WO2016133048A1

WO2016133048A1 - Medical tool

Info

Publication number: WO2016133048A1
Application number: PCT/JP2016/054306
Authority: WO
Inventors: 木下　康; 隆行毛利
Original assignee: テルモ株式会社
Priority date: 2015-02-20
Filing date: 2016-02-15
Publication date: 2016-08-25

Abstract

A medical tool is provided with: a long-length body which has a long shape and has flexibility; a functional section which can exert a function of treating a blood vessel in an inserted state, i.e., such a state that the long-length body is inserted into the blood vessel; a first light-emitting section which is provided on the tip side relative to the functional section in the long-length body, and can emit light in the above-mentioned inserted state so that the light can be visually recognized through the surface of a living body; and a second light-emitting section which is provided on the base end side relative to the functional section in the long-length body, and can emit light in the above-mentioned inserted state so that the light can be visually recognized through the surface of the living body. The functional section is equipped with an expandable and shrinkable balloon.

Description

Medical tools

The present invention relates to a medical device.

Conventionally, a medical instrument for removing a thrombus generated in a blood vessel is known (for example, see Patent Document 1). Prior to using this medical device, it is necessary to know the position of the thrombus. In this case, for example, a contrast medium is injected into the blood vessel, and the position of the thrombus is confirmed under fluoroscopy.

However, considering the effects of X-ray irradiation on the exposure and the renal function of contrast medium, it is preferable not to perform X-ray irradiation or contrast medium injection as much as possible.

International Publication No. 2001/074255 Pamphlet

An object of the present invention is to provide a medical device capable of arranging a functional part at a target site while safely grasping the position of the target site within a blood vessel to be treated by the functional unit.

Such an object is achieved by the present inventions (1) to (11) below.
(1) A long body having a long shape and having flexibility;
A functional unit capable of exerting a function of performing a treatment on the blood vessel in an inserted state in which the elongated body is inserted into the blood vessel;
A first light-emitting portion that is provided on the distal end side of the functional portion of the elongated body, emits light in the inserted state, and causes the light to be visually recognized through a living body surface;
And a second light-emitting unit that is provided on a proximal end side with respect to the functional unit of the elongated body, emits light in the inserted state, and causes the light to be visually recognized through a living body surface. Medical tools.

(2) The medical device according to (1), wherein the functional unit includes a balloon that can be expanded and contracted.

(3) The medical device according to (1) or (2), wherein the functional unit has a side hole that opens in an outer peripheral portion of the elongated body.

(4) The medical device according to any one of (1) to (3), wherein the functional unit includes a stent.

(5) The medical device according to any one of (1) to (4), wherein the functional unit includes a debulking device.

(6) Any one of the above (1) to (5), wherein at least one of the first light emitting unit and the second light emitting unit is supported so as to be rotatable about a central axis of the elongated body. Medical device according to crab.

(7) The medical device according to any one of (1) to (6), wherein the first light emitting unit is also used for grasping a position of a stenosis part or an obstruction part in the blood vessel.

(8) In the inserted state, the first light emitting unit and the second light emitting unit continue to emit the light regardless of whether or not the functional unit exhibits the function. The medical device according to any one of 7).

(9) The medical device according to any one of (1) to (8), wherein the first light emitting unit and the second light emitting unit emit light of different colors.

(10) The medical device according to any one of (1) to (9), wherein the first light emitting unit and the second light emitting unit emit light of the same color.
(11) The medical device according to any one of (1) to (10), which is a catheter.

According to the present invention, since visible light can be used, the position of the target site in the blood vessel to be treated by the functional unit can be safely compared with the case of using conventional X-rays or contrast agents. I can grasp it. Thereafter, a functional unit can be arranged at the target site.

