JP2017018468A - Manufacturing apparatus of medical instrument and manufacturing method of medical instrument - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a manufacturing apparatus of a medical instrument capable of suppressing deterioration in processing accuracy due to heat of laser processing or the like.SOLUTION: A manufacturing apparatus of a medical instrument comprises: a thermal spray nozzle 12 for spraying particles; a holding part for holding a sacrificial tube 13; a mask 14 disposed between the sacrificial tube and the thermal spray nozzle and having an opening pattern 14a; a sweep mechanism 31 for sweeping the mask; a slit mask 15 disposed between the mask and the thermal spray nozzle; a rotation mechanism 32 for rotating the sacrificial tube; and a control unit 33 for controlling the sweep mechanism and the rotation mechanism. The control unit controls so that particles passing through a slit 15a of the slit mask and the opening pattern adhere to the sacrificial tube by sweeping the mask while spraying the particles jetted from the thermal spray nozzle onto the slit mask and rotating the sacrificial tube at the same time.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a medical device manufacturing apparatus and a medical device manufacturing method.

  An example of a medical device is a stent. A stent is a medical device that expands a tubular portion (blood vessel, trachea, esophagus, duodenum, large intestine, biliary tract, etc.) from the inside of a lumen. As an example of the stent, there is a cylindrical tube made of metal, and a stent corresponding to a site to be treated is used. Stent graft endoscopy is performed as a treatment for angina pectoris, acute myocardial infarction, acute coronary syndrome, blood vessels due to cancer, trachea, esophagus, duodenum, large intestine, biliary stricture, and cerebral infarction.

A conventional method for manufacturing a stent is as follows.
A single metal or alloy pipe made of medical stainless steel (SUS316L, SUS316LVN), cobalt chromium, NiTi or the like is processed by laser light from the outer periphery, and then the stent is processed through heat treatment, acid cleaning, and electropolishing. Produced. The acid cleaning and electropolishing processes are processes in which burrs are generated at the cut surface during laser processing, and thus the burrs are removed to finish the stent surface smoothly.

  In the conventional stent manufacturing method, the pipe of the material itself is overheated during laser processing, causing segregation of impurities and the like on the surface of the pipe, and part of the mesh of the stent may be disconnected during the acid cleaning process. .

  In addition, when attempting to manufacture a long stent having a longitudinal direction of, for example, 100 mm or more, there is a problem that when the stent is cooled after laser processing, the processing accuracy required for dripping due to the weight of the stent cannot be maintained. Therefore, the length of the stent that can maintain the required processing accuracy is limited to about 30 to 40 mm, and the processing accuracy cannot be improved with a stent longer than that, so the conventional method for manufacturing a stent corresponds to a long stent. There is a problem that can not be.

  That is, in the stent manufacturing method using laser processing, there is a problem that processing accuracy is lowered by heat applied to the stent during laser processing.

JP 2014-36817 A

  An object of one embodiment of the present invention is to provide a medical device manufacturing apparatus or a medical device manufacturing method capable of suppressing a decrease in processing accuracy due to heat such as laser processing.

Hereinafter, various aspects of the present invention will be described.
[1] A thermal spray nozzle for injecting particles;
A holding part for holding the sacrificial material;
A mask having an aperture pattern disposed between the sacrificial material held by the holding unit and the thermal spray nozzle;
A moving mechanism for moving the sacrificial material or the thermal spray nozzle held by the mask and the holding unit;
A control unit for controlling the moving mechanism;
Comprising
The control unit moves the mask and the sacrificial material or the spray nozzle while spraying the particles ejected from the spray nozzle on the mask, so that the particles that have passed through the aperture pattern are applied to the sacrificial material. An apparatus for manufacturing a medical instrument, which is controlled to adhere.

[2] a thermal spray nozzle for injecting particles;
A holding part for holding the sacrificial tube;
A mask having an aperture pattern disposed between the sacrificial tube held by the holding unit and the thermal spray nozzle;
A sweep mechanism for sweeping the mask;
A slit mask disposed between the mask and the thermal spray nozzle;
A rotation mechanism for rotating the sacrificial tube;
A control unit for controlling the sweep mechanism and the rotation mechanism;
Comprising
The control unit sweeps the mask while rotating the sacrificial tube while spraying the particles ejected from the thermal spray nozzle onto the slit mask, thereby passing the slit and the opening pattern of the slit mask. An apparatus for manufacturing a medical device, wherein particles are controlled to adhere to the sacrificial tube.

