WO2007051417A1

WO2007051417A1 - Method for manufacturing an intra-uterine contraceptive device of a shape memory alloy

Info

Publication number: WO2007051417A1
Application number: PCT/CN2006/002943
Authority: WO
Inventors: Fengyang Shi; Xiaofeng Wu
Original assignee: Fengyang Shi; Xiaofeng Wu
Priority date: 2005-11-03
Filing date: 2006-11-02
Publication date: 2007-05-10
Also published as: CN1957864A; CN1957864B

Abstract

A method for manufacturing an intra-uterine contraceptive device of a shape memory alloy is provided. The temperature at which the shape memory alloy stent of the intra-uterine contraceptive device recovers completely to its design shape is not more than 36.9°C, and the elasticity of the stent is in the range of 0.15~0.75N. The manufacture method comprises a process of volume-producing the stent of the intra-uterine contraceptive device of a shape memory alloy by a mould, a process of machining the contraceptive components, and a process of assembling the contraceptive components onto the shape memory alloy stent.

Description

Shape memory alloy intrauterine device manufacturing method _

Technical field

The invention relates to a female intrauterine contraceptive device, in particular to a method for manufacturing a shape memory alloy intrauterine device.

Background technique

The IUD was used for human contraception from 1909. China began to promote the IUD in 1957. Nearly one hundred years of clinical practice has proved that it is a simple, economical, safe, effective and reversible contraceptive tool. It is a major birth control measure. In 1993, the National Family Planning Commission decided to stop using the inert intrauterine device (mainly made of stainless steel, polymer materials, and silica gel). Requires an active intrauterine device to be replaced. In recent years, the use of a variety of intrauterine devices containing copper and drugs has reduced the rate of shedding to a certain extent, and the contraceptive effect has been significantly improved. However, the high rate of shedding, the pregnancy of the belt, and the side effects of the belt still have a great influence on women of childbearing age. The main reason is: The stent material of the intrauterine device is made of stainless steel and polymer materials, which has poor anti-fatigue strength and is easily deformed and detached under the uterus repulsion, causing pregnancy or unexpected pregnancy. Other products use a stent-free form, which is connected to copper by a wire, and a surgical knot is made with a wire at one end. The surgical procedure is used to embed the surgical uterus into the muscle layer at the bottom of the uterus. Although this kind of birth control device avoids the disadvantages of easy deformation of the IUD stent, the surgical method is traumatic surgery, which is not preferable. The placement surgery is complicated and is not suitable for use by grassroots medical staff.

As early as 1951, humans began to pay attention to the memory effect of alloys. In 1963, the TiNi memory alloy with equal atomic ratio was discovered. People began to understand the shape memory effect, which led to extensive research. In the early 1990s, TiNi memory alloys with shape memory and superelasticity have entered the engineering and medical fields. In the medical field, it is mainly used for bone and joint, cardiovascular stents, cavity stents, skull-forming plates, fixation nails, dental orthodontic products, etc. But the IUD used to control oysters has only begun in recent years.

Since the concept of the shape memory alloy IUD, people have been able to design various shapes of shape memory alloy intrauterine devices, but these forms of intrauterine devices can only produce a small number of samples, rarely invented Content

The invention aims to provide a series of new assembly schemes for shape memory alloy stents and contraceptive components, and the invention overcomes the defects that the shape memory alloy intrauterine device is difficult to mass-produce, and the shape I I recall alloy palace produced by the invention is mass-produced. The internal IUD can make the IUD in the human uterus environment, fully exert the memory characteristics of the alloy, maintain the original design shape, not easy to deform, downward displacement, and thus achieve good contraception, especially in the It has a significant effect in preventing accidental pregnancy caused by the fall of the device.

Brief description of the preparation method of the shape memory alloy intrauterine device of the present invention:

The method for manufacturing a shape memory alloy intrauterine device of the present invention is characterized in that: the method comprises: mass-producing a shape of an intrauterine device memory alloy stent by using a mold, processing a contraceptive part, and processing the contraceptive part The process of assembling to a memory alloy stent.

First, the process of mass production of the shape IUD memory alloy stent by using the mold is realized according to the following steps -

1, choose raw materials

2〜0. 7mm; The diameter of the wire is 0. 2~0. 7mm;

2, choose the mold

The heat treatment sizing mold is prepared according to the shape of the product, and the heat treatment mold comprises four parts: a concave mold, a punch, a baffle and a lock mold;

The basic form of the mold support is A, B, C -

A die holder substantially corresponding to the form: There are seven bend bracket, R, ~R _7, into an open bow and two symmetrical arm structure, a supporting ring opening bow, two traverse width H 23~40, longitudinal length H, 15~30 hidden, the angle α between the two cross arms is 60~180 degrees;

The basic shape of the bracket corresponding to the Β mold: The bracket has 3 bends, ~1 ., and the structure is divided into an open bow body and two symmetrical cross arms. The width of the two cross arms is 23 to 40 hidden, and the longitudinal length is 15 ~30 hidden, the angle α between the two cross arms is 60~180 degrees;

