JP2009118927A - Medical instrument for tissue anastomosis - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical device for tissue anastomosis (cuff) which perform a procedure completely by one operator. <P>SOLUTION: In the medical device (1) for tissue anastomosis, a handle (3) is extended at the upper side end part of a roughly cylindrical core part (2) and a plurality of hooks (4) are projected at the upper end part of the core part (2). The distal end in the direction of the handle (3) of the hook (4) is formed into a sharp tip at least. Also, the hook (4) is projected in a roughly triangular shape or a roughly rectangular shape or a roughly semicircular shape from the upper end part of the core part (2) to the direction of the handle (3), and the distal end in the direction of the handle (3) is formed into the sharp tip. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

The present invention relates to a medical device for tissue anastomosis having a hollow structure used for anastomosing a hollow tubular structure of a living body such as a blood vessel, a digestive tract, a bile duct, and a ureter.
The present invention can be used for all surgical procedures that use anastomosis procedures, regardless of the size of the tube.

  Conventionally, in various operations, for anastomosis of human tissue having a hollow structure tissue such as blood vessels, the stumps of each hollow structure tissue are sutured multiple times with a thread, and further along the circumference of the hollow structure tissue. This is done by combining multiple times. The technique of stitching the multiple stumps with a thread depends on the operator's technique. Also, stitching with a thread takes time depending on the procedure. In such a case, there is a case where the suture cannot be given up due to the time restriction of the operation.

As conditions for the anastomosis of the hollow structure tissue,
(1) Do not apply excessive stress to the hollow structure tissue during anastomosis, (2) Internal structure of the hollow structure tissue, inner surface of the hollow structure so that bodily fluids do not touch the external tissue (3) The success rate when the anastomosis is performed does not depend on the technique by the surgeon, (4) It can be easily anastomosed and does not take time, and (5) One operator completes the procedure. (6) There is no adverse effect when the hollow structure grows and its hollow diameter increases.
Needless to say, the internal solution (body fluid) does not leak due to internal pressure when anastomosing.

In order to solve such a problem, the prior art has attempted to solve the problem by various methods.
For example, Patent Document 1 (Japanese Patent No. 3038068) discloses a technique of placing an antithrombotic material inside an anastomosis portion when anastomosing. However, at first glance, this technique simply puts a carrier inside when anastomosing, improving convenience during anastomosis. Furthermore, there is a concern that placing an artificial material inside a hollow structural tissue (a blood vessel in the same document 1) facilitates the formation of a thrombus. No anti-thrombogenic material has been invented in human inventions so far.
Furthermore, this indwelling is formed of a biodegradable material. The degradation behavior of biodegradable materials is that the commonly used aliphatic polyester compounds (polylactic acid, polyglycolic acid, etc.) are massively decomposed, and the behavior does not become a water-soluble oligomer from the surface of the material. The molecular weight decreases uniformly, it becomes difficult to maintain the physical shape, and it should be finely crushed and then absorbed and metabolized as a water-soluble oligomer.
For this reason, it is not recommended to place such a material inside the blood vessel because there is a risk that the biodegradable polymer that has been crushed and started flowing will cause a thrombus other than the anastomosis. That is, it does not satisfy the above condition (2), and thus may have a serious adverse effect on the patient used by the generation of a thrombus, and is not a satisfactory anastomosis method and anastomosis instrument.

Furthermore, Patent Document 2 (Japanese Patent No. 3514513) discloses an instrument (cuff) in which a coupling pin is attached to a stump of a hollow structure (a blood vessel in the same Document 2) during anastomosis. The instrument (cuff) does not have a problem in the formation of a thrombus because the material is not placed in the blood vessel as in the invention of Patent Document 1 when anastomosing.
However, since the surgical procedure is complicated and an auxiliary instrument that has not been used by the conventional surgical procedure is used, the operator is highly dependent on the technique. Further, in view of the surgical procedure, it is assumed that at least two subsidiary procedure assistants are required to complete the anastomosis procedure.
Further, when the anastomosis is performed as a big problem, the blood vessel at the stump portion is greatly expanded at right angles to the blood flow direction, so that the blood vessel may be damaged. In addition, blood vessels spread vertically in the direction of blood flow will eventually adhere and heal in both directions, but there is a device of biodegradable material that expands in the vertical direction and further surrounds it when it heals. It is feared that a tumor-like aneurysm is created as the nucleus of the tissue mass.
In such a situation, unnecessary adhesion with the surrounding tissue is inevitable, and the invasion to the surrounding tissue becomes large and cannot be recommended. Further, when adhesion occurs with surrounding tissues, when the anastomosis site grows and the inner cavity becomes larger, the growth may be hindered and the flow of the internal fluid may be inhibited. That is, among the above conditions, (1), (3), (4), and (5) are not satisfied and the anastomosis method and anastomosis device are not always satisfactory.

