JP6741403B2 - Medical device manufacturing apparatus and medical device manufacturing method - Google Patents

Description

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

A stent is an example of a medical device. A stent is a medical device that expands a tubular portion of a human body (blood vessel, trachea, esophagus, duodenum, large intestine, biliary tract, etc.) from the inside of a lumen. An example of the stent is a tubular mesh made of metal, and a stent depending on the site to be treated is used. Stent graft insertion is performed as a treatment for angina, acute myocardial infarction, acute coronary syndrome, blood vessels due to cancer, narrowing of trachea and esophagus, duodenum, large intestine, biliary tract, cerebral infarction, and the like.

The conventional method for manufacturing a stent is as follows.
A stainless steel (SUS316L, SUS316LVN) for medical use, a pipe of a single metal or an alloy which is a material such as cobalt chrome, NiTi, etc. is processed from the outer circumference by laser light, and then a stent is processed through a process of heat treatment, acid cleaning and electrolytic polishing. It is produced. In the steps of acid cleaning and electrolytic polishing, burrs are generated at the cut end during laser processing, so the burrs are removed to smooth the surface of the stent for finishing.

In the above-described conventional method for manufacturing a stent, during laser processing, the material pipe itself is overheated to cause segregation of impurities and the like on the surface of the pipe, and a part of the mesh of the stent may be broken in the step of acid cleaning. ..

Further, when a long stent having a longitudinal direction of, for example, 100 mm or more is manufactured, there is a problem that when the stent is cooled after laser processing, the processing accuracy required cannot be maintained due to sag of the stent due to its own weight. 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. Therefore, the conventional stent manufacturing method described above must handle a long stent. There is a problem that you can not.

That is, in the method of manufacturing a stent using laser processing, there is a problem that the processing accuracy is lowered by the 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 device for manufacturing a medical device or a method for manufacturing a medical device capable of suppressing a reduction in processing accuracy due to heat such as laser processing.

Various aspects of the present invention will be described below.
[1] A spray nozzle for spraying particles,
A holding portion for holding the sacrificial material,
A mask having an opening pattern arranged between the sacrificial material held by the holding portion and the thermal spray nozzle;
A moving mechanism for moving the sacrificial material or the spray nozzle held by the mask and the holding portion;
A control unit for controlling the moving mechanism,
Equipped with,
The controller moves the mask and the sacrificial material or the thermal spray nozzle while spraying the particles sprayed from the thermal spray nozzle onto the mask, so that the particles that have passed through the opening pattern become the sacrificial material. A device for manufacturing a medical instrument, which is controlled to adhere.

[2] A spray nozzle for spraying particles,
A holding part for holding the sacrificial tube,
A mask having an opening pattern arranged between the sacrificial tube held by the holding portion and the thermal spray nozzle;
A sweep mechanism for sweeping the mask,
A slit mask arranged between the mask and the spray nozzle,
A rotating mechanism for rotating the sacrificial tube,
A control unit for controlling the sweep mechanism and the rotation mechanism,
Equipped with,
The control unit sweeps the mask while rotating the sacrificial tube while spraying the particles sprayed from the thermal spray nozzle onto the slit mask, thereby passing through the slits and the opening pattern of the slit mask. An apparatus for manufacturing a medical device, wherein particles are controlled so as to adhere to the sacrificial tube.

[3] In the above [2],
A chamber for accommodating the thermal spray nozzle, the holder, the mask and the slit mask;
An exhaust system for reducing the pressure in the chamber, or a gas introduction mechanism for introducing an inert gas into the chamber, a manufacturing apparatus comprising:
Alternatively, the manufacturing apparatus for a medical device is a manufacturing apparatus including a gas shroud device that makes a path of the particles ejected from the thermal spray nozzle into an inert gas atmosphere.
[3-1] In the above [2],
A chamber for accommodating the thermal spray nozzle, the holder, the mask and the slit mask;
An exhaust mechanism for reducing the pressure in 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 for making a path of the particles ejected from the thermal spray nozzle into an inert gas atmosphere.