The basic form of the bracket corresponding to the C mold: The bracket has five bends, Ri~, and the structure is divided into two longitudinal arms and two symmetrical cross arms. The two longitudinal arms have a ring at the joint, and the width of the two cross arms is 23~40. Hidden, the longitudinal length is 15~30 sleep, and the angle α between the two cross arms is 60~180 degrees;

3, tire loading, winding, clamping

Combine the punch and the baffle, and evenly wrap the alloy wire around the punch of the heat treatment mold, put on the die sleeve, apply an external force, and put the two outer molds together, and use the mold to fold the two molds. The mold is locked so that the two outer concave molds are not swollen by the tension of the alloy wire;

4, heat treatment

The singularity is 0. 15~0. 75N _; the temperature is 0. 15~0. 75N _;

Putting the mold with the shaped alloy wire into the electric heating furnace, performing one-way shape memory heat treatment or two-way shape memory heat treatment on the alloy wire support, and then taking out the mold for cooling;

5, open the mold, determine the size

The mold is smashed, the punch is taken out, and the excess bracket is removed according to the size required by the different types of the device; the above process can mass-produce the part of the intrauterine shape memory alloy bracket of the required specifications. 2. The processing process of the contraceptive component comprises at least one of the following processing processes:

1. Processing process of copper parts;

2. Processing process of nano-particles/germanium-containing composite materials containing copper elements;

3. Processing process of nano-particle/polymer composite tube containing copper element;

4. The processing process of the silica gel block; 5. Processing process of a silica gel block containing a prostaglandin synthetase inhibitor;

6. Processing process of silicone tube;

7. Processing process of a silicone tube containing a prostaglandin synthetase inhibitor;

8. Processing process of progesterone-containing sustained-release capsules;

9. Process for processing porous polymer fibers containing progesterone;

3. The processing process of the copper component in the processing method of the contraceptive component includes at least one of the following:

1, copper processing

Use thick-walled copper tube, outer diameter 1.5~3 painting, inner diameter 0.3~0.7 painting, processing with automatic lathe, complete the closed end hole, turning the circular arc surface, cutting and other steps with four turning tools, request The surface of the copper particles is smooth and burr-free;

It is also possible to bend the closed end of the copper tube into a shape of "0", "C", "U", "D", "P", etc. on the basis of the above work;

Finished product specifications: plugging holes 0~5 let, diameter 1.5~3mm, full length L 3~15 sleep;

2, copper sleeve processing

Use thin-walled copper tube, outer diameter 1.0~3, inner diameter 0.3~2.6 to be processed by lathe, so that the surface of the product is smooth;

Finished product specifications: OD 1.0~3 draw, inner diameter 0.3~2.6瞧, full length L 3~12mm.

3, copper spiral tube processing

Use copper wire, diameter 0.2~0.8mm, hand-wound wire or mechanical wire wrap, cut the wound copper spiral tube into small sections; Finished product specifications: spiral tube outer diameter 1.0~2.5mm, inner diameter 0.3~2.0 hidden, full length L 3~12 sleep; 4. The process of assembling the contraceptive component to the memory alloy stent is carried out according to the following steps: Selecting materials

Selecting at least one of the following materials to be mounted to any of the memory alloy stents selected from the memory alloy stents of the /\, B, C form;

(1) Copper

(2) Copper sleeve or copper spiral tube;

(3) a silicone tube containing a prostaglandin synthetase inhibitor;

(4) Progesterone-containing sustained-release body: progesterone-containing sustained release capsule or progesterone-containing porous composite fiber;

(5) Nanoparticles containing copper elements/髙 molecular composite tubes;

(6) medical silicone tube;

(7) Preparation of copper-containing nanoparticles/polymer composite material: nanoparticles containing copper and medical molecular materials;

(8) Raw materials for producing a gelatin block of a prostaglandin synthetase inhibitor drug: a prostaglandin synthetase inhibitor drug, a silica gel, and a vulcanizing agent;

(9) Raw materials for making silica gel blocks: silica gel, vulcanizing agent. 2, installation

Install according to the following combinations -

(1) A contraceptive member that can be attached to the ends of the two arms of the stent is at least one of the following materials:

X, : copper;

3⁄4: Nanoparticle/polymer composite body containing copper element;

a silica gel block or a silica gel block containing a prostaglandin synthetase inhibitor drug;

X, _{l :} silicone tube or silicone tube containing prostaglandin synthetase inhibitor.

(2) Contraceptive parts that can be mounted on the bracket outside the ends of the two arms:

Y, _: copper sleeve or copper spiral tube;

Υ,: Nanoparticles containing copper elements / polymer composite tubes;

Υ:,: a copper sleeve and a silicone tube containing a prostaglandin synthetase inhibitor, or a copper spiral tube and a silicone tube containing a prostaglandin synthetase inhibitor;

Copper sleeve and progesterone-containing sustained release body, or copper spiral tube and progesterone-containing sustained release body;

Υ _{5: a} copper-containing nanoparticle/polymer composite tube and a silicone tube containing a prostaglandin synthetase inhibitor;

Υ,: Nanoparticles containing copper elements/polymer composite tubes and progesterone-containing sustained release bodies;

Υ ₇ : Silicone tube containing prostaglandin synthetase inhibitor drugs;

Υ«: Progesterone-containing sustained release;

Υ,: Any one of the medical silicone tube and Υ, ~Υ«;

Υ, „ _: Medical silicone tube.