Non-patent document 1 discloses a solution as an academic study for solving such a problem. Non-Patent Document 1 discloses a simple instrument (hereinafter abbreviated as “cuff”) used when anastomosing a hollow structure (in the same document, a blood vessel).
This cuff is shaped like a tube with a cylindrical synthetic resin cuff, and the blood vessels are anastomosed using the cuff. This method is simple and highly effective. However, since it is necessary to widen the blood vessel while holding the blood vessel as a problem, it cannot be performed by one operator, and a subordinate procedure assistant is required.
The outline of the known anastomosis method described in Non-Patent Document 1 is shown below.
(1) As shown in FIG. 6 of Non-Patent Document 1, a blood vessel is passed through a cuff.
(2) As shown in FIG. 7A of Non-Patent Document 1, the handle and blood vessel are sandwiched between clips and temporarily fixed.
(3) As shown in FIGS. 7B and 7C of Non-Patent Document 1, the blood vessel is inverted using two tweezers so as to cover the trunk portion of the cuff.
(4) Using a suture, as shown in FIG. 7D of Non-Patent Document 1, the cuff and the blood vessel are ligated and fixed at the groove portion of the trunk portion.
(5) A suture thread is applied to both ends of the blood vessel stump to which the cuff is inserted to form a support thread.
(6) As shown in FIG. 8A of Non-Patent Document 1, the vascular lumen is filled with physiological saline while taking care not to allow air bubbles to enter by pulling the support yarn.
(7) As shown in FIG. 8B of Non-Patent Document 1, the cuffed blood vessel is inserted around the cuffed blood vessel so as to cover the cuffed blood vessel (two operators are required).
(8) Ligate and fix the cuff and blood vessel using sutures.

Japanese Patent No. 3038068 (Claims, FIGS. 1 and 2) Japanese Patent No. 3514513 (Claims, FIGS. 1 and 2) "Cell engineering separate volume organ transplant experiment manual Shujunsha 1999 pages 53-55"

The problems to be solved by the present invention are as follows:
As in Patent Document 1 (Japanese Patent No. 3038068), placing an artificial material inside a hollow structure tissue (blood vessel in the same Document 1) is likely to make it easier to create a thrombus.
As in Patent Document 2 (Patent No. 3514513), an operator in which a connecting pin is attached to a stump of a hollow structure (in the same Document 2, a blood vessel), an operator's procedure is required to use an auxiliary instrument. High dependency. In addition, a minimum of two auxiliary procedure assistants are required. Further, when the anastomosis is performed, the blood vessel at the stump is greatly expanded at right angles to the blood flow direction, so that there is a risk of damage to the blood vessel. In addition, since there is a device of biodegradable material that expands in the vertical direction and further surrounds the blood vessel during healing, it is feared that a tumor-like aneurysm is produced using these as the nucleus of the tissue mass.
In view of such a current situation, the present inventors have conducted extensive studies,
<1> Do not apply excessive stress to the hollow tissue during anastomosis.
<2> The internal tissue of the hollow tissue, the inner surfaces of the hollow tissue are anastomosed so that the body fluid does not touch the outside,
<3> The success rate when anastomosing is not dependent on the technique by the surgeon,
<4> Easy anastomoses and less time,
<5> A single surgeon completes the procedure.
<6> The invention of a medical instrument (cuff) for tissue anastomosis satisfying the six points that there is no adverse effect when a hollow structural tissue grows and its hollow diameter expands has been reached.

