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WO2025182981A1 - Dispositif de ponction automatique et partie de maintien d'aiguille de ponction - Google Patents

Dispositif de ponction automatique et partie de maintien d'aiguille de ponction

Info

Publication number
WO2025182981A1
WO2025182981A1 PCT/JP2025/006619 JP2025006619W WO2025182981A1 WO 2025182981 A1 WO2025182981 A1 WO 2025182981A1 JP 2025006619 W JP2025006619 W JP 2025006619W WO 2025182981 A1 WO2025182981 A1 WO 2025182981A1
Authority
WO
WIPO (PCT)
Prior art keywords
outer tube
puncture
hub
inner needle
needle
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.)
Pending
Application number
PCT/JP2025/006619
Other languages
English (en)
Japanese (ja)
Inventor
太輝人 犬飼
拓磨 片平
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
Publication of WO2025182981A1 publication Critical patent/WO2025182981A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles

Definitions

  • the present invention relates to an automatic puncture device and a puncture needle holder that automatically punctures blood vessels.
  • vascular puncture is performed by inserting a flexible outer tube into the human body over an inner needle with a sharp tip. After the inner needle and outer tube reach the blood vessel, the inner needle can be removed alone, securing the access route with the outer tube.
  • devices capable of automatically performing vascular puncture have become available (see, for example, Patent Document 1).
  • an automatic puncture device In order for an automatic puncture device to precisely puncture at coordinates determined from information such as an ultrasound, the tip of the inner needle must be moved to the correct position.
  • the hub located at the base end of the inner needle is grasped.
  • the cannula (needle portion) and hub of the inner needle are glued or fused together, and there is a possibility that the axis may be misaligned. Even if the axis misalignment is slight, there is a length from the hub to the needle tip, so the positional deviation of the needle tip will be in the order of 1 mm.
  • the target blood vessel is the artery in the upper arm, which generally has a diameter of 2 to 4 mm, a deviation of 1 mm can lead to a failed puncture.
  • the present invention was made to solve the above-mentioned problems, and aims to provide an automatic puncture device and puncture needle holder that can move the tip of the inner needle to the desired position for puncture without being affected by axial misalignment caused by tolerances between the inner needle and the inner needle hub.
  • an automatic puncture device includes a puncture needle holding unit that holds a puncture needle, a drive unit that drives the puncture needle holding unit at least along the puncture direction in which the puncture needle extends, an acquisition unit that acquires cross-sectional images of the object, and a control unit that controls the drive unit, wherein the puncture needle holding unit includes an inner needle hub holding unit that holds an inner needle hub located at the base end of the inner needle of the puncture needle, an outer tube hub holding unit that holds an outer tube hub located at the base end of an outer tube that houses the inner needle, and an outer tube clamping unit that is provided on the tip side of the outer tube hub holding unit and clamps the outer tube.
  • the automatic puncture device described in (1) above can clamp the outer tube using the outer tube clamping section, so the tip of the inner needle can be moved to the desired position for puncture without being affected by axial misalignment caused by tolerances between the inner needle and the inner needle hub.
  • the outer tube clamping portion may have a groove portion and a pressing portion that can move back and forth relative to the groove portion. This allows the outer tube, which is placed in the groove portion, to be pressed by the pressing portion, thereby accurately positioning the outer tube at a predetermined position in the groove portion, thereby allowing the tip of the inner needle to be positioned at a desired position without being affected by axial misalignment between the inner needle and the inner needle hub.
  • the puncture needle holding section may include an inner needle hub housing having the inner needle hub holding section, and an outer barrel hub housing having the outer barrel hub holding section and detachably connected to the inner needle hub housing.
  • the automatic puncture device described in (3) above may have a separation mechanism that separates the inner needle hub housing from the outer tubular hub housing. This allows the automatic puncture device to automatically separate the inner needle hub housing from the outer tubular hub housing using the separation mechanism after puncture is completed.
  • the inner needle hub housing may have a first restricting portion that is a hole or groove
  • the outer cylindrical hub housing may have a second restricting portion that is a hole or groove
  • the separation mechanism may have a fixing pin that enters the first restricting portion and the second restricting portion, and a pressing shaft that can enter the first restricting portion and/or the second restricting portion and press the fixing pin.
  • the puncture needle holding section may have an elastic member that generates a force in a direction that separates the inner needle hub housing and the outer tubular hub housing. This allows the automatic puncture device to automatically separate the needle hub housing and the outer tubular hub housing using the force of the elastic member.
  • the lancing needle holding unit may be removable from the automatic lancing device. This allows the automatic lancing device to replace the lancing needle holding unit, reducing the possibility of contamination.
  • the puncture needle holding section includes an inner needle hub housing having the inner needle hub holding section, and an outer tube hub housing having the outer tube hub holding section and detachably connected to the inner needle hub housing, and the inner needle hub housing may have a cover section fixed to its surface. This allows the cover section to separate a clean field from an unclean field of the automatic puncture device.
  • the puncture needle holding unit may include a housing holding unit that is movable when driven by the drive unit, a guide member that is connectable to the housing holding unit, and an outer tube hub housing that is detachably connected to the guide member and has the outer tube hub holding unit. This allows the automatic puncture device to indirectly connect the outer tube hub housing to the housing holding unit via the guide member, thereby improving operability.
  • the guide member and the outer hub housing may have a retaining portion that uses magnetic force to maintain their connected state. This makes it easy to connect and separate the guide member and the outer hub housing, improving workability.
  • the automatic lancing device described in (10) above may have a cover portion sandwiched between the guide member and the outer cylindrical hub housing. This allows the cover portion to be sandwiched between the guide member and the outer cylindrical hub housing, which can be connected contactlessly by magnetic force, and the cover portion can reliably separate the clean field and unclean field of the automatic lancing device.
