WO2020196427A1

WO2020196427A1 - Method for manufacturing ultrasonic probe, and ultrasonic probe

Info

Publication number: WO2020196427A1
Application number: PCT/JP2020/012776
Authority: WO
Inventors: 雄紀坂口
Original assignee: テルモ株式会社
Priority date: 2019-03-26
Filing date: 2020-03-23
Publication date: 2020-10-01
Also published as: JPWO2020196427A1; JP7405833B2

Abstract

The method for manufacturing an ultrasonic probe pertaining to the present invention includes: an attachment step for attaching, to at least two electrical signal lines, a retaining body capable of retaining a relative positional relationship between portions of each of the at least two electrical signal lines; and a connection step for connecting portions of the at least two electrical signal lines that are adjacent to the retaining body to a piezoelectric element.

Description

Manufacturing method of ultrasonic probe and ultrasonic probe

The present disclosure relates to a method for manufacturing an ultrasonic probe and an ultrasonic probe.

The ultrasonic probe is used as an ultrasonic transmitter / receiver for medical ultrasonic diagnostic equipment. The ultrasonic probe is also used for ultrasonic diagnosis performed with the catheter inserted in the body by being loaded into the catheter.

Patent Document 1 describes an active transducer element having a top main surface and a bottom main surface, a top electrode formed on the top main surface, a bottom electrode formed on the bottom main surface, and conductivity covering the low electrode. An ultrasonic probe comprising a sex backing element, a first lead electrically connected to a top electrode, and a second lead electrically connected to a conductive backing element is disclosed.

Japanese Unexamined Patent Publication No. 2006-198425

There is a high demand for miniaturization of the ultrasonic probe loaded in the catheter in order to reduce the burden on the patient and to improve the insertability into a smaller diameter body cavity such as a deep blood vessel.

The miniaturization of the ultrasonic probe can be realized by miniaturizing the ultrasonic vibrator including the piezoelectric element and the piezoelectric element composed of a pair of electrodes. However, when the ultrasonic oscillator is miniaturized, the piezoelectric element is also miniaturized. Therefore, the electrode of the piezoelectric element also becomes small, and it becomes difficult to connect the electric signal line connecting the piezoelectric element and the external power source to the electrode of the piezoelectric element.

An object of the present disclosure is to provide a method for manufacturing an ultrasonic probe that facilitates the work of connecting an electric signal line to a piezoelectric element. Another object of the present disclosure is to provide an ultrasonic probe having a configuration that facilitates connection of an electric signal line to a piezoelectric element.

The method for manufacturing an ultrasonic probe as the first aspect of the present disclosure is a method for manufacturing an ultrasonic probe, wherein at least two electric signal lines are opposed to at least two electric signal lines. A mounting step of attaching a holding body capable of maintaining a relative positional relationship between a part of the above, and a connecting step of connecting a portion of the at least two electric signal lines adjacent to the holding body to a piezoelectric element. including.

In a method of manufacturing an ultrasonic probe as one embodiment of the present disclosure, at least two electric signal lines are held at positions on both sides of a holding position held by the holding body before the mounting step. Includes a pinching step.

As one embodiment of the present disclosure, in the sandwiching step, the at least two electric signal lines are sandwiched so that the at least two electric signal lines extend along one direction at the holding position.

A method of manufacturing an ultrasonic probe as one embodiment of the present disclosure is a coating that removes the coating material of at least two electric signal lines after the sandwiching step and before the connecting step. Includes removal step.

In the method for manufacturing an ultrasonic probe as one embodiment of the present disclosure, the connection position of the piezoelectric element and the connection position of at least two electric signal lines are aligned before the connection step. Includes an alignment step adjusted by a jig.

The ultrasonic probe as the second aspect of the present disclosure is attached to the piezoelectric element, at least two electric signal lines connected to the piezoelectric element, and at least the two electric signal lines, and is described. It includes a holding body that holds a relative positional relationship between a part of at least two electric signal lines, and a housing that houses the piezoelectric element and the holding body.

The ultrasonic probe as one embodiment of the present disclosure includes a fixing member for fixing the position of the holder in the housing.

As one embodiment of the present disclosure, the fixing member is an adhesive body that is interposed between the holding body and the housing and adheres the holding body to the housing.

In one embodiment of the present disclosure, the adhesive and the retainer contain rubber or resin as a main component, and the rubber material or resin material as the main component of the adhesive is rubber which is the main component of the retainer. Different from material or resin material.

According to the present disclosure, it is possible to provide a method for manufacturing an ultrasonic probe that facilitates the work of connecting an electric signal line to a piezoelectric element. Further, according to the present disclosure, it is possible to provide an ultrasonic probe having a configuration that facilitates connection of an electric signal line to a piezoelectric element.

It is a figure which shows the state which the image diagnostic catheter including the ultrasonic probe as one Embodiment of this disclosure, and the external device are connected. It is sectional drawing which shows the cross section parallel to the longitudinal direction in the tip part of the diagnostic imaging catheter shown in FIG. It is a cross-sectional view which shows the cross section orthogonal to the longitudinal direction in the tip part of the diagnostic imaging catheter shown in FIG. 1, and is the cross-sectional view at the position of line I-I of FIG. It is a figure which shows the ultrasonic transducer of the ultrasonic probe shown in FIG. It is a flowchart which shows an example of the manufacturing method of the ultrasonic probe shown in FIG. It is a figure which shows the outline of the pinching step S1. It is a figure which shows the outline of the mounting process S2. It is a figure which shows the outline of the coating removal step S3. It is a figure which shows the outline of the cutting process S4. It is a figure which shows the outline of the alignment process S5. It is a figure which shows the outline of the connection process S6. FIG. 5 is a cross-sectional view showing a part of a diagnostic imaging catheter including an ultrasonic probe as an embodiment of the present disclosure.

Hereinafter, an embodiment of the method for manufacturing an ultrasonic probe according to the present disclosure and an embodiment of the ultrasonic probe according to the present disclosure will be described with reference to the drawings. The same reference numerals are given to common members and parts in each figure.

