JP2011206392A - Method of manufacturing medical pipe - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a method of manufacturing a medical pipe which equalizes the inside diameters of the medical pipes when the medical pipes of sizes insertable into blood vessels or the like are manufactured.SOLUTION: The method of manufacturing the medical pipes is intended for manufacturing the medical pipes 10 from a tubular pipe 11 having tiny irregularities formed on the inside periphery. The medical pipe manufacturing method has a process of carrying out flattening to reduce the irregularities. The flattening process is a process of inserting a wire rod 1 harder than the pipe 11 into the pipe 11 and rotating it around the axis of the pipe 11 while moving it along the axial direction of the pipe 11.

Description

  The present invention relates to a method for manufacturing a medical pipe.

  When a catheter is inserted into a biological lumen such as a digestive tract or a blood vessel, a guide wire is used to guide the catheter to a target site in the biological lumen (for example, see Patent Document 1). The guide wire described in Patent Document 1 is used by being inserted into a catheter. When it is desired to replace the catheter through which the guide wire is inserted with another catheter, an extension guide wire (hereinafter referred to as “second guide wire”) is provided at the proximal end portion of the guide wire (hereinafter referred to as “first guide wire”). ”) And connect the parts. As a connection structure between the first guide wire and the second guide wire, the following structure is used.

  The first guide wire is provided with a tubular first connection portion at the base end portion thereof. On the other hand, the second guide wire is provided with a second connection portion having an outer diameter that is large enough to fit the first connection portion at the distal end portion thereof. By inserting the second connection portion into the first connection portion, these connection portions are fitted and connected.

  However, in the guide wire described in Patent Document 1, since the outer diameter of the first guide wire is 0.0457 mm (0.018 in), the inner diameter of the first connecting portion is smaller than that. Dimension management is very difficult. For example, in order to make the inner diameter of the first connection portion a desired size, the first connection portion in a state larger than the inner diameter can be processed by an etching method. Depending on the level of the concentration, the inner diameter after treatment may be too large or too small than the desired inner diameter. And even if it inserts a 2nd connection part in the 1st connection part whose internal diameter is too large, the fitting force of these connection parts is weak, and the 2nd connection part can be easily extracted from the 1st connection part. End up. On the other hand, even if an attempt is made to insert the second connection portion into the first connection portion whose inner diameter is too small, the insertion is difficult or impossible. Furthermore, after that, the etching solution must be washed, which increases one process. In addition to the etching method described above, a method using a drill is also conceivable, but it is practically difficult to process a drill having an inner diameter of 1 mm or less. Further, in machining with a drill, shavings are generated, and it is necessary to remove the shavings.

  Similarly, a medical instrument that has a small inner diameter and requires fine processing, such as a stent used by being placed in a blood vessel, requires highly accurate inner diameter management. And the yield will deteriorate.

  As described above, the conventional method has a problem in that when manufacturing a thin tube, the inner diameter tends to vary, that is, the yield is poor and it is difficult to obtain a uniform product.

JP-A-6-197979

  An object of the present invention is to provide a method for manufacturing a medical pipe in which the inner diameter of the medical pipe is uniform when manufacturing a medical pipe of a size that can be inserted into a blood vessel.

Such an object is achieved by the present inventions (1) to (12) below.
(1) A method for producing a medical pipe from a pipe having minute irregularities on its inner peripheral surface,
Having a step of performing a smoothing treatment to reduce the unevenness;
The smoothing process forms a waveform that is bent or curved at a plurality of locations, and a wire rod that is harder than the pipe is inserted into the pipe and moved along the axial direction of the pipe, while moving around the axis of the pipe. A method for producing a medical pipe, comprising rotating the medical pipe.

  (2) The said smoothing process is a manufacturing method of the medical pipe as described in said (1) which is a process which crushes the convex part in the said unevenness | corrugation, fills a recessed part, and smoothes with respect to the said internal peripheral surface.

