JPH10192321A - Human body penetrating member - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a living body penetrating member where evacuation and urination management is easily executed and also which is superior in the all of affinity, durability and formation property and is inexpensively produced so as to contribute to a patient for more perfect return to society. SOLUTION: In an artificial anus 1, a penetrating member 2 having a through- hole 3 where one part is opened to the inner side of a human body belly part and the other part is opened to the outer side of it is provided. In the through- hole 3, the exit part of an enteric canal F inserted to the inside of the penetrating member 2 is fixed to the inner peripheral surface of the through-hole 3 directly or indirectly with another material and also feces from the enteric canal F is evacuated from an outer side opening part 3a to the outside of a human body. At least a part of the penetrating member 2 is formed by the composite material of a ceramic material having affinity with a high molecular material having affinity in a same way.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a living body penetrating member used for an artificial anus, an artificial bladder, and the like.

[0002]

2. Description of the Related Art A colostomy (or gastrointestinal stoma), which is currently constructed in cases where it is impossible or inconvenient to defecate from the anus in colorectal cancer, rectal cancer or other conditions, is shown in FIG. As shown, a through hole H is formed in the abdominal wall B, and the end of the intestinal tract L is sewn and fixed to the through hole H. In such a colostomy, the intestinal wall protruding outside does not pass through the nerve because the nerve does not pass through, but the opening of the intestinal tract L is always kept open. Because of the inability to control excretion by the contractors, the stool comes out irrespective of the ostomate's will. In this case, not only defecation management but also generation of odor is a serious problem for ostomates aiming at rehabilitation, and various devices for defecation treatment have been devised conventionally.

For example, in FIG. 21, a flange-shaped resin ring 101 is adhered to the skin surface of the human body at the peripheral portion of the opening of the intestinal tract L with an adhesive material 102, and a resin bag 103 is held by an engaging portion 103a. Resin ring 101
, The opening of the intestinal tract L is covered with the bag 103, and waste such as stool is stored therein. On the other hand, Japanese Patent Publication No. Hei 3-62429 discloses that an opening member made of ceramic is buried so that one end is located inside a living body and the other end is located outside the living body, and excrement is removed from the body by a catheter passed through the through hole. Have been proposed.

[0004]

However, FIG.
In the artificial anus shown in FIG.
Since 1 is adhered, the adhesive strength is easily loosened due to sweat or grease generated from the skin, and there is a drawback that direct sticking gives a feeling of foreign matter or discomfort. In addition, since the adhesive is repeatedly adhered to the same place on the skin, a special device is required for the material of the adhesive, for example, so as not to damage the skin. Further, in the above publication technique using a ceramic opening member, since the stool and the like are guided outside the body by a catheter, defecation treatment using a special device is required, and ostomates that are healthy except for defecation are required. In many cases, they are forced to have difficulty. Furthermore, although the opening member is entirely formed of a sintered body of ceramics, there are drawbacks in that ceramics are difficult to process and that firing at a high temperature is necessary, resulting in high costs.

[0005] An object of the present invention is to provide easy management of defecation or urination when used for a colostomy or an artificial bladder, for example, without the feeling of foreign matter due to sticking of a resin ring, and furthermore, biocompatibility, durability and molding. An object of the present invention is to provide a penetrating member for a living body which is excellent in both properties and can be manufactured at a low cost, and which can contribute to a more complete reintegration of ostomate.

[0006]

Means for Solving the Problems and Actions / Effects In order to solve the above-mentioned problems, a living body penetrating member according to the present invention has a through hole, one of which opens inside the abdomen of the human body and the other opens outside the abdomen. And at least a part thereof is formed of a composite material of a ceramic material having biocompatibility and a polymer material having biocompatibility.

The penetrating member for a living body is formed of a composite material of a biocompatible ceramic material and a polymer material, and therefore has a high affinity when embedded in a human body, is lightweight, and has excellent durability. . Furthermore, since it is configured to contain a polymer material, it is easy to mold and process, and as a result, a penetrating member having excellent durability and biocompatibility can be manufactured at low cost and efficiently. The living body penetrating member can be entirely composed of the above-described composite material, or only a part thereof, for example, only a contact portion with the abdominal wall can be composed of the composite material.

The above-mentioned penetrating member for a living body can be applied to, for example, an artificial anus or an artificial bladder. In this case, instead of directly suturing the intestinal tract or ureter to the abdominal wall as in a conventional colostomy, by attaching the intestinal tract or ureter to the penetrating member having a through hole and embedded and fixed in the abdominal wall, A configuration of an artificial anus or an artificial bladder that discharges excretions such as stool and urine from the intestinal tract or ureter via the penetrating member can be realized. Specifically, the configuration of the colostomy or artificial bladder can be as follows. That is, a penetrating member constituted by the above-described penetrating member for living body has a through hole in which one is opened inside the abdomen of the human body and the other is opened outside the abdomen, and inserted into the penetrating member at the through hole. The intestinal tract or ureter is fixed directly or indirectly via another member to the inner peripheral surface of the through-hole, and the excretion from the intestinal tract or ureter passes through the abdominal outside opening (outside opening) of the through-hole. Part) is discharged outside the body. Then, at least a part of the penetrating member is formed of a composite material of a biocompatible ceramic material and a biocompatible polymer material.

[0009] According to the above configuration, since it is possible to discharge directly from the penetrating member without using a catheter or the like, a special device for defecation treatment is not required, and the inconvenience of the ostomate for defecation is reduced. In addition, since it is no longer necessary to attach the resin ring for fixing the bag directly to the skin as in the related art, there is no trouble such as feeling of a foreign substance or discomfort due to sticking the ring, or dropping of the ring due to sweat or fat. .