[4] A mask having an opening pattern is arranged at a position facing the sacrificial material, particles are sprayed on the mask, and the particles that have passed through the opening pattern are attached to the sacrificial material. A step of forming a film of the particles on
Removing the sacrificial material to separate the film from the sacrificial material,
A method of manufacturing a medical device, comprising:

[5] In the above [4],
In the step of forming the film, the mask is disposed between a spray nozzle and the sacrificial material, and the spray nozzle or the sacrificial material and the mask are moved while spraying particles sprayed from the spray nozzle onto the mask. By so doing, the particles that have passed through the opening pattern are attached to the sacrificial material to form a film of the particles on the sacrificial material.

[6] A mask having an opening pattern is arranged between the spray nozzle and the sacrificial tube, and a slit mask is arranged between the mask and the spray nozzle, and the particles sprayed from the spray nozzle are slit. By sweeping the mask while rotating the sacrificial tube while spraying on the mask, the particles passing through the slits and the opening pattern of the slit mask adhere to the sacrificial tube, and the particles on the outer surface of the sacrificial tube. A step of forming a film by
Removing the sacrificial tube and separating the film from the sacrificial tube to form a tubular object made of the film,
A method of manufacturing a medical device, comprising:

[7] In the above [6],
The opening pattern has a first pattern and a second pattern,
In the step of forming the film, the sacrificial tube makes one rotation to form the film having the first pattern, and the sacrificial tube makes one more rotation to make the second pattern on the film having the first pattern. A method for manufacturing a medical device, wherein a patterned film is synthesized.

[8] In any one of the above [4] to [7],
The method of manufacturing a medical device, wherein the step of forming the film is performed in a reduced pressure atmosphere or an inert gas atmosphere.

According to one aspect 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 the manufacturing apparatus of the medical device which concerns on 1 aspect of this invention typically. (A) is a plan view of the slit mask 15 shown in FIG. 1, and (B) is a plan view of the mask 14 shown in FIG. 1. FIG. 3 is a plan view showing a pattern in which the element 1 pattern and the element 2 pattern of the mask shown in FIG. 2B are combined. 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 the manufacturing apparatus of the medical device which concerns on 1 aspect of this invention typically.

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 is easily understood by those skilled in the art that modes and details can be variously modified 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. The mask 14 shown in FIG. 2(B) is a mask in which the black portions of the pattern of the element 1 and the pattern of the element 2 are opened. That is, the portions in which the pattern of element 1 and the pattern of element 2 in FIG. 2B are 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 combining the element 1 pattern and the element 2 pattern of the mask shown in FIG. FIG. 4 is a diagram showing a process flow for explaining a method for manufacturing a medical device according to an aspect of the present invention. The medical device of this embodiment is a stent.

The apparatus for manufacturing a medical device shown in FIG. 1 has a chamber 11, and in the chamber 11, a spray gun having a spray nozzle 12, a holder 30 for holding a sacrificial tube 13, a mask 14 and a slit mask 15 are arranged. The spray nozzle 12 is a nozzle that sprays spray particles formed by plasma. A mask 14 is arranged between the sacrificial tube 13 held by the holding portion 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) that are opening patterns 14a. When a pattern (see FIG. 3) that is a combination of the element 1 pattern and the element 2 pattern is formed on the mask 14 without separating 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. 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 one round of the outer surface of the sacrificial tube 13. That is, the length L is equal to R×circularity, where R is the outer diameter of the sacrificial tube 13.

A slit mask 15 having a slit 15a for controlling the direction of spray particles is disposed between the mask 14 and the spray nozzle 12. 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 by the slit mask 15 reach the mask 14. That is, with the slit mask 15, only the particles that go straight to the sacrificial tube 13 directly below the thermal spray nozzle 12 can be taken out. The spray particles that have passed through the slit 15 a and the opening pattern 14 a of the mask 14 are attached to the sacrificial tube 13.

The manufacturing apparatus also includes a sweep mechanism 31 for sweeping the mask 14 in the direction of arrow 18, a rotating mechanism 32 for rotating the sacrificial tube 13 in the direction of arrow 19, and a controller for controlling the sweep mechanism 31 and the rotating mechanism 32. Has 33. The holding unit 30 is connected to the rotating mechanism 32, and the rotating mechanism 32 is located at a position that does not appear in the cross section of FIG. 1. The control unit 33 sweeps the mask 14 by the sweep mechanism 31 while rotating the sacrificial pipe 13 by the rotating mechanism 32 while spraying the spray particles sprayed from the spray nozzle 12 onto the slit mask 15, thereby sweeping the slit 15a and the opening. The spray particles that have passed through the pattern 14a are controlled so as to adhere to the sacrificial tube 13.

