JP2008237786A - Artificial sphincter - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an artificial sphincter giving an autonomous evacuation to an ostomate to thereby improve QOL (quality of life) and reduce postoperative complications. <P>SOLUTION: This artificial sphincter is buried to clamp an internal excretory duct such as large intestine, ileum, or ureter connected to a stoma under the ostomy peripheral skin or in a muscular coat of a patient subjected to ostomy such as colostomy, ileostomy and urostomy, and the internal excretory duct can be manually closed and opened from above the skin. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a patient who has undergone ostomy such as colostomy, ileostomy, and urostomy (ostomate). Implanted in the skin or muscle layer of the body so as to sandwich the body conduit (colon, ileum, ureter, etc.) connected to the stoma, and manually close and open the opening of the stoma from the top of the skin, and to the body conduit The present invention relates to an artificial sphincter that can be manually adjusted.

  The ultimate goal of modern medicine is to improve therapeutic quality of life (QOL). Patients who underwent ostomy procedures such as colostomy, ileostomy, and urostomy escaped life-threatening risks However, it is necessary to wear a pouch that accepts stool and urine on a daily basis, and economic, mental, physical, and social stress cannot be avoided. The withdrawal of these patients from wearing a pouch has great significance in reducing complications and improving QOL. Currently, the technology that can be applied to ostomate is limited to pouches or similar products, and there is no technology that gives an autonomous defecation function.

  Currently, implantable therapeutic implants for incontinence include the AMS800 system (American Medical Systems, AMS) for urinary incontinence (see, for example, Patent Document 1). Fecal incontinence includes the ACTICON Neosphincter system (AMS), which has a structure similar to AMS800. Both require an inflatable cuff around the body conduit, a reservoir for storing liquid to control its internal pressure, and a manual pump to control the fluid flow path. Cuffs, reservoirs, and pumps each need to be implanted in different parts of the body, and the surgery is complex, so there is a high risk of postoperative complications. In addition, there is no function of adjusting the closing pressure to a long-term change on the living body side after the operation, and there are concerns about problems such as ischemia and tissue atrophy due thereto.

  In addition, a soft artificial sphincter using a shape memory gel (for example, see Patent Document 2), an artificial sphincter using a magnetic fluid and a permanent magnet (for example, see Patent Document 3), and movement of a string surrounding a body conduit with a magnet pair Artificial sphincter to control (for example, see Patent Document 4), artificial sphincter using shape memory alloy and transcutaneous power transmission system (for example, see Patent Document 5), artificial sphincter using shape memory alloy (for example, Patent Document) 6), an artificial sphincter using an electric field responsive polymer actuator (see, for example, Patent Document 7), and a magnetically controlled artificial sphincter having a magnetic control means outside the body (see, for example, Patent Document 8). Both must be driven by heat or electromagnetic fields.

In addition, a device that can be inserted into a colostomy and functions as both a stopper and a lid has been developed. However, there is a problem that is effective only for skin sores and solid excrement.
Based on the above, in order to improve the patient's QOL and reduce postoperative complications, it does not come into contact with the body surface skin, does not require a driving source by heat or electromagnetic field, and is long-term on the living body side after the operation There is a need for a fully implantable artificial sphincter that can cope with various changes.

Japanese Patent Laid-Open No. 2-52647 Japanese Patent Application No. 11-55910 JP 2006-25824 A Japanese Patent Application No. 2004-204430 JP 2002-263125 A JP 2001-161729 A Japanese Patent Application No. 2004-502890 JP-T-2001-519202

  An object of the present invention is to provide an artificial sphincter that can provide an autonomous excretion function to a stoma patient and can improve QOL and reduce postoperative complications.

