WO2017149974A1

WO2017149974A1 - Medical device

Info

Publication number: WO2017149974A1
Application number: PCT/JP2017/001603
Authority: WO
Inventors: 泰徳山下
Original assignee: テルモ株式会社
Priority date: 2016-02-29
Filing date: 2017-01-18
Publication date: 2017-09-08
Also published as: JPWO2017149974A1; JP6823043B2

Abstract

[Problem] To provide a medical device which improves the rigidity of the device on the base end side thereof, while suppressing an increase in the size of the external shape of the device. [Solution] A medical device (1) according to the present invention is equipped with a shaft section 2 that has: a first shaft part (21) equipped with an imaging lumen (211) into which an imaging core (4) for acquiring image information inside a living organism is inserted; a second shaft part (22) provided so as to be adjacent to the first shaft part, and equipped with a guidewire lumen (221) into which a guidewire (W) can be inserted; a connecting wall (23) formed between the first and second shaft parts along at least the base end side of the first shaft part; and a reinforcing member (24) embedded in the connecting wall along at least the base end side of the connecting wall. Therein, the connecting wall has an outer wall surface (231) that tangentially connects the arc-shaped outer-wall surfaces of the first and second shaft parts along at least the tip end side thereof.

Description

Medical device

The present invention relates to a medical device having an imaging function.

As a medical device having an imaging function, a device using intravascular ultrasonic diagnosis (IVUS: Intra Vascular Ultra Sound) can be mentioned. In general, in a device using intravascular ultrasonic diagnosis, an ultrasonic detector (probe) including an ultrasonic transducer is rotatably disposed in a long tubular body (see Patent Document 1). The tube body is formed with an observation portion lumen for rotatably storing the probe, and a guide wire lumen into which a guide wire for guiding a diagnostic imaging device to a target position can be inserted.

Then, a guide wire previously inserted to the vicinity of the target position in the blood vessel is inserted into the guide wire lumen, and the probe is placed at the target position by moving the tube body along the guide wire. After that, by scanning the probe radially within the tube, after receiving the reflected wave (ultrasonic echo) reflected from the living tissue with the same probe, the ultrasonic echo generated is processed by amplification, detection, etc. Based on the intensity of the blood vessel, a cross-sectional image of the blood vessel can be drawn.

JP 2004-97286 A

As in Patent Document 1, in IVUS, a cross-sectional image is acquired by rotating a probe. However, since the catheter is a thin and long medical instrument, the proximal side of the catheter is intended as the probe rotates. There is a risk of swinging without affecting the procedure. Therefore, there is a demand for a medical device used in IVUS to increase the rigidity of the proximal side and efficiently transmit the force from the proximal side applied by the operator to the distal end side of the catheter. However, the medical device used in IVUS is provided with the observation lumen and the guide wire lumen separately as described above. Therefore, the outer shape of the catheter tends to be large, and if the thickness of the catheter is simply increased in order to increase rigidity, it may be difficult to introduce a medical device to a peripheral site, for example.

Therefore, an object of the present invention is to provide a medical device that suppresses an increase in the size of the outer shape of the device and improves the rigidity of the device on the proximal end side.

A medical device that achieves the above object includes a first shaft portion including an observation portion lumen into which an observation portion that acquires image information in a living body is inserted, and a guide wire lumen into which a guide wire can be inserted. A second shaft portion provided adjacent to the first shaft portion, a connecting wall formed between the first shaft portion and the second shaft portion at least on the proximal end side of the first shaft portion, and at least a connecting wall And a reinforcing member embedded in the connecting wall on the base end side. In the present invention, the connecting wall has an outer wall portion that connects arcuate outer wall surfaces provided on the first shaft portion and the second shaft portion by a tangent line at least on the distal end side.

As described above, the medical device according to the present invention is configured such that the outer wall portion of the connecting wall at least on the distal end side of the connecting wall connects the arcuate outer wall surfaces of the first shaft portion and the second shaft portion with a tangent line. is doing. Therefore, the outward extension of the connecting wall on the distal end side can be suppressed, and an increase in the outer shape on the distal end side of the shaft portion can be suppressed. The connecting wall is provided at least on the proximal end side of the first shaft portion, and a reinforcing member is embedded on the proximal end side of the connecting wall. Therefore, the rigidity on the proximal end side of the shaft portion can be improved, and the rigidity on the proximal side of the medical device can be improved.