  (3) The said smoothing process is a manufacturing method of the medical pipe as described in said (2) performed to such an extent that generation | occurrence | production of the waste from the internal peripheral surface of the said pipe is prevented or suppressed.

  (4) The method for manufacturing a medical pipe according to any one of (1) to (3), wherein the movement of the wire is reciprocation.

  (5) The method for manufacturing a medical pipe according to any one of (1) to (4), wherein the wire is rotated continuously.

  (6) The method for manufacturing a medical pipe according to any one of (1) to (5), wherein when the wire is inserted into the pipe, the wire is compressed in a radial direction of the pipe.

  (7) The manufacturing of the medical pipe according to any one of (1) to (6), wherein the wire is in a natural state in which an external force is not applied, and an amplitude of the waveform is larger than an average inner diameter of the pipe. Method.

  (8) The said wire is a manufacturing method of the medical pipe in any one of said (1) thru | or (7) whose wavelength of the said waveform is 0.5-10 mm in the natural state which does not provide external force.

  (9) The method for manufacturing a medical pipe according to any one of (1) to (8), wherein the cross-sectional shape of the wire is circular or elliptical.

  (10) The medical wire according to any one of (1) to (9), wherein the wire has two portions that differ in at least one of a shape and a constituent material, and the portions are used in order. Pipe manufacturing method.

  (11) The method for manufacturing a medical pipe according to any one of (1) to (10), wherein the medical pipe is made of a superelastic alloy.

  (12) The medical pipe manufacturing method according to any one of (1) to (11), wherein an average inner diameter of the medical pipe is 0.1 to 2 mm.

  According to the present invention, in order to smooth the pipe, the wire is rotated around the axis of the pipe while being moved in the axial direction of the pipe while being inserted into the pipe. By such a displacement of the wire, the unevenness of the inner peripheral surface of the pipe can be reliably reduced. The medical pipes manufactured in this way all have a uniform inner diameter, and since impurities such as a lubricant used during the manufacture of the medical pipe can be removed at the same time, the roughness and resistance Can be greatly reduced.

It is a fragmentary longitudinal cross-section which shows the state which manufactures a medical pipe with the manufacturing method (1st Embodiment) of the medical pipe of this invention. It is a cross-sectional view showing the state (a) of the medical pipe before the smoothing process and the state (b) of the medical pipe after the smoothing process. It is an expanded cross-sectional view which shows typically the state which manufactures a medical pipe with the manufacturing method (1st Embodiment) of the medical pipe of this invention. It is a fragmentary longitudinal cross-section which shows the state which manufactures a medical pipe with the manufacturing method (2nd Embodiment) of the medical pipe of this invention. It is a longitudinal cross-sectional view which shows an example of the usage condition of the medical pipe manufactured with the manufacturing method of the medical pipe of this invention.

  Hereinafter, the manufacturing method of the medical pipe of this invention is demonstrated in detail based on suitable embodiment shown to an accompanying drawing.

<First Embodiment>
FIG. 1 is a partial longitudinal sectional view showing a state where a medical pipe is manufactured by the method for manufacturing a medical pipe of the present invention (first embodiment), and FIG. 2 is a state (a) of the medical pipe before smoothing processing (a) ) And a cross-sectional view showing the state (b) of the medical pipe after the smoothing treatment, FIG. 3 schematically shows a state in which the medical pipe is manufactured by the method for manufacturing a medical pipe of the present invention (first embodiment). FIG. 5 is a longitudinal sectional view showing an example of a usage form of a medical pipe manufactured by the method for manufacturing a medical pipe of the present invention. In FIG. 2 and FIG. 3, for the sake of easy understanding, the minute irregularities formed on the inner peripheral surface of the medical pipe are schematically shown exaggeratedly. The ratio of the pipe thickness is different from the actual one.

  First, before explaining the manufacturing method of a medical pipe, an example of the usage form of the medical pipe 10 manufactured by this manufacturing method will be described.