  • the puncture needle holding unit is attachable to an external device and capable of holding a puncture needle, and is characterized by including an outer tube hub holding unit that holds an outer tube hub located at the base end of an outer tube that houses the inner needle of the puncture needle, and an outer tube clamping unit that is provided at the tip side of the outer tube hub holding unit and clamps the outer tube.
  • the puncture needle holding part described in (12) above can clamp the outer tube using the outer tube clamping part, so the tip of the inner needle can be moved to the desired position for puncture without being affected by axial misalignment caused by tolerances between the inner needle and the inner needle hub.
  • FIG. 1 is a side view of an automatic lancing device according to an embodiment.
  • FIG. 2 is a perspective view showing a puncture needle holding portion and a puncture needle.
  • 10A and 10B are cross-sectional views of the puncture needle holding portion, in which (A) shows the outer cylindrical hub housing and the inner needle hub housing connected together, and (B) shows the outer cylindrical hub housing separated from the inner needle hub housing.
  • FIG. 4 is a cross-sectional view showing an outer cylinder clamping portion and a puncture needle.
  • 5A and 5B are cross-sectional views taken along line AA in FIG. 4, where (A) shows the present embodiment, (B) shows a first modified example, (C) shows a second modified example, and (D) shows a third modified example.
  • 1A to 1C are side views illustrating a method of using the automatic lancing device, in which (A) shows the state before lancing, (B) shows the state during lancing, and (C) shows the state after lancing.
  • 10A and 10B are front views showing a fourth modified example, in which (A) shows a state in which the clamping members of the outer tube clamping portion are open, and (B) shows a state in which the clamping members of the outer tube clamping portion are closed.
  • 10A and 10B are perspective views showing a fifth modified example, in which (A) shows a state in which the clamping members of the outer tube clamping portion are open, and (B) shows a state in which the clamping members of the outer tube clamping portion are closed.
  • FIG. 13 is a perspective view of an outer tube clamping portion showing a sixth modified example.
  • FIG. 13 is a side view of a puncture needle holding section showing a seventh modified example.
  • FIG. 13 is a rear view of the automatic lancing device according to the seventh modified example, as viewed from the base end side.
  • 13A and 13B are cross-sectional views of the puncture needle holding portion in the eighth modified example, where (A) shows the state in which the outer tube hub housing and the inner needle hub housing are connected, and (B) shows the state in which the outer tube hub housing is separated from the inner needle hub housing.
  • FIG. 13A and 13B are cross-sectional views of the puncture needle holding portion in the ninth modified example, where (A) shows the state in which the outer tube hub housing and the inner needle hub housing are connected, and (B) shows the state in which the outer tube hub housing is separated from the inner needle hub housing.
  • FIG. 23 is a perspective view showing an outer cylindrical hub housing and a puncture needle in a tenth modified example.
  • FIG. 23 is a side view showing an outer cylindrical hub housing in a tenth modified example.
  • 13A and 13B are front views showing an outer cylindrical hub housing according to a tenth modified example, in which FIG. 13A shows a state in which the clamping members are closed, and FIG. 13B shows a state in which the clamping members are open.
  • FIG. 13A shows a state in which the clamping members are closed
  • FIG. 13B shows a state in which the clamping members are open.
  • FIG. 23 is a perspective view showing an outer cylindrical hub housing, a puncture needle, and a guide member in a tenth modified example.
  • FIG. 23 is a perspective view showing a puncture needle holding part in a tenth modified example.
  • 16A and 16B are perspective views showing a tenth modified example, in which FIG. 16A shows a guide member, and FIG. 16B shows a state in which the guide member is connected to a housing holding portion.
  • FIG. 23 is a front view showing a puncture needle holding section in a tenth modified example.
  • the automatic puncture device 10 is used to puncture a human arm (target object), acquiring a cross-sectional image of the arm to detect the position of the artery to be punctured, and then automatically puncturing that artery.
  • the automatic puncture device 10 comprises a probe body 20 having an acquisition unit 22 that contacts the skin surface to acquire cross-sectional images of the human body, a puncture needle 30 that performs the puncture, a puncture needle holding unit 40 that holds the puncture needle 30, a drive unit 50 that moves the puncture needle holding unit 40, a display unit 70 that can display the cross-sectional image, and a control unit 60 that performs image analysis of the cross-sectional image and controls the drive unit 50.
  • the probe body 20 has a vertically long handle portion 21 that is held by the surgeon, and an acquisition portion 22 that is located at the bottom end of the handle portion 21.
  • the probe body 20 is disposed integrally with the automatic puncture device 10 and is configured to be inseparable from the automatic puncture device 10. However, the probe body 20 may also be configured to be separable from the automatic puncture device 10.
  • the acquisition unit 22 is provided at the center of the underside of the probe body 20, spanning almost the entire width.
  • the acquisition unit 22 is an ultrasound device that has a transducer that generates ultrasound waves and obtains cross-sectional images of the inside of the human body by detecting the reflected waves.
  • cross-sectional images that are roughly perpendicular to the axial direction of the blood vessels are obtained, so the acquisition unit 22 is positioned so that the scanning direction is roughly perpendicular to the longitudinal direction of the arm.
  • the puncture needle 30 comprises a metal inner needle 31 with a sharp needle tip 32 formed at its tip, and a flexible tubular outer tube 33 that is positioned to cover the outer surface of the inner needle 31.
  • the inner needle 31 may be solid or hollow.
  • the needle tip 32 is located distal to the point where the outer diameter of the inner needle 31 is constant, and has a cutting edge that is inclined relative to the axis.
