JPS63130073A - Prothese apparatus and method retaining original shape of pipe and enabling repeated use thereof - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a device for maintaining a percutaneous canal constructed for the introduction or removal of fluids or substances by catheterization.

Long-term, intermittent access through sinus tracts is necessary for various medical procedures, such as catheterization for long-term peritoneal dialysis.

The standard procedure for long-term peritoneal dialysis is performed by surgically implanting a silastic catheter or with a trocar or stylet device under general or local anesthesia.

One trocar design for such purposes is described in U.S. Pat. No. 3,064,653 and U.S. Pat.
9.196 in detail. Such devices are commonly known as "trocar peritoneal dialysis catheters" and consist of a catheter, a style left (trocar), and a device that attaches to a dialysis machine.

A trocus consists of a metal stylet (trocar) with a handle and a catheter that is fitted around the stylet. It also typically includes a coupling device for attachment to the catheter after insertion.

The trocus catheter and stylet are introduced through an enlarged hole in the epidermis and then carefully pushed through the peritoneal cavity to form a sinus canal surrounding the catheter and stylet. The stylet is then removed and the catheter pushed further into the abdominal cavity until it reaches the left or right pelvic groove. The dialysis machine is then connected to a coupling device attached to the catheter. A dialysis treatment is then performed.

After the catheterization is completed, it is usually preferable to remove the catheter between each procedure, as in the case of chronic peritoneal dialysis. However, this often results in the undesirable disappearance of the full canal created by the surgical procedure or trocar stylet, so that it is necessary to create a new full canal with the help of a physician before the next procedure.

It is also desirable to avoid repeating the sinus canaloplasty procedure for subsequent processing.

Previously, maintenance of full tube integrity for intermittent peritoneal dialysis treatments has been attempted through the use of the device described in US Pat. No. 3,505,988, known as the "Dean Peritoneal Prosthesis."Dean's prosthesis consists of a flexible plastic rod with terminal plates. The Dean prosthesis is introduced into the empty tube following removal of the catheter, with the plastic rod placed in the tube while the terminal plate rests on the epidermis. It is then fixed, usually with adhesive tape. Dean's prosthesis is left in place until the next catheter is reintroduced.

However, when a rigid, monolithic peritoneal prosthesis is utilized, such as the Dean prosthesis, it is discovered that the peritoneum is no longer full prior to catheter insertion into the retroperitoneum after removal of the prosthesis. % of time and the reintroduction of a new peritoneal trocar or another surgical procedure to form a new full canal to the LTL membrane, again creating the need for skilled medical attention and its associated inconveniences. Furthermore, reintroduction of the catheter requires the use of a rigid catheter when only Dean's prosthesis is used in order to maintain the original full shape of the canal, which precludes the use of a flexible catheter.

It is an object of the present invention to provide a prosthesis that easily maintains the sinus canal during each catheterization procedure.

Another object of the invention is to provide a prosthesis that maintains the original full shape of the canal while forming a guide for reintroduction of the catheter.

Another object of the present invention is to provide a means for easily sealing the sinus canal during each catheterization procedure while maintaining the integrity of the full canal and reducing the risk of infection or undesired introduction or loss of material through the full canal. The aim is to provide a prosthesis that

Another object of the present invention is to provide a prosthesis that maintains the integrity of the full canal and allows reintroduction of a catheter through the full canal into the peritoneum or other site without the need for skilled medical attention. .

Another object of the invention is to provide a pipe maintenance prosthesis that is easy to use and has a wide range of uses.

Other objects, features and advantages of the invention will become more apparent from the following description.

Although the present invention can be used in any procedure requiring catheterization through a tube formed in a body cavity wall, membrane, or woven structure, a particularly useful application of the present invention is for peritoneal dialysis. The description will be made assuming that it is applied to catheter treatment.

In accordance with the principles of the present invention, the above object is accomplished by introducing an outer hollow tubular member with a flange around the catheter in encircling relation, the flange being i.i.
This is achieved by placing the full tube in abutting engagement with the outer wall of the outer hollow tubular member, thereby maintaining the original shape of the full tube. After the medical procedure requiring catheterization is completed, the catheter is removed from the outer tubular member along the full canal and the second portion of the prosthesis, and the rigid inner cylindrical member is removed from the outer tubular member to close or seal the sinus canal opening. It is introduced and fixed into the tubular member. When a subsequent catheterization procedure is required, the rigid inner cylindrical member is removed and a new catheter can be easily inserted into the outer tubular member along the first full canal, where it can be utilized. Once a new catheter is installed, the above procedure is repeated with a new sterilized inner cylindrical member, where the initially formed full tube is used for further catheterization of another medical procedure requiring the use of a full tube. maintained for.

