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WO2013129027A1 - Procédé de formation de sections de marquage pour tube médical, tube médical, et dispositif médical - Google Patents

Procédé de formation de sections de marquage pour tube médical, tube médical, et dispositif médical Download PDF

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Publication number
WO2013129027A1
WO2013129027A1 PCT/JP2013/052399 JP2013052399W WO2013129027A1 WO 2013129027 A1 WO2013129027 A1 WO 2013129027A1 JP 2013052399 W JP2013052399 W JP 2013052399W WO 2013129027 A1 WO2013129027 A1 WO 2013129027A1
Authority
WO
WIPO (PCT)
Prior art keywords
marking
sheath
medical tube
marking part
catheter
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2013/052399
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English (en)
Japanese (ja)
Inventor
泰徳 山下
徹 大田
陽樹 会見
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
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 Terumo Corp filed Critical Terumo Corp
Priority to JP2014502086A priority Critical patent/JP6430825B2/ja
Publication of WO2013129027A1 publication Critical patent/WO2013129027A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type

Definitions

  • the present invention relates to a method for forming a marking portion of a medical tube, and more particularly, to a method for forming a marking portion of a medical tube for diagnosis that is inserted into a body lumen such as a blood vessel and a blood vessel and used for various diagnoses. .
  • a catheter In recent years, various treatments and examinations have been performed in the medical field using a long and soft hollow tubular medical device called a catheter.
  • treatment methods include the method of administering a drug directly to the affected area using the length of the catheter, and the use of a catheter with a balloon that is expanded by pressurization attached to the tip to push the stenosis in the body cavity.
  • a method of expanding and opening There are a method of expanding and opening, a method of scraping the affected part using a catheter with a cutter attached to the tip, and a method of closing the aneurysm, bleeding site or feeding blood vessel using a catheter.
  • the diagnostic catheter is mainly used in the percutaneous treatment of a stenosis in a body cavity, as an aid to a decision for observing the property of the stenosis and selecting a treatment method. It is also used to observe the condition after treatment.
  • diagnostic catheter examples include an ultrasonic catheter that performs sensing with an ultrasonic detector, and an optical coherence tomographic imaging catheter that uses low-interference light.
  • a marking portion is formed on the outer periphery of the catheter by printing or stamping, and the catheter is inserted while referring to the marking portion.
  • the present invention has been made to solve the above-described problems, and provides a marking portion forming method for forming a marking portion on a medical tube that is not difficult to read and does not reduce the rigidity of the medical tube. Objective.
  • the marking part forming method of the present invention that achieves the above object is a marking part forming method for forming a visible marking part on a cylindrical medical tube, wherein the laser light emitted from the laser irradiation part is irradiated by an optical lens.
  • Marking part formation which has the marking part formation process which condenses in the deeper position than the outer surface of the said medical tube, and forms the said marking part by the component contained in the said medical tube absorbing the said laser beam and discoloring Is the method.
  • the marking part forming method is configured as described above, the marking part can be formed at a position deeper than the outer surface of the medical tube. For this reason, the marking part which does not become difficult to read and does not reduce the rigidity of the medical tube can be formed on the medical tube.
  • FIG. 6A is a plan view showing the marking portion when the first scanning in the XY direction is completed
  • FIG. 6B is a side view of FIG. 6A.
  • FIG. 6A is a top view which shows the marking part after the scan of the first XY direction was completed and the process of step S01 was performed.
  • FIG. 11A is a plan view showing another modification of the present embodiment
  • FIG. 11B is a side view of FIG.
  • FIG. 11A is a plan view showing another modification of the present embodiment
  • FIG. 11B is a side view of FIG.
  • FIG. 11A is a plan view showing another modification of the present embodiment
  • FIG. 11B is a side view of FIG.
  • the forming apparatus 100 that forms the marking part M places the laser light L emitted from the laser irradiation part 111 at a position deeper than the outer surface of the ultrasonic catheter 1 by the optical lens 120.
  • the marking component M is formed by condensing the carbon component contained in the ultrasonic catheter 1 by absorbing the laser light L and changing its color.
  • the axial direction of the catheter 1 is the X direction
  • the optical axis direction of the laser light L is the Z direction