[3] In the above [2],
A chamber for housing the thermal spray nozzle, the holding unit, the mask, and the slit mask;
A manufacturing apparatus comprising: an exhaust mechanism for reducing the pressure in the chamber; or a gas introduction mechanism for introducing an inert gas into the chamber;
Or it is a manufacturing apparatus which comprises the gas shroud apparatus which makes the path | route of the said particle injected from the said thermal spray nozzle the inert gas atmosphere, The manufacturing apparatus of the medical device characterized by the above-mentioned.
[3-1] In the above [2],
A chamber for housing the thermal spray nozzle, the holding unit, the mask, and the slit mask;
An exhaust mechanism for decompressing the inside of the chamber, or a gas introduction mechanism for introducing an inert gas into the chamber;
An apparatus for manufacturing a medical instrument, comprising:
[3-2] In the above [1] or [2],
An apparatus for manufacturing a medical instrument, comprising: a gas shroud device that makes a path of the particles ejected from the thermal spray nozzle an inert gas atmosphere.

[4] A mask having an aperture pattern is disposed at a position facing the sacrificial material, particles are sprayed on the mask, and the particles that have passed through the aperture pattern are attached to the sacrificial material, thereby allowing the sacrificial material to Forming a film of the particles in
Removing the sacrificial material to separate the film from the sacrificial material;
A method for manufacturing a medical device, comprising:

[5] In the above [4],
The step of forming the film includes disposing the mask between the spray nozzle and the sacrificial material, and moving the spray nozzle or the sacrificial material and the mask while spraying particles sprayed from the spray nozzle onto the mask. The method of manufacturing a medical device, characterized in that the particle having passed through the opening pattern adheres to the sacrificial material and forms a film of the particle on the sacrificial material.

[6] A mask having an opening pattern is disposed between the thermal spray nozzle and the sacrificial tube, and a slit mask is disposed between the mask and the thermal spray nozzle, and particles ejected from the thermal spray nozzle are disposed in the slit. By sweeping the mask while rotating the sacrificial tube while spraying on the mask, the particles that have passed through the slits and the opening pattern of the slit mask adhere to the sacrificial tube, and the particles are attached to the outer surface of the sacrificial tube. Forming a film by:
Removing the sacrificial tube and separating the membrane from the sacrificial tube to form a tubular article made of the membrane;
A method for manufacturing a medical device, comprising:

[7] In the above [6],
The aperture pattern has a first pattern and a second pattern;
In the step of forming the film, the sacrificial tube is rotated once to form the film of the first pattern, and the sacrificial tube is further rotated one time to form the second pattern on the film of the first pattern. A method of manufacturing a medical device, wherein a pattern film is synthesized.

[8] In any one of [4] to [7] above,
The process for forming the film is performed in a reduced pressure atmosphere or an inert gas atmosphere.

  According to one embodiment of the present invention, it is possible to provide a medical device manufacturing apparatus or a medical device manufacturing method capable of suppressing a decrease in processing accuracy due to heat such as laser processing.

It is sectional drawing which shows typically the manufacturing apparatus of the medical device which concerns on 1 aspect of this invention. (A) is a top view of the slit mask 15 shown in FIG. 1, (B) is a top view of the mask 14 shown in FIG. It is a top view which shows the pattern which synthesize | combined the element 1 pattern and element 2 pattern of the mask shown to FIG. 2 (B). It is a figure which shows the process flow for demonstrating the manufacturing method of the medical device which concerns on 1 aspect of this invention. It is sectional drawing which shows typically the manufacturing apparatus of the medical device which concerns on 1 aspect of this invention.

  Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. However, the present invention is not limited to the following description, and it will be easily understood by those skilled in the art that modes and details can be variously changed without departing from the spirit and scope of the present invention. Therefore, the present invention should not be construed as being limited to the description of the embodiments below.

