WO2022071157A1 - Arbre d'entraînement et cathéter pour diagnostic d'image - Google Patents

Arbre d'entraînement et cathéter pour diagnostic d'image Download PDF

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Publication number
WO2022071157A1
WO2022071157A1 PCT/JP2021/035187 JP2021035187W WO2022071157A1 WO 2022071157 A1 WO2022071157 A1 WO 2022071157A1 JP 2021035187 W JP2021035187 W JP 2021035187W WO 2022071157 A1 WO2022071157 A1 WO 2022071157A1
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WO
WIPO (PCT)
Prior art keywords
drive shaft
sheath
shaft
weakened portion
housing
Prior art date
Application number
PCT/JP2021/035187
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English (en)
Japanese (ja)
Inventor
健太 鈴木
泰徳 山下
ひかる 月原
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2022071157A1 publication Critical patent/WO2022071157A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters

Definitions

  • the present disclosure relates to a drive shaft and a catheter for diagnostic imaging.
  • a diagnostic imaging catheter that enables diagnosis by transmitting an ultrasonic wave and / or a light signal in the body cavity of a living body and receiving the reflected wave to image the surface and the inside of the lesion ().
  • the diagnostic imaging catheter is configured to generate an image by retracting an imaging core having a signal transmitting / receiving unit while rotating it at a predetermined rotation speed in the sheath.
  • the imaging core has a housing for accommodating a signal transmission / reception unit and a drive shaft fixed to the base end of the housing, and is rotationally driven by an external device.
  • the drive shaft is usually formed of a coil shaft composed of a multi-layered multi-row coil as described in Patent Document 1 extending over the entire length of the drive shaft.
  • the above-mentioned imaging core usually enables image generation by repeating transmission and reception while rotating at a constant rotation speed of about 1000 to 10000 rpm.
  • the housing accommodating the signal transmission / reception unit comes into contact with the sheath bent due to bending or lesions of the living lumen during rotation of the imaging core, there is a risk that the sheath will be damaged due to the friction of the contact.
  • the drive shaft as the first aspect of the present disclosure is a drive shaft fixed to the base end of a housing accommodating a signal transmission / reception unit for forming an imaging core of a diagnostic imaging catheter, and has a torsional strength. It has a weakened portion that is locally reduced to be smaller than any portion of the drive shaft.
  • the drive shaft has the weakened portion as a base end.
  • the drive shaft is more than a coil shaft having a tip fixed to the base end of the housing and a weakened portion fixed to the base end of the coil shaft. It has a shaft member having a large torsional rigidity.
  • the shaft member is a pipe having a notch.
  • the shaft member has a main portion in which a plurality of slits having a predetermined width arranged in the circumferential direction are arranged in a predetermined pattern in which a plurality of slits having a predetermined width are arranged in an axial direction at a predetermined pitch, and the weakened portion of the shaft member.
  • the plurality of slits are arranged in the same pattern as the main portion except that the predetermined width and / or the predetermined pitch is smaller than that of the main portion.
  • a pair of slits having the predetermined width facing each other in the radial direction and extending along the circumferential direction rotate at the predetermined pitch by a predetermined angle in the axial direction. It is a pattern that is arranged so as to line up while.
  • the weakened portion is located closer to the proximal end side than the main portion.
  • the diagnostic imaging catheter as the second aspect of the present disclosure includes a drive shaft as the first aspect of the present disclosure, a housing fixed to the tip of the drive shaft, and a signal transmission / reception unit housed in the housing. It has an imaging core comprising, and a sheath into which the imaging core is inserted.
  • the diagnostic imaging catheter has an outer tube connected to the proximal end of the sheath and an inner tube that is integrally inserted with the imaging core and inserted into the outer tube. ..
  • the weakened portion is located closer to the proximal end side than the sheath when the inner tube is most advanced.
  • a unit connector that is connected to the base end of the outer pipe, holds the inner pipe so as to be able to move forward and backward, and can release the holding of the inner pipe, and the weakened portion is the inner pipe. Is located closer to the proximal end than the unit connector when is most advanced.
  • a drive shaft and a catheter for diagnostic imaging capable of suppressing damage to the sheath due to contact between the housing accommodating the signal transmitting / receiving unit and the sheath.
  • FIG. 6 is a cross-sectional view taken along the line AA of FIG.
  • FIG. 6 is a cross-sectional view taken along the line BB of FIG.