  • the direction orthogonal to the X direction and the Z direction is the Y direction.
  • the laser irradiation unit 111 that irradiates a laser beam L having a wavelength of 532 nm and the drive unit 112 that scans the laser beam L in the X direction and the Y direction constitute a laser irradiation apparatus 110.
  • the laser irradiation device 110 for example, MD-S9910A manufactured by Keyence Corporation can be used.
  • the forming apparatus 100 further includes a holding unit 130 for holding the ultrasonic catheter 1, a rotating unit 140 for rotating the catheter 1, and a control unit 150 for controlling the operation of the driving unit 112 and the rotating unit 140. .
  • an ultrasonic catheter 1 as a medical device is used without being inserted into a body cavity for operation by a user and a sheath 2 inserted into a living body such as a body cavity. It is comprised from the hub 3 arrange
  • the sheath 2 as a medical tube has a sheath distal end portion 21 and a sheath main body portion 22.
  • One end of the sheath body 22 is connected to the sheath tip 21, and the hub 3 is connected to the other end of the sheath body 22.
  • the sheath body 22 is formed with a marking portion M for determining the insertion depth of the ultrasonic catheter 1 into the body.
  • the position where the marking part M is formed differs depending on whether the patient to be used is an adult or a child, and may be appropriately formed at an appropriate position.
  • the sheath 2 is made of polyetheretherketone (PEEK) resin.
  • the sheath distal end portion 21 and the sheath main body portion 22 are provided with observation portion lumens 23 and 24 that communicate with each other.
  • the observation portion lumens 23 and 24 are hollow passages formed in the sheath 2, and are formed from the sheath main body portion 22 to the sheath distal end portion 21.
  • the imaging core 40 is arranged in the observation unit lumens 23 and 24.
  • the imaging core 40 includes a transducer unit 41 for transmitting and receiving ultrasonic waves toward the body cavity tissue, a drive shaft 42 that attaches the transducer unit 41 to the tip and transmits rotational power, and a tip of the transducer unit 41. And a rotation stabilizing coil 43 attached to the side.
  • the transducer unit 41 includes an ultrasonic transducer 411 that transmits and receives ultrasonic waves and an ultrasonic transducer housing 412 that houses the ultrasonic transducer 411.
  • the ultrasonic transducer 411 enables the formation of an ultrasonic tomographic image of the affected area by transmitting ultrasonic waves toward the body and receiving the reflected ultrasonic waves.
  • the ultrasonic transducer housing 412 is formed in a concave shape, and holds and protects the ultrasonic transducer 411 in the concave concave portion.
  • the drive shaft 42 is flexible and has a characteristic capable of transmitting the rotational power generated in the hub 3 to the vibrator unit 41.
  • a multi-layer coil such as a three-layer coil in which the right and left and the winding direction are alternated
  • the outer diameter of the tube is constant.
  • the rotation stabilizing coil 43 is attached to the tip of the transducer unit 41 and serves as a guide for the transducer unit 41 to rotate stably when the imaging core 40 rotates. Further, the rotation stabilization coil 43 can enter the metal coil 32 fixed to the distal end of the sheath distal end portion 21. Since the rotation stabilizing coil 43 enters the metal coil 32, the imaging core 40 and the sheath 2 are integrated at the distal end of the sheath distal end portion 21, and the structure is strong against bending when the ultrasonic catheter 1 is inserted into the living body.
  • observation unit lumens 23 and 24 include the imaging core 40 as described above, and also serve as a path for the ultrasonic transmission liquid injected from the port 31 of the hub 3.
  • the ultrasonic transmission liquid supplied from the port 31 flows and fills through the observation portion lumens 23 and 24 to the sheath distal end portion 21, that is, from the proximal end side to the distal end side of the sheath 2.
  • the ultrasound transmission liquid is disposed between the ultrasound transducer 411 and the blood vessel wall, and the ultrasonic wave is transmitted. It is transmitted to the affected area via the ultrasonic transmission liquid and can be reflected back from the affected area.
  • the transducer unit 41 can acquire an image signal based on ultrasonic waves.
  • the ultrasonic transmission liquid is discharged into the body from the discharge port 30 provided in the sheath distal end portion 21. For this reason, physiological saline or the like that does not affect the human body is used as the ultrasonic transmission liquid.
  • the sheath distal end portion 21 is provided with an X-ray contrast marker 29 so that the distal end position of the ultrasonic catheter can be confirmed under fluoroscopy when inserted into the living body.
  • the sheath distal end portion 21 is further provided with a guide wire lumen 26 as a passage for passing the guide wire 25.
  • the guide wire lumen 26 includes a first guide wire lumen 27 and a second guide wire lumen. And a lumen 28.
