JP2009125439A - Member for anastomosis - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To anastomose tubular biomedical tissues in a reliable and stable joint state with a simple operation. <P>SOLUTION: The member 1 for an anastomosis is formed into a cylindrical shape of an outer shape dimension capable of being inserted into openings at the end parts 2a, 3a of the paired tubular organism tissue 2, 3 with the use of a knitted material obtained by knitting yarn made of bio-compatible polymer. The member 1 has: flexibility for clogging the inner opening so as to be crushed to seal the inner surface by outer force to be added in a radius direction from an external side; heat resistance against temperature higher than the melting point of collagen; and elasticity to open the clogged inner opening by releasing the outer force after heating. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to an anastomosis member for anastomosing a pair of tubular biological tissues.

  Conventionally, in order to anastomoses tubular biological tissues such as intestinal tracts and blood vessels, end openings of two biological tissues are joined to each other and the joined parts are sutured. However, the stitching operation of the joint portion is complicated, and particularly difficult to perform endoscopically.

  When joining the internal thoracic artery to the wall of the coronary artery as a technique for anastomosing the living tissue without performing such a complicated suturing operation, the joining portion is welded by applying ultrasonic energy to the joining portion. An anastomosis technique is also known (for example, refer to Patent Document 1). Furthermore, there is known an anastomosis shape memory material that is disposed radially outward of the butted portion of two blood vessels and is contracted by heating so as to be in close contact with the outer peripheral surface of the blood vessel and maintain the blood vessel in a joined state by its frictional force. (For example, see Patent Document 2).

Japanese Patent No. 3766520 Japanese Patent No. 3503045

However, although the anastomosis technique of Patent Document 1 can be applied to an application in which tubular biological tissues can be sandwiched in an overlapped state, the range that can be anastomosed at a time is limited to a part in the circumferential direction. Joining over the entire circumference in a state where the end openings of the living tissue are brought together is complicated because it is necessary to perform the work a plurality of times while shifting the joining portion in the circumferential direction.
In addition, the shape memory material for anastomosis disclosed in Patent Document 2 is simple because it can be bonded to the outer peripheral surface of a blood vessel in a butted state only by being contracted by heating, and can be joined all at once at the entire circumference. Therefore, the bonding force is weak and it is difficult to maintain a stable bonding state.

  The present invention has been made in view of the above-described circumstances, and an object thereof is to provide an anastomosis member capable of anastomosing a tubular living tissue to a more stable and stable state by a simple operation. .

In order to achieve the above object, the present invention provides the following means.
The present invention is formed by a braided material knitted with a biocompatible polymer, and is formed into a cylindrical shape having an external dimension that can be inserted into the end openings of a pair of tubular biological tissues, and by external force applied in the radial direction from the outside. , Flexibility that can be crushed until the inner opening is closed and the inner surface is brought into close contact, heat resistance to a temperature higher than the melting point of collagen, and external force is released after heating, thereby opening the closed inner opening An anastomosis member having elasticity that can be used is provided.

  In order to anastomoses a pair of tubular biological tissues using the anastomosis member according to the present invention, first, the anastomosis member is immersed in an electrolyte solution such as physiological saline and impregnated with physiological saline. Next, each of the pair of tubular biological tissues is partially inserted into the end openings, the end openings of the biological tissues are butted together, or the ends are overlapped in the radial direction.

  In this state, an external force is applied in the radial direction in the vicinity of the portion to be joined to squeeze the living tissue and the anastomosis member into a flat plate shape until the inner opening is closed and the inner surface is in close contact. Since the anastomosis member according to the present invention has flexibility, even if it is crushed into a flat plate shape, its form can be maintained without breaking.

  And in this state, it supplies with electricity to thickness direction. Since the anastomosis member according to the present invention has conductivity by impregnation with physiological saline, a current flows in the thickness direction of the biological tissue and the anastomosis member, and the magnitude of the current value and the biological tissue Heat is generated with a magnitude corresponding to the magnitude of the resistance value. By setting the calorific value generated in the living tissue in advance near the melting point of the collagen, carbonization of the living tissue can be prevented while melting the collagen.

