WO2013172474A1

WO2013172474A1 - Body insertion tube self-adhering to tissue, and method for adhering body insertion tube to body organ tissue

Info

Publication number: WO2013172474A1
Application number: PCT/JP2013/063880
Authority: WO
Inventors: 増澤　徹; 敏行青代
Original assignee: 国立大学法人茨城大学
Priority date: 2012-05-15
Filing date: 2013-05-14
Publication date: 2013-11-21
Also published as: JP2013255789A; JP6206838B2

Abstract

Provided are a body insertion tube capable of self-adhering to a tissue that is applicable to a combined low-energy adhesion method, and a method for adhering the aforesaid body insertion tube to a body organ tissue to thereby adhere the body insertion tube to the body organ tissue more quickly and easily than in conventional cases and establish a high adhesion strength without forming a gap that allows the invasion of bacteria. The body insertion tube according to the present invention, which is to be contacted with a body organ tissue and adhered thereto in a state of being coated with the aforesaid body organ tissue, is characterized in that, on the side of the body insertion tube to be in contact with the body organ tissue, at least a groove, hole or depressed part is formed, said groove, hole or depressed part having such a size as allowing a part of the body organ tissue to enter therein through deformation or displacement and thus achieve an anchoring effect, and a passage for applying a negative pressure to the groove, hole or depressed part, upon the adhesion of the body insertion tube to the body organ tissue, is also formed.

Description

Tissue self-joining intracorporeal insertion tube and method of joining the intracorporeal insertion tube and internal organ tissue

The present invention relates to an in-vivo insertion tube to be joined with an in-vivo tissue, in particular, used as a devascularized vessel, a blood-delivery vessel or a part thereof joined to an artificial heart, and prevents infection by bacteria etc. Tissue self-adhering intracorporeal insertion tube and a method of joining the intracorporeal insertion tube with internal organ tissue.

In order to attach an auxiliary artificial heart, it is necessary to attach it to the heart via blood removal and blood delivery. At that time, attachment of the devascularized blood to the heart is carried out with a purse string suture 20 using a needle and thread on the heart 19 using a cuff 18 of the devascularized blood vessel 17 as shown in FIG. ing. Similarly, as shown in FIG. 15 (b), attachment of the blood delivery vessel 21 to the artery 19 is also performed by suturing. However, it is reported that such a suture causes a slight gap at the connection between the blood vessel and the cuff or at the connection between the blood supply and the heart, and the bacteria invade from the gap and cause various infections. There is.
As a method to remove the gaps in the junctions that occur when attaching the artificial heart to the heart and removing blood vessels, consider living tissue bonding using high energy such as ultrasonic scalpel and electric scalpel, medical adhesive, etc. Be Ultrasonic scalpels are used in coronary artery bypass surgery and the like, and when cutting blood vessels of several mm, they are used in a method of performing hemostasis by joining and closing the cut surfaces of the blood vessels. An electric scalpel is a device that applies a voltage between return electrodes to cause an electric current to flow to a living tissue, and uses the heat generated thereby to bond. In addition to that, there is a laser knife that utilizes tissue coagulation in which tissue is modified using an argon (Ar) laser or a YAG laser. However, such devices using high energy have a problem that the high energy easily carbonizes the tissue and the living tissue damage is severe. In addition, there is concern about the electric shock to the human body and noise disturbance to other devices.
Medical adhesives are used, for example, for adhesion of soft tissues such as artificial blood vessels used as substitutes for living blood vessels, and cyanoacrylates and fibrins are mainly used as materials. Medical adhesives are excellent in workability and characterized by adhesion for a short time, but have problems in terms of toxicity to the living body and antibacterial properties. In addition, due to adhesive deterioration, adhesive component exuding, etc. during use, not only the adverse effect on the living body but also a significant decrease in adhesion may occur, which limits the use range.
As a living body tissue joining method which does not depend on the above-mentioned high energy, medical adhesive, etc., in patent document 1, a part or the whole is formed of a porous structure or a porous formed body formed from a linear shape. Disclosed is a blood circulation assisting inflow cannula consisting of a porous structure. The porous structures described in Patent Document 1 and Patent Document 2 stabilize the thrombus by utilizing the voids generated by the unevenness and pores of the porous structure in order to prevent blood flow disorder and disease caused by the thrombus. To be anchored to the
In addition, according to Patent Document 3, the endocardium of the heart extends along the outer peripheral surface of the cannula and cuts the extending portion, and the cut endocardial piece mixes in the blood and occludes the blood vessel. In order to prevent the problem, a cannula having a tubular main body and a cylindrical porous body disposed so as to go around the outer peripheral surface of the main body is proposed.
Further,

Patent Documents

4 and 5 propose an in-vivo insertion tube used for anastomosis of a digestive tract, a blood vessel or the like as in-vivo tissue, or a connection between an artificial blood vessel and a living blood vessel. The bioabsorbable connecting tube described in Patent Document 4 described above is provided with a structure having a flange for retaining. Further, in Patent Document 5 described above, the hollow cylindrical member is integrally formed of a corrosion-resistant metal material, and a plurality of through holes are formed in the peripheral wall of the cylindrical member, and the outer periphery of the cylindrical member is formed. A connection for an artificial blood vessel is disclosed in which at least one circumferential groove is formed along the circumferential direction.

JP, 2010-264274, A JP, 2010-104806, A JP 2008-279188 A JP-A-9-38119 Patent No. 3568756

As described above, when attaching blood vessels or attaching blood vessels to the heart, or joining or connecting blood vessels, the conventional purse string suture should be joined with high strength without gaps so that bacteria do not enter. Is difficult. In addition, biological tissue bonding using high energy, medical adhesives and the like not only have adverse effects such as damage to the living body and toxicity but also requires high skill and technology to obtain high bonding strength.