  • the first guide wire lumen 27 is provided on the distal end side of the ultrasonic catheter 1 in the in-vivo insertion direction, and the second guide wire lumen 28 is provided on the rear end side, that is, on the proximal end side of the ultrasonic catheter 1. It has been.
  • the first guide wire lumen 27 and the second guide wire lumen 28 are not connected to each other, but are arranged so that the guide wire passages formed with each other are substantially straight. Therefore, the guide wire 25 can pass through the guide wire lumen 26 in a straight line without bending.
  • the guide wire 25 is inserted in advance to the vicinity of the affected part in the living body before the ultrasonic catheter 1 is inserted into the living body, and is used to guide the ultrasonic catheter 1 to the affected part.
  • the ultrasonic catheter 1 is guided to the affected part while passing the guide wire lumen 26 through the guide wire 25.
  • a first outer wall 21A for defining the first guide wire lumen 27 and a second outer wall 21B for defining the second guide wire lumen 28 are formed on the outer peripheral surface of the sheath distal end portion 21, and the first outer wall is formed.
  • 21A and the second outer wall 21B are formed by fixing independent tubes to the outer surface of the sheath 2, respectively.
  • the first guide wire lumen 27 is provided on the distal end side in the insertion direction of the ultrasonic catheter 1 relative to the transducer unit 41 of the imaging core 40, and the second guide wire lumen 28 is provided on the rear end side. ing. Therefore, since the guide wire lumen 26 does not exist on the outer peripheral surface of the sheath distal end portion 21 serving as an ultrasonic path, transmission / reception of ultrasonic waves by the transducer unit 41 is not hindered by the guide wire lumen 26.
  • the vibrator unit 41 can be moved back and forth within the observation unit lumen 23 via the drive shaft 42 to observe the living body in a wide range. In this case, transmission / reception of ultrasonic waves is not hindered if the first guidewire lumen 27 and the second guidewire lumen 28 are separated from each other by a range in which the transducer unit 41 moves back and forth.
  • the guide wire lumen 26 is not coaxial with the observation portion lumen 23, and is provided separately in parallel.
  • the guide wire lumen 26 extends not only to the distal end portion but also to the proximal end side of the ultrasonic catheter 1, the guide wire 25 and the ultrasonic catheter 1 stably cooperate with each other along the guide wire 25.
  • the force for inserting the sheath 2 is easily transmitted to the distal end of the sheath 2 in the insertion direction, and the operability of the ultrasonic catheter 1 can be improved.
  • the guide wire 25 and the sheath distal end 21 are long and parallel to each other. Thus, the guide wire 25 is not bent, and thus the living body is not damaged.
  • the guide wire lumen 26 is composed of the first guide wire lumen 27 and the second guide wire lumen 28, the length of the first guide wire lumen 27 is set to the second guide wire. Even if the guide lumen 25 is shorter than the lumen 28, the guide wire 25 can be appropriately placed along the sheath 2 in the vicinity of the distal end of the sheath 2. Therefore, by shortening the length of the first guide wire lumen 27, the transducer unit 41 of the imaging core 40 can be brought close to the most distal portion of the sheath 2, and the affected part can be appropriately observed.
  • a priming operation for filling the inside of the ultrasonic catheter 1 with physiological saline is performed. By performing this priming operation, air in the ultrasonic catheter 1 can be removed and air can be prevented from entering the living body lumen.
  • the ultrasonic catheter 1 is connected to the external drive device 80. That is, the male connector 51 is connected to the female connector of the external drive device 80.
  • the sheath 2 is inserted into the body, and the insertion is stopped after the distal end of the sheath 2 has passed over the affected area.
  • the guiding catheter is inserted into the body before the ultrasound catheter 1 is inserted, and the guiding catheter is placed at the entrance of the coronary artery blood vessel.
  • the guide wire 25 is inserted through the guiding catheter to the target position of the coronary artery blood vessel.
  • the ultrasonic catheter 1 is inserted along the guide wire 25 in the guiding catheter.
  • a Y-shaped Y connector (not shown) having a main body portion coaxially communicating with the guiding catheter and a side port branched from the main body portion is connected to the proximal end of the guiding catheter.
  • the ultrasonic catheter 1 is inserted into the living body lumen through the valve body of the Y connector connected to the proximal side of the guiding catheter, and is inserted into the living body lumen when the marking portion M approaches the valve body.
  • the guide wire 25 is inserted to the affected part to be observed.