  • the needle tip 32 may be a point where the outer diameter decreases toward the sharp tip.
  • the drive unit 50 comprises a first linear motion unit 51 that holds the puncture needle holding unit 40 and moves it linearly, a tilting unit 52 that tilts the first linear motion unit 51, a second linear motion unit 53 that moves the tilting unit 52 in the height direction from one end where the acquisition unit 22 of the probe main body 20 is located to the other end on the opposite side, and a rotating unit 54 that rotates the second linear motion unit 53 around a predetermined rotation axis P.
  • the drive unit 50 is only required to comprise at least the first linear motion unit 51, and may not, for example, comprise the tilting unit 52, second linear motion unit 53, or rotating unit 54.
  • the first linear motion part 51 holds the housing holding part 41 (described later) of the puncture needle holding part 40, and can move the puncture needle holding part 40 linearly back and forth along the extension direction (puncture direction) of the inner needle 31.
  • the first linear motion part 51 adjusts the position of the puncture needle 30 and is used to puncture a blood vessel with the puncture needle 30.
  • the first linear motion part 51 includes, for example, a rotary drive source such as a motor whose drive can be controlled by the control part 60, and a structure (for example, a feed screw mechanism) that converts the rotary motion of the rotary drive source into linear motion.
  • the first linear motion part 51 may also hold the outer tube hub housing 90.
  • the tilting unit 52 can tilt the first linear motion unit 51.
  • the tilting unit 52 is used to change the puncture angle of the puncture needle 30 relative to the surface of the patient's skin.
  • the tilting unit 52 includes, for example, a hinge whose angle can be changed, and a rotary drive source such as a motor whose drive can be controlled by the control unit 60 to change the hinge angle.
  • the second linear motion section 53 is used to move the puncture needle 30 closer to or further away from the patient's skin.
  • the second linear motion section 53 can move the tilting section 52 linearly back and forth along the height direction of the probe body 20.
  • the second linear motion section 53 includes, for example, a rotary drive source such as a motor whose drive can be controlled by the control section 60, and a structure (for example, a feed screw mechanism) that converts the rotary motion of the rotary drive source into linear motion.
  • the rotating unit 54 is used to change the direction of the inner needle 31 when the second linear motion unit 53 is viewed approximately perpendicular to the surface of the patient's skin.
  • the rotating unit 54 can rotate the tilting unit 52 around a rotation axis P that is parallel to the height direction of the probe body 20.
  • the rotating unit 54 is equipped with a rotation drive source such as a motor whose drive can be controlled by the control unit 60.
  • the drive sources used for the first linear motion unit 51, the second linear motion unit 53, the tilting unit 52, and the rotating unit 54 are preferably configured to be able to control rotation and displacement with high precision while being monitored by the control unit 60, such as a servo motor.
  • the drive unit 50 uses the rotating unit 54 to move the puncture needle 30 in a direction perpendicular to the extension direction of the puncture needle 30 and perpendicular to the height direction of the probe body 20 (the depth direction in the plane of the paper in Figure 1), but may also be configured to move the puncture needle 30 linearly in the aforementioned depth direction.
  • the control unit 60 sends signals to the acquisition unit 22 to cause the acquisition unit 22 to output ultrasound.
  • the control unit 60 can also form cross-sectional images from signals obtained from the acquisition unit 22.
  • the control unit 60 can also display the obtained cross-sectional images on a display unit 70, such as a monitor.
  • the control unit 60 can also perform arithmetic processing such as image analysis based on the cross-sectional image information to identify the position of blood vessels in the image.
  • the control unit 60 can also control the operation of the drive unit 50, which performs the puncture.
  • the control unit 60 is physically configured with a memory circuit and an arithmetic circuit.
  • the memory circuit can store programs and various parameters.
  • the arithmetic circuit can perform arithmetic processing.
  • the control unit 60 and display unit 70 may be located in the probe main body 20, drive unit 50, or puncture needle holding unit 40, or may be configured separately from the probe main body 20, drive unit 50, or puncture needle holding unit 40.
  • the puncture needle holding unit 40 has a housing holding unit 41 held by the first linear motion unit 51, an inner needle hub housing 80 that holds the inner needle hub 34, an outer tube hub housing 90 that holds the outer tube hub 35, and a separation mechanism 110 that separates the inner needle hub housing 80 and the outer tube hub housing 90.
  • the housing holding portion 41 is held by the first linear motion portion 51 and has a storage portion 42 that can store the inner needle hub housing 80 and the outer tube hub housing 90, and a support portion 43 that supports part of the separation mechanism 110.
  • the storage portion 42 is a recess that removably stores the inner needle hub housing 80 and the outer tube hub housing 90, which are aligned in the puncture direction of the inner needle 31.
  • the storage portion 42 stores the inner needle hub housing 80 so that it does not move in the puncture direction, and stores the outer tube hub housing 90 so that it can slide in the puncture direction.
  • the storage portion 42 has an outer receiving portion 44, which is a through hole through which the pressing shaft of the separation mechanism 110, described below, can pass. Note that the outer receiving portion 44 may not be a through hole but may be a groove extending in the extension direction of the inner needle 31.
  • the support portion 43 protrudes from the storage portion 42 in a direction perpendicular to the puncture direction.
  • the inner needle hub housing 80 is removably housed in the housing portion 42 on the proximal side of the housing holding portion 41.
  • the inner needle hub housing 80 housed in the housing portion 42 is housed so as not to move in the puncture direction relative to the housing holding portion 41.
  • the inner needle hub housing 80 has an inner needle hub housing main body 81 that holds the inner needle hub 34, and a protrusion 82 that protrudes from the inner needle hub housing main body 81 toward the distal end.