First, an example of an diagnostic imaging apparatus to which the ultrasonic probe according to the present disclosure can be applied will be described. FIG. 1 is a diagram showing an image diagnostic apparatus 100 including an ultrasonic probe 10 as an embodiment.

The diagnostic imaging device 100 includes a diagnostic imaging catheter 110 and an external device 120. FIG. 1 shows a state in which the diagnostic imaging catheter 110 is connected to the external device 120. FIG. 2 is a cross-sectional view showing a cross section parallel to the longitudinal direction A at the tip of the diagnostic imaging catheter 110. FIG. 3 is a cross-sectional view showing a cross section of the tip of the diagnostic imaging catheter 110 perpendicular to the longitudinal direction A. FIG. 3 shows a cross section at the position of the I-I line of FIG. FIG. 4 is a diagram showing an ultrasonic transducer 11. In FIG. 4, for convenience of explanation, the position of the electric signal line 14 connected to the ultrasonic vibrator 11 is shown by a chain double-dashed line.

<Catalog for diagnostic imaging 110>
The diagnostic imaging catheter 110 is applied to an intravascular ultrasound (abbreviated as "IVUS"). As shown in FIG. 1, the diagnostic imaging catheter 110 is driven by being connected to an external device 120. More specifically, the diagnostic imaging catheter 110 of the present embodiment is connected to the drive unit 120a of the external device 120.

Hereinafter, for convenience of explanation, in the diagnostic imaging catheter 110, the side inserted into the living body in the longitudinal direction A of the diagnostic imaging catheter 110 is described as the "tip side", and the opposite side is described as the "base end side". To do. Further, the direction from the proximal end side to the distal end side of the diagnostic imaging catheter 110 may be simply described as "insertion direction A1". Further, the direction from the distal end side to the proximal end side of the diagnostic imaging catheter 110 may be simply described as "removal direction A2".

As shown in FIG. 1, the diagnostic imaging catheter 110 includes an insertion portion 110a and an operation portion 110b. The insertion portion 110a is a portion of the diagnostic imaging catheter 110 that is inserted into the living body and used. The operation unit 110b is a portion of the diagnostic imaging catheter 110 that is operated in vitro with the insertion unit 110a inserted into the living body. In the diagnostic imaging catheter 110 of the present embodiment, the portion on the distal end side of the distal end side connector 42 (see FIG. 1) described later is the insertion portion 110a, and the portion on the proximal end side from the distal end side connector 42 is the operation portion 110b. is there.

As shown in FIGS. 1 and 2, the insertion portion 110a includes an ultrasonic probe 10 and a sheath 20.

As shown in FIG. 1, the operation unit 110b includes an inner pipe member 30 and an outer pipe member 40. The inner tube member 30 holds an end portion of the ultrasonic probe 10 on the proximal end side. The outer tube member 40 holds an end portion of the sheath 20 on the base end side. Although the details will be described later, the ultrasonic probe 10 can move in the sheath 20 in the longitudinal direction A by moving the inner tube member 30 in the outer tube member 40 in the central axis direction. Further, as will be described in detail later, the drive shaft 13 and the electric signal line 14 which are a part of the ultrasonic probe 10 pass through the inside of the inner tube member 30 and the outer tube member 40, and the insertion portion 110a is inserted in the longitudinal direction A. It extends not only to the region of the above but also to the region of the operation unit 110b. That is, the operation unit 110b of the present embodiment is partially composed of the ultrasonic probe 10 in addition to the inner tube member 30 and the outer tube member 40.

[Ultrasonic probe 10]
As shown in FIG. 2, the ultrasonic probe 10 includes an ultrasonic transducer 11, a housing 12, a drive shaft 13, an electric signal line 14, a holding body 15, and a fixing member 16.

As shown in FIG. 4, the ultrasonic transducer 11 includes a piezoelectric element 1, a support member 2, and an acoustic matching member 3. Specifically, the piezoelectric element 1 includes a flat piezoelectric body 4, a first electrode 5 laminated on at least one side of the piezoelectric body 4 in the thickness direction B, and at least the other of the piezoelectric body 4 in the thickness direction B. It is composed of a second electrode 6 laminated on the side. Hereinafter, for convenience of explanation, one side of the thickness direction B of the piezoelectric body 4 in which at least a part of the first electrode 5 is provided will be referred to as “the surface side of the piezoelectric element 1”. Further, for convenience of explanation, the other side of the piezoelectric body 4 in the thickness direction B in which at least a part of the second electrode 6 is provided is described as "the back surface side of the piezoelectric element 1". The surface side of the piezoelectric element 1 is a side that transmits and receives ultrasonic waves. Further, the back surface side of the piezoelectric element 1 is the side opposite to the side that transmits and receives ultrasonic waves.

The piezoelectric body 4 of the piezoelectric element 1 is composed of, for example, a piezoelectric ceramic sheet. Examples of the material of the piezoelectric ceramic sheet include piezoelectric ceramic materials such as lead titanate (PZT) and lithium niobate. The piezoelectric body 4 may be made of crystal instead of the piezoelectric ceramic material.

The first electrode 5 and the second electrode 6 of the piezoelectric element 1 are laminated as electrode layers on both sides of the piezoelectric body 4 in the thickness direction B by, for example, an ion plating method using a mask material, a vapor deposition method, or a sputtering method. Can be formed by Examples of the material of the first electrode 5 and the second electrode 6 include metals such as silver, chromium, copper, nickel, and gold, and laminates of these metals.

The first electrode 5 of this embodiment is formed only on the surface side of the piezoelectric element 1.