This novel peritoneal prosthesis can be used for patients associated with peritoneal dialysis located in a hospital or outside a hospital, including at home with the assistance of a suitably trained nurse or similar person or suitably trained family member. This allows patients to undergo peritoneal dialysis. This means that without the use of the present invention, the physician would have to resort to introducing a peritoneal trocar if the peritoneal tract is missing when the peritoneal prosthesis is withdrawn.
It becomes possible. However, a suitably trained nurse or similar person or family member can easily be obtained to reintroduce the peritoneal dialysis catheter according to the invention.

As a result, for the first time, the peritoneal dialysis prosthesis of the present invention can be used to maintain a full duct for a long period of time without the risk of losing the full duct.

The invention will now be described by way of example with reference to the accompanying drawings, in which: FIG.

1 through 7 illustrate prior art techniques for forming a full tube and maintaining the original shape of the full tube.

Figures 8-12 illustrate a prosthesis according to the principles of the present invention, with application to peritoneal dialysis catheter procedures. However, the principle of the present invention is that the present invention
Its use is not limited to peritoneal dialysis as used in connection with medical procedures requiring catheterization and maintenance in woven structures.

In the drawings and (Figs. 1 to 7), the catheter 4
The inner trocar stylet 2 is introduced into the epidermis 6 at the location of the enlarged hole. The sharp tip of the stylet 2 is used to separate the tissue and form a full canal 10, which is further enlarged by the introduction of the catheter 4. The stylet 2 within the catheter 4 is then gently pushed through the epidermis 6 into the subcutaneous tissue 7, and the stylet 2
A full tube 10 is formed around the catheter 4 in abutting relationship with the catheter 4 containing the catheter. The stylet 2 and catheter 4 are gently pushed further through the subcutaneous tissue 7 until the peritoneum or abdominal wall 9 is reached.

The stylet 2 and the enclosing catheter 4 move along the peritoneum and the full canal 10 formed as shown in FIG.
It is gently pushed into the abdominal cavity. The stylet 2 is then removed and the catheter 4 is gently pushed further along the created canal until it reaches the left or right pelvic groove (not shown) as shown in FIG. After that, the connecting means 1
2 is attached to the catheter 4, and said coupling means 12 is attached to a dialysis machine (not shown) as shown in FIG. When dialysis is completed, the connecting tube 12 is removed from the catheter as shown in FIG. According to the prior art, catheter 4 is removed as shown in FIG. 5 and Dean's prosthesis 14 is introduced into full canal 10 as shown in FIGS. 6 and 7. The full tube 10 is placed in abutting relation to the flexible bottle portion of Dean's prosthesis 14, with its flange portion resting on the epidermis 6 as shown in FIG.

However, before introducing Dean's prosthesis 14 into the formed full canal 10, or when Dean's prosthesis 1
4, the full tube 10 disappears, making it impossible to introduce a new catheter 4 into the full tube 10 without subsequent use of the trocar styler with the catheter 4.

Regeneration of a full tube 10 to allow the introduction of a new catheter 4 for subsequent dialysis treatment always requires the attention of a skilled medical practitioner and avoids any unsoundness such as tube or lumen and/or peritonitis associated with this closure procedure. It will be related.

Reference is made to FIGS. 8-12 to explain the invention. FIG. 8 is similar to FIG. 3, but with the addition of a hollow outer tubular member 16 of the present invention which is intended to be fitted over catheter 4 so as to contain or surround catheter 4. FIG. As shown in FIG. 9, the outer tubular member is gently introduced through the opening in the epidermis 6 surrounding the catheter 4 and along the full tube 10 until the full tube 10 is in the abdominal cavity 8.
The catheter 4 is placed in abutting relation to the outer wall of the outer tubular member and extends so that the catheter 4 is placed in abutting relation to the wall of the outer tubular member.

