KR101745997B1 - Micro-catheter system with active steering and insertion functions - Google Patents

Micro-catheter system with active steering and insertion functions Download PDF

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Publication number
KR101745997B1
KR101745997B1 KR1020160031526A KR20160031526A KR101745997B1 KR 101745997 B1 KR101745997 B1 KR 101745997B1 KR 1020160031526 A KR1020160031526 A KR 1020160031526A KR 20160031526 A KR20160031526 A KR 20160031526A KR 101745997 B1 KR101745997 B1 KR 101745997B1
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KR
South Korea
Prior art keywords
core tube
module
guide wire
handler
cover spring
Prior art date
Application number
KR1020160031526A
Other languages
Korean (ko)
Inventor
박석호
박종오
고성영
강병전
최현철
Original Assignee
전남대학교산학협력단
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Priority to KR1020160031526A priority Critical patent/KR101745997B1/en
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Publication of KR101745997B1 publication Critical patent/KR101745997B1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133Tip steering devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133Tip steering devices
    • A61M25/0147Tip steering devices with movable mechanical means, e.g. pull wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133Tip steering devices
    • A61M25/0158Tip steering devices with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09058Basic structures of guide wires
    • A61M2025/09083Basic structures of guide wires having a coil around a core

Abstract

The present invention relates to a micro catheter system which is easy to steer and insert into a blood vessel while minimizing damage to a blood vessel wall during a procedure and can easily enter the target site. The micro catheter system includes a hollow core A tube 110; A coil-shaped cover spring 120 fixed to the tip of the core tube to surround the core tube; A guide wire (130) having a magnetic body (130) at its tip and insertable along the core tube; And a magnetic field generator 140 for generating a magnetic field for steering operation of the magnetic body 130.

Description

[0001] Micro-catheter system with active steering and insertion functions [

The present invention relates to a micro catheter system that can be easily stowed and inserted in a blood vessel while minimizing damage to a vessel wall during a procedure and easily enter the target site.

Generally, a catheter is a medical device that is used to deliver drugs to a local area by vascular disease and certain lesions using a flexible tube of a hollow shaft. In order to reach the catheter, the catheter must be inserted along the wire after reaching the desired site using a thin flexible wire called a guide wire.

The guidewire insertion is performed by the practitioner while observing the X-ray screen while administering the contrast agent in the blood vessel in real time. In this process, it is difficult to steer the tip portion of the guide wire and it takes a lot of time. If the direction of the tip portion is not directed toward the center of the blood vessel, there is a problem that the inner wall of the blood vessel may be damaged and punctured during the procedure. In addition, these procedures require a very high level of proficiency by the practitioner, and the success rate of the procedure is determined according to the ability of the practitioner.

To solve this problem, various types of active steering / insertion microcatheter technologies have been developed. However, the addition of a mechanism for active steering and insertion has the limitation that it can be used in large blood vessels or atrial / ventricular chambers because of the increased diameter of microcatheter, but it is difficult to use in microvascular systems. In order to compensate for this, an apparatus for steering and inserting a catheter using a magnetic field has been developed. However, it has a disadvantage in that a magnetic field generator is always provided outside, and only the tip of a relatively thin guide wire can be steered.

In the related art, a system capable of remotely inserting a catheter to reduce the radiation dose of a practitioner is disclosed in Korean Patent No. 10-1133268. According to the disclosed catheter remote control system, a slave unit provided so that the catheter can rotate and move linearly can be remotely controlled using the master unit. However, since there is no mention of the driving mechanism of the catheter and the guidewire end, there is a limit to the possibility of implementation.

Korean Registered Patent No. 10-1133268 (Publication Date: Apr. 04, 2012)

An object of the present invention is to provide a microcatheter system which can easily perform steering and insertion in a blood vessel while minimizing damage of a blood vessel wall in a procedure and easily enter the target site.

To achieve these and other advantages and in accordance with the purpose of the present invention, as embodied and broadly described herein, there is provided a microcatheter system comprising: a hollow core tube having a curved shape at a predetermined interval from a distal end; A coil-shaped cover spring fixed to the tip of the core tube to surround the core tube; A guide wire having a magnetic body at its tip end and insertable along the core tube; And a magnetic field generating portion for generating a magnetic field for steering drive of the magnetic body.