On the other hand, the second electrode 6 of the present embodiment is composed of a folded electrode. Specifically, the second electrode 6 of the present embodiment includes a back surface electrode layer 6a, a front surface electrode layer 6b, and a connecting conductive portion 6c. The back surface electrode layer 6a is located on the back surface side of the piezoelectric element 1. The surface electrode layer 6b is located on the surface side of the piezoelectric element 1. The connecting conductive portion 6c connects the back surface electrode layer 6a and the front surface electrode layer 6b. In other words, the second electrode 6 of the present embodiment is formed from the back surface side to the front surface side of the piezoelectric element 1. By using the second electrode 6 as a folded electrode, the first electrode 5 and the surface electrode layer 6b of the second electrode 6 can be arranged together on the surface side of the piezoelectric element 1. As a result, the connection work between the electric signal line 14, the first electrode 5, and the second electrode 6 is made piezoelectric as compared with the case where each of the first electrode and the second electrode is arranged only on separate surfaces of the piezoelectric element. This can be done only on one side of the element 1.

In the present embodiment, the second electrode 6 is composed of the folded electrode, but instead of the second electrode 6, the first electrode 5 may be composed of the folded electrode.

As shown in FIG. 4, the support member 2 supports the piezoelectric element 1 from the back surface side of the piezoelectric element 1. Specifically, the support member 2 is laminated on the piezoelectric element 1 so as to cover the back surface side of the piezoelectric element 1. As a result, it is possible to absorb the ultrasonic waves from the piezoelectric element 1 that become noise. That is, the support member 2 of the present embodiment constitutes a sound absorbing layer that absorbs the ultrasonic waves of the piezoelectric element 1.

The sound absorbing layer as the support member 2 can be formed by a method in which a sheet material forming the sound absorbing layer is attached to the piezoelectric element 1, a method in which a liquid sound absorbing material forming the sound absorbing layer is applied and cured, and the like. .. Examples of the material of the support member 2 include rubber and an epoxy resin in which a metal powder such as tungsten powder is dispersed.

As shown in FIG. 4, the acoustic matching member 3 is laminated so as to cover a part of the surface side of the piezoelectric element 1. More specifically, in the acoustic matching member 3 of the present embodiment, the position where the electric signal line 14 is connected in the first electrode 5 and the electric signal line 14 in the surface electrode layer 6b of the second electrode 6 are connected. It is laminated so as to cover the entire surface side of the piezoelectric element 1 except for the position where it is formed. By providing the acoustic matching member 3, it is possible to improve the propagation efficiency of ultrasonic waves to the subject. That is, the acoustic matching member 3 of the present embodiment constitutes an acoustic matching layer that enhances the propagation efficiency of ultrasonic waves.

The acoustic matching layer as the acoustic matching member 3 is formed by a method in which a sheet material forming the acoustic matching layer is attached to the piezoelectric element 1, a method in which a liquid acoustic matching material forming the acoustic matching layer is applied and cured, and the like. Can be formed. Examples of the material of the acoustic matching member 3 include a resin material such as an epoxy resin. Further, the acoustic matching member 3 may be composed of a laminate of resin layers made of a resin material.

As shown in FIG. 2, the housing 12 houses the ultrasonic oscillator 11 inside. The base end side of the housing 12 is connected to the drive shaft 13. The housing 12 has a shape in which an opening 12a is provided in a part of the peripheral wall of a cylindrical metal pipe, and is formed by carving from a metal block, MIM (metal powder injection molding), or the like. Further, the housing 12 may be formed by ceramics formed by firing zirconia or the like or by molding a resin material such as polycarbonate.

Further, as shown in FIGS. 2 and 3, at least a part (all in the present embodiment) of the holding body 15 and the fixing member 16 is housed inside the housing 12. More specifically, the housing 12 of the present embodiment includes a tip wall portion 12b located on the tip side of the above-mentioned opening 12a and a base end-side tubular portion 12c located on the base end side of the above-mentioned opening 12a. , Equipped with. In the present embodiment, at least a part of the holding body 15 and the fixing member 16 is housed in the proximal end side tubular portion 12c.

The tip end side and the base end side of the housing 12 of the present embodiment are closed. As shown in FIG. 2, a tip wall portion 12b is provided at a position on the housing 12 on the tip side of the ultrasonic vibrator 11. Further, as shown in FIG. 2, a holding body 15 and a fixing member 16 are arranged at a position on the base end side of the housing 12 with respect to the ultrasonic vibrator 11, and close the base end side tubular portion 12c of the housing 12. are doing. By doing so, the accuracy of diagnostic imaging can be improved.

The drive shaft 13 is made of a flexible tubular body. Inside the drive shaft 13, an electric signal line 14 connected to the ultrasonic transducer 11 is arranged. The drive shaft 13 is composed of, for example, a multi-layer coil having different winding directions around the shaft. Examples of the coil material include stainless steel and Ni—Ti (nickel / titanium) alloy. By using such a drive shaft 13, even if the two electric signal lines 14 are composed of a double spiral twist pair cable, the shielding property is improved and the influence of noise generated from the electric signal lines 14 is reduced. be able to.

The drive shaft 13 passes through the inside of the inner pipe member 30 and the outer pipe member 40 and extends to the hub 32 described later located at the base end portion of the inner pipe member 30. That is, the drive shaft 13 extends from the tip end portion of the insertion portion 110a to the base end portion of the operation portion 110b in the longitudinal direction A.

As shown in FIG. 2, the electric signal line 14 extends in the drive shaft 13 and electrically connects the ultrasonic vibrator 11 and the external device 120. That is, like the drive shaft 13, the electric signal line 14 extends from the tip end portion of the insertion portion 110a to the base end portion of the operation portion 110b in the longitudinal direction A. A plurality of electric signal lines 14 (two in this embodiment) are provided, and are connected to the first electrode 5 and the second electrode 6 described above, respectively. The plurality of electric signal lines 14 are composed of, for example, a twisted pair cable in which two electric signal lines 14 are twisted together. Each electric signal line 14 can be a flexible thin wire member having an outer diameter of more than 0 mm and 0.2 mm or less. Each electric signal line 14 can be composed of, for example, a lead wire larger than 0 mm and 0.2 mm or less, and a covering material formed of an insulating material and covering the periphery of the lead wire. Such an electric signal line 14 is connected to the piezoelectric element 1 by a connecting portion 14a (see FIG. 4) formed of a conducting wire whose covering material is removed and exposed.