  • the inner needle hub housing main body 81 has an inner needle hub holding portion 83, which is a recess in which the inner needle hub 34 is held, and a first storage portion 84 that stores a portion of the elastic member 114, which will be described later.
  • the first storage portion 84 is formed from the distal end surface of the inner needle hub housing main body 81 toward the proximal end.
  • the protruding portion 82 is formed with a first restricting portion 85, which is a groove or hole (groove in this embodiment) extending in a direction perpendicular to the puncture direction.
  • the inner needle hub holding portion 83 prevents the inner needle hub 34 it holds from moving distally (puncture direction) and proximally relative to the inner needle hub holding portion 83.
  • the inner needle hub holding portion 83 has a puncture force transmission portion 86 that abuts against the proximal end surface of the outer tube hub 35, and can effectively transmit distal force to the inner needle hub 34 during puncture. As a result, even if the outer tube 33 slips relative to the outer tube clamping portion 97, the inner needle 31 can be punctured without any problems.
  • the outer tube hub housing 90 is removably housed in the housing portion 42 on the distal side of the housing holding portion 41.
  • the outer tube hub housing 90 housed in the housing portion 42 is positioned adjacent to the distal side of the inner needle hub housing 80 and is housed so as to be movable (slidable) in the distal and proximal directions relative to the housing holding portion 41.
  • the outer tube hub housing 90 has an outer tube hub housing main body 91 that holds the outer tube hub 35, a clamping member 92 that rotates relative to the distal end of the outer tube hub housing main body 91, and a hinge portion 93 that rotatably connects the clamping member 92 to the outer tube hub housing main body 91.
  • the outer tube hub housing main body 91 has an outer tube hub holding portion 94, which is a recess that holds the outer tube hub 35, a second storage portion 95 that stores a portion of the elastic member 114 (described below), and a second restricting portion 96.
  • the second restricting portion 96 is a groove or hole that extends in a direction perpendicular to the puncture direction, and is formed to communicate with the first restricting portion 85 when the outer tube hub housing 90 and the inner needle hub housing 80 are connected.
  • the second storage portion 95 is positioned on the distal side of the first storage portion 84.
  • the second storage portion 95 is formed from the base end surface of the outer tube hub housing main body 91 toward the distal end.
  • the tip of the outer tube hub housing main body 91 and the clamping member 92 form an outer tube clamping portion 97 that clamps the outer tube 33.
  • the outer tube hub holding portion 94 prevents the held outer tube hub 35 from moving in the distal and proximal directions relative to the outer tube hub holding portion 94.
  • the outer tube hub holding portion 94 has a portion that abuts against the proximal end surface of the outer tube hub 35, and can effectively transmit force in the distal direction to the outer tube hub 35 during puncture. This allows for smooth puncture even if the outer tube 33 slips relative to the outer tube clamping portion 97.
  • the tip of the outer tube hub housing main body 91 has a first groove portion 98 extending in the puncture direction and first magnets 99 on either side of the first groove portion 98.
  • the clamping member 92 has a second groove portion 100 extending in the puncture direction and second magnets 101 located on either side of the second groove portion 100 and capable of attracting the first magnet 99.
  • the first groove portion 98 and the second groove portion 100 are arranged to overlap.
  • the first groove portion 98 and the second groove portion 100 are arc-shaped in a cross section perpendicular to the puncture direction, and it is preferable that the groove width W is greater than twice the groove depth D.
  • the clamping force of the outer tube clamping portion 97 is preferably less than a force that will not damage the outer tube 33 or inner needle 31, for example, 20 N or less.
  • the outer tube hub housing main body 91 and clamping member 92 do not have to be equipped with magnets.
  • the outer tube hub housing main body 91 and clamping member 92 may have a structure that fits together and are connected by fitting together to generate a clamping force.
  • the shape of the outer tube clamping portion 97 is not limited.
  • a first groove portion 98 having a V-shaped cross section perpendicular to the puncture direction may be formed in the outer tube hub housing main body 91, and a pressing portion 102 that can enter the first groove portion 98 may be formed in the clamping member 92.
  • the top of the pressing portion 102 is formed, for example, as a flat surface. This allows the outer tube 33, which is placed in the first groove portion 98, to be pressed by the pressing portion 102, thereby accurately positioning the outer tube 33 at a predetermined position in the first groove portion 98.
  • the first groove portion 98 may not be V-shaped, but may be, for example, arc-shaped.
  • a soft member 103 made of a soft material such as rubber or elastomer may be arranged on the surface of the first groove portion 98 and the surface of the top of the pressing portion 102.
  • the soft member 103 may be arranged only on the first groove portion 98 without being arranged on the pressing portion 102, or, although not shown, may be arranged only on the pressing portion 102 without being arranged on the first groove portion 98. The soft member 103 can reduce damage to the surface of the outer tube 33 that comes into contact with it.
  • the length L in the puncture direction of the portion of the outer tube clamping portion 97 that comes into contact with the outer tube 33 is not limited, but is, for example, 3 mm or more, and preferably 5 mm or more.
  • a long length L can prevent the puncture needle 30 from rotating around the outer tube clamping portion 97 as a fulcrum.
  • grooves do not have to be formed in the outer tube hub housing main body 91 and the clamping member 92 of the outer tube clamping portion 97.
  • the outer tube 33 can be gripped between the outer tube hub housing main body 91 and the clamping member 92.
  • the distance between the clamping surfaces can be set to the same as the outer diameter of the outer tube 33, or slightly larger or smaller than the outer diameter. This allows the outer tube 33 to be clamped by the outer tube clamping portion 97 without damaging the surface of the outer tube 33.