Preferably, a first module for a relative displacement movement and an axial rotation operation between the core tube and the cover spring, and a second module for an axial rotation operation of the guide wire in the core tube Unit.

More preferably, the drive unit further includes a guide member for guiding the longitudinal sliding of the first module and the second module.

More preferably, the apparatus further includes a driving unit for independently driving the first module and the second module back and forth along the guide member.

More preferably, the first module includes: a first movable member that is guided by the guide member and is driven forward and backward by the driving unit; A first handler for holding and fixing the core tube and the cover spring by being seated in the first movable member; A first drive motor provided to the first handler to provide a rotational operation force in the axial direction of the cover spring; And a second drive motor provided on the first handler to provide a pulling force to the core tube, and still more preferably, the first handler is configured such that an end of the cover spring is fixed, A first bevel gear for driving; And a movable bracket to which the end of the core tube is fixed and which is driven forward and backward by the second driving motor.

Preferably, the second module includes: a second movable member that is guided by the guide member and is driven forward and backward by the drive unit; A second handler which is seated on the second movable member and holds and fixes the guide wire; And a third driving motor provided on the second handler for providing an axial rotational driving force to the guide wire. More preferably, the second handler includes a guide wire fixed to an end of the guide wire, And a second bevel gear rotatably driven by a motor.

A microcatheter system according to the present invention comprises: a hollow core tube having a curved tip at its tip; A coil-shaped cover spring fixed to the tip of the core tube to surround the core tube; Wherein the core tube is made of a guide wire which can be inserted along the core tube so that the magnetic body is provided at the tip end so as to be steered by the external magnetic field. The macro movement by the mechanical movement by the relative displacement movement between the core tube and the cover spring, It is possible to actively steer / insert the catheter with respect to a minute blood vessel by the micro-motion by the steering drive of the guide wire, thereby providing effective angioplasty.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a block diagram of a microcatheter system according to the present invention;
2 (a) and 2 (b) are views illustrating an example of the operation of the guide wire of the microcatheter system according to the present invention,
3 (a) and 3 (b) illustrate an operation example of a microcatheter system according to the present invention,
4 (a), (b) and 5 are perspective views showing a preferred embodiment of the driving unit in the microcatheter system according to the present invention,
FIG. 6 is a conceptual diagram showing an image-based remote control operation example using the microcatheter system of the present invention. FIG.

The specific structure or functional description presented in the embodiment of the present invention is merely illustrative for the purpose of illustrating an embodiment according to the concept of the present invention, and embodiments according to the concept of the present invention can be implemented in various forms. And should not be construed as limited to the embodiments described herein, but should be understood to include all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

It is to be understood, however, that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The singular expressions include plural expressions unless the context clearly dictates otherwise. It will be further understood that the terms " comprises ", or "having ", and the like in the specification are intended to specify the presence of stated features, integers, But do not preclude the presence or addition of steps, operations, elements, parts, or combinations thereof.

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

1, the microcatheter system of the present invention comprises a catheter 100 composed of a core tube 110, a cover spring 120 and a guide wire 140 having a magnetic body 130 at its tip, And a magnetic field generator 150 capable of generating a magnetic field for driving the steering wheel of the vehicle. Particularly, in the present invention, the catheter 100 includes: a hollow core tube 110 having a distal portion 111 curved at a predetermined interval from the distal end; A coil-shaped cover spring 120 fixed to the tip of the core tube 110 to surround the core tube 110; And a guide wire 140 provided with a magnetic body 130 at its tip and insertable along the core tube 110.

The core tube 110 may be provided by a hollow flexible tube having a curved portion B at a distal end (distal portion). The core tube 110 has a distal end having a predetermined curvature section and a proximal end extending from the distal end to a straight section.

The curved portion B of the core tube may be formed by plastic working a distal portion of a straight line to have a certain curvature r. At this time, the distal end of the curved portion B is elastically deformed within an elastic limit.

The core tube 110 may be provided entirely by a single material or may be provided with a coil spring or metal (not shown) in the proximal portion which is required to have a suitable rigidity (buckling resistance), unlike the distal portion, A braid with braided wires may be provided as a reinforcing member. In another embodiment, the coil tube may be made of a material different from the distal and proximal portions, for example, the core tube may be provided by a proximal portion, such as a synthetic tube, which is assembled to a connecting member such as a band, It will be possible.