As shown in FIGS. 2 and 3, the holding body 15 is attached to a plurality of (two in this embodiment) electric signal lines 14. The holding body 15 holds a relative positional relationship between a part of each electric signal line 14. The two electric signal lines 14 of the present embodiment are held at a position where the holding body 15 is attached in a state where the positional relationship with each other is separated from each other. In other words, the holder 15 holds a gap between a part of each electric signal line 14.

In the present embodiment, the portion of the two electric signal lines 14 adjacent to the holding body 15 is connected to the piezoelectric element 1 by using solder, a conductive adhesive, or the like. More specifically, the portion of the two electric signal lines 14 adjacent to the tip end side of the holding body 15 is connected to the piezoelectric element 1. As described above, the electric signal line 14 of the present embodiment is composed of a conducting wire and a covering material. Therefore, the two electric signal lines 14 of the present embodiment are connected to the first electrode 5 and the second electrode 6 of the piezoelectric element 1 in a state where the covering material is removed and the lead wires are exposed.

As described above, the holding body 15 is located in the housing 12. More specifically, at least a part (all in this embodiment) of the holding body 15 of the present embodiment is located in the proximal end side tubular portion 12c. In other words, the maximum length of the holder 15 orthogonal to the longitudinal direction A is smaller than the inner diameter of the housing 12. As a result, the holding body 15 can be accommodated in the proximal end side tubular portion 12c of the housing 12. Further, the holding body 15 is not in contact with the inner surface of the base end side tubular portion 12c of the housing 12 at least in a part in the circumferential direction of the housing 12. In the present embodiment, the fixing member 16 is interposed between the holding body 15 and the inner surface of the base end side tubular portion 12c of the housing 12.

The retainer 15 may be made of ceramic or the like, but is preferably made of a material containing rubber or resin as a main component. Specifically, as the rubber material of the holding body 15, for example, silicone rubber can be mentioned. Further, examples of the resin material of the holding body 15 include silicone resin and epoxy resin. More specifically, the holding body 15 is formed of, for example, a silicone rubber-based adhesive, a silicone resin-based adhesive, an epoxy resin-based adhesive, or the like. Further, the holding body 15 can be formed by, for example, a UV curable adhesive. Further, a material having X-ray contrast property such as tungsten may be mixed with the holder 15.

As shown in FIGS. 2 and 3, the fixing member 16 fixes the position of the holding body 15 in the housing 12. The structure of the fixing member 16 is not particularly limited as long as the position of the holding body 15 in the housing 12 can be fixed. However, as in the present embodiment, the fixing member 16 is preferably an adhesive body that is interposed between the holding body 15 and the housing 12 and adheres the holding body 15 to the housing 12. In this way, the gap between the holding body 15 and the housing 12 can be filled, and the ultrasonic waves from the ultrasonic transducer 11 pass between the holding body 15 and the housing 12 and are outside the housing 12. It can be suppressed from leaking to. As a result, the ultrasonic waves reflected at the site to be diagnosed can be efficiently received. Therefore, the accuracy of diagnostic imaging can be improved.

In particular, the adhesive body as the fixing member 16 is preferably arranged so as not to form a gap between the holding body 15 and the inner surface of the housing 12 in the entire circumferential direction of the housing 12. In other words, it is preferable that the inside of the housing 12 is closed by the electric signal line 14, the holding body 15, and the adhesive body as the fixing member 16 on the proximal end side of the ultrasonic vibrator 11. By doing so, it is possible to further prevent the ultrasonic waves from the ultrasonic transducer 11 from leaking to the outside of the housing 12 through between the holding body 15 and the housing 12.

The adhesive body as the fixing member 16 is preferably composed of a material containing rubber or resin as a main component. Specifically, the adhesive body as the fixing member 16 is formed of, for example, a silicone rubber-based adhesive, an epoxy resin-based adhesive, or the like.

When the main components of the holding body 15 and the adhesive body as the fixing member 16 are the same as rubber or resin, the rubber material or resin material which is the main component of the adhesive body as the fixing member 16 is It can be different from the rubber material or resin material that is the main component of the holder 15. As described above, when both the holding body 15 and the fixing member 16 are formed by an adhesive, the adhesive forming the holding body 15 is made of a material having a higher viscosity than the adhesive forming the fixing member 16. It is preferable to do so. The highly viscous adhesive constituting the holding body 15 makes it easy to secure the position holding performance between the plurality of electric signal lines 14. Further, the low-viscosity adhesive constituting the fixing member 16 improves the work efficiency of filling the gap between the holding body 15 and the housing 12. Even if the main components of the holding body 15 and the adhesive body as the fixing member 16 are different in rubber or resin, if they are both formed by an adhesive, for the same reason as described above, It is preferable to adopt the same viscosity relationship as described above.

[Sheath 20]
As shown in FIG. 2, the sheath 20 partitions the first hollow portion 21a and the second hollow portion 21b. The ultrasonic probe 10 is housed in the first hollow portion 21a. The ultrasonic probe 10 can move back and forth in the longitudinal direction A in the first hollow portion 21a. A guide wire W can be inserted into the second hollow portion 21b. In the present embodiment, the tubular guide wire insertion portion 20b that partitions the second hollow portion 21b is parallel to the tip of the tubular main body portion 20a that partitions the first hollow portion 21a. Is located in. The main body portion 20a and the guide wire insertion portion 20b can be formed by joining different pipe members by heat fusion or the like, but the forming method is not limited to this.

The main body 20a is provided with a marker 22 having X-ray contrast property, which is formed of a material that is opaque to X-rays. Further, the guide wire insertion portion 20b is also provided with a marker 23 having X-ray contrast property. The

markers

22 and 23 can be configured by, for example, a metal coil or a metal pipe having high X-ray opacity such as platinum, gold, iridium, and tungsten.

In the range in which the ultrasonic vibrator 11 moves in the longitudinal direction A of the sheath 20, a window portion 24 formed in which the transparency of ultrasonic waves is higher than that of other parts is formed. More specifically, the window portion 24 of the present embodiment is formed on the main body portion 20a of the sheath 20.