Patent Documents

1 and 2 above disclose a blood circulation assisting inflow cannula (insertion tube) comprising a porous structure, but the textured surface comprising the porous structure stabilizes a thrombus. In addition to the portion in contact with the heart wall corresponding to the joint portion, the structure further extends to the inside of the heart. In addition, since this inflow cannula has a cuff (collar) and a cuff holding screw, it is clear that the porous structure is not formed to improve the bonding strength with the heart, and the porous structure There has been no recognition at all about the technical task of improving the bonding strength by the body.
The cannula described in Patent Document 3 described above places the porous body in a portion in contact with the endocardium, whereby the endocardium invades the porous body, whereby the endocardium is the outer peripheral surface of the cannula. To suppress stretching along the Therefore, this porous body is not formed to improve the bonding strength with the heart. Furthermore, since the resin exemplified as the material of the porous body has elastic properties, strong bonding strength can not be expected.
Moreover, the bioabsorbable connecting tube described in Patent Document 4 described above and the artificial blood vessel connector described in Patent Document 5 described above are adhesively bonded with a suture needle such as a digestive tract or a blood vessel or a medical adhesive, respectively. , And to aid in the attachment of artificial blood vessels to living blood vessels. Therefore, these intracorporeal insertion tubes do not have a structure that allows them to be firmly joined to the living tissue, and can not solve the problem of bacteria infiltrating from the junction by suture or sewing.
The present invention has been made in view of the above-described conventional problems, and it is more rapid than in the prior art to connect the artificial blood vessel or the blood supply vessel to the heart of the auxiliary artificial heart or the artificial blood vessel to the artificial blood vessel. In order to achieve high bonding strength without forming gaps for bacteria to enter, as well as simple and easy, complex low as part of establishment of high strength bonding technology with living tissue including artificial heart attachment support. An object of the present invention is to provide a tissue self-adhering intracorporeal insertion tube applicable to an energy joining method, and a method of joining the intracorporeal insertion tube and internal organ tissue.
The present invention has intensively studied the structure and configuration of a tissue self-adhering intracorporeal insertion tube capable of increasing the bonding strength with internal organ tissues such as the heart and blood vessels as a substitute for conventionally performed sutures and sewing. As a result, on the side in contact with the body organ tissue of the body insertion tube, to form a surface shape such that an anchoring effect due to deformation or displacement of the body organ tissue can be obtained, and to enhance the anchoring effect It has been found that the above problems can be solved by providing the internal insertion tube with a structure that facilitates deformation or displacement of internal organ tissue, and the present invention has been made.
That is, the constitution of the present invention is as follows.
(1) The present invention relates to an in-vivo insertion tube joined in contact with the in-vivo organ tissue in a state of being covered by in-vivo organ tissue, wherein the in-vivo insertion tube contacts at least the in-vivo organ tissue. A groove, a hole or a recess is formed on the side by which part of the internal organ tissue is invaded by deformation or displacement to obtain an anchoring effect, and the groove is formed when the internal insertion tube and the internal organ tissue are joined. A self-adhesive tissue internal insertion tube is provided, wherein a passage for applying a negative pressure to a hole or a recess is formed in the internal insertion tube.
(2) In the present invention, the tissue self-joining intracorporeal insertion tube according to the above (1) is a tube in which a groove, a hole or a recess is formed for causing deformation or displacement of the internal organ tissue. And an inner tube having an inner cavity functioning as a blood, infusion or wiring passage inside the outer tube, and the passage for applying a negative pressure to the groove, hole or recess is the outer tube. And a self-adhesive tissue intracorporeal insertion tube characterized in that it is formed in at least one of the inner tube and the inner tube.
(3) In the present invention, the tissue self-joining intracorporeal insertion tube according to the above (2) comprises the following (A), (B) and (C), ie, (A) groove, hole or In order to apply negative pressure to the groove, hole or recess by discharging or suctioning the air existing between the internal insertion tube and the internal organ tissue from the recess toward the outside of the internal insertion tube (B) from the groove, hole or recess of the outer tube to the internal cavity of the inner tube, between the internal insertion tube and the internal organ tissue; Providing a passage in the inner pipe for applying a negative pressure to the groove, hole or recess by discharging or sucking air present in the inner tube, and (C) from the groove, hole or recess of the outer pipe, Toward the internal cavity of the inner tube, between the body insertion tube and the body organ tissue Providing a passage for applying a negative pressure to the groove, the hole or the recess by discharging or suctioning air in both the outer pipe and the inner pipe, any one selected from the group consisting of There is provided a tissue self-joining intracorporeal insertion tube characterized by having:
(4) In the tissue self-joining internal insertion tube according to (2) or (3), the present invention is characterized in that the outer tube and the inner tube are fixed via a buffer or an elastic body. I will provide a.
(5) According to the present invention, an outlet or a suction port directly connected to a passage for applying negative pressure to the groove, hole or recess, or the tissue self-joining intracorporeal insertion tube or the outer tube or inner tube described above The tissue self-joining intracorporeal insertion tube according to any one of the above (1) to (4) is provided.
(6) The present invention relates to any one of the above (1) to (5), wherein the tissue self-joining intracorporeal insertion tube or the outer or inner tube comprises a heating heat source. The present invention provides a tissue self-joining intracorporeal insertion tube.
(7) The present invention provides the tissue self-joining intracorporeal insertion tube according to any one of (1) to (6), wherein the intracorporeal insertion tube is artificial heart devascularization.
(8) The present invention uses the tissue self-joining intracorporeal insertion tube according to any one of (1), (5), (6), and (7), and Contacting the body insertion tube with body organ tissue in a state of being covered by organ tissue, (E) an outlet or suction port directly connected to a passage for applying a negative pressure to the groove, hole or recess Applying a negative pressure to the contact portion between the in-vivo insertion tube and the in-vivo organ tissue by suctioning air from the body, and (F) removing the negative pressure or in a state in which the negative pressure is obtained The method for joining the in-vivo insertion tube and the in-vivo organ tissue is provided, comprising the steps of: heating and / or applying micro-vibration to contact the in-vivo tissue with the in-vivo insertion tube and the in-vivo organ tissue. (9) The present invention provides a set according to any one of the above (2) to (7) (G) contacting the in-vivo insertion tube with the in-vivo organ tissue in a state where the outer tube of the in-vivo insertion tube is covered with the in-vivo tissue using a woven self-bonding in-vivo insertion tube; Step of applying a negative pressure to a contact portion between the outer tube and the body organ tissue by suctioning air from a discharge port or a suction port directly connected to a passage for applying a negative pressure to the groove, hole or recess And (I) after removing the negative pressure or in a state where the negative pressure is applied, the contact portion with the body organ tissue is heated and / or micro-vibration is applied to the outer tube and the body of the body insertion tube And b) bonding the organ tissue with the organ tissue.
(10) In the present invention, the step (E) or (H) is carried out by combining the step of applying the negative pressure to the step of applying pressure from the outside to the contact portion with the internal organ tissue, In the step (F) or (I), after removing at least one of the pressure and the negative pressure, or in the state where the pressure and the negative pressure are simultaneously applied, the contact portion with the body organ tissue is (9) A method of joining the internal insertion tube and internal organ tissue according to the above (8) or (9), characterized in that heating and / or micro-vibration is applied.
Effect of the Invention The internal organ insertion tube according to the present invention only has a groove, a hole or a recess on the side in contact with internal organ tissue such that an anchoring effect can be obtained by deformation or displacement of the internal organ tissue. Instead, negative pressure is applied to the joint by providing a passage for discharging or sucking air existing between the body insertion tube and body organ tissue to exert a negative pressure on the groove, hole or recess. When the internal organ tissue is easily deformed or displaced into the grooves, holes or depressions of the internal organ tissue, preventing the occurrence of voids or gaps that reduce the joint strength at the joint interface, thereby improving the joint strength. I can expect it.
Further, according to the present invention, the internal insertion tube has a double tube structure of the outer tube and the inner tube, thereby enhancing the bonding strength with the internal organ tissue and the function as a passage of blood, fluid or wiring. Can be formed separately as the outer tube and the inner tube, so that the shape of the in-vivo insertion tube can be freely changed only by changing the design of the outer tube shape. As a result, it becomes possible to produce an intracorporeal insertion tube in which the shape of the outer tube is matched to the position where it is joined to the shape of the organ tissue in the body, and junction with body organ tissue of various shapes becomes possible. . Furthermore, since at least one of the outer tube and the inner tube is provided with a passage for applying a negative pressure to the groove, the hole or the recess, the exhaust of air existing between the introductory tube and the organ tissue in the body or Deformation and displacement of internal organ tissues occur so that a large anchoring effect can be obtained by suction, and the bonding strength can be further improved.
The method of joining the intracorporeal insertion tube and the internal organ tissue according to the present invention can not only be performed by complex low energy joining, but there is no gap at the joining portion and high joining strength can be obtained. And, it can carry out simply. Furthermore, since the prevention of bacterial infiltration from the junction produces an effect of suppressing the occurrence of thrombus induced by the infiltration of bacteria after conjugation, a safe and highly secure conjugation method can be constructed.

