JP3322867B1 - Insertion member for insertion into tubular organ of living body and method of manufacturing the same - Google Patents

Abstract

Abstract: PROBLEM TO BE SOLVED: To perform shape memory transformation by body temperature without inserting special heating in a tubular organ insertion member such as a urethral stent, and the shape of the member during the insertion process into a tubular organ such as a urethra. Suppress memory metamorphosis and facilitate its insertion. SOLUTION: For example, a stent body 3 as a member body
0, a transformation suppressing layer 31 is formed.
It should be soluble in organs such as the urethra and bladder. When the stent is inserted into the urethra or the like, even if heated at body temperature, the transformation is suppressed by the transformation suppressing layer 31 to facilitate insertion, and then the shape is transformed by body temperature, and the stent is placed in the urethra / bladder.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a member to be inserted into a tubular organ of a living body, for example, a member inserted into a prostatic urethra of a human body.
The present invention relates to a urethral stent which is suitable for treating urinary retention or dysuria due to benign prostatic hyperplasia, and a method for producing the same.

[0002]

2. Description of the Related Art Conventionally, as shown in FIG. 9, for example, this kind of urethral stent has a coiled conical tip 1 and a coiled cylindrical body 2 directly connected to each other. There is a portion 2 in which a drawing piece 7 is connected by a straight portion 8. The urethral stent has an insertion catheter inserted therein, guided by a guide catheter, and inserted into the prostatic urethra of the human body. In addition, this kind of urethral stent has a transformation temperature (Af) higher than the human body temperature.
Using a shape memory alloy having a point, insert the stent into the urethra while holding it at the tip of a catheter or the like, then supply hot water or the like to the urethra and heat it to the transformation temperature to expand the diameter of the stent That is being done. Or,
As another conventional example, a urethral stent in which a transformation point (Af point or the like) is set to a temperature lower than the human body temperature may be used.

[0003]

However, in the above-mentioned conventional urethral stent, when it is placed in the prostatic urethra of the human body, it is positioned by an endoscope or by ultrasonic tomography. The method has a problem that positioning is difficult and mechanical operation is troublesome.

Further, in a urethral stent in which the transformation point of the shape memory alloy is set to a temperature lower than the human body temperature, the urethral stent is heated at the body temperature at the time of insertion into the urethra, and starts the shape memory transformation during the insertion to increase the diameter. Then, the resistance at the time of insertion increases and the insertion operation becomes difficult. Therefore, when inserting while cooling, the insertion work becomes complicated, and when trying to insert before the shape memory alloy transforms, the insertion operation must be completed in a very short time, which places a burden on the patient accordingly. Is not preferred. Therefore, the urethral stent of the present invention has been made for the purpose of solving the above-mentioned conventional problems. That is, an object of the present invention is to facilitate insertion into a living body of an insertion member such as a stent inserted into the inner periphery of a tubular organ of a living body such as the urethra.
Another object of the present invention is to transform a shape memory alloy by heating the body temperature of a living body without adding a special heat source such as hot water, and at the time of insertion into a tubular organ such as the urethra. An object of the present invention is to provide a tubular organ insertion member which suppresses shape memory transformation regardless of heating by body temperature, facilitates its insertion, and has a high positioning function for a tubular organ such as the upper urethra at a predetermined position.

[0005]

A living body tubular organ insertion member according to the present invention is a coil that can be inserted into the inner periphery of a living body tubular organ.
None Le tubular, transformation point is set to a predetermined temperature, and the member body diameter after insertion is composed of a shape memory alloy transforms to the form to expand its diameter by a predetermined heating to the tubular organ A transformation suppressing layer formed so as to cover the member main body, and temporarily suppressing transformation that enlarges the diameter due to heating of the member main body , the transformation suppressing layer comprising:
The coiled cylindrical portion of a substance that can be dissolved over time in government
By the coating layer on the material body, the member body and
It is characterized by being integrally formed . Further, the insertion member in the living body tubular organ of the present invention has a coil tubular shape that can be inserted into the inner periphery of the living body tubular organ, and a transformation point is set to a low temperature depending on the body temperature of the living body, and the tubular organ is inserted into the living body. A member main body made of a shape memory alloy whose diameter after insertion is transformed into a form in which the diameter is enlarged by the body temperature, and formed to cover the member body, and the diameter of the member body is enlarged by the body temperature. temporarily suppressing the transformation, and a time dissolvable transformation suppression layer in the tubular organ, the transformation
The constrain layer is a substance that can be dissolved over time in the tubular organ.
Coating layer for the coil tubular member body
Thereby, it is characterized by being formed integrally with the member main body .