  • the diagnostic imaging catheter 1 is a dual type that uses both an intravascular ultrasonic diagnostic method (IVUS) and an optical coherence tomography diagnostic method (OCT).
  • the dual type diagnostic imaging catheter 1 has three modes: a mode in which a tomographic image is acquired only by IVUS, a mode in which a tomographic image is acquired only by OCT, and a mode in which a tomographic image is acquired by IVUS and OCT. It exists and you can switch between these modes.
  • the diagnostic imaging catheter 1 is connected to and driven by an external device 2.
  • the diagnostic imaging apparatus 3 is composed of the diagnostic imaging catheter 1 and the external device 2.
  • the diagnostic imaging catheter 1 includes a sheath 4 inserted into a body cavity such as a blood vessel (a blood vessel such as a coronary artery) of a living body, and an outer tube connected to the base end of the sheath 4. 5 and the inner pipe 6 inserted into the outer pipe 5 so as to be able to advance and retreat, and the unit connector 7 which is connected to the base end of the outer pipe 5 and holds the inner pipe 6 so as to be able to advance and retreat, and can release the holding of the inner pipe 6.
  • a hub 8 connected to the base end of the inner pipe 6.
  • the diagnostic imaging catheter 1 includes a drive shaft 9, a housing 10 fixed to the tip of the drive shaft 9, and a signal transmission / reception unit 11 that is housed in the housing 10 and transmits / receives ultrasonic and / or light signals. And has an imaging core 12 comprising.
  • the imaging core 12 is inserted into the sheath 4, the outer tube 5, and the inner tube 6, and can move forward and backward in the axial direction integrally with the sheath 4 and the outer tube 5.
  • the tip means the end of the diagnostic imaging catheter 1 on the side inserted into the body cavity
  • the proximal end means the end of the diagnostic imaging catheter 1 on the side held outside the body cavity.
  • the axial direction means the direction along the central axis O of the drive shaft 9 (that is, the extending direction of the drive shaft 9)
  • the radial direction means the direction along the straight line orthogonal to the central axis O
  • the circumferential direction is. It means the direction around the central axis O.
  • the drive shaft 9 passes through the sheath 4, the outer pipe 5, and the inner pipe 6 and extends to the inside of the hub 8.
  • the hub 8, the inner pipe 6, the drive shaft 9, the housing 10, and the signal transmission / reception unit 11 are integrally connected to the sheath 4 and the outer pipe 5 so as to be able to move forward and backward in the axial direction. Therefore, for example, when the hub 8 is pushed toward the tip end side, that is, when the pushing operation is performed, the inner pipe 6 connected to the hub 8 is pushed into the outer pipe 5 and the unit connector 7, and the drive shaft is driven. 9.
  • the housing 10, the signal transmission / reception unit 11, that is, the imaging core 12 moves forward in the sheath 4, that is, toward the tip side.
  • the inner tube 6 is pulled out from the outer tube 5 and the unit connector 7 as shown by an arrow A1 in FIGS. 1 and 2B.
  • the imaging core 12 moves inside the sheath 4 toward the proximal end side as shown by the arrow A2.
  • the tip of the inner pipe 6 reaches the vicinity of the relay connector 13.
  • the signal transmission / reception unit 11 is located at the tip of the sheath 4 (near the lumen tip surface of the sheath 4).
  • the relay connector 13 connects the sheath 4 and the outer tube 5.
  • a locking portion 14 for preventing disconnection is provided at the tip of the inner pipe 6.
  • the locking portion 14 prevents the inner pipe 6 from coming out of the outer pipe 5.
  • the unit connector 7 has a distal end side partial connector 7a and a proximal end side partial connector 7b detachably connected to the distal end side partial connector 7a.
  • the locking portion 14 is the proximal end side partial connector 7b of the unit connector 7 when the hub 8 is most pulled out to the proximal end side, that is, when the inner tube 6 is most pulled out from the outer tube 5 and the unit connector 7. It is configured to be hooked in place on the inner wall. By disconnecting the proximal end side partial connector 7b from the distal end side partial connector 7a, the inner tube 6 including the locking portion 14 can be pulled out from the outer tube 5.
  • the drive shaft 9 is a long hollow member, and an electric signal line (electric cable) 15 and an optical signal line (optical fiber) 16 connected to the signal transmission / reception unit 11 are inside the drive shaft 9. Have been placed.
