JP2017047040A - Medical device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical device capable of further enhancing safety in use by effectively preventing influence of heat generated from a drive shaft from reaching the body.SOLUTION: An inner face of a distal end of a sheath 110 and an outer face of a distal end of a drive shaft 140 include first areas on which temperature-responsive lubricated coating layers 181 and 182 are disposed. When there is a difference between the number of rotations of the drive shaft at the first area and the number of rotations of the drive shaft at a second area, a guide part guides a proximal end of the drive shaft in the radiation-direction outward.SELECTED DRAWING: Figure 3

Description

  The present invention relates to a medical device.

  In the medical field, an imaging diagnostic catheter used for acquiring a diagnostic image in a living body lumen, an atherectomy catheter used for the treatment of a stenosis formed in a blood vessel, and the like are known (for example, (See Patent Document 1). In these medical devices, the drive shaft is rotated inside the elongated sheath, and the signal transmitting / receiving unit and the cutter disposed on the distal end side of the drive shaft are rotated, thereby obtaining a diagnostic image and Treatment such as resection is performed.

JP2015-119994A

  The medical device configured as described above is in a state in which the sheath and the drive shaft are in contact with each other during the treatment using the medical device, for example, at a meandering site in a blood vessel. It may become. When the drive shaft is rotated while the sheath and the drive shaft are in contact with each other, heat is generated by friction between the drive shaft and the inner surface of the sheath. Therefore, when this frictional heat rises, this heat becomes noise, which makes it difficult to obtain a clear diagnostic image, and the normal operation of the drive shaft may be hindered by the influence of heat.

  In addition, there is a concern about the influence on the body due to heat transmitted to a living organ (for example, the inner wall of a blood vessel). For this reason, in a medical device including a component member that performs a rotational operation such as a drive shaft, an attempt to increase safety during use has been made by providing a safety mechanism for suppressing the generation of heat as described above. Has been made. As such a safety mechanism, for example, when a rotation speed difference occurs between the distal end portion and the proximal end portion of the drive shaft by rotating the distal end portion of the drive shaft in contact with the inner surface of the sheath, the proximal end A mechanism that stops the rotation by losing the alignment of the part is employed.

  The present invention is based on the knowledge that, when heat is generated from the drive shaft, the rotation of the drive shaft is quickly stopped to further improve safety during use of the medical device. It was made with repeated efforts.

  An object of the present invention is to provide a medical device capable of effectively preventing the influence of heat generated from a drive shaft from reaching the body and further improving safety during use. .

  A medical device according to the present invention includes a sheath inserted into a living body lumen, a drive shaft that is rotatable inside the sheath, a proximal end side of the sheath, and a distal end portion of the sheath. And at least one of the inner surface of the distal end portion of the sheath and the outer surface of the distal end portion of the drive shaft has hydrophilicity and lubricity at less than a critical temperature when wet. And has a first region in which a temperature-responsive lubricating coating layer that is hydrophobic and non-lubricating at a critical temperature or higher when wet is disposed, and the sheath and the drive shaft are connected to the first region and the induction The temperature-responsive lubrication coating layer is not disposed between the second region and the guide portion, and the guide portion is configured to rotate the drive shaft in the first region and the second region in the second region. Of the rotational speed of the drive shaft Differences are inducibly constituting the base end portion of the drive shaft when generated to radially outward.

  According to the medical device of the present invention, when heat is generated at the distal end portion of the drive shaft, the temperature-responsive lubrication coating layer disposed in the first region exhibits non-lubricity, so that the distal end portion of the drive shaft The number of rotations at the base end increases. When a difference in rotational speed occurs between the distal end portion and the proximal end portion of the drive shaft, the proximal end portion of the drive shaft is deformed so as to be twisted, and is guided radially outward in the guiding portion. Then, the subsequent rotation is stopped by the entanglement of the drive shaft. Thus, when heat is generated from the drive shaft, the rotation of the drive shaft can be stopped quickly. Thereby, since the influence of the heat generated from the drive shaft can be effectively prevented from reaching the body, the safety during use of the medical device is further enhanced.