[First Embodiment]
FIG. 1 is a cross-sectional view schematically showing a medical device manufacturing apparatus according to an aspect of the present invention. 2A is a plan view of the slit mask 15 shown in FIG. 1, and FIG. 2B is a plan view of the mask 14 shown in FIG. A mask 14 shown in FIG. 2B is a mask in which the pattern of the element 1 and the pattern of the element 2 shown in black are opened. That is, the portion of element 1 shown in FIG. 2B and the portion of element 2 shown in black correspond to the opening pattern 14a of the mask 14 shown in FIG.
FIG. 3 is a plan view showing a pattern obtained by synthesizing the element 1 pattern and the element 2 pattern of the mask shown in FIG. FIG. 4 is a diagram illustrating a process flow for describing the method for manufacturing the medical device according to one embodiment of the present invention. The medical device of this embodiment is a stent.

  The medical device manufacturing apparatus of FIG. 1 has a chamber 11, in which a thermal spray gun having a thermal spray nozzle 12, a holding unit 30 for holding a sacrificial tube 13, a mask 14 and a slit mask 15 are arranged. The thermal spray nozzle 12 is a nozzle that ejects thermal spray particles formed by plasma. A mask 14 is disposed between the sacrificial tube 13 held by the holding unit 30 and the thermal spray nozzle 12. The mask 14 is a planar mask and has an element 1 pattern (also referred to as a first pattern) and an element 2 pattern (also referred to as a second pattern) which are aperture patterns 14a. If a pattern (see FIG. 3) composed of the element 1 pattern and the element 2 pattern is formed on the mask 14 without dividing the element 1 pattern and the element 2 pattern, the mask falls off at the portion where the element 1 pattern and the element 2 pattern are connected. It is because it becomes impossible to become independent. Each of the element 1 pattern and the element 2 pattern has a length L in the longitudinal direction of the mask 14 (see FIG. 2B). The length L is equal to the length of one round of the outer surface of the sacrificial tube 13. That is, the length L is equal to R × circularity when the outer diameter of the sacrificial tube 13 is R.

  Between the mask 14 and the thermal spray nozzle 12, a slit mask 15 having a slit 15a for controlling the direction of the thermal spray particles is disposed. The slit 15a penetrates. Since the spray particles sprayed from the spray nozzle 12 are mixed with particles in different traveling directions, only the spray particles that have passed through the slit 15a are made to reach the mask 14 by the slit mask 15. That is, only the particles that go straight to the sacrificial tube 13 directly below the thermal spray nozzle 12 can be taken out by the slit mask 15. The thermal spray particles that have passed through the slit 15 a and the opening pattern 14 a of the mask 14 are configured to adhere to the sacrificial tube 13.

  The manufacturing apparatus also includes a sweep mechanism 31 that sweeps the mask 14 in the direction of the arrow 18, a rotation mechanism 32 that rotates the sacrificial tube 13 in the direction of the arrow 19, and a control unit that controls the sweep mechanism 31 and the rotation mechanism 32. 33. The holding unit 30 is connected to the rotation mechanism 32, and the rotation mechanism 32 is located at a location that does not appear in the cross section of FIG. The control unit 33 sweeps the mask 14 by the sweep mechanism 31 while rotating the sacrificial tube 13 by the rotation mechanism 32 while spraying the spray particles sprayed from the spray nozzle 12 to the slit mask 15, so that the slit 15 a and the opening are formed. Control is performed so that the sprayed particles that have passed through the pattern 14 a adhere to the sacrificial tube 13.