  Since the anastomosis member of the present invention has heat resistance to a temperature higher than the melting point of collagen, it can maintain its properties without being denatured by heating. Thereby, the collagen contained in the living tissue is heated to the melting point of the collagen, and the outer peripheral surface of the anastomosis member and the inner surface of the living tissue are made to leak between the anastomosis member and the living tissue. Glue.

  Thereafter, the energization is stopped and the applied external force is released. Since the anastomosis member of the present invention has elasticity, when the externally crushed external force is released, the tubular living tissue is expanded by the elasticity of the anastomosis member, and the closed internal opening is opened. To do. Thereby, a pair of tubular biological tissues are anastomosed via the anastomosis member, and can be integrated as a continuous tubular biological tissue.

  That is, according to the present invention, a single tubular living tissue can be obtained by simply inserting it into a joint between a pair of tubular living tissues, releasing the external force after energizing in a state of being crushed by applying an external force in the radial direction. It can be easily anastomosed. Since the anastomosed living tissue is adhered to the anastomosis member using collagen instead of only frictional force, it can be anastomosed in a more stable state.

  Furthermore, according to the member for anastomosis according to the present embodiment, it is possible to sufficiently impregnate physiological saline in the gap between the yarns by configuring the braided material by knitting the yarn, and ensure high conductivity. can do.

In the said invention, it is preferable that the said thread | yarn is knitted at intervals of 5-500 micrometers.
By providing an interval of 5 μm or more, the electrolyte solution can be easily absorbed between the yarns, and high conductivity can be easily ensured. Further, the elasticity can be improved by making the interval as small as possible. Further, by limiting the distance to 500 μm or less, when the tissue is sandwiched with the living tissue and pressurized with an external force, the living tissue enters between the threads and adheres on the inner surface side of the anastomosis member. Can be prevented.

Moreover, in the said invention, the said thread | yarn may be comprised by twisting 20-30 fibers.
By doing so, irregularities are formed on the surface of the yarn, and the absorbed electrolyte solution can be easily retained. As a result, it is possible to prevent a decrease in conductivity due to running out of liquid and easily ensure high conductivity.

Moreover, in the said invention, the said thread | yarn is good also as being comprised by the thickness of 80-120 denier.
By doing in this way, elasticity can be improved and it can restore | restore easily in the original tubular form by releasing after pressurization.

  According to the anastomosis member according to the present invention, an effect is obtained that a tubular living tissue can be anastomosed more reliably and stably to a joined state.

An anastomosis member 1 according to an embodiment of the present invention will be described below with reference to FIGS.
As shown in FIG. 1, the anastomosis member 1 according to the present embodiment is a tubular member, and is an 80 to 120 denier yarn 1 a formed by twisting 20 to 30 fibers of a polylactic acid polymer. Is made of a braided material knitted with a gap of 5 to 500 μm. As a method for weaving the braided material, an arbitrary weaving method such as a fourth stitch can be adopted.

  The anastomosis member 1 according to the present embodiment configured as described above is constituted by a thread 1a made of a polylactic acid-based polymer, so that an external force F is applied as shown in FIGS. 2 (a) and 2 (b). Even if it is crushed in the radial direction, the inner opening is closed and the inner surface is brought into close contact with each other, so that it does not break. In addition, the anastomosis member 1 according to the present embodiment has heat resistance that is not denatured even when heated to a temperature higher than the melting point of collagen by being composed of a thread 1a made of a polylactic acid polymer.

  In addition, the anastomosis member 1 according to this embodiment is configured by weaving 80 to 120 denier yarn 1a formed by twisting 20 to 30 fibers made of a polylactic acid-based polymer. When the external force is released after being heated to a temperature higher than the melting point of collagen in a crushed state, it has elasticity that can be restored to open the closed internal opening.

  Furthermore, since the anastomosis member 1 according to the present embodiment is composed of a braided material knitted with a gap of 5 to 500 μm between the adjacent yarn 1a and the yarn 1a, Water can be easily absorbed so that the liquid is accommodated in the gap. Therefore, for example, high conductivity can be easily imparted by impregnating an electrolyte solution such as physiological saline.