Next, the biocompatible ceramic material used for the penetrating member for a living body of the present invention includes, specifically, hydroxyapatite ceramic, calcium phosphate glass (for example, apatite-wollastonite glass ceramic, calcium phosphate). (Based crystallized glass) and the like. Among them, hydroxyapatite has particularly good biocompatibility, and for example, down growth that occurs when a material having poor biocompatibility is used, the epithelium between the penetrating member embedded in the abdominal wall and the abdominal wall tissue. Phenomenon that the tissue penetrates and a gap is formed between the penetrating member and the abdominal wall tissue) is scarcely caused, and the tissue can be suitably used for the colostomy of the present invention.

As the composite material, a material in which a ceramic material powder is dispersed in a polymer material can be used. When the living body penetrating member of the present invention is formed from such a composite material, a method for producing the same is to knead a polymer material and a ceramic material powder, and heat and soften the polymer material to flow the kneaded material. It is possible to suitably employ an injection molding method of molding into a desired shape by injecting into a cavity in a mold in a state. In this case, at least a part of the penetrating member for a living body is configured as an injection molded part of the composite material. When only a part of the living body penetrating member is formed as an injection molded part, at least a part of the remaining part can be integrated with the injection molded part by an insert molding method. In addition to the injection molding method, a method of casting a kneaded material in a fluid state or a mold press molding method can also be adopted. Further, a method of subjecting the composite material to processing such as cutting or cutting to obtain an intended shape may be used.

In the case of forming the penetrating member for living body of the present invention by injection molding, the polymer material mainly composed of any one of polymethyl methacrylate, polyglycidyl methacrylate and polyethylene terephthalate resin has excellent moldability. In addition, since it has good biocompatibility, it can be particularly preferably used in the present invention. On the other hand, a polymer material that is excellent in biocompatibility but is not necessarily suitable for injection molding due to low plasticity (for example, high-density polyethylene resin or polytetrafluoroethylene resin) can be mixed with polymer material powder. The desired shape of the penetrating member may be obtained by mixing with a ceramic powder and press-molding the mold. In this case, if heating is performed during or after molding, the compression or fusion of the polymer material powder particles proceeds, and the strength of the molded product can be increased. Further, a rubber material having excellent biocompatibility such as silicon rubber can be used. In this case, ceramic powder is kneaded into an uncured (uncrosslinked) rubber material in a fluidized state, and this can be molded into a desired penetrating member shape by casting or die press molding. On the other hand, the penetrating member may be formed by impregnating the continuous ventilation holes of the porous ceramic fired body with a resin.

[0013]

Embodiments of the present invention will be described below with reference to embodiments shown in the drawings. FIG. 1 is a schematic cross-sectional view showing an artificial anus 1 constructed using the penetrating member for a living body of the present invention. That is, in the artificial anus 1, the penetrating member 2 formed into a cylindrical shape as the living body penetrating member of the present invention has one end face on one side of the human body abdominal wall B, that is, the inside of the abdomen, and the other end face on the other side. It is embedded in the abdominal wall B so as to be located on the other side of the abdominal wall B, that is, outside the abdominal part, and a through hole 3 is formed in the axial direction thereof, and an inner opening 3a is formed in an end face located inside the abdominal part. The outside openings 3b are respectively opened in the end faces similarly located outside.

The penetrating member 2 is formed with a flange-like overhanging portion 4 on the outer peripheral surface at a position near the inner opening 3a so as to project laterally as shown in FIG.
As shown in FIG. 1, this is buried in the abdominal wall B, and further fixed by suturing as shown in FIG. On the other hand, the end on the side of the outer opening 3b protrudes from the outer surface of the abdominal wall B by a predetermined height (for example, about 10 to 20 mm). Also,
As shown in FIG. 1, a low fitting rib 5 is formed on the outer peripheral surface of the protruding portion along the periphery of the outer opening 3b.
The valve mechanism section 20 is engaged with the valve mechanism section 20, and a waste collection bag 40 as an opening / closing member is mounted on the valve mechanism section 20, and the outer opening 3b of the penetrating member 2 is closed so as to be openable and closable. It has become.

The entire penetrating member 2 is formed of a composite material of a biocompatible ceramic material and a biocompatible polymer material. As shown in FIG. 9B, the composite material 50 is configured as a polymer material 52 in which a ceramic material powder 51 is dispersed. In this case, as the polymer material 50, polymethyl methacrylate, polybisglycidyl methacrylate, polyethylene terephthalate resin, or the like is suitably used. On the other hand, as the ceramic material powder 51, hydroxyapatite ceramic powder can be used.

As a method for forming the penetrating member 2 from the composite material 50, an injection molding method can be employed. Specifically, a compound (kneaded material) of the composite material 50 is prepared by kneading the polymer material and the ceramic material powder, and this is heated and softened as shown in FIG. By injecting into the cavity K, the penetrating member 2 is formed. When the injection molding method is used, the blending amount of the ceramic material powder with respect to the polymer material is 10 to
It is preferable to be about 80% by volume. If the amount of the ceramic material powder exceeds 80% by volume, the fluidity of the kneaded material is reduced, and defects are likely to occur in the molded body (that is, the penetrating member 2). On the other hand, if the blending amount is less than 10% by volume, a problem may occur in the durability of the penetrating member 2 or the biocompatibility may be insufficient.

Returning to FIG. 1, the valve mechanism section 20 includes a base member 21 and a rotation shielding member 22. The base member 21 has a disc-shaped bottom 21 a that covers the outer opening 3 b of the penetrating member 2, and a side wall that is formed integrally with the periphery along the periphery thereof and that fits into the end of the penetrating member 21 from outside. 21b. The side wall 21
An annular rib 21c is formed along the circumferential direction on the inner peripheral surface edge of b.
Is formed as a penetrating member valve side engaging portion, which is engaged with the fitting rib 5 (the penetrating member side engaging portion) of the penetrating member 2, whereby the base member 21 is detachable from the penetrating member 2. It will be attached to. Also, bottom 2
1 is the thickness direction (that is, the discharge direction of the waste)
Is formed with a through hole 21d.