[0006] Further, the transformation point is below the body temperature at the point Af, and at the point below the point Af, the tip and the body have a substantially uniform cylindrical shape in the form of a coil.
At and above the Af point, the tip portion can be deformed into an expanded, preferably coiled inverted conical shape, and the body portion can be formed into an expanded coiled cylindrical shape.

[0007] The transformation suppressing layer may be formed, for example, by the coil
Cylindrical coating mainly composed of polysaccharide or monosaccharide, which is coated on the main body (stent body, etc.)
Layer (it can dissolve in the body fluid in the tubular organ), a tubular coating layer mainly composed of fatty waxes (it can dissolve at body temperature of the tubular organ), or cylindrical co consisting ice
A suitable layer such as a coating layer (which can be dissolved at the body temperature in the tubular organ) and a coating layer which can be dissolved by injecting or administering a predetermined solution can be appropriately used.

[0008]

The living body tubular organ insertion member of the present invention comprises:
The following effects are obtained by applying the above means. That is, even when the transformation point of the shape memory alloy is lower than or equal to the body temperature when inserted into the inner periphery of a tubular organ of a living body such as the urethra, the transformation suppression layer becomes a resistance to the shape memory transformation in a heating state by the body temperature. Therefore, an increase in the diameter of an organ insertion member such as a stent is prevented or suppressed, and insertion into a predetermined organ such as the urethra can be performed easily. Moreover, after the insertion into the tubular organ such as the urethra, the transformation inhibiting layer can be melted over time in the tubular organ, so that after the melting or at some time during the melting, the shape memory alloy is suppressed from being transformed. The force is released, and the shape memory alloy constituting the organ insertion member can be transformed to be expanded by heating the body temperature of the living body without adding a special heat source such as hot water. Furthermore, if the tip portion is deformed into a preferably coiled inverted conical shape at the point Af or higher, and if the body portion is deformed into an expanded coiled cylindrical shape, the inverted conical shape is obtained. The distal end serves as a tubular organ insertion member having a high positioning function with respect to a predetermined position of the tubular organ such as the urethra. When a urethral stent as an insertion member is inserted into the prostatic urethra and placed there, when a balloon catheter is used, the balloon is expanded from the distal end of the stent, and the bladder is expanded by the expanded balloon. Since the position of the cervix can be located, it is not essential that the tip has an inverted conical shape after the transformation, and it may have a substantially uniform cylindrical shape even after the transformation. Further, when the transformation point Af of the shape memory alloy exceeds the body temperature, the transformation is performed by using a heat source such as hot water separately. Even in such a case, the transformation suppression layer suppresses the expansion starting from the As point. The effect of facilitating insertion into a living body is produced. Even when the function of temporarily suppressing the transformation expansion is not exhibited, the coating layer or the like as the outer surface layer makes the unevenness of the outer surface of the coil-shaped stent or the like smoother, thereby forming the tubular portion of the living body (urethra, etc.). The effect of facilitating insertion into the device can be expected.

[0009]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment in which the organ insertion member of the present invention is applied to a urethral stent will be described below with reference to the drawings. This urethral stent is less than the average human body temperature, for example, 3
It is made of a shape memory alloy having an Af point (austenite transformation completion point) of 6 ° C. or lower and, for example, about 0 to 35 ° C. FIG. 1 shows the shape below the Af point, and FIG. 2 shows the shape above the Af point. As a shape memory alloy having an Af point equal to or lower than the body temperature of the human body as described above, titanium-nickel based, copper-based
Although a zinc-based alloy or the like is known, any shape memory alloy having an Af point in this range can be used, and the composition of the shape memory alloy is not particularly limited.

The urethral stent of the present invention has a coiled (coiled) cylindrical shape in which the distal end portion 1 and the body portion 2 are continuous as shown in FIG. 1 below the Af point.

