Catheter tip insert

Details Catheter tip insert Catheter tip insert

1999-04-30

2002-07-09

Brinson, Patrick (Department: 3752)

Pipes and tubular conduits

End protectors

Threaded

C138S089000, C604S256000

Reexamination Certificate

active

06415823

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to catheters used to drain cerebrospinal fluid from the ventricles of a brain and more particularly relates to a device for preventing the closure of such a catheter having a slit tip at the end of the shunt.
2. Description of Related Art
A typical adult has a total of about 120-150 cc of (cerebrospinal fluid) CSF with about 40 cc in the ventricles in the brain. A typical adult also produces about 500 cc/day of CSF, all of which is reabsorbed into the blood stream on a continuous basis. CSF is comprised primarily of water but also includes small amounts of minerals and proteins.
Hydrocephalus is a condition of excessive accumulation of CSF in the ventricles or brain cavities. Hydrocephalus can result from congenital conditions interfering with normal CSF circulation or as the result of a problem with CSF reabsorbtion.
Excessive accumulation of CSF, due to hydrocephalus causes increased pressure upon the brain. Whatever the cause, over time, this increased CSF pressure causes damage to the brain tissue. It has been found that shunting the excess CSF to another area of the body pressure is therapeutically beneficial and generally allows the patient to lead a full and active life.
To treat the condition of hydrocephalus a shunt is used as a conduit to transport CSF from one location in the body to another. A typical shunt for transporting CSF from the ventricle to another part of the body is comprised of a ventricular catheter, valve and distal catheter. CSF shunts also exist for transporting fluid from the spine to another part of the body.
A common material for shunt catheters is silicone. Examples of systems to continuously drain excess CSF from the ventricles of the brain are the Delta® Shunt and the CSF—Flow Control Shunt Assembly made and sold by Medtronic—PS Medical of Goleta, Calif. Such systems use a catheter
2
that is placed in the patient's ventricle
4
in the brain
6
(
FIG. 14
) to drain the excess CSF.
All of these systems continuously transport excess accumulation of CSF from the patient's ventricle through the catheter
2
to another part of the family. It has been shown to be highly advantageous to use fiber-optic technology to help place a ventricular catheter such as catheter
2
in the ventricles
4
of a brain
6
. To this end, as shown in
FIG. 5
, endoscopes
8
have been developed that are passed through the central lumen
16
of the catheter
2
. These endoscopes
8
are advanced beyond the ultimate ventricular end
10
of the catheter
2
once the catheter
2
has been placed in the ventricle
4
of the brain
6
.
As the endoscope
8
is advanced beyond the ultimate ventricular end
10
of the catheter
2
, the physician is able to view the environment of the ventricle
4
to determine whether the catheter
2
is placed at a desirable location. If the catheter
2
is not located at a desirable location, the physician can change the location of the catheter
2
and confirm, by viewing the location through the endoscope
8
, that the final location of the ultimate ventricular end
10
of catheter
2
is a desired location.
In such a system incorporating both an endoscope
8
and a catheter
2
, catheter
2
is preferably of the type disclosed in U.S. Pat. No. 5,738,666 issued to David A. Watson and Lori Cone Speckman on Apr. 14, 1998 entitled “Slit Tip Ventricular Catheter and Method of Manufacturing Same”, the teaching of which is incorporated herein in its entirety by reference. Such a catheter is shown in
FIGS. 1-6
generally labeled
2
. Catheter
2
has a proximal end
12
, a distal end
14
and a central lumen
16
. A plurality of holes
18
are located at the distal end
14
. A valve is attached proximal to the plurality of holes
18
.
A slit
20
is located at the ultimate ventricular end
10
. Slit
20
extends across the ultimate ventricular end
10
. Slit
20
is defined by a first side wall
22
and a second side wall
24
that meet at contact points
26
and
28
. First and second side walls
22
,
24
each have a midpoint
30
. When slit
20
is closed, first side wall
22
is in contact with second side wall
24
along substantially the entire length of both first and second side walls
22
,
24
. When slit
20
is open, first and second side walls
22
,
24
are separated at their respective midpoints
30
. Such a catheter
2
is the Model #99102 “Innervision Catheter” sold by Medtronic—PS Medical of Goleta, Calif.
In use, as shown in
FIG. 2
, when the distal end
34
of an endoscope
8
is passed through catheter
2
, the distal end
34
will contact slit
20
. As shown in
FIG. 3
, as distal end
34
is advanced distally, distal end
34
will pass through slit
20
and extend distally beyond the ultimate ventricular end
10
of catheter
2
.
Catheter
2
is typically made. of silicone. During storage, slit
20
will be in the “closed” position so that first and second side walls
22
,
24
will be in contact along substantially their entire lengths. A problem with this is that when silicone comes into contact with silicone for an extended time period, silicone to silicone bonds forms. This phenomenon is called “contact bonding”. With catheter
2
, when catheter
2
is in the “closed” position, contact bonding begins to occur between first and second side walls
22
,
24
. This tends to “close” slit
20
so that slit
20
will not easily “open” when needed as the distal end
34
of endoscope
8
is advanced through slit
20
. This is a problem in need of a solution.
Although catheter
2
has been described as being made of silicone, the problem of the slit
20
closing due to bond formation may also occur in catheters made of any polymeric material susceptible to contact bonding. Examples of such polymeric material include, but are not limited to, natural and synthetic latex, plastized PVC, thermoplastic elastomers and polyurethanes as will be clear to those skilled in the art.
SUMMARY OF THE INVENTION
An insert is disclosed that is placed in the slit in a slit tipped catheter during storage and transport of the catheter. This insert prevents the opposite sides of the slit from contacting and forming bonds that tend to close the slit. When the catheter is to be used, the insert is removed and the catheter is used in its intended way.
It is therefore a primary object of the invention to provide a device that prevents the slit in a slit tipped catheter made of a material susceptible to contact bonding from closing due to bonds forming between opposite sides of the slit during storage and transport of the catheter.
It is another object of one embodiment of the invention to provide a device that prevents the slit in a slit tipped catheter made of a material susceptible to contact bonding from closing due to bonds forming between opposite sides of the slit during storage and transport of the catheter that will not adversely affect the ultimate operation of the catheter.
These and other objects of the invention will be clear from the description of the invention given herein and particularly with reference to the attached drawings and the Detailed Description of the Invention. Throughout this description, like reference numbers refer to like elements.


REFERENCES:
patent: 3307552 (1967-03-01), Strawn
patent: 3589368 (1971-06-01), Jackson
patent: 3835862 (1974-09-01), Villari
patent: 5280809 (1994-01-01), Tive
patent: 5443081 (1995-08-01), Klosterman
patent: 5738666 (1998-04-01), Watson et al.
patent: 5996637 (1999-12-01), Larsson
Medtronic PS Medical Model 99102 “Innervision Catheter”.

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