On the other hand, the rotation shielding member 22 is
It has a bottom portion 22a formed to have a diameter slightly larger than 1 and a side wall portion 22b formed integrally with the periphery along the periphery thereof and fitted into the base member 21 from outside. Bottom 22a
Is rotatably connected to the bottom 21 a of the base member 21 by a pin 23. An annular rib 22c is formed along the circumferential direction at the inner peripheral surface edge of the side wall portion 22b, and engages with an annular groove 21e formed on the outer peripheral surface of the base member 21. I have. On the other hand, a through-hole 22d is formed in the bottom portion 22a in the thickness direction (that is, the discharge direction of the discharge). Note that the pin 23 may be omitted.

Further, as shown in FIG.
Reference numeral 0 denotes a resin bag main body 41 in which a waste collection inlet 41a is formed, and a ring-shaped attaching / detaching portion 42 integrated with the bag main body 41 at the periphery of the collection inlet 41a by thermocompression bonding or the like. Have. And, as shown in FIG.
An annular rib 42a (bag-side engaging portion) provided to protrude from the inner peripheral surface of the attaching / detaching portion 42 is provided with an annular groove 22e (bag-side engaging for bag) formed on the outer peripheral surface of the rotation shielding member 22. Part)
Is removably attached to the rotation shielding member 22, that is, the valve mechanism 20. Then, as shown in FIG. 2, when an overlap is formed between the through hole 22 d and the through hole 21 d on the base member 21 side, discharge of the excretion from the intestinal tract F is allowed, while FIG. As shown in FIG. 1, when no overlap is formed, the discharge of the discharge is shut off.

Next, a detachable member 7 is detachably fixed inside the penetrating member 2, and the distal end of the intestinal tract F is fixed to the detachable member 7. As shown in FIG. 4, the detachable member 7 has a structure in which two ring-shaped members 7a made of an elastic material such as plastic are arranged to face each other, and they are connected and integrated with each other by a connecting member 7b. As shown in FIG. 1, a film member 8 made of a silicon rubber sheet or the like is fixed on the inside so as to cover the inner peripheral surface. The outlet end of the intestinal tract F is inserted into the inside thereof and fixed to the membrane member 8. Further, the detachable member 7 with the intestinal tract F fixed is engaged and fixed in the through hole 3 of the penetrating member 2.

The operation for constructing the artificial anus 1 is performed, for example, as follows. That is, a through hole H is formed by incision in the abdominal wall B (FIG. 7), the intestinal tract is pulled out therefrom, and the detachable member 7 is attached to the intestinal tract F as shown in FIG. In the ring member 7a of the attaching / detaching member 7, a plurality of thread insertion holes 7c penetrating in the thickness direction are formed at predetermined intervals along the circumferential direction, for example.
Is sewn with a suture 7d. The intestinal tract F is sewn to the membrane member 8 with a suture thread 7e at a position close to each ring member 7a, for example.

As shown in FIG. 4, a slit 7f is formed in the ring member 7a of the attaching / detaching member 7 in the radial direction, and intersects with the forming direction of the slit 7f as shown in FIG. By applying a compressive force from both sides in the radial direction in the direction, the diameter of the ring member 7a can be reduced. On the other hand, as shown in FIG.
The through hole 3 of the penetrating member 1 has an inner diameter substantially the same as the outer diameter of the ring member 7a to allow the insertion of the ring member 7a, and is lower at both ends of the inner peripheral surface along the circumferential direction. Engagement ribs 3c and 3d are formed, respectively, and the distance between the inner edges of the ribs 3c and 3d is substantially equal to the height of the detachable member 7 in the axial direction. Then, as shown in FIG. 6B, the upper and lower ring members 7a with the intestinal tract F fixed.
When the detachable member 7 is inserted into the through hole 3 from the outer opening 3b and the compression is released in this state, the ring members 7c are elastically restored, and the detachable member 7 is engaged. Engagement is made between the mating ribs 3c and 3d to be fixed to the penetrating member 2 together with the intestinal tract 7.

In this state, as shown in FIG. 7, the abdominal muscle B2 and the peritoneum B1 are separated from each other in the through hole H, and the projection 4 of the penetrating member 2 is inserted there. A plurality of thread insertion holes 4a penetrating the overhang portion 4 in the thickness direction are formed at predetermined intervals along the circumferential direction, and the abdominal muscles B2, the overhang portion 4, and the peritoneum B1 are respectively formed. By suturing with the suture 4b penetrating them in the thread insertion hole 4a,
That is, the construction of the artificial anus 1 is completed. The intestinal tract F is inserted into the through hole 3 of the penetrating member 2, and after the penetrating member 2 is sewn to the abdominal wall B in this state, a detachable member is attached to the distal end of the intestinal tract F pulled out from the outer opening 3b of the penetrating member 2. 7 may be fixed, and then the detachable member 7 may be pushed together with the intestinal tract F into the penetrating member 2 to perform the attachment. Further, as shown in FIG. 8, the overhang portion 4 may be fixed to the lower surface of the peritoneum B1.

Hereinafter, the operation of the artificial anus 1 will be described. That is, when the valve mechanism 20 is closed as shown in FIG. 1, excretion such as stool from the intestinal tract F is blocked by this, and leakage to the outside is prevented. In this state, the waste collection bag 40 may be removed. Next, when discharging the waste, the collection bag 40 is attached to the valve mechanism unit 20, and then, as shown in FIG. 2, the rotation shielding member 22 is rotated to make the through hole 22 d of the base member 21 side. When aligned with the through-hole 21d, the exudate from the intestinal tract F is collected from the inner opening 3a of the through-hole 3 of the penetrating member 2, through the through-holes 21d and 22d, and collected in the collection bag 40. When the discharge is completed, the rotation shielding member 22 is again rotated to the cutoff state shown in FIG.
The collection bag 40 may be removed from the penetrating member 2 and disposed. By keeping the valve mechanism 20 closed at all times, the leakage of the discharged matter from the outer opening 3b hardly occurs, and the generation of odor is not bothersome.

