JP4223798B2 - Chemical solution injection catheter and balloon catheter manufacturing method - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to an improvement in a method for producing a drug solution injection catheter or a balloon catheter used for PTCA (percutaneous coronary angioplasty) in PTA (percutaneous angioplasty), for example.
[0002]
[Prior art and problems to be solved by the invention]
FIG. 3 is a schematic view of a method for manufacturing the double lumen tube 32 that forms the first lumen 32a protruding from the tip of the second lumen 32b. The tip 32T is connected to the tip of the first lumen 32a by heat welding.
Since the end faces are connected to each other, there is a concern that the strength of the connecting portion is weak and breaks. Further, in the heat welding, the resin is melted in the inner and outer peripheral directions of the connection portion, and the melted resin in the connection inner space of the opening 39 and the first lumen 32a may rise and cause foreign matters.
FIG. 4 is a schematic view in which a balloon 33 is mounted on a double lumen tube 32 formed by the means of FIG.
The tip of the balloon 33 and the rear end of the balloon 33 are attached to the outer periphery of the tip 32T of the first lumen 32a and the outer periphery of the double lumen tube 32, respectively.
Since the position of the central axis S1 of the double lumen tube 32 to which the rear end of the balloon 33 is attached and the central axis S1 of the distal end portion 32T of the first lumen 32a to which the tip of the balloon 33 is attached is different, the balloon 33 has the distal end portion 32T. Mounted in a tilted direction. Accordingly, when the balloon 33 is expanded to expand the stenosis (not shown), the stenosis cannot be uniformly expanded due to the inclination.
[0003]
For example, in Patent Document 1, an inflatable tube-like balloon is fixed to a protruding guide wire lumen and a multi-lumen shaft. As shown in FIG. 2, the mounting portions at the front end and the rear end of the balloon are different from each other with respect to the axial direction of the shaft. Accordingly, when the balloon is expanded, the balloon is expanded in a biased manner with respect to the axial direction of the shaft, so that the balloon cannot be expanded uniformly.
[0004]
FIG. 5 is a cross-sectional view of the vicinity of the distal end of the chemical injection catheter 41.
The distal end of the second lumen 42b of the drug solution injection catheter 41 in which the first lumen 42a and the second lumen 42b are integrally formed has a potting agent 45 (for example, silicon or PVC) from the distal end of the second lumen 42b to the distal end of the opening 49. Etc.) was necessary.
[0005]
For example, Patent Document 2 requires a step of placing or enclosing an embedded object in the lumen of the unused portion at the tip from the opening formed in the front side portion of the multiple lumen.
[0006]
[Patent Document 1]
JP-A-10-290837 (FIG. 2, [0026])
[0007]
[Patent Document 2]
Japanese Patent No. 2832722 (FIGS. 3 and 7)
[0008]
[Means for solving the problems]
Therefore, as a result of intensive studies to solve the above problems, the present inventor has reached the following invention.
[1] The present invention provides:
(Step 1):
The first lumen (2a) protrudes from the second lumen (2b), and the first lumen (2a) and the second lumen (2b) are integrally molded in substantially parallel to form a double lumen. Forming a shaft tube (2) as a tube (12);
The core material (10) is inserted into the first lumen (2a) protruding from the second lumen (2b),
A mold (11) is mounted from the tip of the second lumen (2b) to the outer periphery of the tip (2T) of the first lumen (2a),
The mold (11) is heated, and the tip (2T) of the first lumen (2a) and the core material (10) are simultaneously pulled toward the tip length direction of the first lumen (2a),
Closing the opening (9) of the second lumen (2b) by thermal welding ;
The shaft tube (2) is formed by only the first lumen (2a) from the vicinity of the opening (9) toward the distal direction,
On the other hand, from the vicinity of the opening (9) toward the rear end, the first lumen (2a) and the second lumen (2b) are formed from a double lumen tube (12) integrated substantially in parallel,
The central axis (S1) of the tip (2T) of the first lumen (2a) is connected to the central axis (S) of the double lumen tube (12) comprising the first lumen (2a) and the second lumen (2b). Forming the layers so as to be stacked,
(Process 2):
Drilling an opening (9a) at the tip of the second lumen (2b);
(Step 3):
Step balloon (3), mounted distal end of said first lumen (2a) from (2T) the double lumen over the distal end of the tube (12),
A method for producing a balloon catheter (1) including the above steps is provided.
[2] In the present invention, following (Step 1) described in [1],
(Process 2 '):
There is provided a method for producing a drug solution injection catheter (21) including a step of perforating an opening (9b) in the outer periphery of a second lumen (2b) and the above steps.
[0009]
DETAILED DESCRIPTION OF THE INVENTION
1A is a schematic view of the balloon catheter 1, FIG. 1B is a cross-sectional view taken along the line AA ′ of the distal end portion 2T of the first lumen 2a, and FIG. 1C is a cross-sectional view taken along the line BB ′ of the shaft tube 2. FIG.