Further, the manufacturing apparatus has a vacuum pump 16 as an exhaust mechanism for reducing the pressure inside the chamber 11, and a gas introduction mechanism 17 for introducing an inert gas into the chamber 11. In this embodiment, both the vacuum pump 16 and the gas introduction mechanism 17 are provided, but a medical device having either one of the vacuum pump 16 and the gas introduction mechanism 17 may be a manufacturing apparatus.
Further, in the present embodiment, the 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, and instead of these, A medical device manufacturing apparatus in which a gas shroud device (not shown) is added may be used. The use of a gas shroud eliminates the need for a chamber to create a reduced pressure or inert atmosphere. This gas shroud device has a member (not shown) that extends from the thermal spray nozzle 12 and covers the thermal spray work (for example, the sacrificial tube 13, the mask 14, the slit mask 15) and introduces an inert gas into the member in advance. By doing so, it is an apparatus that makes the path of the spray particles sprayed from the spray nozzle 12 an inert gas atmosphere. As a result, it becomes possible to spray the spray particles mixed with the inert gas onto the slit mask 15. In addition to the gas shroud device described above, a member for covering the thermal spray nozzle 12 itself is provided, and an inert gas is introduced into the member to trap the inert gas, thereby spraying from the thermal spray nozzle 12. A device may be used in which the spray particles and the inert gas are mixed and the mixed spray particles and the inert gas are mixed and sprayed onto the slit mask 15. By using such a device, it is possible to suppress oxidation of the spray particles during flight.

Next, a method of manufacturing a stent using the manufacturing apparatus of FIG. 1 will be described.
In the present embodiment, by using the plane mask pattern of FIG. 2B on the outer side of the sacrificial tube 13, a 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 of obtaining a stent shape.

The details will be described below. The process flow of the stent manufacturing method is as shown in FIG.
First, the sacrificial tube 13 is held by the holder 30 and set on the rotating mechanism 32, the mask 14 is set on the sweeping mechanism 31, and the slit mask 15 is set 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. As a result, 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 made into a reduced pressure atmosphere. In the present embodiment, the inside of the chamber 11 is replaced with an inert gas to create a reduced pressure atmosphere. However, the atmosphere may be replaced with a reduced pressure atmosphere without being replaced with an inert gas, or may be replaced with an inert gas atmosphere without reducing pressure. ..

Thereafter, spray particles are sprayed from the spray nozzle 12, and the mask 14 is swept in the direction of arrow 18 while rotating the sacrificial tube 13 as shown by arrow 19 while spraying the spray particles on the slit mask 15. As a result, the sprayed particles that have passed through the slits 15a of the slit mask 15 and the opening pattern 14a adhere to the outer surface of the sacrificial tube 13 to form a sprayed film of the sprayed particles on the outer surface of the sacrificial tube 13. When using the above-described medical device manufacturing apparatus to which the gas shroud device and the like are added, spray particles mixed with an inert gas can be ejected from the spray nozzle 12 and sprayed onto the slit mask 15. This makes it possible to suppress the oxidation of the spray particles during flight even in the air atmosphere.

Here, the step of forming a sprayed film of sprayed particles on the outer surface of the sacrificial tube 13 will be described in detail.
First, a sprayed film having a stent segment pattern, which is the 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 the spray particles from the spray nozzle 12, the mask 14 is gradually moved in the direction of arrow 18 and the sacrificial pipe 13 is gradually rotated in the direction of arrow 19, thereby forming the sacrificial pipe 13 on the outer surface. Allow the membrane to progress slowly. By adjusting the rotation speed of the sacrificial tube 13 and the sweep speed of the mask 14 so that the time for the sacrificial tube 13 to rotate once and the time for sweeping the mask 14 by the length L are the same, the sacrificial tube 13 rotates once. At that time, film formation of the stent segment pattern (element 1) on the outer surface of the sacrificial tube 13 by the spray particles is completed.
After that, a sprayed film having 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 the spray particles from the spray nozzle 12, the mask 14 is gradually moved in the direction of arrow 18 and the sacrificial pipe 13 is gradually rotated in the direction of arrow 19, thereby forming the sacrificial pipe 13 on the outer surface. Allow the membrane to progress slowly. By adjusting the rotation speed of the sacrificial tube 13 and the sweep speed of the mask 14 so that the time for the sacrificial tube 13 to rotate once and the time for sweeping the mask 14 by the length L are the same, the sacrificial tube 13 rotates once. At that time, the film formation of the link pattern (element 2) on the outer surface of the sacrificial tube 13 by the spray particles is completed.