In addition, the manufacturing apparatus includes a vacuum pump 16 as an exhaust mechanism that decompresses the inside of the chamber 11 and a gas introduction mechanism 17 that introduces an inert gas into the chamber 11. In this embodiment, both the vacuum pump 16 and the gas introduction mechanism 17 are provided. However, a medical instrument having either the vacuum pump 16 or the gas introduction mechanism 17 may be a manufacturing apparatus.
In this embodiment, a medical device manufacturing apparatus having the chamber 11, the gas introduction mechanism 17, and the vacuum pump 16 is used, but the chamber 11, the gas introduction mechanism 17, and the vacuum pump 16 are not provided. Alternatively, a medical device manufacturing apparatus in which a gas shroud device (not shown) is added may be used. If a gas shroud device is used, a chamber for creating a reduced pressure atmosphere or an inert atmosphere becomes unnecessary. This gas shroud apparatus has a member (not shown) that extends from the spray nozzle 12 and covers a sprayed workpiece (for example, the sacrificial tube 13, the mask 14, and the slit mask 15), and an inert gas is introduced into the member in advance. This is an apparatus for making the path of the spray particles sprayed from the spray nozzle 12 into an inert gas atmosphere. As a result, the spray particles mixed with the inert gas can be sprayed onto the slit mask 15. Further, in addition to the gas shroud device described above, a member that covers the spray nozzle 12 itself is provided, and the inert gas is introduced into the member to cause the inert gas to be injected, so that the spray is sprayed from the spray nozzle 12. An apparatus may be used in which spray particles and inert gas are mixed and the mixed spray particles and inert gas are sprayed onto the slit mask 15. By using such an apparatus, it becomes possible to suppress oxidation during spraying of spray particles.

Next, a method for manufacturing a stent using the manufacturing apparatus of FIG. 1 will be described.
In the present embodiment, by using the planar mask pattern of FIG. 2B on the outside of the sacrificial tube 13, the stent pattern is sprayed on the outer surface of the sacrificial tube 13, and after the thermal spraying, the sacrificial tube 13 is removed by etching. This is a method for obtaining a stent shape.

This will be described in detail below. The process flow of the stent manufacturing method is as shown in FIG.
First, the sacrificial tube 13 is held by the holding unit 30 and installed in the rotation mechanism 32, the mask 14 is installed in the sweep mechanism 31, and the slit mask 15 is installed at a predetermined position.

  Next, the pressure inside the chamber 11 is reduced by the vacuum pump 16. An inert gas is introduced into the chamber 11 by the gas introduction mechanism 17. Thereby, the inside of the chamber 11 is replaced with an inert gas (for example, nitrogen gas or Ar gas), and the inside of the chamber 11 is set to a reduced pressure atmosphere. In this embodiment, the inside of the chamber 11 is replaced with an inert gas to form a reduced-pressure atmosphere. However, a reduced-pressure atmosphere may be used instead of the inert gas, or an inert-gas atmosphere may be used without reducing the pressure. .

  Thereafter, spray particles are sprayed from the spray nozzle 12 and the mask 14 is swept in the direction of the arrow 18 while rotating the sacrificial tube 13 as shown by the arrow 19 while spraying the spray particles on the slit mask 15. As a result, the sprayed particles that have passed through the slit 15 a and the aperture pattern 14 a of the slit mask 15 adhere to the outer surface of the sacrificial tube 13, and a sprayed film of the sprayed particles is formed on the outer surface of the sacrificial tube 13. In addition, when the manufacturing apparatus of the medical instrument which added the gas shroud apparatus etc. which were mentioned above is used, the thermal spray particle mixed with the inert gas can be ejected from the thermal spray nozzle 12, and it can spray on the slit mask 15. FIG. This makes it possible to suppress oxidation during spraying of spray particles even in an air atmosphere.