At least one of the portions that are mounted outside the ends of the two arms of the bracket, and then at least one of them is mounted at the ends of the two arms of the bracket; or directly, or the Χ 2 is mounted at the ends of the two arms of the bracket.

3. Fix the contraceptive part at the end of the cross arm

The contraceptive member mounted at the ends of the two cross arms is fixed to the bracket with a bonding force of not less than 5 。.

The prostaglandin synthetase inhibitor drugs mentioned in the present invention may be carbazoles such as Indomethaein, Benzyrin, and acid-killing agents such as mefenamic acid and chlorination. Acid, flufenamic acid, phenylpropionic acid derivatives: such as ibuprofen, naproxen sodium salt, phenylbutazone: such as phenylbutazone or hydroxybutazone. Among them, indomethacin is the best choice.

The copper-containing nanoparticle/polymer composite body referred to in the present invention refers to an object which is made of a copper-containing nanoparticle/polymer composite material and which is adapted to the morphology of the uterine cavity, and of course, it also contains Copper element nanoparticle/polymer composite tube.

The invention relates to a method for manufacturing a shape memory alloy intrauterine device, and the intrauterine device for mass production by the method uses the active mechanics principle of the human uterus, so that the arch bracket of the device is more reasonable in morphology and conforms to the human body. The shape and activity of the uterus. The contraceptive active substance copper is delivered to the highest part of the uterus. The memory alloy material is used to make the stent of the device, so that the node has a memory function, and the thrifty device can be closed with the contraction of the uterus. It achieves the balance with the repulsion of the uterus, making it difficult for the device to move down and fall off in the uterus, reducing the occurrence of accidental pregnancy, increasing the contraceptive effect, reducing the occurrence of side effects of the device, and reducing the side effects of the device. It is used to treat a variety of gynecological diseases and the auxiliary effects of postmenopausal hormone replacement therapy. The clinical placement of the available inserter is safe and easy to operate. DRAWINGS

These and/or other aspects and advantages of the present invention will be apparent from the Schematic diagram of the basic structure of the stent;

Figure 2 is a schematic view showing the basic structure of a stent according to a second embodiment of the present invention;

Figure 3 is a schematic view showing the basic structure of a stent according to a third embodiment of the present invention;

4 is a schematic view of a method for measuring the elastic force of a stent according to a first embodiment of the present invention;

Figure 5 is a schematic view showing a method for measuring the elastic force of a stent according to a second embodiment of the present invention;

Figure 6 is a schematic view showing a method for measuring the elastic force of a stent according to a third embodiment of the present invention;

Figure 7 is a schematic view showing a first assembly and assembly scheme of an intrauterine device according to the present invention;

Figure 8 is a schematic view showing a second assembly and assembly scheme of the intrauterine device according to the present invention;

Figure 9 is a schematic view showing a third assembly and assembly scheme of the intrauterine device according to the present invention;

Figure 10 is a schematic view showing a fourth assembly and assembly scheme of the intrauterine device according to the present invention;

- Figure 11 is a schematic view of a fifth assembly and assembly scheme of an intrauterine device according to the present invention;

Figure 12 is a schematic view showing a sixth assembly and assembly scheme of the intrauterine device according to the present invention;

Figure 13 is a schematic view showing a seventh assembly and assembly scheme of the intrauterine device according to the present invention;

In the figure: H is the width of the IUD bracket, the longitudinal length of the IUD bracket, ~ is the bend on the bracket, α is the angle between the two arms of the IUD bracket, F is the external force applied when measuring the elastic value 1 is a TiNi memory alloy wire stent, 2 is a copper particle or a copper-containing nanoparticle/polymer composite body, 3' is a silica gel block or a silicone block containing a prostaglandin synthetase inhibitor drug, and 4 is a copper sleeve. , copper spiral tube or copper-containing nanoparticle / polymer composite tube, 5 is a medical silicone tube, a silicone tube containing a prostaglandin synthetase inhibitor or a progesterone-containing sustained release body. detailed description

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now in detail to the embodiments of the invention, in the drawings The embodiments are described below in order to explain the present invention by referring to the figures.

The invention relates to a method for manufacturing a shape memory alloy intrauterine device, which introduces the shape memory property of the memory alloy into the processing technology of the intrauterine device stent, so that the intrauterine device has memory function and superelasticity; in the temperature environment of the human uterus Under the full play of the memory characteristics of the alloy, so that the IUD maintains the original design shape, is not easy to deform,

Replacement page (Article 26) Displaces downwards to achieve good contraception. It is characterized in that it comprises: an intrauterine device shape memory alloy stent processing process, a copper component processing process and an assembly and assembly process.

Intrauterine device TNi shape memory alloy stent processing process:

First, the process of mass production of shape intrauterine device memory alloy stent by mold

(1) Choosing raw materials

5度。 (1) The medical TiNi shape memory alloy wire, the atomic fraction of the composition is Ti 49% ~ 49. 5 ° /. 7〜0. 7画。 Ni 50. 5%~51%, the wire diameter is 0. 2~0. 7 paintings. It should be noted that the present invention can also be realized by using a memory alloy wire of other components, and the technical effects produced are equivalent.