FIG. 1 is a view showing devascularization as an example of the tissue self-joining intracorporeal insertion tube of the present invention.
FIG. 2 is a schematic cross-sectional view showing a groove, a hole and a recess formed in the tissue self-joining body insertion tube of the present invention and provided with a passage for applying a negative pressure.
FIG. 3 is a view showing an example of the joining mechanism of the internal organ tissue and the internal insertion tube of the present invention by the combined low energy.
FIG. 4 is a view showing an example in which a single tube structure introductory tube having a passage for applying a negative pressure according to the present invention is applied as devascularization of the heart.
FIG. 5 is a view showing cut surfaces of the groove portion and the discharge port or suction port portion in the single-body tube insertion tube according to the present invention.
FIG. 6 is a view showing an example of formation of a passage for applying a negative pressure in the single-body tube insertion tube according to the present invention.
FIG. 7 is a view showing an internally inserted tube having a double tube structure according to the present invention, which has an outer tube and an inner tube in which a groove, a hole or a recess is formed and a passage for applying a negative pressure to the inside.
FIG. 8 is a view schematically showing a cross section of a double-pipe internal-body insertion pipe having an outer pipe and an inner pipe, and the outer pipe or the inner pipe having a passage for applying a negative pressure.
FIG. 9 is a view showing an intracorporeal insertion tube having an outer tube and an inner tube and provided with a passage for applying a negative pressure around the inner tube.
FIG. 10 is a view showing a bonding state of a body insertion tube and a body organ tissue having an outer tube and an inner tube and provided with a passage for applying a negative pressure around the inner tube.
FIG. 11 is a view showing another form of a body insertion tube having an outer tube and an inner tube and having a structure in which a passage for applying a negative pressure is connected from a groove of the outer tube to an inner cavity of the inner tube. .
FIG. 12 is a view showing a bonding method using micro-vibration by a piezoelectric element in bonding the in-vivo insertion tube and the body organ tissue according to the present invention.
FIG. 13 is a schematic view of a prototype of a tissue self-adhesive devascularization according to the present invention.
FIG. 14 is a view showing the results of measurement of the bonding strength by tension at the bonding portion between the in-vivo insertion tube and the heart of the present invention.
FIG. 15 shows a conventional method of suturing with the heart using a devascularized cuff.