The window portion 24 of the main body portion 20a and the guide wire insertion portion 20b 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, transpolyisoprene, fluororubber, and chlorinated polyethylene, and one of them. Alternatively, a polymer alloy, a polymer blend, a laminate, or the like in which two or more kinds are combined can also be used.

The base end side of the main body portion 20a with respect to the window portion 24 has a reinforcing portion reinforced with a material having a higher rigidity than the window portion 24. The reinforcing portion is formed, for example, by disposing a reinforcing material in which a metal wire such as stainless steel is braided in a mesh shape on a flexible tubular member such as resin. The tubular member is made of the same material as the window portion 24.

It is preferable to arrange a hydrophilic lubricating coating layer that exhibits lubricity when wet on the outer surface of the sheath 20.

At the tip of the main body 20a of the sheath 20, a communication hole 26 for communicating the inside and the outside of the first hollow portion 21a is formed. At the time of priming, the gas in the main body 20a can be discharged through the communication hole 26.

[Inner tube member 30 and outer tube member 40]
As shown in FIG. 1, the inner pipe member 30 includes an inner pipe 31 and a hub 32. The inner pipe 31 is inserted so as to be movable back and forth in the outer pipe member 40. The hub 32 is provided on the base end side of the inner pipe 31.

As shown in FIG. 1, the outer tube member 40 includes an outer tube 41, a tip end side connector 42, and a proximal end side connector 43. The outer pipe 41 is located on the outer side in the radial direction of the inner pipe 31, and the inner pipe 31 moves back and forth inside the outer pipe 41. The tip-side connector 42 connects the base end of the main body 20a of the sheath 20 and the tip of the outer tube 41. The base end side connector 43 is provided at the base end portion of the outer pipe 41, and is configured to receive the inner pipe 31 in the outer pipe 41.

The drive shaft 13 and the electric signal line 14 of the ultrasonic probe 10 described above are the main body 20a of the sheath 20, the outer tube member 40 connected to the proximal end side of the main body 20a, and the outer tube member 40. It extends to the hub 32 located at the base end of the inner pipe member 30 in which a part of the inner pipe member 30 is inserted.

The ultrasonic probe 10 and the inner tube member 30 described above are connected to each other so as to move back and forth in the longitudinal direction A integrally. Therefore, for example, when the inner pipe member 30 is pushed in the insertion direction A1, the inner pipe member 30 is pushed into the outer pipe member 40 in the insertion direction A1. When the inner tube member 30 is pushed into the outer tube member 40 toward the insertion direction A1, the ultrasonic probe 10 connected to the inner tube member 30 moves in the main body 20a of the sheath 20 in the insertion direction A1. To do. On the contrary, when the inner pipe member 30 is pulled in the pulling direction A2, the inner pipe member 30 is pulled out from the outer pipe member 40 in the pulling direction A2. When the inner tube member 30 is pulled out from the inside of the outer tube member 40 in the removal direction A2, the ultrasonic probe 10 connected to the inner tube member 30 moves in the main body 20a of the sheath 20 in the removal direction A2.

When the inner pipe member 30 is pushed most in the insertion direction A1, the tip portion of the inner pipe member 30 reaches the vicinity of the tip side connector 42 of the outer pipe member 40. At this time, the ultrasonic transducer 11 of the ultrasonic probe 10 is located near the tip of the main body 20a of the sheath 20.

At the tip of the inner pipe member 30, the inner pipe member 30 is prevented from popping out toward the tip side of the outer pipe member 40, and the outer pipe member 40 is pulled to the most proximal side when the inner pipe member 30 is pulled to the most proximal side. A stopper is provided on the base end side of the tube to prevent it from falling off. The stopper portion is not particularly limited as long as it can realize the above function, and may be configured by, for example, a wall portion that abuts the outer pipe member 40 at a predetermined position in the longitudinal direction A.

A connector portion that is mechanically and electrically connected to the external device 120 is provided at the base end of the hub 32 of the inner pipe member 30. That is, the diagnostic imaging catheter 110 is mechanically and electrically connected to the external device 120 by a connector portion provided on the hub 32 of the inner tube member 30. More specifically, the electric signal line 14 of the ultrasonic probe 10 extends from the ultrasonic transducer 11 to the connector portion of the hub 32, and the connector portion of the hub 32 is connected to the external device 120. Then, the ultrasonic vibrator 11 and the external device 120 are electrically connected. The received signal in the ultrasonic vibrator 11 is transmitted to the external device 120 via the connector portion of the hub 32, is subjected to predetermined processing, and is displayed as an image.

<External device 120>
As shown in FIG. 1, the external device 120 has a motor 121 which is a power source for rotating the drive shaft 13 and a motor 122 which is a power source for moving the drive shaft 13 in the longitudinal direction A. .. The rotational motion of the motor 122 is converted into axial motion by the ball screw 123 connected to the motor 122.

More specifically, the external device 120 of the present embodiment includes a drive unit 120a, a control device 120b electrically connected to the drive unit 120a by wire or wirelessly, and the control device 120b is a diagnostic imaging catheter 110. A monitor 120c capable of displaying an image generated based on a received signal received from is provided. The above-mentioned motor 121, motor 122 and ball screw 123 of the present embodiment are provided in the drive unit 120a. The operation of the drive unit 120a is controlled by the control device 120b. The control device 120b can be configured by a processor including a CPU and a memory.

The external device 120 is not limited to the configuration shown in the present embodiment, and may be further provided with an external input unit such as a keyboard, for example.

<Manufacturing method of ultrasonic probe 10>
Next, an example of a method for manufacturing an ultrasonic probe according to the present disclosure will be described. Here, a method for manufacturing the ultrasonic probe 10 as an embodiment of the ultrasonic probe according to the present disclosure will be described.

