JP2000166933A - Anastomotic butting material - Google Patents

Abstract

PROBLEM TO BE SOLVED: To prevent anastomotic failure, bleeding, etc., and to execute sure anastomose by once operation by forming a staple prosthesis part with an opening at a center part as an anastomotic prosthesis material. SOLUTION: A anastomotic prosthesis material 1 is formed by providing the doughnut-shaped staple prosthesis part 3 and a cylindrical fitting part 4 with a coaxial opening 2 in a center. At the time of using it, in the case of anastomosing a cut-off bowel e.g. an anvil part 9 to which the material is fitted is inserted to one of the cut-off parts of the bowel and an automatic anastomosing device main body 7 mounting the material 1 to a staple housing part 5 is inserted to the other of the cut-off parts. Then, a trocar is put out by penetrating a parietal from the opening of the material 1 and after connecting an anvil shaft 8, both of 6 and 8 are housed in the main body 7 to be stapled and at the same time, the inner surface of the staple is cut off to pull out the main body 7 from an enteric canal and the cut-off part of the bowel is sewn to anastomose the enteric canal.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an anastomotic prosthesis suitable for use in an automatic anastomosis device in a surgical operation and the like, and an automatic anastomosis device having the anastomotic prosthesis.

[0002]

2. Description of the Related Art A stapler-type automatic anastomosis device having a large number of staples can be used in a situation where a surgical field is deep and it is difficult to perform hand-sewn anastomosis. It is commonly used for end-to-end, end-to-side, and side-to-side anastomosis in thoracic, obesity, colon, rectal surgery and laparoscopic surgery for reasons. However, it has been pointed out that staples at the anastomotic portion are not properly formed, and that anastomotic defects such as leak at the anastomotic portion, stenosis at the anastomotic portion, tissue damage, insertion of soft tissue into the anastomotic device, rupture and bleeding are caused. Also, once the anastomosis fails, the reconstructed portion is already short, making reanastomosis much more difficult.

[0003]

SUMMARY OF THE INVENTION An object of the present invention is to provide an anastomotic prosthetic material which can be used for an automatic anastomotic device without anastomotic failure, bleeding, etc., and which can be securely anastomosed at once.

[0004]

Means for Solving the Problems The present invention provides the following items 1 to
Regarding item 6. Item 1. An anastomotic prosthesis comprising a staple prosthesis having an opening in the center. Item 2. Item 2. The anastomotic prosthetic material according to Item 1, wherein the staple prosthesis is a donut-shaped film or nonwoven fabric. Item 3. Item 2. The anastomotic prosthesis according to Item 1, further comprising a cylindrical mounting portion that covers the staple housing portion or the anvil portion of the automatic anastomosis device. Item 4. Item 2. The anastomotic prosthetic material according to Item 1, wherein the staple prosthesis includes a biodegradable and absorbable material. Item 5. Item 5. The anastomotic prosthetic material according to Item 4, wherein the biodegradable and absorbable material comprises a copolymer of lactic acid and caprolactone. Item 6. An automatic anastomosis device having an anvil portion and a staple housing portion, wherein the anastomosis prosthesis material according to any one of Items 1 to 5 is attached to the anvil portion and / or the staple housing portion.

[0005]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The automatic anastomosis device to which the prosthetic material of the present invention is applied is not particularly limited as long as it is a staple-type automatic anastomosis device having a large number of staples embedded therein, for example, manufactured by UNITED STATE SURGICAL. AUTO SUTURE curved
DEEA 21,25,28,31 (trade name), PROXIMATE ILS CDH 21,25,29,33 (trade name) manufactured by ETHICONENDO SURGERY and the like can be used.

As shown in FIG. 4, such a known automatic anastomosis device has an automatic anastomosis device main body 7 having a staple housing part 5 (not shown) and a trocar 6, and opposes the housing part 5. A cutter (not shown) including a staple receiving groove (not shown) and an anvil portion 9 having an anvil shaft 8 and having a circular blade that slides inside the cylindrical staple housing portion 5 is provided.