  According to the present invention, the stoma of a patient who has undergone stoma construction surgery such as colostomy, ileostomy, urostomy, urostomy, etc. An artificial sphincter that is embedded in the surrounding subcutaneous layer or muscle layer so as to sandwich a body conduit such as the large intestine, ileum, and ureter connected to the stoma, and is configured so that the body conduit can be manually closed and opened from above the skin. It is possible to obtain an artificial sphincter that is characterized by

  Moreover, it is preferable that the artificial sphincter according to the present invention is configured to be able to manually adjust the closing pressure to the body conduit. The artificial sphincter according to the present invention preferably has a plurality of arms for closing the body conduit and a connection mechanism for connecting the ends of the arms so as to surround the body conduit. In the artificial sphincter according to the present invention, the connection mechanism may be provided with a degree of freedom of translation between adjacent arms, and the connection mechanism is provided with a degree of freedom of rotation between adjacent arms. It may be. The artificial sphincter according to the present invention may have a spring mechanism that urges the body conduit in an opening direction or a closing direction by changing an angle or a distance between adjacent arms. The artificial sphincter according to the present invention has a lock / release mechanism, and the lock / release mechanism functions at a fixed position so that the angle between adjacent arms or You may be provided so that distance can be hold | maintained. In the artificial sphincter according to the present invention, the lock / release mechanism further enters the release position by changing the angle or distance between adjacent arms against the biasing force of the spring mechanism from the lock position, and the lock is released. The internal conduit may be reopened or closed by the urging force of the spring mechanism, and the lock / release mechanism has a plurality of lock positions, and locks between adjacent arms by locking at each position. The angle or the distance may be manually adjustable. In the artificial sphincter according to the present invention, each arm may have one or a plurality of joints and be provided so as to be able to warp toward the body conduit. The artificial sphincter according to the present invention is preferably made of at least one of stainless steel, titanium, resin and ceramics having biocompatibility, and may be coated with a soft material having biocompatibility.

  The artificial sphincter according to the present invention can normally close the stoma, does not require a pouch, and can be manually opened when needed by the patient. The present invention also provides an artificial sphincter that can manually adjust the closing pressure on the large intestine, ileum, ureter, etc., and can cope with long-term changes in living tissue after implantation.

  According to the present invention, an artificial sphincter can be embedded in the ostomate under the stoma around the stoma or in the muscle layer close to the skin, and the intestinal tract and ureter can be normally closed. The ostomate can be given an autonomous defecation function that cannot be obtained with the current pouch and similar technologies.

  The artificial sphincter according to the present invention can be manually adjusted to adapt to long-term changes in the living body after implantation, in particular to changes in the size of the closed site due to the formation of scar tissue around the intestine. As a result, it is possible to remove the disadvantage that conventional systems cannot cope with long-term changes on the living body side, always provide a safe closing pressure, and solve postoperative complication problems such as ischemia and tissue atrophy.

  Since the present invention can be applied to a patient who has already undergone a stoma construction operation, and the implantation position is in the subcutaneous or near-muscular layer, the operation is performed with a tunnel for implantation around the stoma from a small incision near the stoma. It is as simple as making and inserting the device. As a risk countermeasure, it is easy to remove from the muscle layer near the skin or the skin and replace the device.

  The artificial sphincter according to the present invention is completely implantable and can be used semi-permanently, so no post-operative maintenance is required. Currently, it is superior in terms of medical economy compared to consumables such as pouches that are borne by ostomates.

  Since the artificial sphincter according to the present invention closes the intestinal tract and ureter in the body, it is possible to construct a stoma that does not protrude outside the body instead of a stoma that protrudes outside the body in order to use a conventional pouch. It becomes. Further, since no pouch is required, there is an effect of eliminating complications such as skin irritation caused by the use of the pouch.

Hereinafter, embodiments of the present invention will be described with reference to the drawings.
FIG. 1 is a diagram showing Example 1 of an embodiment of an artificial sphincter according to the present invention.