FIG. 1 is a view showing devascularization as an example of the tissue self-joining intracorporeal insertion tube of the present invention. FIG. 1A shows an example of blood removal in which four incised grooves 2 are formed in the periphery of the upper part where joining with the heart is performed in the body layer insertion tube 1 of the present invention. (B) of FIG. 1 is an example of the devascularization in which the groove | channel 2 was intermittently interrupted and formed. FIG. 2 is a schematic cross-sectional view of a groove, a hole and a recess formed in the tissue self-joining intracorporeal insertion tube of the present invention. In the intracorporeal insertion tube 1 of the present invention, not only the shape of the groove 2 but also the hole 3 or the recess 4 is formed at the junction with the organ tissue in the body. The groove 2, the hole 3 and the recess 4 are respectively connected to the internal cavity 7 of the body insertion tube 1 via a passage 5 for applying a negative pressure. Grooves 2, holes 3 and depressions 4 shown in FIG. 2 should be formed so as to go around at the junction with the organ tissue in the body or separately as shown in (a) or (b) of FIG. Can.
The intracorporeal insertion tube 1 of the present invention has a groove 2, a hole 3 or a recess on the side in contact with the internal organ tissue in order to perform a tissue self-joining with high joint strength without any gap at the junction with living organ tissue. It is characterized in that 4 is formed. The groove 2, the hole 3 or the recess 4 is a joint portion covered with internal organ tissue when performing low energy joining such as heat or minute vibration in a state where pressure is applied, deformation of the internal organ tissue Or form a displacement for the purpose of obtaining the throwing effect. The effective anchoring effect is ensured by the negative pressure created through the passage 5 that it deforms or displaces a part of the organ tissue in the body and penetrates into the groove 2, the hole 3 or the recess 4 and is thus retained within them. Is achieved by Therefore, tissue self-bonding having high bonding strength can be performed without using suture or sewing with a thread or the like or a medical adhesive. Therefore, it is not necessary to form a special structure such as a cuff (collar) used for sewing or sewing.
FIG. 3 shows an example of the joining mechanism of the internal organ tissue and the internal insertion tube of the present invention by the combined low energy. Body organ tissues such as the heart and blood vessels contain a large amount of protein collagen molecules, collagen fibers and the like. These internal organ tissues are placed in a body insertion tube in which a groove, a hole or a recess is formed on the surface ((a) in FIG. 3), and negative pressure is applied from the body insertion tube by the passage 5 to adhere ( FIG. 3 (b)) is simultaneously heated (FIG. 3 (c)). Thereby, as shown in (d) of FIG. 3, the collagen fibers in the organ tissue of the body are deformed or displaced, and simultaneously or after entering into the asperities of the internally inserted tube, the organ tissue of the body including the collagen fiber etc. Is gelled. After the heating is stopped, the temperature starts to fall, and the gelled part coagulates to bond the internal organ tissue to the internal insertion tube. In the case of the tissue self-joining type joining method as shown in FIG. 3, the joining strength is high when the anchoring effect can be sufficiently obtained by the internal organ tissue which has invaded into the asperities of the internally inserted tube. However, in order to achieve high strength bonding, not only the formation of a channel for applying a negative pressure and the bonding method and bonding conditions, but also the groove formed on the side to be in contact with the material of internal insertion tube and internal organ tissue. It is necessary to sufficiently study the diameter or area and the depth of the opening of the hole or recess.
First, with regard to the in-vivo insertion tube, it is required that there is less deformation when in the negative pressure state shown in FIG. In addition, if the heat conductivity from the in-vivo insertion tube to the organ tissue in the body during the heat treatment is not high, it is necessary to raise the heating temperature or extend the heating time, so there is a problem of thermal damage to the organ tissue in the body. Happens. In the case of applying micro-vibration instead of or in combination with heat treatment in low energy bonding, since the transmission of micro-vibration energy is reduced if the internal insertion tube is soft, the internal insertion tube is required to have a certain degree of rigidity . Therefore, in the present invention, a highly rigid metal, ceramic or resin composite material is suitable as the material of the body insertion tube. Furthermore, since the intracorporeal insertion tube is used in vivo, it must be excellent in biocompatibility. Therefore, a body insertion tube made of stainless steel, titanium, silicon or fiber reinforced plastic is more preferable. As these intracorporeal insertion tubes, those whose surface is surface-treated so as to contain atoms such as fluorine, carbon or titanium may be used.
As shown in FIG. 3, since the organ tissue in the body contains high molecular weight protein and collagen fibers, the surface roughness (Ra defined by JIS B 0601) on the side in contact with the organ tissue in the body is in the range of 1 to 20 μm. In the intracorporeal insertion tube uniformly having the formed surface irregularities, the deformation or displacement of the organ tissue in the body can not sufficiently follow the small surface irregularities, and minute voids or interfacial peeling occur, resulting in a sufficient anchoring effect. As a result, the bonding strength is reduced.
Thus, in order to improve the bonding strength (adhesive force) between the in-vivo insertion tube and the in-vivo organ tissue, the surface roughness of the in-vivo insertion tube alone is limited. The present invention, unlike the conventional method in which the bonding strength is increased by the surface roughness, causes sufficient deformation or displacement of internal organ tissue when negative pressure is applied so that a reliable anchoring effect can be obtained at the time of bonding. This is a great feature in that the bonding strength is greatly improved thereby. Therefore, the in-vivo insertion tube of the present invention needs to form a surface asperity slightly larger than the conventional surface roughness. Therefore, when the groove, hole or recess formed in the in-vivo insertion tube of the present invention is continuously formed in the circumferential direction of the in-vivo insertion tube 1 as shown in (a) of FIG. Or it is preferable that the opening diameter of the hole 3 and the hollow 4 is more than 20 micrometers and 10 mm or less. When the groove width or opening diameter is 20 μm or less, deformation or displacement of the organ tissue in the body is insufficient and the anchoring effect is hardly obtained. On the other hand, when it exceeds 10 mm, the body organ having invaded the groove 2, hole 3 or recess 4 The phenomenon of easy removal of tissue occurs, and similarly, sufficient injection effect can not be obtained. Here, the groove 2, the hole 3 or the recess 4 may be divided into several parts in the circumferential direction of the intracorporeal insertion tube 1. Also, as shown in FIG. 1 (b), when the groove 2, the hole 3 or the recess 4 is formed independently, the anchoring effect by the deformation or displacement of the organ tissue in the body is sufficiently obtained. The groove width of the groove 2 or the opening area of the holes 3 and the recess 4 is 3 × 10 ^-4 mm ² (About 20 μm in terms of a circle diameter) is preferable. The upper limit of the opening area is 80 mm so as to secure the bonding strength with the body organ tissue. ² It is preferable that it is (about 10 mm in terms of a circle diameter).
Furthermore, the maximum depth of the opening of the groove, the hole or the recess is preferably more than 20 μm and 10 mm or less. When the maximum depth of the opening is 20 μm or less, the anchoring effect is hardly obtained. On the other hand, when it exceeds 10 mm, the internal organ tissue invading the groove, hole or recess is easily removed. Can not get enough throwing effect. In the present invention, in a tensile test performed after bonding with internal organ tissue, the bonding strength by tension measured when the internal insertion tube is pulled in the longitudinal axis direction is 0.01 MPa or more, preferably 0.02 MPa or more. For example, the diameter or area and the maximum depth of the opening of the groove, hole or recess can be set arbitrarily within the above range.
The bonding method of the present invention performs low energy bonding, preferably combining two or more, using at least one of pressure, heat and minute vibration. The conditions of pressure, heat and minute vibration applied in bonding are in the range of 0.01 to 10 MPa, 50 to 250 ° C., and 1 Hz to 1 MHz, respectively. When the pressure at the time of heating is less than 0.01 MPa, the temperature is less than 50 ° C., and the vibration is less than 1 Hz, not only in the case of single application, but also when vibration, heat and pressure are combined to be combined energy However, the bonding strength with internal organ tissues can not be sufficiently increased. Even if it appears that both sides are joined after the joining operation, the condition of vibration, heat and pressure must be at least the lower limit value mentioned above, because exfoliation and detachment of the intracorporeal insertion tube occur during use even if it appears that both are joined. . When the pressure exceeds 10 MPa, the heating temperature is 250 ° C., and the vibration exceeds 1 MHz, damage to the tissue created in the body may be increased, or the insertion tube may be damaged. In addition, since local exfoliation occurs due to stress or heat generation at the joint portion of internal organ tissue, the joint strength to the internal joint tissue generally decreases, and there is also a problem in terms of durability reliability and safety. Therefore, it is necessary to make the conditions of vibration, heat and pressure below the upper limit shown above.