It is a side view which shows roughly the whole structure of the catheter for image diagnosis which concerns on embodiment, and is a figure which shows the state before implementing pull back operation. It is a side view which shows roughly the whole structure of the catheter for image diagnosis which concerns on embodiment, and is a figure which shows the mode at the time of implementing pull back operation. It is an expanded sectional view showing the composition of the tip side of the diagnostic imaging catheter concerning an embodiment. It is an expanded sectional view showing the composition at the hand side of the diagnostic imaging catheter concerning an embodiment. It is a figure for demonstrating the effect | action of the catheter for image diagnosis which concerns on embodiment, Comprising: It is sectional drawing which shows typically the mode at the time of using in the blood vessel. It is a figure for demonstrating the effect | action of the catheter for image diagnosis which concerns on embodiment, Comprising: It is sectional drawing which expands and shows the guidance | guidance | derivation part with which the catheter for image diagnosis is equipped.

  Hereinafter, the medical device 100 according to the present embodiment will be described with reference to FIGS. In the present specification, an embodiment in which the medical device 100 is applied to an ultrasonic diagnostic imaging catheter (hereinafter referred to as diagnostic imaging catheter) will be described. 1 and 2 show the entire configuration of the diagnostic imaging catheter 100, and FIGS. 3 and 4 show the configuration of the distal end side and the configuration of the proximal end side of the diagnostic imaging catheter 100 in enlarged sectional views. FIG. 5 shows a usage example of the diagnostic imaging catheter 100, and FIG. 6 shows a guiding portion 168 provided in the diagnostic imaging catheter 100. FIG.

  In this specification, the side on which the hub 160 is disposed in the diagnostic imaging catheter 100 is referred to as a proximal end side. Further, the side that is positioned on the opposite side to the proximal end side in the diagnostic imaging catheter 100 and is introduced into the living body is referred to as the distal end side. A direction in which the diagnostic imaging catheter 100 extends is referred to as an axial direction. Note that the distal end portion means a certain range including the distal end (the most distal end) and the periphery thereof, and the proximal end portion means a certain range including the proximal end (the most proximal end) and the periphery thereof.

  As shown in FIG. 1, the diagnostic imaging catheter 100 includes a sheath 110 inserted into a living body lumen such as a blood vessel, an outer tube 120 provided on the proximal end side of the sheath 110, and advancing and retracting into the outer tube 120. An inner shaft 130 that is movably inserted, a signal transmission / reception unit 145 that transmits and receives signals are provided on the distal end side, and are provided on the proximal end side of the outer shaft 120 and a drive shaft 140 that can rotate inside the sheath 110. The unit connector 150 is configured to receive the inner shaft 130, and the hub 160 is provided on the proximal end side of the inner shaft 130.

  As shown in FIGS. 1, 3, and 4, the drive shaft 140 passes through the sheath 110, the outer tube 120 connected to the proximal end of the sheath 110, the inner shaft 130 inserted into the outer tube 120, and the hub 160. It extends to the inside.

  The hub 160, the inner shaft 130, the drive shaft 140, and the signal transmission / reception unit 145 are connected to each other so as to move forward and backward in the axial direction. Therefore, for example, when the hub 160 is pushed toward the distal end side, the inner shaft 130 connected to the hub 160 is pushed into the outer tube 120 and the unit connector 150, and the drive shaft 140 and the signal are transmitted. The transmission / reception unit 145 moves inside the sheath 110 toward the distal end side.

  When the operation of pulling the hub 160 toward the proximal end is performed, the inner shaft 130 is pulled out from the outer tube 120 and the unit connector 150 as indicated by an arrow a1 in FIG. 145 moves inside the sheath 110 to the proximal end side, as indicated by an arrow a2 in FIG.

  As shown in FIG. 1, when the inner shaft 130 is pushed most into the distal end side, the distal end portion of the inner shaft 130 reaches the vicinity of the relay connector 170. At this time, the signal transmission / reception unit 145 is located near the distal end of the sheath 110. The relay connector 170 is a connector used to connect the sheath 110 and the outer tube 120.

  As shown in FIG. 2, a disconnection prevention connector 131 is provided at the tip of the inner shaft 130. The disconnection prevention connector 131 has a function of preventing the inner shaft 130 from coming out of the outer tube 120. The disconnection prevention connector 131 is pulled to a predetermined position on the inner wall of the unit connector 150 when the hub 160 is pulled most proximally, that is, when the inner shaft 130 is most pulled out from the outer tube 120 and the unit connector 150. It is configured to hang.

