 mm are integrated. A vascular prosthesis characterized in that the materials constituting the main tube portion and at least one branch tube portion are different. The material constituting the main pipe part is a polyester fiber knitted fabric or a structure containing a polyester fiber knitted fabric, and the branch pipe part is a structure containing a stretched fibrillated fluororesin. The vascular prosthesis according to item 1. From the structure which the material which comprises the said main pipe part is comprised from the structure containing the polyester fiber knitted fabric or the polyester fiber knitted fabric, and the said branch pipe part contains the other porous synthetic polymer resin except polyester The vascular prosthesis according to claim 1, which is configured. The material constituting the main pipe part is composed of a structure containing a fluorinated resin stretched and fibrillated, and at least one of the branch pipe parts is composed of a polyester fiber knitted fabric or a structure containing polyester. The vascular prosthesis according to the first item in the range. In joining the main pipe part and the branch pipe part, the diameter of the end part of the branch pipe part joined to the main pipe part is 1.2 times or more than the diameter of the remaining end part of the branch pipe part, and 1.2 The vascular prosthesis according to claim 1, wherein a non-absorbable synthetic polymer and a suture having a permanent elongation of 2% or less in a test according to JIS K6301 are present in a caliber portion of which the diameter is twice or more. .