Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-06-24
2001-03-06
Nguyen, Anh-Tuan T. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C128SDIG008
Reexamination Certificate
active
06197004
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to devices for fixing subcutaneous catheters.
DESCRIPTION OF THE PRIOR ART
Subcutaneous catheters must be implanted in the human body to be used for parenteral administering of medicines, liquids and nutritional solutions in specific regions, e.g. through the venous circle, peridural space, etc.
The catheters are indicated for patients who must undergo repeated blood samples taking, injections or prolonged infusion therapies.
If the catheters are implanted in one of the veins of the central venous systems or in the peridural space, it is necessary to implant the catheter distal end in the desired anatomic area.
Such implantation is obtained by the preparation of a subcutaneous pocket-like cut, a few centimeters long, made in the cutaneous or subcutaneous tissue.
Afterwards, a subcutaneous tunnel is prepared so as to allow the catheter to pass and be located and to set in communication the desired anatomic area and the subcutaneous pocket.
The catheter, properly introduced into the tunnel, goes out from the subcutaneous pocket.
It is possible to implant, in the subcutaneous pocket, a pump container, whose upper part is equipped with a feeding membrane which touches the skin.
The container is fed with medical substances by introducing needles into the skin in the membrane area.
The catheter is connected to the container by a corresponding connecting sleeve.
This type of implantation defines a closed or wholly implantable system.
According to another system, known as open or partially implantable system, the catheter is introduced in a subcutaneous tunnel and moved to the desired anatomic area.
The catheter of the subcutaneous pocket exits from the skin through another cutaneous hole, so as to be connected to an external infusion system.
With this system, the subcutaneous pocket is used to lock the catheter to a suitable device which fastens it, thus preventing it from detaching.
A first example of a fastening device is characterized in that a disc is introduced into the subcutaneous pocket.
A suitable adhesive is applied to the disc, so that the catheter can adhere thereto, thus eliminating or reducing to acceptable values, the catheter movement.
According to a second example, a material adhering to the catheter and to the subcutis is introduced to the portion of the catheter near the subcutaneous pocket.
Also in this case, the catheter is fastened and cannot be displaced.
A third example of fastening device is characterized by the use of another catheter, whose connecting end is equipped with a kind of pin coupling with a corresponding metallic connecting sleeve situated in the proximal end of the first catheter (or catheter to be fixed).
According to a fourth example, the fastening device is formed by two elements, the first of which is connectable to a sleeve and the second to a ring nut.
The catheter passes inside the two elements.
The ring nut is then screwed on the threading of the sleeve thus necking the sleeve and fastening the catheter inside the two elements.
The two just described systems have some drawbacks deriving from the devices for implantation and fastening the subcutaneous catheters.
In case of a close system of implantation and fastening, i.e. when the venous port is introduced in the subcutaneous pocket, the catheter can be displaced from the port, causing the system loss.
Before a medicine or a particular solution can be introduced to the membrane of the venous port, through a needle, the skin over the venous port must be disinfected; during this operation an infection of the area, where the catheter is placed, can occur.
Moreover, it is to be pointed out that this device is very expensive.
Also, the catheter implantation and fastening open system presents numerous disadvantages.
One of the most frequent disadvantages of the catheters implanted with the open system lies in the fact that the catheter moves very easily.
At present, this problem cannot be solved by any simple technical solution without complications and other difficulties.
If the catheter is fastened in the subcutaneous pocket by a disc with adhesive, an allergic reaction is possible.
Moreover, a possible unsticking can provoke a displacement of the catheter with respect to the disc, and consequently the loss of contact of the end of catheter with the anatomic region to be infused.
If the catheter is fastened in the subcutaneous pocket by introduction of the material adhering to the catheter as well as to the subcutis, the stick-in-place time is long, because the subcutis must produce fiber tissue which allows the introduced material to adhere to the pocket subcutis.
If the fastening device uses a second catheter, It can displace with respect to the catheter to be fastened, which results in medicine leakage to the pocket while the desired point or area is not reached by this substance.
The displacement occurs because of the detachment of the plug-in pin corresponding to the end of the second catheter from the connecting sleeve of the catheter to be fastened.
Moreover, a fastening device using a second catheter is expensive, due to high manufacturing costs of the plug-in pin implanted in the second catheter and of the connecting sleeve implanted in the first catheter.
The fastening device formed by the sleeve and ring nut is expensive, complicated and easy to wear and tear.
SUMMARY OF THE INVENTION
The present invention has been evolved with the main object to propose a device for fixing catheters which overcomes the above mentioned disadvantages and which is easy to be implanted.
Another object of the present invention is to propose a system which carries out a simple, cheap, extremely functional and reliable technical solution.
The above mentioned objects are obtained, in accordance with the contents of claims, by means of a device for fixing subcutaneous catheters connected to an open, or partially implantable system, in which a catheter is connected to a venous port, a peridural space, or other parts of a human body, and is situated outside a subcutaneous pocket and introduced into a relative subcutaneous tunnel, wherein the device t includes a member which is introduced in said subcutaneous pocket and which features, made therein, at least three tubular through cavities, first, second and third, respectively, not intersecting each other, with said catheter introduced into said tubular through cavities.
According to another embodiment, the member which is introduced in said subcutaneous pocket, features, made therein, two tubular through cavities.
According to another embodiment, the member is a disc and the tubular cavities define relative entrance and exit holes along a circumference of said disc.
Another embodiment is disclosed in which the member is a cylinder of anallergic material and the tubular cavities define entrance and exit holes along an extension of said cylinder.
REFERENCES:
patent: 5643217 (1997-07-01), Dobkin
Coleman Sudol Sapone P.C.
Nguyen Anh-Tuan T.
Sapone William J.
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