The urethral stent according to the present invention has a coiled cylindrical shape in which the distal end portion 1 is deformed into a coiled inverted conical shape and the trunk portion 2 is expanded as shown in FIG. It is supposed to be transformed.

Further, the urethral stent of the present invention is characterized in that
The shape of the tip portion 1 and the body portion 2 at and below the point f is made into a mesh cylindrical shape, and the shape of the tip portion 1 at and above the Af point is changed to an expanded mesh-shaped inverted conical shape. The present invention can also be embodied as being deformed into a mesh-like cylindrical shape having an expanded shape. In addition, below the Af point, the tip 1
The dimensions are, for example, about 5 mm in diameter and about 5 mm in length, and the dimensions of the body 2 are about 5 mm in diameter.
The length is about 45 mm. Above the point Af, the size of the tip 1 is, for example, 15 mm in diameter of the conical bottom.
The length of the body 2 is, for example, about 7 mm in diameter and about 30 mm in length.

In the urethral stent having the above-described configuration, the stent main body 30 as a shape memory alloy is formed so as to cover a stent main body (hereinafter, simply referred to as a main body) 30 including the coiled distal end portion 1 and the body portion 2. Transformation suppressing layer 3 that suppresses metamorphosis and can be dissolved over time in the urethra or bladder
1 is provided. The transformation suppressing layer 31 is formed of a film covered so as to be in contact with the outer periphery of the stent main body 30, a coating layer coated on the stent main body 30, or the like.

The metamorphosis suppressing layer 31 can be dissolved over time by, for example, body fluid in the urethra or water such as urine in the bladder (for example, at least one within 5 minutes, preferably within 2 minutes after being inserted into the urethra / bladder). Part dissolves). The dissolvable layer may be a layer that dissolves at the heat of the body temperature due to the heat due to the body temperature in addition to the water, or instead of the water. Here, preferably, the transformation inhibition layer 31 can be formed by mounting or coating a film of a polysaccharide (polysaccharide). In addition, monosaccharides, polymers,
The transformation inhibiting layer 31 may be formed by forming a wax (fat / wax) into a film or coating the stent body 30.

The polysaccharide (s) refers to all carbohydrates that generate two or more monosaccharides by hydrolysis, including oligosaccharides such as disaccharides, trisaccharides, and tetrasaccharides (polysaccharid).
e). In a narrow sense, polysaccharides have significantly different solubilities than monosaccharides,
It often refers to a high molecular compound having taste and chemical properties (usually a condensed monosaccharide of 7 or more molecules), but here includes both narrow and broad senses, and is either a single polysaccharide or a complex polysaccharide. May be. Examples of polysaccharides include starch, glycogen, inulin, lichenin, cellulose, chitin, hemicellulose (eg, agar), galactose, and pectin. The dissolution process in the urethra and bladder may be caused by swelling in body fluids (including urine) to form a colloid solution,
Alternatively, it is hydrolyzed by a dilute acid (weak acid), passes through intermediate products such as trisaccharides and disaccharides, and is finally decomposed into monosaccharides.

In any case, during the period in which the stent body 30 is inserted into the urethra / bladder and heated by the body temperature, a certain period of time (at least until the insertion of the stent into the urethra / bladder) is completed. Due to the presence of 31, the transformation that enlarges the diameter of the stent body 30 is suppressed, and then a part or the whole of the transformation suppressing layer 31 is dissolved (decomposed or colloidalized, or heat-melted). At that time, the transformation suppressing force is defeated by the transformation force of the stent body 30 in the radial direction, and as a result, the transformation of the stent body 30 is allowed.

That is, the material and thickness of the transformation suppressing layer 31 and the covering ratio (covering area) or covering shape with respect to the outer peripheral surface of the stent body 30 are determined so as to obtain such a function. When inserting a stent into the urethra, the diameter of the stent is prevented or suppressed, so the insertion operation is easy, and after insertion, the transformation inhibition layer dissolves and the stent is automatically transformed by heating the body temperature. Because it enlarges the urethra, there is no need to inject hot water etc. into the urethra for its enlarged metamorphosis,
Work is easy. In addition, when the stent is inserted into the urethra, the presence of the transformation suppressing layer 31 makes the unevenness of the outer peripheral surface of the coil-shaped stent body 30 smoother, reduces the resistance at the time of insertion, and dissolves the transformation suppressing layer 31. May become a lubricant at the time of insertion. It should be noted that even a monosaccharide which is a kind of carbohydrate and is not hydrolyzed to a simpler molecule can be employed as long as it can form the transformation inhibition layer 31 as described above.