FIG. 5 is a flowchart showing an example of a method for manufacturing the ultrasonic probe 10. The method for manufacturing the ultrasonic probe 10 shown in FIG. 5 includes a sandwiching step S1, a mounting step S2, a coating removing step S3, a cutting step S4, an alignment step S5, and a connecting step S6. FIG. 6A is a diagram showing an outline of the sandwiching step S1. FIG. 6B is a diagram showing an outline of the mounting process S2. FIG. 6C is a diagram showing an outline of the coating removal step S3. FIG. 6D is a diagram showing an outline of the cutting step S4. FIG. 6E is a diagram showing an outline of the alignment step S5. FIG. 6F is a diagram showing an outline of the connection step S6. Hereinafter, each process S1 to S6 will be described in detail with reference to FIGS. 5 and 6A to 6F.

As shown in FIG. 6A, in the sandwiching step S1, a plurality of electric signal lines 14 are sandwiched at positions on both sides of the holding position P3 described later, which is held by the holding body 15. In the present embodiment, the two electric signal lines 14 formed of the twisted pair cable are sandwiched at two places by using the first clamp member 201a and the second clamp member 201b. More specifically, at the first position P1 in which the first clamp member 201a sandwiches the two electric signal lines 14, the second clamp member 201b holds the two electric signal lines 14 in the extending direction C of the twist pair cable. It is different from the second position P2 to be sandwiched. In the extending direction C, a holding position P3, which will be described later, to which the holding body 15 is attached is located between the first position P1 and the second position P2. The sandwiching step S1 can improve the workability of the mounting step S2, which will be described later. Each of the first clamp member 201a and the second clamp member 201b can be configured such that two electric signal lines 14 are sandwiched by, for example, a sponge material.

Further, in the present embodiment, in the sandwiching step S1, one of the first clamp member 201a and the second clamp member 201b is rotated with respect to the other in a state where a predetermined tension is applied to the extending direction C, and 2 The twist of the electric signal line 14 of the book is eliminated. By doing so, in the pinching step S1, a plurality of (two in this embodiment) electric signal lines 14 extend along one direction (extending direction C in this embodiment) at the holding position P3 described later. As such, a plurality of electric signal lines 14 can be sandwiched. More specifically, in the present embodiment, of the two electric signal lines 14, the portion between the first position P1 and the second position P2 extends so as to be substantially parallel to the extending direction C. The state can be realized. As a result, the workability of the mounting step S2, which will be described later, can be further improved. The distance in the extending direction C between the first position P1 and the second position P2 is preferably 3 cm or more in consideration of workability such as the mounting step S2 described later.

As shown in FIG. 6B, in the attachment step S2, a holder 15 capable of maintaining a relative positional relationship between a part of the electric signal lines 14 is attached to the plurality of electric signal lines 14. More specifically, at the holding position P3 between the first position P1 and the second position P2 in the extending direction C, the two electric signal lines 14 substantially parallel to the extending direction C are separated from each other. A holder 15 that keeps the distance constant is attached. The retainer 15 can be, for example, a UV curable adhesive. When the retainer 15 is formed of such a UV curable adhesive, for example, a split mold formed of a UV permeable material may be used. In this way, the UV curable adhesive is filled in the split molds arranged so as to sandwich the plurality of electric signal lines 14, and UV is irradiated from the outside. As a result, the adhesive can be cured to form the holding body 15.

The distance between the plurality of electric signal lines 14 separated by the holding body 15 may be appropriately determined according to the separation distance between the locations where the electric signal lines 14 are connected in the piezoelectric element 1.

The shape of the holding body 15 is not particularly limited, but since it is housed in the housing 12 (see FIGS. 2 and 3) as described above, it is molded in a size and shape that can be housed in the housing 12.

As shown in FIG. 6C, in the coating removal step S3, for example, the coating material of at least two electric signal lines 14 out of the plurality of electric signal lines 14 is removed by laser irradiation. This exposes the lead wire of the electric signal line 14. In the coating removal step S3, the covering material of the two electric signal lines 14 is applied at either a position between the first position P1 and the holding position P3 or between the second position P2 and the holding position P3. Remove. In particular, in the coating removal step S3, it is preferable to at least remove the coating material located at a portion adjacent to the holding body 15 of the two electric signal lines 14. In the portion adjacent to the holding body 15, even if the first clamp member 201a and the second clamp member 201b are removed from the electric signal line 14, the separation distance between the two electric signal lines 14 is relatively easy to be maintained. Therefore, of the two electric signal lines 14, the portion adjacent to the holding body 15 can be easily used as a portion to be connected to the piezoelectric element 1 in the connection step S6 described later, and the workability of the connection step S6 can be improved. ..

Here, the "portion adjacent to the holding body" means the holding body 15 in the extending direction C with respect to the minimum separation distance at the holding position P3 in which the two electric signal lines 14 are held by the holding body 15. It means a portion located closer to the holder 15 than a position separated by a distance of 5 times from.

As shown in FIG. 6D, in the cutting step S4, of the two electric signal lines 14, the portion from which the coating material has been removed by the coating removing step S3 is cut and connected to the piezoelectric element 1 (see FIG. 4). Part 14a is formed. This cutting step S4 is executed in a state where the two electric signal lines 14 are sandwiched between the first clamp member 201a and the second clamp member 201b.

As shown in FIG. 6E, in the alignment step S5, the connection position between the piezoelectric element 1 and the connection portion 14a of the two electric signal lines 14 is adjusted by the alignment jig 203. The alignment jig 203 of the present embodiment includes a vibrator fixing portion 203a in which the ultrasonic vibrator 11 including the piezoelectric element 1 is fixed in position, and a holding body fixing portion 203b in which the holding body 15 is fixed in position. In FIG. 6E, only the piezoelectric element 1 of the ultrasonic oscillator 11 is shown for convenience of explanation. In the alignment jig 203, the holding body fixing portion 203b is slidably attached to the vibrator fixing portion 203a so as to be close to and separated from the thickness direction B in a direction orthogonal to the thickness direction B. The position of the ultrasonic vibrator 11 fixed to the vibrator fixing portion 203a and the holding body 15 fixed to the holding body fixing portion 203b are different in the thickness direction B so as not to interfere with each other when sliding. There is. When such an alignment jig 203 is used, by sliding the holder fixing portion 203b with respect to the vibrator fixing portion 203a, at least a part of the piezoelectric element 1 of the ultrasonic vibrator 11 and two electric wires are used. It can be aligned so that it overlaps with the connecting portion 14a of the signal line 14 in the thickness direction B. In this way, by using the alignment jig 203, the connection operation in the connection step S6 described later can be executed more reliably and easily.