  • the outer tube clamping portion 97 clamps the outer tube 33 from both sides (the front and back sides of the paper in Figure 1) that sandwich the blood vessels extending along the skin.
  • the puncture direction of the puncture needle 30 coincides with the direction in which the blood vessel extends
  • the outer tube clamping portion 97 clamps the outer tube 33 from both sides that sandwich the blood vessel. Therefore, the outer tube clamping portion 97 aligns the puncture direction of the puncture needle 30 with the direction in which the blood vessel extends, making it easy to position the puncture needle 30 in a position that allows it to accurately puncture the blood vessel.
  • the outer tube clamping portion 97 clamps the outer tube 33 at a position close to the outer tube hub 35, it can prevent the needle tip 32 from being damaged by the outer tube clamping portion 97 while also preventing the needle tip 32 from shifting out of position.
  • the separation mechanism 110 has a separation drive unit 111, a pressing shaft 112, a fixed pin 113, and an elastic member 114.
  • the separation drive unit 111 is a drive source supported by the support unit 43 and moves the pressing shaft 112 linearly.
  • the separation drive unit 111 is, for example, a solenoid operated by electromagnetic force, but may also be a motor or the like.
  • the pressing shaft 112 is a long member that can be moved linearly by the separation drive unit 111 to press and move the fixed pin 113.
  • the pressing shaft 112 extends approximately perpendicular to the puncture direction and can enter the storage unit 42 from the outside of the housing holding unit 41 through the outer receiving unit 44.
  • the fixing pin 113 is arranged across both the first restricting portion 85 of the inner needle hub housing 80 and the second restricting portion 96 of the outer tube hub housing 90.
  • the fixing pin 113 prevents the inner needle hub housing 80 and the outer tube hub housing 90 from moving relative to each other in the puncture direction.
  • the elastic member 114 is stored in the first storage section 84 and the second storage section 95 in a state where it is contracted in the puncture direction. Therefore, the elastic member 114 biases the inner needle hub housing 80 and the outer tube hub housing 90 so that they move apart in the puncture direction.
  • the surgeon places the inner needle hub 34 in the inner needle hub holding portion 83 and places the sheath hub 35 in the sheath hub holding portion 94.
  • the surgeon closes the clamping member 92 to clamp the sheath 33 between the first groove portion 98 of the sheath hub housing main body 91 and the second groove portion 100 of the clamping member 92.
  • the fixing pin 113 is positioned across both the first restricting portion 85 of the inner needle hub housing 80 and the second restricting portion 96 of the sheath hub housing 90. The surgeon places the sheath hub housing 90 and the inner needle hub housing 80 in the accommodation portion 42 of the housing holding portion 41.
  • the control unit 60 acquires a cross-sectional image from the acquisition unit 22 and operates the drive unit 50 based on the surgeon's instructions or a preset calculation method, placing the puncture needle holding unit 40 in the desired position and posture for puncturing the blood vessel, as shown in Figure 6 (A).
  • control unit 60 activates the first linear motion unit 51, causing the puncture needle 30 to perform puncture, as shown in Figure 6 (B).
  • This causes both the inner needle hub housing 80 and the outer tube hub housing 90 held by the housing holding unit 41 to move, and the inner needle 31 and outer tube 33 are inserted into the blood vessel.
  • the control unit 60 activates the separation drive unit 111 to push the pressing shaft 112 into the outer receiving portion 44.
  • the pressing shaft 112 pushes the fixing pins 113, which are arranged in the first restricting portion 85 and the second restricting portion 96, until they pass through the first restricting portion 85 and are arranged only in the second restricting portion 96.
  • the operation of the separation drive unit 111 is deactivated, returning the pressing shaft 112 to its position before activation.
  • the outer tube 33 moves distally while the position of the inner needle 31 is fixed, and the needle tip 32 is retracted into the outer tube 33.
  • control unit 60 activates the first linear motion unit 51 to retract the housing holding unit 41 to the position before puncture. This allows the inner needle 31 to be removed from the outer tube 33, leaving the outer tube 33 inside the blood vessel.
  • surgeon then opens the clamping member 92 relative to the outer tube hub housing main body 91, and removes the outer tube hub 35 and inner needle hub 34 from the outer tube hub housing 90 and inner needle hub housing 80.
  • the automatic puncture device 10 of this embodiment has a puncture needle holding unit 40 that holds the puncture needle 30, a drive unit 50 that drives the puncture needle holding unit 40 at least along the puncture direction in which the puncture needle 30 extends, an acquisition unit 22 that acquires a cross-sectional image of the object, and a control unit 60 that controls the drive unit 50.
  • the puncture needle holding unit 40 includes an inner needle hub holding unit 83 that holds the inner needle hub 34 located at the base end of the inner needle 31 of the puncture needle 30, an outer tube hub holding unit 94 that holds the outer tube hub 35 located at the base end of the outer tube 33 that houses the inner needle 31, and an outer tube clamping unit 97 that is provided on the tip side of the outer tube hub holding unit 94 and clamps the outer tube 33.
  • the automatic puncture device 10 can clamp the outer tube 33 using the outer tube clamping section 97, allowing the needle tip 32 of the inner needle 31 to be moved to the desired position for puncture without being affected by axial misalignment caused by tolerances between the inner needle 31 and the inner needle hub 34.
  • the outer tube clamping portion 97 may have a first groove portion 98 (groove portion) and a pressing portion 102 that can move back and forth relative to the first groove portion 98.
  • first groove portion 98 groove portion
  • pressing portion 102 the outer tube 33 placed in the first groove portion 98 with the pressing portion 102, the outer tube 33 can be accurately positioned at a predetermined position in the first groove portion 98, and the needle tip 32 of the inner needle 31 can be positioned at a desired position without being affected by axial misalignment between the inner needle 31 and the inner needle hub 34.
