JPS6326657B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to the treatment of ascites, and more particularly to an apparatus for treating ascites using peritoneal cavity-venous drainage means.

For the treatment of ascites, that is, when a large amount of ascites has accumulated in the peritoneal cavity of a patient, methods have been proposed to drain or divert the ascites from the peritoneal cavity to the superior vena cava, the thoracic duct, or the bladder. Although the provision of drainage devices from the peritoneal cavity to the central venous system provides numerous benefits over other types of devices, there are several problems with conventional devices and methods for providing such treatments. Ta. Drainage devices proposed for the treatment of ascites have either been extremely bulky or have been extremely susceptible to blockage by complex protein compounds in the ascites.

The object of the present invention is to provide a device that is extremely difficult to block, is extremely suitable for treating ascites, can be easily implanted by a relatively simple surgical procedure, and has a relatively simple and inexpensive structure. It is an object of the present invention to provide an improved peritoneal cavity and venous drainage device that is extremely reliable and can be sterilized in an autoclave without replacing the internal mechanisms. Other objects and features will become apparent from the description below.

Referring now to FIG. 1, a patient with ascites is indicated generally by the reference numeral 11. In accordance with an embodiment of the invention, a foraminated entry or peritoneal catheter 13 is surgically introduced into the patient's peritoneal cavity through an abdominal incision 14 to provide a means for draining accumulated ascitic fluid. Ru. The peritoneal catheter 13 is connected to the anterior chamber 17 and to the valve assembly 19 by means of coupling means, a straight coupling 12 and a tube 15. The anterior chamber 17 and the valve unit 19 will be explained in more detail later, but the sternum 1 of the patient
6, it is implanted into a subcutaneous pocket formed by surgery. The tube 15, the anterior chamber 17 and the valve unit 19 are implanted into the subcutaneous tunnel by conventional surgery. Ascitic fluid is directed to the central venous system via a posterior tube 20 and an atrial catheter 22 through the valve unit 19. Compared to conventional equipment,
The tube 20 and drainage catheter, or atrial catheter 22, are of relatively small diameter. This reduced diameter allows for easier implantation of the tube 20 through the subcutaneous tunnel and into the patient's neck where the neck incision 21 has been made. The atrial catheter 22 is connected to the incision 2
1 and is inserted into the external jugular vein indicated at 24. The length of the atrial catheter 22 is such that its tip reaches from the external jugular vein introduction point down the superior vena cava to the patient's right atrium. After such an implantation operation, the atrial catheter 22 and tube 20 are appropriately cut at the neck incision and connected by a connecting means, ie, a V-shaped connector 23. The relatively small diameter of the atrial catheter allows its introduction into the external jugular vein. By placing the tip of the catheter within the atrium, inward elongation of the catheter or the catheter as would occur if the tip of the catheter terminated near the point where the catheter is inserted into the venous system. Accidental occlusions are suppressed. The overall structure of the drainage (diversion) device is shown in detail in FIG. 2, and the actual structure of the valve unit 19 is shown in FIG.

According to the invention, the valve unit 19 includes two sets of one-way valves connected in series by a flexible conduit or silicone rubber valve housing 35, described below. In the illustrated preferred embodiment, four identical one-way valve elements 31-34 are used in a series and parallel arrangement within a flexible valve housing 35. That is, the valve element 31 is arranged parallel to the valve element 32,
This set of parallel oriented valve elements is also arranged in series with a second set of parallel oriented valve elements 33 and 34. The series connection is defined by an elongated region 37 of the valve housing 35. The region 37 functions as a deformable conduit for purposes explained below.

Each valve element 31-34 is generally described in U.S. Pat.
It is of the type disclosed in No. 3288142. The structure shown in FIG. 4 has a rigid base 51.
A conical valve seat 53 connected to an inlet port 55 is formed in the base. A rigid spherical valve element 57 is biased toward the conical valve seat by a convoluted cantilever spring 59 attached to the base 51, for example by spot welding. Cylindrical shell 58
is the base 51, the spherical valve element 57 and the cantilever spring 59.
and retain it within the valve housing 35. Other suitable forms of valve elements are illustrated in co-pending US patent application Ser. No. 2354. In each embodiment, one-way valve actuation is achieved with a rigid or hard valve element biased toward a rigid valve seat. The structure is suitable for soft valves, such as those made of silicone rubber, in that a hard surface is preferred to provide a seal in the event that proteins are present and become attached to the valve actuating surface. It can be said that it is preferable to the actuating element. If complete valve closure is not achieved, highly undesirable backflow from the venous system can occur.