Here, the process of forming the sprayed film with the sprayed particles on the outer surface of the sacrificial tube 13 will be described in detail.
First, a sprayed film of a stent segment pattern which is an element 1 pattern of the planar mask 14 shown in FIG. 2B is formed on the outer surface of the sacrificial tube 13. That is, while spraying spray particles from the spray nozzle 12, the mask 14 is moved gradually in the direction of the arrow 18 and the sacrificial tube 13 is rotated gradually in the direction of the arrow 19, thereby forming the outer surface of the sacrificial tube 13. Progress the membrane gradually. By adjusting the rotational speed of the sacrificial tube 13 and the sweep speed of the mask 14 so that the time for the sacrificial tube 13 to make one revolution and the time for sweeping the mask 14 by the length L are the same, the sacrificial tube 13 makes one revolution. When this is done, the film formation with the sprayed particles on the outer surface of the sacrificial tube 13 of the stent segment pattern (element 1) is completed.
Thereafter, a sprayed film of a link pattern between segments, which is the element 2 pattern shown in FIG. 2B, is formed on the outer surface of the sacrificial tube 13. That is, while spraying spray particles from the spray nozzle 12, the mask 14 is moved gradually in the direction of the arrow 18 and the sacrificial tube 13 is rotated gradually in the direction of the arrow 19, thereby forming the outer surface of the sacrificial tube 13. Progress the membrane gradually. By adjusting the rotational speed of the sacrificial tube 13 and the sweep speed of the mask 14 so that the time for the sacrificial tube 13 to make one revolution and the time for sweeping the mask 14 by the length L are the same, the sacrificial tube 13 makes one revolution. When this is done, the film formation with the sprayed particles on the outer surface of the sacrificial tube 13 of the link pattern (element 2) is completed.

  By forming the sprayed film as described above, the sprayed film having the stent pattern shown in FIG. 3 in which the stent segment pattern (element 1) and the link pattern (element 2) are synthesized can be obtained. In other words, as shown in FIG. 3, the stent segment pattern growing in the circumferential direction of the sacrificial tube 13 is an element 1 pattern with respect to the stent pattern, and the link pattern connecting the element 1 and the element 1 is an element. Two patterns are used. Since the final stent structure is produced by synthesizing the patterns in this way, the stent pattern is not limited to the stent pattern shown in FIG. 3, and stents having various pattern shapes can be produced.

  In addition, you may spray a thermal spray particle, moving the thermal spray nozzle 12 along the slit 15a as needed. In other words, the sprayed particles may be sprayed while moving the mask 14 in the direction of the arrow 18, rotating the sacrificial tube 13 in the direction of the arrow 19, and moving the spray nozzle 12 along the slit 15a.

  In the present embodiment, the sacrificial tube 13 is rotated twice to form the sprayed particles on the entire outer surface of the sacrificial tube 13. However, the sacrificial tube 13 is rotated once or three or more times to increase the outer surface of the sacrificial tube 13. The entire film may be formed by thermal spraying particles. In that case, the opening pattern 14 a of the mask 14 is produced in accordance with the rotational speed of the sacrificial tube 13.

  Next, the inside of the chamber 11 is returned to atmospheric pressure, and the sacrificial tube 13 is removed from the holding unit 30. Next, the sacrificial tube 13 is removed by etching, and the sprayed film formed of the sprayed particles is separated from the sacrificial tube 13, whereby a self-supporting tubular sprayed film (tubular material) can be formed. This tubular sprayed film becomes a stent.

Then, if necessary, the stent may be heat treated to recrystallize and remove residual stress. If necessary, the stent after thermal spraying can be subjected to chemical polishing or mechanical polishing to obtain a final shape. Moreover, you may perform surface treatments, such as surface grinding | polishing of a stent and an end surface R process, as needed. In addition, before etching the sacrificial tube 13 as necessary, a noble metal for improving X-ray visibility may be coated on the surface of the stent by a thermal spraying method. Thereby, it becomes possible to obtain X-ray visibility in the whole stent.
Next, a final inspection of the stent is performed.

  According to this embodiment, since a stent as an example of a medical instrument is formed by a thermal spraying method, even a material that is difficult to etch can be used as a thermal spray particle, and various materials can be used. .

  Examples of spray particles include various metals (Li, Na, K, Rb, Cs, Fr, Be, Mg, Ca, Sr, Ba, Ra, lanthanoids, actinides, Sc, Ti, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, Y, Zr, Nb, Mo, Tc, Ru, Rh, Pd, Ag, Cd, Hf, Ta, W, Re, Os, Ir, Pt, Au, Hg, Al, Ga, In, Sn, Tl, Pb, Bi, B, Si, Ge, As, Sb, Te, Po), alloys of the metals, stainless steel as biomaterials, CoCr alloys, titanium alloys, super-elastic body shapes A memory alloy or the like can be used.