  • the signal transmission / reception unit 11 has an ultrasonic transmission / reception unit 11a for transmitting / receiving ultrasonic waves and an optical transmission / reception unit 11b for transmitting / receiving light.
  • the ultrasonic transmission / reception unit 11a has an oscillator that transmits ultrasonic waves based on pulse signals into the body cavity and receives ultrasonic waves reflected from living tissues in the body cavity.
  • the oscillator is electrically connected to the electric connector 15a (see FIG. 4) via the electric signal line 15.
  • the oscillator can be made of a piezoelectric material such as ceramics or quartz.
  • the light transmission / reception unit 11b has an optical element that transmits light into the body cavity and receives the light reflected from the living tissue in the body cavity.
  • the optical element is optically connected to the optical connector 16a (see FIG. 4) via the optical signal line 16.
  • the optical element can be formed by a lens such as a ball lens.
  • the signal transmission / reception unit 11 is housed inside the housing 10.
  • the base end of the housing 10 is fixed to the tip of the drive shaft 9.
  • the housing 10 is formed of a metal cylindrical tube, and an opening 10a is provided on the peripheral surface thereof so as not to hinder the progress of signals transmitted and received by the signal transmission / reception unit 11.
  • the housing 10 can be formed, for example, by laser processing or the like.
  • the housing 10 may be formed by cutting from a metal ingot, MIM (metal powder injection molding), or the like.
  • a tip member 17 is provided at the tip of the housing 10.
  • the tip member 17 has a substantially hemispherical outer shape, whereby friction and catching with the inner surface of the sheath 4 are suppressed.
  • the tip member 17 may not be provided.
  • the sheath 4 has a lumen 4a into which the drive shaft 9 is inserted so as to be able to move forward and backward.
  • a tubular guide wire insertion member 18 through which a guide wire can be passed is attached to the tip of the sheath 4 so as to be offset from the axial center of the lumen of the sheath 4.
  • the sheath 4 and the guide wire insertion member 18 are integrated by heat fusion or the like.
  • the guide wire insertion member 18 is provided with a marker 19 having X-ray contrast enhancement.
  • the marker 19 is made of a metal pipe having high X-ray impermeableness such as Pt and Au.
  • a communication hole 20 that communicates the inside and the outside of the lumen 4a is formed.
  • a reinforcing member 21 joined to the guide wire insertion member 18 is provided at the tip of the lumen 4a of the sheath 4.
  • the reinforcing member 21 is formed with a communication passage 21a that communicates the inside of the lumen 4a arranged on the proximal end side of the reinforcing member 21 with the communication hole 20.
  • the reinforcing member 21 may not be provided at the tip of the sheath 4.
  • the communication hole 20 is a priming liquid discharge hole for discharging the priming liquid.
  • the diagnostic imaging catheter 1 when the priming process for filling the sheath 4 with the priming liquid is performed, the priming liquid is discharged to the outside from the communication hole 20, and a gas such as air is discharged together with the priming liquid in the sheath 4. Can be discharged from the inside of.
  • the sheath 4, the guide wire insertion member 18, and the reinforcing member 21 are made of a flexible material, and the material is not particularly limited, for example, styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, and the like.
  • thermoplastic elastomers such as polyimide-based, polybutadiene-based, transpolyisoprene-based, fluororubber-based, and chlorinated polyethylene-based are mentioned, and one or a combination of two or more of them (polymer alloy, polymer blend). , Laminates, etc.) can also be used.
  • the hub 8 has a tubular shape coaxial with the inner pipe 6 and is detachably and integrally attached to the external device 2, and the hub body 8a projects radially outward from the hub body 8a and the hub body.
  • a port 8b communicating with the inside of 8a, a connecting pipe 8c integrally attached to the outer peripheral surface of the drive shaft 9, a bearing 8d rotatably supporting the connecting pipe 8c, and a base end between the connecting pipe 8c and the bearing 8d.
  • a sealing member 8e that prevents the priming liquid from leaking toward the side, and a connector portion 8f that is provided with an electric connector 15a and an optical connector 16a and is detachably and integrally attached to the first drive portion 2a of the external device 2.
  • the connector portion 8f can rotate integrally with the connection pipe 8c and the drive shaft 9.
  • the base end of the inner tube 6 is integrally connected to the tip of the hub body 8a.
  • the drive shaft 9 is pulled out from the inner pipe 6 inside the hub main body 8a.
  • an injection device 22 (see FIG. 1) for injecting a priming liquid is connected to the port 8b when performing a priming process.