  Moreover, since the thread 1a constituting the anastomosis member 1 according to the present embodiment is formed by twisting 20 to 30 polylactic acid polymer fibers, a large number of irregularities are formed on the surface of the thread 1a, The absorbed electrolyte solution can be retained by the unevenness. As a result, it is possible to prevent the occurrence of inconvenience that the liquid breakage occurs and the conductivity decreases, and the high conductivity can be maintained.

The operation of the anastomosis member 1 according to this embodiment configured as described above will be described below.
The case where the anastomosis of the tubular biological tissue, for example, the intestinal canals 2 and 3 is described using the anastomosis member 1 according to the present embodiment.

  In order to anastomoses the intestinal tracts 2 and 3 using the anastomosis member 1 according to this embodiment, first, the anastomosis member 1 is immersed in physiological saline and impregnated with physiological saline. Since the anastomosis member 1 is composed of a braided material made up of a large number of yarns 1a knitted with a gap of 5 to 500 μm, it absorbs physiological saline so that the gap is sufficiently impregnated and has high conductivity. To have.

  In this state, as shown in FIG. 3, the anastomosis member 1 according to the present embodiment is inserted into the openings of the joint end portions 2 a and 3 a of the pair of intestinal tracts 2 and 3 to be anastomosed. Thus, it is set as the state which joined the joining edge parts 2a and 3a of a pair of intestinal canals 2 and 3. FIG. In this insertion operation, a part of the physiological saline impregnated in the anastomosis member 1 flows toward the intestinal tracts 2 and 3, but the anastomosis member 1 according to this embodiment is composed of 20 to 30 polylactic acid-based polymers. Since it is comprised by the thread | yarn 1a formed by twisting a fiber, the physiological saline can be kept on many unevenness | corrugations formed in the surface of the thread | yarn 1a. Thereby, the electroconductive fall by generation | occurrence | production of a liquid breakage can be prevented.

  Next, as shown in FIG. 4, a pair of electrodes 4 for pressurization are brought close to the outer sides in the radial direction in the vicinity of the joining end portions 2a and 3a, and the intestinal canals 2 and 3 are applied with an external force F as shown in FIG. The anastomosis member 1 is sandwiched in the radial direction.

  Since the anastomosis member 1 has flexibility, as shown in FIG. 5, the internal opening can be closed by the external force F and the inner surface can be crushed. In this state, current is applied by applying a voltage between the electrodes 4 as shown in FIG. Since the anastomosis member 1 has high conductivity due to the impregnated physiological saline, an electric current I flows between the electrodes 4 through the intestinal canals 2 and 3 and the anastomosis member 1, and the intestinal canals 2 and 3 Heat is generated with a calorific value proportional to the product of the magnitude of the resistance value and the square of the magnitude of the current I.

  In this case, the anastomosis member 1 according to the present embodiment has high conductivity so that the resistance value is sufficiently smaller than the resistance values of the intestinal tracts 2 and 3. The amount of heat generated is small and energy is not wasted. In addition, since the anastomosis member 1 according to this embodiment has heat resistance higher than the melting temperature of collagen, it can maintain its properties without being denatured even when heated to a temperature at which the collagen melts. it can.

  At this time, the voltage applied between the electrodes 4 is adjusted so that the temperature is slightly higher than the melting temperature of collagen due to heat generation in the intestinal tracts 2 and 3. Collagen that is an extracellular matrix can be melted to facilitate flow. Then, the collagen flowing due to heat generation penetrates into the gap between the intestinal tracts 2 and 3 and the anastomosis member 1. As shown in FIG. 7, this phenomenon occurs over the entire circumference of the anastomosis member 1, so that the flowing collagen penetrates the entire circumference of the anastomosis member 1.

In this case, in this embodiment, the gap between the adjacent threads 1a and 1a is set narrowly to 500 μm or less, so that the flowed collagen is prevented from entering the inner surface of the anastomosis member 1 through the gap. can do.
From this state, the voltage applied to the electrode 4 is stopped, and the external force F applied to the electrode 4 is released as shown in FIG. Since the anastomosis member 1 has high elasticity, when the external force F is released, the anastomosis member 1 is restored to spread outward in the radial direction, and the closed internal opening is opened.

