JP7165268B2 - medical instruments - Google Patents

Description

The present disclosure relates to heat shrink tubing and medical devices.

Heat-shrinkable tubing, which shrinks primarily in the radial direction when heated, is used as a covering or reinforcing material at joints or ends of electrical wires, cables, and the like. Heat shrink tubing is also used in the field of medical equipment.

Patent Document 1 discloses a technique of covering the outer layer with a heat-shrinkable tube and heating the outer layer, the coil layer, the inner layer, and the hollow tube in the radial direction of the inner layer, thereby melting the outer layer. disclosed.

Patent Literature 2 discloses a technique for manufacturing an outer layer coated body by using a heat-shrinkable tube.

JP 2013-165926 A JP 2014-100322 A

Conventional technology only uses the heat-shrinkable tube for covering or reinforcement, or temporarily as a jig, and uses it as a resin structural material to gradually change the rigidity in the longitudinal direction. do not have.

Therefore, the present disclosure provides a technique that can be used as a resin structural material for gradually changing rigidity in the longitudinal direction.

In order to achieve such an object, the heat-shrinkable tube according to one aspect of the present disclosure has more material weight per unit length in the longitudinal direction on the proximal side than on the distal side.

The thickness dimension may gradually change toward the tip in the longitudinal direction.

It may be formed in a tapered shape in which the diameter is gradually reduced toward the distal end in the long axis direction.

ADVANTAGE OF THE INVENTION According to this indication, the technique which changes rigidity gradually in a longitudinal direction can be provided.

1 is a longitudinal cross-sectional view of a heat shrink tube according to an embodiment of the present disclosure; FIG. FIG. 2 is a cross-sectional view taken along the direction of arrows II-II in FIG. 1; FIG. 4 is an external view showing a state in which a plurality of heat-shrinkable tubes are continuous; FIG. 10 is a longitudinal cross-sectional view of a heat-shrinkable tube according to a second embodiment; It is a cross-sectional view of a heat-shrinkable tube. It is an external view of the heat-shrinkable tube which concerns on a modification. FIG. 11 is an external view of a heat-shrinkable tube according to another modified example; FIG. 11 is a longitudinal sectional view of a heat-shrinkable tube according to a third embodiment; FIG. 11 is a longitudinal sectional view of a heat-shrinkable tube according to a fourth embodiment; FIG. 11 is a longitudinal sectional view of a heat-shrinkable tube according to a modification; FIG. 11 is a schematic diagram of a catheter according to a fifth embodiment; FIG. 4 is a cross-sectional view showing a portion of the catheter shaft; FIG. 11 is a cross-sectional view showing a portion of a catheter shaft according to a sixth embodiment; FIG. 21 is a cross-sectional view showing part of a catheter shaft according to a seventh embodiment; FIG. 20 is a cross-sectional view showing part of a catheter shaft according to an eighth embodiment; FIG. 20 is a longitudinal sectional view of a heat-shrinkable tube according to a ninth embodiment; FIG. 20 is a longitudinal cross-sectional view of a heat-shrinkable tube according to a tenth embodiment;

Embodiments of the present disclosure will be described below. This embodiment describes a heat shrink tube in which the weight of material per unit length in the longitudinal direction is greater proximally than distally. By using this heat-shrinkable tube as the outer layer of a long medical device such as a catheter, it is possible to easily gradually change the rigidity of the medical device in the longitudinal direction.

Embodiment 1 will be described with reference to FIGS. 1 to 3. FIG. FIG. 1 is a longitudinal sectional view (longitudinal sectional view) of the heat-shrinkable tube 1. FIG. FIG. 2 is a cross-sectional view (horizontal cross-sectional view) seen from the direction of arrows II--II in FIG.

The heat-shrinkable tube 1 is formed in a tapered elongated cylindrical shape. The inner diameter dimension Φ of the heat-shrinkable tube 1 is gradually reduced from the proximal end 11 to the distal end 13 via the intermediate portion 12 . That is, the inner diameter dimension Φ1 of the base end portion 11 is larger than the inner diameter dimension Φ2 of the intermediate portion 12 (Φ1>Φ2), and the inner diameter dimension Φ2 of the intermediate portion 12 is greater than the inner diameter dimension Φ3 of the distal end portion 13 (Φ2>Φ3). . Hereinafter, the base end portion 11 may be referred to as the base end side, and the distal end portion 13 may be referred to as the distal end side.

