阅读说明：本技术 图像诊断用导管 (Catheter for image diagnosis ) 是由 坂口雄纪 于 2020-03-23 设计创作，主要内容包括：本公开的图像诊断用导管具备：插入至生物体内的导引鞘；能够在所述导引鞘内旋转的驱动轴；以及在所述导引鞘内安装于所述驱动轴的成像核心部,所述成像核心部具备：能够收发信号的收发构件；以及保持所述收发构件的壳体,所述壳体的朝向所述导引鞘的径向的侧面具有倾斜部,所述倾斜部以到远位端为止随着趋向远位侧而向所述驱动轴的中心轴线靠近的方式倾斜,所述倾斜部从与所述收发构件的远位端相比的近位侧延伸至与所述收发构件的远位端相比的远位侧。(The catheter for image diagnosis of the present disclosure includes: an introducer sheath for insertion into a living body; a drive shaft rotatable within the introducer sheath; and an imaging core unit attached to the drive shaft within the guide sheath, the imaging core unit including: a transmitting/receiving member capable of transmitting/receiving a signal; and a housing that holds the transceiver member, wherein a side surface of the housing facing the guide sheath in the radial direction has an inclined portion that is inclined so as to approach the central axis of the drive shaft toward the distal end, and the inclined portion extends from a proximal side with respect to the distal end of the transceiver member to a distal side with respect to the distal end of the transceiver member.)

1. A catheter for image diagnosis, comprising:

an introducer sheath for insertion into a living body;

a drive shaft rotatable within the introducer sheath; and

an imaging core mounted to the drive shaft within the introducer sheath,

the imaging core unit includes:

a transmitting/receiving member capable of transmitting/receiving a signal; and

a housing for holding the transceiver component,

a side surface of the housing facing the guide sheath in a radial direction has an inclined portion that is inclined so as to approach the central axis of the drive shaft toward a distal end thereof,

the inclined portion extends from a proximal side to a distal side of the transmitting/receiving member.

2. The catheter for image diagnosis according to claim 1,

the side surface of the housing has a support surface for supporting the transceiver member,

the inclined portion is formed on a side surface of the housing located on at least one side with the transmission/reception member interposed therebetween, in a plan view of the housing viewed from the support surface side.

3. The catheter for image diagnosis according to claim 1,

the side surface of the housing has a support surface for supporting the transceiver member,

the inclined portion is formed at a position on a back surface of the support surface among side surfaces of the housing.

4. The catheter for image diagnosis according to claim 2 or 3,

the back surface of the support surface among the side surfaces of the housing is formed by a peripheral surface.

5. The catheter for image diagnosis according to any one of claims 2 to 4,

a proximal protrusion portion protruding toward an inner surface of the introducer sheath with respect to the transmitting and receiving member supported by the support surface is provided on a proximal side with respect to the support surface in a side surface of the housing.

6. The catheter for image diagnosis according to any one of claims 2 to 5,

a distal raised portion that is raised toward the inner surface of the introducer sheath compared to the transmitting and receiving member supported by the support surface is provided on a distal side with respect to the support surface among the side surfaces of the housing.

7. The catheter for image diagnosis according to any one of claims 1 to 6,

the angle of the inclined portion with respect to the central axis becomes larger toward the distal side.

8. The catheter for image diagnosis according to any one of claims 1 to 7,

the transmitting/receiving member is an ultrasonic oscillator capable of transmitting/receiving an ultrasonic wave by an ultrasonic transmitting/receiving surface,

the distal end surface of the ultrasonic oscillator is formed by a convex curved surface.

Technical Field

The present disclosure relates to a catheter for image diagnosis.

Background

Conventionally, as an example of a catheter for image diagnosis for obtaining a tomographic image of a blood vessel or the like, a catheter for obtaining an image by an intravascular ultrasound diagnostic method (IVUS: abbreviation of Intra Vascular Ultra Sound) is known. Patent document 1 describes such a catheter for image diagnosis. Patent document 1 describes an ultrasonic transducer as a signal transmission/reception member attached to a terminal housing as a housing.

Documents of the prior art

Patent document

Patent document 1: JP 2006-198425 publication

Disclosure of Invention

The housing to which the signal transmission/reception member is attached is made of a hard and hardly deformable material in order to stabilize the rotation shaft of the transmission/reception member with respect to the rotation of the drive shaft. On the other hand, the housing is required to be able to easily follow the curved shape of the blood vessel.

An object of the present disclosure is to provide a catheter for image diagnosis having a housing that can improve the compatibility with the shape of a blood vessel.

A catheter for image diagnosis according to a first aspect of the present disclosure includes: an introducer sheath for insertion into a living body; a drive shaft rotatable within the introducer sheath; and an imaging core unit attached to the drive shaft within the guide sheath, the imaging core unit including: a transmitting/receiving member capable of transmitting/receiving a signal; and a housing that holds the transceiver member, wherein a side surface of the housing facing the guide sheath in the radial direction has an inclined portion that is inclined so as to approach the central axis of the drive shaft toward the distal end, and the inclined portion extends from a proximal side with respect to the distal end of the transceiver member to a distal side with respect to the distal end of the transceiver member.

In one embodiment of the present disclosure, a side surface of the housing has a support surface for supporting the transmission/reception member, and the inclined portion is formed on a side surface of the housing located on at least one side with the transmission/reception member therebetween in a plan view of the housing from the support surface side.

In one embodiment of the present disclosure, a side surface of the housing has a supporting surface that supports the transmission/reception member, and the inclined portion is formed at a position on a rear surface of the supporting surface in the side surface of the housing.

In one embodiment of the present disclosure, a rear surface of the support surface among side surfaces of the housing is formed by a peripheral surface.

In one embodiment of the present disclosure, a proximal protrusion portion protruding toward an inner surface of the introducer sheath with respect to the transceiver member supported by the support surface is provided on a proximal side with respect to the support surface in a side surface of the housing.