(2) Choosing a mold

The special steel lCrl8Ni9Ti is used to make the heat treatment setting die according to the shape of the product. The heat treatment mold consists of four parts, the concave die, the punch, the baffle and the clamping part. The punch is provided with the top pin, and the clamping part is preferably bolted. And the shape of the nut, the die and the punch are designed according to the shape of the bracket. The present invention mainly introduces the form of the three brackets, which can best reflect the advantages of the characteristics of the TiNi shape memory alloy for intrauterine birth control. .

A basic form of the mold corresponding to the holder: FIG. 1, the bracket 7 there are bend with a R, ~R _7, the open structure is divided into two symmetrical body and the bow arm, a support opening bow ring The wire diameter is preferably 0. 45~0. 55mm, the width of the two arms is preferably 26mm, 28瞧, 30mm, 32, 34, 36, six sizes, the longitudinal length is preferably 18~24瞧, the clip between the two arms The angle α is preferably 115 to 125 degrees;

The basic shape of the bracket corresponding to the Β mold: As shown in Figure 2, the bracket has three main bends, 1^~R:, and the structure is divided into a bow body and a symmetrical two cross arms, and the wire diameter is preferably 0. 45~0. 55 paintings, two cross arm widths are preferably 26 countries, 28 sleeps, 30mm, 32 circumferences, 34 hidden, 36 off six sizes, the longitudinal length is preferably 18~24瞧, and the angle α between the two cross arms is preferably 1 15 to 125 degrees;

C Mold holder substantially corresponding to the form: 3, there are five main stent bends, R, ~R _5, is divided into two longitudinal arms and two transverse arms symmetrical structure, the two longitudinal arms connected with a ring Preferably, the wire diameter is 0. 30~0. 40 countries, the width of the two arms is preferably 28 inches, 30 pictures, 32 mrn, 34 inches, the longitudinal length is preferably 18 to 26, and the angle α between the two arms is preferably 115. ~125 degrees.

(3) Silk polishing

By hand polishing or mechanical polishing, the oxide film produced after the heat treatment of the polished wire material is dense and uniform.

(4) Tyre, wire winding, clamping

Combining the core and the baffle, and then winding the polished alloy wire on the punch of the heat treatment mold, putting on the concave mold sleeve, taking out the top pin on the punch, and applying an external force on the press, The two outer molds are brought together and the two female molds are locked with bolts and nuts.

(5) Heat treatment

The process is to perform memory training on the shaped alloy wire, so that the temperature of the stent which is processed by the process parameter completely recovers the temperature of the design body does not exceed the lower limit of the normal human uterus temperature, and the body temperature of the same individual is also different due to the large individual difference of the human body. Constantly changing, and the normal temperature of the uterus does not have an authoritative statistic, given the uterus and The rectum is close, we take the temperature of the rectum 36. 9T: ~ 37. 9 °C as a reference, here we set no more than 36. 9 °C, for example: no more than 36 ° C, no more than 34 ° C, no more than 32 °C, no more than 30 Ό, no more than 28 ° C, no more than 26 ° C, no more than 24 ° C, no more than 22 ° C, no more than 2 (TC, no more than 18 ° C, no more than 16 ° C.

A, B mold bracket elastic value preferred range 0· 25~0. 35Ν, C mold bracket elastic value preferred range 0. 2~ 0. 4Ν, the elastic value is determined by:

Α or Β form bracket: As shown in Figure 4 or Figure 5, at the temperature of 36.5 °C, fix the end of a cross arm of the IUD, apply a force F and press the two cross arms in the vertical direction to keep the IUD. The axis of symmetry is parallel to the horizontal plane, so that the inflection point at the proximal end of the two cross arms is about to be connected but not in contact, and the F value at this time is used as the elastic value of the A or B form bracket;

C-shaped stent: As shown in Fig. 6, at the temperature of 36.5 °C, the two longitudinal arms are bound together at the R^PR ₂ bend, and the end of the cross arm of the IUD is fixed, and a force F is applied in the vertical direction. Press the two cross arms, keep the axis of symmetry of the IUD parallel to the horizontal plane, and make the distance between the two arms is 12, and the F value at this time is the elastic value of the C-shaped bracket.

双In the two-way shape memory heat treatment process is complicated, the one-way shape memory heat treatment of the alloy wire after the throttle device is placed in the conveyor to replace the two-way shape memory heat treatment of the stent at room temperature, so it is preferred to single-pass shape memory heat treatment . One-way shape memory heat treatment generally has three methods: medium temperature treatment, low temperature treatment, and aging treatment. The low temperature treated alloy has a low shape memory function and fatigue life, and the aging treatment process is relatively complicated. Therefore, it is preferable to treat the medium temperature, that is, put the mold with the shaped alloy wire into the electric heating furnace, 40 (TC~50 (temperature at rC temperature) A few minutes to several hours, then the mold is taken out and cooled.

The medium temperature heat treatment is preferably the following two types:

1. Warm the electric furnace to 500 °C first, then put the mold with the shaped alloy wire into the electric heating furnace, and place it evenly. The constant temperature is 20~60 minutes, then the temperature is lowered to 480 °C~490O, and the temperature is kept constant. After 20~40 minutes, the mold is taken out. Put it into the water tank for water cooling, the water temperature is between 0~25 °C, and take it out after the mold is cooled.

