Medical tube and medical device

A medical tube includes a connection portion that is removably attached to an end of a catheter including a guide wire lumen through which a guide wire is inserted and a tube main body that includes a lumen through which the guide wire is inserted. The lumen communicates with the guide wire lumen while being attached to the end of the catheter through the connection portion.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is based on and claims priority to Japanese Application No. 2016-160596 filed on Aug. 18, 2016, the entire content of which is incorporated herein by reference.

TECHNICAL FIELD

The present invention generally relates to a medical tube and a medical device.

BACKGROUND DISCUSSION

Hitherto, various treatment methods have been known as a method of treating a lesion of a body lumen. For example, Japanese Application Publication No. 10-500584 discloses a method of performing a predetermined diagnosis or treatment on a lesion area by first inserting a guide wire to the lesion area and then inserting a medical device including a guide wire lumen into a body lumen along the guide wire.

SUMMARY

In general, since a position for operating the medical device is determined by the length of the catheter of the medical device, the position cannot be adjusted flexibly. For this reason, since there is a need to perform a work at a position where the medical device can be operated by an operator, situations arise in which a burden on the operator increases when the operator performs a work in an unreasonable posture.

Further, when the guide wire is inserted through the body lumen or the lesion area is diagnosed or treated by the medical device, work is performed while confirming the position of the guide wire or the medical device in the body lumen on the basis of an angiographic image captured by irradiating an X-ray from the outside of the body. Since the position where the medical device can be operated is limited as described above, there is a possibility that an exposure amount to the operator may increase when the operator performs work (an operation) at a position where the amount of irradiation of the X-ray is relatively high.

The medical tube and a medical device disclosed here improve workability while reducing the operator's exposure amount.

A medical tube includes: a connection portion that is removably attached to an end of a catheter including a guide wire lumen through which a guide wire is inserted; and a tube main body that includes a lumen through which the guide wire is inserted. The lumen communicates with the guide wire lumen while being attached to the end of the catheter through the connection portion.

A medical device is a medical device for acquiring an image while being inserted into a body lumen. The medical device includes: an imaging sheath that includes an imaging lumen into which a rotatable drive shaft is inserted; a guide wire sheath that includes a guide wire lumen which is disposed in parallel to the imaging lumen and through which a guide wire is inserted; a hub portion that is connected to a proximal end of the guide wire sheath; an imaging unit that is fixed to a distal end of the drive shaft and is able to acquire image information; and a medical tube that includes a connection portion removably attached to the hub portion and a tube main body including a lumen through which the guide wire is inserted. The lumen communicates with the guide wire lumen while the medical tube is attached to the hub portion through the connection portion.

According to the medical tube and the medical device with the above-described configuration, it is possible to flexibly adjust a working position of an operator who operates the guide wire by the medical tube. Accordingly, the workability of the operator can be improved. Further, since the working position is adjusted by the medical tube, the operator can perform a work at a position where the amount of irradiation of the X-ray is relatively low when a patient is photographed by an X-ray. For this reason, the amount of exposure of the X-ray to the operator can be reduced.

According to another aspect, a method comprises introducing a guide wire into an open distal end of a medical device while the guide wire is positioned in a blood vessel and moving the medical device in a distal direction along the guide wire while the guide wire is positioned in the blood vessel so that the medical device is introduced into the blood vessel and the guide wire moves along a guide wire lumen in the medical device. The medical device comprises a hub through which the guide wire lumen passes, wherein the hub includes a hub portion through which the guide wire lumen passes and a proximal end. The medical device also includes a medical tube removably connected to the proximal end of the hub portion, with the medical tube including a lumen that communicates with the guide wire lumen passing through the hub portion. The method also involves advancing the medical device along the guide wire to cause the guide wire to pass through the guide wire lumen in the hub and the hub portion; and further advancing the medical device along the guide wire to cause the guide wire to pass through the lumen in the medical tube so that the guide wire projects proximally beyond a proximal end of the medical tube so that the medical tube is located outside the medical tube.

DETAILED DESCRIPTION

set forth below with reference to the accompanying drawings is a detailed description of an embodiment of a medical tube and medical device representing an example of the inventive medical tube and medical device disclosed here. The following description does not limit the technical scope and the meaning of the terms described in the claims. The illustrated dimensional ratios of the drawings are exaggerated for convenience of explanation and may be different from the actual ratios.

A medical device1is, as illustrated inFIGS. 1 and 2, an ultrasound catheter which internally accommodates an imaging core4for an ultrasound diagnosis and is configured to be inserted into a body lumen. The medical device1is connected to an external drive apparatus7(seeFIG. 5) which holds the medical device1and drives or moves the imaging core4and is used to diagnose the inside of a body lumen such as a blood vessel. In the description which follows, the side to be inserted into a lumen of a living body is referred to as a “distal end” or a “distal side” and the proximal side to be operated will be referred to as a “proximal end” or a “proximal side”.

The medical device1includes, as illustrated inFIG. 1, an elongated shaft portion2which is inserted into a lumen, an operation unit3which operates the imaging core4, the imaging core4which transmits and receives ultrasound waves to tissue inside a lumen, a hub5through which the imaging core4passes and which is located at the proximal side in relation to the shaft portion2, and a medical tube8.

The shaft portion2includes a shaft distal portion21and a shaft main body portion22which is disposed at the proximal side of the shaft distal portion21.

The shaft distal portion21is provided with a guide wire lumen26into which a guide wire W is inserted. In the description which follows, a direction following the longitudinal directions of the shaft portion2and the guide wire W will be referred to as an “axial direction”.