Further, since the intestinal tract F is fixed to the membrane member 8 made of silicone rubber or the like, when the intestinal tract F performs peristaltic movement, the membrane member 8 also expands and contracts following the movement and penetrates. The relative movement of the intestinal tract F with respect to the member 2 is allowed. Thereby, the smooth movement of the intestinal tract F is maintained. Furthermore, since the intestinal tract F is fixed to the detachable member 7 separate from the penetrating member 2 and is attached to the penetrating member 3 together with the detachable member 7 by one-touch using the elastic deformation of the ring member 7a, As compared with the case where the intestinal tract F is directly sewn to the penetrating member 2 embedded in the abdominal wall B, the mounting operation can be easily performed.

On the other hand, since the entire penetrating member 2 is made of a composite material of hydroxyapatite ceramic powder and a polymer material, it has excellent biocompatibility. For example, when the penetrating member 2 is made of a material having a relatively low biocompatibility, as shown in FIG. 22, the epithelial tissue B3 sneaks between the penetrating member 2 embedded in the abdominal wall B and the abdominal wall tissue to penetrate. There is a problem that a so-called down growth occurs, which causes a gap between the member 2 and the tissue. However, by forming the penetrating member 2 from the above-described composite material, it is possible to make it extremely unlikely to cause the down growth. . Further, the weight of the penetrating member 2 can be reduced as compared with the case where the whole of the penetrating member 2 is formed of a ceramic fired body.

The penetrating member 2 may be manufactured by subjecting a composite material to cutting or cutting. FIG. 10 shows an example in which the material is turned with a cutting tool V to form the penetrating member 2. In this case, the entire penetrating member 2 may be formed by processing. However, a preliminary body is formed by injection molding or the like, and the preliminary body is partially processed to finish the final shape. If the processing steps are simplified, the penetrating member 2 can be manufactured more efficiently.

On the other hand, even if a high-molecular-weight material such as a high-density polyethylene resin or a polytetrafluoroethylene resin is not suitable for injection molding because of its low plasticity, if it has excellent biocompatibility, it can be used as shown in FIG. The penetrating member 2 can be formed by press molding as shown in FIG. That is, the polymer material powder 52a and the ceramic material powder 51 are mixed, filled into the cavity K of the die D, and compressed while being heated by the heater H, whereby the penetrating member 2 can be molded. At this time, the mixture of the above-mentioned powders is obtained by combining the particles of the polymer material powder 52a with each other by heating and compression to form the polymer material substrate 52.
Is formed, and the particles of the ceramic material powder 51 are dispersed and converted into the composite material 50. This method is also applicable to the case where a resin having relatively high plasticity, such as the above-mentioned polymethyl methacrylate resin, is used. In this case, the mixing ratio of the ceramic material powder should be larger than that of the injection molding method. (For example, up to about 95% by volume). Thereby, the biocompatibility and durability of the penetrating member 2 can be further improved.

Further, a rubber material having excellent biocompatibility, such as silicon rubber, can be used. In this case, as shown in FIG. 11 (b), a fluid rubber kneaded material Q obtained by kneading ceramic powder into an uncured and fluid rubber material is molded into a mold M
By casting and curing the cavity K, the penetrating member 2 can be molded. The use of the rubber material has the following advantages, for example. That is, by adjusting the composition of the ceramic material powder,
Appropriate elasticity is imparted to the composite material formed by curing the kneaded material, and for example, there is little discomfort when embedded in a living body. Even if the intestinal tract is directly sewn to the penetrating member, the elasticity of the penetrating member 2 eases the restraint on the intestinal tract F, and the direct suturing may be possible.

Hereinafter, several modified examples of the colostomy of the present invention will be described. The projecting portion 4 of the penetrating member 2 is formed in a continuous flange shape along the circumferential direction of the penetrating member 2 as shown in FIG. 4, or intermittently as shown in FIG. (For example, in the form of petals). Also, in FIG. 4, the overhang 4 is formed at the end of the penetrating member 2 on the side of the inner opening 3b.
As shown in FIG. 2 (b), it can be formed in an intermediate portion near the inner opening 3b. In this case, as shown in FIG. 3C, the end of the penetrating member 2 and the lower surface of the overhanging portion 4 can be integrated so that a smooth cross-sectional outer diameter line is formed. .

The membrane member 8 to which the intestinal tract F is fixed is shown in FIG.
As shown in (a), it may be formed in a bellows shape with a flexible plastic material or the like. In this case, the intestinal tract F and the membrane member 8 can be connected to each other at a position corresponding to each vertex of the bellows, for example, by a suture thread 7e penetrating the both.

As shown in FIGS. 13 (b) and 13 (c), the intestinal tract F may be structured to be directly fixed to the penetrating member 2 without using the detachable member 7. For example, FIG.
In the above, the membrane member 8 is fixed to the penetrating member 2 only at the edge on the distal end side of the intestinal tract by the binding thread 57d, and the other side thereof expands and contracts relatively to the inner surface of the through hole 3 of the penetrating member 2. I can do it. The intestinal tract F has its membrane member 8
For example, it can be fixed to both end edges using a suture thread 57e. In FIG. 3C, the film member 8 has both end edges folded back to the penetrating member 2 side, and is fixed to the penetrating member 2 at the folded portion by a binding thread 57d. On the other hand, as shown in FIG. 14A, both sides in the width direction of the band-shaped film member 8 are folded back.
The edges are bonded to each other by bonding or stitching to form a tubular article 8 'as shown in FIG.
Are joined together to form an annular member 8 "shown in FIG. 9C. This is disposed in the through hole 3 of the penetrating member 2 as shown in FIG. It may be fixed.