By depositing the thermal spray coating as described above, the thermal spray coating having the stent pattern shown in FIG. 3 in which the stent segment pattern (element 1) and the link pattern (element 2) are combined 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 the element 1 pattern with respect to the pattern of the stent, and the link pattern connecting the elements 1 and 1 is the element. There are two patterns. Since the patterns are synthesized in this manner to produce the final stent structure, not only the stent pattern of FIG. 3 but also various pattern-shaped stents can be produced.

In addition, the spray particles may be sprayed while moving the spray nozzle 12 along the slits 15a as necessary. That is, the mask 14 may be moved in the direction of the arrow 18, the sacrificial tube 13 may be rotated in the direction of the arrow 19, and the spray particles may be sprayed while the spray nozzle 12 is moved along the slit 15a.

Further, in the present embodiment, the sacrificial tube 13 is rotated twice to form a film of the sprayed particles on the entire outer surface of the sacrificial tube 13. However, the sacrificial tube 13 is rotated once or three times or more to form the outer surface of the sacrificial tube 13. A film of sprayed particles may be formed on the entire surface. In that case, the opening pattern 14 a of the mask 14 is manufactured according to the rotation 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 portion 30. Next, the sacrificial tube 13 is removed by etching, and the sprayed film of sprayed particles is separated from the sacrificial tube 13 to form a self-supporting tubular sprayed film (tubular object). This tubular sprayed film serves as a stent.

Thereafter, the stent may be subjected to heat treatment to recrystallize and remove residual stress, if necessary. Further, if necessary, the stent after the thermal spraying may be subjected to chemical polishing or mechanical polishing to have a final shape. In addition, the surface of the stent may be subjected to surface treatment such as surface polishing or end face R treatment, if necessary. Further, if necessary, before etching the sacrificial tube 13, a noble metal for improving X-ray visibility may be coated on the surface of the stent by a thermal spraying method. This makes it possible to obtain X-ray visibility over the entire stent.
Next, the final inspection of the stent is performed.

According to this embodiment, since a stent as an example of a medical device is formed by a thermal spraying method, even a material that is difficult to etch can be used as a thermal spraying 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 these metals, stainless steel as biomaterials, CoCr alloys, titanium alloys, bioelastic shapes with superelasticity A memory alloy or the like can be used.

Further, when a stent is made of a sprayed film made of a bio-use shape memory alloy having superelasticity, it can be applied to a stent used in a portion that can be bent at a joint. The details will be described below.

With a stent having no superelasticity, even if the shape of the stent is devised, when it is inserted into a tortuous blood vessel together with a balloon catheter, the bending followability and the insertion characteristic are insufficient. A self-expanding stent, that is, a stent having superelastic characteristics, rather than a balloon-expandable type, is suitable for improving the bending followability.

Due to the superelasticity, it becomes possible to use the stent not only in the flexibility of bending when the stent is inserted but also in a portion having high flexibility of bending deformation. Materials having superelasticity include titanium alloys such as nickel titanium, and specific superelastic materials include Ti-Ni, Ti-6Al-4V, Ti-Nb, Ti-Pd, Ti-Zr-Nb. , Ti-Mo-Sn, Ti-Mo-Ga, Ti-Ni-O, Ti-Ni-Al, and other binary alloys containing titanium, ternary alloys or higher alloys. Since titanium alloys are difficult to process, laser processing of the prior art results in poor processability of titanium alloy stents. On the other hand, in the present embodiment, the titanium alloy, which is a difficult-to-process material, is directly formed into a stent shape by the thermal spraying method, so that the process is simple and the manufacturing cost can be reduced. At the same time, it becomes possible to manufacture a long-chain stent or a small-diameter tubular stent having superelasticity.