[0010]
[Balloon catheter 1]
The double lumen tube 12 of the balloon catheter 1 is a double lumen tube in which the first lumen 2a and the second lumen 2b are integrally formed, and the tip of the second lumen 2b is shaved with, for example, a cutter knife, and the tip of the first lumen 2a. 2T is formed to protrude from the tip of the second lumen 2b.
The contrast tube 5 and the first lumen are attached to the distal end of the shaft tube 2 which is the double lumen tube 12 and the rear end of the shaft tube 2 communicates with the second lumen 2b via the branch connector 4. A guide wire tube 7 communicating with 2a is attached. Luer connectors 6 a (6 b) are attached to the ends of the contrast tube 5 and the guide wire tube 7.
The tip portion 2T of the first lumen 2a has a circular inner periphery as illustrated in FIG. As illustrated in FIG. 1C, the shaft tube 2 (double lumen tube 12) has a first lumen 2a and a second lumen 2b formed integrally.
[0011]
FIG. 2 is a cross-sectional view of each process of manufacturing the drug solution injection catheter 21 or the balloon catheter 1 from the double lumen tube 12, (1) is a cross-sectional view of the double lumen tube 12, and (2) is the first lumen of the double lumen tube 12. 2 is a cross-sectional view in which the core material 10 is inserted into 2a and the mold 11 is mounted, (3) is a cross-sectional view in which the opening 9a or 9b is perforated, and (4) is a double lumen tube 12 in which the opening 9a is perforated. It is sectional drawing equipped with the balloon 3. FIG.
[0012]
[Double lumen tube 12]
The double lumen tube 12 is formed integrally with a first lumen 2a and a second lumen 2b, and a tip 2T of the first lumen 2a protrudes from a tip of the second lumen 2b.
[0013]
[Mold 11]
As illustrated in FIG. 2B, the mold 11 includes a molding part 11a and a flange part 11b. The molding part 11a is formed of a taper part 11at and a straight part 11as.
The tapered portion 11at is brought into contact with the distal end of the second lumen 2b and the base outer periphery of the distal end portion 2T, and closes the opening 9 by heat welding. The straight portion 11as also forms the outer periphery of the tip portion 2T by heat in the same manner as described above.
The flange 11b is disposed on the outer periphery of the distal end portion 2T of the first lumen 2a and supports the molding portion 11a.
The center axis S is a center axis of the double lumen tube 12 attached to the rear end of the balloon 3 as will be described in detail later. The central axis S1 is the central axis of the distal end portion 2T of the first lumen 1a attached to the distal end of the balloon 3.
The mold 11 processes the double lumen tube 12 by heat welding.
[0014]
A part of manufacturing process of the drug injection catheter 21 or the balloon catheter 1 from the double lumen tube 12 illustrated in (1) of FIG. 2 will be described.
(1) The core material 10 is inserted into the first lumen 2a of the double lumen tube 12 shown in FIG. The molding part 11a is mounted over the opening 9 at the tip of the second lumen and the root outer periphery of the tip 2T. The mold 11 is heated, and the distal end portion 2T of the first lumen 2a and the core material 10 are simultaneously pulled toward the distal end length direction of the first lumen 2a.
The opening portion 9 is closed by the molding portion 11a, and the central axis S of the double lumen tube 12 and the central axis S1 of the distal end portion 2T of the first lumen 2a are arranged so as to overlap each other.
(2) The opening 9a is formed by punching the end of the second lumen 2b of the processed double lumen tube 12 with, for example, a punch or a cutter knife. (In this case, the opening 9b is not formed.)
(3) The balloon 3 is mounted from the distal end 2T of the first lumen 2a to the outer periphery of the double lumen tube 12. When the balloon 3 is mounted, it is preferable that the opening 9 a is disposed substantially in the middle of the balloon 3.
By arranging the center axis S1 of the tip 2T of the first lumen 2a so as to overlap the center axis S of the double-lumen tube 12 after processing, the balloon 3 is in the length direction of the double-lumen tube 12 (shaft tube 2). Can be mounted symmetrically.
(4) A contrast tube 5 communicating with the second lumen 2b via the branch connector 4 and a guide wire tube 7 communicating with the first lumen 2a are attached to the rear of the processed double lumen tube 12, and the contrast tube 5 and guide Luer connectors 6a (6b) are attached to the ends of the wire tubes 7, respectively.
[0015]
Following the step (1),
(2) The opening 9b is formed by perforating the outer periphery of the second lumen of the processed double lumen tube 12 with a punch, a cutter knife or the like in the same manner as in the step (2). (In this case, the opening 9a remains closed without being perforated.)