  As shown in FIG. 3, the drive shaft 140 has a flexible tube 140a and a signal line 140b inserted into the tube 140a.

  The tube body 140a can be configured by, for example, a multilayer coil having different winding directions around the axis. Examples of the constituent material of the coil include stainless steel and Ni—Ti (nickel / titanium) alloy. As will be described later, a second temperature-responsive lubricating coating layer 182 is disposed on the outer surface of the distal end portion of the tubular body 140a included in the drive shaft 140 (see FIG. 3).

  The signal transmission / reception unit 145 includes an ultrasonic transducer 145a that transmits and receives ultrasonic waves, and a housing 145b in which the ultrasonic transducer 145a is accommodated. The ultrasonic transducer 145a is electrically connected to the signal line 140b. The signal line 140b can be constituted by, for example, a twisted pair cable or a coaxial cable. The ultrasonic transducer 145a has a function of transmitting an ultrasonic wave as a test wave into the living body lumen and receiving an ultrasonic wave reflected from the living body lumen side.

  A priming liquid discharge member 117 in which a priming liquid discharge hole 116 for discharging the priming liquid is formed at the distal end portion of the sheath 110. When the diagnostic imaging catheter 100 is used, the sheath 110 is filled with a priming solution in order to reduce attenuation of ultrasonic waves due to air in the sheath 110 and to efficiently transmit and receive ultrasonic waves. By filling the priming liquid, a gas such as air staying in the sheath 110 can be discharged from the priming liquid discharge hole 116 formed in the priming liquid discharge member 117.

  A guide wire insertion member 114 having a lumen through which the guide wire W can be inserted is attached to the distal end portion of the sheath 110. The guide wire insertion member 114 is provided with a marker 115 having X-ray contrast properties.

  The sheath 110 is formed of a material having high ultrasonic permeability. The range in which the ultrasonic transducer 145a moves in the axial direction of the sheath 110 (the range indicated by the arrow A1 in FIGS. 1 and 2) is an acoustic window portion (having a higher ultrasonic permeability than other portions). Window portion) 118 is formed. As will be described later, a first temperature-responsive lubricating coating layer 181 is disposed on the inner surface of the portion constituting the acoustic window 118 in the sheath 110 (see FIG. 3).

  The sheath 110 is formed of a flexible material, and the material is not particularly limited. For example, the sheath 110 is a styrene, polyolefin, polyurethane, polyester, polyamide, polyimide, polybutadiene, or transpolyisoprene system. In addition, various thermoplastic elastomers such as fluororubbers and chlorinated polyethylenes can be used, and one (or a combination of two or more of these) (polymer alloy, polymer blend, laminate, etc.) can also be used. . A hydrophilic lubricating coating layer that exhibits lubricity when wet can be disposed on the outer surface of the sheath 110.

  As shown in FIG. 4, the hub 160 is a joint in which a hub body 161a having a hollow shape and a connector 165 mechanically and electrically connected to a motor driving device (not shown) as an external device are disposed. 161b, an anti-kink protector 161c, a port 162 communicating with the inside of the hub body 161a, a seal member 164a that seals the base end side from the port 162, a connection pipe 164b that holds the drive shaft 140, and a connection pipe A bearing 164c that rotatably supports 164b and a guide portion 168 described later are included.

  An inner shaft 130 is connected to the tip of the hub body 161a. The drive shaft 140 is pulled out from the inner shaft 130 inside the hub body 161a. A protective tube 133 is disposed between the inner shaft 130 and the drive shaft 140. The protective tube 133 has a function of preventing the drive shaft 140 from being damaged due to interference between the inner shaft 130 and the drive shaft 140.

  The drive shaft 140 is connected to the tip of the connection pipe 164b. A connector 165 is connected to the proximal end of the connection pipe 164b. The connection pipe 164b and the drive shaft 140 rotate in conjunction with the rotation of the connector 165. A signal line 140b (see FIG. 3) disposed inside the drive shaft 140 is inserted into the connection pipe 164b and electrically connected to the connector 165.