  That is, on the outer peripheral surface of the anastomosis member 1, collagen penetrates between the intestinal tracts 2 and 3 and the anastomosis member 1. 1 is bonded. On the other hand, since there is no collagen as an adhesive on the inner surface of the anastomosis member 1, the inner surfaces that are in close contact with each other are not bonded, and when the external force F is released, they are separated by the elasticity of the anastomosis member 1. , Come to open.

As a result, as shown in FIG. 9, the region A in the vicinity of the joint end of the intestinal tracts 2 and 3 sandwiched between the electrodes 4 and the anastomosis member 1 disposed radially inward thereof are all formed. The bonded end portions 2a and 3a of the pair of intestinal canals 2 and 3 are bonded in a butted state in a state where they are bonded over the circumference and integrated.
That is, according to the member 1 for anastomosis according to the present embodiment, the intestinal tracts 2 and 3 that are a pair of tubular living tissues can be easily and simply formed by simply applying a voltage while being sandwiched between the pair of electrodes 4 by a predetermined external force F. Can be anastomosed.

  As a result, there is an advantage that the operation can be greatly simplified as compared with the conventional anastomosis by suturing and the anastomosis by applying ultrasonic waves multiple times in the circumferential direction. In particular, in an endoscopic operation with little space for handling the energy treatment device, it is sufficient to secure a space for pinching the intestinal canals 2 and 3 once in the radial direction, which greatly increases the complexity of the anastomosis work. There is an advantage that it can be reduced.

  In addition, according to the anastomosis member 1 according to the present embodiment, since it is adhered to the inner walls of the intestinal tracts 2 and 3 by collagen, the anastomosis state is compared with a conventional anastomosis member that is fixed only by friction. There is an advantage that it can be stably maintained. Furthermore, according to the anastomosis member 1 according to the present embodiment, the anastomosis member 1 is composed of a highly biodegradable polylactic acid-based polymer. That is, when the anastomosed region A is joined and healed, the anastomosis member 1 according to the present embodiment disappears, so that there is an advantage that no foreign matter remains in the body.

Here, the braiding material constituting the anastomosis member 1 according to the present embodiment will be described.
A braided material is formed into a cylindrical shape having a diameter of 8 to 30 mm by weaving a yarn made of a polylactic acid polymer fiber, the gap between the adjacent yarn 1a and the yarn 1a, the structure of the yarn 1a, and the thickness of the yarn 1a. The elasticity and the conductivity by impregnation with physiological saline were measured respectively.

The elasticity is applied to the digestive tract of pigs, energized while applying pressure with a force of 1 to 4 kg, and the pressure is released after the digestive tract and the anastomosis member 1 are adhered, so that the anastomosis member 1 is cylindrical. It was measured by the degree to which it was restored.
The conductivity was measured by the degree of adhesion between the digestive tract and the anastomosis member 1. The results are shown in Tables 1 to 3.

  According to Table 1, when the gap between the adjacent yarn 1a and the yarn 1a is less than 5 μm, the elasticity to restore the original shape is high, but the physiological saline absorbs water between the yarn 1a and the yarn 1a. Rather, it was rather water-repellent and the conductivity was low. On the other hand, if the gap is 500 μm or more, sufficient physiological saline is absorbed and the conductivity is high, but the collagen melted by heating the digestive tract is heated from the gap between the thread 1a and the thread 1a. There is a problem that it penetrates to the inner surface of 1 and the inner surfaces adhere to each other. As a result, it was found that the gap between adjacent yarns 1a and 1a is preferably in the range of 5 μm to 500 μm because both elasticity and conductivity can be achieved.