The above heat treatment is carried out using a heating jig from the outside of the internal organ tissue while the internal insertion tube is covered with internal organ tissue, or the internal insertion tube before insertion is placed in a thermostatic bath to a predetermined temperature. Heat it up. Alternatively, a method may be employed in which a resistance heating wire such as a nichrome wire is inserted into the body insertion tube, or a resistance heating wire is wound around the body insertion tube and heated from the outside. At this time, as the heating method, not only the resistance heating method but also another method such as arc heating, induction heating, dielectric heating or infrared heating may be used.
The intracorporeal insertion tube of the present invention is inserted into the body in order to ensure the anchoring effect by assisting the deformation or displacement of the internal organ tissue containing high molecular weight proteins and collagen fibers into grooves, holes or depressions during low energy joining. The internal insertion tube and the internal tissue are directed from the groove, hole or recess formed on the external surface of the internal tube to the internal cavity functioning as a passage for blood, infusion or wiring of the internal insertion tube or the external insertion tube. It is necessary to provide a connecting channel for discharging or sucking the air present between them, that is, a channel for applying a negative pressure to the groove 2, the hole 3 or the recess 4.
FIG. 4 shows an example in which an intracorporeal insertion tube 1 of a single tube structure provided with a passage 5 for applying a negative pressure to the groove 2 is used as a devascularization of the heart. The passage 5 is spatially connected to the bottom of the groove 2 formed in the internal connection pipe 1, and is shaped so as to be opened to the outside atmosphere toward the outside of the internal insertion tube 1 through the discharge port or suction port 6. have. As shown in FIG. 4 (a), the intracorporeal insertion tube of the present invention has an internal cavity 7 that functions as a blood, infusion or wiring passage. The arrow shown in the internal cavity 7 of the intracorporeal insertion tube is the flow direction of blood or fluid. A heating resistance wire 8 such as a nichrome wire is wound around the body insertion tube 1, and heat treatment is performed using the heating resistance wire 8 after the body insertion tube is covered and crimped by the internal organ tissue. To raise the temperature. Since this method can perform localized heating of the joint, there is no need to raise the temperature more than necessary, and in addition, the heating part can be performed with a minimum area, and thermal to the organ tissue in the body It has the effect of reducing damage.
As shown in (b) of FIG. 4, the passage 5 has a function of discharging the air 22 existing between the internal organ tissue 9 and the internal insertion tube 1 at the time of joining. If there is no discharge passage in the groove 2 formed on the surface of the intracorporeal insertion tube, air 22 is likely to be accumulated by deformation or displacement of the internal organ tissue 9 at the time of joining. The same phenomenon is observed in the case of a body insertion tube in which a hole or a recess is formed instead of the groove 2. In the case where the air 22 is not released to the surface, the pressure at the deep part of the opening is increased to act to inhibit the deformation or displacement of internal organ tissue. Therefore, in order to improve the adhesion of the internal organ tissue 9, it is necessary to increase the pressure applied from the outside at the time of joining. However, as shown in (b) of FIG. 4, in the case of the structure having the passage 5, the air 22 accumulated in the deep part of the opening is discharged or sucked through the discharge port or suction port 6 by decompression processing or the like. The adhesion between the internal insertion tube and the organ tissue in the body is improved, so that no gap or peeling is caused at the interface between the two, and as a result, the anchoring effect due to the deformation or displacement of the organ tissue in the body is reliably obtained. Can be improved.
FIG. 5 shows the cut surfaces of the groove 2 of the left half and the outlet (or suction port) 6 in the single-body internal insertion tube shown in FIG. Each cut surface of the part of the groove | channel 2 shown to (a) of FIG. 5 and the part of the discharge port (or suction port) 6 was each shown as AA 'and B-B' in FIG. 5 (b). And (c). As shown in FIG. 5, the passage 5 for applying a negative pressure to the groove 2 is connected to the groove 2 and the discharge port or suction port 6. The passage 5 can be formed, for example, by forming the passage 5 inside the body insertion tube 1 with a digging jig such as a drill, and then closing the digging inlet portion with a hermetic plug 23 such as metal or plastic. At this time, in order to prevent the dropout of the airtight plug 23 and improve the airtightness, fixing or reinforcement with an adhesive or the like may be performed. Further, the single-tube internal insertion tube shown in FIG. 5 can also be manufactured using a computer-controlled three-dimensional modeling apparatus (three-dimensional printer).
FIG. 6 is a view showing an example of formation of a passage for applying a negative pressure in the single-body tube insertion tube according to the present invention. FIG. 6 shows only the right side cross-sectional view of the in-vivo insertion tube 1 of the present invention, and the connection passage 5 is directly connected from the bottom of the groove 2 formed in the in-vivo connection tube to the internal cavity 7 of the in-vivo insertion tube 1 It has an open shape. The passage 5 shown in (a) of FIG. 6 has an opening diameter that is constant from the bottom of the groove 2 toward the internal cavity. In the case where the opening diameter of the passage 5 is formed to have a certain size, it is necessary to adjust the negative pressure by vacuum suction at the time of bonding. On the other hand, the passage 5 shown in FIG. 5B has a shape in which the opening diameter gradually decreases toward the internal cavity 7. This has the effect of preventing the internal organ tissue 9 from invading the internal cavity 7 at the time of bonding.
Next, a tissue self-joining intracorporeal insertion tube having a double tube structure consisting of an outer tube and an inner tube will be described using the drawings.
FIG. 7 shows a tube in which a groove, a hole or a recess is formed to cause deformation or displacement of the internal organ tissue as described above is an outer tube 10, and inside the outer tube 10, blood, infusion or wiring Fig. 6 shows an intracorporeal insertion tube comprising an inner tube 11 with an internal cavity 7 functioning as a passage. (A) of FIG. 7 is a figure which shows the external appearance of a body insertion tube, (b) of FIG. 7 shows sectional drawing of a body insertion tube, respectively.
As shown in FIG. 7, the intracorporeal insertion tube of the present invention has a double tube structure of the outer tube 10 and the inner tube 11 to increase the bonding strength with the tissue of the body organ, blood, infusion solution or wire The function as a passage can be divided separately. Thereby, it is possible to freely change the design of the shape of the outer tube having a function to enhance the bonding strength with the internal organ tissue while leaving the inner tube shape functioning as a passage of blood, infusion or wiring as it is. . Therefore, since it is possible to produce an intracorporeal insertion tube having an outer tube shape that matches the shape and joining position of the organ tissue in the body, it can be applied to junction with body organ tissue consisting of various shapes, and a wide range of applications Can be
The intracorporeal insertion tube 1 shown in FIG. 7 shows an example in which the outer tube is provided with a passage 5 for discharging or sucking air existing between the intracorporeal insertion tube and the internal organ tissue to apply negative pressure. There is. Not only the outer tube 10 shown in FIG. 7 but also the passage 5 for applying a negative pressure can be provided in both tubes at the surface where the inner tube 11 or the outer tube and the inner tube are in contact with each other.
FIG. 8 is a structural group of channels provided in the in-vivo insertion tube of the present invention for applying a negative pressure to a groove, a hole or a recess, and schematically showing only a left sectional view of the in-vivo insertion tube. FIG. 8A shows that (A) the air existing between the in-vivo insertion tube and the in-vivo tissue is discharged from the groove 2, the hole 3 or the recess 4 of the outer tube 10 toward the outside of the in-vivo insertion tube. Alternatively, the outer pipe 10 is provided with a passage 5 for applying a negative pressure by suction. In the intracorporeal insertion tube shown in FIG. 8A, the passage 5 is formed inside the outer tube 10, but in the present invention, the surface of the outer tube 10 in contact with the inner tube 11 is cut with a predetermined thickness Then, a step may be provided, and the step may be used as a passage. Conversely, the surface of the inner pipe 11 on the side in contact with the outer pipe 10 may be cut with a predetermined thickness to provide a step, and the step may be used as a passage to connect with the discharge port or suction port 6. In (b) of FIG. 8, the air existing between the body insertion tube and the body tissue is discharged or suctioned from the groove, hole or recess of the outer tube 10 toward the inner cavity of the inner tube 11. It is a structure provided with the channel | path 5 for applying a negative pressure to the said inner pipe | tube 11, for example, has shown the body insertion tube by which the groove | channel 2 and the hole 3 were formed in the surface. Further, in FIG. 8C, air existing between the body insertion tube and the body tissue is discharged toward the inner cavity of the inner tube 11 from the groove, hole or recess of the outer tube 10 (C). Alternatively, a passage 5 for applying a negative pressure by suction is provided in both the outer tube and the inner tube, and as an example, there is shown an intracorporeal insertion tube in which a recess 4 is formed on the surface. The recess 4 shown in (c) of FIG. 8 is connected to the passage 5 provided in the inner tube via the passage 5 provided in the outer tube, resulting in spatial connection from the recess to the cavity of the inner tube doing. As described above, the diameter or area of the opening and the maximum depth of the groove 2, the hole 3 or the recess 4 shown in FIG. 8 are defined in the same range as in the case of FIG. 2.