  • the injection device 22 has a connector 22a connected to the port 8b and a syringe (not shown) connected to the connector 22a via a tube 22b.
  • the external device 2 includes a first drive unit 2a for rotationally driving the drive shaft 9, and a second drive unit 2b for moving the drive shaft 9 in the axial direction (that is, for pushing operation / pullback operation).
  • the first drive unit 2a can be configured by, for example, an electric motor.
  • the second drive unit 2b can be composed of, for example, an electric motor and a linear motion conversion mechanism.
  • the linear motion conversion mechanism can convert a rotary motion into a linear motion, and can be configured by, for example, a ball screw, a rack and pinion mechanism, or the like.
  • the operation of the first drive unit 2a and the second drive unit 2b is controlled by the control device 2c electrically connected to the first drive unit 2a and the second drive unit 2b.
  • the control device 2c includes a CPU (Central Processing Unit) and a memory.
  • the control device 2c is electrically connected to the display 2d.
  • the signal received by the ultrasonic transmission / reception unit 11a is transmitted to the control device 2c via the electric connector 15a, is subjected to predetermined processing, and is displayed as an image on the display 2d.
  • the signal received by the optical transmission / reception unit 11b is transmitted to the control device 2c via the optical connector 16a, subjected to predetermined processing, and displayed as an image on the display 2d.
  • the drive shaft 9 includes a coil shaft 23 having a tip 23a fixed to the base end of the housing 10 (see FIG. 3) and a tip 24a fixed to the base end 23b of the coil shaft 23. It also has a shaft member 24 having a higher torsional rigidity than the coil shaft 23.
  • the axial length of the drive shaft 9 is preferably 1200 mm or more and 2000 mm or less.
  • the outer diameter of the drive shaft 9 is not particularly limited, but is, for example, 0.56 mm.
  • the inner diameter of the drive shaft 9 is not particularly limited, but is, for example, 0.3 mm.
  • the coil shaft 23 can be formed of, for example, a multilayer coil 23c having a different winding direction.
  • Each coil 23c is usually a multi-row winding type.
  • the coil shaft 23 is formed by a three-layer double-wound type coil 23c, but the number of layers and the number of rows can be changed as appropriate.
  • Each coil 23c is made of a metal such as stainless steel or Ni—Ti (nickel-titanium) alloy.
  • the peripheral surface of the base end 23b of the coil shaft 23 is reduced in diameter by cutting.
  • the shaft member 24 is a metal pipe such as stainless steel or Ni—Ti (nickel / titanium) alloy having a notch 25.
  • the notch 25 includes a plurality of slits 25a.
  • the shaft member 24 is twisted more than the main portion 26 in which a plurality of slits 25a having a predetermined width W arranged in the circumferential direction are arranged in a predetermined pattern arranged at a predetermined pitch P in the axial direction, and the main portion 26 and the coil shaft 23. It has a weakened portion 27 having a low strength, that is, a weakened portion 27 that is easily twisted. The weakened portion 27 is located closer to the proximal end side than the main portion 26. The main portion 26 occupies most of the axial length of the shaft member 24.
  • the axial length of the weakened portion 27 is preferably 10 mm or more and 50 mm or less, more preferably 10 mm or more and 30 mm or less.
  • the shaft member 24 has a tip 24a located on the tip side of the main portion 26 and a base end 24b located on the base end side of the weakened portion 27.
  • the inner peripheral surface of the tip 24a of the shaft member 24 has a diameter expanded on the tip side portion by shaving.
  • the base end 23b of the coil shaft 23 is inserted into the tip 24a of the shaft member 24 and is fixed by welding using, for example, solder.
  • a connecting pipe 8c is integrally attached to the base end 24b of the shaft member 24.
  • a pair of slits 25a having a predetermined width W each facing each other in the radial direction and extending along the circumferential direction are arranged while rotating at a predetermined pitch P by a predetermined angle ⁇ in the axial direction. It is a pattern arranged like this.
  • the predetermined angle ⁇ is 90 °.
  • the predetermined angle ⁇ is not limited to 90 °.
  • a pair of slits 25a having a predetermined width W each facing each other in the radial direction and extending inclined with respect to the circumferential direction are arranged so as to rotate at a predetermined pitch P by a predetermined angle ⁇ in the axial direction. It may be a pattern arranged in.