(3) The processed double lumen tube 12 communicates with the first lumen 2a and the contrast tube 5 provided with a luer connector 6a communicating with the second lumen 2b via the branch connector 4 in the same manner as the balloon catheter 1. A guide wire tube 7 equipped with a luer connector 6b is attached, and a chemical solution injection catheter 21 that can inject two types of chemical solutions into the body can be formed.
[0016]
[Effects of the invention]
The mold 11 is attached to the double lumen tube 12, and the center axis S of the double lumen tube 12 and the center axis S1 of the distal end portion 2T of the first lumen 2a are arranged so as to overlap with each other. The balloon 3 can be mounted symmetrically with respect to the axis S. Therefore, the balloon 3 can be expanded evenly in the circumferential direction, and the constricted portion can be expanded.
As illustrated in FIG. 3, it is not necessary to connect the distal end portion 32 </ b> T to the first lumen by thermal welding, so that it is possible to eliminate the bending from the welding portion and the blockage of the opening 39 due to melting of the thermal welding.
[0017]
The process of filling the potting agent 45 as in the conventional drug solution injection catheter 41 by drilling the opening 9b and forming the tip of the drug solution injection catheter 21 after the die 11 is mounted on the double lumen tube 12 and processed. Is no longer needed.
[Brief description of the drawings]
1A is a schematic view of a balloon catheter 1, FIG. 1B is a cross-sectional view taken along the line AA ′ of the distal end portion 2T of the first lumen 2a of FIG. 1A, and FIG. FIG. 2 is a cross-sectional view of the distal end of the balloon catheter 1 or the distal end of the drug solution injection catheter 21 according to the present invention, (1) is a cross-sectional view of the double lumen tube 12, and (2) is the above ( 1) A cross-sectional view in which the mold 11 is attached to the double lumen tube 12, (3) a cross-sectional view in which the opening 9a is perforated in the processed double lumen tube 12, or the opening 9b in the processed double lumen tube 12. Perforated sectional view (4) is a sectional view in which balloon 3 is attached to double lumen tube 12 having perforated opening 9a in (3). FIG. 3 shows a conventional double lumen forming a protruding first lumen 32a. 4 is a cross-sectional view of the main tube 32. FIG. 4 is a cross-sectional view of the double lumen tube 32 formed by the connection method of FIG. ]
DESCRIPTION OF SYMBOLS 1 Balloon catheter 2 Shaft tube 2a 1st lumen | rumen 2b 2nd lumen | rumen 2T The front-end | tip part 3 and 33 of 1st lumen | rumen 2a Balloon 4 Branch connector 5 Contrast tube 6a, 6b Luer connector 7 Guide wire tube 9, 9a, 9b, 39, 49 Opening portion 10 Core material 11 Mold 11a Molded portion 11at Taper portion 11as Straight portion 11b Flange portion 12, 32 Double lumen tube 21, 41 Chemical solution injection catheter 32a, 42a First lumen 42a, 42b Second lumen 45 Potting material (silicone or PVC etc.)
S The central axis of the double lumen tube 12 (32) S1 The central axis of the tip 2T (32T) of the first lumen 2a (32a)

Claims (2)

(Step 1):
The first lumen (2a) protrudes from the second lumen (2b), and the first lumen (2a) and the second lumen (2b) are integrally molded in substantially parallel to form a double lumen. Forming a shaft tube (2) as a tube (12);
The core material (10) is inserted into the first lumen (2a) protruding from the second lumen (2b),
A mold (11) is mounted from the tip of the second lumen (2b) to the outer periphery of the tip (2T) of the first lumen (2a),
The mold (11) is heated, and the tip (2T) of the first lumen (2a) and the core material (10) are simultaneously pulled toward the tip length direction of the first lumen (2a),
Closing the opening (9) of the second lumen (2b) by thermal welding ;
The shaft tube (2) is formed by only the first lumen (2a) from the vicinity of the opening (9) toward the distal direction,
On the other hand, from the vicinity of the opening (9) toward the rear end, the first lumen (2a) and the second lumen (2b) are formed from a double lumen tube (12) integrated substantially in parallel,
The central axis (S1) of the tip (2T) of the first lumen (2a) is connected to the central axis (S) of the double lumen tube (12) comprising the first lumen (2a) and the second lumen (2b). Forming the layers so as to be stacked,
(Process 2):
Drilling an opening (9a) at the tip of the second lumen (2b);
(Step 3):
Step balloon (3), mounted distal end of said first lumen (2a) from (2T) the double lumen over the distal end of the tube (12),
The manufacturing method of the balloon catheter (1) characterized by including each said process. Following (Step 1) of claim 1,
(Process 2 '):
The manufacturing method of the chemical | medical solution injection | pouring catheter (21) characterized by including the process of drilling an opening part (9b) in the outer periphery of a 2nd lumen | rumen (2b), and each said process.

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