The shaft main body portion22is provided with an imaging lumen25into which the imaging core4is inserted and a guide wire lumen26into which the guide wire W is inserted. The guide wire lumen26is disposed substantially in parallel to the imaging lumen25. The guide wire lumen26is formed to communicate from the shaft distal portion21to the shaft main body portion22. That is, the guide wire lumen26extends from the shaft distal portion21to the shaft main body portion22. The cross-sectional shapes of the imaging lumen25and the guide wire lumen26are not particularly limited, but may be, for example, substantially circular.

The guide wire W used in the medical device1of the embodiment is an elongated body which has flexibility and has a substantially constant outer diameter throughout the entire length. The cross-sectional shape of the guide wire W is not particularly limited, but may be, for example, substantially circular.

The guide wire W can be observed by an angiographic image obtained by photographing the body lumen from the outside of the body through X-rays. A material forming the guide wire W is not particularly limited as long as an observation can be performed by the angiographic image and, for example, metal such as stainless steel, spring steel, titanium, tungsten, tantalum, and super elastic alloy like nickel-titanium alloy can be used.

The shaft portion2is formed by thermally fusing (or bonding) an imaging sheath61provided with the imaging lumen25and a guide wire sheath62provided with the guide wire lumen26.

As illustrated inFIG. 2, the imaging sheath61includes a distal end opening portion61a, and the guide wire sheath62includes a distal end opening portion62a. The distal portion of the imaging sheath61is provided with a reinforcement tube23for rigidly bonding and supporting the guide wire sheath62. The reinforcement tube23is a cylindrical body or tubular body provided with a communication hole24communicating with the distal end opening portion61a. The reinforcement tube23is thermally fused (or bonded) to the imaging sheath61by a relatively rigid material (rigid so as to reinforce to firmly bond and support).

The shaft main body portion22includes, as illustrated inFIG. 3, a shaft intermediate portion221which has the imaging lumen25and the guide wire lumen26formed in parallel at the distal side and a first shaft proximal portion222and a second shaft proximal portion223which extend away from and are branched from the shaft intermediate portion221toward the proximal end. The imaging lumen25is formed inside the first shaft proximal portion222and the guide wire lumen26is formed inside the second shaft proximal portion223. The outer diameter and the inner diameter of the shaft main body portion22may be different (i.e., may vary) depending on the position in the axial direction. For example, when the outer diameter and the inner diameter are decreased in a taper shape from the proximal side toward the distal side so that an extreme change in physical property does not occur, it is possible to suppress the occurrence of kinking while realizing high pushability and passability.

The length of the shaft portion2in the axial direction is not particularly limited and may be, for example, 600 mm to 2000 mm. In a case where the medical device1is used for a procedure for a lower limb, that is, a femoral artery puncture, the axial length of the shaft portion2can be shorter than the medical device used for a heart procedure, the latter of which may be in a range, for example, from 600 mm to 1200 mm.

The shaft distal portion21and the shaft main body portion22are formed of a flexible material, and the material thereof is not particularly limited. For example, various thermoplastic elastomers such as styrene type, polyolefin type, polyurethane type, polyester type, polyimide type, polyimide type, polybutadiene type, trans polyisoprene type, fluoro rubber type, and chlorinated polyethylene type can be exemplified and one or a combination of two or more thereof (polymer alloy, polymer blend, laminate, and the like) can be employed. Additionally, it is desirable to form the imaging sheath61provided with the imaging lumen25by a material with high ultrasound transmittance.

In the operation unit3, as illustrated inFIG. 3, a distal portion is connected to the first shaft proximal portion222through a first hub portion51to be described later and a proximal portion is connected to the external drive apparatus7in order to operate the imaging core4. The operation unit3includes, as illustrated inFIG. 1, a flexible portion31which is connected to the first hub portion51, a third anti-kink protector32, a tubular member33that is connected to the proximal portion of the flexible portion31, a unit connector34which is connected to the proximal portion of the tubular member33, and an operation proximal portion35which is connected to the proximal portion of the unit connector34.

The flexible portion31is more flexible than the tubular member33. Since the medical device1is pulled toward the proximal side or in the proximal direction along the axial direction of the guide wire W when the medical device1is separated from the guide wire W, for example, while the position of the external drive apparatus7is fixed, the operation unit3extending in a direction intersecting the axial direction is deformed. At this time, since the flexible portion31connected to the first hub portion51is flexibly deformed, it is possible to prevent damage to the connection portion between the operation unit3and the first hub portion51. Further, the outer diameter of the flexible portion31is smaller than that of the tubular member33. Accordingly, the flexibility can be further improved.

The flexible portion31can be formed of polyetheretherketone (PEEK) or the same material as those of the shaft distal portion21and the shaft main body portion22.

The third anti-kink protector32is disposed at the connection portion between the flexible portion31and the tubular member33and suppresses kinking of the flexible portion31and the tubular member33.

The inner lumens of the flexible portion31and the tubular member33communicate with the imaging lumen25and a drive shaft42is inserted therethrough.

The unit connector34is inserted so that the proximal portion of the tubular member33is fitted into the unit connector34. The unit connector34is connectable to the holding portion73(seeFIG. 5) of the external drive apparatus7.

The operation proximal portion35holds the drive shaft42. The operation proximal portion35includes a port351, a joint352, a hub side connector353connected to the proximal portion of the drive shaft42, and a second anti-kink protector354.