It is a top view which shows the medical device which concerns on one Embodiment of this invention. It is a top view which shows an intraluminal diagnostic system. It is longitudinal direction sectional drawing which shows the front-end | tip part of a medical device. 4A is along line 4A-4A in FIG. 1, FIG. 4B is along line 4B-4B in FIG. 1, and FIG. 4C is along line 4C-4C in FIG. FIG. 4D is a sectional view taken along the line 4D-4D in FIG. 1, and FIG. 4E is a sectional view taken along the line 4E-4E in FIG. It is a top view which shows the hub of a medical device. It is a top view which shows a 1st casing and a 2nd casing. It is the perspective view which expanded a part of the 1st casing and the 2nd casing. It is a fragmentary perspective view which shows 8 parts of FIG. 6, and shows the abutting part in a 1st casing. It is a top view which shows the medical device at the time of pulling back the vibrator unit. FIG. 10A and FIG. 10B are cross-sectional views showing modifications of FIG.

Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In addition, the following description does not limit the technical scope and terms used in the claims. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may differ from actual ratios.

1 and 2, the medical device 1 according to the present embodiment is an ultrasonic catheter that is inserted into a living body lumen with an imaging core 4 for ultrasonic diagnosis housed therein. The medical device 1 is connected to an external driving device 7 (see FIG. 2) that holds the medical device 1 and drives the imaging core 4, and is used mainly for diagnosing the inside of a blood vessel. In this specification, the side to be inserted into the lumen of the living body is referred to as “tip” or “tip side”, and the proximal side for operation is referred to as “base end” or “base end side”.

As shown in FIG. 1, the medical device 1 includes a long shaft portion 2 that is inserted into a lumen, and an imaging core 4 (corresponding to an observation portion) that transmits and receives ultrasonic waves toward the lumen tissue. A hub 5 that penetrates the imaging core 4 and is located on the proximal side of the shaft portion 2 and an operation portion 3 that operates the imaging core 4 are provided. Hereinafter, each configuration will be described in detail.

As shown in FIGS. 1 and 4D, the shaft portion 2 extends from the proximal end side to the distal end side, and has a long first shaft portion 21 through which the imaging core 4 is slidably inserted. A long second shaft portion 22 extending from the first shaft portion 21 to the distal end side than the first shaft portion 21 and inserting the guide wire W, and a connecting wall 23 formed between the first shaft portion 21 and the second shaft portion 22. And a reinforcing member 24 embedded in the connecting wall 23.

As shown in FIGS. 3 and 4 (B), the first shaft portion 21 is formed with an image lumen 211 (corresponding to the observation portion lumen) through which the imaging core 4 can be inserted, and the cross section has a substantially hollow cylindrical shape. Is formed. The second shaft portion 22 is formed with a guide wire lumen 221 through which the guide wire W is inserted, and the cross section is formed in a substantially hollow cylindrical shape like the first shaft portion 21. Due to the difference in size between the guide wire W and the imaging core 4, the guide wire lumen 221 has a smaller cross section than the image lumen 211.

As shown in FIG. 4B, the second shaft portion 22 is arranged so that the guide wire lumen 221 is not adjacent to the inner lumen (coaxial) of the image lumen 211 but is adjacent to the image lumen 211 separately. The first shaft portion 21 is disposed adjacent to the first shaft portion 21. The first shaft portion 21 and the second shaft portion 22 are arranged side by side from the distal end to the distal end side of the hub 5, and are configured to branch inside the hub 5. In the first shaft portion 21 and the second shaft portion 22,

outer wall surfaces

212 and 222 are formed in a substantially circular shape at a relatively distal end side position shown in FIG. Further, as shown in FIG. 4C, the first shaft portion 21 and the second shaft portion 22 have

outer wall surfaces

213 and 223 that are separated from each other in a cross section in which the connection wall 23 is formed in a substantially circular shape. Has been.

The outer diameter and / or inner diameter of the first shaft portion 21 and the second shaft portion 22 may be different depending on the position in the longitudinal direction. For example, by reducing the outer diameter and inner diameter in a tapered shape from the base end side to the tip end side and not causing an extreme change in physical properties, high pushability and passability are achieved while suppressing the occurrence of kinks. be able to.

In the image lumen 211, the imaging core 4 is disposed so as to be slidable in the axial (longitudinal) direction of the shaft portion 2. The imaging core 4 includes a transducer unit 41 for transmitting and receiving ultrasonic waves from the lumen toward the living tissue, and a drive shaft 42 that attaches the transducer unit 41 to the tip and rotates the transducer unit 41. The transducer unit 41 includes an ultrasonic transducer 411 that transmits and receives ultrasonic waves, and a housing 412 that houses the ultrasonic transducer 411.

The vibrator unit 41 can be observed from an angio image obtained by photographing a blood vessel by X-ray photography from outside the body. Although the material of the housing 412 is not limited, for example, a metal such as gold, platinum, a platinum alloy, and a tungsten alloy, or an X-ray such as barium sulfate, bismuth oxide, and tungsten so as to function as an X-ray contrast unit. It preferably contains an impermeable material. Further, an X-ray contrast marker may be separately provided in the vicinity of the housing 412.