As shown in FIG. 6F, in the connection step S6, a portion of the plurality of electric signal lines 14 adjacent to the holding body 15 of at least two electric signal lines 14 is connected to the piezoelectric element 1 of the ultrasonic vibrator 11. .. In this embodiment, both of the two electric signal lines 14 are connected to the piezoelectric element 1. Specifically, one of the two electric signal lines 14 is connected to the first electrode 5 (see FIG. 4) of the piezoelectric element 1, and the other of the two electric signal lines 14 is connected to the second electrode of the piezoelectric element 1. Connect to 6 (see FIG. 4). The connection of the electric signal line 14 to the piezoelectric element 1 can be realized by, for example, the preliminary solder 204 in the molten state and the solder paste 205. Preliminary solder 204 is applied to the first electrode 5 and the second electrode 6 of the piezoelectric element 1 in advance, and after arranging the electric signal line 14, the solder paste 205 is applied to apply the electric signal line 14 to the preliminary solder 204 and It is sandwiched between solder paste 205. By heating with hot air in this state, the solder paste 205 is melted, integrated with the preliminary solder 204 in the melted state, and the electric signal line 14 is joined. Further, even if the applied solder paste 205 adheres so as to straddle the two electric signal lines 14, the solder paste 205 is integrated with each electric signal line 14 by being heated by hot air. It separates into the part to be soldered. In this way, the electric signal line 14 can be connected to the piezoelectric element 1 by using the preliminary solder 204 and the solder paste 205.

In the present embodiment, the preliminary solder 204 is applied to the piezoelectric element 1 in advance, and the solder paste 205 is applied later so as to sandwich the electric signal line 14, but the reverse is also possible. That is, the solder paste 205 may be applied to the piezoelectric element 1 in advance, and the preliminary solder 204 may be applied later so as to sandwich the electric signal line 14. Further, when the preliminary solder 204 or the solder paste 205 is applied to the piezoelectric element 1 in advance, it is preferable to quantify the applied amount by using a metal mask.

Further, as a method of not using the preliminary solder 204 and the solder paste 205, a UV curable adhesive may be used for connection.

As described above, the two electric signal lines 14 are held by the holder 15. Therefore, of the two electric signal lines 14, the portions located within a predetermined distance from the holding body 15 can maintain a state of being separated from each other by a predetermined distance. Therefore, in the connection step S6 described above, there is a case where two electric signal lines 14 having flexibility, for example, an outer diameter of about 0.1 mm, are connected to a small piezoelectric element 1 of 0.5 mm square, for example. However, since the two electric signal lines 14 can be maintained at a predetermined distance (the distance between the points where the two electric signal lines 14 are connected in the piezoelectric element 1), the piezoelectric element 1 can be relatively easily separated. Can make a connection to.

Further, a manufacturing apparatus capable of executing one or more of the above steps S1 to S6 may be used. In this way, it is possible to suppress manual failures and further improve production efficiency.

In particular, a place where one of the first electrode 5 and the second electrode 6 of the piezoelectric element 1 is composed of a folded electrode, and two electric signal lines 14 are connected to only one of the front surface side or the back surface side of the piezoelectric element 1. If there is, the separation distance between the points where the two electric signal lines 14 are connected in the piezoelectric element 1 becomes very small. Therefore, it is particularly difficult to connect the two electric signal lines 14 to different positions of the piezoelectric element 1. In the case of the piezoelectric element 1 having such a folded electrode, it is particularly preferable to use the above-mentioned manufacturing method using the holding body 15.

Further, the method for manufacturing the ultrasonic probe 10 shown in FIG. 4 further includes a housing step of housing the holder 15 in the housing 12 (see FIGS. 2 and 3). After the holding body 15 is housed in the housing 12 by this housing step, the connection step S6 described above may be executed. Further, the method for manufacturing the ultrasonic probe 10 shown in FIG. 4 further includes a fixing step of fixing the position of the holding body 15 in the housing 12 by using the fixing member 16 (see FIGS. 2 and 3). In the fixing step, for example, an adhesive forming the fixing member 16 is filled between the housing 12 and the holding body 15 to fix the position of the holding body 15 with respect to the housing 12. In this way, by accommodating the holding body 15 for holding the electric signal line 14 in the housing 12, the electric signal line is increased by the volume of the holding body 15 as compared with the case where only the electric signal line 14 is housed in the housing 12. The gap between the 14 and the housing 12 can be reduced. Therefore, when a liquid adhesive is used as the fixing member 16, the filling amount of the adhesive as the fixing member 16 can be reduced. As a result, the amount of wasted adhesive that flows out of the housing 12 during filling can also be reduced.

The method for manufacturing an ultrasonic probe and the ultrasonic probe according to the present disclosure are not limited to the specific configuration / process specified in the above-described embodiment, and are not limited to the description of the scope of the claim. , Various modifications and changes are possible. As described above, the method for manufacturing the ultrasonic probe 10 shown in FIG. 4 may include, for example, the above-mentioned accommodating step in addition to the steps S1 to S6. Further, in the method for manufacturing the ultrasonic probe 10 shown in FIG. 4, for example, the mounting step S2 is executed before the coating removing step S3, but the coating removing step S3 may be executed first. As described above, the method for manufacturing the ultrasonic probe according to the present disclosure is not limited to the steps S1 to S6 shown in the above-described embodiment and the order thereof. Therefore, the method for manufacturing the ultrasonic probe according to the present disclosure may include, for example, a step of dissolving the holding body 15 with a solvent or the like after connecting the electric signal line 14 and the piezoelectric element 1. By melting the holding body 15, for example, the connected piezoelectric element 1 and the electric signal line 14 may be fixed to the housing 12 by another fixing method that does not use an adhesive as the fixing member 16. Further, the ultrasonic probe 10 of the above-described embodiment has only two electric signal lines 14, and the two electric signal lines 14 are held by the holding body 15, but three of them. The above electric signal line 14 may be held by the holding body 15. In such a case, at least two electric signal lines 14 of three or more electric signal lines 14 may be connected to the piezoelectric element 1.