The outer tube 10 or the inner tube 11 shown in FIG. 8 is a groove for providing a passage 5 for discharging or sucking air existing between the body insertion tube 1 and body organ tissue to apply a negative pressure, Air accumulated in the deep opening of the hole or recess is discharged or sucked through the outlet or suction port 6 by decompression processing. This has the effect of improving the adhesion between the in-vivo insertion tube and the in-vivo organ tissue and eliminating gaps and exfoliation at the interface between the two. As a result, since the anchoring effect due to the deformation and displacement of the internal organ tissue is increased, the bonding strength can be further improved.
As described above, the intracorporeal insertion tube having the double tube structure of the present invention has a passage for applying a negative pressure to the groove, hole or recess, the outer tube of the double tube, the inner tube, and the outer tube and the inner tube. It can be formed anywhere between the tubes.
FIG. 9 shows a double-layered internal insertion tube comprising an outer tube 10 and an inner tube 11 and a passage 5 for applying a negative pressure around the inner tube 11. (A) and (b) of FIG. 9 are an external view and a cross-sectional view of a body insertion tube, respectively. As shown in (b) of FIG. 9, the passage 5 provided in the inner pipe 11 is connected to the groove 2 formed in the outer pipe 11. Reference numeral 12 in FIG. 9 denotes an air suction hole for performing a pressure reduction process when being in a negative pressure state, and can be regarded as part of the passage 5 in which the outer pipe 10 is formed. Further, in the double pipe structure including the outer pipe 10 and the inner pipe 11 shown in FIG. 9, the outer pipe and the inner pipe are fixed via an O-ring 13 made of rubber, thermoplastic elastomer or the like. Since the O-ring 13 is an elastic body, mounting of the outer pipe and the inner pipe is easy, and at the same time, the adhesion between the both can be improved. By using the O-ring 13, both can be firmly fixed in a state of high airtightness. In the present invention, instead of an elastic body such as an O-ring, a buffer such as a foamable plastic, a non-woven fabric or a metal buffer ring may be used.
The O-ring 13 shown in FIG. 9 can ensure the heat insulation of the outer pipe and the inner pipe by using a material whose thermal conductivity is lower than the material of the outer pipe. In this case, when the outer tube covered with internal organ tissue is heated by resistance heating wire 8 such as a nichrome wire wound around it in bonding with internal organ tissue, the temperature rise is large in the outer tube. In the inner pipe, the heat conduction can be suppressed, so that the temperature rise can be suppressed, and the joining operation becomes easy. In addition, since only the joint portion can be heated, there is an advantage that thermal damage to internal organ tissues other than the joint portion can be reduced. In the present invention, the outer tube and the inner tube are made of metal, and by using rubber or thermoplastic elastomer having a thermal conductivity lower than that of metal as the O-ring, the effect of heat insulation by the O-ring can be exhibited. it can. In the present invention, when the temperature rise at the time of heating is efficiently performed in a short time, not only the outer pipe but also the inner pipe can be provided with a heating heat source constituted of a resistance heating wire or the like.
The joined state when joining with the internal organ tissue is performed using the intracorporeal insertion tube 1 shown in FIG. 9 is shown in FIG. As shown in FIG. 10, the intracorporeal insertion tube 1 is a passage formed from the groove 2 formed on the outer surface of the intracorporeal insertion tube 1 at the time of low energy joining such as heating and / or micro vibration etc. The air existing between the in-vivo insertion tube 1 and the in-vivo tissue 9 is discharged or sucked toward the outside of the outer tube 10 via the air port 5 to form a negative pressure state. As a result, deformation or displacement of body organ tissue 9 into groove 2 is assisted to ensure that the anchoring effect is obtained, and after low energy joining, the joint strength between body insertion tube 1 and body organ tissue 9 ( Adhesion strength is greatly improved.
FIG. 11 is a view showing another form of an in-vivo insertion tube having a double tube structure consisting of an inner tube and an outer tube. (A) and (b) of FIG. 11 are an external view and a cross-sectional view of a body insertion tube, respectively. The intracorporeal insertion tube has a structure in which a passage 5 for applying a negative pressure is connected from the groove 2 of the outer tube 10 to the internal cavity 7 of the inner tube 11 as shown in FIG. In addition, since the air existing between the outer tube 10 and the organ tissue in the body at the time of bonding is a structure for discharging or sucking out through the internal cavity 7 of the inner tube 11, Differently, an outlet or suction port 6 is formed in the inner tube 11. Except for these, it has basically the same structure and configuration as the intracorporeal insertion tube shown in FIGS. 9 and 10.
The intracorporeal insertion tube according to the present invention is used for attaching and detaching tubes and blood vessels used in artificial heart attachment, in particular, for improving the joint strength when used as a devascularization vessel which has been difficult to join by the prior art. Show great effect. In addition, since the intracorporeal insertion tube of the present invention does not need to have a special structure having a cuff (collar) and the like, it can be applied for joining or connecting other in vivo tissues, for example, an anastomoses such as digestive tract and blood vessels. It can be used for connecting an artificial blood vessel and a living blood vessel, bonding a digestive tract and an insertion tube, such as gastrostomy, an artificial anus, or bonding a portion where the insertion tube penetrates the skin and comes out of the body. Besides, it can also be used for joining the skin penetration part of the energy supply cable of an artificial heart. In doing so, it is easy to design the shape of the intracorporeal insertion tube to the shape of these applications within the scope of design changes that are usually made.
The method of the present invention for joining an intracorporeal insertion tube and an internal organ tissue is carried out including the following steps.
First, as shown in FIG. 4 to FIG. 7, as a process of a tissue self-joining intracorporeal insertion tube having a single tube structure, (D) the intracorporeal insertion tube of the present invention is covered with internal organ tissue; Contacting the intracorporeal insertion tube with the internal organ tissue, (E) inserting the intracorporeal insertion tube by suctioning air from a discharge port or a suction port directly connected to a passage for applying a negative pressure to the groove, hole or recess Applying a negative pressure to the contact portion with the internal organ tissue, and (F) heating and / or heating the contact portion with the internal organ tissue after removing the negative pressure or in a state where the negative pressure is applied. Applying vibration to join the in-vivo insertion tube and the organ tissue in the body.
Next, as shown in FIGS. 7 to 11, in the case of a tissue self-joining intracorporeal insertion tube having a double tubular structure, (G) a state in which the outer tube of the intracorporeal insertion tube is covered by the internal tissue. And (H) contacting the internal organ tube with the internal organ tissue, (H) sucking the air from the outlet or suction port directly connected to the passage for applying negative pressure to the groove, hole or recess. Applying a negative pressure to the contact portion between the tube and the internal organ tissue, and (I) heating and / or heating the contact portion with the internal organ tissue after or after removing the negative pressure. Or applying microvibration to join the outer tube of the in-vivo insertion tube and the organ tissue in the body.
Furthermore, in the two bonding methods described above, the step of applying the negative pressure may be performed in combination with the step of applying pressure from the outside to the contact portion with the internal organ tissue. That is, the step of (E) or (H) in the step of (E) or (H) using the intracorporeal insertion tube having a single-layer tube structure or a double-tube structure of the present invention is a contact portion with internal organ tissue (F) or (I) is carried out after removing at least one of the pressure and the negative pressure, or simultaneously applying the pressure and the negative pressure. The bonding method is characterized in that heating and / or micro-vibration is applied to the contact portion with the body tissue in a state where
In the above-described negative pressure step, a negative pressure state can be formed by performing a pressure reduction treatment using a vacuum pump or the like. The negative pressure at this time may be −0.01 MPa or more (as an absolute value of the pressure, 0.01 MPa or less), and it is not necessary to intentionally make a high vacuum state. When performing the junction according to the present invention under negative pressure, if the exhaust port or suction port provided outside the internal insertion tube is not completely covered with internal organ tissue, decompressing treatment makes the connecting passage high negative pressure. I can not Therefore, the junction part of internal organ tissue can be easily confirmed by the vacuum pump pressure gauge used at the time of decompression processing, and furthermore, the junction position can be adjusted while looking at the pressure gauge. In this way, if it is possible to define a position at which the connecting passage can be brought to a high negative pressure, the negative pressure will not shift the junction of the internal organ tissue. Therefore, in the present invention, in order to perform detection, adjustment and firm fixation of the joint portion, it is a major feature that the internal organ tissue is joined by negative pressure treatment.