The connecting wall 23 is provided in the vicinity of the rear end of the range in which the imaging core 4 moves back and forth in the axial direction in the shaft portion 2. The connecting wall 23 is formed to the near side of the front end of the first shaft portion 21 and the second shaft portion 22 in the longitudinal direction of the shaft portion 2, and as shown in FIG. The shaft portion 22 is configured to cover at least a part of the outer wall surface. By configuring the connecting wall 23 in this way, the first shaft portion 21 and the second shaft portion 22 are integrated with each other while preventing the cross-sectional shape of the distal end of the medical device 1 from being as large as possible. Contributes to improvement.

In the cross section orthogonal to the longitudinal axis of the shaft portion 2 in FIG. Arranged in pairs. The connecting wall 23 is configured to have substantially the same shape when symmetrically reversed in FIG. However, as long as the shaft portion 2 can be bent or curved without being biased in a specific direction, the cross-sectional shape is not necessarily symmetrical.

4C, the first shaft portion 21 has a substantially arc-shaped outer wall surface 213, and the second shaft portion 22 has a substantially arc-shaped outer wall surface 223. In FIG. 4C, the cross sections of the first shaft portion 21 and the second shaft portion 22 are illustrated as perfect circles, but are not limited thereto, and may be, for example, oval. The connecting wall 23 has a substantially straight cross section in which the arcuate outer wall surface 213 and the arcuate outer wall surface 223 are connected by a tangent line in the cross section of FIG. The outer wall surface 231 has a shape (corresponding to the outer wall portion). This prevents the outer shape of the shaft portion 2 from becoming excessively large.

Conversely, in FIG. 4E, which shows a relatively proximal cross section of the connecting wall 23, the outer wall surface 232 (corresponding to the protruding outer wall portion) of the connecting wall 23 is not linear and protrudes outward. It is configured with a curved shape. However, the shape of the outer wall surface of the connecting wall 23 is not limited to this as long as the outer shape on the distal end side of the shaft portion 2 can be reduced and the rigidity on the hand side can be improved.

As shown in FIGS. 1 and 4D, the reinforcing member 24 is embedded in the connection wall 23 on the base end side from the position where the imaging core 4 is most retracted. The reinforcing member 24 is provided so as not to protrude between the outer wall surface 231 of the connecting wall 23, the inner wall surface 214 of the first shaft portion 21, and the inner wall surface 224 of the second shaft portion 22. Similar to the connecting wall 23, the reinforcing member 24 is provided in pairs on both sides across a line CL connecting the centers of the first shaft portion 21 and the second shaft portion 22 shown in FIG. The reinforcing member 24 contributes to the improvement of the rigidity of the shaft portion 2, particularly on the proximal end side, like the connecting wall 23. The reinforcing member 24 is configured in a substantially circular shape by taking a cross-sectional shape as an example.

The material of the first shaft portion 21 and the second shaft portion 22 in the shaft portion 2 is made of a material having high ultrasonic permeability. The first shaft portion 21 and the second shaft portion 22 are formed of a flexible material, and the material is not particularly limited. For example, styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polyimide-based, Various types of thermoplastic elastomers such as polybutadiene, trans polyisoprene, fluororubber, chlorinated polyethylene, etc., one or a combination of two or more of these (polymer alloys, polymer blends, laminates, etc.) ) Can be used.

The material of the reinforcing member 24 is not particularly limited, and examples thereof include a stainless steel wire and a Ni—Ti alloy.

Here, the position where the connecting wall 23 and the reinforcing member 24 are provided in the longitudinal direction of the shaft portion 2 will be described below with reference to a cross section at a predetermined position in the longitudinal direction of the shaft portion 2.

First, at the point 4A on the distal end side of the shaft portion 2, as shown in FIG. 4A, only the substantially hollow cylindrical first shaft portion 21 through which the guide wire W is inserted exists. Yes.

At a point 4B located on the proximal end side from the point A on the distal end side of the shaft portion 2, the distal end of the second shaft portion 22 having a substantially hollow cylindrical shape in addition to the first shaft portion 21 as shown in FIG. The part is formed. As shown in FIG. 3, a filling liquid inlet / outlet member 215 is provided at the tip of the second shaft portion 22. The filling liquid inlet / outlet member 215 is provided in order to flow physiological saline or the like filled in the image lumen 211 to the outside, and therefore, a priming port 216 that is a hole is formed.

At a point 4C located on the base end side of the

points

4A and 4B of the shaft part 2, the first shaft part 21 and the second shaft part 22 are added to the first shaft part 21 and the second shaft part 22 as shown in FIG. A connecting wall 23 is formed between the two shaft portions 22. Due to the connecting wall 23, the outer wall surface of the shaft portion 2 protrudes outward from the

points

4A and 4B.