  When using the diagnostic imaging catheter 100 configured as described above, first, the hub 160 is connected to the motor drive device. Then, from the state where the drive shaft 140 and the signal transmission / reception unit 145 are arranged on the distal end side of the sheath 110, a pullback operation is performed to move the drive shaft 140 and the signal transmission / reception unit 145 backward toward the proximal end side of the sheath 110. At this time, the driving shaft 140 and the signal transmission / reception unit 145 are rotated (radial scanning) by the driving force provided by the motor driving device. By performing the pull-back operation and moving the signal transmission / reception unit 145 in the axial direction, it becomes possible to acquire a 360 ° tomographic image of the surrounding tissue body in the axial direction in the living body lumen (for example, blood vessel). . Note that the rotational speed of the drive shaft 140 during normal operation is, for example, 1800 rpm.

  Next, the first temperature-responsive lubricating coating layer 181 disposed on the sheath 110 and the second temperature-responsive lubricating coating layer 182 disposed on the drive shaft 140 will be described.

  The first temperature-responsive lubricating coating layer 181 and the second temperature-responsive lubricating coating layer 182 exhibit hydrophilicity and lubricity below the critical temperature when wet, and are hydrophobic and non-lubricating above the critical temperature when wet. It is the coating layer shown.

  In the diagnostic imaging catheter 100, a portion where the first temperature-responsive lubricating coating layer 181 and the second temperature-responsive lubricating coating layer 182 are disposed is referred to as a first region for convenience. In the present embodiment, the region where the acoustic window 118 of the sheath 110 is formed (the distal end of the sheath 110) and the portion of the drive shaft 140 that moves within the acoustic window 118 (the distal end of the drive shaft 140). Is the first region.

  A portion where the first temperature-responsive lubricating coating layer 181 and the second temperature-responsive lubricating coating layer 182 are not disposed with respect to the first region is referred to as a second region for convenience. In the present embodiment, a region closer to the proximal end than the acoustic window 118 of the sheath 110 (region existing between the acoustic window 118 and a connector 165 connected to a drive device not shown) and the base of the drive shaft 140. The end region is the second region.

  The material (temperature responsive material) constituting each temperature-responsive lubricating coating layer 181 and 182 exhibits water and lubricity below a predetermined critical temperature, while being hydrophobic and resistant above the predetermined critical temperature. It is a material exhibiting (non-lubricity). The layer containing such a material reduces the frictional resistance between the drive shaft 140 and the sheath 110 due to its hydrophilicity and lubricity (surface lubricity) while the drive shaft 140 rotates below the critical temperature. To allow smooth movement of the drive shaft 140. On the other hand, the layer exhibits hydrophobicity and resistance (non-lubricity) by being heated to a temperature higher than the critical temperature by the heat generated with the rotation of the drive shaft 140. For this reason, the magnitude of the frictional resistance is different between the first region where the temperature-responsive lubricating coating layers 181 and 182 are arranged and the second region where the temperature-responsive lubricating coating layers 181 and 182 are not arranged. As a result, the rotational speed at the distal end portion of the drive shaft 140 and the rotational speed at the proximal end portion of the drive shaft 140 are different. Note that the critical temperature of the temperature-responsive material is such that the safety mechanism of the diagnostic imaging catheter 100 can be operated at a temperature higher than the body temperature, and the effect of heat generated from the drive shaft 140 on the body (for example, thrombus) In order to effectively alleviate the occurrence of the blood vessel damage and the damage to the blood vessel wall, it is preferably 38 degrees or more and less than 60 degrees. The critical temperature of the temperature-responsive material is more preferably 38 degrees or more and less than 42 degrees in order to more effectively reduce the influence of heat generated from the drive shaft 140 on the blood. Further, the critical temperature of the temperature-responsive material is more preferably 40 degrees or more and less than 42 degrees from the viewpoint of the operability of the drive shaft 140.