FIG. 1 is a longitudinal sectional side view showing a first embodiment when the medical device of the present invention is applied to a catheter. FIG. 2 is a side view sequentially illustrating the use state of the catheter shown in FIG. FIG. 3 is a side view sequentially illustrating the use state of the catheter shown in FIG. FIG. 4 is a side view sequentially illustrating the use state of the catheter shown in FIG. FIG. 5 is a side view sequentially illustrating the use state of the catheter shown in FIG. FIG. 6 is a side view sequentially illustrating the use state of the catheter shown in FIG. FIG. 7 is a longitudinal sectional view showing a second embodiment when the medical device of the present invention is applied to a catheter. FIG. 8 is a longitudinal sectional side view showing a third embodiment when the medical device of the present invention is applied to a catheter. FIG. 9 is a longitudinal sectional view showing a fourth embodiment when the medical device of the present invention is applied to a catheter. FIG. 10 is a longitudinal sectional view showing a fifth embodiment when the medical device of the present invention is applied to a catheter. FIG. 11 is a longitudinal sectional view showing a sixth embodiment when the medical device of the present invention is applied to a catheter.

Hereinafter, the medical device of this invention is demonstrated in detail based on suitable embodiment shown to an accompanying drawing.
<First Embodiment>
FIG. 1 is a longitudinal sectional side view showing a first embodiment when the medical device of the present invention is applied to a catheter. 2 to 6 are side views sequentially showing the use state of the catheter shown in FIG. In the following, for convenience of explanation, the right side in FIGS. 1 to 6 (the same applies to FIGS. 7 to 11) is referred to as “base end”, and the left side is referred to as “tip”.

The catheter 1 shown in FIG. 1 is a medical device that is inserted from the upper limb or the lower limb 300 and used in the blood vessel 200 of the lower limb 300, that is, the peripheral region. The catheter 1 is provided on the distal side of the catheter body 2 constituted by a long body, a functional part 3 that can exhibit a function of performing a predetermined treatment on the blood vessel 200, and a functional part of the long body. The first light-emitting portion 4A, the second light-emitting portion 4B provided on the proximal end side with respect to the functional portion of the elongated body, and the hub 5 provided on the proximal end portion of the catheter body 2 are provided. . Hereinafter, the configuration of each unit will be described.

The catheter body 2 is a long tube having flexibility. The total length of the catheter body 2 is not particularly limited, and is preferably, for example, 100 mm or more and 2000 mm or less, and more preferably 100 mm or more and 1500 mm or less. Moreover, it does not specifically limit as an outer diameter (average) of the catheter main body 2, For example, it is preferable that they are 1.0 mm or more and 4.0 mm or less, and it is more 1.5 mm or more and 3.0 mm or less. preferable.

The constituent material of the catheter body 2 is not particularly limited. For example, various thermoplastic resins or thermosetting resins such as polyolefin resin, polyamide resin, urethane resin, polyimide resin, and polyester resin are used. it can. Further, the catheter body 2 may have a multilayer laminated structure made of a plurality of types of materials or a single layer structure made of a single type of material.

The hollow portion of the catheter body 2 is, for example, a lumen 21 through which a working fluid for expanding and contracting a later-described balloon 31 passes, and the distal end of the lumen is closed by the distal end wall portion 22.

The hub 5 is fixed to the proximal end portion of the catheter body 2. The hub 5 has a cylindrical shape and communicates with the lumen 21. Thereby, for example, a syringe pump, an injector, or the like can be connected to the hub 5, and the working fluid can be supplied to the lumen 21 from the syringe pump, the injector, or the like. With this supply, the balloon 31 is expanded (see “balloon 31 shown by a solid line” in FIG. 1). On the other hand, the working fluid can be returned to a syringe pump, an injector or the like. As a result, the balloon 31 is deflated (see “the balloon 31 indicated by a two-dot chain line” in FIG. 1).

The constituent material of the hub 5 is not particularly limited. For example, the hub 5 is made of a resin material such as polyamide, polyvinyl chloride, polyethylene, polypropylene, polycarbonate, polymethyl methacrylate, acrylonitrile-styrene-butadiene copolymer, or various metal materials. be able to.

As shown in FIG. 1, in this embodiment, the functional unit 3 is a balloon 31 that is provided on the outer peripheral portion of the distal end of the catheter body 2 and can be expanded and contracted. Thus, the catheter 1 is a balloon catheter having the balloon 31.

The balloon 31 is composed of a stretchable elastic membrane, and the elastic membrane is wound around the outer periphery of the distal end of the catheter body 2 and both ends thereof are fixed.