Further, as shown in FIG. 15A, the valve mechanism 20 can be omitted. In this case, the waste collection bag 40 is directly attached to and detached from the penetrating member 2. In the figure, the waste collection bag 40 has an annular rib 42 a as a bag-side engaging portion formed on the inner peripheral surface of the ring-shaped attaching / detaching portion 42 on the outer peripheral surface at the end of the penetrating member 2. Annular groove 5a as formed penetrating member side engaging portion
Is fitted to the penetrating member 2. On the other hand, as shown in FIG. 16, the waste collection bag 40 may be adhered to the penetrating member 2 with an adhesive layer 42b such as a double-sided adhesive tape. As shown in FIG. 15B, in a configuration in which the valve mechanism 20 is omitted, the intestinal tract F
May be fixed so as to extend from the outer opening 3b of the penetrating member 2 to a maximum of about 10 cm.

Here, as shown in FIG.
May be removably closed by a plastic or rubber lid 6 as an opening / closing member. In the figure, the lid 6 is fitted to the end of the penetrating member 2 from outside. As shown in FIG. 18A, a female screw 6a formed on the inner peripheral surface of the lid 6
Is screwed into a male screw portion 6a formed on the outer peripheral surface of the penetrating member 2, or a projecting portion 6c is provided on the lid portion 6 as shown in FIG. Female threaded portion 2b formed on the inner peripheral surface of penetrating member 2
As shown in FIG.
The ring-shaped groove 6d formed on the outer peripheral surface of the projection 6c has O
Various modes are possible, such as a mode in which a ring-shaped seal member 6e such as a ring is fitted and pressed into the outside opening 3a of the penetrating member 2.

In FIG. 19 (a), the fitting rib 5 of the penetrating member 2 is further protruded outward to form a flange, and a notch 5a cut in one or a plurality of positions of its outer edge in the radial direction is provided. Has formed. The lid 6 is formed in a cap shape that fits into the fitting rib 5 from the outside, and a protruding portion 6a corresponding to the notch 5a is formed on the inner peripheral surface between the notch 5a and the bottom surface 6b. Are formed so as to protrude in the radial direction with a gap d corresponding to the thickness of the fitting rib 5. The lid 6 is fitted to the fitting rib 5 with the projection 6a aligned with the notch 5a, and the lid 6 is further rotated around the axis of the penetrating member 2, whereby the lid 6 is The projection 6a is attached to the penetrating member 2, and the projection 6a is engaged with the lower surface of the fitting rib 5 to prevent the rib from coming off. If the gap d is set to be slightly smaller than the thickness of the fitting rib 5, an appropriate friction is generated between the protrusion 6a and the fitting rib 5, and the sealing force of the lid 6 to the penetrating member 2 is reduced. It is raised and loosening is less likely to occur. In addition,
The engaging structure of the lid 6 with the penetrating member 2 may be the engaging structure of the base member 21 of the valve mechanism 20 shown in FIG. 1 with the penetrating member 2 or the penetrating member 2 of the attaching / detaching portion 42 of the waste collection bag 40. Can be diverted to the engagement structure with respect to.

Further, as shown in FIG.
A ceramic portion 2 m made of the composite material 50 (FIG. 9) and a ceramic layer 2 made of a hydroxyapatite ceramic fired body and covering the outer peripheral surface of the cylindrical portion 2 m.
p and a two-layer structure. For example, in the example shown in FIG. 2A, the outer opening 3 of the cylindrical portion 2s is provided.
A flange portion 2f is formed at the end on the a side so as to protrude from the outer peripheral surface, and the ceramic layer 2p is formed in a cylindrical shape covering the outer peripheral surface of the cylindrical portion 2s except for the flange portion 2f. I have. Further, a male screw portion 2a is formed on the outer peripheral surface of the flange portion 2f, and the lid portion 6 (or the attaching / detaching portion 42 of the waste collection bag 40) is screwed into the male screw portion 2a. The cylindrical portion 2m and the ceramic layer 2p are
For example, the screw insertion hole 2 formed on the ceramic layer 2p side
A screw 2r is inserted through q and screwed into a female screw hole 2s formed in the cylindrical portion 2m to fasten each other. In addition, as shown in FIG.
The outer peripheral portion may slightly protrude from the outer peripheral surface of the ceramic layer 2p to form the fitting rib 5, and the lid 6 (or the detachable portion 42 of the waste collection bag 40) may be fitted therein. The ceramic layer 2p and the cylindrical portion 2m can be integrated by insert molding.

It should be noted that all the configurations of the colostomy described above are applicable to the artificial bladder. In this case, for example, as shown in FIG.
Alternatively, what is indirectly fixed via the attaching / detaching member 7 or the membrane member 8 or the like is different only in that the intestinal tract is not the intestinal tract F but the ureter U.

Incidentally, the structure of the penetrating member for living body described in the claims of the present invention may be a structure obtained by adding at least one content of each invention described below.

Invention A The structure of the living body penetrating member with a membrane member is such that at least a part thereof is made of a material having biocompatibility and is buried in the abdominal wall of the human body, and one of the members is opened inside the abdominal part of the human body. The other has a penetrating member having a through hole that opens to the outside of the abdomen, and allows the penetrating member to cover the inner peripheral surface of the through hole and to move at least a part of the inner peripheral surface with respect to the inner peripheral surface. And a membrane member to which the intestinal tract or ureter is to be attached, which is directly or indirectly attached via another member, and is inserted into the through hole. The film member can be configured to have flexibility.

The above-mentioned penetrating member for living body with a membrane member can be applied to, for example, an artificial anus or an artificial bladder. In this case, instead of suturing the intestinal tract or ureter directly to the abdominal wall as in a conventional colostomy, attaching the intestinal tract or ureter to the living body penetrating member having a through hole and embedded and fixed in the abdominal wall. Accordingly, a configuration of an artificial anus or an artificial bladder that discharges excrement such as stool or urine from the intestinal tract through the living body penetrating member can be realized. Specifically, at least a part of the penetrating member is made of a material having biocompatibility and is embedded in the abdominal wall of the human body, and one of the penetrating members is opened inside the abdominal part of the human body and the other is opened outside the abdominal part. It is configured as having a through-hole. In addition, in the penetrating member, the membrane member covers the inner peripheral surface of the through hole and at least a part thereof is allowed to move with respect to the inner peripheral surface, and the membrane member is directly or through another member. Attached indirectly. Then, the intestinal tract or ureter inserted into the penetrating member in the through-hole is fixed to the membrane member covering the inner peripheral surface of the through-hole, and the discharge from the intestinal tract or ureter is outside the abdomen of the through-hole. It is discharged out of the body from the opening (outer opening).