FIGS. 1 to 3 show, as an embodiment of the anastomotic prosthesis 1 of the present invention, an anastomotic prosthesis comprising a donut-shaped staple prosthesis 3 having a concentric opening 2 at the center and a cylindrical mounting portion 4. 1 is shown. Anastomotic prosthesis 1 of FIGS.
5 are attached to the anvil part 9 and the staple housing part 5 of the automatic anastomotic apparatus body 7, respectively, as shown in FIGS. If the diameter of the opening 2 is substantially the same as the diameter of the anvil shaft 8 and the trocar 6, the anastomotic prosthesis material is fixed by the anvil shaft 8 and the trocar 6, so that the mounting portion 4 is not necessarily required. Further, when the staple prosthetic part 3 is bonded to the anvil part 8 or the staple housing part 5 with an adhesive, the mounting part 4 is unnecessary.

An example of a procedure for performing anastomosis of the intestine using an automatic anastomosis device equipped with the anastomotic prosthesis 1 of the present invention is shown in FIGS.

[0009] As shown in FIGS.
An anvil 9 fitted with the anastomotic prosthesis 1 of the present invention is inserted into one of the 10 and an automatic anastomotic device body 7 fitted with the anastomotic prosthesis 1 of the present invention is inserted into the staple housing 5 on the other side. After the insertion of the automatic anastomotic device body 7, the opening 2 of the anastomotic prosthesis 1
The trocar 6 is taken out of the intestinal wall from. Trocar 6
After connecting the trocar 6 and the anvil shaft 8 to the automatic anastomotic apparatus main body 7, the staple 5a is fastened and the inner surface of the staple is cut off, and the automatic anastomotic apparatus main body 7 connected to the anvil section 9 is connected to the intestinal tract. From the intestine, and suturing the cut portion 10 of the intestine, the anastomosis of the intestinal tract can be performed. 8 and 9, 11
Indicates a stapled anastomosis, and 12 indicates a suture. The staples and the anastomotic prosthesis after the anastomosis are dropped into the anastomotic portion and discharged according to the adhesion at the anastomotic portion of the intestinal tract.
The anastomotic prosthesis is preferably composed of a biodegradable and absorbable material.

The anastomotic prosthesis 1 of the present invention can provide the effect of protecting the tissue of the anastomosis portion even when it is mounted on only one of the anvil portion 9 and the staple housing portion 5.
And stapling with the anastomotic prosthesis materials 1 and 1 sandwiching the tissue between the anastomotic prostheses 1 and 1 from the viewpoint of preventing tissue damage, tearing, bleeding, and the like.

The anastomotic prosthesis 1 of the present invention has an opening through which the anvil shaft 8 and the trocar 6 pass through the portion corresponding to the inside of the staple receiving groove so that the anastomotic prosthesis 1 can be mounted on the anvil shaft 8 and the trocar 6 of the automatic anastomosis apparatus. It has a formed staple prosthesis part, and has a mounting part that can be mounted on the outer circumference of the anvil or the outer circumference of the staple housing as required. The mounting portion may have any shape such as a cylindrical shape, an elliptical cylindrical shape, a rectangular cylindrical shape, and a net shape as long as the mounting portion can be mounted on the outer periphery of the anvil or the outer periphery of the staple housing portion. The mounting portion of the anastomotic prosthesis material of the present invention, a film, a nonwoven fabric, a woven fabric,
A knitted fabric, a power net, or the like can be used, and the same material (film, nonwoven fabric, or the like) as the staple prosthesis is preferably used.

The anastomotic prosthetic material 1 of the present invention is used by being attached to the staple housing 5 and anvil 9 of such an automatic anastomotic apparatus. This is a donut-shaped sheet having a circular opening 2 at the center that can be attached to the shaft 8, and the staple 5a stops the tissue via the prosthetic material 1 during the anastomosis. The presence of the anastomotic prosthesis of the present invention is characterized in that a force is evenly applied to the entire stapled donut-shaped tissue. When the anastomotic prosthesis material of the present invention further has a mounting portion, the staple prosthesis portion and the mounting portion may be separately molded and then manufactured by fusion, or may be manufactured by integral molding by an injection molding method or the like. Good.

The stapling force is evenly applied to the tissue by the anastomotic prosthetic material of the present invention, so that an appropriate anastomotic staple can be formed and the tissue can be prevented from being damaged, torn, and bleeding. Further, when the mounting portion covers the anvil portion or the side surface of the staple housing portion of the main body, when the automatic anastomosis device is moved back and forth or rotated after tissue insertion,
Damage to tissue at the end of the anastomosis device can be prevented.