The port351communicates with the imaging lumen25. The port351is connected to a priming syringe or a Y-connector and is used to supply a fluid such as a priming solution to the imaging lumen25.

The joint352includes an opening formed at the proximal side, and the hub side connector353is disposed in the opening. The hub side connector353is connectable to a drive side connector711(seeFIG. 5) of the external drive apparatus7from the proximal side of the joint352, and the external drive apparatus7and the hub side connector353are mechanically and electrically connected by the connection.

One end of a signal line43(seeFIG. 2) is connected to the hub side connector353and the signal line43passes through the drive shaft42so that the other end of the signal line43is connected to an oscillator unit41as illustrated inFIG. 2. By a signal which is transmitted from the external drive apparatus7to the oscillator unit41through the drive side connector711, the hub side connector353, and the signal line43, an ultrasound wave is emitted from the oscillator unit41. Further, a signal which is detected by the oscillator unit41while receiving an ultrasound wave is transmitted to the external drive apparatus7through the signal line43, the hub side connector353, and the drive side connector711.

The second anti-kink protector354is disposed in the periphery of the tubular member33and the operation proximal portion35to suppress kinking of the tubular member33.

The imaging core4is disposed inside the imaging lumen25of the shaft portion2as illustrated inFIG. 2. The imaging core4includes the oscillator unit41(an imaging unit) which transmits an ultrasound wave from a lumen to a biological tissue and receives the ultrasound wave therefrom, and a drive shaft42which rotates the oscillator unit41and whose distal end is connected to the oscillator unit41. The oscillator unit41includes an ultrasound transducer411which transmits and receives an ultrasound wave and a housing412which accommodates the ultrasound transducer411.

The oscillator unit41can be observed by an angiographic image. Although the material of the housing412is not limited, it is desirable to include metal such as gold, platinum, platinum alloy, and tungsten alloy or an X-ray contrasting material such as barium sulfate, bismuth oxide, and tungsten so that the housing serves as an X-ray contrasting portion. Further, an X-ray contrast marker may be separately provided in the vicinity of the housing412.

The drive shaft42is flexible, is able to transmit rotational power generated in the operation unit3to the oscillator unit41, and is formed as, for example, a multilayered coil-shaped pipe body or cylindrical body such as a three-layer coil having alternate right and left winding directions. When the drive shaft42transmits rotational power, the oscillator unit41rotates and thus a lesion area inside a body lumen such as a blood vessel can be observed in the circumferential direction. Further, the signal line43which transmits a signal detected by the oscillator unit41to the operation unit3passes through the drive shaft42.

The hub5includes, as illustrated inFIG. 3, the first hub portion51which is air-tightly and liquid-tightly connected to the first shaft proximal portion222, a second hub portion52(the end of the catheter) which is air-tightly and liquid-tightly connected to the second shaft proximal portion223, a hub main body portion53which is connected to the first hub portion51and the second hub portion52, and a first anti-kink protector54. The first hub portion51, the second hub portion52, and the hub main body portion53are integrally formed in one piece.

As illustrated inFIGS. 1 and 3, the first hub portion51is connected by thermal fusing or bonding while the distal portion of the flexible portion31is fitted from the proximal side of the first hub portion51and the first shaft proximal portion222is inserted from the distal side of the first hub portion51. Thus, the saline solution (saline) and the drive shaft42passing through the flexible portion31are movable toward the imaging lumen25through the first hub portion51.

The second hub portion52is air-tightly and liquid-tightly connected by thermal fusing or bonding while the second shaft proximal portion223is inserted from the distal side of the second hub portion52. The second hub portion52communicates with the guide wire lumen26and the guide wire W can pass therethrough. The outer peripheral surface of the second hub portion52is provided with a male screw portion521(male connector) having a screw thread protruding in an annular shape. The male screw portion521can be threaded into a female screw portion81a(female connector) of a first connection portion81of the medical tube8to be described later (seeFIG. 4(B)).

As illustrated inFIG. 3, the hub main body portion53covers the outer peripheral surfaces of the first shaft proximal portion222and the second shaft proximal portion223respectively connected to the first hub portion51and the second hub portion52.

A portion which is branched into the first shaft proximal portion222and the second shaft proximal portion223from the shaft intermediate portion221toward the proximal end is disposed inside the hub main body portion53. For this reason, since the imaging sheath61and the guide wire sheath62are not bonded to each other, the first shaft proximal portion222and the second shaft proximal portion223having rigidity smaller than that of the shaft intermediate portion221can exhibit high pushability while not being positioned at the outside of the hub main body portion53.

As illustrated inFIG. 1, the first anti-kink protector54surrounds the shaft main body portion22drawn from the hub main body portion53and the distal portion of the hub main body portion53to suppress kinking of the shaft main body portion22.

Materials forming the first hub portion51, the second hub portion52, the hub main body portion53, the tubular member33, the unit connector34, and the operation proximal portion35are not particularly limited. Examples of such materials include various resins such as polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly-(4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyester such as polyethylene terephthalate and polyethylene naphthalate, butadiene-styrene copolymer, and polyamide (for example, nylon 6, nylon 6·6 (Nylon-6,6 or Nylon-6/6), nylon 6·10 (Nylon-6,10 or Nylon-6/10), and nylon 12).

In addition, the configuration of the hub5is not limited to the above-described configuration and, for example, a casing having a split structure may be used to cover the proximal portion of the shaft intermediate portion221and the outer peripheral surfaces of the first shaft proximal portion222and the second shaft proximal portion223.