Furthermore, the thickness dimension t of the heat-shrinkable tube 1 also gradually decreases from the proximal end 11 to the distal end 13 via the intermediate portion 12 . That is, the thickness t1 of the proximal portion 11 is greater than the thickness t2 of the intermediate portion 12 (t1>t2), and the thickness t2 of the intermediate portion 12 is greater than the thickness t3 of the distal portion 13 ( t2>t3).

The resin material of the heat-shrinkable tube 1 is not particularly limited, but examples thereof include biocompatible resin materials such as polyamide resin and fluororesin. Among the resin materials, resins having a relatively high melting point (eg, PEEK (polyetheretherketone), FEP (fluoroethylene propylene), PTFE (polytetrafluoroethylene)) are preferred.

The heat-shrinkable tube 1 of this embodiment is formed such that both the inner diameter dimension Φ and the thickness dimension t decrease from the base end side toward the tip end side. Therefore, not only the outer peripheral surface 14 of the heat shrinkable tube 1 is tapered, but also the inner peripheral surface of the heat shrinkable tube 1 is tapered. A space 16 formed in the longitudinal direction of the heat-shrinkable tube 1 is provided with an elongated object such as a catheter, for example.

FIG. 3 is an external view showing how a plurality of heat-shrinkable tubes 1(1), 1(2), and 1(3) are continuous. The heat-shrinkable tube 1 can be manufactured as a single product, or as a continuous product as shown in FIG. At the time of use, a required number of heat-shrinkable tubes may be cut off from the continuous product with a cutter or the like.

In the heat-shrinkable tube 1 according to this embodiment configured in this way, the weight of the material per unit length in the longitudinal direction is greater on the proximal side than on the distal side. Therefore, the rigidity of the heat-shrinkable tube 1 gradually decreases from the proximal side to the distal side.

As a result, by covering and heating a long, flexible object with the heat shrinkable tube 1 of this embodiment, the thickness of the outer layer provided on the outside of the object can be easily controlled in the longitudinal direction. and the stiffness of the object can be changed in the longitudinal direction. That is, the rigidity of the object having the heat-shrinkable tube 1 as the structural material of the outer layer gradually decreases from the proximal side to the distal side. In other words, the rigidity of the object gradually increases from the distal end side to the proximal end side.

Therefore, the object having the heat-shrinkable tube 1 according to the present embodiment can increase the rigidity of the base end side, while reducing the rigidity of the distal end side to obtain flexibility.

A second embodiment will be described with reference to FIGS. 4 to 7. FIG. Each of the following embodiments, including this embodiment, corresponds to modifications included in the concept of the first embodiment. Therefore, the difference from the first embodiment will be mainly described below.

FIG. 4 is a longitudinal sectional view of the heat-shrinkable tube 1A according to this embodiment. FIG. 5 is a cross-sectional view of the heat-shrinkable tube 1A. The heat-shrinkable tube 1A according to the present embodiment has a uniform inner diameter dimension Φ and a uniform thickness dimension t from the base end portion 11 to the tip end portion 13 via the intermediate portion 12, that is, over the entire length.

The heat-shrinkable tube 1A of this embodiment is provided with a plurality of pores 17 penetrating from the outer peripheral surface 14 to the inner peripheral surface 15 at intervals in the circumferential and axial directions. That is, the pores 17 are formed apart in the circumferential direction of the heat-shrinkable tube 1A, and are also formed so as to be spaced apart in the longitudinal direction of the heat-shrinkable tube 1A.