Further, the ultrasonic probe 10 of the above-described embodiment is configured to include only an ultrasonic transducer 11 capable of intravascular ultrasonic diagnosis as an imaging core, but is not limited to this configuration, for example, light. It may be configured to further include an optical transmission / reception unit that enables interference fault diagnosis (Optical Coherence Tomography, abbreviated as “OCT”). FIG. 7 is a cross-sectional view showing a part of an image diagnostic catheter 410 including an ultrasonic transducer 11 and an ultrasonic probe 310 including an optical transmission / reception unit 301. The ultrasonic probe 310 shown in FIG. 7 is different from the above-mentioned ultrasonic probe 10 in that a configuration that enables optical interference tomographic diagnosis is added.

Specifically, in the ultrasonic probe 310 shown in FIG. 7, an optical transmitter / receiver 301 is arranged in the housing 12 in addition to the ultrasonic oscillator 11. The optical transmission / reception unit 301 continuously transmits light (measurement light) transmitted from the optical fiber cable as the optical signal line 302 extending in the drive shaft 13 into the biological lumen, and also in the biological lumen. Continuously receives reflected light from the living body tissue of. The optical transmission / reception unit 301 transmits the received reflected light to the external device 120 (see FIG. 1) through the optical signal line 302. The control device 120b (see FIG. 1) of the external device 120 generates interference light data by interfering the reflected light obtained by the measurement with the reference light obtained by separating the light from the light source. Further, the control device 120b of the external device 120 generates an optical tomographic image based on the generated interference light data and displays it on the monitor 120c (see FIG. 1).

As shown in FIG. 7, in the drive shaft 13, the plurality of electric signal lines 14 are spirally wound around the optical signal lines 302, and the plurality of electric signal lines 14 extend in parallel with each other. .. More specifically, the two electric signal lines 14 shown in FIG. 7 extend around the optical fiber cable as the optical signal line 302 extending in the longitudinal direction A in a double spiral shape.

Further, the method for manufacturing an ultrasonic probe according to the present disclosure can be applied even to an ultrasonic probe 310 having a configuration capable of diagnosing an optical interference fault as shown in FIG. 7.

1: piezoelectric element 2: support member 3: acoustic matching member 4: piezoelectric body 5: first electrode 6: second electrode 6a: back surface electrode layer 6b: front surface electrode layer 6c: connected conductive part 10, 310: ultrasonic probe Child 11: Ultrasonic transducer 12: Housing 12a: Opening 12b: Tip side wall 12c: Base end side tubular part 13: Drive shaft 14: Electric signal line 14a: Connection part 15: Holder 16: Fixing member 20: Sheath 20a: Main body 20b: Guide wire insertion part 21a: First hollow part 21b: Second hollow part 22, 23: Marker 24: Window part 26: Communication hole 30: Inner pipe member 31: Inner pipe 32: Hub 40: Outer tube member 41: Outer tube 42: Tip side connector 43: Base end side connector 100: Diagnostic imaging device 110, 410: Diagnostic imaging catheter 110a: Insertion unit 110b: Operation unit 120: External device 120a: Drive unit 120b: Control Device 120c: Monitor 121: Motor 122: Motor 123: Ball screw 201a: First clamp member 201b: Second clamp member 203: Alignment jig 203a: Transducer fixing part 203b: Holder fixing part 301: Optical transmission / reception part 302: Optical Signal line A: Longitudinal direction of diagnostic imaging catheter B: Thickness direction of piezoelectric element C: Extension direction of electric signal line P1: First position sandwiched by first clamp member P2: Sandwiched by second clamp member Second position P3: Holding position W held by the holding body: Guide wire

Claims

It is a method of manufacturing an ultrasonic probe.
An attachment step of attaching a holder capable of maintaining a relative positional relationship between a part of the at least two electric signal lines to at least two electric signal lines,
A method for manufacturing an ultrasonic probe, which comprises a connection step of connecting a portion of at least two electric signal lines adjacent to the holding body to a piezoelectric element.
The ultrasonic probe according to claim 1, further comprising a sandwiching step of sandwiching at least two electric signal lines at positions on both sides of a holding position held by the holding body before the mounting step. Production method.
The ultrasonic probe according to claim 2, wherein in the sandwiching step, the at least two electric signal lines are sandwiched so that the at least two electric signal lines extend along one direction at the holding position. How to make a tentacle.
The ultrasonic probe according to claim 2 or 3, further comprising a coating removing step of removing the coating material of at least two electric signal lines after the sandwiching step and before the connecting step. Production method.
Any one of claims 1 to 4, further comprising an alignment step of adjusting the connection position of the piezoelectric element and the connection position of at least two electric signal lines by an alignment jig before the connection step. The method for manufacturing an ultrasonic probe described in 1.
With a piezoelectric element
At least two electric signal lines connected to the piezoelectric element,
A holder attached to the at least two electric signal lines and maintaining a relative positional relationship between a part of the at least two electric signal lines.
An ultrasonic probe comprising the piezoelectric element and a housing for accommodating the holder.
The ultrasonic probe according to claim 6, further comprising a fixing member for fixing the position of the holder in the housing.
The ultrasonic probe according to claim 7, wherein the fixing member is an adhesive body that is interposed between the holding body and the housing and adheres the holding body to the housing.
The adhesive and the holder contain rubber or resin as a main component and contain rubber or resin.
The ultrasonic probe according to claim 8, wherein the rubber material or resin material as the main component of the adhesive is different from the rubber material or resin material as the main component of the holder.