JPH0430869B2 - - Google Patents

Description

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

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

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

One trocar device for such purposes is disclosed in U.S. Pat. No. 3,064,653;
It is described in detail in the specification of No. 3149196. Such devices are usually “trokas peritoneal dialysis catheters”
The device consists of a catheter, a stylet (trocar), and a device that attaches to a dialysis machine.

A trocar 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 foramen in the epidermis and then carefully pushed through the abdominal 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 sinus canal created by the surgical procedure or trocar stylet, so that it is necessary to create a new sinus canal with the assistance of a physician before the next procedure.
It is also desirable to avoid repeating the sinus canaloplasty procedure for subsequent processing.

Previously, maintaining the integrity of the sinus tract 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 sinus canal following removal of the catheter, with the terminal plate resting on the epidermis while the plastic rod remains in the sinus canal. It is then usually secured with adhesive tape. Dean's prosthesis is left in place until just before reintroducing the next catheter.

However, when a rigid, one-piece peritoneal prosthesis, such as the Dean prosthesis, is utilized, the sinus canal to the peritoneum is often found to be missing prior to catheter insertion into the retroperitoneum after removal of the prosthesis. 15% of the time and reintroduction of a new peritoneal trocar or another surgical procedure is required to create a new sinus canal into the peritoneum, again requiring skilled medical attention and its associated inconveniences. Furthermore, in order to maintain the original shape of the sinus canal when reintroducing the catheter, it is necessary to use a rigid catheter when only the Dean prosthesis is used, 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 shape of the sinus canal while forming a guide for reintroduction of the catheter.

Another object of the present invention is to easily seal the sinus canal during each catheterization procedure while maintaining the original shape of the sinus canal;
It is an object of the present invention to provide a prosthesis with means for reducing the risk of infection or the undesired introduction or loss of material through the sinus canal.

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

Another object of the present invention is to provide a sinus 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 that requires catheterization through a tube formed in a body cavity wall, membrane, or tissue structure, a particularly useful application of the present invention is a catheter for peritoneal dialysis. It will be explained as applied to the treatment.

According to the principles of the present invention, the above object is achieved by introducing an outer hollow tubular member with a flange around the catheter in encircling relation, the flange resting on the epidermis when inserted into the sinus canal, and This is accomplished by abutting the outer wall of the outer hollow tubular member, thereby maintaining the original shape of the sinus canal. After the medical procedure requiring catheterization is completed, the catheter is removed from the outer tubular member along the sinus 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 subsequent catheterization is required, the rigid inner cylindrical member is removed and a new catheter is easily inserted along the first sinus canal into the outer tubular member, whereupon the first sinus canal can be accessed. Once a new catheter is installed, the above procedure is repeated with a new sterilized inner cylindrical member, where the initially formed sinus canal is replaced by another medical procedure requiring the use of the sinus canal for subsequent catheterization. maintained for medical treatment.

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 is not possible because without the present invention the physician would have to resort to introducing a peritoneal trocar if the sinus canal to the peritoneum had disappeared when the peritoneal prosthesis was withdrawn. Become. 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 for long-term maintenance of the sinus canal without much risk of loss of the sinus canal.

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

Figures 1-7 illustrate prior art techniques for forming sinus canals and maintaining the original shape of the sinus canal.

Figures 8-12 illustrate a prosthesis according to the principles of the present invention, with application to peritoneal dialysis catheter procedures. However, the principles of the invention lend themselves to its use in peritoneal dialysis as used in connection with medical procedures requiring catheterization and maintenance in body walls, membranes or tissue structures. It is not limited.

In the drawings, particularly in FIGS. 1-7, the trocar stylet 2 within the catheter 4 is introduced into the epidermis 6 at the location of the enlarged hole. The sharp tip of the stylet 2 separates the tissue and separates the sinus canal 10.
The sinus canal 10 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 sinus canal 10 is formed around the catheter 4 in abutting relationship with the catheter 4 containing the catheter 4 . 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, together with the surrounding catheter 4, is gently pushed into the peritoneum and abdominal cavity along the sinus canal 10 formed as shown in FIG. Stylet 2 is then removed and catheter 4 is gently pushed further along the created sinus canal until it reaches the left or right pelvic groove (not shown) as shown in FIG. Thereafter, a coupling means 12 is attached to the catheter 4, said coupling means 12 being attached to the fourth
It is attached to a dialysis machine (not shown) as shown. When the dialysis is finished, the connecting tube 12 is connected to the fourth
It is removed from the catheter as shown. According to the prior art, the catheter 4 is removed as shown in FIG.
It is introduced into the sinus canal 10 as shown in FIG. The canal 10 is placed in abutting relation to the flexible pin portion of the Dean prosthesis 14, and its flange portion rests on the epidermis 6 as shown in FIG.

However, before introducing Dean's prosthesis 14 into the created sinus canal 10 or after removing Dean's prosthesis 14, the sinus canal 10 disappears without subsequent use of the trocar stylet with catheter 4. makes it impossible to introduce a new catheter 4 into the sinus canal 10. New catheter 4 for subsequent dialysis treatment
Regeneration of the sinus canal 10 to allow the introduction of the sinus tube 10 always requires the attention of a skilled physician and is associated with unsoundness of the intestinal tract or foramen and/or peritonitis associated with this closure procedure.