Further, the metamorphosis suppressing layer 31 made of or mainly composed of fat (wax / wax) starts dissolving in the urethra or bladder due to body temperature. In this case, the wax is completely or partially melted by heat, but at the time of insertion into the urethra, it also plays a role of a lubricant for smooth insertion.

In the case of a urethral stent to be inserted into the urethra / bladder, urine is generally weakly acidic. Therefore, it is convenient to employ a transformation inhibition layer 31 that dissolves in a weakly acidic manner. further,
The transformation inhibiting layer 31 may be a complex or mixed composition of, for example, a mixture of polysaccharide and fat (wax). In this case, the dissolution timing can be controlled while smoothing the insertion into the urethra. In addition, the stent body 30
If the Af point is set to be higher than the body temperature,
The function of the transformation suppressing layer is not to suppress transformation, but rather to produce an effect of smoothing the irregularities on the outer surface of the coil and smooth insertion into the urethra. In that sense, it can be said that it is an insertion resistance reducing layer or an outer surface forming layer. In order to impart solubility to the stent, it is also possible to positively inject or administer a solution into the stent to dissolve the transformation inhibition layer (insertion resistance reducing layer or outer surface forming layer).

Next, a plurality of examples of the form of the transformation suppressing layer will be described with reference to the drawings. In the stent shown in FIG. 10, a cylindrical transformation suppressing layer 31 a is formed around the coil-shaped stent body 30.
It has. This can also be referred to as a tube or a cylindrical capsule, and can be formed by coating a tube or the like prepared in advance so as to cover the outer periphery of the stent body 30 or by coating.

The transformation suppressing layer 31b shown in FIG. 11A has a cylindrical tube shape, and has an inner peripheral portion of the transformation suppressing layer 31 between coiled wires. In this case, a predetermined material such as a polysaccharide is coated on the outer periphery of the stent body 30, or the stent body 3 is placed in a tank containing a predetermined fluid material such as a polysaccharide.
0 can be immersed (such as immersion). In that case, as shown in FIG. 11B, the transformation suppressing layer 31m is interposed so as to connect the gap between the wires of the coil-shaped stent body 30, or the wires of the stent body 30 are in close contact with each other as shown in FIG. 11C. If it is, the flow material adheres to the outer and inner circumferences of the wire in close contact with almost the same thickness,
Transformation suppressing layers 31n are formed on the outer and inner circumferences across the wire.

The transformation suppressing layer 31c shown in FIG. 12 is in the form of a cylindrical tube and has a closed end 31d at one end (tip at the time of insertion into the urethra) and the other end (at the end of the urethra). The rear end at the time of insertion) is an opening 31e. The catheter 5 as shown in FIG. 3 is inserted from the opening 31e. When the stent is inserted into the urethra without using a catheter, the opening 31e may be closed to form a closed end 31d similar to the distal end.

FIG. 13 shows an example in which the transformation suppressing layers 31f and 31g are formed in two parts in a form separated into the distal end portion 1 and the body portion 2 of the stent body 30. That is, the transformation suppressing layer may be a continuous tube or may be separated. FIG.
Reference numeral 15 denotes a plurality of transformation suppression layers 31h arranged at a predetermined interval from each other. By such a division form, the dissolution rate or the transformation inhibition force is adjusted to be reduced, and after insertion into the urethra / bladder, the dissolution of the transformation inhibition layer is delayed, and thus, the diameter expansion transformation of the stent body is inhibited. It can be said to be effective in eliminating

FIG. 16 shows a transformation suppressing layer 31i having a cylindrical shape.
Are formed through a plurality of holes or openings 31j in the thickness direction. In this form, the transformation suppression force can be reduced and adjusted. If the transformation force of the stent body based on the heating of the body temperature exceeds the transformation suppression force, the transformation suppression layer in the course of dissolution is destroyed (broken) or It expands and the stent body is transformed.