  • the predetermined pattern may be a pattern in which three or more slits 25a having a predetermined width W arranged in the circumferential direction are arranged at a predetermined pitch P in the axial direction.
  • a plurality of slits 25a are arranged in the weakened portion 27 in the same pattern as the main portion 26 except that the predetermined width W and the predetermined pitch P are smaller than those of the main portion 26.
  • the weakening portion 27 may have a configuration in which only one of the predetermined width W and the predetermined pitch P of the plurality of slits 25a is smaller than the main portion 26.
  • Each slit 25a in the main portion 26 and the weakened portion 27 can be formed, for example, by shaving with a laser scanned in the circumferential direction while passing through the central axis O of the shaft member 24.
  • the predetermined width W, the predetermined pitch P, and the peripheral length of the slit 25a in the main portion 26 can be appropriately set.
  • the predetermined width W of the slit 25a in the main portion 26 is, for example, 0.15 mm.
  • the predetermined pitch P of the slit 25a in the main portion 26 is, for example, 0.25 mm.
  • the peripheral length of the slit 25a in the main portion 26 is, for example, 0.63 mm (the length on the outer peripheral surface of the main portion 26).
  • the predetermined width W, the predetermined pitch P, and the peripheral length of the slit 25a in the weakened portion 27 can be appropriately set.
  • the predetermined width W of the slit 25a in the weakened portion 27 is, for example, 0.02 mm.
  • the predetermined pitch P of the slit 25a in the weakened portion 27 is, for example, 0.07 mm.
  • the peripheral length of the slit 25a in the weakened portion 27 is, for example, 0.63 mm (the length on the outer peripheral surface of the weakened portion 27).
  • the weakening portion 27 is provided at the base end of the drive shaft 9 and is located inside the hub 8. Therefore, the weakening portion 27 is located on the proximal end side of the sheath 4 when the inner tube 6 is most advanced, and is located on the proximal end side of the unit connector 7 when the inner tube 6 is most advanced.
  • the sheath 4 is inserted into the body cavity, and the imaging core 12 is rotationally driven by the first driving unit 2a of the external device 2 at a constant rotation speed of about 1000 to 10000 rpm, and the second external device 2 is driven.
  • the imaging core 12 retracts at a constant speed in the cavity 4a of the sheath 4 by the pullback operation by the drive unit 2b.
  • the control device 2c of the external device 2 transmits / receives signals to / from the signal transmission / reception unit 11. Based on the signal received by scanning by rotating and retreating the signal, the state of the tissue around the body cavity is displayed as an image on the display 2d.
  • the drive shaft 9 is composed of not only the coil shaft 23 but also the coil shaft 23 and the shaft member 24 having a higher torsional rigidity than the coil shaft 23, the drive shaft 9 is unique.
  • the frequency can be increased. Therefore, the rotation speed region in which the drive shaft 9 resonates can be made larger than the upper limit of the rotation speed of the imaging core 12 that can be set by the external device 2 (for example, 10000 rpm), whereby the generation of NURD can be suppressed.
  • the external device 2 can select the rotation speed of the imaging core 12 from a plurality of stages, the rotation speed region in which the drive shaft 9 resonates is adjusted to a size that deviates from any of the selectable rotation speeds (for example). When three of 1800 rpm, 3600 rpm, and 5600 rpm can be selected, for example, the size may be adjusted to be just halfway between 3600 rpm and 5600 rpm), whereby the occurrence of NURD may be suppressed.
  • the tip side portion of the drive shaft 9 is composed of the coil shaft 23
  • flexibility and kink resistance can be easily ensured in the tip end side portion, whereby the signal can be signaled.
  • Stable scanning can be enabled.
  • the proximal end side portion of the drive shaft 9 is composed of the shaft member 24, buckling resistance can be easily ensured in the proximal end side portion, thereby facilitating. Pushing operation can be enabled.
  • the axial length of the coil shaft 23 is preferably 250 mm or more and 1000 mm or less. If it is 250 mm or more, the drive shaft 9 can flexibly follow the bent biological lumen and scan, and more reliably and stably scan of the signal can be enabled. If it is 1000 mm or less, the generation of NURD can be suppressed more reliably.
  • the axial length of the shaft member 24 is preferably 200 mm or more and 1750 mm or less. If it is 200 mm or more, the generation of NURD can be suppressed more reliably, and the pushing operation can be more reliably and easily enabled. If it is 1750 mm or less, it is possible to more reliably enable stable scanning of the signal by ensuring a sufficient axial length of the coil shaft 23.