The pressure, heating, and micro-vibration used in the bonding step performed simultaneously with or after the above-described negative pressure step are 0.01 to 10 MPa and 50 to 250 ° C., respectively, as described above. , And 1 Hz to 1 MHz. As a bonding method by micro-vibration, for example, as shown in FIG. 12, a method using a piezo element 24 which is a passive element using a piezoelectric element can be mentioned. The intracorporeal insertion tube 1 shown in FIG. 12 is shown by way of example as having a single tube structure (note that grooves, holes or depressions formed on the surface of the intracorporeal insertion tube 1 are not shown). Micro-vibration energy is applied to the joint interface between the in-vivo insertion tube 1 and the in-vivo organ tissue 9 by the piezoelectric element 24 disposed around the in-vivo organ tissue 9.
In the present invention, together with the above-mentioned negative pressure treatment, application of pressure may be performed simultaneously from the surroundings of internal organ tissue. The negative pressure treatment or both methods of negative pressure treatment and pressure application can be combined according to the bonding method, bonding conditions (time, etc.) and bonding device as well as the bonding part and bonding strength of internal organ tissue.
The invention will now be described by means of specific embodiments.
First Embodiment
FIG. 13 shows a tissue self-adhering blood vessel, which is manufactured by extracting a portion surrounded by a broken line in the in-vivo insertion tube shown in (a) of FIG. (A) and (b) of FIG. 13 are an external view and a sectional view, respectively. The tissue self-joining type devascularization tube 1 is made of stainless steel excellent in biocompatibility, and has a double tube structure consisting of an outer tube 10 and an inner tube 11 having a total length of 37 mm, an outer diameter of 21 mm and an inner diameter of 14 mm. The outer pipe 10 and the inner pipe 11 are fixed / insulated by an O-ring 13. In the present embodiment, there is no passage for blood flow or transport for prototyping, and by plugging up and down 14 and reducing the pressure by using a vacuum pump via the outlet or suction port 6 of the inner tube. The structure is easy to generate pressure. Further, as shown in FIG. 13B, a nichrome wire is attached as a heating resistance heating wire 8 to the groove side surface of the outer tube 10, and a thermocouple 15 is disposed near the groove for temperature measurement. It is done. The nichrome wire as the resistance heating wire 8 and the thermocouple 15 are respectively wired and drawn out from the wire outlet 16 through the cavity in the inner tube. The conductor outlet 16 is filled with silicone rubber to seal the cavity in the inner tube.
The groove formed on the surface of the outer tube of the tissue self-joining type blood removal vessel of the present embodiment has an opening width of 2.5 mm and a depth of 1.5 mm, and two grooves are continuously formed in the circumferential direction of the outer tube. Form. The distance between the two grooves is 2 mm. The heating temperature of the outer tube at the time of joining is controlled by a temperature control system. The tissue self-joining devascularization of this embodiment is joined to the internal tissue organ in the region of width W shown in (a) of FIG. Specifically, a pig heart was used as an internal tissue organ.
The bonding strength between the tissue self-bonding type devascularization and the heart after bonding is determined by conducting a tensile test. The tensile strength is determined by using a tensile tester in which a load transducer is fixed on the upper side and a tensile load is applied in the vertical direction by a linear movement actuator fixed on the lower side. Measure in two directions. In the case of the heart-devascularization radial direction, the upper chuck for attaching the heart to the load transducer is fixed, the lower chuck for attaching the devascularization to the linear actuator is fixed, and a tensile load is applied in the vertical direction for measurement. On the other hand, in the case of the heart-devascularization axis direction, fix a channel to put the heart on the load transducer, fix a check to attach the devascularization to the linear actuator, and apply a tensile load in the vertical direction Measure.
The measurement results of the joint strength by radial tension and axial tension are shown in (a) and (b) of FIG. 14 respectively. In FIG. 14, the pressure in the blood removal vessel is set to a negative pressure of −0.1 MPa by reduced pressure treatment with a vacuum pump, and the junction temperature and junction time are changed in the range of 80 ° C. to 100 ° C. and 60 to 90 seconds, respectively. The results of bond strength measured in tension are shown.
As can be seen from (a) and (b) of FIG. 14, the bonding strength measured by radial tension and axial tension increases as the bonding temperature increases. In addition, the longer the bonding time, the higher the bonding strength between the two. In addition, the bonding strength by tension is higher in the axial direction than in the radial direction. It is considered that this is because the concavo-convex portion of the myocardial tissue formed by bonding becomes a resistance in the axial direction. Thus, the tissue self-bonding type devascularization of this embodiment has a high bonding strength with the heart and has excellent bonding. In addition, when the junction surface of the heart after junction is disassembled and observed, in all junction conditions, the junction cross section of the heart is formed with an unevenness that forms a pair with the groove of the outer vessel of the blood vessel, and the heart formed by junction It has been confirmed that the asperities are joined also on the groove side of the outer tube. Therefore, the joining method using the tissue self-joining type devascularization of the present embodiment is an excellent joining method capable of preventing the infiltration of bacteria because the joining portion can be joined with high strength without any gap.
Second Embodiment
The in-vivo insertion tube shown in FIG. 13 has an O-ring 13 and exhibits a heat insulating effect between the outer tube 10 and the inner tube 11. The insulation effect between the outer tube 10 and the inner tube 11 is heated at 100 ° C. for 120 seconds to compare with the case of devascularization in which the outer tube is fixedly fitted to the outside of the inner tube without using an O-ring. The temperature difference between the outer tube and the inner tube was determined by transient heat transfer analysis simulation. In the analysis simulation, density, thermal conductivity and specific heat were used as physical property values of each material (stainless steel, fluororubber used as a plug, nichrome wire, etc.). As a result, the devascularization in the first embodiment is uniformly 100 ° C. for the outer tube and 50 ° C. for the inner tube, while the O-ring devascularization is 90 ° C. for both the outer and inner tubes. It turned out that it was. This result is in good agreement with the actual measurement value, and by using the O-ring, the devascularization of the dual tube structure of the present invention can obtain adiabatic effect between the outer tube and the inner tube.
Further, while the temperature of the outer tube is 100 ° C. when the O-ring is present, the temperature of the outer tube is slightly lowered to 90 ° C. without the O-ring. This is considered that without the O-ring, the heat transfer to the inner pipe is large, so the temperature of the outer pipe can not be increased and it is slightly reduced. As described above, the O-ring is effective as a configuration of an in-vivo insertion tube including devascularization when performing efficient heating in the bonding of the present invention because the effect of holding the set temperature of the outer tube is obtained. .
Third Embodiment
As shown in FIG. 9, a trial for removing blood vessels of a double pipe structure including an outer pipe 10 and a passage 5 for applying negative pressure to the interface in contact with the outer pipe 10 and an inner pipe 11 having an internal cavity is manufactured. did. The outer tube of this intracorporeal insertion tube has an opening width of 2.5 mm in the circumferential direction, and two grooves 2 each having a depth of 1.0 mm are formed, and the distance between the two grooves is set to 2 mm. . The bottom of the groove 2 is provided with a hole connected to the passage 5 formed by cutting a portion with a depth of 0.5 mm at the boundary surface of the inner tube 11 in contact with the outer tube 10.
When the heating performance was tested on the tissue self-bonding type devascularization of this embodiment, the same performance as the first embodiment was confirmed. Bonding of pigs used as a tissue organ in the same manner and conditions as in the first embodiment was performed, and similar bonding performance and bonding strength results were obtained.
In the first to third embodiments, mainly the devascularization of the double-tubular structure is specifically described, but the same effect can be obtained also in de-vascularization of a single-tubular structure as shown in FIGS. 4 and 5. It goes without saying that
As described above, according to the present invention, it is possible to obtain high joint strength without any gap in the joint portion in the joint with internal organ tissue. This not only forms grooves, holes or depressions for causing deformation or displacement of the body organ tissue on the side in contact with body organ tissue, but also exists between the body insertion tube and body organ tissue By providing a passage for applying negative pressure to the grooves, holes or depressions, thereby obtaining a great anchoring effect. Thereby, when negative pressure is applied to the joint portion, deformation or displacement of body organ tissue into the groove, hole or recess is facilitated, and generation of voids or gaps that reduce the joint strength at the joint interface Thus, the bonding strength can be further improved.