FIG. 17 shows an example in which the transformation suppressing layer 31k is provided only on the distal end portion 1 side of the stent body 30, and the body 2 is left in a coil shape. In other words, if the transformation due to the body temperature of the leading end portion 1 at the time of insertion into the urethra can be suppressed, even if the trunk portion 2 on the trailing side starts to undergo some transformation, there is a case where there is not so much difficulty in the operation of inserting the stent. If there is, a smaller transformation suppression layer 31k is sufficient. Here, the transformation suppression layer 31k may have a cylindrical shape with both ends opened, or may have a closed end portion 31p on the tip side.

FIGS. 18 and 19 show a cylindrical transformation suppressing layer 31q.
Are formed, for example, on the outer peripheral surface thereof, a plurality of ridges 31r extending in the axial direction. Since these ridges 31r substantially coincide with the insertion direction of the stent into the urethra, these ridges 3r
1r makes the stent insertion even smoother. Further, FIGS. 20 and 21 are not in the axial direction but in the transformation suppression layer 31s.
A ridge 31t extending spirally is formed on the outer periphery of. For example, in the case where the stent is inserted into the urethra while rotating, a spiral ridge 3 is formed along the rotation operation.
1t functions, and an effect of making rotation insertion smoother can be expected.

The insertion and placement of the urethral stent of the present invention in the prostatic urethra of the human body is performed as follows. For example, when using a balloon catheter, first, the urethral stent of the present invention is mounted on the outer periphery of the balloon catheter 5 as shown in FIG. Then, this balloon catheter 5 is inserted into the urethra 10 as shown in FIG.
The balloon section 5a is set to reach the inside of the bladder 11. When about 5 ml of water is injected into the balloon catheter 5 in this state, the balloon section 5a expands and swells from the distal end of the urethral stent. Thus, when the balloon catheter 5 is slightly pulled in the direction in which the balloon catheter 5 is taken out, the balloon portion 5a hits the bladder neck 11a as shown in FIG.
The position of a can be located, and the urethral stent can be positioned on the bladder neck 11a.

Next, the water in the balloon catheter 5 is discharged to cause the balloon to disappear. In the operation (operation) as described above, since the stent body 30 has a transformation point below the body temperature, the stent body 30 is heated at the body temperature by insertion into the urethra. The presence of the layer 31 suppresses the transformation of the stent body 30 at least in the process of insertion into the urethra. Therefore, insertion into the urethra / bladder is easy.

Further, by the time when the positioning by the balloon is completed and the time when the diameter expansion transformation of the stent body 30 is required, the transformation suppressing layer 31 continues to be dissolved by urine or the like. At a certain time, the transformation force of the stent body 30 overcomes the restraint of the transformation suppression layer 31 and tears or stretches the transformation suppression layer 31 to transform the shape of the stent body 30.

That is, since the shape changes as shown in FIG. 6, the tip 1 is located at the bladder neck 11a, and the trunk 2 is located at the prostatic urethra 10a. When the balloon catheter 5 is withdrawn from the urethra 10 in this state, the urethral stent of the present invention can be placed in the prostatic urethra of the human body while being extended.

Further, when it becomes unnecessary to replace the urethral stent or when it is to be replaced, the urethral stent of the present invention is removed from the prostatic urethra as follows. First,
The balloon catheter 5 is inserted from the urethra 10, and the balloon catheter 5 is inserted into the urethral stent placed in the prostatic urethra 10a. Then, when cold water of about 25 ° C. or less is injected into the balloon catheter 5, the cold heat is conducted, and the temperature of the urethral stent, which has been maintained at the body temperature, falls to the Ms point or lower. Then, the urethral stent of the present invention made of a shape memory alloy is superelastically deformed. Therefore, as shown in FIG. 7, the urethral stent is elongated and thinned, or a coil (not shown) is unwrapped into a thin wire to form a urethra. Can be taken out through.

In addition, even if the above-mentioned transformation suppressing layer 31 dissolves and disappears, or remains to some extent, it is discharged together with urine or taken out together with the used stent, so that no problem occurs.