The medical tube8includes, as illustrated inFIG. 4(A), the first connection portion81, a second connection portion82, and a tube main body83which is disposed between the first connection portion81and the second connection portion82.

The first connection portion81is air-tightly and liquid-tightly connected to the distal portion of the tube main body83. The inner peripheral surface of the inner lumen of the first connection portion81is provided with the female screw portion81ahaving a thread groove. The first connection portion81is removably attached to the second hub portion52in such a manner that the male screw portion521of the second hub portion52is threaded into the female screw portion81aas illustrated inFIG. 4(B).

The second connection portion82is air-tightly and liquid-tightly connected to the proximal portion of the tube main body83. The second connection portion82serves as a port for supplying a fluid such as a priming solution to the tube main body83. The second connection portion82includes a male screw portion82ahaving a screw thread protruding in an annular shape and threaded into a female screw portion (not illustrated) of a priming syringe or a Y-connector.

The second connection portion82includes a blade portion821which is widened in a direction intersecting the axial direction. The operator can grip the blade portion821when operating the medical tube8and so the operability is improved.

The tube main body83includes a lumen83athrough which the guide wire W is inserted. The diameter of the lumen83ais not particularly limited as long as the guide wire W can be pass through the lumen. An example of a diameter of the lumen83ais 0.3 mm to 1.0 mm.

The length L of the medical tube8in the axial direction can be appropriately selected in accordance with the length of the shaft portion2or the application of the medical device and can be, for example, 300 mm to 600 mm when the medical device1is used for a procedure for a lower limb.

It is desirable to form the first connection portion81, the second connection portion82, and the tube main body83by the same material and, for example, polyethylene can be used. Due to the same forming material, the first connection portion81and the tube main body83can be connected by thermal fusing as in the second connection portion82and the tube main body83. Accordingly, since a connection portion is formed without a step or the like, it is possible to suppress the guide wire W from being caught by the connection portion.

The medical device1is driven while being connected to the external drive apparatus7as illustrated inFIG. 5. The external drive apparatus7includes a drive unit71which rotates the drive shaft42and has an external drive source such as a motor embedded on a base75, a fixing portion72which fixes the drive unit71by gripping, and a holding portion73which holds a part of the medical device1in a fixed manner. The external drive apparatus7is connected to a control unit79which controls the drive unit71and the fixing portion72and an image obtained by the oscillator unit41is displayed on a display unit78connected to the control unit79.

The drive unit71includes a drive side connector711to which the hub side connector353of the medical device1is connectable and a joint connection portion712which is connectable to the joint352of the medical device1. Since the joint connection portion712is connected to the joint352, a signal can be transmitted to and received from the oscillator unit41and the drive shaft42can be rotated.

In the ultrasound scanning (scan) of the medical device1, the rotation of the motor inside the drive unit71is transmitted to the drive shaft42to rotate the housing412fixed to the distal end of the drive shaft42. Accordingly, the ultrasound transducer411provided in the housing412rotates and thus an ultrasound wave which is transmitted and received by the ultrasound transducer411can be scanned in the substantially radial direction. Accordingly, it is possible to obtain a tomographic image of 360° for a surrounded tissue body inside a body lumen.

Next, an operation of observing a biological tissue from the inside of a body lumen such as a blood vessel using the medical device1according to the embodiment will be described with reference toFIGS. 6 to 8. In the following description, a lesion area which is formed in a blood vessel of a lower limb of the patient P corresponds to an observation area.

First, at step S1, the first connection portion81of the medical tube8is connected to the second hub portion52(seeFIG. 4(B)).

Next, at step S2, a priming treatment or priming procedure is performed to charge the medical device1with a saline solution. By the priming treatment, an ultrasound wave can be transmitted from the ultrasound transducer411and air inside the medical device1is removed, thereby preventing air from intruding into a blood vessel.

In order to perform a priming treatment on the imaging lumen25, a physiological saline is injected through a mechanism including a three-way stopcock and a tube connected to the port351of the operation proximal portion35by using, for example, a syringe or the like. The injected saline solution passes through the first hub portion51from the operation proximal portion35and is charged into the imaging lumen25. Then, the saline solution comes out from the distal end opening portion61a(seeFIG. 2). Accordingly, the charging of the saline solution is confirmed and the priming operation inside the imaging lumen25is completed.

In order to perform a priming operation on the guide wire lumen26, a saline solution is injected through a mechanism including a three-way stopcock and a tube connected to the second connection portion82of the medical tube8by using, for example, a syringe or the like. The injected saline solution passes through the second hub portion52from the medical tube8and is charged into the guide wire lumen26. Then, the saline solution comes out from the distal end opening portion62a(seeFIG. 2). Accordingly, the charging of the saline solution is confirmed and the priming treatment inside the guide wire lumen26is completed.

Next, at step S3, as illustrated inFIG. 5, the medical device1is connected to the external drive apparatus7covered with a sterilized polyethylene bag or the like. That is, the joint352of the operation proximal portion35of the medical device1is connected to the joint connection portion712of the drive unit71. Accordingly, a signal can be transmitted and received between the oscillator unit41and the external drive apparatus7and the drive shaft42can be rotated. Then, when the unit connector34is fitted to the holding portion73, the connection is completed.

Next, at step S4, the guide wire W is inserted into a blood vessel through the guiding sheath S percutaneously inserted into the blood vessel by the Seldinger method. Next, the proximal portion of the guide wire W is inserted into the guide wire lumen26through the distal end opening portion62a.