In addition, in the present embodiment, it is possible to suppress a reduction in processing accuracy due to heat as in the conventional laser processing. Therefore, it becomes possible to manufacture a long stent having a longitudinal direction of 100 mm or more, which was 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 minimum stent pattern of several tens of μm or less can be manufactured. For example, the width of the opening pattern 14a of the mask 14 can be changed to manufacture a stent in which the wire strength is controlled.

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

Further, by using a plurality of spray guns, it is possible to locally use a part of the stent with another metal material. Further, since it is possible to spray a plurality of metals, it is possible to manufacture a stent having a laminated structure of various metals.

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

Further, in the present embodiment, the stent is manufactured by the thermal spraying method, but it is also possible to manufacture the stent by 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 the medical device manufacturing apparatus according to one embodiment of the present invention, and the same portions as those in FIG. 1 are denoted by the same reference numerals.

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

In addition, in the present embodiment, the slit mask of the first embodiment is not arranged in the chamber 11, but the present invention is not limited to this, and the direction of the spray particles may be set between the mask 24 and the spray nozzle 12. A slit mask having slits for controlling may be arranged.

Further, 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 portion 22. In FIG. 5, a part of the moving mechanism 41 is shown. The control unit 42 moves the mask 24 and the sacrificial material 23 by the moving mechanism 41 while spraying the thermal spray particles sprayed from the thermal spray nozzle 12 onto the mask 24, so that the thermal spray particles that have passed through the opening pattern 24a are transferred to the sacrificial material 23. It is controlled to adhere. In this embodiment, the thermal spray nozzle 12 is fixed and the mask 24 and the sacrificial material 23 are moved, but the mask 24 and the sacrificial material 23 may be fixed and the thermal spray nozzle 12 may be moved.

Further, the manufacturing apparatus has a vacuum pump 16 as an exhaust mechanism for reducing the pressure inside the chamber 11, and a gas introduction mechanism 17 for introducing an inert gas into the chamber 11. In this embodiment, both the vacuum pump 16 and the gas introduction mechanism 17 are provided, but a medical device having either one of the vacuum pump 16 and the gas introduction mechanism 17 may be a manufacturing apparatus.

Next, a method of manufacturing a medical device using the manufacturing apparatus of FIG. 5 will be described.
In the present embodiment, a flat mask pattern is used on the sacrificial material 23 to spray the pattern of the medical device on the sacrificial material 23, and after the thermal spraying, the sacrificial material 23 is removed by etching to obtain the shape of the medical device. Is the way.

The details will be described below.
First, the sacrificial material 23 is held by 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. As a result, 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 made into 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 arrow 29 while spraying the spray particles on the mask 24. As a result, the sprayed particles that have passed through the opening pattern 24a adhere to the sacrificial material 23, and a sprayed film of the sprayed particles is formed on the sacrificial material 23. When the present manufacturing apparatus is configured to fix the mask 24 and the sacrificial material 23 and move the spray nozzle 12 as described above, 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 formed by the sprayed particles is separated from the sacrificial material 23, whereby a self-supporting sprayed film can be formed. This sprayed film serves as a medical device.

Then, if necessary, the medical device may be subjected to heat treatment to recrystallize and remove residual stress. If necessary, the surface of the medical device may be subjected to surface polishing or end surface R treatment, or the surface of the medical device may be coated with a noble metal. If necessary, it is also possible to subject the medical device after thermal spraying to chemical polishing or mechanical polishing to obtain the final shape.
Next, a final inspection of the medical device is performed.

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

Further, by using a plurality of spray guns, it is possible to locally use a part of the medical device with another metal material. Further, since it is possible to spray a plurality of metals, it is possible to manufacture a medical device having a laminated structure of various metals.

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

Further, in the present embodiment, the medical device is manufactured by the thermal spraying method, but it is also possible to manufacture the medical device by 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 combine the first and second embodiments with each other.

Further, in the first embodiment, an example in which a stent is applied as a medical device is given, but the invention is not limited to this, and various medical treatments that can be made in the first embodiment or the second embodiment. It is possible to apply one aspect of the present invention to a device. For example, it can be applied to flow diverter, stent retriever system, cerebrovascular coil, guide wire, marker for imaging, inferior aortic filter, peripheral protection filter, medical clip, medical needle, metal or resin using springs, etc. is there.