  • the sheath 4 when the sheath 4 is inserted into a narrow lesion or a sharply curved blood vessel, if the imaging core 12 continues to rotate with the housing 10 or the like in contact with the sheath 4, the sheath 4 and the housing are generally rotated. There is a risk that the sheath 4 will be damaged due to friction with 10 or the like.
  • the shaft member 24 has a weakened portion 27 having a smaller torsional strength than either the main portion 26 or the coil shaft 23. That is, the drive shaft 9 has a weakened portion 27 whose torsional strength is locally reduced so as to be smaller than any portion of the drive shaft 9. Therefore, when the imaging core 12 continues to rotate with the portion of the housing 10 or the drive shaft 9 on the tip side of the weakened portion 27 in contact with the sheath 4, the weakened portion 27 is first twisted and the weakened portion 27 is twisted. The rotation of the imaging core 12 on the tip side of 27 can be stopped, whereby damage to the sheath 4 can be suppressed.
  • the weakened portion 27 is located on the proximal end side of the sheath 4 when the inner pipe 6 is most advanced, the sharp cut surface of the weakened portion 27 is formed when the weakened portion 27 is twisted. It is possible to prevent the sheath 4 from being damaged by contact with the sheath 4.
  • the weakened portion 27 is located closer to the base end side than the unit connector 7 when the inner pipe 6 is most advanced. Therefore, after the weakened portion 27 is completely twisted, the inner pipe 6 by the unit connector 7 is used. By releasing the holding of the weakened portion 27, the tip end side portion of the cut weakened portion 27 can be exposed to the outside, and the exposed weakened portion 27 can be grasped and the imaging core 12 can be easily removed from the inside of the sheath 4. Can be done.
  • the weakening portion 27 is provided at the base end of the drive shaft 9, damage to the sheath 4 can be suppressed more reliably.
  • the weakened portion 27 is located closer to the proximal end side than the main portion 26, damage to the sheath 4 can be more reliably suppressed from this point as well.
  • the shaft member 24 is composed of a pipe having a notch 25
  • the shaft member 24 having both appropriate flexibility and appropriate torsional rigidity that is easy to bend and deform is realized. can do.
  • the notch 25 has a non-spiral shape, an appropriate torsional rigidity can be easily realized.
  • the notch 25 since the notch 25 includes a plurality of slits 25a extending along the circumferential direction, it is possible to easily realize the shaft member 24 having both appropriate flexibility and appropriate torsional rigidity. Can be done.
  • the shaft member 24 has a main portion 26 in which a plurality of slits 25a having a predetermined width W arranged in the circumferential direction are arranged in a predetermined pattern arranged at a predetermined pitch P in the axial direction.
  • a shaft member 24 having both high torsional rigidity can be realized.
  • a pair of slits 25a having a predetermined width W each facing each other in the radial direction and extending along the circumferential direction are arranged while rotating at a predetermined pitch P by a predetermined angle ⁇ in the axial direction. Since the pattern is arranged in such a manner, the shaft member 24 having both high flexibility and high torsional rigidity can be realized more reliably.
  • a plurality of slits 25a are arranged in the weakened portion 27 in the same pattern as the main portion 26 except that the predetermined width W and the predetermined pitch P are smaller than those of the main portion 26.
  • the weakened portion 27 can be formed only by changing the predetermined pitch P, whereby the shaft member 24 can be easily formed.
  • the drive shaft 9 is a drive shaft 9 fixed to the base end of a housing 10 accommodating a signal transmission / reception unit 11 for forming an imaging core 12 of a diagnostic imaging catheter 1, and has a torsional strength of the drive shaft 9. As long as it has a weakened portion 27 that is locally reduced to be smaller than any portion of the throat, it can be changed in various ways.
  • the drive shaft 9 has a weakened portion 27 at the base end.
  • the drive shaft 9 has a coil shaft 23 having a tip 23a fixed to the base end of the housing 10, and a weakening portion 27 that is fixed to the base end 23b of the coil shaft 23 and has a torsional rigidity higher than that of the coil shaft 23. It is preferable to have a large shaft member 24.
  • the shaft member 24 is preferably a pipe having a notch 25.