In this embodiment, the rigidity of the heat-shrinkable tube 1A is changed in the long-axis direction by changing the formation density of the pores 17 along the long-axis direction of the heat-shrinkable tube 1A. For example, in the heat-shrinkable tube 1A of the present embodiment, the formation pitch pha1 of the pores 17 in the longitudinal direction in the base end portion 11 is made larger than the formation pitch pha2 of the intermediate portion 12 (pha1>pha2), and the intermediate portion 12 is set larger than the formation pitch pha3 of the tip portion 13 (pha2>pha3). The formation pitch pha may be changed gradually along the longitudinal direction of the heat-shrinkable tube 1A, or may be changed for each predetermined section dividing the heat-shrinkable tube 1A in the longitudinal direction.

The formation pitch phc of the pores 17 in the circumferential direction may be uniform over the entire length of the heat-shrinkable tube 1A, or may vary in the longitudinal direction. That is, the value of the formation pitch phc in the circumferential direction may be gradually decreased from the proximal portion 11 to the distal portion 13 via the intermediate portion 12 .

In the present embodiment configured as described above, since the formation density of the pores 17 penetrating from the outer peripheral surface 14 to the inner peripheral surface 15 is gradually changed from the base end side to the distal end side, the same as in the first embodiment. , the rigidity of the heat-shrinkable tube 1A can be gradually changed. Therefore, the subject having the heat-shrinkable tube 1A of the present embodiment can secure high rigidity on the base end side, while decreasing the rigidity toward the distal end side to obtain flexibility.

FIG. 6 is an external view of a heat-shrinkable tube 1A showing a first modified example of this embodiment. The pores 17 may be spaced apart in a spiral shape with the major axis as the center of rotation.

FIG. 7 is an external view of a heat-shrinkable tube 1A showing a second modified example of this embodiment. The pores 17 can also be formed so as to be spaced apart in the circumferential direction of the heat-shrinkable tube 1A and spaced apart in the longitudinal direction.

Example 3 will be described with reference to FIG. The outer diameter of the heat-shrinkable tube 1B according to this embodiment is gradually reduced from the proximal end 11 toward the distal end 13 . That is, the heat-shrinkable tube 1</b>B is formed in a stepped tubular shape whose diameter is reduced toward the distal end portion 13 .

The outer peripheral surface 14B of the heat-shrinkable tube 1B is, for example, an outer peripheral surface 14B(1), 14B(2), 14B(3), 14B(4), 14B(5) in order from the base end side to the tip side. diameter is reduced. That is, the thickness dimension of the heat-shrinkable tube 1B decreases stepwise from the proximal side to the distal side to thickness dimensions t1b, t2b, t3b, t4b, and t5b.

The inner diameter dimension Φ of the heat-shrinkable tube 1B is the same over the entire length of the heat-shrinkable tube 1B. Not limited to this, the inner diameter dimension Φ may also be formed so as to decrease stepwise or continuously from the proximal side toward the distal side.

Example 4 will be described with reference to FIGS. 9 and 10. FIG. In the heat-shrinkable tube 1C according to the present embodiment, concave portions 17C are employed instead of the pores 17 described in the second embodiment.

FIG. 9 is a longitudinal sectional view of the heat-shrinkable tube 1C according to this embodiment. The heat-shrinkable tube 1</b>C according to this embodiment has a uniform inner diameter dimension Φ and a uniform thickness dimension t from the proximal end portion 11 to the distal end portion 13 via the intermediate portion 12 .

A plurality of recesses 17C recessed from the outer peripheral surface 14 toward the inner peripheral surface 15 are formed in the heat-shrinkable tube 1C so as to be spaced apart in the circumferential and axial directions. The recesses 17C are spaced apart in the circumferential direction of the heat shrinkable tube 1C and also spaced apart in the longitudinal direction of the heat shrinkable tube 1C.

In this embodiment, the rigidity of the heat-shrinkable tube 1C is changed in the long-axis direction by changing the forming density of the concave portions 17C along the long-axis direction of the heat-shrinkable tube 1C. For example, in the heat-shrinkable tube 1C, the formation pitch pha1 of the concave portions 17C in the longitudinal direction in the base end portion 11 is set larger than the formation pitch pha2 of the intermediate portion 12 (pha1>pha2), and the formation pitch pha2 of the intermediate portion 12 is set to It is made larger than the formation pitch pha3 at the tip portion 13 (pha2>pha3).