[1] In the present invention, the handle (3) is extended to the upper end portion of the substantially cylindrical trunk portion (2), and a plurality of ridges (4) are projected from the upper end portion of the trunk portion (2). Provided is a medical device (1) for tissue anastomosis.
[2] The tissue anastomosis medical instrument (1) according to [1], wherein the heel (4) is formed with at least a sharp tip at a tip in the handle (3) direction.
[3] In the present invention, the collar 4 projects in a substantially triangular shape, a substantially rectangular shape, or a substantially semicircular shape from the upper end portion of the trunk portion (2) toward the handle (3), and the handle (3 The medical instrument (1) for tissue anastomosis according to claim [1] or [2], wherein a tip in a direction) is formed into a sharp tip.

The medical instrument for tissue anastomosis (cuff) according to the present invention,
(1) The procedure is completed by one surgeon. That is, by forming a plurality of ridges 4 on the backbone 2, the techniques (5) and (6) of the conventional cuff technique [0006] can be performed by one person.
(2) When anastomosing the hollow structural tissue, the hollow structural tissue is not stressed more than necessary. In the present invention, when the hollow structural tissue is anastomosed, the hollow structural tissue is inverted and fixed in the longitudinal direction of the hollow structural tissue, so that an unnecessary stress is not applied.
(3) The internal structures of the hollow structural tissue and the inner surfaces of the hollow structural tissue are anastomosed so that the body fluid does not touch the outside. When the inner surfaces are anastomosed, there is a low possibility of thrombosis when the internal solution is retained or the hollow structure is a blood vessel.
(4) The success rate when anastomosing is not dependent on the technique by the operator. The main item that depends on the operator's technique for anastomosis is the suture of stumps between the hollow structures, but it does not depend on the operator's technique because it is not necessary to suture the stumps by using a cuff. .
(5) It can be easily anastomosed and does not take time. When the stump is sutured as in the invention of Patent Document 2, it is necessary to sew about six or more locations along the circumference of the hollow structure. However, in the present invention, the cuff and the hollow structure need to be ligated twice, but the suturing time can be simply reduced to about one third.
In the present invention, the effect (1) can be shortened to one third or more.
(6) There is no adverse effect when the hollow structure grows and its hollow diameter expands. By using a biodegradable polymer, it is decomposed and absorbed after a certain period of anastomosis.
(7) Apparatuses (cuffs) that individually satisfy the conditions <1> to <6> of [0008] exist as in Patent Document 1, Patent Document 2, and Non-Patent Document 1, but the greatest feature of the present invention Is a point that satisfies all the conditions <1> to <6> at the same time.

  Although an example of the form of the suitable tissue anastomosis medical instrument of this invention is described below, it is not limited to this.

FIG. 1 is a schematic view illustrating an example of a tissue anastomosis medical instrument 1 (hereinafter simply referred to as “cuff 1”) of the present invention. As illustrated in FIG. 1, the cuff 1 has a substantially cylindrical shape and a substantially hollow shape as a whole.
As illustrated in FIG. 1, the cuff 1 of the present invention has a handle 3 extending at the upper end of a substantially cylindrical base 2 and a plurality of ridges 4 projecting from the upper end of the main 2. is doing.
In order to pass through the hole formed in the hollow structural tissue in order to fix the hollow structural tissue to be anastomosed, the heel 4 is formed with at least a sharp tip at the tip in the direction of the handle 3.
The shape and the number of the ridges 4 are not limited, but preferably the shape of the ridge 4 is substantially triangular as illustrated in FIG. 1, and the tip (vertex) in the pattern 3 direction protrudes in the direction of the pattern 3 to sharpen the shape. The structure formed in is preferable. More specifically, the “substantially isosceles triangle shape” that protrudes (extends) longer in the direction of the handle 3 is more preferable than the “substantially equilateral triangle shape”.
More specifically, it should project in a substantially quadrangular shape (rectangular, substantially rectangular shape) or a substantially semicircular shape (semi-elliptical shape) toward the handle 3 direction, and the tip in the handle 3 direction may be formed at the apex. .
Further, the number of ridges 4 should be suitably controlled by the diameter of the hollow structure tissue to be anastomosed, but the most versatile number is preferably 2 or 3. Fixation is incomplete with one, and it is not preferable. If four or more, fixation takes a long time, and the effect of shortening the anastomosis time, which is the effect of the present invention, is reduced.