The sheet-like staple prosthesis can be produced by a usual plastic film molding method, and specifically, melt extrusion methods such as inflation, T die casting, press method, solution casting method, calendering method and the like. It can be manufactured by cutting a sheet obtained by an arbitrary method into a predetermined shape and forming an opening.

[0015] Even if the sheet is in the form of a non-woven fabric, the effect as a prosthetic material is exhibited.

Such a non-woven fabric is obtained by any method such as a method of needle-punching a woven and knitted cloth and a melt extrusion method such as spun bonding, flashing and melt blowing.

The sheet is not particularly limited in raw material and form as long as it can be cut by a cutter of an anastomotic device and has strength as a prosthetic material. The conductive material is preferred. Examples of such biodegradable absorbent materials include natural polymers such as collagen, gelatin, chitin, and chitosan, and aliphatic polyesters (polyglycolic acid, polylactic acid, polycaprolactone, polyvalerolactone, and copolymers thereof).
Or polyester ethers (poly-1,4-dioxanone-2-one, poly-1,5-dioxepan-2-one, ethylene glycol-the aliphatic polyester copolymer), and the aliphatic polyester and the polyester ether. And a biodegradable and absorbable synthetic polymer such as a copolymer of lactic acid (L-form, D-form, DL-form) and caprolactone copolymer, more preferably L-lactic acid and ε-
It is a copolymer of caprolactone.

The copolymer of lactic acid and ε-caprolactone is
It is preferable that it is flexible and retains the strength to protect the tissue from staples, and that the mechanical properties and the decomposition rate can be easily controlled. The copolymerization weight ratio of both is preferably 80/20 to 30/70 (lactic acid / caprolactone), more preferably 60/40 to 45 /.
55 (lactic acid / caprolactone).

The anastomotic prosthesis of the present invention requires a certain thickness of the staple prosthesis in order to stabilize the force applied to the anastomosis by staples. Also does not damage tissue,
The prosthetic part has a thickness of 0.05 to 1 mm, preferably 0.1 to 0.7 mm, and more preferably 0.2 to 0.5, because it must be cut with an anastomotic cutter.
mm.

In addition, the anastomotic device is often moved back and forth or rotated after tissue insertion during use. In this case, if the anastomotic prosthesis is present only on the staple surface, the tissue may be damaged at the corner of the anastomotic device, or the anastomotic prosthesis of the present invention may move from the attachment site. In order to solve the above-mentioned drawbacks, it is preferable that the mounting portion of the anastomotic prosthesis cover the anvil and the side surface of the end of the automatic anastomotic device body. Such sides serve not only to fix the prosthesis but also to prevent tissue damage when moving the anastomotic device through the tissue. Such a mounting portion is mounted on the anastomotic device with a certain tension or more. After the anastomosis, when the anastomotic device is taken out, the anastomotic prosthesis material of the present invention needs to be detached from the anastomotic device and remain in the anastomotic portion.

[0021]

The present invention will be described below with reference to examples.
However, the following examples do not limit the present invention. Production Example 1: Production of Sheet L-lactic acid / ε-caprolactone copolymer (weight ratio 55/45, weight average molecular weight by GPC 22
Hereafter, it is described as P (L-LA / CL) (weight ratio 55/45). ) Was prepared. The obtained P (L-LA / CL) was dissolved in a solvent (chloroform) to a concentration of 5 wt%,
After complete dissolution, the mixture was filtered to remove unmelted substances. next,
A certain amount is cast (cast) on a glass plate, air-dried, and then vacuum-dried at 50 ° C. for 12 hours to remove the solvent and to remove P.
A sheet composed of (L-LA / CL) (weight ratio 55/45) was obtained. Sheet thickness 85, 190, and 270μ
m. Each sheet was cut into a strip of 25 × 10 mm. Comparative Example 1 After immersing dried sheep intestine of 80 × 25 mm in physiological saline at 25 ° C. for 1 hour, 5 mm portions were overlapped from the short side end, and two places were fixed with 8 × 4 mm staples, and tested. It was a piece. Example 1 An 80 × 25 mm dried sheep intestine was immersed in a physiological saline solution at 25 ° C. for 1 hour, 5 mm portions were overlapped from the short side end, and then the overlapped portions of the intestine were placed on both sides with an 85 μm sheet. Between the sheets, and staple each sheet with 8 x 4 mm staples.
The test pieces were retained at the three locations. Example 2 An 80 × 25 mm dried sheep intestine was immersed in a physiological saline solution at 25 ° C. for 1 hour, 5 mm portions were overlapped from the short side end, and the overlapped portions of the intestine were placed on both sides with a 190 μm sheet. , And the sheet was fixed at two places with 8 × 4 mm staples to obtain a test piece. Example 3 An 80 × 25 mm dried sheep intestine was immersed in a physiological saline solution at 25 ° C. for 1 hour, and then a 5 mm portion was overlapped from the short-side end, and then the overlapped intestine was placed on both sides with a 270 μm sheet. , And the sheet was fixed at two places with 8 × 4 mm staples to obtain a test piece. Tensile test The test pieces obtained in Examples 1 to 3 and Comparative Example were subjected to a tensile test at a distance between chucks of 100 mm and a tensile speed of 10 mm / min using an Instron tensile tester (Instron4302 manufactured by Instron Japan). The strength at break was measured.