  • the puncture needle holding unit 40 has an inner needle hub housing 80 having an inner needle hub holding portion 83, and an outer tube hub housing 90 having an outer tube hub holding portion 94 and detachably connected to the inner needle hub housing 80.
  • an inner needle hub housing 80 By separating the inner needle hub housing 80 from the outer tube hub housing 90 after puncture with the inner needle 31 is completed, the inner needle 31 held in the inner needle hub housing 80 can be housed in the outer tube 33 held in the outer tube hub housing 90. Therefore, the automatic puncture device 10 can remove the inner needle 31 from inside the outer tube 33 after puncture is completed.
  • the inner needle hub holding portion 83 may be integral with the automatic puncture device 10 and inseparable from the automatic puncture device 10.
  • the automatic puncture device 10 has a separation mechanism 110 that separates the inner needle hub housing 80 and the outer tube hub housing 90. This allows the automatic puncture device 10 to automatically separate the inner needle hub housing 80 and the outer tube hub housing 90 using the separation mechanism 110 after puncture is complete.
  • the inner needle hub housing 80 has a first restricting portion 85 which is a hole or groove
  • the outer tube hub housing 90 has a second restricting portion 96 which is a hole or groove
  • the separation mechanism 110 has a fixing pin 113 which enters the first restricting portion 85 and the second restricting portion 96, and a pressing shaft 112 which can enter the first restricting portion 85 and/or the second restricting portion 96 and press the fixing pin 113.
  • the automatic puncture device 10 can automatically release the connection between the inner needle hub housing 80 and the outer tube hub housing 90 by the fixing pin 113, by using the pressing shaft 112 to push the fixing pin 113 out of the first restricting portion 85 and/or the second restricting portion 96.
  • the puncture needle holding portion 40 has an elastic member 114 that generates a force in a direction that separates the inner needle hub housing 80 and the outer tube hub housing 90. This allows the automatic puncture device 10 to automatically separate the needle hub housing and the outer tube hub housing 90 using the force of the elastic member 114.
  • the puncture needle holding unit 40 is removable from the automatic puncture device 10. This allows the automatic puncture device 10 to use a replaceable puncture needle holding unit 40 as a disposable part, while also reducing the possibility of contamination.
  • the puncture needle holding unit 40 in this embodiment is attachable to an external device and capable of holding the puncture needle 30, and includes an outer tube hub holding unit 94 that holds the outer tube hub 35 located at the base end of the outer tube 33 that houses the inner needle 31 of the puncture needle 30, and an outer tube clamping unit 97 that is provided on the tip side of the outer tube hub holding unit 94 and clamps the outer tube 33.
  • the puncture needle holding unit 40 can clamp the outer tube 33 using the outer tube clamping unit 97, so the needle tip 32 of the inner needle 31 can be moved to the desired position for puncture without being affected by axial misalignment caused by tolerances between the inner needle 31 and the inner needle hub 34.
  • the present invention is not limited to the above-described embodiment, and various modifications may be made by those skilled in the art within the technical spirit of the present invention.
  • the form of the drive unit 50 is not particularly limited, and it may be a robot arm, etc.
  • the outer tube clamping portion 97 may clamp the outer tube 33 at two points spaced apart in the puncture direction.
  • the distance between the two points is, for example, 3 mm or more, and preferably 5 mm or more. This prevents the outer tube 33 from rotating around the outer tube clamping portion 97 as a fulcrum.
  • the shape of the outer tube clamping portion 97 is not limited.
  • the outer tube clamping portion 97 may have a toggle 120 connected to the clamping member 92, which can open and close the clamping member 92.
  • the toggle 120 is a long member that can be operated by the surgeon.
  • the toggle 120 has a connecting hole 121 at one end that is rotatably connected to a connecting shaft 115 formed at a position away from the hinge portion 93 of the clamping member 92, and has an operating portion 122 at the other end that can be operated by the surgeon. It is also possible for the connecting shaft 115 to be formed in the toggle 120, and the connecting hole 121 to be formed in the clamping member 92.
  • the toggle 120 slidably passes through a toggle holding hole 124 of a toggle holding portion 123 extending from the outer tube hub housing 90, between the connecting hole 121 and the operating portion 122. This allows the surgeon to operate the operating unit 122 to rotate the clamping member 92 and open or close the outer tube clamping portion 97.
  • the outer tube clamping unit 97 may have a structure in which the clamping member 92 is operated by a link mechanism.
  • the outer tube clamping unit 97 has a clamping member 92 in which a second groove portion 100 is formed, a guide rail 150 that supports the clamping member 92 so that it can move linearly, an input shaft 130 for inputting a force to open and close the clamping member 92, and a link 140 that transmits force between the clamping member 92 and the input shaft 130.
  • the guide rail 150 is a member extending from the outer cylindrical hub housing 90.
  • the guide rail 150 extends perpendicular to the puncture direction so that the surface of the supporting clamping member 92, on which the second groove portion 100 is formed, can move toward and away from the surface of the outer cylindrical hub housing main body 91, on which the first groove portion 98 is formed.
  • the clamping member 92 has a sliding portion 116 that can slide along the guide rail 150 and a first connecting shaft 117 that is connected to the link 140.
  • the input shaft 130 has an input portion 131 at one end to which a force is input, and a second connecting shaft 132 at the other end that is connected to the link 140.
  • the input shaft 130 slidably passes through an input shaft holding hole 133 formed in a member extending from the outer cylindrical hub housing 90, between the input portion 131 and the second connecting shaft 132.