2. Warm the electric furnace to 500 °C, then put the mold with the shaped alloy wire into the electric heating furnace, and place the position in the hook. The constant temperature is 60~120 minutes, usually 90 minutes, and the mold is taken out. . Put it in the water tank for water cooling, the water temperature is between 0~25 °C, and take it out after the mold is cooled.

(6) Modeling, positioning, cutting

The mold is smashed, the punch is taken out, and the clamp of the online cutting machine is installed. The automatic operation is performed according to the set program, and the excess portion of the bracket is cut and removed.

Through the above process, the intrauterine device TiNi shape memory alloy stent portion of the required specifications can be mass-produced.

Second, the processing technology of the contraceptive part includes at least one of the following processing processes -

(1) The processing process of copper parts;

(2) Processing process of nanoparticles containing copper elements/髙 molecular composite materials;

(3) Processing process of nanoparticles containing copper elements/polymer composite tubes;

(4) Processing process of the silica gel block; (5) Processing process of a silica gel block containing a prostaglandin synthetase inhibitor;

(6) processing process of silicone tube;

(7) Processing process of silicone tube containing prostaglandin synthetase inhibitor;

side

(8) The processing technology of the progesterone sustained release capsule;

(9) Processing process of porous polymer fiber containing progesterone;

The copper component processing process includes at least one of the following:

Use oxygen-free copper tube with a purity of 99.99%, divided into two types: thick-walled tube, outer diameter 1.5~3 let, inner diameter 0.3~0.7 draw; thin-walled tube, outer diameter 1.0~3 hidden, inner diameter 0.3~2.6诵;

Use a copper wire with a purity of not less than 99.95%, with a diameter of 0.2 to 0.8;

1, copper processing

The thick-walled copper pipe is selected and processed by an automatic lathe, and the four steps are used to simultaneously seal the hole, turn the circular arc surface at both ends, and cut the steps. The copper grain surface is required to be smooth and free of burrs. It is also possible to bend the closed end of the copper tube into a shape of "0", "C", "U", "D", "P" or the like on the basis of the above work.

Capillary copper tube blank

Finished product specification

2, copper sleeve processing

The thin-walled tube is used and processed by a lathe to make the surface of the product smooth.

Capillary copper tube blank

(3) Copper spiral tube processing

Use copper wire, hand-wound wire or mechanical wire-wound, cut the wound spiral tube into small pieces; The finished product specification: spiral tube outer diameter 1. 0~2. 5瞧, inner diameter 0. 3~2. 0 coffee, full length L 3~12 painting.

Third, the assembly combination

(1) Select materials

Selecting at least one of the following materials to be mounted to any of the memory alloy stents selected from the memory alloy stents of the eighth, B, and C forms;

Copper grain

2. Copper sleeve or copper spiral tube;

3. Silicone tube containing a prostaglandin synthetase inhibitor: for example, a silicone tube containing indomethacin 30% to 50%;

4. Progesterone-containing sustained-release body: Progesterone-containing sustained release capsule or progesterone-containing porous composite fiber, progesterone is preferably estrone, dienone, levonorgestrel, drospirenone, naloxone, hydrazine The release rate of norgestyl ester and progesterone is 2~20 micrograms/day;

5. Nanoparticles containing copper elements / polymer composite tubes: inner diameter 0. 3~1. 5诵, outer diameter 1. 2~3 hidden, length 3~ 10mtn;

6, medical silicone tube;

7. Preparation of copper-containing nanoparticles/polymer composite materials:

(1) Nanoparticles containing copper: may be nano copper particles or nano copper oxide particles or a mixture thereof or a mixture of any of the first three kinds of nanoparticles with zinc, silver, or the like;

(2) Medical polymer material: It may be polyethylene or silica gel;

8. Raw materials for making a silica gel block containing a prostaglandin synthetase inhibitor: a prostaglandin synthetase inhibitor (such as indomethacin), a silica gel, a vulcanizing agent;

9. Raw materials for making silica gel blocks: silica gel, vulcanizing agent.

It should be noted that the prostaglandin synthetase inhibitor drugs mentioned in the present invention may be carbazoles such as Indomethaein, Benzyrin, and acid-killing: Acid elimination, chlorinated acid, flufenamic acid, phenylpropionic acid derivatives: such as ibuprofen, naproxen sodium salt, phenylbutazone: such as phenylbutazone or hydroxybutazone. Among them, indomethacin is the best choice.

In addition, the copper-containing nanoparticle/polymer composite body referred to in the present invention refers to any object adapted to the uterine cavity shape made of a copper-containing nanoparticle/polymer composite material, and of course, it also includes A nanoparticle/polymer composite tube containing copper elements.

(2) Installation

Install according to the following combinations -

1. The contraceptive component that can be mounted at the ends of the two arms of the stent is at least one of the following materials:

X, : copper;

,: a nanoparticle containing a copper element / a polymer composite body;

X,: a silica gel block or a silica gel block containing a prostaglandin synthetase inhibitor; Silicone tube or silicone tube containing prostaglandin synthetase inhibitor drugs.