As shown in FIG. 4D, the first shaft portion 21, the second shaft portion 22, and the connecting wall 23 are disposed at a point 4D located on the base end side of the

points

4A, 4B, and 4C of the shaft portion 2. In addition, a reinforcing member 24 is embedded in the connection wall 23. Although it is assumed that the outer shape of the shaft portion 2 is almost the same at the point 4C and the point 4D, the outer shape of the shaft portion 2 at the point 4C and the point 4D is as long as insertion into a desired lumen is possible. May vary in size.

At the point 4E located on the base end side from the

points

4A, 4B, 4C, and 4D of the shaft portion 2, the outer shapes of the outer wall surfaces 213 and 223 are similar to the point 4D as shown in FIG. On the other hand, the outer wall surface 232 of the connecting wall 23 is configured to project outward from the outer wall surface 231 of the point 4D. The reinforcing member 24 is configured such that the reinforcing member 24 itself is thicker than the point 4D shown in FIG. 4D in accordance with the position of the outer wall surface of the connecting wall 23 as shown in FIG.

By configuring in this manner, the distal end side of the shaft portion 2 such as the point 4A to the point 4D maintains a small diameter as in the case where there is no reinforcing member or the like, and can be inserted into various biological lumens. be able to. Further, the proximal end side of the shaft portion 2 such as the point 4E can increase the rigidity of the proximal side by the connecting wall 23 or the reinforcing member 24 as the distance from the proximal end increases, thereby improving the operability of the medical device 1. Can do.

The drive shaft 42 is flexible and has a characteristic capable of transmitting the rotational power generated in the operation unit 3 to the vibrator unit 41. For example, as shown in FIG. It is composed of a multilayer coil-like tube body such as a layer coil. When the driving shaft 42 transmits the rotational power, the vibrator unit 41 rotates and the affected part in the lumen such as a blood vessel and a blood vessel can be observed in the circumferential direction. The drive shaft 42 has a signal line 43 for transmitting a signal detected by the vibrator unit 41 to the operation unit 3.

As shown in FIG. 5, the hub 5 includes a first hub portion 51 that is airtightly connected to the first shaft portion 21, a second hub portion 52 that is airtightly connected to the second shaft portion 22, and a first hub portion. A hub casing 53 that covers 51 and the second hub portion 52 and a first anti-kink protector 54 are provided.

The first hub portion 51 is connected to the operation portion 3 connected to the external drive device 7 in order to operate the imaging core 4. As shown in FIG. 1 and the like, the operation unit 3 includes an outer tube 32 coupled to the first hub unit 51, a unit connector 37 coupled to the proximal end portion of the outer tube 32, and an axial direction with respect to the outer tube 32. And an operation base end portion 31 connected to the base end portion of the inner tube.

The operation base end portion 31 holds the drive shaft 42 and the inner tube 34. When the operation base end portion 31 moves and the inner tube 34 is pushed into the unit connector 37 and the outer tube 32 (see FIG. 1) or pulled out (see FIG. 9), the drive shaft 42 is interlocked with the shaft. Slide in the axial direction in the part 2. A port 311 for injecting physiological saline for priming is formed in the operation base end portion 31. The port 311 communicates with the image lumen 211.

When the inner tube 34 is pushed in the most, as shown in FIG. 1, the end of the inner tube 34 moves inside the outer tube 32 and reaches the vicinity of the first hub portion 51. In this state, the transducer unit 41 is located near the tip of the image lumen 211 as shown in FIG.

Further, when the inner tube 34 is most pulled out, as shown in FIG. 9, the stopper 315 formed at the tip of the inner tube 34 is caught by the inner wall of the unit connector 37, and the portions other than the vicinity of the caught tip are exposed. In this state, the vibrator unit 41 is pulled back with the shaft portion 2 remaining. Thus, the transducer unit 41 can create a tomographic image of a blood vessel or the like by moving along the axial direction while rotating.

As shown in FIG. 1, the operation base end portion 31 includes a joint 312, a hub side connector 313 connected to the base end portion of the drive shaft 42, and a second kink protector 314.

The joint 312 has an opening on the base end side, and the hub side connector 313 is disposed inside. The hub-side connector 313 can be connected to the drive female connector 711 (see FIG. 2) of the external drive device 7 from the base end side of the joint 312. By connecting, the external drive device 7 and the hub-side connector 313 are connected. Are mechanically and electrically connected.

One end of a signal line 43 is connected to the hub side connector 313, and the signal line 43 passes through the drive shaft 42 and the other end is connected to the vibrator unit 41 as shown in FIG. Yes. The ultrasonic wave is irradiated from the transducer unit 41 by a signal transmitted from the external driving device 7 to the transducer unit 41 via the female connector for driving 711, the hub side connector 313, and the signal line 43. Further, a signal detected by the transducer unit 41 by receiving the ultrasonic wave is transmitted to the external drive device 7 through the signal line 43, the hub side connector 313, and the drive female connector 711.