  Fig.1 (a) shows the open state of the body conduit | pipe of Example 1 of embodiment. Structure of slide mechanism capable of changing in parallel the distance between each rigid bar 1 and 2 at each end of each rigid bar 1 and rigid bar 1 and rigid bar 1 and 2 for closing a body conduit It is composed of parts 3 and 4. In addition, springs 5 acting in the direction of increasing the distance between the rigid bar 1 and the rigid bar 2 are disposed at both ends. Each of the rigid bars 1 and 2 is provided with components 6 and 7 of the lock / release mechanism, and the rigid bar 1 and the rigid bar are locked by a lock function at a position where the rigid bar 1 and the rigid bar 2 are approaching each other. It is locked so that the distance to 2 can be maintained. The position to be locked is the number of notches of the part 6. When the distance between the rigid bar 1 and the rigid bar 2 is further reduced from the notch at the closest position, the lock is released by the release function, and the distance between the rigid bar 1 and the rigid bar 2 is increased by the action of the spring 5. It grows again. By this series of operations, the lumen and the outer shell of the material 8 covering the entire component are deformed, and the opening and closing of the body conduit inside the lumen can be realized. FIG.1 (b) shows the closed state of the body conduit | pipe of Example 1 of embodiment.

FIG. 2 is a diagram showing Example 2 of the embodiment of the artificial sphincter according to the present invention.
A rigid arm 9 and a rigid arm 10 for closing the body conduit are connected by a rotating shaft 11, and a spring 12 is connected to the rigid arm 9 and the rigid arm 10, and an angle between the rigid arm 9 and the rigid arm 10. Acts in the direction of increasing When the rigid arm 9 and the rigid arm 10 are provided with lock / release parts 13 and 14 in the vicinity of the rotating shaft 11, respectively, and when the angle between the rigid arm 9 and the rigid arm 10 is reduced to a constant value, By engaging and locking the parts 13 and 14, the angle can be maintained. The angle can be maintained by the number of teeth of the latch having the part 13. When the angle is further decreased from the lock position with the smallest angle, the lock is released, and the angle between the rigid arm 9 and the rigid arm 10 is increased again by the acting force of the spring 12. The artificial sphincter constructed as described above is covered with the flexible material 15. The series of operations can open and close the body conduit in the lumen of the covering.

FIG. 3 is a diagram showing Example 3 of the embodiment of the artificial sphincter according to the present invention.
The rigid arm 9 and the rigid arm 10 of Example 2 have additional joints 16 and 17 and forearms 18 and 19, respectively. The joints 16 and 17 are provided with limiters that limit the rotation of the forearms 18 and 19 to the outside of the artificial sphincter. With this structure, the forearms 18 and 19 are stored inside the artificial sphincter when they are opened, so that no extra space is required in the body.

FIG. 4 is a view showing a modified type of the artificial sphincter according to the present invention.
The basic structure of the artificial sphincter shown in FIG. 4 (a) is a combination of the two basic opening / closing structures of the artificial sphincter shown in FIG. 2, and FIGS. 4 (b) and 4 (c) show the number of basic structures 3 and 4. FIG. It is. In either case, the connecting additional joint has a rotation angle limiter.

  Parts other than the covering material can be produced by a method such as cutting, casting or sintering using biocompatible metals, ceramics, resins and the like. The covering material can be produced by casting using a flexible material such as silicon elastomer, PVC or polyurethane having biocompatibility.

  FIG. 5 shows an implantable surgery of the artificial sphincter embodiment of the present invention. An incision is made on one side of the ostomate stoma, and a U-shaped tunnel is created to surround the intestine in the subcutaneous or muscle layer. After inserting the artificial sphincter shown in FIG. 3 into this U-shaped tunnel, the incision is sutured. In other embodiments, the opening as shown in FIG. 3 can be realized by a part of a rigid bar or arm, and can be easily combined in the body.

  As a post-operation operation, by applying a load in such a direction that the distance between the rigid bars and the angle between the arms is reduced from above the skin where the artificial sphincter is implanted, the internal conduit is located at the lock position of the lock / release mechanism. Close. In order to open, the load is applied to further reduce the distance and angle, and the lock / release mechanism is released. The acting force of the spring increases the distance between the rigid bars and the angle between the arms, and can open the body conduit.