  In addition, when a stent is made of a thermal spray film made of a biomedical shape memory alloy having superelasticity, it can also be applied to a stent used for a portion that can be bent by a joint. This will be described in detail below.

  In a stent that does not have superelastic characteristics, even when the shape of the stent is devised, bending followability and insertion characteristics are insufficient when inserted into a tortuous blood vessel together with a balloon catheter. In order to improve the bending followability, not a balloon expandable type but a self-expandable stent, that is, a stent having superelastic characteristics is suitable.

  By having superelastic characteristics, it becomes possible to use the stent not only at the bending followability at the time of insertion of the stent but also at a portion having a high bending deformability. Examples of superelastic materials include titanium alloys including nickel titanium, and specific superelastic materials include Ti-Ni, Ti-6Al-4V, Ti-Nb, Ti-Pd, and Ti-Zr-Nb. Binary, ternary or higher alloys containing titanium such as Ti-Mo-Sn, Ti-Mo-Ga, Ti-Ni-O and Ti-Ni-Al. Since titanium alloys are difficult to process, the prior art laser processing has low processability of titanium alloy stents. On the other hand, in this embodiment, since the titanium alloy, which is a difficult-to-work material, is directly formed into a stent shape by a thermal spraying method, the process becomes simple and the manufacturing cost can be reduced. At the same time, it becomes possible to produce a long-chain stent or a small-bore tube stent having super elasticity.

  Moreover, in this embodiment, the fall of the processing precision by heat | fever like the laser processing of a prior art can be suppressed. Accordingly, it is possible to manufacture a long stent having a longitudinal direction of 100 mm or more, which is difficult to manufacture by the conventional technique.

  The accuracy of the stent pattern depends on the dimensional accuracy of the opening pattern 14a of the mask 14, and a stent pattern of several tens of μm or less can be produced at the minimum. For example, a stent in which the wire strength is controlled by changing the width of the opening pattern 14a of the mask 14 can be manufactured.

  Moreover, it is possible to control the state of the sprayed film by controlling the film forming conditions. For example, it is possible to produce a superelastic stent under porous conditions.

  Further, by using a plurality of spray guns, it is possible to locally make a part of the stent another metal material. In addition, since a plurality of metals can be sprayed, it is possible to manufacture a stent having a laminated structure of various metals.

  Further, the thermal spraying method can form a film other than metal, and the outermost surface of the stent can be coated with ceramics such as hydroxyapatite (HAp).

  In this embodiment, the stent is manufactured by the thermal spraying method, but it is also possible to manufacture the stent using the cold spray method. In that case, the thermal spray nozzle 12 shown in FIG. 1 is changed to a cold spray nozzle.

[Second Embodiment]
FIG. 5 is a cross-sectional view schematically showing a medical device manufacturing apparatus according to an aspect of the present invention, and the same parts as those in FIG.

  The medical device manufacturing apparatus of FIG. 5 includes a chamber 11, and a spray gun having a spray nozzle 12, a holding portion 22 for holding a plate-like sacrificial material 23, and a mask 24 are disposed in the chamber 11. A mask 24 is disposed between the sacrificial material 23 held by the holding unit 22 and the thermal spray nozzle 12. The mask 24 is a planar mask and has an opening pattern 24a. FIG. 5 shows a part of each of the mask 24, the sacrificial material 23, and the holding portion 22.

  In the present embodiment, the slit mask of the first embodiment is not disposed in the chamber 11, but the present invention is not limited to this, and the direction of the sprayed particles is set between the mask 24 and the spray nozzle 12. You may arrange | position the slit mask which has the slit for controlling.

  In addition, the manufacturing apparatus includes a moving mechanism 41 that moves the mask 24 and the sacrificial material 23 in the direction of the arrow 29, and a control unit 42 that controls the moving mechanism 41. The moving mechanism 41 is connected to the mask 24, the sacrificial material 23, and the holding unit 22. FIG. 5 shows a part of the moving mechanism 41. The control unit 42 moves the mask 24 and the sacrificial material 23 by the moving mechanism 41 while spraying the spray particles sprayed from the spray nozzle 12 onto the mask 24, so that the sprayed particles that have passed through the aperture pattern 24 a are applied to the sacrificial material 23. It controls to adhere. In this embodiment, the spray nozzle 12 is fixed and the mask 24 and the sacrificial material 23 are moved. However, the mask 24 and the sacrificial material 23 may be fixed and the spray nozzle 12 may be moved.