2 Contraceptive parts that can be mounted on the bracket outside the ends of the two arms:

Υ, : copper sleeve or copper spiral tube;

Υ,: Nanoparticles containing copper elements/髙 molecular composite tube;

Υ ₃ : a copper sleeve and a silicone tube containing a prostaglandin synthetase inhibitor, or a copper spiral tube and a silicone tube containing a prostaglandin synthetase inhibitor;

Υ, _: copper sleeve and progesterone-containing sustained-release body, or copper spiral tube and progesterone-containing sustained release body;

Y _{s : a} copper-containing nanoparticle/polymer composite tube and a silicone tube containing a prostaglandin synthetase inhibitor;

Y _fi : a nanoparticle/polymer composite tube containing copper element and a progesterone-containing sustained release body;

Y _{7 :} a silicone tube containing a prostaglandin synthetase inhibitor drug;

Y _S : progesterone-containing sustained release body;

Y«: medical silicone tube and any one of Υ, ~Υ«;

Υ, ο: Medical silicone tube.

Take at least one of the 横, Υ _{1 (} , at least one of the two arms outside the end of the bracket, then take Χ, ~ Χ, ι at least one of the two arms at the end of the bracket; can also be taken directly! or ^ Installed on the ends of the two arms of the stent. The assembled IUD stent should have at least one of copper and progesterone.

(iii) Fixing the end of the cross arm

The components installed at the ends of the two cross arms of the bracket need to have a certain binding force with the bracket so as not to fall off, and the bonding force should be no less than 5 Ν, for example: no less than 10 Ν, no less than 15 Ν, no less than 20 Ν, not low At 25 Ν, not less than 30 Ν, not less than 40 Ν, not less than 50 Ν, not less than 75 Ν, not less than 100 Ν, not less than 120 Ν, different methods can be adopted for different parts:

1. Install copper particles at the end of the cross arm of the bracket: use the tire and the punching machine to rive or squeeze the shape, and combine the copper material and the end of the cross arm of the bracket;

2. Mounting the copper-containing nanoparticle/polymer composite body at the end of the cross arm of the bracket: Taking nano-copper particles and polyethylene as an example, the nano-copper particles and poly? The olefin is put into the injection molding machine for mixing, and is directly combined with the end of the cross arm of the stent in the tire, or extruded and granulated and bonded to the end of the cross arm of the stent to make the copper-containing nanoparticle/髙 molecular composite material. One end of the body and the bracket are fixed together;

3. Install a silicone block or a silicone block containing a prostaglandin synthetase inhibitor at the end of the cross arm of the stent: Prostaglandin synthetase inhibitors, for example, indomethacin, a silicone rubber raw material, or a content ratio of 3: 7~7: 3 of silicone rubber and indomethacin, put into the smelting machine, and add vulcanizing agent for kneading. After taking out, molding with a tire, and then performing 100 ° C ~ 30 (TC hot air vulcanization molding, Fixing the silicone block or the end of the indomethacin-containing silica gel block and the stent together;

4. Install a silicone tube or a silicone tube containing a prostaglandin synthetase inhibitor at the end of the cross arm of the stent: Prostaglandin synthetase inhibitors, such as indomethacin, can be used in A, B, and C forms. On the basis of Add a bend at the end of the two cross arms of the bracket, and insert the silicone tube or the silicone tube containing indomethacin in the bend, and then heat-vulcanize at 100 °C~300 °C to make the silicone tube or the indomethacin-containing silica gel. One end of the tube and the bracket are fixed together.

(4) The tail wire

The TiNi shape memory alloy intrauterine device can be equipped with or without the tail wire, so the process of the tail wire is optional, and the process is only for the type with the tail wire;

Attach the tail wire to the bare bracket and apply a proper amount of medical glue. You can also attach the tail wire to the part mounted on the bracket.

Installation examples of A and B form brackets:

Assembly Example 1 : Two copper particles are respectively mounted on the ends of the two cross arms of the bracket, and the copper particles are riveted by the tire and the punching machine;

Assembly Example 2: 2~6 copper sleeves are mounted on the bow body, and 2 copper particles are respectively installed at the ends of the two cross arms of the bracket, and the copper particles are riveted by the tire and the punching machine;

Assembling Example 3: As shown in Fig. 7, the silicone tube is installed on the portion other than the ends of the two arms of the bracket, and two copper particles are respectively mounted on the ends of the two arms of the bracket, and the copper particles are riveted by the tire and the punching machine;

Assembly Example 4: As shown in Fig. 8, the silicone tube is installed in the lower part of the bow body, and 2 to 6 copper sleeves are mounted on the bow body, and two copper particles are respectively mounted on the ends of the two cross arms of the bracket, and the tire is used. And punching machine copper particles;

Assembly Example 5: As shown in Fig. 9, the 3⁄4 silicone tube is installed in the lower part of the bow body, and two parts containing the indomethacin silicone tube and 2 to 4 copper sleeves are installed on the outside of the ends of the two arms of the bracket, and take 2 The copper particles are respectively mounted on the ends of the two cross arms of the bracket, and the copper particles are riveted by the tire and the punching machine.