In one embodiment of the present disclosure, a distal protruding portion protruding toward an inner surface of the introducer sheath compared to the transmission/reception member supported by the support surface is provided on a distal side with respect to the support surface in the side surface of the housing.

As an embodiment of the present disclosure, an angle of the inclined portion with respect to the central axis becomes larger toward a distal side.

In one embodiment of the present disclosure, the transmitting/receiving member is an ultrasonic oscillator capable of transmitting/receiving an ultrasonic wave by an ultrasonic transmitting/receiving surface, and a distal end surface of the ultrasonic oscillator is formed by a curved surface having a convex shape.

Effects of the invention

According to the present disclosure, it is possible to provide a catheter for image diagnosis having a housing that can improve the compatibility with the shape of a blood vessel.

Drawings

Fig. 1 is a diagram illustrating a state in which a catheter for image diagnosis as an embodiment of the present disclosure is connected to an image diagnosis apparatus.

Fig. 2 is a cross-sectional view showing a cross section parallel to the longitudinal direction of the distal end of the catheter for image diagnosis shown in fig. 1.

Fig. 3 is a lateral side view of the vicinity of the imaging core portion of the catheter for image diagnosis shown in fig. 1.

Fig. 4 is an upper side view of the vicinity of the imaging core portion of the catheter for image diagnosis shown in fig. 1.

Fig. 5 is a perspective view of the vicinity of the imaging core portion of the catheter for image diagnosis shown in fig. 1.

Fig. 6 is a use state diagram showing a state in which the catheter for image diagnosis shown in fig. 1 is inserted into a blood vessel.

Fig. 7 is a diagram showing a specific example of an ultrasonic oscillator in which the outer shape of the ultrasonic transmission/reception surface is an elliptical shape.

Detailed Description

Hereinafter, embodiments of the catheter for image diagnosis according to the present disclosure will be described by way of example with reference to the accompanying drawings. The same members/portions are denoted by the same reference numerals in the drawings. Hereinafter, for convenience of explanation, in the catheter for image diagnosis of the present disclosure, the longitudinal direction of the catheter for image diagnosis is referred to as "longitudinal direction a". In the longitudinal direction a of the catheter for image diagnosis, the side of the catheter for image diagnosis inserted into the living body is referred to as "distal side", and the opposite side is referred to as "proximal side". The direction of the diagnostic imaging catheter of the present disclosure from the proximal side toward the distal side may be simply referred to as "insertion direction a 1". The direction of the catheter for image diagnosis 1 from the distal side to the proximal side may be simply referred to as "the drawing direction a 2".

First, an example of an image diagnostic system to which the image diagnostic catheter of the present disclosure can be applied will be described. Fig. 1 is a diagram illustrating an image diagnostic system 100 having a catheter 1 for image diagnosis according to an embodiment of the present disclosure.

The image diagnostic system 100 includes a catheter 1 for image diagnosis and an image diagnostic apparatus 120. Fig. 1 shows a state in which the catheter for image diagnosis 1 is connected to the image diagnosis apparatus 120. Fig. 2 is a cross-sectional view showing a cross section parallel to the longitudinal direction a of the distal end portion, which is the distal end portion of the catheter 1 for image diagnosis. Fig. 3 is an upper side view of the vicinity of the imaging core section 10 of the catheter for image diagnosis 1. Fig. 4 is a lateral side view of the vicinity of the imaging core section 10 of the catheter for image diagnosis 1. Fig. 5 is a perspective view of the vicinity of the imaging core section 10 of the catheter 1 for image diagnosis. In fig. 5, the introducer sheath 40 is omitted from illustration.

< catheter for image diagnosis 1 >

The catheter 1 for image diagnosis according to the present embodiment can be applied to IVUS. As shown in fig. 1, the catheter for image diagnosis 1 is driven by being connected to an image diagnosis apparatus 120. More specifically, the catheter for image diagnosis 1 of the present embodiment is connected to the driving unit 120a of the image diagnosis apparatus 120.

As shown in fig. 1, the catheter for image diagnosis 1 includes an insertion portion 1a and an operation portion 1 b. The insertion portion 1a is a portion of the catheter 1 for image diagnosis to be inserted into a living body and used. The operation unit 1b is a site of the catheter 1 for image diagnosis that is operated outside the living body in a state where the insertion unit 1a is inserted into the living body. In the catheter 1 for diagnostic imaging according to the present embodiment, a portion on the distal side from a distal side connector 62 (see fig. 1) described later is an insertion portion 1a, and a portion on the proximal side from the distal side connector 62 is an operation portion 1 b.

As shown in fig. 1 and 2, the insertion portion 1a has an imaging core 10, a drive shaft 20, a signal wire 30, and a guide sheath 40. The imaging core 10 is coupled to the distal side of the drive shaft 20. The introducer sheath 40 is inserted into a living body and used (see fig. 6). The imaging core 10, the drive shaft 20, and the signal wire 30 are located in the guide sheath 40, and are inserted into the living body together with the guide sheath 40 for use (see fig. 6).

As shown in fig. 1, the operation portion 1b includes an inner tube member 50 and an outer tube member 60. The inner tube member 50 holds the proximal end of the drive shaft 20. The outer tube member 60 holds the proximal end of the introducer sheath 40. The inner tube member 50 moves in the central axial direction within the outer tube member 60, whereby the imaging core 10, the drive shaft 20, and the signal wire 30 shown in fig. 2 can move in the longitudinal direction a within the introducer sheath 40. The drive shaft 20 and the signal line 30 pass through the inner tube member 50 and the outer tube member 60, and extend in the longitudinal direction a not only in the region of the insertion portion 1a but also in the region of the operation portion 1 b.

[ imaging core part 10]

As shown in fig. 2, the imaging core 10 is located within an introducer sheath 40 inserted into the living body. The imaging core unit 10 of the present embodiment includes a transmission/reception member 11 that can transmit/receive a signal, a housing 12 that holds the transmission/reception member 11, and a contrast mark 13.