Introduction of the outer tubular member 16 can occur at any time before or after dialysis. However, usually it is introduced after the catheter 4 has been placed in the sinus canal IO as shown in FIGS. 8 and 9. Prior to its introduction, the outer tubular member 16 is trimmed and shaped to account for variations in the angle and length of the full tube 10 that vary from patient to patient.

After completion of a medical procedure requiring catheterization, such as peritoneal dialysis, the catheter 4 is removed from within the outer tubular member 16 while the outer tubular member 16 is inserted into the sinus, as shown in FIG. The flange 21 rests on the epidermis 6 and maintains the original shape of the sinus 10 continuously, as shown in FIG. 10, which could never be achieved with the prior art. That was not the case.

The antral cavity 10 can then be sealed using the inner cylindrical member 20 as shown in FIG.

FIG. 11 is similar to FIG. 10, but with the addition of an inner cylindrical member 20 which is to be introduced into the outer tubular member 16 to effectuate such a seal of the sinus 10. As shown in FIG. 12, an outer tubular member 16 is provided along the antral cavity 10, while an inner cylindrical member 20 is provided along the outer tubular member 1.
6 is introduced into the outer tubular member 16 so as to sit along the inner wall of the outer tubular member 16 . The inner cylindrical member 20 is secured along the inner wall of the outer tubular member 16 and sealed to maintain the sinusoidal integrity and prevent the unwanted introduction of foreign objects or bacteria or the unwanted exudation of bodily fluids.

10.1+, 12 and 13, when subsequent catheterization is desired, the inner cylindrical member 20
is removed from outer tubular member 16 while said outer tubular member 16 is retained within sinus canal 10 as shown in FIG. Thereafter, as shown in FIG.
is introduced into the outer tubular member 16 and the catheter 4 is easily introduced into the outer tubular member 16 along the first antrum 10, aligning the catheter 4 along the antrum 10.

The introduction of such a new catheter 4 into the outer tubular member 16 along the sinus 10 can be carried out without the assistance of a skilled medical practitioner.

This is because it is no longer a closed procedure with the risk of disease. Subsequent dialysis is then performed and the procedure is repeated to facilitate subsequent catheterization. However, periodically (within 1 week or 5 to 5 days)
After six catheterizations) it is desirable to replace the outer tubular member 16 with a new sterile outer tubular member 16 in the manner described below.

That is, catheter 4 is carefully held in place and outer tubular member 10 is removed and discarded. A new sterile outer tubular member 16 is fitted onto catheter 4 in the same manner as shown in FIGS. 8 and 9. When the new catheter 4 is removed, the antrum IO is again maintained by a new outer tubular member I6 and sealed by the introduction of a new sterile inner cylindrical member 21 in the same manner as shown in Figures 1Q, 11 and 12. Ru.

FIG. 13 is the same as FIG. 12 but with at least one ridge 22 on the surface of the inner cylindrical member 20 and the outer tubular member 1.
6, the inner cylindrical member 20 fits snugly within the outer tubular member I6 to prevent sudden removal of the inner cylindrical member 20 from the outer tubular member 16.

The invention may be constructed of any suitable material, such as plastic or silicone rubber or a combination thereof, or other suitable material, so that the assembled device is suitably flexible and sterilized or sterilizable for the above applications. It is.

Although the above procedures relate to the application of the present invention in connection with catheterization for long-term peritoneal dialysis procedures, the principles of the present invention also apply to long-term, intermittent labroscopies, or catheterization for long-term peritoneal dialysis procedures. It is also suitable for maintaining the integrity of any 113[B sinus canal] formed for the purpose of other medical procedures requiring the introduction of a catheter across the tube.

[Brief explanation of the drawing]