  In addition, the manufacturing apparatus includes a vacuum pump 16 as an exhaust mechanism that decompresses the inside of the chamber 11 and a gas introduction mechanism 17 that introduces an inert gas into the chamber 11. In this embodiment, both the vacuum pump 16 and the gas introduction mechanism 17 are provided. However, a medical instrument having either the vacuum pump 16 or the gas introduction mechanism 17 may be a manufacturing apparatus.

Next, a method for manufacturing a medical instrument using the manufacturing apparatus of FIG. 5 will be described.
In the present embodiment, the shape of the medical device is obtained by spraying the pattern of the medical device on the sacrificial material 23 using the flat mask pattern on the sacrificial material 23 and removing the sacrificial material 23 by etching after spraying. Is the method.

This will be described in detail below.
First, the sacrificial material 23 is held on the holding portion 22 and the mask 24 is set on the moving mechanism.

  Next, the pressure inside the chamber 11 is reduced by the vacuum pump 16. An inert gas is introduced into the chamber 11 by the gas introduction mechanism 17. Thereby, the inside of the chamber 11 is replaced with an inert gas (for example, nitrogen gas or Ar gas), and the inside of the chamber 11 is set to a reduced pressure atmosphere.

  Thereafter, spray particles are sprayed from the spray nozzle 12, and the sacrificial material 23 and the mask 24 are moved in the direction of the arrow 29 while spraying the spray particles on the mask 24. As a result, the sprayed particles that have passed through the aperture pattern 24 a adhere to the sacrificial material 23, and a sprayed film of the sprayed particles is formed on the sacrificial material 23. As described above, when the manufacturing apparatus is configured to fix the mask 24 and the sacrificial material 23 and move the spray nozzle 12, spray particles are sprayed from the spray nozzle 12, and the spray particles are applied to the mask 24. The spray nozzle 12 is moved while spraying.

  Next, the inside of the chamber 11 is returned to atmospheric pressure, and the sacrificial material 23 is removed from the holding portion 22. Next, the sacrificial material 23 is removed by etching, and the sprayed film made of the sprayed particles is separated from the sacrificial material 23, whereby a self-supporting sprayed film can be formed. This sprayed film becomes a medical instrument.

Thereafter, if necessary, the medical device may be heat treated to recrystallize and remove residual stress. Further, surface treatment such as surface polishing and end face R treatment of the medical device may be performed as necessary, or the surface of the medical device may be coated with a noble metal. If necessary, the medical device after thermal spraying can be subjected to chemical polishing or mechanical polishing to obtain a final shape.
Next, a final inspection of the medical device is performed.

In this embodiment, the same effect as that of the first embodiment can be obtained.
As the spray particles, the same particles as those in the first embodiment can be used.

  In addition, by using a plurality of spray guns, it is possible to locally make a part of the medical device another metal material. In addition, since a plurality of metals can be sprayed, it is possible to manufacture a medical device having a laminated structure of various metals.

  In addition, the thermal spraying method can form films other than metals, and the outermost surface of a medical device can be coated with ceramics such as hydroxyapatite (HAp).

  Moreover, in this embodiment, although the medical device is manufactured by the thermal spraying method, it is also possible to manufacture a medical device using the cold spray method. In that case, the thermal spray nozzle 12 shown in FIG. 5 is changed to a cold spray nozzle.

  It is also possible to implement the first and second embodiments in combination with each other.

  In the first embodiment, an example in which a stent is applied as a medical device is described. However, the present invention is not limited to this, and various medical devices that can be manufactured in the first embodiment or the second embodiment. One embodiment of the present invention can be applied to a device. For example, it can be applied to flow diverter, stent retriever system, cerebrovascular coil, guide wire, contrast marker, lower aortic filter, peripheral protection filter, medical clip, medical needle, metal or resin using springs, etc. is there.