In the above-described embodiment, a balloon catheter is used when the urethral stent is inserted and placed in the urethra of the prostate region. The metamorphosis suppressing layer may be formed on a urethral stent in the shape of a urethra or a urethral stent whose tip is narrowed. Even in that case, a certain effect can be obtained.

In the above description, a urethral stent is taken as an example.
The present invention can also be applied to a tubular organ insertion member to be inserted into a blood vessel, trachea, intestine, or the like. FIG. 8 shows a state in which a tubular organ insertion member held by a catheter 5 is positioned on an inner wall 20a of a bile duct or blood vessel 20, for example, by a balloon 5a.

[Brief description of the drawings]

FIG. 1 is a side perspective view showing a shape before transformation of a urethral stent which is an example of a tubular organ insertion member of the present invention.

FIG. 2 is a side perspective view showing the shape of the urethral stent after transformation.

FIG. 3 is an explanatory view in which the urethral stent is held by a catheter for insertion and placement in the prostatic urethra of a human body.

FIG. 4 is an explanatory view in which the urethral stent is inserted into a prostatic urethra of a human body.

FIG. 5 is an explanatory view showing a state where a balloon is inflated in a space portion of the urethral stent.

FIG. 6 is an explanatory view in which the shape of the urethral stent is transformed.

FIG. 7 is an explanatory view in the case where the urethral stent is taken out from the prostatic urethra of a human body.

FIG. 8 is a stent (insertion member into a tubular organ) of the present invention.
Explanatory drawing in the case of inserting into a bile duct or a blood vessel and positioning with a balloon.

FIG. 9 is an explanatory view showing an example of a conventional urethral stent.

FIG. 10 is a sectional view showing Example 1 of the transformation suppressing layer according to the present invention.

FIG. 11A is a sectional view showing Example 2 of the transformation suppression layer.

FIG. 11B is a sectional view showing Example 3 of the transformation suppression layer.

FIG. 11C is a sectional view showing Example 4 of the transformation suppressing layer.

FIG. 12 is a cross-sectional view showing Example 5 of the transformation suppression layer.

FIG. 13 is a sectional view showing Example 6 of the transformation suppression layer.

FIG. 14 is a cross-sectional view showing Example 7 of the transformation suppression layer.

FIG. 15 is a perspective view of Example 7.

FIG. 16 is a perspective view showing Example 8 of the transformation suppressing layer.

FIG. 17 is a cross-sectional view showing Example 9 of the transformation suppression layer.

FIG. 18 is a perspective view showing Example 10 of the transformation suppression layer.

FIG. 19 is a front view of an example 10.

FIG. 20 is a perspective view showing Example 11 of the transformation inhibition layer.

FIG. 21 is a sectional view showing a main part of Example 11.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Tip part 2 Body part 30 Stent main body (member main body) 31 Metamorphosis suppression layer

────────────────────────────────────────────────── ─── Continuation of front page (56) References JP-A-7-213620 (JP, A) JP-A 2-1296 (JP, A) JP-A 2000-135290 (JP, A) JP-A 8-33719 (JP, A) JP-A 2-104050 (JP, U) (58) Fields investigated (Int. Cl. ⁷ , DB name) A61M 29/00 A61M 29/02 A61F 2/06

Claims (13)