FIG. 1 is a schematic diagram of a trocas peritoneal dialysis catheter (trocas) that is to be introduced into the epidermis according to the prior art. FIG. 2 is a view of the trocus after it has been introduced into the peritoneal cavity through the epidermis and peritoneum; FIG. 3 is a view of the catheter in the sinus canal after removal of the trocar stylet. FIG. 4 is a diagram of the catheter attached to the coupling means of the dialysis machine. Figure 5 is a view of the sinus after the catheter has been removed. FIG. 6 is a view of the side canal into which the Dean prosthesis is to be introduced after removal of the catheter according to the prior art procedure, and FIG. 7 is a view of the Dean prosthesis within the side canal according to the prior art procedure. FIG. 8 is a schematic representation of the hollow outer tubular member of the prosthesis according to the invention to be introduced around the catheter and along the side tube;
Figure 9 shows the flange placed around the catheter and along the side tube on the epidermis. FIG. 3 is a view of the outer tubular member of the prosthesis in place. FIG. 10 is a view of the outer tubular member of the prosthesis along the side canal as in FIG. 9 after catheter removal; FIG. 11 is a view similar to FIG. 10 and with its inner cylindrical member being introduced into the outer tubular member; FIG. 3 is a view of the outer tubular member of the prosthesis. FIG. 12 is a view of the outer tubular member of the prosthesis along the side tube and the inner cylindrical member within the outer tubular member of the prosthesis. FIG. 13 is a view of the outer tubular member of the prosthesis with ridges and grooves and the inner cylindrical member of the prosthesis within the outer tubular member. 10--one sinus canal, 4-catheter, 6-.-epidermis. 16-Outer/side tubular member, 20--Cylindrical member 21-1--Flange material FIG, θ FIG, I/f

Claims (1)

Claims: 1. A prosthetic device that maintains the original shape of a sinus canal formed during a first catheterization for a medical procedure and allows its repeated use for subsequent catheterizations, comprising: a) A flange device is inserted into the initially formed sinus canal in an encircling relationship to the catheter within the canal formed during the initial catheterization, and a flange device provided at one end thereof is positioned on the epidermis at the origin of the sinus canal. b) an outer hollow tubular member suitable for placing the catheter therein; and b) an outer hollow tubular member for sealing the sinus canal after the catheter is withdrawn from the sinus canal following a medical procedure requiring catheterization. c) a rigid inner cylindrical member suitable for insertion into the outer hollow tubular member, and c) subsequent removal of said rigid inner cylindrical member into a new sterilized outer hollow tubular member along the same initially formed antral canal. A prosthetic device that allows the insertion of a catheter through said canal for subsequent medical catheterization; and maintains the original shape of the sinus canal to enable its repeated use for subsequent catheterization. 2. A prosthetic device according to claim 1, wherein the outer hollow tubular member and the rigid inner cylindrical member include fixation means to prevent sudden removal of the rigid inner cylindrical member. 3. The prosthetic device of claim 1, wherein the rigid inner cylindrical member fits snugly into the outer hollow tubular member to prevent sudden removal of the rigid inner cylindrical member. 4. The prosthetic device of claim 1, wherein the device is comprised of a flexible material. 5. A prosthetic device according to claim 1, wherein the device is made of plastic material. 6. The prosthetic device of claim 1, wherein the device is made of silicone rubber material. 7. The prosthetic device of claim 1, wherein the device is comprised of a combination of silicone rubber, rubber and plastic materials. 8. The prosthetic device of claim 1, wherein the device is made of sterilizable material. 9. The securing means is constituted by at least one ridge on the rigid inner cylindrical member and a corresponding groove in the outer hollow tubular member, and when the rigid inner cylindrical member is fitted into the outer hollow tubular member, said rigid inner cylindrical member 3. A prosthetic device according to claim 2, which fits snugly into the outer tubular member. 10. A method for maintaining the original shape of a sinus canal formed in a body lumen wall, membrane or tissue structure during an initial catheterization to enable its repeated use for subsequent catheterization, comprising: a) a catheter and inserting a stylet through the body lumen wall, membrane or tissue structure to form a canal therethrough; b) removing the stylet leaving the catheter within the canal; c) connecting the catheter to a coupling means and catheterizing the catheter. enabling a medical procedure requiring the performance of a procedure; d) separating said coupling means when said medical procedure is completed; e) an outer hollow tubular member having a uniform diameter and a uniform wall thickness. f) removing the catheter from the tube leaving the outer hollow tubular member within the tube; g) removing the catheter; inserting a rigid inner cylindrical member into the outer hollow tubular member to seal the tube, such that subsequent removal of the inner cylindrical member allows a new catheter to be inserted through the tube and into the outer hollow tubular member; Maintains the original shape of the sinus canal formed in the body cavity walls, membranes, or tissue structures during the initial catheterization step, allowing for subsequent medical procedures, allowing its repeated use for subsequent catheterization procedures. How to do it. 11. The method of claim 10, wherein the outer hollow tubular member is withdrawn from the antral canal and a new outer hollow member is guided therein in surrounding relation to the catheter.