Plastic and nonmetallic article shaping or treating: processes – With printing or coating of workpiece – Anti-stick or adhesion preventing coating
Reexamination Certificate
1999-07-20
2001-05-22
Silbaugh, Jan H. (Department: 1732)
Plastic and nonmetallic article shaping or treating: processes
With printing or coating of workpiece
Anti-stick or adhesion preventing coating
C264S134000, C264S139000, C264S250000, C264S279000, C264S317000, C427S002300, C427S300000, C427S443000
Reexamination Certificate
active
06235226
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a method for manufacturing a balloon catheter, and more particularly, the present invention relates to a method for manufacturing a balloon catheter which is, as a medical appliance, fitted into a tube-shaped organ of the body and a portion of which is maintained in an expanded state to allow liquid medicine to be injected therein and liquid excrement to be removed therefrom.
2. Description of the Related Art
Generally, a balloon catheter is made of silicone to be medically superior. A method for manufacturing a balloon catheter will be described hereinafter with reference to U.S. Pat. No. 5,137,671.
Referring to the drawings, a tube
10
as shown in
FIG. 1
is provided. The tube
10
is formed with a first lumen
14
(a capillary tube of a smaller diameter) and a second lumen
12
(a tube of a larger diameter).
In a state that the tube
10
as described above is prepared, a middle portion of the tube
10
, that is, a balloon expansion section of the tube
10
is, as shown in
FIG. 2
, formed with a first hole
16
which communicates an inside of the first lumen
14
with an outside of the tube
10
. Then, polymeric filler material
18
such as silicone rubber is filled into a part of the first lumen
14
which extends from a lower end of the first lumen
14
to a point where the first hole
16
is defined, and a tip member
20
is attached to a lower end of the tube
10
from which the polymeric filler material
18
is filled into the first lumen
14
, whereby lower ends of the first and second lumens
14
and
12
are closed.
Thereafter, a part of the tube
10
which extends from the lower end thereof and to an upper end of the balloon expansion section as shown by the line A—A in
FIG. 3
, is dipped into releasing agent solution (such as soapy water, Vaseline solution or the like), and the releasing agent solution is solidified to leave releasing agent
30
onto the part of the tube
10
. At this time, releasing agent
30
is filled into the first hole
16
and another part of the first lumen
14
which extends from the point where the first hole
16
is defined to the upper end of the balloon expansion section as shown by the line A—A in FIG.
3
. Consequently, the tube
10
has a cross-section as shown in FIG.
3
. That is to say, the releasing agent
30
is filled into the first lumen
14
from the upper end of the balloon expansion section as shown by the line A—A in
FIG. 3
to the first hole
16
, and is coated onto an outer surface of the tube
10
between the upper end of the balloon expansion section as shown by the line A—A in FIG.
3
and the end of the tip member
20
as shown in FIG.
3
.
Then, as shown in
FIG. 4
, another part of the tube
10
which extends from the lower end thereof to the lower end of the balloon expansion section as shown by the line B—B in
FIG. 4
is dipped again into water or hot liquid, to remove the releasing agent coated onto the outer surface of the tube
10
except the balloon expansion section, and a first over-coating layer
41
and a second over-coating layer
42
are sequentially coated onto an entire outer surface of the tube
10
, to define an over-coating layer
40
.
Then, the releasing agent which is filled into the first lumen
14
and the first hole
16
and coated onto the outer surface of the balloon expansion section, is removed through the first lumen
14
, thereby defining a space part
44
as shown in
FIG. 6
for allowing the balloon expansion section to be expanded.
However, when a balloon catheter is manufactured by the processes of the conventional art, as described above, an amount of waste water which is generated when removing the releasing agent coated onto the outer surface of the tube
10
except the balloon expansion section after dipping the tube
10
into releasing agent solution, is increased in the course of dipping the tube
10
into water, etc. through a number of times, thereby causing environmental pollution.
Further, in the case that the releasing agent is not perfectly removed, when the balloon expansion section is expanded after the space part is formed, a portion of the over-coating layer adjoining the balloon expansion section is peeled off, thereby to be expanded together with the balloon expansion section.
SUMMARY OF THE INVENTION
Accordingly, the present invention has been made in an effort to solve the problems occurring in the related art, and an object of the present invention is to provide a method for manufacturing a balloon catheter which can actively cope with a problem of environmental pollution caused in the process of coating and removing releasing agent and eliminate a phenomenon that a portion of an over-coating layer adjoining a balloon expansion section is peeled off, thereby preventing the portion of the over-coating layer from being expanded together with the balloon expansion section.
In order to achieve the above object, according to one aspect of the present invention, there is provided a method for manufacturing a balloon catheter, the method comprising the steps of: a first step of preparing a tube which is formed with a plurality of lumens including at least a first lumen and a second lumen, the tube possessing a balloon expansion section in which a first hole for communicating an inside of the first lumen with an outside of the balloon catheter is defined; a second step of filling polymeric filler material into a part of the first lumen which extends from one end of the first lumen to a point where the first hole is defined, and attaching a tip member to one end of the tube from which the polymeric filler material is filled; a third step of fitting a cap member around the one end of the tube to which the tip member is attached except at least the balloon expansion section in which the first hole is defined, and dipping the tube into releasing agent solution and solidifying the releasing agent solution, such that an outer surface of the balloon expansion section of the tube is coated with releasing agent and such that the first hole and another part of the first lumen which extends from the point where the first hole is defined to the other end of the balloon expansion section, are filled with releasing agent; a fourth step of dipping the resultant tube obtained from the third step into liquid silicone to form an over-coating layer onto an entire outer surface of the tube; and a fifth step of removing through the first lumen the releasing agent which is coated onto the outer surface of the balloon expansion section and filled into the first hole and the another part of the first lumen.
By the features of the present invention, due to the fact that a cap member is used upon coating releasing agent, since the releasing agent is not coated onto a portion of a tube except a balloon expansion section, a problem of environmental pollution caused when removing an unnecessary portion of the releasing agent in the conventional art is solved, and it is possible to prevent a portion of an over-coating layer adjoining the balloon expansion section from being expanded along with the balloon expansion section when water is poured into the balloon expansion section.
REFERENCES:
patent: 5137671 (1992-08-01), Conway et al.
patent: 5484565 (1996-01-01), Larsen et al.
patent: 5571567 (1996-11-01), Shah
patent: 5811043 (1998-09-01), Horrigan et al.
Lee Edmund H.
Lee & Hong
Silbaugh Jan H.
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