  Further, according to Table 2, when the yarn 1a constituted by twisting 20 fibers or less is used, sufficient elasticity cannot be obtained, and the cylindrical form is difficult to be restored, and The impregnated physiological saline was not retained, and the conductivity decreased due to running out of liquid. On the other hand, the elasticity was improved by twisting 20 to 30 fibers, and the conductivity was improved by being retained by the unevenness of the yarn 1a. As a result, it was found that it is preferable to use a yarn formed by twisting 20 to 30 fibers for the structure of the yarn 1a.

  Further, according to Table 3, it was found that sufficient elasticity could not be obtained when the thickness was about 40 denier, and that rigidity was increased when the thickness was about 160 denier, and sufficient elasticity could not be obtained. As a result, it was found that it is preferable to use the yarn 1a having a thickness of 80 to 120 denier because sufficient elasticity can be obtained.

  In the anastomosis member 1 according to the present embodiment, collagen B may be applied to at least a part of the outer peripheral surface as shown in FIG. By doing in this way, even when there is little collagen contained in the living tissue to be anastomosed, the inner surface of the living tissue and the outer peripheral surface of the anastomosis member 1 can be more reliably bonded. Elastin may be applied instead of collagen or together with collagen. By doing so, even when the amount of elastin contained in the living tissue is small, the flexibility can be maintained by supplying elastin to the living tissue.

  In this embodiment, the polylactic acid-based polymer is adopted. Instead, any material is used as long as it is a biocompatible material having the above-described flexibility, elasticity, and heat resistance. It is good as well. In addition, a biodegradable material may not be used for a portion that is allowed to be placed in the body.

  Furthermore, the tubular biological tissue to be anastomosed is not limited to the intestinal tracts 2 and 3 and can be applied to any tubular biological tissue such as other digestive tract, blood vessel, or urinary tract. In particular, when applied to a site where there is a concern about the occurrence of a thrombus on the surface of the anastomosis member 1, such as a blood vessel, the entire surface or the entire surface exposed in the blood vessel may be an antithrombotic material, for example, collagen. Or with elastin. Alternatively, the anastomosis member 1 may be made of an antithrombotic material.

It is a perspective view which shows the member for anastomosis concerning one Embodiment of this invention. It is a figure explaining the softness | flexibility of the member for anastomosis of FIG. 1, Comprising: (a) The shape before applying external force, (b) The perspective view which shows the shape after applying external force, respectively. It is a longitudinal cross-sectional view which shows the procedure of anastomosis of a pair of intestinal tract using the member for anastomosis of FIG. It is a longitudinal cross-sectional view which shows the state which inserted the member for anastomosis from the state of FIG. FIG. 5 is a longitudinal sectional view showing a state in which the intestinal tract and the anastomosis member are pressed with electrodes in the radial direction from the state of FIG. 4. It is a longitudinal cross-sectional view which shows the state which supplied with electricity to the intestinal tract and the member for anastomosis with the electrode from the state of FIG. It is the cross-sectional view which looked at the state of FIG. 6 from the axial direction of the member for anastomosis. FIG. 8 is a transverse cross-sectional view showing a state in which energization is stopped and pressure is released from the state of FIG. 7. It is a longitudinal cross-sectional view which shows a pair of intestinal tracts which were anastomosed and integrated by the anastomosis member of FIG. It is a perspective view which shows the 1st modification of the member for anastomosis of FIG.

Explanation of symbols

B Collagen 1 Anastomotic member 2, 3 Intestine (living tissue)
2a, 3a Joining end (end)
5 steps

Claims (4)

A braided material knitted with a biocompatible polymer is formed into a cylindrical shape having an outer dimension that can be inserted into the end openings of a pair of tubular biological tissues,
The external force applied from the outside in the radial direction closes the internal opening and can be crushed until the inner surface is brought into close contact, heat resistance to temperatures higher than the melting point of collagen, and release of external force after heating An anastomosis member provided with elasticity capable of opening an inner opening that has been formed.   The anastomosis member according to claim 1, wherein the yarn is knitted with an interval of 5 to 500 μm.   The anastomosis member according to claim 1 or 2, wherein the yarn is constituted by twisting 20 to 30 fibers.   The anastomosis member according to any one of claims 1 to 3, wherein the thread has a thickness of 80 to 120 denier.

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