The transmitting/receiving means 11 of the present embodiment is an ultrasonic oscillator 11a capable of transmitting/receiving an ultrasonic signal. The ultrasonic oscillator 11a as the transmitting and receiving member 11 is described below by way of example, but the transmitting and receiving member 11 is not limited to the ultrasonic oscillator 11a, and may be an optical element capable of receiving and transmitting a light emission signal, for example. Examples of the optical element capable of collecting the light emission signal include a ball lens provided at a distal end of an optical fiber and having a lens function of collecting light and a reflection function of reflection.

The ultrasonic oscillator 11a as the transmission/reception member 11 of the present embodiment includes a piezoelectric element 14, a support member 15, and an acoustic matching member 16.

Specifically, the piezoelectric element 14 is composed of a flat piezoelectric body, a1 st electrode laminated on at least one side in the thickness direction of the piezoelectric body, and a2 nd electrode laminated on at least the other side in the thickness direction of the piezoelectric body. Hereinafter, for convenience of explanation, the side of the piezoelectric body in the thickness direction where the ultrasonic wave transmitting/receiving surface 11a1 of the ultrasonic oscillator 11a capable of transmitting/receiving an ultrasonic wave is located is referred to as "front surface side", and the side of the piezoelectric body in the thickness direction opposite to the ultrasonic wave transmitting/receiving surface 11a1 of the ultrasonic oscillator 11a is referred to as "back surface side".

The piezoelectric body of the piezoelectric element 14 is formed of, for example, a piezoelectric ceramic sheet. Examples of the material of the piezoelectric ceramic sheet include piezoelectric ceramic materials such as lead zirconate titanate (PZT) and lithium niobate. The piezoelectric body is not a piezoelectric ceramic material, but may be formed of crystal.

The 1 st electrode and the 2 nd electrode of the piezoelectric element 14 can be formed by stacking as electrode layers on both surfaces of the piezoelectric body in the thickness direction thereof by, for example, ion plating, vapor deposition, or sputtering using a mask material. Examples of the material of the 1 st electrode and the 2 nd electrode include metals such as silver, chromium, copper, nickel, and gold, and a laminate of these metals.

The 1 st electrode is laminated only on the surface side of the piezoelectric body. The 2 nd electrode is laminated on the back surface side of the piezoelectric body, and a part of the 2 nd electrode is folded back toward the front surface side of the piezoelectric body. That is, the 2 nd electrode of the present embodiment is formed of a folded electrode. However, the 1 st electrode and the 2 nd electrode may not be folded electrodes. The 2 nd electrode may not be a folded electrode, but may be a folded electrode in which a part of the 1 st electrode is folded back to the back surface side.

The support member 15 supports the piezoelectric element 14 from the back side thereof. Specifically, the support member 15 is laminated on the piezoelectric element 14 so as to cover the entire area of the back surface side of the piezoelectric element 14. This allows absorption of the ultrasonic wave from the piezoelectric element 14, which is a noise. That is, the support member 15 of the present embodiment constitutes a sound absorbing layer that absorbs the ultrasonic waves of the piezoelectric element 14.

The sound absorbing layer serving as the support member 15 can be formed by a method of bonding a sheet forming the sound absorbing layer to the piezoelectric element 14, a method of applying a liquid sound absorbing material forming the sound absorbing layer and curing the applied material, or the like. Examples of the material of the support member 15 include rubber, and epoxy resin in which metal powder such as tungsten powder is dispersed.

The acoustic matching member 16 is laminated so as to cover the surface side of the piezoelectric element 14. More specifically, the acoustic matching unit 16 of the present embodiment is laminated so as to cover the entire area of the front surface side of the piezoelectric element 14, except for the portions of the piezoelectric element 14 to which the signal lines 30 are connected to the 1 st electrode and the 2 nd electrode. By providing the acoustic matching member 16, the propagation efficiency of the ultrasonic wave to the subject can be improved. That is, the sound matching member 16 of the present embodiment constitutes a sound matching layer that improves the propagation efficiency of the ultrasonic wave.

The acoustic matching layer of the acoustic matching member 16 can be formed by a method of bonding a sheet forming the acoustic matching layer to the piezoelectric element 14, a method of applying a liquid acoustic matching material forming the acoustic matching layer and curing the applied acoustic matching material, or the like. As a material of the acoustic matching member 16, for example, a resin material such as epoxy resin is cited. The acoustic matching member 16 may be formed of a laminate of resin layers made of a resin material.

The ultrasonic wave transmitting and receiving surface 11a1 of the ultrasonic oscillator 11a as the transmitting and receiving member 11 of the present embodiment is configured by the surface of the ultrasonic oscillator 11 a. That is, in the ultrasonic oscillator 11a of the present embodiment, the planar ultrasonic transmission/reception surface 11a1 is configured by the acoustic matching member 16.

The ultrasonic oscillator 11a as the transmission/reception member 11 of the present embodiment has an elliptical shape in a plan view as viewed in the thickness direction of the piezoelectric body, that is, in a plan view of the ultrasonic transmission/reception surface 11a 1. The details thereof will be described later.

As shown in fig. 2 to 4, the housing 12 holds an ultrasonic oscillator 11a as the transmission/reception member 11 in the guide sheath 40. The proximal side of the housing 12 is connected to a drive shaft 20. As shown in fig. 2 to 4, the side surface of the housing 12 facing the radial direction B of the introducer sheath 40 has an inclined portion 71, and the inclined portion 71 is inclined so as to approach the central axis O of the drive shaft 20 toward the distal end as it approaches the distal side. The "side surface of the housing" refers to a surface of the housing facing the radial direction B of the introducer sheath, and refers to a surface constituting the entire region around the radial direction B of the introducer sheath. The side surface of the case 12 of the present embodiment is provided with a support surface 12a that supports the ultrasonic oscillator 11a as the transmission/reception member 11. The side of the housing 12 will be described in detail later.