(57) [Claims] A carp which can be inserted into the inner periphery of a tubular organ of a living body
None Le tubular, transformation point is set to a predetermined temperature, and the member body diameter after insertion is composed of a shape memory alloy transforms to the form to expand its diameter by a predetermined heating to the tubular organ A transformation suppressing layer formed so as to cover the member main body, and temporarily suppressing a transformation that enlarges the diameter due to heating of the member main body , the transformation suppressing layer being formed in the tubular organ over time. Dissolvable
Coating of the material with respect to the coil tubular member body
A living body tubular organ insertion member characterized by being formed integrally with said member main body by a ring layer . 2. A carp that can be inserted into the inner periphery of a tubular organ of a living body.
None Le tubular, transformation point to a temperature below the body temperature of the living body is set, member diameter after insertion into the tubular organ is constituted by a shape memory alloy transforms to the form to expand its diameter by the body temperature A main body, formed so as to cover the member main body, and temporarily suppresses a transformation that enlarges the diameter of the member main body due to the body temperature;
Including a time dissolvable transformation suppression layer in the tubular organ
Seen, the transformation suppressing layer over time can be dissolved in the tubular organ
Coating of the material with respect to the coil tubular member body
A living body tubular organ insertion member characterized by being formed integrally with said member main body by a ring layer . 3. The transformation point is at or below body temperature at point Af, and the member main body has a cylindrical shape with a substantially uniform coil shape at the tip and body below point Af.
3. The insertion member for a living body into a tubular organ according to claim 1 or 2, wherein the shape of the distal end portion is deformed into an inverted conical shape in the form of a coil at the point f or more. 4. The method according to claim 1, wherein the transformation inhibiting layer is formed inside the tubular organ.
A coating of a temporally dissolvable substance on the member body
When formed integrally with the member main body by the
In particular, the inner periphery of the transformation suppression layer enters between the coil wires.
4. Any one of claims 1 to 3, wherein
2. The member for insertion into a tubular organ of a living body according to claim 1 . 5. The method according to claim 1, wherein the transformation inhibiting layer is formed inside the tubular organ.
A coating of a temporally dissolvable substance on the member body
When formed integrally with the member main body by the
In addition, the transformation is suppressed so as to connect the gap between the coil wires.
4. The method according to claim 1, wherein a control layer is interposed.
A member to be inserted into a tubular organ of a living body. 6. The metamorphosis suppressing layer is formed inside the tubular organ.
A coating of a temporally dissolvable substance on the member body
When formed integrally with the member main body by the
It is almost the same on the outer and inner circumferences of
Formed based on the adherence of fluid material with the same thickness
The insertion member for a living body into a tubular organ according to any one of claims 1 to 3 . 7. The metamorphosis suppressing layer is formed inside the tubular organ.
A coating of a temporally dissolvable substance on the member body
When formed integrally with the member main body by the
In addition, the transformation suppression layer divided into a plurality of
7. The method according to claim 1, wherein the light emitting devices are arranged at predetermined intervals.
Item 8. The insertion member for insertion into a tubular organ of a living body according to Item 1 . 8. The layer for suppressing transformation in the thickness direction.
No claim 1 wherein a plurality of holes or openings are formed through
8. The member for insertion into a tubular organ of a living body according to any one of items 7 to 7 . 9. The transformation inhibition layer comprises a polysaccharide or a monosaccharide.
Is formed by a tubular coating layer mainly, it claims 1 and is capable of dissolving in the body fluid of the tubular organ 8
The member for insertion into a tubular organ of a living body according to any one of the above. 10. The transformation inhibiting layer is mainly composed of a fatty wax.
Formed in a tubular coating layer,
Vivo tubular organ within the insertion member according to any one of claims 1 to 8 is capable dissolved at body temperature. 11. The transformation suppressing layer is a cylindrical member made of ice.
Formed with a coating layer, it melts at body temperature in the tubular organ
Vivo tubular organ within the insertion member according to any one of claims 1 to 8 is capable solutions. 12. The urethra according to claim 12, wherein said member to be inserted into a tubular organ of a living body is
Stent is a coil tube that can be inserted into the urethra of the human body,
The transformation point is set at a lower temperature, and immediately after insertion into the urethra.
The diameter transforms to a form that expands its diameter depending on the body temperature
As a member body made of shape memory alloy
A body and a stent formed over the stent body;
Temporarily suppresses metamorphosis that enlarges the diameter due to the body temperature of the body
Control layer that can be dissolved in the urethra over time.
Seen, the transformation suppressing layer over time can be dissolved in the tubular organ
Of a substance to the coil tubular stent body.
Formed integrally with the stent body by the
12. The insertion member according to any one of claims 1 to 11, wherein the member is inserted into a tubular organ of a living body. 13. A core insertable into the inner periphery of a tubular organ of a living body.
It has a cylindrical shape, a transformation point is set at a predetermined temperature,
The diameter after insertion into the tubular organ is
Made of shape memory alloy that transforms into a form that enlarges
Immersing the material body in a substance that can be dissolved over time in the tubular organ.
And dissolving the dissolvable material into the coil tubular member.
Coating the main body,
A transformation suppression layer that temporarily suppresses the transformation to enlarge the diameter.
Of a living body cylindrical organ that is integrated with the
Manufacturing method.