The method for joining an in-vivo insertion tube and an organ tissue in the body according to the present invention is a method which can prevent the infiltration of bacteria which has been a problem in the conventional method, has high safety, and is excellent in durability reliability. In addition, since the intracorporeal insertion tube of the present invention does not need to have a special structure having a cuff (brim) or the like, it is not only used for devascularization or blood delivery of the heart but also for joining or connecting other in vivo tissues. Applicable to For example, since it can be used for anastomosis of a digestive tract, a blood vessel or the like, or a connection between an artificial blood vessel and a living blood vessel, its usefulness is extremely high.

Claims

An in-vivo insertion tube joined in contact with the body organ tissue in a state of being covered by the body organ tissue,
A groove, a hole or a recess is formed in the intracorporeal insertion tube at least on the side in contact with the intracorporeal organ tissue as a part of the intracorporeal organ tissue invades due to deformation or displacement to obtain an anchoring effect. A tissue self-joining intracorporeal insertion tube characterized in that a passage for applying a negative pressure to the groove, hole or recess is formed when the intracorporeal insertion tube and the internal organ tissue are joined.
The tissue self-joining intracorporeal insertion tube according to claim 1 is a tube in which a groove, a hole or a recess is formed for causing deformation or displacement of the internal organ tissue as an outer tube, and the inside of the outer tube is formed. And an inner tube having an inner cavity functioning as a blood, infusion or wiring passage, and the passage for applying a negative pressure to the groove, hole or recess is at least one of the outer tube and the inner tube. A tissue self-joining intracorporeal insertion tube characterized in that it is formed in one piece.
The tissue self-joining intracorporeal insertion tube according to claim 2 includes the following (A), (B), and (C), that is, (A) the groove, hole or recess of the outer tube, A channel for applying a negative pressure to the groove, hole or recess by discharging or suctioning the air existing between the intracorporeal insertion tube and the internal organ tissue toward the outside, the outer tube or the inside of the passage Preparing for the tube,
(B) The groove by discharging or suctioning air present between the body insertion tube and the body organ tissue from the groove, hole or recess of the outer tube toward the inner cavity of the inner tube, Providing a passage in the inner pipe for applying a negative pressure to the hole or recess, and (C) moving from the groove, hole or recess of the outer pipe to the internal cavity of the inner pipe, Providing a passage in both the outer tube and the inner tube for applying a negative pressure to the groove, hole or recess by evacuating or aspirating the air present between the organ tissue and the body tissue;
A tissue self-joining intracorporeal insertion tube characterized by having any one selected from the group consisting of:
The tissue self-bonding intracorporeal insertion tube according to claim 2 or 3, wherein the outer tube and the inner tube are fixed via a buffer or an elastic body.
The tissue self-joining intracorporeal insertion tube, or the outer or inner tube, is provided with an outlet or suction port directly connected to a passage for applying a negative pressure to the groove, hole or recess. The tissue self-joining intracorporeal insertion tube according to any one of Items 1 to 4.
6. The tissue self-joining intracorporeal insertion tube according to any one of claims 1 to 5, wherein the tissue self-joining intracorporeal insertion tube, or the outer tube or the inner tube comprises a heating heat source.
7. The tissue self-joining intracorporeal insertion tube according to any one of claims 1 to 6, wherein the intracorporeal insertion tube is artificial heart devascularization.
A tissue self-joining intracorporeal insertion tube according to any one of claims 1, 5, 6, 7
(D) bringing the in-vivo insertion tube into contact with the in-vivo organ tissue in a state where the in-vivo insertion tube is covered by the in-vivo organ tissue;
(E) A negative pressure is applied to a contact portion between the in-vivo insertion tube and the in-vivo organ tissue by suctioning air from an outlet or a suction port directly connected to a passage for applying a negative pressure to the groove, hole or recess. And (F) after removing the negative pressure or in a state where the negative pressure is applied, the contact portion with the body tissue is heated and / or micro-vibration is applied to the body insertion tube and Bonding the body organ tissue with the body organ tissue.
Using the tissue self-joining intracorporeal insertion tube according to any one of claims 2 to 7,
(G) contacting the in-vivo insertion tube with the in-vivo organ tissue in a state where the outer tube of the in-vivo insertion tube is covered by the in-vivo tissue;
(H) Negative pressure is applied to the contact portion between the outer tube and the internal organ tissue by suctioning air from an outlet or suction port directly connected to a passage for applying a negative pressure to the groove, hole or recess. And (I) after removing the negative pressure or in the state where the negative pressure is applied, the contact portion with the body tissue is heated and / or micro-vibration is applied to the outer tube of the body insertion tube and Bonding the body organ tissue with the body organ tissue.
In the step (E) or (H), the step of applying the negative pressure is performed in combination with the step of applying pressure from the outside to the contact portion with the internal organ tissue, and the step (F) or (I) is performed. After removing at least one of the pressure and the negative pressure or in the state where the pressure and the negative pressure are simultaneously applied, heating the contact portion with the organ tissue in the body and / or micro-vibration The method according to claim 8 or 9, wherein the intracorporeal insertion tube and the internal organ tissue are added.