After the guide wire W is drawn to the proximal side or proximal end from the second connection portion82of the medical tube8, the shaft portion2of the medical device1is moved forward along the guide wire W and the distal portion of the shaft portion2is disposed at the far side (the distal side) in relation to the observed lesion area. That is, the distal portion of the shaft portion2is moved past the lesion area so that the distal portion of the shaft portion2is positioned distally beyond the lesion area. At this time, since the first hub portion51and the second hub portion52are directed in different directions, the guide wire W can be operated without the interference with the operation unit3or the external drive apparatus7.

Further, since the guide wire lumen26is opened at the second connection portion82of the medical tube8, the guide wire W can be rather easily replaced. For this reason, the medical device1can reach a deep portion of a complex portion by properly using the guide wire W having a desired load and a desired shape. That is, the medical device1can reach a deep portion of a complex portion by replacing guide wires W and using different guide wires W having a desired load and a desired shape. Further, a contrast agent or a medicine can be supplied to the guide wire lumen26through the second connection portion82of the medical tube8to be discharged from the distal end opening portion62ainto the body.

Next, at step S5, an angiographic image is acquired by photographing a position (a lesion area) provided with the oscillator unit41through an X-ray from the outside of the body. By confirming the angiographic image, the position or the posture of the distal portion of the medical device1can be checked.

In a procedure of treating a lesion area of a lower limb, the distance from a position where an operator H1of the medical device1operates the guide wire W to the lesion area is relatively short compared to a procedure of treating a lesion area of a heart. For this reason, as illustrated inFIG. 7(A), there is a case where the operator H1works within a range R in which the amount of irradiation of the X-ray is relatively high. Accordingly, there is a possibility that the amount of exposure of the X-ray to the operator H1may increase.

In contrast, in the illustrated embodiment representing an example of the disclosed medical device, as illustrated inFIG. 7(B), the distance between a position where the operator H1operates the guide wire W by the medical tube8and the lesion area may be extended. Accordingly, since the operator H1can work outside the range R in which the amount of irradiation of the X-ray is relatively high, it is possible to suppress the operator H1from being exposed to the X-ray during work.

Further, since the operator H1can select a desired working position by adjusting the length of the medical tube8, the operator H1does not need to work in an unreasonable posture and thus a burden on the operator H1can be reduced. Further, since a range of a position where the operator H1can work by the medical tube8is widened even when the position of the external drive apparatus7is fixed, the workability can be improved.

Furthermore, in the medical device1according to the embodiment, the other operator H2holds the external drive apparatus7in a fixed state while the operator H1operates the guide wire W. Since a distance between the operator H1and the other operator H2can be adjusted in accordance with the adjustment of the working position of the operator H1using the medical tube8, a work can be smoothly performed without any interference during the work.

In order to improve the workability of the operator H1, for example, a method of increasing the length of the guide wire lumen26of the medical device1without using the medical tube8as in the embodiment may be considered. However, when the length of the guide wire lumen26is extended, the length of the guide wire W also needs to be extended. When the length of the guide wire W is extended, a friction force against the guide wire lumen26increases so that the guide wire W does not move easily or the transmission of power such as pushing or rotating by the operation from the proximal side of the operator H1becomes difficult. Accordingly, the workability of the operator H1is degraded.

Next, at step S6, the drive shaft42is rotated by the drive unit71so that the ultrasound transducer411is radially scanned and a tomographic image of a biological tissue including a lesion area is acquired.

When the directions of the tomographic image and the angiographic image are aligned to each other by checking a positional relation of the guide wire W and the oscillator unit41using both the tomographic image and the angiographic image, the guide wire W can be efficiently moved to a position of the lesion area which is seen by the tomographic image.

Next, at step S7, the medical device1is removed from the blood vessel while the guide wire W is left inside the blood vessel.

To accomplish this, the medical tube8is first separated from the second hub portion52from the state illustrated inFIG. 8(A)to achieve the state illustrated inFIG. 8(B). Next, as illustrated inFIG. 8(C), the medical device1is pulled to the proximal side or in the proximal direction along the guide wire W and the medical device1is separated from the guide wire W. Subsequently, a treatment catheter device is inserted into a blood vessel along the guide wire W.

Since the medical tube8is separated from the second hub portion52as illustrated inFIG. 8(B)when the medical device1is removed from the blood vessel, the length of the guide wire W that is exposed to the proximal side of the medical device1is increased by the length L of the medical tube8(seeFIG. 4(A)). By virtue of the increased exposure length of the guide wire W, a distance in which the medical device1can move toward the proximal side along the guide wire W increases.

For this reason, an exposure portion of the guide wire W also remains at the proximal side of the second hub portion52when the medical device1is drawn to the proximal side until a state where the guide wire W is exposed to a gap (a portion surrounded by a dashed line inFIG. 8(C)) between the guiding sheath S and the distal portion of the medical device1(the shaft portion2) is confirmed as illustrated inFIG. 8(C). Accordingly, when the medical device1is drawn to the proximal side or moved in the proximal direction along the guide wire W while the guide wire W exposed to the distal side of the medical device1is gripped, the medical device1can be easily separated. In this way, since the medical tube8is separated, the medical device1can be relatively easily removed even when the relatively short guide wire W is used. By using the relatively short guide wire W, the operability of the guide wire W can be improved.

After the medical device1is removed from the blood vessel, a replacement operation of inserting a medical device different from the medical device1into the blood vessel along the guide wire W can be performed.