  • the link 140 has a first connecting hole 141 at one end that is rotatably connected to the first connecting shaft 117 of the clamping member 92, and a second connecting hole 142 at the other end that is rotatably connected to the second connecting shaft 132 of the input shaft 130.
  • the link 140 also has an elongated hole 143 between the first connecting hole 141 and the second connecting hole 121, into which a support shaft 151 formed on a member extending from the outer cylindrical hub housing 90 slidably fits.
  • the rotating link 140 can move the surface of the clamping member 92 on which the second groove portion 100 is formed toward or away from the surface of the outer cylindrical hub housing main body 91 on which the first groove portion 98 is formed, while keeping it parallel to the surface.
  • the surgeon places the inner needle hub 34 in the inner needle hub holding portion 83 and the outer tube hub 35 in the outer tube hub holding portion 94 with the clamping member 92 open relative to the outer tube hub housing main body 91.
  • the surgeon places the outer tube hub housing 90 and the inner needle hub housing 80 in the storage portion 42 of the housing holding portion 41. This causes the input portion 131 of the input shaft 130 to abut against the housing holding portion 41 and be pressed by the housing holding portion 41.
  • the link 140 is pressed and tilted by the input shaft 130, and the surface on which the second groove portion 100 of the clamping member 92 is formed approaches the surface on which the first groove portion 98 of the outer tube hub housing main body 91 is formed.
  • This allows the outer tube 33 to be clamped by the outer tube clamping portion 97 in conjunction with the action of placing the outer tube hub housing 90 and the inner needle hub housing 80 in the storage portion 42 of the housing holding portion 41.
  • the input unit 131 may also be pressed manually by the surgeon.
  • the outer tube clamping portion 97 may have two rotatable first rollers 161 aligned to form a first groove portion 98, and two rotatable second rollers 162 aligned to form a second groove portion 100.
  • the outer tube clamping portion 97 may have a clamping configuration between two opposing flat surfaces or a clamping configuration between two opposing curved surfaces.
  • a flexible cover part 170 for ensuring a clean field may be fixed to the surface of the inner needle hub housing 80 on the side where the inner needle hub holding part 83 is formed.
  • the fixing part 171 (fused part) for the surface on the side where the inner needle hub holding part 83 is formed is indicated by diagonal lines.
  • the cover part 170 is fixed to the inner needle hub housing 80 by, for example, fusion.
  • the method for fixing the cover part 170 is not limited to fusion and may be, for example, adhesive bonding.
  • the side of the inner needle hub housing 80 on which the cover part 170 is fixed is the clean field, and the opposite rear and side surfaces are the unclean fields, which can come into direct contact with the housing holding part 41 of the device.
  • the outer tubular hub housing 90 is placed in the clean field around its entire circumference and comes into contact with the clean surface of the inner needle hub housing 80.
  • the inner needle hub housing 80 has a cover portion 170 fixed to its surface. This allows the cover portion 170 to separate the clean and unclean areas of the automatic puncture device 10.
  • the outer tube hub housing 90 may have a cover portion fixed to its surface by fusion bonding or the like, similar to the inner needle hub housing 80 described above.
  • the configuration of the separation mechanism 110 is not limited.
  • the outer tube hub housing 90 may have an inclined surface 180 inclined with respect to a plane perpendicular to the movement direction of the pressing shaft 112, at a position where the tip of the pressing shaft 112 moved by the separation drive unit 111 abuts against it. It is preferable that the tip surface of the pressing shaft 112 abutting against the inclined surface 180 is also inclined so as to make surface contact with the inclined surface 180.
  • the separation drive unit 111 is activated and the pressing shaft 112 moves, the pressing shaft 112 presses against the inclined surface 180, as shown in FIG. 12(B). This allows the outer tube hub housing 90 to move in the tip direction away from the inner needle hub housing 80.
  • the separation mechanism 110 may have a separation drive unit 111 that generates rotational force from a motor or the like, a threaded portion 190 that is rotated by the separation drive unit 111, and a pressing shaft 112 that has a female thread 191 that threads into the male thread of the threaded portion 190.
  • the outer tube hub housing 90 has an abutment portion 192 against which the pressing shaft 112 can abut.
  • the puncture needle holding portion 200 may have a structure in which the outer tube hub housing 230 that holds the outer tube hub 35 is connected to the housing holding portion 220 via another member, the guide member 210.
  • the outer tube hub housing 230 comprises an outer tube hub housing main body 231, a clamping member 232 that rotates relative to the outer tube hub housing main body 231, a hinge portion 233 that rotatably connects the clamping member 232 to the outer tube hub housing main body 231, a fixing screw 234 that secures the clamping member 232 to the outer tube hub housing main body 231, and a first retaining portion 235 that maintains the state in which it is held by the guide member 210.
  • the outer tube hub housing main body 231 is formed with a first groove portion 236 that grips the outer tube 33, and a threaded hole 237 into which the fixing screw 234 can be screwed.
  • the first retaining portion 235 is a magnet arranged on the bottom surface of the outer tube hub housing main body 231 and on the back surface on the housing holding portion 220 side.
  • the clamping member 232 is formed with a second groove portion 238 that grips the outer tube 33, and a screw insertion groove 239 into which the fixing screw 234 can be passed.
  • the housing holding part 220 holds the above-mentioned outer tube hub housing 230 and the inner needle hub housing that holds the inner needle hub 34 so that they can be moved relatively by the drive part 50.
  • the housing holding part 220 has two support protrusions 221 that protrude from the lower end toward the outer tube hub housing 230 and guide member 210 and support the guide member 210.
  • the two support protrusions 221 are aligned in the extension direction of the puncture needle 30.