The housing 12 of the present embodiment includes a body 12b, a distal end 12c, and a proximal end 12 d. The main body 12b has the above-described support surface 12 a. The distal end portion 12c is located on the distal side of the body portion 12b and includes a distal end. The proximal end portion 12d is located closer to the main body portion 12b and is connected to the contrast mark 13. Each part of the housing 12 will be described in detail later.

The case 12 can be made of resin such as polycarbonate. The housing 12 is formed by injection molding a resin material, for example. The housing 12 may be made of metal. Such a case 12 can be made of, for example, stainless steel, gold-plated stainless steel, platinum-iridium alloy, platinum-zirconia alloy, or the like. The housing 12 is formed by metal chips cut from a metal block, MIM (metal powder injection molding), or the like. The housing 12 may also be made of ceramic made of fired zirconia or the like.

The contrast mark 13 has a substantially cylindrical outer shape and is coupled to the proximal end 12d of the housing 12 on the distal side. In the present embodiment, the proximal end portion 12d of the housing 12 is bonded to the contrast mark 13 with an adhesive or the like in a state inserted therein. However, the coupling structure between the housing 12 and the contrast mark 13 is not limited to the above-described structure. The contrast marker 13 can be formed by a metal coil or a metal tube having high X-ray impermeability, such as platinum, gold, iridium, or tungsten.

As shown in fig. 2, an absorbing member 18 formed of the same material as the supporting member 15 is disposed inside the substantially cylindrical contrast mark 13 of the present embodiment. By filling the inside of the contrast mark 13 with such an absorption member 18, transmission of ultrasonic waves from the ultrasonic oscillator 11a as the transmission and reception member 11 to a region different from the target region can be suppressed. The ultrasonic oscillator 11a as the transmission/reception member 11 can suppress reception of the ultrasonic wave reflected to a portion different from the target portion.

The imaging core 10 of the present embodiment has a configuration in which the contrast mark 13 is provided on the proximal side of the housing 12, but may be an imaging core without the contrast mark 13. That is, the proximal end 12d of the housing 12 may be coupled to the drive shaft 20 described later without the contrast mark 13. In the case of providing the imaging core portion without the contrast mark 13, the housing 12 itself may be formed of a material having a contrast property, such as metal, resin including a material having a high X-ray opacity, or ceramics.

[ drive shaft 20]

The drive shaft 20 is rotatable about the central axis O within the introducer sheath 40. The imaging core 10 is attached to the drive shaft 20 inside the guide sheath 40. Thus, the drive shaft 20 rotates the imaging core 10 about the central axis O within the introducer sheath 40. More specifically, the drive shaft 20 rotates around the central axis O inside the introducer sheath, thereby rotating the coupled transmission/reception member 11, the housing 12, and the imaging marker 13 around the central axis O. The power source for rotating the drive shaft 20 is a motor 121 (see fig. 1) of the image diagnostic apparatus 120 described later.

The drive shaft 20 is formed of a flexible tube. A signal line 30 connected to an ultrasonic oscillator 11a as the transmission/reception member 11 is disposed inside the drive shaft 20. The drive shaft 20 is formed of, for example, a plurality of layers of coils wound in different directions around the shaft. Examples of the material of the coil include stainless steel and Ni — Ti (nickel/titanium) alloy. By providing such a drive shaft 20, even if two electrical signal lines are formed by using a twisted pair cable of a double helix as the signal line 30, the shielding property can be improved and the influence of noise generated from the electrical signal lines can be reduced.

The drive shaft 20 extends from the inside of the inner tube member 50 and the outer tube member 60 to a hub 52, which will be described later, located at the proximal end of the inner tube member 50. That is, the drive shaft 20 extends from the distal end of the insertion portion 1a to the proximal end of the operation portion 1b in the longitudinal direction a.

[ Signal line 30]

The signal line 30 extends inside the drive shaft 20 and electrically or optically connects the transmission/reception member 11 and the image diagnostic apparatus 120. The signal line 30 of the present embodiment is an electrical signal line that electrically connects the ultrasonic oscillator 11a as the transmission/reception member 11 and the image diagnostic apparatus 120.

The electric signal line as the signal line 30 of the present embodiment extends from the distal end of the insertion portion 1a to the proximal end of the operation portion 1b in the longitudinal direction a, similarly to the drive shaft 20. A plurality of (two in the present embodiment) electrical signal lines are provided as the signal lines 30 in the present embodiment, and are connected to the 1 st electrode and the 2 nd electrode of the ultrasonic oscillator 11a, respectively. The plurality of electrical signal lines as the signal lines 30 are formed by, for example, twisted pair cables obtained by twisting two electrical signal lines.

The signal line 30 of the present embodiment is an electric signal line, but when the transmission/reception member 11 is configured to be able to transmit and receive an optical signal, the signal line 30 can be configured by, for example, an optical fiber line.

[ guide sheath 40]

As shown in fig. 2, the guide sheath 40 is divided into a1 st hollow portion 41a and a2 nd hollow portion 41 b. The imaging core unit 10, the drive shaft 20, and the signal line 30 are housed in the 1 st hollow portion 41 a. The imaging core section 10, the drive shaft 20, and the signal line 30 can move forward and backward in the longitudinal direction a in the 1 st hollow section 41 a. The guide wire W can be inserted into the 2 nd hollow portion 41 b. In the present embodiment, the tubular guide wire insertion portion 40b defining the 2 nd hollow portion 41b is positioned substantially parallel to the distal end portion of the tubular body portion 40a defining the 1 st hollow portion 41 a. The main body portion 40a and the guide wire insertion portion 40b can be formed by joining different tube members by thermal fusion or the like, but are not limited to such a forming method.