  • the position of the sheath 2 is fixed. In this state, by performing a pullback operation while rotating the drive shaft 42, it is possible to acquire an image in the axial direction of the biological lumen.
  • the pull-back operation can be performed by operating the axial movement device 82 connected to the rear end portion of the ultrasonic catheter 1 by the control unit 83.
  • the acquired data is digitally processed by the control unit 83 and then displayed on the display unit 84 as image data.
  • the configuration and operation of the ultrasonic catheter 1 have been described above.
  • a marking part forming method for forming the marking part M on the sheath body 22 using the forming apparatus 100 will be described with reference to the flowchart of FIG.
  • a case where two marking portions M are formed in the axial direction of the sheath body portion 22 will be described.
  • the operations of the driving unit 112 and the rotating unit 140 are controlled by the control unit 150.
  • the laser light L is condensed by the optical lens 120 at a position deeper than the outer surface of the sheath body 22 and shallower than the inner surface of the sheath (hereinafter sometimes referred to as a focal point P).
  • the laser irradiation device 110 and the optical lens 120 are arranged so that the sheath main body portion 22 is placed on the holding portion 130.
  • step S01 as shown in FIG. 1, the laser irradiation unit 111 is moved in the X direction by the driving unit 112 to a place where the marking unit M is to be formed.
  • step S02 the laser irradiation device 110 is turned on and the laser beam L is irradiated.
  • the carbon component of the polyetheretherketone contained in the sheath 2 absorbs the laser light L and changes the vicinity of the focal point P. Thereafter, the portion through which the laser beam L has passed is changed in color by the same principle.
  • step S03 the laser beam L is scanned in the XY direction by the drive unit 112 while maintaining the height of the focal point P in the Z direction.
  • step S04 whether or not the scanning in the XY direction is completed. Is judged. If it is determined that scanning in the XY direction has not been completed (step S04: NO), the process returns to step S03, and the process in S03 is repeated until scanning in the XY direction is completed. If it is determined that the scanning in the XY direction has ended (step S04: YES), the process proceeds to step S05.
  • FIG. 6A is a plan view showing the marking portion M when the first scanning in the XY direction is completed
  • FIG. 6B is a diagram when scanning in the first XY direction is completed. It is a side view which shows the marking part M.
  • step S03 the laser beam L is scanned, for example, 10 mm in the X direction. Further, in the Y direction, as shown in FIG. 6B, the laser beam L is scanned by, for example, 5 mm until the surface layer S is exceeded.
  • the outer diameter of the sheath body 22 is, for example, 1.06 mm. Scanning in the XY direction can be performed continuously in the X and Y directions simultaneously or one in each of the X and Y directions.
  • step S05 If it is determined that two marking portions M are formed (step S05: YES), the process proceeds to step S07.
  • step S08 When it is determined that the laser beam L is not irradiated over the entire circumference of the sheath body 22 (step S07: NO), in step S08, the sheath 2 is rotated by 60 degrees by the rotating unit 140, and the process of step S03 is performed. Return to.
  • step S07 If it is determined that the laser beam L has been irradiated over the entire circumference of the sheath body 22 (step S07: YES), that is, if the processing from step S03 to step S07 is repeated six times, the process ends. At this time, as shown in FIG. 8, the marking portion M is formed over the entire circumference of the axial cross section of the sheath body portion 22.
  • FIG. 9 shows the surface roughness R in the X direction of the sheath body 22 after the marking portion M is formed. Since the surface roughness is in the range of plus or minus 5 ⁇ m from the graph, there is almost no decrease in rigidity. it is conceivable that.
  • the marking portion M can be formed at a position deeper than the outer surface of the sheath body 22 by the marking portion forming method according to the present embodiment. For this reason, the marking part M which does not become difficult to read and does not reduce the rigidity of the sheath body part 22 can be formed in the sheath body part 22.
  • the marking part forming step includes a relative movement step of moving the laser beam L relative to the sheath body 22. For this reason, the marking part M is formed in a wider range, and the visibility is improved.
  • the marking portion M is formed over the entire circumference of the sheath body portion 22 in the axially orthogonal cross section. For this reason, the marking part M is formed in a wider range, and the visibility is further improved.
  • the sheath main body portion 22 includes polyether ether ketone (PEEK) resin. For this reason, the laser beam L can be absorbed and the sheath main-body part 22 can be discolored.
  • PEEK polyether ether ketone