  • the guide member 210 has a back support portion 211 that supports the back surface of the outer cylindrical hub housing 230 facing the housing holding portion 220, a bottom support portion 212 that supports the bottom surface of the outer cylindrical hub housing 230, a connecting portion 213 that can be connected to the housing holding portion 220, and a second holding portion 214 that maintains the holding state of the outer cylindrical hub housing 230.
  • the bottom support portion 212 extends approximately vertically from the lower end of the back support portion 211.
  • the connecting portion 213 protrudes downward from the bottom support portion 212 and extends from the protruding end toward the back support portion 211.
  • the second retaining portion 214 is a magnet that attracts the magnet of the first retaining portion 235 by being the opposite polarity, and is disposed on each of the back support portion 211 and the bottom support portion 212.
  • the guide member 210 is removably connected to the housing retaining portion 220 by inserting the connecting portion 213 between the two support protrusions 221 of the housing retaining portion 220.
  • the outer tube hub housing 230 is placed on the bottom support portion 212 of the guide member 210.
  • the second retaining portion 214 which is a magnet on the outer tube hub housing 230, attracts the first retaining portion 235, which is a magnet on the guide member 210, by magnetic force, thereby maintaining the outer tube hub housing 230 connected to the guide member 210.
  • the guide member 210 and the outer tube hub housing 230 can be connected without contact by magnetic force, so the connected state can be maintained by sandwiching the cover portion 240 between them.
  • the cover portion 240 can maintain the device side on which the guide member 210 and housing retaining portion 220 are arranged as an unclean area, and the side on which the outer tube hub housing 230 and puncture needle 30 are arranged as a clean area.
  • the cover portion 240 may be fixed to the surface of the guide member 210.
  • the cover portion 240 is fixed to the guide member 210 by fusion bonding.
  • the method for fixing the cover part 240 is not limited to fusion bonding, and may be, for example, adhesive bonding.
  • the lancing needle holding unit 200 has a housing holding unit 220 that can be moved when driven by the drive unit 50, a guide member 210 that can be connected to the housing holding unit 220, and an outer tube hub housing 230 that is detachably connected to the guide member 210 and has an outer tube hub holding unit 94.
  • the guide member 210 and the outer cylindrical hub housing 230 have retaining portions (first retaining portion 235, second retaining portion 214) that use magnetic force to maintain their connected state. This makes it easy to connect and separate the guide member 210 and the outer cylindrical hub housing 230, improving workability.
  • the automatic lancing device 10 also has a cover section 240 that is sandwiched between the guide member 210 and the outer cylindrical hub housing 230. This allows the cover section 240 to be sandwiched between the guide member 210 and the outer cylindrical hub housing 230, which can be connected contactlessly by magnetic force, and the cover section 240 can reliably separate the clean and unclean areas of the automatic lancing device 10.

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  • Life Sciences & Earth Sciences (AREA)
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  • Veterinary Medicine (AREA)
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  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
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  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Pulmonology (AREA)
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  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif de ponction automatique et une partie de maintien d'aiguille de ponction capable de déplacer la pointe d'aiguille d'une aiguille interne vers une position souhaitée et de réaliser une ponction, sans être affectée par un désalignement axial provoqué par la tolérance entre l'aiguille interne et un raccord d'aiguille interne. Le dispositif de ponction automatique comprend : une partie de maintien d'aiguille de ponction (40) pour maintenir une aiguille de ponction (30) ; une partie d'entraînement (50) pour entraîner la partie de maintien d'aiguille de ponction (40) au moins le long d'une direction de ponction dans laquelle l'aiguille de ponction (30) s'étend ; une partie d'acquisition (22) pour acquérir une image en coupe transversale d'un objet cible ; et une partie de commande (60) pour commander la partie d'entraînement (50). La partie de maintien d'aiguille de ponction (40) comprend : une partie de maintien de raccord d'aiguille interne (83) qui maintient un raccord d'aiguille interne (34) positionné au niveau d'une partie d'extrémité proximale d'une aiguille interne (31) de l'aiguille de ponction (30) ; une partie de maintien de raccord de cylindre extérieur (94) qui maintient un raccord de cylindre extérieur (35) positionné au niveau d'une partie d'extrémité proximale d'un cylindre extérieur (33) qui contient l'aiguille interne (31) ; et une partie de fixation par serrage de cylindre extérieur (97) qui se situe du côté extrémité distale de la partie de maintien de raccord de cylindre extérieur (94) et fixe par serrage le cylindre extérieur (33).
PCT/JP2025/006619 2024-03-01 2025-02-26 Dispositif de ponction automatique et partie de maintien d'aiguille de ponction Pending WO2025182981A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2024031100 2024-03-01
JP2024-031100 2024-03-01

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8088107B1 (en) * 2008-03-17 2012-01-03 Frank Willis Hemodialysis needle and method for inserting the same
JP2015501685A (ja) * 2011-11-18 2015-01-19 ベラソン インコーポレイテッドＶｅｒａｔｈｏｎ Ｉｎｃ． ニューロバスキュラーアクセスシステムおよびデバイス
EP3831303A1 (fr) * 2010-12-22 2021-06-09 Veebot, LLC Systèmes permettant l'introduction autonome d'une aiguille intraveineuse

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8088107B1 (en) * 2008-03-17 2012-01-03 Frank Willis Hemodialysis needle and method for inserting the same
EP3831303A1 (fr) * 2010-12-22 2021-06-09 Veebot, LLC Systèmes permettant l'introduction autonome d'une aiguille intraveineuse
JP2015501685A (ja) * 2011-11-18 2015-01-19 ベラソン インコーポレイテッドＶｅｒａｔｈｏｎ Ｉｎｃ． ニューロバスキュラーアクセスシステムおよびデバイス

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