The constituent material of the balloon 31 is not particularly limited. For example, various rubber materials (particularly vulcanized) such as isoprene rubber, butadiene rubber, styrene-butadiene rubber, urethane rubber, silicone rubber, and fluororubber are used. Can be used.

Further, a side hole 23 as a communication hole for communicating the inside of the balloon 31 and the lumen 21 is formed at a position facing the balloon 31 on the outer peripheral portion of the distal end of the catheter body 2. The working fluid can travel between the inside of the balloon 31 and the lumen 21 through the side hole 23. Then, in a state in which the catheter body 2 is inserted into the blood vessel 200 (hereinafter, this state is referred to as “inserted state”), the balloon 31 is expanded to perform a treatment on the blood vessel 200, that is, a stenosis portion (occlusion) of the blood vessel 200. Part) 201 can be expanded (see FIGS. 5 and 6).

The number of side holes 23 formed is two in the configuration shown in FIG. 1, but is not limited to this, and may be one or three or more, for example.

The first light emitting unit 4A is disposed on the distal end side of the balloon 31, and the second light emitting unit 4B is disposed on the proximal end side of the balloon 31.

As shown in FIG. 1, the first light emitting unit 4 </ b> A is electrically connected to a power source (not shown) via a cable 41 a that passes through the lumen 21. Accordingly, the first light emitting unit 4A can emit light (visible light) L _4A . Similar to the first light emitting unit 4A, the second light emitting unit 4B is also electrically connected to a power source (not shown) via a cable 41b that passes through the lumen 21. Thereby, the 2nd light emission part 4B can emit light (visible light) _L4B .

4 A of 1st light emission parts and the 2nd light emission part 4B are each provided along the outer peripheral part 24 of the catheter main body 2, The outer diameter becomes the same as the outer diameter of the outer peripheral part 24 of the catheter main body 2. ing. Thereby, there is a step between the outer peripheral part 42a of the first light emitting part 4A and the outer peripheral part 24 of the catheter main body 2, or between the outer peripheral part 42b of the second light emitting part 4B and the outer peripheral part 24 of the catheter main body 2. Occurrence can be prevented, and therefore insertion of the catheter body 2 into the blood vessel 200 can be performed smoothly.

In addition, since the first light emitting portion 4A is provided along the outer peripheral portion 24 of the catheter body 2, the light L _4A is preferentially emitted from the first light emitting portion 4A toward the side. As a result, even when the catheter 1 is rotated about its axis in the inserted state, the light L _4A can be reliably viewed through the living body surface (skin) (see FIGS. 3 to 6). The light L _4A is also emitted toward the distal direction, that is, the traveling direction (forward) of the catheter 1 within the blood vessel 200. 3 to 6 (the same applies to FIG. 2), the portion indicated by a broken line is not actually visually recognized.

Since the second light-emitting portion 4B is also provided along the outer peripheral portion 24 of the catheter body 2, the light L _4B is preferentially emitted from the second light-emitting portion 4B toward the side. Accordingly, even when the catheter 1 rotates around its axis in the inserted state, the light L _4B can be reliably viewed through the living body surface (see FIGS. 3 to 6).

Then, by visually recognizing the light L _4A and the light L _4B , the side of the blood vessel 200 where the balloon 31 between the first light emitting unit 4A and the second light emitting unit 4B is located is grasped. can do.

In the present embodiment, the light L _4A emitted from the first light emitting unit 4A and the light L _4B emitted from the second light emitting unit 4B may be the same color or different colors. .

When the light L _4A and the light L _4B have the same color, for example, the first light emitting unit 4A and the second light emitting unit 4B can be configured by the same light emitting diode, and thus the catheter 1 is configured. Manufacturing costs can be reduced by reducing the types of parts. Further, if the luminescent colors are the same, there is an advantage that the difference in depth from the living body surface to the blood vessel 200 can be known from the difference in the amount of light captured.

On the other hand, when the light L _4A and the light L _4B have different colors, there is an advantage that the positional relationship between the distal end and the proximal end of the catheter 1 can be known, for example.

The distance between the first light emitting unit 4A and the second light emitting unit 4B depends on the size of the balloon 31, but is preferably 3 mm or more and 400 mm or less, preferably 5 mm or more and 300 mm or less. More preferably.