  As shown in FIG. 5, the medical pipe 10 is used as a connecting member that connects the ends 201 of the long first wire 20a and the second wire 20b having flexibility. The single connected wire can be used as a guide wire, for example. In this case, examples of the constituent material of the medical pipe 10 include superelastic alloys such as a Ni—Ti alloy, a Ni—Al alloy, and a Cu—Zn alloy. Moreover, as a constituent material of the 1st wire 20a and the 2nd wire 20b, various metal materials, such as the said superelastic alloy and stainless steel, are mentioned, for example, 1 type or 2 types or more of these are mentioned. They can be used in combination. By using such a constituent material, the guide wire becomes rich in flexibility. A superelastic alloy is a material that is relatively soft among metal materials, and is therefore a material that can be easily processed. Thereby, when manufacturing the medical pipe 10 which consists of a superelastic alloy, the manufacture can be performed easily. Here, a guide wire is taken as an example. Needless to say, such a medical pipe 10 is used for various medical instruments such as a stent using a fine tubular pipe that can be inserted into a blood vessel. Used.

  Next, a method for manufacturing the medical pipe 10 will be described. This manufacturing method is particularly suitable for manufacturing a thin tube that can be used in a medical instrument intended to be inserted into a blood vessel. Here, the “capillary tube” means that the inner diameter (average) φd is preferably 0.1 to 2 mm, more preferably 0.2 to 0.5 mm.

  As shown in FIG. 2, the medical pipe 10 is obtained from a tubular pipe 11 made by a conventional method such as etching or drilling. The pipe 11 is formed by forming irregularities generated when the pipe 11 is formed on the inner peripheral surface 101, that is, a plurality of minute concave portions 102 and convex portions 103 are formed on the inner peripheral surface 101. is there. Then, the inner diameter φd of the pipe 11 is the target inner diameter φd, that is, the position of the inner peripheral surface 101 of the pipe 11 is the position of the two-dot chain line in FIG. Thus, the smoothing process which reduces an unevenness | corrugation with respect to the pipe 11 is performed.

  In the smoothing process, the wire 1 having a circular cross section is used as the jig for the smoothing process. As shown in FIG. 1A, the wire 1 is a member that forms a waveform (including a coil shape) that is curved at a plurality of locations in a natural state (hereinafter simply referred to as “natural state”) in which no external force is applied. To smooth the pipe 11, as shown in FIG. 1 (b), the wire 1 is inserted into the pipe 11 and moved in the direction of arrow A along the axial direction of the pipe 11. Rotate in the direction of arrow B around the axis. Due to such displacement of the wire 1, as shown in FIG. 3, the convex portion 103 can be crushed at each bending point (the peak of the corrugated mountain) 2 of the wire 1, and the crushed convex portion 103 The peripheral recess 102 can be filled. Thereby, the inner peripheral surface 101 is smoothed and the smoothing process for the inner peripheral surface 101 can be reliably performed.

  Note that when the smoothed inner peripheral surface 101 is observed with, for example, an electron microscope, it is possible to confirm a trace in which the convex portion 103 is crushed and the crushed convex portion 103 is transferred to the concave portion 102.

  The wire 1 is made of a material harder than the pipe 11 (medical pipe 10). As the material, when the pipe 11 is the superelastic alloy, for example, stainless steel can be cited. Among these, Stainless steel is particularly preferable. By displacing the hard wire 1 with respect to the pipe 11 as described above, the convex portion 103 can be reliably crushed and the concave portion 102 can be filled, so that the inner peripheral surface 101 can be further smoothed. It can be done reliably.