Although illustration is omitted, the formation pitch of the concave portions 17C in the circumferential direction may be uniform over the entire length of the heat shrinkable tube 1C, or may be changed in the longitudinal direction. That is, the value of the formation pitch in the circumferential direction may be gradually decreased from the proximal end 11 to the distal end 13 via the intermediate portion 12 .

In the present embodiment configured in this manner, the formation density of the recesses 17C recessed from the outer peripheral surface 14 to the inner peripheral surface 15 is gradually changed from the base end side to the distal end side in the same manner as described in the second embodiment. Therefore, as in the first embodiment, the rigidity of the heat-shrinkable tube 1C can be gradually changed. Therefore, the object having the heat-shrinkable tube 1CA of the present embodiment can secure high rigidity on the base end side, and can obtain flexibility by lowering the rigidity toward the distal end side.

FIG. 10 shows a modification of this embodiment. The heat-shrinkable tube 1C does not have the concave portion 17C on the base end side. That is, recesses 17C are formed in the distal end portion 13 and the intermediate portion 12 of the heat shrinkable tube 1C. By not forming the concave portion 17C near the proximal end portion 11, the rigidity on the proximal end side can be further increased. Also in Example 2, by eliminating the pores 17 on the proximal side, the rigidity on the proximal side of the heat-shrinkable tube 1A can be increased.

Example 5 will be described with reference to FIGS. 11 and 12. FIG. In this embodiment, a case will be described in which the heat-shrinkable tube 1 described in Embodiment 1 is applied to a catheter 2 as a medical device. It can be used not only for the catheter 2 but also for a balloon catheter or the like.

Catheter 2 is, for example, a catheter used for diagnosing or treating stenosis or occlusion. The catheter 2 mainly includes a catheter shaft 21 , a tip 22 joined to the distal end of the catheter shaft 21 , and a connector 23 joined to the rear end of the catheter shaft 21 .

The entire catheter shaft 21 may be covered with the heat-shrinkable tube 1 , or a portion of the catheter shaft 21 may be covered with the heat-shrinkable tube 1 . When a portion of the catheter shaft 21 is covered with the heat-shrinkable tube 1 , the heat-shrinkable tube 1 may cover a predetermined length range from the distal end of the catheter shaft 21 . A region of the catheter shaft 21 excluding the tip portion may be covered with the heat-shrinkable tube 1 . The catheter shaft 21 may be covered with a plurality of heat shrinkable tubes 1 spaced apart in the longitudinal direction.

FIG. 12 is a longitudinal sectional view showing an enlarged part of the catheter 2 covered with the heat-shrinkable tube 1. As shown in FIG.

The catheter shaft 21 includes, for example, a coil body 211 and a heat-shrinkable tube 1 covering the outside of the coil body 211 . A lumen 212 through which a guide wire or other catheter can be inserted is formed along the longitudinal direction of the coil body 211 on the inner peripheral side of the coil body 211 .

The heat-shrinkable tube 1 functions as a resin structure forming an outer layer. As described in Example 1, the heat-shrinkable tube 1 is formed so that the amount of resin per unit length in the long axis direction is greater on the proximal side than on the distal side. As a result, the stiffness of the catheter shaft 21, which is formed by covering the coil body 211 with the heat-shrinkable tube 1, gradually changes from the proximal side to the distal side. In other words, the stiffness of the catheter shaft 21 gradually increases from the distal side to the proximal side.

The inner peripheral surface 15 of the heat-shrinkable tube 1 is located outside the coil body 211 and is in close contact with the coil body 211 . By inserting the coil body 211 into the space 16 of the heat-shrinkable tube 1 before shrinking and heating, the heat-shrinkable tube 1 is softened and adheres tightly to the outside of the coil body 211 .

A resin layer (not shown) may be provided inside the coil body 211 . Further, another resin layer (not shown) may be provided outside the heat-shrinkable tube 1 .