The tip end of the cover spring 120 is integrally fixed to the core tube 110. In this embodiment, the distal end of the core tube 110 is formed with a fixed end 111 protruding in a radial direction, 120 may be fitted with the fixed end 111 or fixed by heat welding.

The core tube 110 and the cover spring 120 can be relatively moved (displaced) by the respective drive units provided on the proximal side.

In the present invention, the core tube 110 has a greater elastic modulus than the cover spring 120. Therefore, when no external operating force acts on the core tube 110 and the cover spring 120, Elastic deformation is performed in accordance with the shape of the core tube 110. When the relative displacement is generated by the operation of the core tube 110 and the cover spring 120, the degree of curvature of the core tube 110 changes due to the compression or expansion of the cover spring 120 in the curved portion B The manipulation of the direction of the tip can be performed.

The thickness d of the magnetic substance 130 including the guide wire 140 is smaller than the inner diameter D of the core tube 110 and the guide wire 140 is wound on the guide wire 140. [ 140 can be inserted or withdrawn along the core tube 110.

In the present invention, the magnetic substance 130 may be a permanent magnet, or is not particularly limited as long as it is magnetized in a magnetic field such as a ferromagnetic material or a paramagnetic material.

The guide wire 140 may be configured to have different materials of distal and proximal portions, and preferably the distal portion may be made of a more flexible material compared to the proximal portion. For example, a metal material may be used for the proximal portion of the guide wire, and a synthetic resin material may be used for the distal portion where the magnetic material is provided.

The guidewire 140 has a modulus of elasticity smaller than that of the core tube 110 so that the guide wire 140 has the same shape as the core tube 110 when the magnetic field does not act on the magnetic substance 140 the curved portion B of the core tube 110 is moved in accordance with the position of the tip of the guide wire 140 by the magnetic force acting on the magnetic body 140 when the external magnetic field acts on a certain size or more, Elastic deformation can be made.

2 (a) and 2 (b) illustrate an example of the operation of the guide wire of the microcatheter system according to the present invention. In this embodiment, the cover spring is omitted and the guide wire 140 The tube 110 'is illustrated as a straight line.

The magnetic field generating unit 150 generates a magnetic field for steering operation of the magnetic body 130, and the magnetic field generating unit 150 may be provided by an electromagnet or a permanent magnet. Specifically, the magnetic field generator 150 may be provided by a plurality of electromagnets or permanent magnet modules arranged so as to generate a magnetic field in an arbitrary direction in a three-dimensional space and to steer the magnetic body 130 in that direction .

The core tube 110 'and the guide wire 140 can be operated in the forward and backward directions by the respective drive units provided at the proximal portion.

The microcatheter system according to the present invention configured as described above is constructed so that the guide wire 140 is driven by the macro motion and / or the external magnetic field by the mechanical driving of the core tube 110 and the cover spring 120, Steering / inserting can be done for various blood vessel sizes by micro motion and will be described with reference to Fig.

3 (a) and 3 (b) are views showing an operation example of the microcatheter system according to the present invention.

3 (a), in a state where an external magnetic field is not applied, an operation force F1 (F2) in opposite directions is applied to the core tube 110 and the cover spring 120 using the drive unit at the proximal portion The distal end of the core tube 120 can be deformed into a linear shape by the compressive force of the cover spring 120. [ The steering angle of the tip of the core tube 110 can be adjusted by appropriately controlling the magnitude and direction of the operating force F1 and F2 acting on the core tube 110 and the cover spring 120. [

In this way, the catheter can be steered / inserted inside the large blood vessel by the mechanical operation of the core tube 110 and the cover spring 120.

3 (b), when the guide wire 110 is advanced from the front end of the core tube 110 by the operation of the guide wire 110, the steering of the front end of the guide wire 110 So that the target lesion position can be reached by the insertion / steering operation of the front end of the guide wire 110 as described above. After the front end of the guide wire 110 reaches the target lesion position, when the core tube 110 is manipulated and inserted, the core tube 110 is inserted along the guide wire 110, After reaching the target lesion position, the guide wire 110 may be removed and removed, and then a wire for other procedures may be inserted into the core tube 110 to perform the procedure.