  As shown in FIG. 1 (a), it is preferable that the amplitude e of the waveform of the wire 1 in the natural state, in particular twice, is larger than the inner diameter φd of the pipe 11. Although the size is not particularly limited, for example, 2e / φd is preferably 1.01 to 4, more preferably 1.5 to 2.5. As a result, as shown in FIG. 1B, in the state where the wire 1 is inserted into the pipe 11, the bending point 2 of the wire 1 is restricted by the inner peripheral surface 101 of the pipe 11. It becomes a state compressed in the radial direction. Thereby, each bending point 2 can contact | abut to the internal peripheral surface 101 of the pipe 11, respectively, Therefore, as above-mentioned, the convex part 103 can be crushed by the curved point 2, and the recessed part 102 can be filled.

  In addition to the amplitude e, the formation condition of the wire 1 is preferably set to the following numerical range.

  Although the wavelength λ of the waveform in the natural state of the wire 1 is not particularly limited, for example, it is preferably 0.5 to 10 mm, and more preferably 2 to 3 mm.

  The diameter φf of the wire 1 is constant along the longitudinal direction, and the size is preferably 30 to 99% of the inner diameter φd of the pipe 11 and more preferably 90 to 99%.

  By setting the forming condition of the wire 1 within such a numerical range, the wire 1 is particularly suitable for manufacturing the above-mentioned size of the thin tube, and therefore the smoothing process can be performed efficiently. Further, impurities and hard foreign matters such as a lubricant used in manufacturing the medical pipe 10 can be removed.

  Moreover, when trying to make the internal diameter φd of the medical pipe 10 to a desired size by conventional machining such as grinding or polishing, chips are generated and a removal process for removing the chips must be performed. . On the other hand, since this manufacturing method has the effect of leveling the unevenness of the metal inner surface, chips are not generated, and the removal step can be omitted unlike the conventional machining.

  In addition, as a method of confirming that generation | occurrence | production of the said waste is prevented or suppressed, it can carry out by confirming the internal diameter of the medical pipe 10, for example.

  The medical pipe 10 manufactured by the above manufacturing method as described above has a smooth inner surface 101 and a desired inner diameter φd. The surface roughness Ra (specified in JIS B 0601) of the smoothed inner peripheral surface 101 is usually 0.01 to 0.02 μm.

  Further, as described above, when the medical pipe 10 is used as a connecting member for connecting the first wire 20a and the second wire 20b, the inner peripheral surface 101 of the medical pipe 10 is smoothed. The connecting operation, that is, the operation of inserting the end 201 of the first wire 20a into one end of the medical pipe 10 and inserting the end 201 of the second wire 20b into the other end of the medical pipe 10 is easily performed. be able to.

  In addition, when this manufacturing method is used for a stent, the thickness of the metal used for the stent becomes more constant in the circumferential direction, so that there is variation during laser cutting (leaves a cut and leaves a cut on the inner surface on the opposite side. Etc.) can be prevented. Further, only substances other than the pipe 11 of the medical pipe 10 (for example, the remainder of the lubricant or oil used in the manufacturing) can be efficiently removed, and thereby the inner and outer surfaces of the chemicals to be polished after that can be removed. Differences in polishing are less likely to occur.

Second Embodiment
FIG. 4 is a partial longitudinal sectional view showing a state in which a medical pipe is manufactured by the method for manufacturing a medical pipe of the present invention (second embodiment).

  Hereinafter, the second embodiment of the method for manufacturing a medical pipe according to the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted. .

  This embodiment is the same as the first embodiment except that the configuration of the wire used in the method for manufacturing a medical pipe of the present invention is different.

The wire 1A shown in FIG. 4 has a large wavelength portion 3a and a small wavelength portion 3b. The large wavelength portion 3a and the small wavelength portion 3b are portions having different waveform wavelengths along the longitudinal direction of the wire 1A. In nature, the wavelength lambda _a large wavelength portion 3a is, for example, is preferably 150 to 500% of the wavelength lambda _b of the small wavelength portion 3b, and more preferably 200 to 300%.

  In the smoothing process, the small wavelength portion 3b and the large wavelength portion 3a are used in this order. In this case, rough smoothing processing can be performed by the small wavelength portion 3b having high rigidity, and finer smoothing processing can be performed by the large wavelength portion 3a having a wide contact surface. In this way, the smoothing process can be performed in stages, so that the obtained medical pipe 10 has a more uniform inner diameter.