[0022]

[Table 1]

From the above test, it is found that the strength of the prosthetic portion is increased by interposing the anastomotic prosthesis.

Therefore, by using the anastomotic prosthetic material of the present invention, insufficiency of an anastomosis, generation of a leak, and the like can be prevented, and anastomosis can be reliably performed at one time.

[0025]

According to the present invention, when used in an automatic anastomosis apparatus, damage to human tissue by staples can be reduced. In addition, since the formation of staples is further ensured by the prosthetic material, a reduction in anastomosis failure can be expected.

[Brief description of the drawings]

FIG. 1 is a front view of an anastomotic prosthesis.

FIG. 2 is a side view of an anastomotic prosthesis.

FIG. 3 is a perspective view of an anastomotic prosthesis.

FIG. 4 is a schematic diagram of an automatic anastomosis device.

FIG. 5 is a view showing the attachment of the anastomotic prosthesis material of the present invention to an automatic anastomotic anvil part.

FIG. 6 is a view showing the attachment of the anastomotic prosthesis material of the present invention to an automatic anastomotic instrument body.

FIG. 7 is a schematic view showing a procedure for performing an anastomosis.

FIG. 8 is a schematic view showing a procedure for performing an anastomosis.

FIG. 9 is a diagram showing a state of an anastomosis portion.

[Explanation of symbols]

 Reference Signs List 1 anastomotic prosthetic material 2 opening 3 staple prosthetic part 4 mounting part 5 staple housing part 5a staple 6 trocar 7 automatic anastomotic device main body 8 anvil shaft 9 anvil part 10 intestinal cutting part 11 anastomotic part 12 suture part

 ──────────────────────────────────────────────────続 き Continued on the front page (72) Inventor Yoshito Raft 2-182 Gokasho Hirookadani, Uji-shi, Kyoto (72) Inventor Eiji Ito 43-43 Tennocho, Okazaki, Sakyo-ku, Kyoto Lions Mansion F-term (reference) 4C060 CC02 CC06 CC32 CC36 4C081 AC02 AC03 BA16 BB04 BB09 CA171 CA191 CC01 DA01 DA03 DA04 DA05 EA02 EA03

Claims (6)

[Claims] An anastomotic prosthesis comprising a staple prosthesis having an opening in the center. 2. The anastomotic prosthesis according to claim 1, wherein the staple prosthesis is a donut-shaped film or a non-woven fabric. 3. The anastomotic prosthetic material according to claim 1, further comprising a cylindrical mounting portion for covering the staple housing portion or the anvil portion of the automatic anastomotic device. 4. The anastomotic prosthesis according to claim 1, wherein the staple prosthesis comprises a biodegradable and absorbable material. 5. The anastomotic prosthetic material according to claim 4, wherein the biodegradable and absorbable material comprises a copolymer of lactic acid and caprolactone. 6. An automatic anastomosis device provided with an anvil portion and a staple housing portion, wherein the anastomosis prosthesis material according to any one of claims 1 to 5 is mounted on the anvil portion and / or the staple housing portion. Anastomosis device.