  The artificial sphincter and its variants according to the present invention are implanted under the ostomate's percutaneous stoma or in the muscle layer and can normally close the intestinal tract and open manually when needed by the patient It is possible to provide the ostomate with an autonomous defecation function that cannot be obtained with current pouches or similar technologies.

  The artificial sphincter manufactured by the present invention and its modified type are characterized in that the number of materials used is small, the structure is simple, and the compactness is required from the viewpoint of implantation in the body. In addition, the implantation operation is extremely simple, and the burden on patients and doctors is small. Because it can be used semi-permanently, it has better medical economy compared to the pouch cost that ostomate currently bears. Furthermore, the use of the artificial sphincter according to the present invention can be expected to eliminate complications related to the use of conventional pouches.

It is the schematic which shows Example 1 of embodiment of the artificial sphincter of this invention. It is the schematic which shows Example 2 of embodiment of the artificial sphincter of this invention. It is the schematic which shows Example 3 of embodiment of the artificial sphincter of this invention. It is the schematic which shows the deformation | transformation type | mold of embodiment of the artificial sphincter muscle of this invention. It is a figure which shows the example of the surgery method of embodiment of the artificial sphincter of this invention.

Explanation of symbols

1, 2 Rigid bar 3, 4 (Slide mechanism) component 5 Spring 6, 7 (Lock / release mechanism) component 8 (Coating) material 9, 10 Rigid arm 11 Rotating shaft 12 Spring 13, 14 (Lock / release) Release) Parts 15 Flexible material 16, 17 Joint 18, 19 Forearm

Claims (12)

  An artificial sphincter that is implanted under the stoma around the stoma or in the muscle layer of a patient who has undergone a stoma construction operation so as to sandwich the internal conduit connected to the stoma, and the internal conduit is manually closed and opened from above the skin. An artificial sphincter characterized by being configured.   The artificial sphincter according to claim 1, wherein the artificial sphincter is configured to be able to manually adjust a closing pressure to the body conduit.   The artificial sphincter according to claim 1 or 2, further comprising a plurality of arms for closing the body conduit and a connection mechanism for connecting the ends of the arms so as to surround the body conduit.   4. The artificial sphincter according to claim 3, wherein the coupling mechanism is provided so as to give a degree of freedom of translation between adjacent arms.   4. The artificial sphincter according to claim 3, wherein the coupling mechanism is provided so as to give a degree of freedom of rotation between adjacent arms.   6. The artificial sphincter according to claim 3, further comprising a spring mechanism that biases the body conduit in an opening direction or a closing direction by changing an angle or a distance between adjacent arms.   It has a lock / release mechanism, and the lock / release mechanism is provided so that the lock mechanism functions at a fixed position so that the angle or distance between adjacent arms can be maintained against the biasing force of the spring mechanism. The artificial sphincter according to claim 6, wherein   The lock / release mechanism further enters the release position by changing the angle or distance between adjacent arms against the urging force of the spring mechanism from the lock position, and the lock is released, and the urging force of the spring mechanism releases the lock. The artificial sphincter according to claim 7, wherein the body conduit is provided so that it can be opened or closed again.   The lock / release mechanism has a plurality of lock positions, and is provided so that an angle or a distance between adjacent arms can be manually adjusted by locking at each position. 8. The artificial sphincter according to 8.   Each of the arms has one or a plurality of joints, and is provided so as to be able to warp toward the side of the body conduit. The claim 3, 4, 5, 6, 7, 8, or 9 The described artificial sphincter.   It consists of at least any one of stainless steel, titanium, resin, and ceramics which have biocompatibility, The 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 characterized by the above-mentioned. Artificial sphincter. The artificial sphincter according to claim 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 11, wherein the artificial sphincter is coated with a biocompatible soft material.

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