The inner diameter D1 and the outer diameter D2 of the substantially cylindrical base portion 2 are determined according to the hollow structure tissue to be anastomosed.
A suitable inner diameter D1 derived from the anatomy is preferably, for example, 0.1 mm to 50 mm. Moreover, when the usage method of the cuff 1 is assumed, it is assumed that the cuff 1 is carried by a medical device such as tweezers, and the compressive strength of the substantially cylindrical base portion 2 of the cuff 1 is preferably 10 mN or more.
The length L of the handle 3 is formed 0.1 to 10 times the height H of the backbone 2.
The cuff 1 of the present invention is mainly composed of a biodegradable polymer.

[how to use]
An example of how to use the cuff 1 of the present invention will be described.
(1) A blood vessel is passed through the trunk 2 (similar to FIG. 6 of Non-Patent Document 1).
(2) Temporarily fix the base 3 and the blood vessel with clips (similar to FIG. 7A of Non-Patent Document 1).
(3) (similar to FIG. 7B and FIG. 7C of Non-Patent Document 1) Using two tweezers, the blood vessel is inverted so as to cover the trunk 2, and the heel 4 (newly created in the present invention) is Hang blood vessels (may be pierced for blood vessels).
(4) A suture thread is applied to both ends of the blood vessel stump in which the cuff 1 is inserted to form a support thread.
(5) (Similar to FIG. 8A of Non-Patent Document 1) The support thread is pulled and the vascular lumen is filled with physiological saline while being careful not to enter air bubbles.
(6) (Similar to FIG. 8B of Non-Patent Document 1) The cuffed blood vessel is inserted all around so that the blood vessel into which the cuff 1 is inserted is covered with the cuffed blood vessel, and a hole is made in the cuff collar 4 Hang blood vessels. These operations can be performed by one surgeon.
(7) The cuff 1 and the blood vessel are ligated and fixed using a bioabsorbable suture.

The table below compares the stump anastomosis method (described in Patent Document 2), the known cuff method (described in Non-Patent Document 1), and the cuff method using the present invention (new cuff method).

The effects of the present invention will be specifically described below with reference to examples. There is no limitation to this embodiment.
[Example 1]
[Production of cuff 1]
As raw materials for cuff 1, a copolymer of lactic acid, glycolic acid, ε-caprolactone, copolymerization ratio (85/10/5) (hereinafter biodegradable polymer) (weight ratio 60%) and tricalcium phosphate (weight ratio 40) %) Was dissolved and slurried in tetramethylene oxide to 3 wt / vol%. Thereafter, the inner layer of a hollow stainless steel pipe (inner diameter 0.8 mm) was coated and dried at 60 degrees for 2 hours.
The biodegradable polymer coated on the inner layer was carefully peeled off to obtain a hollow tube having an inner diameter of about 0.7 mm. The obtained tube was stretch-molded according to the outer diameter of the hollow tissue of the animal used in this experiment.
The stretch-formed tube was cut into a length of 4 mm and processed into the form shown in FIG. 1 with a surgical knife.
The height H of the backbone 2 was 1 mm, and the length L of the handle 3 was 3 mm.
Furthermore, the inner diameter D1 and the outer diameter D2 were adjusted to an inner diameter of 0.6 to 0.9 mm and an outer diameter of 0.8 to 1.1 mm according to the indwelling blood vessel.
Two ridges 3 were formed as shown in FIG.
The molecular weight of the biodegradable polymer of the produced tissue anastomosis medical device (cuff) was Mn 250,000.
The compressive strength until the trunk 2 of the tissue anastomosis medical instrument (cuff) was blocked was 10 mN or more. (Hereafter referred to as new cuff)
[Comparative Example 1]
An indwelling needle for 22G manufactured by TERUMO [trade name: Surfflow (R), material: polyethylene (hereinafter referred to as PE)] was used as a cuff material.
This indwelling needle was processed so as to have the same form as in Example 1 except that the ridge 4 was not formed as in Example 1. (Hereafter referred to as the old cuff).
(Animal experiments for cuff adaptation to blood vessels)
The carotid artery was visually inspected by incising the neck of approximately 30 rats at 8 weeks of age. Thereafter, in order to conduct an anastomosis experiment, the carotid artery was cut by ligating upstream and downstream of the planned anastomosis portion with a cantilever. Anastomoses were performed between the new cuff and the old cuff using the cut carotid artery allogeneic blood vessel (graft blood vessel). In other words, the anastomosing blood vessels are sutured in the order of (anastomosis blood vessel-old cuff (new cuff)-graft blood vessel-new cuff (old cuff)-anastomosis blood vessel) so that the new cuff and the old cuff can be compared under the same solid and the same conditions. did.
When the anastomosis was performed, the approximate time required for the procedures (2) to (8) of the cuff usage method described in Non-Patent Document 1 was measured and used as the work time. Rats used after anastomosis were allowed to survive and vascular patency was confirmed.
The results of Example 1 and Comparative Example 1 are shown in Table 1. In addition, data at the time of stump anastomosis was also described as reference data.