The second kink resistant protector 314 is disposed around the inner tube 34 and the operation base end portion 31 and suppresses kinking of the inner tube 34.

The unit connector 37 is inserted so that the base end portion of the outer tube 32 attached to the first hub portion 51 is fitted inside, and the inner tube extending from the operation base end portion 31 is inserted into the outer tube 32. 34 is inserted. The unit connector 37 can be connected to a holding portion 73 (see FIG. 2) of the external drive device 7.

As shown in FIGS. 1 and 5, the first hub portion 51 is connected by fitting the distal end portion of the outer tube 32 from the proximal end side, and the first shaft portion 21 is inserted from the distal end side to perform heat fusion. It is connected airtight by wearing or bonding. Accordingly, the drive shaft 42 and the physiological saline that have passed through the inner tube 34 and the outer tube 32 can move to the image lumen 211 through the first hub portion 51. On the outer peripheral surface of the first hub portion 51, a first connecting convex portion 511 protruding in a ring shape is formed in order to connect to the hub casing 53.

The second hub portion 52 is connected in an airtight manner by inserting the second shaft portion 22 from the front end side and heat-sealing or bonding. Therefore, the second hub portion 52 communicates with the guide wire lumen 221 so that the guide wire W can pass therethrough. On the outer peripheral surface of the second hub portion 52, a second connecting convex portion 521 that protrudes in a ring shape is formed in order to connect to the hub casing 53.

As shown in FIG. 6, the hub casing 53 includes two first casings 531 configured in a split structure so as to sandwich the outer peripheral surfaces of the shaft portion 2, the first hub portion 51, and the second hub portion 52 from both sides. And a second casing 532. The first casing 531 and the second casing 532 are formed in a symmetrical shape with the shaft portion 2, the first hub portion 51 and the second hub portion 52 interposed therebetween. The first casing 531 and the second casing 532 include a front end side fitting portion 533 into which the shaft portion 2 is fitted, a first hub fitting portion 534 into which the first hub portion 51 is fitted, and a second hub portion 52. The second hub fitting portion 535 is formed.

The first hub fitting portion 534 is formed with a first connection concave portion 536 into which the first connection convex portion 511 formed on the outer peripheral surface of the first hub portion 51 can be fitted. The second hub fitting portion 535 is formed with a second coupling recess 537 into which the second coupling projection 521 formed on the outer peripheral surface of the second hub portion 52 can be fitted.

As shown in FIGS. 6 and 7, the first casing 531 and the second casing 532 are caught by overlapping the outer peripheral surfaces of the shaft portion 2, the first hub portion 51, and the second hub portion 52 from both sides. A connecting hook 538 and a connecting step 539 are formed. By overlapping the first casing 531 and the second casing 532, the connecting hook 538 is once bent and then hooked to the connecting step 539, so that the first casing 531 and the second casing 532 are connected. The first casing 531 and the second casing 532 may be joined by an adhesive or heat fusion without using a mechanical structure such as the connecting hook 538 and the connecting step 539.

Further, as shown in FIG. 8, the first casing 531 and the second casing 532 are provided with a fixing portion 541 that fixes the proximal end of the reinforcing member 24 embedded in the connecting wall 23 of the shaft portion 2. ing. The fixing portion 541 is joined to the reinforcing member 24 with an adhesive or the like, but the manner of joining is not limited to the adhesive. Further, the shape or the like of the fixing portion 541 is not limited to that shown in FIG. 8 as long as the displacement of the reinforcing member 24 in the longitudinal direction can be prevented.

The first connecting convex portion 511 of the first hub portion 51 is fitted into the first connecting concave portion 536, and the second connecting convex portion 521 of the second hub portion 52 is fitted into the second connecting concave portion 537. When the first casing 531 and the second casing 532 are connected in this state, the first hub portion 51 and the second hub portion 52 are fixed to the hub casing 53 so as not to drop off. The first hub portion 51 and the hub casing 53 are joined by an adhesive or heat fusion without using a mechanical structure such as the first connecting convex portion 511 and the first connecting concave portion 536. Also good. Further, the second hub portion 52 and the hub casing 53 are also joined by an adhesive or heat fusion without using a mechanical structure such as the second connection convex portion 521 and the second connection concave portion 537. Also good.

The shaft portion 2 has a portion connected to the outer tube 32 positioned inside the hub casing 53.

In the hub casing 53, the inclination | θ1 | of the central axis Y 1 of the first hub portion 51 with respect to the axis X is set to the axis X of the base end portion of the shaft portion 2 as a reference line. The inclination of the central axis Y2 is larger than | θ2 |.