According to the catheter 2 of this embodiment configured as described above, the heat-shrinkable tube 1 whose rigidity gradually decreases from the proximal side to the distal side is used as the outer layer structural material of the catheter shaft 21, so that the proximal end Both rigidity on the side and flexibility on the tip side can be achieved, and operability and manufacturing cost can be improved.

Example 6 will be described with reference to FIG. A catheter 2A of this embodiment uses the heat-shrinkable tube 1A of Embodiment 2 described with reference to FIG. In this embodiment, the outside of the coil body 211 is covered with the heat-shrinkable tube 1A and heated, so that the heat-shrinkable tube 1A is shrunk and brought into close contact with the coil body 211 . Thereby, the catheter shaft 21A is formed.

This embodiment configured in this way also has the same effect as the fifth embodiment. This embodiment can also be applied to the heat-shrinkable tube 1A and the heat-shrinkable tube 1C described in FIGS.

Example 7 will be described with reference to FIG. The heat-shrinkable tube 1B described in FIG. 8 is used for the catheter 2B of this embodiment. In this embodiment, the catheter shaft 21B is formed by covering the outside of the coil body 211 with the heat-shrinkable tube 1B and heating it.

This embodiment configured in this way also has the same effect as the fifth embodiment.

An eighth embodiment will be described with reference to FIG. A catheter 2</b>D of this embodiment uses a resin tube 213 instead of the coil body 211 . The resin tube 213 is formed, for example, from PTFE or the like in a long cylindrical shape, and a lumen 212 extending in the axial direction is formed therein.

In this embodiment configured as described above, by covering the outside of the resin tube 213 with the heat-shrinkable tube 1 and heating, the same effect as in the fifth embodiment can be obtained. By forming the resin tube 213 from a plurality of materials having different rigidity, the rigidity of the resin tube 213 itself can also be changed in the longitudinal direction.

A ninth embodiment will be described with reference to FIG. In the heat-shrinkable tube 1E of this embodiment, the amount of the resin material gradually decreases from the axial center to both ends in the axial direction, and the thickness and inner diameter Φ It decreases towards the part. As a result, the rigidity of the heat-shrinkable tube 1E is highest at the central portion in the axial direction and gradually decreases toward both ends in the axial direction.

The heat-shrinkable tube 1 described in Example 1 can also be obtained by cutting the heat-shrinkable tube 1E at its central portion.

A tenth embodiment will be described with reference to FIG. In the heat-shrinkable tube 1F of this embodiment, too, the amount of the resin material gradually decreases from the central portion in the axial direction toward both ends in the axial direction. However, although the thickness dimension of the heat-shrinkable tube 1F gradually decreases from the central portion in the axial direction toward both ends in the axial direction, the inner diameter dimension does not change.

Two heat-shrinkable tubes can be obtained by cutting the heat-shrinkable tube 1F at its center.

Although the embodiments of the present disclosure have been described above, the present disclosure is not limited to these embodiments, and various modifications are possible.

The above embodiments have been described in detail for easy understanding of the present invention, and are not necessarily limited to those having all the described configurations. Also, part of the configuration of one embodiment can be replaced with the configuration of another embodiment. Moreover, the configuration of another embodiment can be added to the configuration of one embodiment. Also, a part of the configuration of each embodiment can be added, deleted, or replaced with another configuration.

Moreover, the technical features included in the above-described embodiments are not limited to the combinations specified in the claims, and can be combined as appropriate.

1, 1A, 1B, 1C, 1E, 1F: heat shrink tube, 2, 2A, 2B, 2D: catheter, 17: pore, 17C: recess, 21: catheter shaft, tip, 23: connector, 211: coil body , 212: Lumen

Claims (1)

a coil body;
The weight of the material per unit length in the long axis direction covering the outside of the coil body is greater at the proximal end than at the distal end.
With heat shrink tubing on the side,
has
The heat-shrinkable tube has a plurality of holes penetrating from the outer peripheral surface to the inner peripheral surface or recesses formed from the outer peripheral surface to the inner peripheral surface, which are spaced apart in the circumferential direction and the longitudinal direction .
medical instruments.

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