When the penetrating member for living body with a membrane member of the present invention is used, the intestinal tract or ureter is not directly fixed to the penetrating member, but is attached to the membrane member covering the inner peripheral surface of the through hole of the penetrating member. For example, when the intestinal tract moves (for example, peristaltic movement), the membrane member follows the movement and moves relatively to the inner peripheral surface of the penetrating member, so that the activity of the intestinal tract can be maintained in a smooth state. As the film member, a flexible material such as silicon rubber, a sheet of polyethylene terephthalate resin, polytetrafluoroethylene resin, or a non-woven or net-like material formed of fibers of these resins or other resins is used. Can be configured.

Next, in the above configuration, an opening / closing member such as a lid for closing the outer opening can be detachably attached to the penetrating member. In this way, the opening of the penetrating member can be sealed, and defecation or urination management can be performed extremely easily. When defecation or urination is performed, the opening / closing member is removed from the penetrating member and the waste is received by a tray or the like, or a stool collection bag is attached to the outer opening side of the penetrating member and the waste is collected here. Is stored, the waste can be collected smoothly. Further, since it is not necessary to attach the resin ring for fixing the bag directly to the skin as in the related art, troubles such as a feeling of a foreign substance due to the attachment of the ring and a detachment of the ring due to sweat or fat do not occur.

Further, in the above configuration, since the discharge can be directly discharged from the penetrating member without using a catheter or the like, a special device for defecation treatment is not required, and the ostomate suffers from defecation or urination. Is also reduced.

Next, in the penetrating member for living body with a membrane member having the above-described structure, the membrane member to which the intestinal tract or ureter is attached is fixed inside, and inserted into the through hole of the penetrating member. A detachable member detachably engaged with the member can be provided. In this way, by attaching the detachable member to the intestinal tract or ureter, then attaching the detachable member to the penetrating member, and further attaching the penetrating member to the abdominal wall, it is possible to perform a surgical operation of a colostomy or an artificial bladder. Easy to do. Further, after suturing the penetrating member to the abdominal wall in a state where the intestinal tract or ureter is inserted into the through hole of the penetrating member, the detachable member is fixed to the intestinal tract or ureter pulled out from the outer opening of the penetrating member, The attachment may be performed by pushing the detachable member together with the intestinal tract toward the penetrating member.

Further, it is also possible to use a combination of a plurality of materials instead of using a single material for the entire penetrating member. For example, the penetrating member may have at least a two-layer structure of a first layer including the outer peripheral surface thereof and a second layer adjacent thereto, and at least the first layer may be a ceramic material or a metal material having biocompatibility. . Specifically, the second layer is formed of a metal material (preferably, Ti or Ti
Alloys, Co-Cr alloys, etc., plastics or rubbers (preferably, high-density polyethylene resin, polyethylene terephthalate resin, silicon rubber, etc.), or ceramics (zirconia, alumina, etc.). The layers can be composed of the calcium phosphate ceramic described above. In other words, only the portion of the penetrating member that directly contacts the abdominal wall, which is a living tissue, is made of calcium phosphate ceramic such as hydroxyapatite, which is particularly excellent in biocompatibility, and the other is made of a metal material or a polymer material. While avoiding the above-described problems such as downgrowth, for example, the strength or toughness of the penetrating member is improved when a metal is used, and the weight can be reduced when a polymer material is used.

In the case of manufacturing such a penetrating member having a two-layer structure, the first layer portion may be formed by coating the second layer portion by a method such as plasma spraying or a sol-gel method. A method is also possible in which the layer portion and the second layer portion are separately formed, and these are integrated by joining. In the latter case, the penetrating member is more specifically formed of a metal material or a polymer material, and the inner peripheral surface is formed of a cylindrical portion as the second layer forming the above-described through hole, and a biocompatible ceramic. Having a ceramic layer as a first layer covering the outer peripheral surface of the cylindrical portion,
An opening / closing member engaging portion for detachably engaging the opening / closing member may be formed at an end of the tubular portion on the side where the outer opening is formed.

Specifically, the opening / closing member engaging portion may be, for example, a female screw portion formed on the inner peripheral surface at the outer opening side end of the cylindrical portion. In this case, the opening / closing member removably closes the outer opening by screwing the external thread formed on the opening / closing member to the internal thread. On the other hand, an exposed portion that is not covered by the ceramic layer may be formed at the outer peripheral end of the cylindrical portion on the outer opening side, and a male screw portion as an opening / closing member engaging portion may be formed in the exposed portion. In this case, the opening / closing member removably closes the outer opening by screwing the female screw formed therein to the male screw. Further, an annular ridge or groove as an opening / closing member engaging portion may be formed in the circumferential direction of the exposed portion of the cylindrical portion. In this case, the opening / closing member can be configured to fit into the end of the cylindrical portion from the outside, and the inner peripheral surface thereof is formed with a groove or a convex ridge that engages with the convex ridge or the groove. Can be.

That is, if the outer opening of the penetrating member is closed by, for example, a screw-type or fitting-type opening / closing member, it is more convenient to improve the sealing performance of the colostomy. In the case of using ceramics, there is a problem that it is difficult to form an opening / closing member engaging portion such as a screw portion, a fitting ridge portion or a groove portion by post-processing.
Therefore, if the penetrating member has a two-layer structure, and the inner cylindrical portion is made of a metal material or a polymer material, and the opening / closing member engaging portion is formed thereon, the opening / closing member engaging portion can be processed or processed. It can be easily formed by molding or the like.