11 Chamber 12 Thermal Spray Nozzle 13 Sacrificial Pipe 14 Mask 14a Opening Pattern 15 Slit Mask 15a Slit 16 Vacuum Pump 17 Gas Injecting Mechanism 18, 19 Arrow 22 Holding Part 23 Sacrificial Material 24 Mask 24a Opening Pattern 29 Arrow 30 Holding Part 31 Sweeping Mechanism 32 rotation mechanism 33 control unit 41 moving mechanism 42 control unit

Claims (8)

A manufacturing apparatus for manufacturing a medical device consisting of a self-supporting sprayed film by particles sprayed from a spraying nozzle,
The spray nozzle for injecting the particles;
A holding portion for holding the sacrificial material,
A mask having an opening pattern arranged between the sacrificial material held by the holding portion and the thermal spray nozzle;
A moving mechanism for moving the sacrificial material or the spray nozzle held by the mask and the holding portion;
A control unit for controlling the moving mechanism,
Equipped with,
The controller moves the mask and the sacrificial material or the thermal spray nozzle while spraying the particles sprayed from the thermal spray nozzle onto the mask, so that the particles that have passed through the opening pattern become the sacrificial material. A device for manufacturing a medical instrument, which is controlled to adhere. A spray nozzle that sprays particles,
A holding part for holding the sacrificial tube,
A mask having an opening pattern arranged between the sacrificial tube held by the holding portion and the thermal spray nozzle;
A sweep mechanism for sweeping the mask,
A slit mask arranged between the mask and the spray nozzle,
A rotating mechanism for rotating the sacrificial tube,
A control unit for controlling the sweep mechanism and the rotation mechanism,
Equipped with,
The control unit sweeps the mask while rotating the sacrificial tube while spraying the particles sprayed from the thermal spray nozzle onto the slit mask, thereby passing through the slits and the opening pattern of the slit mask. An apparatus for manufacturing a medical device, wherein particles are controlled so as to adhere to the sacrificial tube. In claim 2,
A chamber for accommodating the thermal spray nozzle, the holder, the mask and the slit mask;
An exhaust system for reducing the pressure in the chamber, or a gas introduction mechanism for introducing an inert gas into the chamber, a manufacturing apparatus comprising:
Alternatively, it is a manufacturing apparatus including a gas shroud device that makes a path of the particles ejected from the thermal spray nozzle into an inert gas atmosphere. A mask having an opening pattern is arranged at a position facing the sacrificial material, particles are sprayed on the mask, and the particles that have passed through the opening pattern are attached to the sacrificial material, whereby the particles on the sacrificial material. A step (a) of forming a sprayed film by
Removing the sacrificial material to separate the sprayed film from the sacrificial material (b),
Equipped with,
Method for producing a medical instrument, characterized by making a medical device comprising the thermally sprayed film autonomous obtained by said step (b). In claim 4,
In the step (a), the mask is arranged between a spray nozzle and the sacrificial material, and the spray nozzle or the sacrificial material and the mask are moved while spraying particles sprayed from the spray nozzle onto the mask. Thus, the method of manufacturing a medical device is characterized in that the particles that have passed through the opening pattern are attached to the sacrificial material to form a sprayed film of the particles on the sacrificial material. A mask having an opening pattern is arranged between the spray nozzle and the sacrificial tube, and a slit mask is arranged between the mask and the spray nozzle, and the particles sprayed from the 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 sprayed film of the particles on the outer surface of the sacrificial tube. A step (a) of forming
A step (b) of removing the sacrificial tube and separating the sprayed film from the sacrificial tube to form a tubular object made of the sprayed film;
A method of manufacturing a medical device, comprising: In claim 6,
The opening pattern has a first pattern and a second pattern,
Prior Symbol step (a), the said sacrificial material layer of the first pattern is formed by one rotation, the sacrificial material further 1 wherein by rotating the first pattern layer on the second of A method for manufacturing a medical device, wherein a patterned film is synthesized. In any one of Claims 4 to 7 ,
The step (a) is performed in a reduced pressure atmosphere or an inert gas atmosphere ,
Wherein, prior to step (b), a manufacturing method of a medical device, characterized in Rukoto to have a process of coating a noble metal on the surface of the sprayed film.

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