  • the laser beam L is a green laser having a wavelength of 532 nm. For this reason, the laser beam L is absorbed by the carbon component contained in the polyether ether ketone (PEEK) resin, and the sheath body 22 can be discolored.
  • the marking portion is formed in a polygonal shape as shown in FIG.
  • the polygonal marking portion has a simple and efficient manufacturing process while maintaining high visibility.
  • the scanning in the XY direction is performed continuously in the X and Y directions or continuously in the X and Y directions one by one.
  • the laser beam L may be turned off, moved slightly in the X direction, the laser beam L may be turned on again, and the scanning operation in the Y direction may be repeated to perform intermittent marking.
  • the laser beam L is scanned by the driving unit 112, but the sheath main body unit 22 may be moved using another driving unit.
  • the sheath main body portion 22 is rotated by 60 degrees by the rotating portion 140, but can be appropriately rotated at an appropriate angle.
  • the sheath 2 is rotated by the rotating unit 140, but the laser light L may be rotated around the axis of the sheath main body 22 using another rotating unit.
  • the laser beam L is scanned in the XY direction, and then the sheath body 22 is rotated to form the marking portion M.
  • the sheath body 22 may be rotated while scanning in the X direction while maintaining a position deeper than the surface layer S.
  • the marking portion M is formed in a spiral shape in the circumferential direction of the sheath main body portion 22 as shown in FIGS.
  • the sheath body 22 may be fixed and the laser light L may be rotated in the circumferential direction of the sheath body 22.
  • the present invention can be applied to the case of one place or three places or more.
  • the marking part M after forming the marking part M in the X direction about one plane, after forming the marking part M by rotating the sheath main-body part 22, 1 of the sheath main-body part 22 was formed. After the marking portion M is formed on the entire circumference of the location, the marking portion M may be formed on the entire circumference of the next location.
  • the laser beam L is scanned in the XY direction by the drive unit 112 to form the marking unit M.
  • the marking part M may be formed so as to draw an arc passing through the focal point P around the exit E of the laser light L of the laser irradiation part 112 using the swing drive part 113.
  • the marking portion M is formed by using one laser irradiation device 110.
  • the laser beam L is appropriately divided by using a plurality of laser irradiation devices 110 or by half mirrors. You may form the marking part M simultaneously in several places of the sheath main-body part 22 using the arrange
  • the scanning lengths in the X direction of the two marking portions M are the same. However, as shown in FIG. 13, the scanning lengths in the X direction of the marking portions M are different, and The distance from the tip may be marked. In FIG. 13, for example, marking portions M are formed at locations of 900 mm and 1000 mm from the tip side.
  • the marking portion M is formed in order to confirm the length inserted into the living body lumen.
  • a marking portion M may be formed on the extension line of the guide wire lumen 26.
  • a green laser having a wavelength of 532 nm is used.
  • an infrared laser having a wavelength of 1064 nm may be used.
  • Infrared lasers are general-purpose lasers that are generally used in various fields, leading to cost reduction and space saving of equipment.
  • an ultrasonic catheter is used as a catheter, but the present invention can also be applied to an optical coherence tomographic imaging catheter or the like.
  • Ultrasonic catheter (medical device), 2 sheath (medical tube), 22 sheath body, 110 Laser irradiation device, 111 laser irradiation part, 112 drive unit, 120 optical lens, 140 rotating part, L Laser light, M marking part, P Focus.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Ultra Sonic Daignosis Equipment (AREA)
PCT/JP2013/052399 2012-02-27 2013-02-01 Procédé de formation de sections de marquage pour tube médical, tube médical, et dispositif médical Ceased WO2013129027A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2014502086A JP6430825B2 (ja) 2012-02-27 2013-02-01 医療用チューブのマーキング部形成方法、医療用チューブ、及び医療用デバイス

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JP2012-040459 2012-02-27
JP2012040459 2012-02-27

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US20230158264A1 (en) * 2014-04-11 2023-05-25 Adroit Surgical, Llc Bougie and method of making and using the same

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WO2004068519A1 (fr) * 2003-01-30 2004-08-12 Sunarrow Limited Procede de marquage de dessus de touche en matiere translucide, dessus de touches ainsi produits, touches et procede de production de touches
JP2006141355A (ja) * 2004-11-24 2006-06-08 Daiwa Seiko Inc 魚釣用具の構成部品
JP2007021543A (ja) * 2005-07-19 2007-02-01 Pentax Corp レーザ印字方法
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CN105771065A (zh) * 2016-05-24 2016-07-20 徐玮泽 一种输送鞘管

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JPWO2013129027A1 (ja) 2015-07-30

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