（考察）
実施例１は、比較例１に対して、吻合時間と、主に延べ時間の短縮ができることが確認できた。
（動物の予後）
カフの適応から６ヵ月後のラットの所見は正常で頚動脈の開存が確認できた。

(Discussion)
It was confirmed that Example 1 can shorten the anastomosis time and mainly the total time compared to Comparative Example 1.
(Prognosis of animals)
The findings of the rat 6 months after the indication of cuff were normal and the patency of the carotid artery could be confirmed.

Example 2
[Measurement of cuff vascular anastomosis]
It was verified in vitro whether sufficient anastomosis strength was obtained when anastomosing with a hollow tissue such as a blood vessel.
(Production of cuff 1)
A cuff 1 was produced in the same manner as in Example 1. At that time, the number of ridges 4 was prepared according to the experimental conditions.
(Anastomosis strength experiment)
Rat carotid artery blood vessels were collected and immersed in physiological saline to prevent drying. The diameter of the collected blood vessel was about 1.0 mm. These blood vessels were cut into approximately 10 mm and used for experiments.
In other words, an octopus thread as a support was bonded to the stump of the blood vessel using an instantaneous adhesive, and the cuffs of Example 2 and Comparative Example 2 were attached to the other stump. In Example 2, the blood vessel was hooked and fixed with the cuff ridge 4 at the time of attachment. Further, in Example 2, the number was assigned to the ridge 4 as 1 to 3. In Comparative Example 2, the old cuff made of PE was tied to a blood vessel and fixed. The fixed blood vessel was pulled at a tensile strength of 0.1 mm / sec, and the force with which the cuff was detached from the blood vessel or the blood vessel was damaged was measured.
The results are shown in Table 2.

（考察）
表２の結果より、本発明の「新カフ」よる血管吻合の吻合強度は、十分であることが確認できた。
また鉤４の数は、２個以上形成したほうが、効果が優れていることが確認できた。

(Discussion)
From the results in Table 2, it was confirmed that the anastomosis strength of the vascular anastomosis by the “new cuff” of the present invention was sufficient.
Further, it was confirmed that the effect was excellent when the number of the ridges 4 was two or more.

Schematic of the tissue anastomosis medical instrument (cuff) of the present invention

Explanation of symbols

1 Tissue anastomosis medical device (cuff)
2 backbone 3 handle 4 鉤 D1 inner diameter D2 (of backbone 2) outer diameter H (of backbone 2) height L (of backbone 2) length (of handle 3)

Claims (3)

  A structure characterized in that a handle (3) is extended from the upper end of the substantially cylindrical trunk (2) and a plurality of ridges (4) are projected from the upper end of the trunk (2). Medical device for anastomosis (1).   The medical instrument (1) for tissue anastomosis according to claim 1, wherein the tip of the ridge (4) is formed with at least a sharp tip in the direction of the handle (3).   The ridge (4) protrudes in a substantially triangular shape, a substantially square shape or a substantially semicircular shape from the upper end portion of the trunk portion (2) toward the handle (3), and the tip in the handle (3) direction is provided. The medical instrument 1 for tissue anastomosis according to claim 1 or 2, which is formed at a sharp point.

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