The front end of the guide wire 140 can be finely steered in arbitrary directions by the steering drive of the magnetic body 130 by the external magnetic field and thus only the macro movement by the operation of the core tube 110 and the cover spring 120 If it is difficult to reach the lesion, the catheter can be inserted / steered to the micro-blood vessel by the micro-motion of the front end of the guide wire 140 by the external magnetic field.

As described above, in the micro catheter system of the present invention, the core tube 110, the cover spring 120, and the guide wire 140, which is steered by the external magnetic field, are subjected to a steering or insertion operation by a relative displacement movement This relative displacement movement is performed by a drive unit provided in the proximal portion.

The driving unit may be configured as an interface module and a driving unit of a catheter that is easy to attach and detach, and in particular, the interface module is preferably configured as a separate module so that the macro movement and the micro movement of the catheter can be independently controlled.

4A and 4B are views showing a preferred embodiment of the drive unit in the microcatheter system according to the present invention, wherein (a) is a perspective view of the drive unit, (b) Fig.

4 (a) and 4 (b), the driving unit 200 of the present invention includes a pair of first and second guide members 211 and 212 arranged side by side, a first guide member A first module 220 for moving the catheter 100 back and forth along the first module 220 and a second module 220 for relative displacement and axial rotation of the core tube and the cover spring, A second module 230 for allowing the catheter 100 to be moved back and forth along the second guide member 212 and for driving the guide wire to rotate in the axial direction and a second module 230 for moving the first module 220 in a front- A first driver 241 for driving the first module 230 and a second driver 252 for driving the second module 230 linearly in the forward and backward directions.

The first guide members 211 and 212 may be provided by a guide bar having both ends fixed to the front case 201 and the rear case 202. The first module 220 and the second module 230 The front and rear sliding operation is possible along the guide bar.

The first module 220 includes a first movable member 220a that is guided by the first guide member 221 and is driven forward and backward by the first driving units 241 and 242, A first handler 221 which seats and fixes the core tube and the cover spring of the catheter 100, a first driving motor 222 provided on the first handler 221 to provide a steering driving force of the cover spring, And a second drive motor 223 provided on the first handler 221 to provide a pulling force on the core tube.

The first driving units 241 and 242 may be provided by a ball screw 242 that converts the rotational driving force of the motor 241 into linear motion.

The second module 230 includes a second movable member 230a guided by the second guide member 212 and driven forward and backward by the second driving units 251 and 252, A second handler 231 for holding and fixing the guide wire of the catheter 100 and a third drive motor 232 provided on the second handler 231 for providing a rotational operation force in the axial direction to the guide wire do.

The second driving units 251 and 252 may be provided by a known ball screw 252 that converts the rotational driving force of the motor 251 into linear motion.

In the driving unit 200 configured as described above, the macro movement by the mechanical operation of the catheter 100 can be performed by the relative displacement movement of the core tube and the cover spring in the first module 220 and the axial rotation movement And the second module 230 can be operated to insert the catheter 100 into the minute blood vessels through the micro-motion by the steering operation of the magnetic body at the tip of the guide wire by the external magnetic field.

5 shows the first handler 221 and the second handler 231 in a state in which the housing is removed from the driving unit of the present invention.

5, the first handler 221 includes a first bevel gear 221a to which the end of the cover spring 120 is fixed and is rotationally driven by the first driving motor 222, a cover spring 120 And a movable bracket 221b to which the end of the core tube 110 interpolated in the second direction is fixed and which is driven forward and backward by rotation of the second drive motor 223 via the rack and pinion gear.

The first bevel gear 221a is rotatably driven by a first fixing bracket 220b formed to protrude perpendicularly to the first movable member 220a.

The first handler 221 configured as described above is configured so that the first bevel gear 221a is rotated clockwise or counterclockwise by the forward rotation or the reverse rotation of the first drive motor 222, And the movable bracket 221b is driven back and forth by the forward rotation or the reverse rotation of the second drive motor 223 to provide the pulling force to the core tube 110. [

The second handler 231 includes a second bevel gear 231a to which the end of the guide wire 140 inserted in the core tube 110 is fixed and is rotationally driven by the third drive motor 232 do.

The second bevel gear 231a is rotatably driven in a second fixed bracket 230b protruding perpendicularly to the second movable member 230a.

The second handler 231 is rotated in the clockwise or counterclockwise direction by the forward rotation or the reverse rotation of the third drive motor 232 to rotate the second bevel gear 231a Thereby providing an axial rotational operating force.