In addition to lengthening the total flow path, by arranging the valve elements in parallel, even if one valve element becomes occluded, the other parallel valve element can drain the desired amount of ascites. Since the structure is suitable for circulation, safety measures against such valve blockage are significant.

As previously mentioned, valve unit 19 is preferably mounted in a suitable subcutaneous pocket located, for example, above the patient's sternum. By arranging the valve unit 19 in this way, the patient or the doctor can press the valve unit manually and thereby periodically open the elongated region 37 existing between the two sets of parallel valve elements. It collapses or compresses the ascites, allowing it to actually pump ascites from the peritoneal cavity into the central venous system. By compressing the elongated area, ascites is released into the venous system by the downstream valve element, while by relaxing the hand and returning the elongated area to its normal shape, it is released into the upstream valve element. It will be appreciated that suction is drawn into the valve unit through the valve, ie the valve element closest to the peritoneal cavity entrance tube. The advantage of this pump operation is that when negative pressure is generated inside the chest and positive pressure is generated in the peritoneal cavity, the patient does not have to perform the troublesome work that would otherwise occur without pump operation. The valve element and the atrial catheter are effectively flushed by the pump action, thereby effectively removing protein deposits that may occlude the device. Previous devices that did not utilize such pump actuation required the use of relatively large pore tubes in the atrial catheter. Such large diameter catheters preclude surgical implantation into the external jugular vein, which is possible with this device, and the possibility of implanting the jugular vein into a location in the atrium where there is virtually no risk of tissue growth. It is also not possible to extend the large diameter catheter along the line. As previously pointed out, inserting an atrial catheter into an external jugular vein is advantageous because it is extremely easy to insert an atrial catheter in this part of the patient's neck where large veins are located near the surface. It is extremely beneficial. This easy access to veins means that surgery can be performed under local anesthesia rather than general anesthesia on patients who are quite weak due to illness.

Antechamber 17, which can also be placed close to the surface of the patient and can be handled, provides a means for momentarily creating backflow in the peritoneal catheter 13.
This is accomplished by fully compressing conduit section 25, thereby effectively closing flow through the valve element. The next step compresses the anterior chamber itself, creating a momentary backflow. The antechamber also provides a suitable means for aspirating samples of ascitic fluid for analysis. For this purpose, the anterior chamber is made of flexible silicone rubber so that it can seal itself when the needle is inserted. A metal needle stopper is provided at the bottom of the vestibule.

The fact that the device can be separated into its components, i.e. peritoneal catheter 13, tube 20, valve unit 19, atrial catheter 22 and couplings 12 and 23, does not require removal of the entire device and can cause failure. Since only the part needs to be removed, reoperation is simplified. By proper use of the front chamber and the valve pump chamber, malfunctions of the device can be easily detected.

From the foregoing, it will be appreciated that the objects of the present invention are achieved and various other benefits are also obtained.

It is to be understood that various modifications may be made within the scope of the invention, and that the foregoing description and accompanying drawings are illustrative only and not limiting.

[Brief explanation of the drawing]

FIG. 1 is a schematic diagram of an ascites treatment device according to the present invention implanted in a patient. FIG. 2 is a partial sectional view of the ascites treatment device of FIG. 1. FIG. 3 is an enlarged detailed partial sectional view of the valve unit. FIG. 4 is an enlarged sectional view of the valve element. 13: Peritoneal ostium catheter, 17: Anterior chamber, 19:
Valve unit, 22: Atrial catheter, 31, 3
2, 33, 34: valve element, 35: valve housing,
37: Elongated region, 51: Base, 53: Valve seat, 5
5: Inlet port, 57: Spherical valve element, 58: Shell, 59: Cantilever spring.

Claims (1)

[Claims] 1. A holed inlet catheter, a drainage catheter,
a valve assembly connecting the inlet catheter and the drainage catheter, the valve assembly having two sets of one-way valves, each set of valves arranged parallel to each other; are connected in series by a flexible conduit, said conduit being configured to be deformable by manual pressure, and providing a flexible vestibule between the inlet catheter and the valve assembly; An ascites treatment device characterized in that the front chamber is configured to self-seal against puncture by a hypodermic needle.