Next, the configuration of the living body penetrating member with the opening / closing member engaging portion is characterized in that it is configured as follows. That is, at least a part thereof is made of a material having biocompatibility and is embedded in the abdominal wall of the human body, and has a through hole that opens on the inside of the abdominal part of the human body and opens on the outside of the abdominal part. It is envisaged that the intestinal tract or ureter may be fixed directly or indirectly through another member in the hole. A cylindrical portion made of a metal material or a polymer material and having an inner peripheral surface forming a through hole, and a ceramic layer made of biocompatible ceramics and covering the outer peripheral surface of the cylindrical portion are provided. An opening / closing member engaging portion for detachably engaging the opening / closing member is formed at the end of the cylindrical portion on the side of the through hole that opens to the outside of the abdomen. In this case, the intestinal tract or ureter can be fixed directly or indirectly with respect to another member to the inner peripheral surface of the through-hole of the penetrating member, and the discharge from the intestinal tract or ureter can be prevented. Can be discharged from an opening (outer opening) located outside the abdomen of the patient. According to this configuration, the opening of the penetrating member can be sealed, and defecation or urination management can be performed extremely easily. When defecation or urination is performed, the opening / closing member is removed from the penetrating member and the waste is received by a tray or the like, or a stool collection bag is attached to the outer opening side of the penetrating member and the waste is collected here. Is stored, the waste can be collected smoothly. Further, since it is not necessary to attach the resin ring for fixing the bag directly to the skin as in the related art, troubles such as a feeling of a foreign substance due to the attachment of the ring and a detachment of the ring due to sweat or fat do not occur. Further, the opening / closing member engaging portion for attaching the opening / closing member can be easily formed by processing or the like.

The structure of the living body penetrating member with the detachable member is such that at least a part thereof is made of a material having biocompatibility and is embedded in the abdominal wall of the human body, and one of the members is opened inside the abdominal part of the human body. The other has a penetrating member having a through hole that opens to the outside of the abdomen, and the intestinal tract or ureter is fixed inside, and is inserted into the through hole of the penetrating member to removably engage with the penetrating member. A callus is provided with a detachable member. Thereby, the discharge from the intestine or the ureter, which is detachably attached to the through hole of the penetrating member via the detachable member, is discharged outside the body from the opening (outside opening) outside the abdomen of the through hole. Can be. Further, by attaching a detachable member to the intestinal tract or ureter, and then attaching the detachable member to the penetrating member, and further attaching the penetrating member to the abdominal wall, it is possible to easily perform an operation for constructing a colostomy or artificial bladder. it can.

It should be noted that the above-described components of the living body penetrating member with a membrane member can be added to the structure of the living body penetrating member with the opening / closing member engaging portion or the living body penetrating member with the detachable member.

Further, in the above-described configurations of the living body penetrating member with the membrane member, the living body penetrating member with the opening / closing member engaging portion, and the living body penetrating member with the detachable member, the lateral projection from the outer peripheral surface of the penetrating member is provided. A structure in which a protrusion is formed integrally with the lever, and the penetrating member is fixed to the abdominal wall by embedding the protrusion in the abdominal wall or by fixing the protrusion to the inner surface of the abdominal wall. It can be. Thus, the penetrating member can be stably attached to the abdominal wall. Further, an opening / closing member that embeds the penetrating member in the abdominal wall so that the side on which the outer opening is formed protrudes from the outer surface of the abdominal wall, and the opening / closing member that closes the outer opening so that it can be opened / closed is detachably attached to the penetrating member at the projecting portion. It can also be configured to be mounted. With this configuration, when the opening and closing member is attached to and detached from the penetrating member, interference between the opening and closing member and the abdominal wall hardly occurs,
As a result, the opening and closing member can be easily attached and detached.

Invention B The structure of the living body penetrating member with the collection bag is such that at least a part thereof is made of a material having biocompatibility and is buried in the abdominal wall of the human body, one of which is open inside the abdominal part of the human body and the other is open. And a penetrating member having a through hole that opens to the outside of the abdomen, and detachably mounted directly or indirectly via another member at an end of the penetrating member, and discharged through the penetrating member. And a waste collection bag for receiving waste such as stool or urine.

The above-mentioned penetrating member for living body with a collection bag can be applied to, for example, an artificial anus or an artificial bladder. In this case, instead of suturing the intestinal tract or ureter directly to the abdominal wall as in a conventional colostomy, attaching the intestinal tract or ureter to the living body penetrating member having a through hole and embedded and fixed in the abdominal wall. Accordingly, a configuration of an artificial anus or an artificial bladder that discharges excretions such as urine from the intestinal tract through the living body penetrating member can be realized. Specifically, at least a part of the penetrating member is made of a material having biocompatibility and is embedded in the abdominal wall of the human body, and one of the penetrating members is opened inside the abdominal part of the human body and the other is opened outside the abdominal part. It is configured as having a through-hole. Further, the intestinal tract or ureter inserted into the penetrating member in the through hole is fixed directly or indirectly through another member to the inner peripheral surface of the through hole, and the discharge from the intestinal tract or ureter penetrates. The body is discharged from the opening (outside opening) on the outside of the abdomen of the hole, and the end on the side of the outside opening of the penetrating member receives discharge from the intestinal tract or ureter. An object collection bag is detachably mounted directly or indirectly via another member.

As is clear from the above, according to the penetrating member for living body with a collecting bag of the present invention, the exudate from the intestinal tract or ureter is transferred to the excrement collecting bag fixed to the outer opening side of the penetrating member. Since the waste is collected and stored, the waste can be smoothly collected. Further, since it is no longer necessary to attach the resin ring for fixing the bag directly to the skin as in the related art, troubles such as a feeling of foreign matter or discomfort caused by sticking the ring or a drop of the ring due to sweat or fat do not occur. .