  • the shaft member 24 has a main portion 26 in which a plurality of slits 25a having a predetermined width W arranged in the circumferential direction are arranged in a predetermined pattern arranged at a predetermined pitch P in the axial direction, and a plurality of weakened portions 27 of the shaft member 24 have a plurality of slits 25a. It is preferable that the slit 25a is arranged in the same pattern as the main portion 26 except that the predetermined width W and / or the predetermined pitch P is smaller than that of the main portion 26.
  • the predetermined pattern is arranged so that a pair of slits 25a having a predetermined width W each facing each other in the radial direction and extending along the circumferential direction are arranged so as to rotate at a predetermined pitch P by a predetermined angle ⁇ in the axial direction. It is preferably a pattern.
  • the weakened portion 27 is preferably located closer to the proximal end than the main portion 26.
  • the notch 25 is preferably non-spiral.
  • the notch 25 preferably includes a plurality of slits 25a extending along the circumferential direction.
  • the diagnostic imaging catheter 1 has an imaging core 12 and an imaging core 12 having a drive shaft 9, a housing 10 fixed to the tip 23a of the coil shaft 23, and a signal transmission / reception unit 11 housed in the housing 10. As long as the sheath 4 is provided, various changes can be made.
  • the diagnostic imaging catheter 1 has an outer tube 5 connected to the base end of the sheath 4 and an inner tube 6 inserted into the outer tube 5 so as to be able to move forward and backward integrally with the imaging core 12.
  • the weakened portion 27 is preferably located closer to the proximal end side than the sheath 4 when the inner tube 6 is most advanced.
  • the diagnostic imaging catheter 1 has a unit connector 7 that is connected to the base end of the outer tube 5 and holds the inner tube 6 so as to be able to move forward and backward, and can release the holding of the inner tube 6. Is preferably located closer to the proximal end than the unit connector 7 when is most advanced.
  • Image diagnostic catheter 2 External device 2a 1st drive unit 2b 2nd drive unit 2c Control device 2d Display 3 Image diagnostic device 4 Sheath 4a Sheath cavity 5 Outer tube 6 Inner tube 7 Unit connector 7a Tip side partial connector 7b base End side connector 8 Hub 8a Hub body 8b Port 8c Connection pipe 8d Bearing 8e Seal member 8f Connector part 9 Drive shaft 10 Housing 10a Opening part 11 Signal transmission / reception part 11a Ultrasonic transmission / reception part 11b Optical transmission / reception part 12 Imaging core 13 Relay connector 14 Locking part 15 Electric signal line 15a Electric connector 16 Optical signal line 16a Optical connector 17 Tip member 18 Guide wire insertion member 19 Marker 20 Communication hole 21 Reinforcing member 22 Injection device 22a Connector 22b Tube 23 Coil shaft 23a Coil shaft tip 23b Coil Shaft base end 23c Coil 24 Shaft member 24a Shaft member tip 24b Shaft member base end 25 Notch 25a Slit 26 Main part 27 Weakened part O Center axis P Predetermined pitch W Predetermined

Abstract

Arbre d'entraînement selon la présente divulgation fixé à l'extrémité proximale d'un boîtier qui loge une unité d'émission-réception de signal pour former un noyau d'imagerie d'un cathéter pour le diagnostic d'image, l'arbre d'entraînement ayant une section affaiblie qui a une résistance à la torsion localement réduite par rapport à une quelconque partie de l'arbre d'entraînement. Un cathéter pour diagnostic d'image selon la présente divulgation comprend : un noyau d'imagerie ayant un arbre d'entraînement selon la présente divulgation, un boîtier fixé à l'extrémité distale de l'arbre d'entraînement et une unité d'émission-réception de signal logée dans le boîtier ; et une gaine dans laquelle est inséré le noyau d'imagerie.
PCT/JP2021/035187 2020-09-29 2021-09-24 Arbre d'entraînement et cathéter pour diagnostic d'image WO2022071157A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2020163878 2020-09-29
JP2020-163878 2020-09-29

Publications (1)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014525761A (ja) * 2011-05-27 2014-10-02 ライトラボ・イメージング・インコーポレーテッド 光コヒーレンス断層撮影法及び圧力に基づくシステム及び方法
JP2017047040A (ja) * 2015-09-03 2017-03-09 テルモ株式会社 医療用デバイス

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014525761A (ja) * 2011-05-27 2014-10-02 ライトラボ・イメージング・インコーポレーテッド 光コヒーレンス断層撮影法及び圧力に基づくシステム及び方法
JP2017047040A (ja) * 2015-09-03 2017-03-09 テルモ株式会社 医療用デバイス

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