  A temperature responsive material will not be restrict | limited especially if the said characteristic is shown, A well-known material can be used. Specifically, poly-N-isopropylacrylamide, poly-N-isopropylmethacrylamide, poly-N-ethyl (meth) acrylamide, poly-Nn-propyl (meth) acrylamide, poly-N-cyclopropyl (meth) ) Chrylamide, poly-N, N-ethylmethyl (meth) acrylamide, poly-N, N-diethyl (meth) acrylamide, poly-N-acrylic prolysine, poly-N-acrylic bihelidine, poly-N-vinyl Amido polymers such as pyrrolidone and poly-ethyloxazoline, polyvinyl acetate partially acetylated products, polyvinyl methyl ether, polyvinyl alcohol derivatives, methyl cellulose, polyhydroxypropyl acrylate, hydroxypropyl methylcellulose, hydroxypropylcellulose , Polyethylene oxide, copolymers of ethylene oxide-propylene oxide, block copolymers of polyethylene oxide-polypropylene oxide-polyethylene oxide, alkyl-polyethylene oxide block polymers, polyether polymers such as polymethyl vinyl ether, and carboxylic acids such as polymethacrylic acid Examples thereof include polymers. One of these temperature-responsive materials may be used alone, or two or more thereof may be used in the form of a mixture. For the purpose of controlling the critical temperature of the temperature-responsive material, a polymer obtained by appropriately copolymerizing a hydrophilic monomer or a hydrophobic monomer can be preferably used. When the hydrophilic monomer is copolymerized with the temperature-responsive material, the critical temperature increases, and when the hydrophobic monomer is copolymerized, the critical temperature decreases. Using this property, the critical temperature can be appropriately adjusted according to the intended use of the device (such as the diagnostic imaging catheter 100).

  Moreover, the formation method of each temperature-responsive lubricating coating layer 181 and 182 is also not particularly limited, and a known method can be applied in the same manner or appropriately modified. For example, it is preferable to prepare a coating solution by adding the temperature-responsive material to a suitable solvent, and apply the coating solution to predetermined positions on the inner surface of the sheath 110 and the outer surface of the drive shaft 140. Here, the coating method is not particularly limited, and is a coating / printing method, dipping method (dipping method, dip coating method), spraying method (spray method), bar coating, die coating, spin coating, gravure coating. A known method such as a mixed solution-impregnated sponge coating method can be used.

  Moreover, the said solvent will not be restrict | limited especially if a temperature-responsive material can be melt | dissolved, According to the kind of lubricity provision material to be used, it can select suitably. Specifically, water, alcohols such as methanol, ethanol, isopropanol and ethylene glycol, ketones such as acetone, methyl ethyl ketone and cyclohexanone, esters such as ethyl acetate, halides such as chloroform, olefins such as hexane, tetrahydrofuran , Ethers such as butyl ether, aromatics such as benzene and toluene, amides such as N, N-dimethylformamide (DMF), sulfoxides such as dimethyl sulfoxide, and the like. It is not something. These solvents may be used alone or in combination of two or more.

  Further, the concentration of the temperature-responsive material in the coating solution is not particularly limited, but from the viewpoint of coating properties and desired effects (hydrophilicity / lubricity imparting effect), the concentration of the lubricity imparting material in the coating solution. Is 0.01 to 20% by weight, more preferably 0.05 to 15% by weight, still more preferably 0.1 to 10% by weight. If the concentration is within the above range, the resulting temperature-responsive lubricating coating layers 181 and 182 exhibit sufficient hydrophilicity and lubricity at a temperature lower than a predetermined temperature (for example, body temperature), while above the predetermined temperature. Show sufficient hydrophobicity and resistance (non-lubricating). Further, uniform temperature-responsive lubricating coating layers 181 and 182 having a desired thickness can be easily obtained by a single coating, which is preferable in terms of operability (for example, ease of coating) and production efficiency. However, even if it is out of the above range, it can be sufficiently utilized as long as it does not affect the operational effects of the present invention. Moreover, you may repeat the said application | coating process according to a desired characteristic.

  In order to make the rotational speeds different between the distal end portion and the proximal end portion of the drive shaft 140 due to the heat generated with the rotation of the drive shaft 140, the temperature is applied to at least one of the sheath 110 and the drive shaft 140. A responsive lubricating coating layer may be disposed. However, when the temperature-responsive lubrication coating layer is disposed on both the sheath 110 and the drive shaft 140 as in this embodiment, the frictional resistance between the sheath 110 and the drive shaft 140 is further increased. The difference between the rotational speed at the distal end and the rotational speed at the proximal end can be further increased. In addition, the temperature-responsive lubricating coating layer is more firmly fixed to the sheath 110 made of a resin material than the drive shaft 140 made of a metal material, and thus is disposed on one of the sheath 110 and the drive shaft 140. In this case, it is preferable to arrange a temperature-responsive lubricating coating layer on the sheath 110.