FIG. 6 is a conceptual diagram illustrating an image-based remote control procedure using the microcatheter system of the present invention.

Referring to FIG. 6, the patient in the surgery is lying in an environment equipped with an X-ray fluoroscopy, and during the operation, the medical staff obtains the images before and after the injection of the contrast agent, Difference) is removed to acquire blood vessel information. The obtained blood vessel information can be superimposed on the perspective diagnostic image to secure the position of the microcatheter in real time. The medical staff can manipulate the driving unit by controlling the steering / insertion of the catheter only with image information in the outer space where the radiation shielding is performed. On the other hand, even when only one visual diagnostic apparatus is used, the catheter can be controlled only by the plane information. In the case of using the two visual diagnostic apparatuses simultaneously, the position of the blood vessel and the position of the catheter can be determined in space, The position of the blood vessel and the catheter viewed from an arbitrary direction can be provided by using a computer.

The microcatheter system of the present invention extracts the path of the blood vessel from the image of the X-ray fluoroscopic diagnosis apparatus used in actual blood vessel intervention as shown in FIG. 5 for steering / insertion, and based on this path, And based on this, it is possible to provide an image based remote control by controlling the driving part of the active steering micro catheter.

It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit or scope of the inventions. It will be apparent to those of ordinary skill in the art.

100: catheter 110: core tube
120: cover spring 130: magnetic substance
140: guide wire 200: drive unit
211: first guide member 212: second guide member
220: first module 230: second module

Claims (8)

A hollow core tube having a curved shape at a predetermined interval from the tip;
A coil-shaped cover spring fixed to the tip of the core tube to surround the core tube;
A guide wire having a magnetic body at its tip end and insertable along the core tube;
A magnetic field generating unit for generating a magnetic field for steering drive of the magnetic body;
A first module for a relative displacement movement and an axial rotation operation between the core tube and the cover spring and a second module for an axial rotation operation of the guide wire in the core tube, Microcatheter system.
delete The microcatheter system according to claim 1, wherein the drive unit further comprises a guide member for guiding the forward and backward sliding of the first module and the second module. The microcatheter system according to claim 3, further comprising a driving unit for independently driving the first module and the second module back and forth along the guide member. 5. The apparatus of claim 4,
A first movable member that is guided by the guide member and is driven forward and backward by the driving unit;
A first handler for holding and fixing the core tube and the cover spring by being seated in the first movable member;
A first drive motor provided to the first handler to provide a rotational operation force in the axial direction of the cover spring;
And a second drive motor provided on the first handler for providing a pulling force to the core tube.
6. The apparatus of claim 5, wherein the first handler comprises:
A first bevel gear whose end portion of the cover spring is fixed and rotationally driven by the first driving motor;
And a movable bracket to which an end of the core tube is fixed and which is driven forward and backward by the second driving motor.
5. The apparatus of claim 4, wherein the second module comprises:
A second movable member that is guided by the guide member and is driven forward and backward by the driving unit;
A second handler which is seated on the second movable member and holds and fixes the guide wire;
And a third drive motor provided to the second handler to provide an axial rotational operation force to the guide wire.
8. The method according to claim 7,
And a second bevel gear to which an end of the guide wire is fixed and rotationally driven by the third drive motor.
KR1020160031526A 2016-03-16 2016-03-16 Micro-catheter system with active steering and insertion functions KR101745997B1 (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102052446B1 (en) * 2018-06-01 2019-12-05 전남대학교산학협력단 An actuating module for a concentric tube robot
KR20220156139A (en) * 2021-05-17 2022-11-25 재단법인대구경북과학기술원 guidewire microrobot and its manufacturing method

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010035951A (en) * 2008-08-08 2010-02-18 Create Medic Co Ltd Catheter

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010035951A (en) * 2008-08-08 2010-02-18 Create Medic Co Ltd Catheter

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102052446B1 (en) * 2018-06-01 2019-12-05 전남대학교산학협력단 An actuating module for a concentric tube robot
KR20220156139A (en) * 2021-05-17 2022-11-25 재단법인대구경북과학기술원 guidewire microrobot and its manufacturing method
KR102638467B1 (en) * 2021-05-17 2024-02-21 재단법인대구경북과학기술원 guidewire microrobot and its manufacturing method

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