Assembly Example 6: As shown in FIG. 10 and FIG. 12, two indomethacin-containing silicone tubes and 2 to 6 copper sleeves are installed on the portions other than the ends of the two arms of the stent, and two copper particles are respectively mounted on The ends of the two cross arms of the bracket are riveted with copper particles using a tire and a punch.

Assembling Example 7: As shown in FIG. 10 and FIG. 12, two to six sections of a copper-containing nanoparticle/polymer composite tube are mounted on a portion other than the ends of the two arms of the stent, and two nanometers containing copper elements are taken. The particle/polymer composite tubes are mounted on the ends of the two arms of the stent and bonded with an adhesive.

Assembly Example 8: Two progesterone-containing sustained-release capsules were installed on the outside of the ends of the two arms of the stent, and two copper particles were respectively attached to the ends of the two arms of the stent, and the copper particles were riveted with a tire and a punch.

Assembly Example 9 (only suitable for B-shaped bracket): As shown in Figure 11, take 2~6 copper sleeves on the bow body, take 1 indomethacin silicone sleeve and tie the bow arms together, take 2 Copper particles are respectively installed at the ends of the two cross arms of the bracket, and the copper particles are riveted by the tire and the punching machine;

Assembly Example 10 (only suitable for B-shaped bracket): Take the silicone tube installed in the lower part of the bow body, take 2~6 copper sleeves and install it on the bow body, take one ingot-containing silicone sleeve to tie the bow arm together. 2 copper particles are respectively installed at the ends of the two cross arms of the bracket, and the copper particles are riveted by the tire and the punching machine; Installation example of c-shaped bracket: .

Assembly Example 11: A section of medical silicone tube is mounted on the lower ring, four copper spiral tubes are respectively mounted on the two longitudinal arms and two cross arms, and one medical silicone sleeve binds the two longitudinal arms together to take the silicone. It is mounted on the ends of the two cross arms of the bracket and is vulcanized and shaped.

Assembly Example 12: A section of a silicone tube containing indomethacin is mounted on the lower ring, four copper spiral tubes are respectively mounted on the two longitudinal arms and two cross arms, and one medical silicone sleeve binds the two longitudinal arms to Together, the indomethacin-containing silica gel is attached to the ends of the two cross arms of the stent, and is vulcanized and shaped.

Assembly Example 13: A medical silicone tube is mounted on the lower ring, two copper spiral tubes are respectively mounted on the two cross arms, and two progesterone-containing sustained release capsules are respectively mounted on the two longitudinal arms, one medical silicone The sleeves are bound together by two longitudinal arms, and the silica gel is installed on the ends of the two cross arms of the stent to be vulcanized and shaped.

Assembly Example 14: A section of an indomethacin-containing silicone tube is mounted on the lower ring, and four copper-containing nanoparticle/polymer composite tubes are respectively mounted on the two longitudinal arms and the two cross arms, one The medical silicone sleeve binds the two longitudinal arms together, and the indomethacin-containing silica gel is installed on the ends of the two cross arms of the stent to be vulcanized and shaped.

Assembly Example 15: As shown in Fig. 13, a section of medical silicone tube is mounted on the lower ring, two copper spiral tubes are respectively mounted on the two cross arms, and one progesterone-containing sustained release capsule binds the two longitudinal arms to Together, the silicone is mounted on the ends of the two cross arms of the stent for vulcanization.

While some embodiments of the present invention have been shown and described, it will be understood by those skilled in the art The claims and their equivalents.

Claims

Rights request

The singularity of the shape memory alloy intrauterine device is 0. 15~0. 75N , The manufacturing method comprises: mass-producing a process of shape intrauterine device memory alloy stent by using a mold, a processing process of a contraceptive component, and a process of assembling a contraceptive component to a memory alloy stent.

2. The method of fabricating a shape memory alloy intrauterine device according to claim 1, wherein: the process of mass-producing the shape IUD memory alloy stent by using the mold is achieved according to the following steps:

(1) Select raw materials

2〜0. 7mm; The diameter of the wire is 0. 2~0. 7mm;

( 2 ) Select the mold

Among them, the basic form of the mold support has three types: A, B, and C:

A die holder substantially corresponding to the form: There are seven bend bracket, R, ~R _7, into an open bow and two symmetrical arm structure, a supporting ring opening bow, two traverse width H 23~40 hidden, the longitudinal length is 15~30 countries, and the angle between the two cross arms is 60~180 degrees;

The basic shape of the bracket corresponding to the Β mold: The bracket has 3 bends, 1^~3⁄4, and the structure is divided into a bow body and a symmetrical two cross arms. The width of the two cross arms is 23~40瞧, and the longitudinal lengthΗ , for 15~30 painting, the angle α between the two cross arms is 60~180 degrees;

The basic form of the bracket corresponding to the C mold: The bracket has five bends, R, ~R _S , and the structure is divided into two longitudinal arms and two symmetrical cross arms. The two longitudinal arm joints have a ring, and the width of the two cross arms is H. 23~40 painting, longitudinal length H, 15~30 hidden, the angle α between the two cross arms is 60~180 degrees;

(3) Tyre, wire, and mold

Combine the punch and the baffle, and evenly wrap the alloy wire around the punch of the heat treatment mold, put on the die sleeve, apply an external force, and put the two outer molds together, and use the mold to fold the two molds. The mold is locked so that the two outer concave molds are not expanded by the tension of the alloy wire;

(4) Heat treatment

The tempering value is 0. 15~0·75N ; the temperature is 0. 15~0·75N ;

Putting the mold with the shaped alloy wire into the electric heating furnace, performing single-pass shape memory heat treatment or double-pass shape heat treatment on the alloy wire support, and then taking out the mold for cooling;

(5) Model, size determination The mold is smashed, the punch is taken out, and the excess bracket is removed according to the size required by the different types of the device; the above process can mass-produce the part of the intrauterine shape memory alloy bracket of the required specifications.