  Next, the guidance unit 168 will be described.

  As shown in FIG. 4, the guide portion 168 is disposed inside the hub 160 located on the proximal end side of the sheath 110. The guide portion 168 has an inner diameter larger than the inner diameter of the distal end portion of the sheath 110. As shown in FIGS. 3 and 4, when the drive shaft 140 is inserted into the sheath 110 and the hub 160, the clearance between the drive shaft 140 and the guide portion 168 is greater than the clearance between the drive shaft 140 and the sheath 110. The clearance between is larger.

  With reference to FIGS. 5 and 6, the function of the guiding unit 168 will be described.

  FIG. 5 shows a state in which the diagnostic imaging catheter 100 is inserted into the blood vessel 210 in order to acquire a tomographic image of the blood vessel 210.

  In the procedure using the diagnostic imaging catheter 100, the acoustic window 118 formed in the sheath 110 and the periphery thereof are arranged in the lumen of the blood vessel 210 in a state of protruding from the guiding catheter or the like.

  As shown in FIG. 5, for example, if the diagnostic imaging catheter 100 is to be inserted into a meandering or curved portion of the blood vessel 210, the outer surface of the sheath 110 comes into contact with the blood vessel inner wall 211, and the outer surface of the drive shaft 140 is removed. The surface may be in contact with the inner surface of the sheath 110.

  When the drive shaft 140 is rotated in such a state, heat is generated by the drive shaft 140 being rubbed against the sheath 110. When heat is generated, the first temperature-responsive lubricating coating layer 181 disposed on the inner surface of the sheath 110 is heated to exhibit non-lubricity, and the second temperature-responsive lubricating coating layer disposed on the outer surface of the drive shaft 140. 182 is also heated to show non-lubricity. As a result, the rotational speed at the distal end portion of the drive shaft 140 is smaller than the rotational speed at the proximal end portion of the drive shaft 140. If the drive shaft 140 is further rotated in this state, as shown in FIG. 6, the drive shaft 140 is deformed so as to be twisted due to the difference in the rotational speed, and the linear outer shape cannot be maintained. Then, it is guided so as to spread radially outward (radially outward) in the guiding portion 168 while being deformed so as to wind a toggle, and finally the drive shaft 140 is entangled to rotate the drive shaft 140. Be inhibited. When the rotation is further continued, the drive shaft 140 is broken on the base end side. In addition, since the torque is not transmitted to the tip of the drive shaft 140 after the drive shaft 140 is broken, the drive shaft 140 has no particular influence on the body after the break.

  As described above, when heat is generated from the drive shaft 140, the rotation of the drive shaft 140 can be quickly stopped. Therefore, it is possible to prevent the heat from continuing to be generated by continuing to rotate the drive shaft 140. For this reason, it is possible to effectively reduce the influence of the heat generated from the drive shaft 140 on the body.

  In the case of using the diagnostic imaging catheter 100 or the like, in order to realize a less invasive procedure, for example, it is conceivable to increase the rotation speed of the drive shaft 140 to increase the rotation speed. By increasing the rotation speed, it is possible to shorten the procedure time, but there is a concern about an increase in temperature accompanying an increase in the number of rotations of the drive shaft 140. Since the diagnostic imaging catheter 100 according to the present embodiment can quickly stop the rotation of the drive shaft 140 when the temperature of the drive shaft 140 increases as described above, the drive shaft 140 rotates at a high speed. The procedure can be advanced while

  As described above, according to the diagnostic imaging catheter 100 according to the present embodiment, when heat is generated at the distal end portion of the drive shaft 140, the temperature-responsive lubricating coating layers 181 and 182 arranged in the first region have non-lubricating properties. By showing, the rotation speed of the base end part with respect to the front-end | tip part of the drive shaft 140 increases. When a difference in rotational speed occurs between the distal end portion and the proximal end portion of the drive shaft 140, the proximal end portion of the drive shaft 140 is deformed so as to be twisted, and is guided radially outward in the guiding portion 168. . Then, the subsequent rotation stops when the drive shaft 140 is entangled. In this way, when heat is generated from the drive shaft 140, the rotation of the drive shaft 140 can be quickly stopped. Thereby, since the influence of the heat generated from the drive shaft 140 can be effectively prevented from reaching the body, the safety when using the diagnostic imaging catheter 100 is further enhanced.