The main body 40a is provided with a marker 42 having X-ray contrast formed of a material that does not transmit X-rays. The guide wire insertion portion 40b is also provided with a marker portion 43 having X-ray contrast. The markers 42 and 43 can be formed by, for example, a metal coil or a metal tube having high X-ray-impermeability, such as platinum, gold, iridium, or tungsten.

A window portion 44 having a higher transmissivity for the ultrasonic wave than other portions is formed in the longitudinal direction a of the guide sheath 40 as a range in which the ultrasonic oscillator 11a of the transmission/reception member 11 moves. More specifically, the window portion 44 of the present embodiment is formed in the main body portion 40a of the introducer sheath 40.

The window portion 44 of the main body portion 40a and the guide wire insertion portion 40b are formed of a flexible material, and the material is not particularly limited. Examples of the constituent material include various thermoplastic elastomers such as polyethylene, styrene, polyolefin, polyurethane, polyester, polyamide, polyimide, polybutadiene, trans-polyisoprene, fluororubber, and chlorinated polyethylene, and a polymer alloy, a laminate, and the like, in which one or two or more of these are combined, can be used.

The reinforcement portion is reinforced with a material having higher rigidity than the window portion 44 on the proximal side of the window portion 44 of the main body portion 40 a. The reinforcing portion is formed by arranging a reinforcing member in a mesh shape by weaving a metallic element wire made of stainless steel or the like on a flexible tubular member made of resin or the like, for example. The tubular member can be formed of the same material as the window portion 44.

A hydrophilic lubricant coating layer exhibiting lubricity when wet is preferably disposed on the outer surface of the introducer sheath 40.

A communication hole 46 for communicating the inside and the outside of the 1 st hollow portion 41a is formed at the distal end of the main body portion 40a of the guide sheath 40. During the gas discharge, the gas in the main body 40a can be discharged through the communication hole 46.

[ inner tube Member 50 and outer tube Member 60]

As shown in fig. 1, the inner tube member 50 has an inner tube 51 and a hub 52. The inner tube 51 is inserted into the outer tube member 60 so as to be movable forward and backward. The hub 52 is provided on the proximal side of the inner tube 51.

As shown in fig. 1, the outer tube member 60 has an outer tube 61, a distal side connector 62, and a proximal side connector 63. The outer tube 61 is positioned radially outward of the inner tube 51 (in the same direction as the radial direction B of the guide sheath 40), and the inner tube 51 moves forward and backward in the outer tube 61. The distal connector 62 connects the proximal end of the main body 40a of the introducer sheath 40 and the distal end of the outer tube 61. The proximal connector 63 is provided at the proximal end of the outer tube 61, and is configured to accommodate the inner tube 51 in the outer tube 61.

The drive shaft 20 and the signal wire 30 can extend from the 1 st hollow portion 41a of the main body portion 40a of the guide sheath 40 to the hub 52 located at the proximal end portion of the inner tube member 50 through the inside of the outer tube member 60 connected to the proximal end side of the main body portion 40a and the inside of the inner tube member 50 partially inserted into the outer tube member 60.

The imaging core section 10 is integrally connected to the inner tube member 50 via the drive shaft 20. Therefore, when the inner tube member 50 is pushed in the insertion direction a1, the inner tube member 50 is pushed into the outer tube member 60 in the insertion direction a 1. When the inner tube member 50 is pressed into the outer tube member 60 in the insertion direction a1, the imaging core unit 10 coupled to the inner tube member 50 via the drive shaft 20 moves in the insertion direction a1 in the main body unit 40a of the introducer sheath 40. Conversely, when the inner tube member 50 is pulled out in the pulling-out direction a2, the inner tube member 50 is pulled out in the pulling-out direction a2 from inside the outer tube member 60. When the inner tube member 50 is pulled out in the pull-out direction a2 from within the outer tube member 60, the imaging core section 10 coupled to the inner tube member 50 via the drive shaft 20 moves in the pull-out direction a2 within the main body section 40a of the introducer sheath 40.

A connector portion that is mechanically and electrically connected to the image diagnostic apparatus 120 is provided at the proximal end of the hub 52 of the inner tubular member 50. That is, the catheter for image diagnosis 1 is mechanically and electrically connected to the image diagnosis apparatus 120 by the connector portion of the hub 52 provided in the inner tubular member 50. More specifically, the electrical signal line as the signal line 30 of the catheter for image diagnosis 1 extends from the ultrasonic oscillator 11a to the connector portion of the hub 52. The electrical signal line as the signal line 30 electrically connects the ultrasonic oscillator 11a and the image diagnostic apparatus 120 in a state where the connector portion of the hub 52 is connected to the image diagnostic apparatus 120. The reception signal in the ultrasonic oscillator 11a is transmitted to the image diagnostic apparatus 120 via the connector portion of the hub 52, and subjected to predetermined processing and displayed as an image.

< image diagnosis apparatus 120 >

As shown in fig. 1, the image diagnostic apparatus 120 includes a motor 121 as a power source for rotating the drive shaft 20, and a motor 122 as a power source for moving the drive shaft 20 in the longitudinal direction a. The rotational motion of the motor 122 is converted into a motion in the axial direction by a ball screw 123 connected to the motor 122.

More specifically, the image diagnostic apparatus 120 of the present embodiment includes a driving unit 120a, a control device 120b, and a monitor 120 c. The control device 120b is electrically connected to the driving unit 120a by wire or wirelessly. The monitor 120c can display an image generated based on a reception signal received by the control device 120b from the catheter for image diagnosis 1. The motor 121, the motor 122, and the ball screw 123 of the present embodiment are provided in the drive unit 120 a. The operation of the driving unit 120a is controlled by the control device 120 b. The control device 120b can be configured by a processor including a CPU and a memory.

The image diagnostic apparatus 120 is not limited to the configuration shown in the present embodiment, and may be configured to further include an external input unit such as a keyboard, for example.