Additionally, a timing of attaching and detaching the medical tube8is not limited to the above-described timing and the medical tube8can be attached and detached at a timing desired by the operator if necessary.

In this way, a treatment method using the medical device1according to the illustrated embodiment representing an example of the disclosed treatment method is a treatment method using the medical tube8removably attached to the end of the medical device1including the guide wire lumen26through which the guide wire W is insertable and a medical procedure including a diagnosis or a treatment is performed while adjusting the length of the lumen through which the guide wire W is inserted after the attachment and detachment of the medical tube8at the end of the medical device1.

Further, the medical procedure includes at least one of an operation of inserting the guide wire W through the guide wire lumen26, an operation of inserting the medical device1into the body lumen, an X-ray photographing operation, an operation of acquiring a tomographic image, and an operation of removing the medical device1from the body lumen.

Further, the medical procedure includes an operation of attaching the medical tube8to the end of the medical device1before the X-ray photographing operation.

Further, the medical procedure includes an operation of separating the medical tube8from the end of the medical device1before the medical device1is removed from the body lumen.

Further, the medical procedure includes an operation of inserting the other medical device into the body lumen along the guide wire W after the medical device1is removed from the body lumen.

Further, the medical device1includes at least one of an image diagnosis catheter, a micro catheter, a guiding catheter, a balloon catheter, a self-expanding stent delivery system, a balloon expandable stent delivery system, a contrast catheter, an atherectomy catheter, an endoscope catheter, and a medical solution administering catheter.

As described above, the medical tube8according to the illustrated embodiment representing an example of the disclosed medical device includes the first connection portion81(the connection portion) which is removably attached to the second hub portion52(the end of the catheter) connected to the second shaft proximal portion223of the shaft portion2including the guide wire lumen26through which the guide wire W is insertable and the tube main body83which includes a lumen83athrough which the guide wire W is insertable and the lumen83acommunicates with the guide wire lumen26while being attached to the second hub portion52through the first connection portion81.

Further, the medical device1according to the embodiment includes the imaging sheath61which includes the imaging lumen25, the guide wire sheath62which includes the guide wire lumen26disposed in parallel to the imaging lumen25and allowing the guide wire W to be insertable therethrough, the second hub portion52(the hub portion) which is connected to the proximal end of the guide wire sheath62, the oscillator unit41(the imaging unit) which is fixed to the distal end of the drive shaft42and is able to acquire image information, and the medical tube8which includes the first connection portion81(the connection portion) removably attached to the second hub portion52and the tube main body83including the lumen83aallowing the guide wire W to be insertable therethrough. In a state where the medical tube8is attached to the second hub portion52through the first connection portion81, the lumen83acommunicates with the guide wire lumen26.

According to the medical tube8or the medical device1, it is possible to flexibly adjust the working position of the operator H1of the guide wire W using the medical tube8. Accordingly, the workability of the operator H1can be improved. Further, it is possible to perform work at a position where the amount of irradiation of the X-ray is relatively low when photographing the lesion area of the patient P through an X-ray by adjusting the working position using the medical tube8. For this reason, the amount of exposure of the X-ray to the operator H1can be reduced.

First Modified Example of Medical Tube

Referring toFIGS. 9(A) and 9(B), a medical tube800according to a first modified example is described. This medical tube800is different from the above-described embodiment in that a plurality of tube main bodies are connectable by a first connection portion and a second connection portion. In this modified example shown inFIGS. 9(A) and 9(B), the same reference numerals are used to identify parts having the same functions as those of the above-described embodiments and a description of such features is not repeated.

The medical tube800includes, as illustrated inFIG. 9(A), a first medical tube800a, a second medical tube800b, and a third medical tube800c.

The first medical tube800aincludes a first connection portion801a, a second connection portion802a, and a tube main body803a. The second medical tube800bincludes a first connection portion801b, a second connection portion802b, and a tube main body803b. The third medical tube800cincludes a first connection portion801c, a second connection portion802c, and a tube main body803c.

The first connection portions801a,801b, and801care respectively air-tightly and liquid-tightly connected to the distal portions of the tube main bodies803a,803b, and803c. The first connection portions801a,801b, and801cinclude the female screw portions81ain which thread grooves are formed in the inner surfaces of the inner lumens.

The second connection portions802a,802b, and802care air-tightly and liquid-tightly connected to the proximal portions of the tube main bodies803a,803b, and803c. The second connection portions802a,802b, and802cinclude the male screw portions82ain which screw threads are formed in an annular shape.

The axial lengths L1, L2, and L3of the first medical tube800a, the second medical tube800b, and the third medical tube800care different from one another and the relationship between the lengths L1, L2, L3may be L1<L2<L3. A ratio (L1:L2:L3) of the lengths L1, L2, and L3can be, for example, 1:2:3.

Additionally, since the axial lengths of the first connection portions801a,801b, and801care the same and the axial lengths of the second connection portions802a,802b, and802care the same, the relationship between the lengths of the tube main bodies803a,803b, and803cmay also be L11<L12<L13.

As illustrated inFIG. 9(B), each of the male screw portion521of the second hub portion52and the male screw portions82aof the second connection portions802a,802b, and802ccan be threaded into the female screw portion81a. Accordingly, the axial length of the medical tube800connected to the second hub portion52can be, for example, L1+L2+L3by connecting all of the first medical tube800a, the second medical tube800b, and the third medical tube800c, can be L1+L2by connecting only the first medical tube800aand the second medical tube800b, or can be L1+L3by connecting only the first medical tube800aand the third medical tube800c. In this way, the length of the medical tube800connected to the second hub portion52can be adjusted in more detail by changing the combination of the first medical tube800a, the second medical tube800b, and the third medical tube800c.