If the inclination | θ1 | of the first hub portion 51 is excessively increased, uneven rotation of the image is likely to occur due to friction between the drive shaft 42 and the first shaft portion 21. Further, when pulling back the imaging core 4, disconnection and image unevenness due to jumping that disturbs the movement of the imaging core 4 are likely to occur. Therefore, the inclination | θ1 | is preferably an angle that does not cause uneven rotation, disconnection, jumping, or the like in the imaging core 4.

If the inclination | θ2 | of the second hub portion 52 is excessively increased, the operability of the guide wire W may be reduced due to friction between the guide wire W and the second shaft portion 22.

Accordingly, in consideration of the above points, | θ1 | ≈0 and | θ2 | ≈0 are preferable, but the angle between the central axis Y1 of the first hub portion 51 and the central axis Y2 of the second hub portion 52. The smaller the value of | θ1-θ2 |, the more the value of | θ1-θ2 | is preferred because the operator's operation of the guide wire W interferes with the external drive device 7.

Also, since the rigidity of the guide wire W is usually considerably higher than the rigidity of the drive shaft 42, it is preferable that | θ2 | ≈0. In the present embodiment, | θ2 | = 0 and | θ1 |> 0. Note that | θ2 | may be equal to or greater than | θ1 |.

In general, the drive shaft 42 that should be arranged so as not to bend in the hub is bent in the hub 5 in this embodiment. The drive shaft 42 is configured to be able to transmit a driving force while being bent in the blood vessel, so that the drive shaft 42 can be bent in the hub 5. Since the first shaft portion 21 in which the image lumen 211 that accommodates the drive shaft 42 is formed extends while being bent in the hub casing 53 and is connected to the first hub portion 51, the hub casing. The position of the drive shaft 42 that rotates within 53 can be appropriately maintained.

Further, since the second shaft portion 22 in which the guide wire lumen 221 for accommodating the guide wire W is formed is connected to the second hub portion 52 in the hub casing 53, the guide is guided in the hub casing 53. The position of the wire W can be appropriately maintained, and the guide wire W can be favorably operated.

As shown in FIG. 1, the first kink protector 54 surrounds the front end portion of the hub casing 53 and the shaft portion 2 led out from the hub casing 53 in the front end direction, and suppresses kink of the shaft portion 2.

The constituent materials of the first hub portion 51, the second hub portion 52, the hub casing 53, the outer tube 32, the inner tube 34, the unit connector 37, and the operation base end portion 31 are not particularly limited. For example, polyvinyl chloride, Polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate, polyester such as polyethylene naphthalate, butadiene-styrene copolymer Examples thereof include various resins such as coalescence and polyamide (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12).

The above-described medical device 1 is connected to and driven by an external drive device 7 as shown in FIG. The external drive device 7 includes a drive unit 71 that incorporates an external drive source such as a motor on the base 75 and rotationally drives the drive shaft 42, and a movement that grips the drive unit 71 and moves it in the axial direction by the motor or the like. Means 72 and a holding part 73 for holding a part of the medical device 1 in a fixed position are provided. The external drive device 7 is connected to a control unit 79 that controls the drive unit 71 and the moving means 72, and an image obtained by the vibrator unit 41 is displayed on a display unit 78 connected to the control unit 79. .

The moving means 72 is a feed mechanism capable of gripping and fixing the drive unit 71 and moving the gripped drive unit 71 back and forth along the groove rail 76 on the base 75.

The drive unit 71 includes a drive female connector 711 to which the hub-side connector 313 of the medical device 1 can be connected, and a joint connection unit 712 that can be connected to the joint 312 of the medical device 1. Signals can be transmitted to and received from the transducer unit 41, and at the same time, the drive shaft 42 can be rotated.

As shown in FIGS. 2 and 9, the ultrasonic scanning (scanning) in the medical device 1 transmits the rotational movement of the motor in the driving unit 71 to the driving shaft 42 while moving the moving means 72 in the axial direction. The housing 412 fixed to the tip of the drive shaft 42 is rotated. Accordingly, the ultrasonic transducer 411 provided in the housing 412 rotates while moving in the longitudinal direction, and ultrasonic waves transmitted and received by the ultrasonic transducer 411 can be scanned in a substantially radial direction. Thereby, a 360 ° cross-sectional image of the surrounding tissue body in the axial direction in the blood vessel can be obtained in a scanning manner up to an arbitrary position.

Next, an operation when observing a living tissue from within a living body lumen such as a blood vessel using the medical device 1 according to the present embodiment will be described.

First, before inserting the shaft portion 2 of the medical device 1 into the lumen, a priming operation for filling the medical device 1 with physiological saline is performed. By performing the priming operation, ultrasonic waves can be transmitted from the ultrasonic transducer 411, and the air in the medical device 1 is removed to prevent the air from entering the lumen of a blood vessel or the like.