Fig. 6 is a use state diagram showing a state in which the image diagnostic catheter 1 according to the present embodiment is inserted into a blood vessel BV. Hereinafter, features of the housing 12 of the imaging core 10 of the catheter for image diagnosis 1 will be described with reference to fig. 2 to 6.

As shown in fig. 6, the introducer sheath 40 of the catheter for image diagnosis 1 is inserted into a living body and used. As described above, the imaging core unit 10 and the drive shaft 20 are housed in the guide sheath 40, and the imaging core unit 10 and the drive shaft 20 are inserted into the living body together with the guide sheath 40 and used.

As shown in fig. 2 to 6, the side surface of the housing 12 facing the radial direction B of the introducer sheath 40 has a slope portion 71, and the slope portion 71 is inclined so as to approach the central axis O of the drive shaft 20 toward the distal end side. The inclined portion 71 extends from the proximal side of the distal end 11a2 of the ultrasonic oscillator 11a as the transmission/reception member 11 to the distal side of the distal end 11a2 of the ultrasonic oscillator 11a as the transmission/reception member 11.

By providing such an inclined portion 71 on the side surface of the housing 12, the adaptability to the shape of the blood vessel can be improved. Therefore, even in such a curved blood vessel shape as shown in fig. 6, by providing the inclined portion 71 on the side surface of the housing 12 of the present embodiment, the housing 12 can be easily brought into surface contact with the inner surface of the introducer sheath 40 extending along the curved blood vessel shape. As a result, the housing 12 is easily advanced and retreated along the inner wall of the blood vessel BV (see fig. 6).

More specifically, the housing 12 of the present embodiment has a main body 12b, a distal end 12c, and a proximal end 12 d. The main body 12b has a substantially elliptic cylindrical recess. The ultrasonic oscillator 11a as the transmission/reception member 11 is held by the housing 12 by accommodating the back surface side on which the support member 15 is disposed in the recess and supporting it on the bottom surface of the recess. Therefore, the support surface 12a of the transmission/reception member 11 of the housing 12 of the present embodiment is constituted by the bottom surface of the recess.

The ultrasonic oscillator 11a of the present embodiment is bonded to the case 12 with an adhesive or the like in a state of being accommodated in the recess. As shown in fig. 3, a through hole 12b1 penetrating to the outside is formed near the bottom surface of the recess formed in the main body 12b of the case 12. The remaining amount of the adhesive bonding the ultrasonic oscillator 11a and the case 12 leaks to the outside through the through-hole 12b 1. Therefore, the adhesive can be prevented from leaking from the side wall of the recess portion to the surface side of the ultrasonic oscillator 11 a. Therefore, the adhesive can be inhibited from adhering to the ultrasonic transmitting/receiving surface 11a1 of the ultrasonic oscillator 11 a.

As shown in fig. 4, inclined portions 71 are formed on side surfaces of the housing 12 located on both sides with the transmission/reception member 11 therebetween in a plan view of the housing 12 from the support surface 12a side. By providing such an inclined portion 71, the housing 12 can be more favorably fitted to the shape of the blood vessel. The plan view of the housing 12 from the support surface 12a side (see fig. 4) is a side view of the housing 12 from the support surface 12a side in the radial direction B of the guide sheath 40. Hereinafter, a plan view of the housing 12 from the support surface 12a side will be simply referred to as a "plan view of the housing 12".

In the present embodiment, the inclined portions 71 are formed on the side surfaces of the housing 12 located on both sides across the transmission/reception member 11 in a plan view of the housing 12 (see fig. 4), but the present invention is not limited to this configuration. In a plan view of the housing 12 (see fig. 4), the inclined portion 71 may be formed on a side surface of the housing 12 located on at least one side with the transmission/reception member 11 interposed therebetween. However, from the viewpoint of improving the compatibility of the housing 12 with respect to the shape of the blood vessel, as in the present embodiment, it is preferable that the inclined portions 71 be formed on the side surfaces of the housing 12 located on both sides across the transmission/reception member 11 in a plan view of the housing 12 (see fig. 4).

In the present embodiment, the inclined portion 71 is also formed at a position on the back surface of the support surface 12a among the side surfaces of the housing 12. Specifically, in the lateral side view of the housing 12 shown in fig. 3, the inclined portion 71 is formed at a position on the back surface of the support surface 12a out of the side surfaces of the housing 12. By providing such an inclined portion 71, the housing 12 can be more favorably fitted to the shape of the blood vessel. The lateral side view of the housing 12 (see fig. 3) is a side view from the radial direction B of the guide sheath 40 viewed from the support surface 12a of the housing 12 in a linear shape. In the present embodiment, as shown in fig. 3, not only the support surface 12a but also the ultrasonic transmission and reception surface 11a1 of the ultrasonic oscillator 11a as the transmission and reception member 11 may be seen linearly in a lateral side view of the housing 12.

As described above, the inclined portions 71 are provided on the side surfaces of the case 12 of the present embodiment at positions on both sides of the ultrasonic oscillator 11a as the transmission/reception member 11 in a plan view (see fig. 4) of the case 12. In addition, the side surface of the housing 12 of the present embodiment is provided with an inclined portion 71 at a position on the back surface of the support surface 12a in a lateral view of the housing 12 (see fig. 3).

In the present embodiment, the inclined portion 71 is formed in all circumferential regions from a position on one side of the case 12 across the ultrasonic oscillator 11a in a plan view (see fig. 4) of the case 12, through a position on the back surface of the support surface 12a in a plan view (see fig. 3) of the case 12, to a position on the other side of the case 12 across the ultrasonic oscillator 11a in a plan view (see fig. 4) of the case 12, in the side surface of the case 12. By providing such a configuration, the compatibility of the housing 12 with the shape of the blood vessel can be further improved.