As described above, the medical tube800according to the first modified example includes the first connection portions801a,801b, and801cand the tube main bodies803a,803b, and803cand the first connection portions801a,801b, and801care connectable to the plurality of tube main bodies803a,803b, and803c. Accordingly, the length of the medical tube800can be adjusted to a length desired by the operator.

Further, the axial lengths of the plurality of tube main bodies803a,803b, and803care different. The length of the medical tube800can be adjusted in more detail by appropriately changing the combination of the plurality of tube main bodies803a,803b, and803c.

Additionally, in the first modified example, a configuration has been described in which the medical tube800includes three tube main bodies803a,803b, and803c, three second connection portions802a,802b, and802c, and three tube main bodies803a,803b, and803c, but the number of the connection portions and the tube main bodies is not limited thereto. Further, the lengths of the plurality of tube main bodies may be the same.

Second Modified Example of Medical Tube

Referring toFIGS. 10(A) and 10(B), a medical tube810according to a second modified example is described. The medical tube810is different from the above-described embodiments in that a tube main body813includes a bellows shaped portion814with a bellows box structure. In addition, in this modified example shown inFIGS. 10(A) and 10(B), features that are the same as features in the above-described embodiments and that have the same function as those of the above-described embodiments are identified by the same reference numbers and a detailed description of such features is not repeated.

The tube main body813includes, as illustrated inFIG. 10(A), the bellows shaped portion814which includes a mountain portion (mountain portions)814aprotruding outward in the radial direction and a valley portion (valley portions)814brecessed inward in the radial direction in relation to the mountain portion814a. As illustrated inFIG. 10(B), it is possible to shorten the axial length of the medical tube810from the length L21to the length L22by folding (axially compressing) the bellows shaped portion814.

When the cross-sectional shape of the bellows shaped portion814is substantially circular, at least a part of the adjacent mountain portions814ahave different outer diameters D11and D12. Further, at least a part of the adjacent valley portions814bhave different outer diameters D21and D22. Accordingly, when the bellows shaped portion814is folded or axially collapsed, it is possible to more largely extend and contract the length of the tube main body813compared to a case where the outer diameters of the mountain portions and the outer diameters of the valley portions are respectively the same. For this reason, the tube main body813can be folded (axially shortened) and extended (axially lengthened).

In addition, at least a part of the outer diameters of the adjacent mountain portions814amay be different and the outer diameters of the valley portions814bmay be the same. In contrast, at least a part of the outer diameters of the adjacent valley portions814bmay be different and the outer diameters of the mountain portions814amay be the same.

Further, a position of the bellows shaped portion814in the tube main body813is not particularly limited as long as the bellows shaped portion is formed in at least a part of the tube main body813, but is desirably formed in the vicinity of the first connection portion81. Further, the cross-sectional shape of the bellows shaped portion814is not limited to a substantially circular shape and may be, for example, a polygonal shape.

As described above, in the medical tube810according to the second modified example, the tube main body813includes the bellows shaped portion814which includes the mountain portion814aprotruding outward in the radial direction and the valley portion814brecessed inward in the radial direction in relation to the mountain portion814a. Accordingly, it is possible to shorten the axial length of the tube main body813by folding or axially collapsing the bellows shaped portion814. For this reason, it is possible to perform an operation of replacing the medical device1without performing an operation of separating the medical tube810from the second hub portion52. Accordingly, since it is possible to omit a trouble of an operation of separating the medical tube810from the second hub portion52, it is possible to efficiently perform an operation.

Third Modified Example of Medical Tube

Referring toFIGS. 11(A) and 11(B), a medical tube820according to a third modified example is described. The medical tube820according to this third modified example is different from the above-described embodiments in that the tube main body823includes a deformation portion824. In addition, in this modified example shown inFIGS. 11(A) and 11(B), features that are the same as features in the above-described embodiments and that have the same function as those of the above-described embodiments are identified by the same reference numbers and a detailed description of such features is not repeated.

The tube main body823includes, as illustrated inFIG. 11(A), the deformation portion824which is deformable in a direction in which the diameter of the lumen83adecreases. The deformation portion824is thinner than the other portions and is formed in a spiral shape in the axial direction. Since the deformation portion824is more easily deformed compared to the other portions, when a force in the twisting direction is applied to the tube main body823, the deformation portion824is twisted so that a part of the diameter of the lumen83adecreases as illustrated inFIG. 11(B). Accordingly, the tube main body823can hold the guide wire W in a predetermined range.

Additionally, the deformation portion824is not limited to the above-described configuration as long as the deformation portion can be deformed in a direction in which the diameter of the lumen83adecreases.

As described above, the medical tube820according to the third modified example includes the deformation portion824which is deformable in a direction in which the diameter of the lumen83adecreases. Accordingly, the operator can easily hold the guide wire W by deforming the deformation portion824. When the guide wire W is pushed into the body lumen in a held state, it is possible to sufficiently transmit a pushing force to the distal end of the guide wire W when the blocked lesion area is perforated by the guide wire W. Further, when the guide wire W having a curved distal end is used, it is possible to maintain the circumferential directionality of the guide wire W so that the curved portion of the distal end of the guide wire W faces a branched or meandered portion inside the body lumen. Accordingly, the guide wire W can move forward in a desired direction when the guide wire W moves forward inside the branched or meandered body lumen.