3. The method of manufacturing a shape memory alloy intrauterine device according to claim 1, wherein: the processing process of the contraceptive component comprises at least one of the following processing processes -

(1) Processing process of copper parts;

(2) Processing process of nano-particle/polymer composite body containing copper element;

(3) Processing process of nano-particle/polymer composite tube containing copper element;

(4) Processing process of the silica gel block;

(5) a processing process of a silica gel block containing a prostaglandin synthetase inhibitor;

(6) Processing process of silicone tube;

(7) a processing process of a silicone tube containing a prostaglandin synthetase inhibitor;

(8) Processing process of progesterone-containing sustained-release capsules;

(9) a process for processing a porous polymer fiber containing progesterone;

4. The method of manufacturing a shape memory alloy intrauterine device according to claim 1, wherein: the processing process of the copper component in the processing of the contraceptive component comprises at least one of the following:

(1) Copper processing

Use thick-walled copper tube, outer diameter 1.5~3mm, inner diameter 0.3~0.7 drawing, use automatic lathe for machining, use four turning tools to complete the closed end hole at the same time, turn the circular arc surface at both ends, cut and other steps, require copper The surface of the grain is smooth and burr-free;

Finished product specifications: Blocking holes 0~ ⁵ draw, diameter 1.5~ ³ let, full length L 3~ ^{1 5}瞧

(2) Copper sleeve processing

Use thin-walled copper tube, outer diameter 1.0~3 hidden, inner diameter 0.3~2.6, use lathe to make the surface of the product smooth;

Finished product specifications: Outer diameter 1.5~3 hidden, inner diameter 0.3~2.6 circumference, full length L 3~12 hidden.

(3) Copper spiral tube processing

Use copper wire, diameter 0.2~0.8, hand-wound or mechanical winding, cut the copper spiral tube into small pieces; Finished product specifications: spiral tube outer diameter 1.0~2.5 painting, inner diameter 0. ³ ~2.0 painting, full Long L 3~12 paintings;

5. The method of fabricating a shape memory alloy intrauterine device according to claim 1, wherein the process of assembling the contraceptive component to the memory alloy stent is carried out according to the following steps:

(1) Select materials

Selecting at least one of the following materials to be mounted to any of the memory alloy stents selected from the memory alloy stents of the B, C, and C forms;

1 copper grain; 2 copper sleeve or copper spiral tube;

3 silicone tube containing prostaglandin synthetase inhibitor drugs;

4 progesterone-containing sustained release body: progesterone-containing sustained-release capsule or progesterone-containing porous composite fiber;

5 nanoparticles containing copper elements / bismuth molecular composite tube;

6 medical silicone tube;

7 Preparation of copper-containing nanoparticles / polymer composite material: copper-containing nanoparticles and medical molecular materials;

8 Preparation of a silica gel block containing a prostaglandin synthetase inhibitor drug: a prostaglandin synthetase inhibitor drug, silica gel and a vulcanizing agent;

9 raw materials for making silica gel blocks: silica gel, vulcanizing agent;

( 2 ) Installation

Install according to the following combinations:

1 The contraceptive component that can be mounted at the end of the two arms of the stent is at least one of the following materials:

X, : copper;

X ₂ : a nanoparticle/polymer composite body containing a copper element;

X,: a silica gel block or a silica gel block containing a prostaglandin synthetase inhibitor;

X,: a silicone tube or a silicone tube containing a prostaglandin synthetase inhibitor;

Υ, ; copper sleeve or copper spiral tube;

Υ,: Nanoparticles containing copper elements/髙 molecular composite tube;

The _Y,; copper sleeve and a silicone tube with prostaglandin synthetase inhibitors drugs, and silicone spiral or copper tube with prostaglandin synthetase inhibitors drugs;

Υ, _{1 :} copper sleeve and progesterone-containing sustained-release body, or copper spiral tube and progesterone-containing sustained release body;

Υ« _: Nanoparticle/polymer composite tube containing copper element and progesterone-containing sustained release body;

Υτ: a silicone tube containing a prostaglandin synthetase inhibitor;

Y _{s :} progesterone-containing sustained release;

Υ»: Any of the medical silicone tubes and any one;

Υπ,: medical silicone tube;

At least one of Υ, Υ Η, is mounted on a portion other than the ends of the two arms of the bracket, and then at least one of χ, 〜 is mounted on the ends of the two arms of the bracket;

It can also be taken directly or mounted on the ends of the two arms of the bracket;

(3) Contraceptive parts fixed at the end of the cross arm