The angle of the inclined portion 71 with respect to the central axis O of the drive shaft 20 is preferably increased toward the distal side in a side view of the housing 12 (see fig. 3 and 4). Specifically, the inclined portion 71 of the present embodiment includes a proximal inclined portion 71a and a distal inclined portion 71b having a larger angle of the inclined portion 71 with respect to the central axis O of the drive shaft 20 than the proximal inclined portion 71a in the side view shown in fig. 3 and 4. The proximal inclined portion 71a extends substantially linearly in a side view of the housing 12 (see fig. 3 and 4). The proximal inclined portion 71a extends across the proximal side and the distal side of the distal end 11a2 of the transceiver member 11. The distal inclined portion 71b extends in a convexly curved manner in a side view of the housing 12 (see fig. 3 and 4). The distal inclined portion 71b continues to the distal end of the proximal inclined portion 71a and extends to the distal end surface 12e of the housing 12.

The distal end surface 12e of the housing 12 is formed by a plane orthogonal to the central axis O of the drive shaft 20, but is not limited to this configuration, and may be a curved surface that projects convexly toward the distal side, for example. The inclined portion 71 on the side surface of the housing 12 is formed of a proximal inclined portion 71a extending linearly and a distal inclined portion 71b curved convexly in a side view (see fig. 3 and 4), but is not limited to this configuration. For example, the inclined portion may be curved and extended so that the angle with respect to the central axis O of the drive shaft 20 gradually increases as the angle goes toward the distal side in a side view (see fig. 3 and 4).

The inclined portion 71 of the present embodiment is formed from the main body portion 12b to the distal end portion 12c of the housing 12. More specifically, the inclined portion 71 of the present embodiment is formed only on the distal side from the proximal end 11a3 of the transceiver member 11, and is not formed on the proximal side from the proximal end 11a3 of the transceiver member 11. That is, the inclined portion 71 of the side surface of the housing 12 of the present embodiment is not formed at the proximal end portion 12d of the housing 12. However, an inclined portion may be provided which extends from the distal end of the housing 12 to a position closer to the proximal end 11a3 of the transmission/reception member 11.

Among the side surfaces of the housing 12 of the present embodiment, the back surface of the support surface 12a is formed by a peripheral surface. More specifically, the back surface of the support surface 12a among the side surfaces of the housing 12 of the present embodiment is configured by a circumferential surface along the inner circumferential surface of the guide sheath 40. Therefore, the inner surface of the guide sheath 40 is easily contacted with the inner surface of the guide sheath 40, and the inner surface of the guide sheath 40 is less likely to be damaged, and the housing 12 is less likely to be caught on the inner surface of the guide sheath 40, thereby improving the compatibility of the housing 12 with the shape of the blood vessel. As described above, in the present embodiment, the inclined portion 71 is formed in all the circumferential regions from the position on one side of the case 12 across the ultrasonic oscillator 11a in the plan view of the case 12 (see fig. 4) to the position on the other side of the case 12 across the ultrasonic oscillator 11a in the plan view of the case 12 (see fig. 4) via the position on the back surface of the support surface 12a in the lateral view of the case 12 (see fig. 3). That is, the back surface of the support surface 12a among the side surfaces of the housing 12 of the present embodiment is a circumferential surface, and the inclined portion 71 is formed. Therefore, the compatibility of the housing 12 with the shape of the blood vessel can be further improved.

In other words, the distal end portion 12c of the housing 12 of the present embodiment has a substantially truncated cone-shaped outer shape. The side surface of the distal end portion 12c is a tapered surface that decreases in diameter from the proximal side toward the distal side. Further, a part of the tapered surface of the distal end portion 12c extends continuously in the main body portion 12b and extends to the proximal side of the distal end 11a2 of the ultrasonic oscillator 11a as the transmission/reception member 11, whereby the inclined portion 71 described above of the side surface of the housing 12 is formed.

In other words, the housing 12 of the present embodiment includes a main body 12b having a support surface 12a for supporting the transmission/reception member 11, and a distal end 12c located on the distal side of the main body 12b and including a distal end. The side surface of the housing 12 has a peripheral surface portion extending to the main body portion 12b and the distal end portion 12c and formed of a peripheral surface along the inner surface of the introducer sheath 40. The circumferential surface portion is formed by the inclined portion 71 described above which is closer to the central axis O of the drive shaft 20 from the proximal side toward the distal side.

As shown in fig. 3, a proximal bulging portion 17a bulging toward the inner surface of the introducer sheath 40 compared to the transmission/reception member 11 supported by the support surface 12a is provided on the proximal side with respect to the support surface 12a of the side surface of the housing 12. With this configuration, the ultrasonic wave transmitting and receiving surface 11a1 of the ultrasonic oscillator 11a can be prevented from coming into contact with the inner surface of the guide sheath 40 when the imaging core unit 10 is advanced and retracted within the guide sheath 40. Therefore, the ultrasonic wave transmitting and receiving surface 11a1 of the ultrasonic oscillator 11a is less likely to be damaged.

As shown in fig. 3, a distal raised portion 17b raised toward the inner surface of the introducer sheath 40 with respect to the transmitting and receiving member 11 supported by the support surface 12a is provided on the distal side with respect to the support surface 12a of the side surface of the housing 12. With this configuration, the ultrasonic wave transmitting and receiving surface 11a1 of the ultrasonic oscillator 11a can be prevented from coming into contact with the inner surface of the guide sheath 40 when the imaging core unit 10 is advanced and retracted within the guide sheath 40. Therefore, the ultrasonic wave transmitting and receiving surface 11a1 of the ultrasonic oscillator 11a is less likely to be damaged.

As shown in fig. 3, the distal raised part 17b is raised toward the inner surface of the introducer sheath 40 compared to the proximal raised part 17 a. With this configuration, the ultrasonic wave transmitting and receiving surface 11a1 of the ultrasonic oscillator 11a can be prevented from coming into contact with the inner surface of the guide sheath 40 when the imaging core unit 10 is advanced and retracted within the guide sheath 40. Therefore, the ultrasonic wave transmitting and receiving surface 11a1 of the ultrasonic oscillator 11a is less likely to be damaged.