Fourth Modified Example of Medical Tube

Referring toFIGS. 12(A) to 12(C), a medical tube830according to a fourth modified example is described. The medical tube830according to this fourth modified example is different from the above-described embodiments in that the inside of the lumen83ais visible from the outside of a tube main body833. In addition, in this modified example shown inFIGS. 12(A)-12(C), features that are the same as features in the above-described embodiments and that have the same function as those of the above-described embodiments are identified by the same reference numbers and a detailed description of such features is not repeated.

The tube main body833is formed of a transparent material or a translucent material which allows the inside of the lumen83ato be visible from the outside. Since the medical tube830is disposed at the outside of the body, the guide wire W inside the lumen83acan be visually checked from the outside.

The tube main body833includes grids834which are provided at a predetermined interval in the axial direction as illustrated inFIG. 12(A). For example, as illustrated inFIG. 12(B), an X-ray contrast marker M1is provided at the distal portion of the guide wire W and a marker M2is provided at the proximal portion. As illustrated inFIG. 12(C), the guide wire W is operated so that the X-ray contrast marker M1moves from the proximal end of the lesion area N to the distal end. At this time, the movement distance of the X-ray contrast marker M1can be visibly checked at the proximal side by the marker M2and the grid834. Accordingly, the axial length of the lesion area N can be relatively simply measured.

The guide wire lumen26and the lumen83aare connected without a check valve from the inside of the body lumen to the outside of the body. Since a pressure inside the body lumen is higher than that of the outside of the body, there is a possibility that blood may flow reversely in the lumen83a. When blood flows reversely in the lumen83a, there is a case where a thrombus may be formed in the lumen83adue to a residue remaining in the lumen83a.

Since the tube main body833according to the fourth modified example is formed of a material allowing the inside of the lumen83ato be visible from the outside, the reverse flow of blood can be checked from the outside. For this reason, it is possible to suppress a thrombus by performing a treatment for the reverse flow of blood in such a manner that a flush solution flows into the lumen83aat the time of checking the reverse flow of blood. Further, the degree of the reverse flow of blood can be checked by the grid834of the tube main body833.

As described above, at least a part of the tube main body833of the medical tube830according to the fourth modified example is formed of a material allowing the inside of the lumen83ato be visible from the outside. Accordingly, it is possible to check the reciprocating length of the guide wire W or to visibly check the reverse flow of blood inside the lumen83a. Accordingly, the operability can be further improved.

Fifth Modified Example of Medical Tube

Referring toFIGS. 13(A) and 13(B), a medical tube840according to a fifth modified example is described. The medical tube840is different from the above-described embodiments in that the tube main body843is wound in a spiral shape. In addition, in this modified example shown inFIGS. 13(A) and 13(B), features that are the same as features in the above-described embodiments and that have the same function as those of the above-described embodiments are identified by the same reference numbers and a detailed description of such features is not repeated.

The tube main body843has flexibility and is wound in a spiral shape as illustrated inFIG. 13(A). When a pulling force is applied to the tube main body843in the axial direction, the axial length of the tube main body843increases from the length L41to the length L42as illustrated inFIG. 13(B). When the pulling force in the axial direction is released, the axial length of the tube main body843decreases from the length L42to the length L41as illustrated inFIG. 13(A).

As described above, the tube main body843of the medical tube840according to the fourth modified example has flexibility and is wound in a spiral shape. Accordingly, it is possible to adaptively adjust the length of the tube main body843in accordance with a distance between the patient and the operator.

While the inventive medical tube and medical device disclosed here have been described above by way of the described embodiment and the modified examples representing examples of the inventive medical tube and medical device, the invention is not limited to the described configurations.

For example, in the above-described embodiment, a case has been described in which the invention is applied to the image diagnosis catheter used in an intra vascular ultra sound (IVUS) for acquiring a diagnosis image used to diagnose a lesion area inside a living body, but can be applied to an image diagnosis catheter for acquiring an image using light according to an optical coherence tomography (OCT) or a hybrid type (dual type) image diagnosis catheter usable for both IVUS and OCT. Further, the invention is not limited to the image diagnosis catheter and can be widely applied to a catheter including a guide wire lumen such as a micro catheter.

Further, in the above-described embodiment, the first connection portion of the medical tube is attached to and detached from the second hub portion of the hub by a thread structure, but the invention is not limited thereto. The attachment and detachment may be performed by other mechanical structures such as an attachable/detachable fitting structure.

Further, the drive shaft may be movable inside the imaging lumen in the axial direction. Accordingly, it is possible to perform a pull-back operation in which the imaging unit disposed at the distal end of the drive shaft rotates while moving in the axial direction. By performing the pull-back operation, it is possible to scanningly obtain a tomographic image of 360° to an arbitrary position in a surrounded tissue body inside the body lumen in the axial direction.

Further, the medical device that employs the medical tube according to the invention is not limited to the image diagnosis catheter and, for example, a micro catheter, a guiding catheter, a balloon catheter, a self-expanding stent delivery system, a balloon expandable stent delivery system, a contrast catheter, an atherectomy catheter, an endoscope catheter, and a medical solution administering catheter can be employed.

The detailed description above describes a medical tube and medical device. The invention is not limited, however, to the precise embodiment, modified examples and variations described. Various changes, modifications and equivalents can be effected by one skilled in the art without departing from the spirit and scope of the invention as defined in the accompanying claims. It is expressly intended that all such changes, modifications and equivalents which fall within the scope of the claims are embraced by the claims.