DESCRIPTION OF SYMBOLS 11 Chamber 12 Spray nozzle 13 Sacrificial pipe 14 Mask 14a Opening pattern 15 Slit mask 15a Slit 16 Vacuum pump 17 Gas introduction mechanism 18, 19 Arrow 22 Holding part 23 Sacrificial material 24 Mask 24a Opening pattern 29 Arrow 30 Holding part 31 Sweep mechanism 32 Rotating mechanism 33 Control unit 41 Moving mechanism 42 Control unit

Claims (8)

A thermal spray nozzle for jetting particles;
A holding part for holding the sacrificial material;
A mask having an aperture pattern disposed between the sacrificial material held by the holding unit and the thermal spray nozzle;
A moving mechanism for moving the sacrificial material or the thermal spray nozzle held by the mask and the holding unit;
A control unit for controlling the moving mechanism;
Comprising
The control unit moves the mask and the sacrificial material or the spray nozzle while spraying the particles ejected from the spray nozzle on the mask, so that the particles that have passed through the aperture pattern are applied to the sacrificial material. An apparatus for manufacturing a medical instrument, which is controlled to adhere. A thermal spray nozzle for jetting particles;
A holding part for holding the sacrificial tube;
A mask having an aperture pattern disposed between the sacrificial tube held by the holding unit and the thermal spray nozzle;
A sweep mechanism for sweeping the mask;
A slit mask disposed between the mask and the thermal spray nozzle;
A rotation mechanism for rotating the sacrificial tube;
A control unit for controlling the sweep mechanism and the rotation mechanism;
Comprising
The control unit sweeps the mask while rotating the sacrificial tube while spraying the particles ejected from the thermal spray nozzle onto the slit mask, thereby passing the slit and the opening pattern of the slit mask. An apparatus for manufacturing a medical device, wherein particles are controlled to adhere to the sacrificial tube. In claim 2,
A chamber for housing the thermal spray nozzle, the holding unit, the mask, and the slit mask;
A manufacturing apparatus comprising: an exhaust mechanism for reducing the pressure in the chamber; or a gas introduction mechanism for introducing an inert gas into the chamber;
Or it is a manufacturing apparatus which comprises the gas shroud apparatus which makes the path | route of the said particle injected from the said thermal spray nozzle the inert gas atmosphere, The manufacturing apparatus of the medical device characterized by the above-mentioned. A mask having an aperture pattern is disposed at a position facing the sacrificial material, particles are sprayed on the mask, and the particles that have passed through the aperture pattern are adhered to the sacrificial material, thereby the particles on the sacrificial material. Forming a film by:
Removing the sacrificial material to separate the film from the sacrificial material;
A method for manufacturing a medical device, comprising: In claim 4,
The step of forming the film includes disposing the mask between the spray nozzle and the sacrificial material, and moving the spray nozzle or the sacrificial material and the mask while spraying particles sprayed from the spray nozzle onto the mask. The method of manufacturing a medical device, characterized in that the particle having passed through the opening pattern adheres to the sacrificial material and forms a film of the particle on the sacrificial material. A mask having an opening pattern is disposed between the thermal spray nozzle and the sacrificial tube, and a slit mask is disposed between the mask and the thermal spray nozzle, and particles ejected from the thermal spray nozzle are sprayed onto the slit mask. While sweeping the mask while rotating the sacrificial tube, the particles that have passed through the slits and the opening pattern of the slit mask adhere to the sacrificial tube, and a film of the particles is formed on the outer surface of the sacrificial tube. Forming, and
Removing the sacrificial tube and separating the membrane from the sacrificial tube to form a tubular article made of the membrane;
A method for manufacturing a medical device, comprising: In claim 6,
The aperture pattern has a first pattern and a second pattern;
In the step of forming the film, the sacrificial material is rotated once to form the film of the first pattern, and the sacrificial material is further rotated one time to form the second pattern on the film of the first pattern. A method of manufacturing a medical device, wherein a pattern film is synthesized. In any one of Claims 4 thru | or 7,
The process for forming the film is performed in a reduced pressure atmosphere or an inert gas atmosphere.

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