In addition, the distal raised portion 17b of the present embodiment is inclined so as to approach the central axis O of the drive shaft 20 as the distal side is moved in the lateral view of the housing 12 (see fig. 3). In a lateral view of the housing 12 (see fig. 3), the distal raised portion 17b has an angle with respect to the central axis O of the drive shaft 20 that increases toward the distal side and extends to the distal end surface 12e of the housing 12. By providing such a distal raised portion 17b, the compatibility of the housing 12 with the shape of the blood vessel can be further improved.

Here, the transmitting/receiving member 11 of the present embodiment is an ultrasonic oscillator 11a that can transmit/receive ultrasonic waves by the ultrasonic transmitting/receiving surface 11a 1. The distal end surface 11a4 of the ultrasonic oscillator 11a including the distal end 11a2 is preferably formed of a convex curved surface. The ultrasonic oscillator 11a of the present embodiment has an elliptical shape in front view of the ultrasonic transmission/reception surface 11a1, but is not limited to this configuration. For example, the ultrasonic transducer may have an outer shape such as a circular shape in a front view of the ultrasonic transmission/reception surface, a substantially quadrangular shape in which only the distal end surface is a curved surface which is convex in a front view of the ultrasonic transmission/reception surface, or the like. However, considering the convergence performance of the ultrasonic oscillator 11a, the outer shape of the ultrasonic transmission/reception surface 11a1 is preferably an elliptical shape or a circular shape, and particularly preferably a circular shape.

In the case of using a small piezoelectric element 14 (see fig. 2) that can be inserted into a living body as in the present embodiment, it is preferable to increase the area of the ultrasonic transmitting/receiving surface 11a1 of the ultrasonic oscillator 11a in order to achieve high ultrasonic output. Therefore, the side surfaces of the case 12 on both sides of the ultrasonic oscillator 11a as the transmission/reception member 11 are likely to be positioned close to the inner surface of the introducer sheath 40 in a plan view of the case 12 (see fig. 4).

As described above, the distal end surface 11a4 of the ultrasonic oscillator 11a is formed by a convex curved surface, and the inclined portion 71 is provided on the side surfaces of the case 12 on both sides across the ultrasonic oscillator 11a so as to follow the curved surface of the distal end surface 11a4 of the ultrasonic oscillator 11a in a plan view of the case 12 (see fig. 4). This can further improve the compatibility of the housing 12 with the shape of the blood vessel. Further, by making the outer shape of the ultrasonic wave transmitting and receiving surface 11a1 elliptical or circular, the convergence performance of the ultrasonic oscillator 11a can be improved. Fig. 7 is a diagram showing a modification of the ultrasonic oscillator 11 a. In the ultrasonic oscillator 211a shown in fig. 7, the outer shape of the ultrasonic transmitting/receiving surface 211a1 has an elliptical shape. However, a part of the near side of the piezoelectric element 214 of the ultrasonic oscillator 211a is located at a position not overlapping the ultrasonic transmission/reception surface 211a1 in the front view of the ultrasonic transmission/reception surface 211a 1. The piezoelectric element 214 is provided with contact portions for the 1 st electrode and the 2 nd electrode to which the signal line 30 is electrically connected, at portions that do not overlap the ultrasonic wave transmission/reception surface 211a 1. According to the ultrasonic oscillator 211a shown in fig. 7, the convergence performance of the ultrasonic waves from the ultrasonic transmitting/receiving surface 211a1 can be improved as compared with the ultrasonic oscillator 11a described above.

The catheter for image diagnosis according to the present disclosure is not limited to the specific configuration specified in the above embodiment, and various modifications and changes can be made without departing from the scope of the claims. The imaging core unit 10 of the above embodiment has only the ultrasonic oscillator 11a capable of transmitting and receiving an ultrasonic signal as the transmitting and receiving means 11, but is not limited to this configuration. The transmission/reception means 11 may be an Optical element capable of receiving a light emission signal, for example, capable of performing Optical Coherence Tomography (OCT).

Industrial applicability

The present disclosure relates to a catheter for image diagnosis.

Description of the reference numerals

1: catheter for image diagnosis

1 a: insertion part

1 b: operation part

10: imaging core

11: transceiver component

11 a: ultrasonic oscillator

11a 1: ultrasonic transceiver

11a 2: distal end of a transceiving member

11a 3: proximal end of transceiving component

11a 4: distal end surface of ultrasonic oscillator

12: shell body

12 a: bearing surface

12 b: main body part

12b 1: through hole

12 c: distal end

12 d: proximal end part

12 e: distal end face

13: contrast markers

14: piezoelectric element

15: supporting member

16: sound matching member

17 a: proximal bulge

17 b: distal bulge

18: absorbent member

20: drive shaft

30: signal line

40: guide sheath

40 a: main body part

40 b: guide wire insertion part

41 a: 1 st hollow part

41 b: hollow part 2

42: marking part

43: marking part

44: window part

46: communicating hole

50: inner pipe member

51: inner pipe

52: concentrator

60: outer tube member

61: outer tube

62: distal connector

63: proximal connector

71: inclined part

71 a: near inclined part

71 b: inclined part at far position

100: image diagnosis system

120: image diagnosis apparatus

120 a: drive unit

120 b: control device

120 c: monitor with a display

121: motor with a stator having a stator core

122: motor with a stator having a stator core

123: ball screw

211 a: ultrasonic oscillator

211a 1: ultrasonic transceiver

214: piezoelectric element

A: longitudinal direction of catheter for image diagnosis

A1: insertion direction of catheter for image diagnosis

A2: direction of drawing out catheter for image diagnosis

B: radial direction of the introducer sheath

O: central axis of the drive shaft

W: guide wire

BV: a blood vessel.