Next, an example of how to use the catheter 1 will be described with reference to FIGS.
[1] As shown in FIG. 2, in the peripheral region, a stenosis 201 occurs in the blood vessel 200 and inhibits blood flow. Here, it aims at eliminating the stenosis part 201 as a method of using the catheter 1. In addition, although the medical worker has grasped | ascertained roughly arrangement | positioning of the constriction part 201, it has not grasped correctly.

[2] Then, from the state shown in FIG. 2, the catheter 1 is inserted into the blood vessel 200 as shown in FIG. In this inserted state, the balloon 31 of the catheter 1 is deflated. Further, the first light emitting portion 4A is light _{L 4A} is irradiated, the second light emitting section 4B is irradiated with light _{L 4B.} Accordingly, the medical staff can visually confirm the light L _4A and the light L _4B that have passed through the living body, and thus can easily grasp the position of the balloon 31 in the blood vessel 200. In addition, since the blood vessel 200 in the peripheral region exists at a position relatively close to the surface of the living body, in this case, visual confirmation is possible.

Further, the irradiation of the light L _4A and the light L _4B is continued until the treatment of the blood vessel 200, that is, the elimination of the stenosis 201 is completed.

[3] As shown in FIG. 4, when the catheter 1 is further advanced in the blood vessel 200, the light L _4A and the light L _4B that are visually _observed also move on the surface of the living body. Can be confirmed. Thereby, the change with time of the position of the balloon 31 can be grasped.

Further, as the catheter 1 advances in the blood vessel 200, the catheter 1 gradually approaches the stenosis 201. In the state shown in FIG. 4, in the light _{L 4A,} the straight light _{L 4A-1} toward the traveling direction of the catheter 1 is reflected by constriction 201. Thereby, the reflected light L _4A-2 is obtained. The portion 202 where the reflected light L _4A-2 and the straight light L _4A-1 cross each other appears bright from the surface of the living body, separately from the first light emitting unit 4A. At this time, the medical staff can grasp that the catheter 1 has approached the stenosis part 201.

In addition, the medical staff can also know from experience the distance to the stenosis 201 depending on the brightness of the crossing portion 202. Thereby, it is possible to determine how much the catheter 1 can be further advanced so that the balloon 31 can be disposed in the stenosis portion 201. Note that this determination may be performed by using a device having a control unit (calculation unit) in addition to being performed by a medical worker.

[4] Next, based on the above determination, as shown in FIG. Determination that the balloon 31 is correctly positioned stenosis 201, visible shadow of stenosis 201 by the light _{L 4A} and the light _{L 4B,} positioned between the shadow and the light _{L 4A} and the light _{L 4B} It is done by doing.

[5] Next, as shown in FIG. 6, the balloon 31 is expanded as described above. As a result, the narrowed portion 201 is eliminated and disappears.

Conventionally, confirmation of the position of the stenosis 201 is performed under fluoroscopy, for example, and the influence of the X-ray irradiation on the patient (exposure) and the influence of the contrast medium on the renal function remain.

However, in the catheter 1, by using the light L _4A and the light L _4B that have extremely low influence on the human body, the target site in the blood vessel 200 to be treated with the balloon 31, that is, the position of the stenosis 201 can be safely Can grasp. Thereafter, the balloon 31 can be accurately placed in the narrowed portion 201.

In addition, when a contrast agent is injected as in the past and an attempt is made to confirm the position of the stenosis 201, if the stenosis 201 exists on the downstream side of the blood flow, the position can be confirmed with the contrast agent. However, if there is a stenosis part on the upstream side of the blood flow, the contrast agent flows backward, making it difficult to confirm the position of the stenosis part 201.

On the other hand, since the catheter 1 uses the light L _4A and the light L _4B , regardless of the position of the stenosis part 201 with respect to the blood flow, that is, the stenosis part 201 is on the upstream side or the downstream side of the blood flow. The position can be easily confirmed regardless of whether or not it exists.

Second Embodiment
FIG. 7 is a longitudinal sectional view showing a second embodiment when the medical device of the present invention is applied to a catheter.

Hereinafter, the second embodiment of the medical device of the present invention will be described with reference to this drawing. However, the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.
This embodiment is the same as the first embodiment except that the configuration of the functional units is different.