Further, the waste collection bag has a bag main body in which a waste collection inlet is formed, and a ring-shaped attaching / detaching portion provided integrally with the bag main body at a periphery of the collection entrance. it can. In this case, the attachment / detachment portion is attached / detached to / from the end of the penetrating member directly or indirectly via another member. Thereby, the attachment and detachment of the waste collection bag with respect to the penetrating member can be easily and reliably performed. Specifically, an annular penetrating member side engaging portion is formed along the circumferential direction on the end surface or outer peripheral surface on the end side of the penetrating member, while the ring-shaped attaching / detaching portion of the waste collection bag is formed. A bag-side engaging portion that detachably engages with the penetrating member-side engaging portion along the circumferential direction can be formed on the end surface or the inner peripheral surface facing the penetrating member. Further, the attachment / detachment portion of the waste collection bag may be attached to the penetrating member via an adhesive layer.

Next, the structure of the penetrating member for a living body with a valve mechanism part is made of a material having biocompatibility, at least part of which is embedded in the abdominal wall of the human body, and one of which is opened inside the abdominal part of the human body. And a penetrating member having a through hole that opens to the outside of the abdomen, and an end of the penetrating member,
A valve mechanism is provided which is switchable between a state in which discharge of waste such as stool or urine discharged through the penetrating member is permitted and a state in which discharge is blocked. In this case, the intestinal tract or ureter can be fixed directly or indirectly with respect to another member to the inner peripheral surface of the through-hole of the penetrating member, and the discharge from the intestinal tract or ureter can be prevented. Can be discharged from an opening (outer opening) located outside the abdomen of the patient. According to this, since the opening of the penetrating member is sealed by the valve mechanism and the waste can be discharged by opening the valve mechanism as needed, defecation or urination management is extremely easy. It is also possible for the ostomate to defecate on his own in a toilet or the like.

The valve mechanism can be provided detachably with respect to the penetrating member. This makes it extremely easy to perform maintenance such as replacement and cleaning of the valve mechanism. Specifically, the valve mechanism portion is detachably engaged with an end of the penetrating member to partially close the outer opening, and a base member having a through hole formed in a discharge direction of the discharge, A through hole is formed on the base member, and a through hole is formed in the discharge direction of the discharged material, and an overlap is formed between the through hole and the through hole on the base member side. A rotatable shielding member rotatably provided with respect to the base member between a discharge position where discharge via the base member is permitted and a blocking position where discharge of the discharged material is also blocked without forming an overlap. Can be configured as With this configuration, the valve mechanism can be made compact and the operability thereof is high, and the ostomate can perform the defecation extremely smoothly, and there is little increase in discomfort due to the addition of the valve mechanism.

The structure of the living body penetrating member with the collecting bag and the structure of the living body penetrating member with the valve mechanism can be combined with each other. In this case, the waste collection bag can be attached to and detached from the valve mechanism. According to this configuration, the waste collection bag is attached to the valve mechanism, then the valve mechanism is opened, the waste is collected in the collection bag, and then the valve is closed. And can be collected smoothly in a collection bag. As a result, the ostomate can easily perform defecation or urination by itself, and can greatly contribute to its complete rehabilitation.

[Brief description of the drawings]

FIG. 1 is a schematic sectional view showing an example of an artificial anus of the present invention.

FIG. 2 is an explanatory view of the operation of the valve mechanism.

FIG. 3 is a perspective view of a waste collection bag.

FIG. 4 is an exploded perspective view of the colostomy of FIG. 1;

FIG. 5 is an explanatory view showing a method of attaching an intestinal tract to a detachable member.

FIG. 6 is a diagram illustrating the operation of a detachable member.

FIG. 7 is an explanatory view showing a method of attaching the penetrating member to the abdominal wall.

FIG. 8 is a sectional view showing a modification of the same.

FIG. 9 is an explanatory view showing a method of forming a penetrating member by injection molding of a composite material.

FIG. 10 is an explanatory view showing a method of forming a penetrating member by cutting a composite material.

FIG. 11 is an explanatory view showing a method of forming a penetrating member by pressing or casting a composite material.

FIG. 12 is a view showing some modified examples of the penetrating member.

FIG. 13 is a view showing some modified examples of the membrane member.

FIG. 14 is an explanatory view showing another modified example.

FIG. 15 is a schematic sectional view showing a configuration of a colostomy in which a valve mechanism is omitted.

FIG. 16 is a schematic sectional view showing another configuration.

FIG. 17 is a schematic sectional view showing a configuration in which an outer opening of a penetrating member is closed by a lid.

FIG. 18 is a cross-sectional view showing some modified examples of the lid.

FIG. 19 is an explanatory view showing another modification of the lid.

FIG. 20 is a sectional view showing an example in which a penetrating member is formed in two layers, together with a modified example thereof.

FIG. 21 shows a conventional colostomy.

FIG. 22 is an explanatory diagram showing a state in which a down glow occurs.

[Explanation of symbols]

 REFERENCE SIGNS LIST 1 colostomy 2 penetrating member 3 through hole 3a outer opening 3b inner opening 4 overhang 6 lid (opening / closing member) 7 detachable member 8 membrane member F intestinal tract

Claims (5)

[Claims] 1. A through hole having one opening inside the abdomen of the human body and the other opening outside the abdomen, at least a part of which has a biocompatible ceramic material and a biocompatible material A penetrating member for a living body, which is formed of a composite material with a polymer material. 2. The biocompatible ceramic material is a calcium phosphate ceramic, and the polymer material is mainly made of either polymethyl methacrylate or glycidyl bismethacrylate.
The penetrating member for living body as described in the above. 3. The composite material according to claim 1, wherein the powder of the ceramic material is dispersed in the polymer material.
Or the biological penetration member according to 2. 4. The penetration member for a living body according to claim 3, wherein at least a part thereof is formed as an injection molded part of the composite material. 5. The penetrating member for a living body according to claim 1, wherein the whole is made of the composite material.