Reference is made to FIGS. 8-12 to explain the invention. FIG. 8 is similar to FIG.
Added is a hollow outer tubular member 16 of the present invention which is to be fitted onto the top. As shown in Figure 9,
The outer tubular member is gently introduced through the opening in the epidermis 6 surrounding the catheter 4 and along the antral canal 10 so that the antral canal 10 just passes through the outer tubular member 16.
The catheter 4 extends to rest 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, typically it is introduced after the catheter 4 has been placed in the sinus canal 10 as shown in FIGS. 8 and 9. Prior to its introduction, the outer tubular member 1
6 is trimmed and shaped in consideration of changes in the angle and length of the sinus canal 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. held in place along tube 10 and flange 2
1 on the epidermis 6 and continuously maintain the original shape of the sinus canal 10 as shown in FIG. 10, something that could never be achieved with the prior art.

Sinus canal 10 may then be sealed using inner cylindrical member 20 as shown in FIG. FIG. 11 is similar to FIG. 10, but the sinus canal 10
The outer tubular member 1
6 has been added an inner cylindrical member 20 which is about to be introduced. As shown in FIG. 12, the outer tubular member 16 is provided along the sinus canal 10, while the inner cylindrical member 20 is introduced into the outer tubular member 16 so that it lies along the inner wall of the outer tubular member 16. Ru. The inner cylindrical member 20 is secured along the inner wall of the outer tubular member 16 and sealed to maintain the integrity of the sinus canal and to prevent the unwanted introduction of foreign objects or bacteria or the unwanted exudation of bodily fluids.

10, 11, 12 and 13, when subsequent catheterization is desired, the inner cylindrical member 20 is removed from the outer tubular member 16 while the outer tubular member 16 is retained within the antral canal 10. The result will be as shown in the figure. Then the 9th
As shown, a new catheter 4 is introduced into the outer tubular member 16, said catheter 4 is easily introduced into the outer tubular member 16 along the initial sinus canal 10, and the catheter 4 is guided along the sinus canal 10. Make it consistent. Introducing such a new catheter 4 along the sinus canal 10 into the outer tubular member 16 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, it may be desirable to periodically (within one week or after five to six catheterizations) replace outer tubular member 16 with a new sterilized 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 sinus tube 10 is replaced again with the new outer tubular member 1.
6 and maintained by the 10th, 11th and 12th
It is sealed by introducing a new sterilized inner cylindrical member 21 in the same manner as shown in the figure.

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 a complementary groove 2 provided on the inside of the outer tubular member 16.
4, the inner cylindrical member 20 is connected to the outer tubular member 16
The snug fit prevents 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 apply to long-term, intermittent laproscopies, or catheterization for long-term peritoneal dialysis procedures. It is also suitable for maintaining the integrity of any peritoneal sinus canal created for the purpose of other medical procedures requiring the introduction of a catheter across the tube.

[Brief explanation of drawings]

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. Figure 2 shows the trocus after it has been introduced into the abdominal cavity through the epidermis and peritoneum. FIG. 3 is a view of the catheter within 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. FIG. 5 is a view of the sinus canal after the catheter has been removed. FIG. 6 is a view of the sinus canal into which the Dean prosthesis is to be introduced after removal of the catheter according to the prior art procedure. FIG. 7 is a diagram of Dean's prosthesis in the sinus canal according to the prior art procedure. FIG. 8 is a schematic illustration of the hollow outer tubular member of a prosthesis according to the invention to be introduced around a catheter and along a sinus canal. FIG. 9 is a view of the outer tubular member of the prosthesis with the flange placed on the epidermis around the catheter and along the sinus canal. 10th
Figure is a view of the outer tubular member of the prosthesis along the sinus canal as in Figure 9 after catheter removal; FIG. 11 is a view of the outer tubular member of the prosthesis similar to FIG. 10 and with its inner cylindrical member being introduced into the outer tubular member; FIG. 12 is a view of the outer tubular member of the prosthesis along the sinus canal 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. DESCRIPTION OF SYMBOLS 10... sinus tube, 4... catheter, 6... epidermis, 16... outer tubular member, 20... cylindrical member, 21... flange material.

Claims (1)

[Scope of 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 catheterization, 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 resting therein; (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; a rigid inner cylindrical member adapted to be inserted into the member; (c) the outer hollow tubular member and the rigid inner cylindrical member are provided with securing means to prevent sudden removal of said rigid inner cylindrical member; and (d) ) the rigid inner cylindrical member is a tight fit on the outer hollow tubular member to prevent sudden removal of the rigid inner cylindrical member;
Removal of the solid inner cylindrical member allows insertion of a new sterile catheter into the outer hollow tubular member along the same initially formed sinus canal and allows subsequent medical catheterization through the canal. A prosthetic device that maintains its original shape and allows its repeated use for subsequent catheterization procedures. 2. The prosthetic device of claim 1, wherein the device is made of flexible material. 3. A prosthetic device according to claim 1, wherein said device is made of plastic material. 4. The prosthetic device of claim 1, wherein the device is made of silicone rubber material. 5. The prosthetic device of claim 1, wherein the device is comprised of a combination of silicone rubber and plastic materials. 6. The prosthetic device of claim 1, wherein the device is made of sterilizable material. 7. said fixing means being constituted by at least one ridge on the rigid inner cylindrical member and a corresponding groove in the outer hollow tubular member, said rigid inner cylindrical member snugly fitting the outer hollow tubular member;
A prosthetic device according to claim 1.