In order to perform priming, as shown in FIG. 9, the operation base end portion 31 is most pulled to the base end side from the unit connector 37, that is, the inner tube 34 is most pulled out from the outer tube 32. Saline is infused using, for example, a syringe or the like through an instrument including a tube (not shown) connected to the port 311 of the proximal end portion 31 and a three-way stopcock. The injected physiological saline is filled into the image lumen 211 from the operation base end portion 31 through the first hub portion 51, and the physiological saline comes out from the priming port 216 of the filling fluid inlet / outlet member 215. Thereby, the air in the medical device 1 is removed, filling of the physiological saline is confirmed, and priming is completed.

Next, as shown in FIG. 2, the medical device 1 is connected to an external drive device 7 covered with a sterilized polyethylene bag or the like (not shown). That is, the joint 312 of the operation base end portion 31 of the medical device 1 is connected to the joint connection portion 712 of the drive unit 71. As a result, signals can be transmitted and received between the vibrator unit 41 and the external drive device 7, and at the same time, the drive shaft 42 can be rotated. Then, when the unit connector 37 is fitted into the holding portion 73, the connection is completed.

Next, by moving the drive unit 71 to the distal end along the groove rail 76 on the base 75, the operation proximal end 31 is pushed toward the distal end, and the inner tube 34 is pushed most into the outer tube 32. (See FIG. 1).

Next, the guide wire W is inserted into the living body lumen, and the tip portion is made to reach the vicinity of the target position to be observed. Next, the proximal end portion of the guide wire W is inserted from the distal end opening of the guide wire lumen 221 of the medical device 1, the shaft portion 2 is moved along the guide wire W, and the ultrasonic transducer 411 is observed. It arranges on the back side (tip side) from the affected part. In this state, as shown in FIG. 9, while holding the shaft portion 2 so as not to move, by performing a pullback operation while rotating the drive shaft 42 by the drive portion 71, the ultrasonic transducer 411 is scanned radially. An image of living tissue including the affected part can be acquired along the axial direction of the lumen by moving the base part to the proximal end side from the affected part.

The pull back operation can be performed by operating the moving means 72 connected to the rear end of the medical device 1 by the control unit 79. The acquired data is digitally processed by the control unit 79 and then displayed on the display unit 78 as image data.

Next, functions and effects according to this embodiment will be described. According to the medical device according to the present embodiment, the outer wall surface 231 at least on the distal end side of the connecting wall 23 is the arc-shaped outer wall surface 213 of the first shaft portion 21 and the arc-shaped outer wall surface 223 of the second shaft portion 22. Are connected by a tangent line. Therefore, the outward extension of the connecting wall 23 on the distal end side can be suppressed, and an increase in the outer shape of the shaft portion 2 can be suppressed. The connecting wall 23 is provided at least on the base end side of the first shaft portion 21, and the reinforcing member 24 is embedded on the base end side of the connecting wall 23. Therefore, the rigidity on the proximal end side of the shaft portion 2 can be improved, and the rigidity on the proximal side of the medical device 1 can be improved.

The connecting walls 23 are provided in pairs on both sides across the line CL connecting the centers of the first shaft portion 21 and the second shaft portion 22, and the reinforcing members 24 are provided in the paired connecting walls 23, respectively. It is configured to be able to. Therefore, the rigidity of the shaft portion 2 that is symmetric in the cross section of FIG. 4D and the like can be improved evenly on the left and right, and the medical device 1 can be satisfactorily introduced into the living body.

Further, the reinforcing member 24 is provided so as not to protrude between the outer wall surface 231 of the connection wall 23, the inner wall surface 214 of the first shaft portion 21, and the inner wall surface 224 of the second shaft portion 22. Thereby, it is possible to suppress an increase in the outer shape of the shaft portion 2 and to suppress a decrease in the cross section of the guide wire lumen 221 and the image lumen 211.

Further, the connecting wall 23 is configured such that the outer wall surface 232 of the connecting wall 23 on the proximal end side projects outward from the outer wall surface 231 on the distal end side. The lumen of the body tends to have a smaller cross section as the distal portion of the device is introduced into the peripheral region. Therefore, by configuring as described above, it is possible to more effectively improve the rigidity on the base end side while suppressing an increase in the size on the front end side for forming an image.

Further, as shown in FIGS. 4D and 4E, the reinforcing member 24 is configured such that the cross section increases from the distal end side to the proximal end side in accordance with the positions of the outer wall surfaces 231 and 232. . Therefore, it is possible to prevent the reinforcing member 24 from protruding from the connecting wall 23 and an excessively large cross section of the shaft portion 2 or a small cross section of the guide wire lumen 221 or the image lumen 211 from the distal end side to the proximal end side. Stiffness can be increased gradually.