  Further, since the first region where the temperature-responsive lubricating coating layer is formed is disposed on the inner surface of the distal end portion of the sheath 110, the temperature-responsive lubricating coating layer is firmly fixed to the sheath 110, and the temperature The non-lubricating property of the responsive lubricating coating layer is well expressed.

  The diagnostic imaging catheter 100 is disposed on the distal end side of the drive shaft 140 and is formed on the distal end side of the sheath 110 and the signal transmission / reception unit 145 that is rotated as the drive shaft 140 rotates. And an acoustic window 118 configured to allow transmission of the transmitted signal and the signal received by the signal transmission / reception unit 145. A first area is arranged in the acoustic window 118. For this reason, when performing a procedure using the diagnostic imaging catheter 100, when heat is generated in the vicinity of the acoustic window 118 that is exposed in the lumen of the blood vessel 210, the drive shaft 140 is quickly rotated. Can be stopped.

  In addition, since the signal transmission / reception unit 145 is configured to be able to transmit and receive ultrasonic waves, an ultrasonic tomographic image of the blood vessel 210 can be obtained by using the diagnostic imaging catheter 100.

  As mentioned above, although the medical device which concerns on this invention was demonstrated through embodiment, this invention is not limited only to each structure demonstrated, It is possible to change suitably based on description of a claim. .

  For example, in the description of the embodiment, the configuration in which the guide portion is provided in the hub is illustrated, but the configuration is not limited to such a form, and the guide portion is formed integrally with a proximal end portion of a hollow member such as a sheath. It is also possible to do.

  In addition, for example, an example in which the medical device is configured as an intravascular ultrasonic diagnostic apparatus (IVUS) has been described. However, the medical device includes an optical coherence tomographic diagnosis apparatus (OCT), an intravascular ultrasonic diagnostic apparatus, and an optical coherent tomography. Dual-type diagnostic imaging catheter that has both functions of the diagnostic apparatus and can be used simultaneously or for each function, for diagnostic imaging using optical frequency domain imaging (OFDI) It can also be configured as a catheter, an atherectomy catheter that can be used to treat a stenosis, and the like.

100 catheter for diagnostic imaging (medical device),
110 sheath,
118 Acoustic window (window),
140 drive shaft,
145 signal transmitter / receiver,
160 hub,
168 Guide part,
181 first temperature-responsive lubricating coating layer (temperature-responsive lubricating coating layer),
182 Second temperature-responsive lubricating coating layer (temperature-responsive lubricating coating layer).

Claims (4)

A sheath inserted into the body lumen;
A drive shaft rotatable within the sheath;
A guide portion provided on the proximal end side of the sheath and having an inner diameter larger than the inner diameter of the distal end portion of the sheath;
At least one of the inner surface of the distal end of the sheath and the outer surface of the distal end of the drive shaft exhibits hydrophilicity and lubricity below the critical temperature when wet, and is hydrophobic and non-lubricated above the critical temperature when wet A first region in which a temperature-responsive lubricating coating layer exhibiting properties is disposed;
The sheath and the drive shaft have a second region in which the temperature-responsive lubricating coating layer is not disposed between the first region and the guide portion,
The guiding portion moves the base end portion of the drive shaft radially outward when a difference between the rotation speed of the drive shaft in the first region and the rotation speed of the drive shaft in the second region occurs. A medical device configured to be navigable.   The medical device according to claim 1, wherein the first region is disposed at least on an inner surface of a distal end portion of the sheath. A signal transmission / reception unit that is disposed on a distal end side of the drive shaft and is rotated in accordance with the rotation of the drive shaft;
A window portion formed on the distal end side of the sheath and configured to transmit a signal transmitted by the signal transmission / reception unit and a signal received by the signal transmission / reception unit;
The medical device according to claim 1, wherein the first region is disposed in the window portion.   The medical device according to claim 3, wherein the signal transmission / reception unit is configured to transmit and receive at least ultrasonic waves.