  In the configuration shown in the figure, the wire 1A has a large wavelength portion 3a and a small wavelength portion 3b in one wire. However, the wire 1A is not limited to this. For example, the wire 1A is composed of two wires. You may have the large wavelength part 3a and the small wavelength part 3b.

  Further, the wire 1A has two portions having different waveform wavelengths in the configuration shown in the drawing, but is not limited to this. For example, the wire 1A has two portions having different waveform amplitudes. It may have two parts with different stiffness) or may be a combination of these.

  As mentioned above, although the manufacturing method of the medical pipe of this invention was demonstrated about embodiment of illustration, this invention is not limited to this.

  In addition, the medical pipe manufacturing method of the present invention may be a combination of any two or more configurations (features) of the above embodiments.

  In addition, the wire used in the method for manufacturing a medical pipe of the present invention is a member having a waveform that is curved at a plurality of locations in each of the above embodiments, but is not limited thereto, and is a member that has a waveform that is bent at a plurality of locations. There may be.

  Further, the wire used in the method for manufacturing a medical pipe of the present invention is a member having a circular cross-sectional shape in each of the above embodiments, but is not limited thereto, and may be a member having an elliptical cross-sectional shape. Good.

1, 1A Wire 2 Curved point (vertical peak of corrugated mountain)
3a the large wavelength portion 3b small wavelength portion 10 medical pipe 11 pipe 101 inner peripheral surface 102 recess 103 protrusion 20a first wire 20b second wire 201 ends φd inner diameter e amplitude φf diameter λ, λ _a, λ _b Wavelength

Claims (12)

A method of manufacturing a medical pipe from a pipe having minute irregularities on an inner peripheral surface,
Having a step of performing a smoothing treatment to reduce the unevenness;
The smoothing process forms a waveform that is bent or curved at a plurality of locations, and a wire rod that is harder than the pipe is inserted into the pipe and moved along the axial direction of the pipe, while moving around the axis of the pipe. A method for producing a medical pipe, comprising rotating the medical pipe.   The method of manufacturing a medical pipe according to claim 1, wherein the smoothing process is a process of crushing a convex portion in the concave and convex portion to fill a concave portion and smoothing the inner peripheral surface.   The said smoothing process is a manufacturing method of the medical pipe of Claim 2 performed to such an extent that generation | occurrence | production of the waste from the internal peripheral surface of the said pipe is prevented or suppressed.   The method for manufacturing a medical pipe according to any one of claims 1 to 3, wherein the movement of the wire is a reciprocating motion.   The method for manufacturing a medical pipe according to any one of claims 1 to 4, wherein the rotation of the wire is continuous rotation.   The method for manufacturing a medical pipe according to any one of claims 1 to 5, wherein when the wire is inserted into the pipe, the wire is compressed in a radial direction of the pipe.   The method for manufacturing a medical pipe according to any one of claims 1 to 6, wherein the wire is in a natural state in which an external force is not applied and the amplitude of the waveform is larger than an average inner diameter of the pipe.   The method for manufacturing a medical pipe according to any one of claims 1 to 7, wherein the wire has a natural state in which an external force is not applied and a wavelength of the waveform is 0.5 to 10 mm.   The method for manufacturing a medical pipe according to any one of claims 1 to 8, wherein a cross-sectional shape of the wire is a circle or an ellipse.   The method for manufacturing a medical pipe according to any one of claims 1 to 9, wherein the wire has two parts that differ in at least one of a shape and a constituent material, and the parts are used in order.   The method for manufacturing a medical pipe according to any one of claims 1 to 10, wherein the medical pipe is made of a superelastic alloy.   The method for manufacturing a medical pipe according to any one of claims 1 to 11, wherein an average inner diameter of the medical pipe is 0.1 to 2 mm.

Images