Further, the imaging core 4 can acquire a cross-sectional image at a desired position in the living body by being capable of moving back and forth in the longitudinal direction of the first shaft portion 21.

In addition, this invention is not limited only to embodiment mentioned above, A various change is possible in a claim. 10 (A) and 10 (B) are cross-sectional views showing a modification of the shaft portion at the position shown in FIG. 4 (D). Although the embodiment in which the cross section of the reinforcing member 24 is substantially circular has been described above, the present invention is not limited to this.

If the rigidity of the medical device 1 on the relatively proximal side can be improved, the medical device has a reinforcing member 24a having a substantially triangular cross section as shown in FIG. It may be configured. Further, as shown in FIG. 10B, the medical device does not have an acute corner like the apex of the triangle of FIG. 10A in the cross section, and is adjacent to the image lumen 211 and the guide wire lumen 221. You may comprise so that the surface may have the reinforcement member 24b provided with a shape like a circular arc.

Further, the embodiment has been described in which two reinforcing members 24 are provided on both sides with a line CL connecting the centers of the first shaft portion 21 and the second shaft portion 22 as a boundary. However, the present invention is not limited to this, and two or more reinforcing members may be provided as long as they do not protrude from the outer shape of the shaft portion 2 on the distal end side and do not protrude from the guide wire lumen 221 and the image lumen 211. Further, the embodiment has been described in which the reinforcing member 24 is provided from the base end side of the shaft portion 2 to the base end side from the position where the imaging core 4 is most retracted at the time of image acquisition. However, the present invention is not limited to this, and the reinforcing member 24 may be provided from the proximal end side of the shaft portion 2 to the distal end side from the position where the imaging core 4 is most retracted.

Further, the embodiment in which the imaging core 4 is movable in the longitudinal direction in the image lumen 211 of the first shaft portion 21 has been described. However, the present invention is not limited to this, and the imaging core may not be moved in the longitudinal direction but may be rotated in the circumferential direction to acquire a cross-sectional image.

In the above description, the embodiment in which the medical device 1 acquires a cross-sectional image using intravascular ultrasound diagnosis (IVUS) has been described. However, the present invention is not limited to this, and devices such as an optical coherence tomography diagnostic device (OCT: Optical Coherence Tomography) and an optical frequency domain imaging diagnostic device (OFDI: Optical Frequency Domain Imaging) are used to acquire cross-sectional images. It is also possible to apply.

This application is based on Japanese Patent Application No. 2016-038230 filed on February 29, 2016, the disclosure of which is incorporated by reference in its entirety.

1 medical device,
2 shaft part,
21 1st shaft part,
211 Lumen for images,
212, 213, 222, 223 outer wall surface,
214, 224 inner wall surface,
22 Second shaft portion,
221 guide wire lumen,
23 connecting wall,
231 outer wall surface (outer wall),
232 the wall surface (protruding outer wall),
24, 24a, 24b reinforcing members,
3 Operation part,
4 Imaging core,
41 vibrator unit,
42 drive shaft,
5 Hub,
51 1st hub part,
52 second hub part,
53 Hub casing,
541 Wall,
CL line connecting the center of the first shaft portion and the second shaft portion,
W Guide wire.

Claims

A first shaft portion having an observation portion lumen into which an observation portion for acquiring image information in a living body is inserted;
A second shaft portion provided with a guide wire lumen into which a guide wire can be inserted and provided adjacent to the first shaft portion;
A connecting wall formed between the first shaft portion and the second shaft portion at least on the base end side of the first shaft portion;
A reinforcement member embedded in the connection wall at least on the base end side of the connection wall,
The connecting wall is a medical device having an outer wall portion that connects arcuate outer wall surfaces provided on the first shaft portion and the second shaft portion at least on the distal end side by a tangent line.
The connecting wall is provided in pairs across the line connecting the centers of the first shaft portion and the second shaft portion, and the reinforcing members are respectively provided in the paired connecting walls. The medical device described.
The medical member according to claim 1 or 2, wherein the reinforcing member is disposed between the outer wall portion of the connection wall, an inner wall surface of the first shaft portion, and an inner wall surface of the second shaft portion. device.
The medical treatment according to any one of claims 1 to 3, wherein the connection wall further includes a protruding outer wall portion in which an outer wall of the connection wall on the base end side projects outward from the outer wall portion on the distal end side. Device.
The medical device according to claim 4, wherein the reinforcing member is configured to increase in thickness from the distal end side to the proximal end side according to a position of an outer wall surface of the outer wall portion or the protruding outer wall portion.
The medical device according to any one of claims 1 to 5, wherein the observation unit is configured to be capable of moving the observation unit lumen forward and backward.