As shown in FIG. 7, in the present embodiment, the functional unit 3 further includes a cylindrical stent 32 that is detachably attached to the balloon 31.

As shown in FIG. 7 (a), the stent 32 is mounted on the deflated balloon 31 in advance. Then, as shown in FIG. 7B, when the balloon 31 is expanded, the stent 32 is pushed and expanded from the inside by the balloon 31 to expand the diameter. With the expanded diameter stent 32, the constricted portion 201 can be maintained in a canceled state.

If the balloon 31 is contracted again after the diameter of the stent 32 is expanded, the catheter 1 can be removed from the blood vessel 200 while the stent 32 remains.

<Third Embodiment>
FIG. 8 is a longitudinal sectional side view showing a third embodiment when the medical device of the present invention is applied to a catheter.

Hereinafter, the third embodiment of the medical device of the present invention will be described with reference to this figure, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.

This embodiment is the same as the first embodiment except that the configuration of the catheter body and the location of the first light emitting unit are different.

As shown in FIG. 8, in this embodiment, the catheter body 2 further includes a shaft 27 that is inserted into the lumen 21 and is rotatable within the lumen 21. A drive source (not shown) such as a motor for rotating the shaft 27 around the central axis O ₂ of the catheter body 2 is connected to the proximal end portion of the shaft 27.

The first light emitting unit 4 </ b> A is installed at the tip of the shaft 27. Thus, the first light emitting portion 4A becomes rotatable around axis O ₂ around with the shaft 27. Further, the first light emitting portion 4A is fixed so as to face in one direction in which the optical axis of the light L _4A is perpendicular to the central axis O _2, are disposed.

A window portion 25 having light permeability is provided at a position where the first light emitting portion 4A of the catheter body 2 faces. Thus, the light L _4A is emitted outward through the window portion 25.

With the above configuration, when the first light emitting portion 4A rotates, the light L _4A is over the entire circumference of the over time windows 25, i.e., it is irradiated radially around the central axis O ₂ It becomes. Thereby, even if the entire catheter 1 rotates about its axis in the inserted state, the light L _4A can be reliably viewed through the living body surface.

In the present embodiment, only the first light emitting portion 4A is rotatably supported around axis O ₂ around, but is not limited thereto. For example, only the second light emitting section 4B may be supported rotatably about axis O ₂ around, to both the central axis O ₂ around the first light emitting portion 4A and the second light emitting section 4B You may be supported so that rotation is possible.

<Fourth embodiment>
FIG. 9 is a longitudinal sectional view showing a fourth embodiment when the medical device of the present invention is applied to a catheter.

Hereinafter, the fourth embodiment of the medical device of the present invention will be described with reference to this drawing. However, the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.
This embodiment is the same as the first embodiment except that the configuration of the functional units is different.

As shown in FIG. 9, in the present embodiment, the functional unit 3 is configured by a side hole 23 opened to the outer peripheral portion 24 of the catheter body 2. Thereby, the liquid can be discharged from the lumen 21 through the side hole 23.

The liquid is not particularly limited, and for example, various liquids such as a thrombolytic drug may be used. In addition, the first light emitting unit 4A and the second light emitting unit 4B that emit light and are heated are used. A refrigerant to be cooled may be used.

In this embodiment, the catheter body 2 has an inner tube 26 that is provided through the lumen 21. A cable 41 a and a cable 41 b are arranged inside the inner pipe 26.

<Fifth Embodiment>
FIG. 10 is a longitudinal sectional view showing a fifth embodiment when the medical device of the present invention is applied to a catheter.

Hereinafter, the fifth embodiment of the medical device of the present invention will be described with reference to this drawing. However, the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.
This embodiment is the same as the first embodiment except that the configuration of the functional units is different.

As shown in FIG. 10, in this embodiment, the functional unit 3 includes a debulking device 33. The debulking device 33 can remove the living tissue constituting the stenosis 201.

The debulking device 33 is not particularly limited, and examples thereof include a cutter, a laser, a rotating body, and a file.

<Sixth Embodiment>
FIG. 11 is a longitudinal sectional view showing a sixth embodiment when the medical device of the present invention is applied to a catheter.

Hereinafter, the sixth embodiment of the medical device of the present invention will be described with reference to this figure, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.

This embodiment is the same as the first embodiment except that the configuration of the catheter body is different.

As shown in FIG. 11, in this embodiment, the catheter body 2 has an inner tube 26 that is provided through the lumen 21. The inner tube 26 has a tip opening 261 that opens to the tip wall 22.

In the catheter body 2 having such a configuration, a guide wire can be inserted through the inner tube 26 and the distal end portion of the guide wire can be projected from the distal end opening 261.

As described above, the medical device of the present invention has been described with respect to the illustrated embodiment. However, the present invention is not limited to this, and each component constituting the medical device has any configuration that can exhibit the same function. Can be substituted. Moreover, arbitrary components may be added.

Further, the medical device of the present invention may be a combination of any two or more configurations (features) of the above embodiments.

Further, the first light emitting unit and the second light emitting unit may be controlled to blink.

The first light emitting unit and the second light emitting unit may be controlled so that the intensity of light can be adjusted. In this case, it is preferable that the intensity of light from the first light emitting unit is greater than the intensity of light from the second light emitting unit. Thereby, the part where reflected light and straight-ahead light cross can be visually recognized more clearly.

In addition, the first light emitting unit and the second light emitting unit may have a prism.

The medical device of the present invention is a long and flexible body, and a functional unit that can exhibit a function of performing treatment on the blood vessel in an inserted state in which the long body is inserted into the blood vessel A first light-emitting part that is provided on the distal end side of the functional part of the long body, emits light in the inserted state, and visually recognizes the light through the living body surface; and A second light-emitting unit that is provided on a proximal end side with respect to the functional unit, emits light in the inserted state, and allows the light to be visually recognized through the surface of the living body. Therefore, the functional unit can be arranged at the target site while safely grasping the position of the target site within the blood vessel to be treated by the functional unit. Therefore, the medical device of the present invention has industrial field applicability.

DESCRIPTION OF SYMBOLS 1 Catheter 2 Catheter main body 21 Lumen 22 Tip wall part 23 Side hole 24 Outer peripheral part 25 Window part 26 Inner tube 261 Tip opening part 27 Shaft 3 Functional part 31 Balloon 32 Stent 33 Debulking device 4A 1st light emission part 4B 2nd

Light emitting part

41a,

41b Cable

42a, 42b Outer peripheral part 5 Hub 200 Blood vessel 201 Stenosis part (occlusion part)
202 Intersection 300 Lower limb L _4A , L _4B light (visible light)
L _4A-1 straight light L _4A-2 reflected light O ₂ central axis

Claims

A long and flexible body,
A functional unit capable of exerting a function of performing a treatment on the blood vessel in an inserted state in which the elongated body is inserted into the blood vessel;
A first light-emitting portion that is provided on the distal end side of the functional portion of the elongated body, emits light in the inserted state, and causes the light to be visually recognized through a living body surface;
And a second light-emitting unit that is provided on a proximal end side with respect to the functional unit of the elongated body, emits light in the inserted state, and causes the light to be visually recognized through a living body surface. Medical tools.
The medical device according to claim 1, wherein the functional unit includes a balloon that can be expanded and contracted.
[Claim 3] The medical device according to claim 1 or 2, wherein the functional part has a side hole that opens to an outer peripheral part of the elongated body.
The medical device according to any one of claims 1 to 3, wherein the functional unit includes a stent.
The medical device according to any one of claims 1 to 4, wherein the functional unit includes a debulking device.
6. The device according to claim 1, wherein at least one of the first light emitting unit and the second light emitting unit is supported so as to be rotatable around a central axis of the elongated body. Medical tools.
The medical device according to any one of claims 1 to 6, wherein the first light-emitting portion is also used for grasping a position of a stenosis portion or an obstruction portion in the blood vessel.
The said 1st light emission part and a said 2nd light emission part continue to emit the said light irrespective of whether the said function part is exhibiting the said function in the said insertion state. Medical device according to item.
The medical device according to any one of claims 1 to 8, wherein the first light emitting unit and the second light emitting unit emit light of different colors.
The medical device according to any one of claims 1 to 9, wherein the first light emitting unit and the second light emitting unit emit light of the same color.
The medical device according to any one of claims 1 to 10, which is a catheter.