KR20130143312A - Operation apparatus for ablating vascular chronic total occlusion - Google Patents

Abstract

The present invention relates to an operation apparatus for ablating vascular chronic total occlusion. The operation apparatus of the present invention includes an inner catheter (110), a cutting tool (120) having a drilling tip (122), an outer catheter (130) having a centering member, and a driving unit (200) for driving the inner catheter (110), the cutting tool (120), and the outer catheter (130).

Description

[0001] The present invention relates to a surgical apparatus for ablating vascular chronic total occlusion,

The present invention relates to a surgical apparatus for treating blood vessels by removing chronic total occlusion (CTO) lesions in blood vessels.

Generally, chronic complete stenosis occurs when lipid-rich cholesterol is deposited on the inner wall of blood vessels and the vessel lumen is occluded.

The multilayered lipid and thrombus complexes constituting the stenotic lesion thus formed are replaced with collagen as time passes. These collagens form a mass of multimolecular molecules from a single molecule, and the cross-linking reaction and the calcination and then calcified to form a mechanically stable phosphorylated layer to prevent blood circulation.

As a method of treating such chronic stricture, a method of reperfusion and a method of physically perforating a fibrin-collagen complex by chemical decomposition are used.

It is generally known that rotary cutting methods are particularly useful for hardened stricture lesions with calcification.

However, currently used physical perforation methods are difficult to penetrate the central part of the lesion along the center of the blood vessel in the process of penetrating the hard calcified lesion, and it is difficult for the angiostatic agent to be injected in the direction of blood flow through the occlusion area of the blood vessel Therefore, there is a problem that it is difficult to secure the shape of the blood vessel after the passage of the entire stricture of the stomach, thereby causing damage and puncture of the inner wall of the blood vessel during the physical procedure.

Therefore, the success rate of angioplasty is 95% in patients without chronic complete stenosis, but only 70% in patients with chronic complete stenosis.

In addition, a typical mechanism of the conventional chronic stricture treatment is a treatment with high stiffness, which is pierced by using a large and sharp wire at the front part.

However, such a device has a disadvantage in that it is difficult to precisely align the center of the stent when the wire is pushed and difficult to adjust the direction.

The Applicant has proposed a surgical apparatus for vascular treatment for physically and effectively removing such chronic stricture lesions, which is disclosed in Patent Application No. 10-2011-0049738 (filed on May 25, 2011) and Patent Application No. 10-2011-0049739 Patent application is filed on May 25, 2011). In the patent application, the puncture member can be positively rotated and reversely rotated in the process of physically removing the chronic complete laceration lesion, thereby effectively puncturing the stenosis in the blood vessel, In addition, we proposed a surgical device for vascular treatment that can prevent damage to the inner wall of the vessel during perforation of the stenosis and increase the success rate of operation.

The present invention relates to a surgical apparatus for removing a chronic stricto-striction lesion in a blood vessel, and in particular, it is easy to steer the perforating means so that the perforating means can be easily introduced to the target site, And to provide a surgical apparatus capable of maintaining accurate centering and correct puncturing of stenosis.

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 surgical device for removing a chronic stricto-stricture lesion in a blood vessel, comprising: an inner catheter having a through hole therein; A cutting tool inserted into the inner catheter and capable of moving forward or backward along the inner catheter, and having a drilling tip that hits a lesion at its distal end; An outer catheter having a centering member which is provided on an outer circumferential surface of the inner catheter so as to be inflatable and supported on an inner wall of the blood vessel; And a driving unit for driving the inner catheter, the cutting tool, and the outer catheter, wherein the driving unit comprises: a housing; An outer catheter fixing member having an end fixed to the outer catheter and elastically supported by the first elastic body in the housing so as to be movable back and forth; An inner catheter fixing member fixed to the distal end of the inner catheter and fixed to the rear end of the outer catheter fixing member and fixed in the housing; A tilting wire driving member which is movable back and forth with respect to the inner catheter fixing member and to which a tilting wire connected to the inner catheter is fixed; A cutting tool holding member provided in the housing so that a distal end of the cutting tool is fixed and closely contacted with a rear end of the tilting wire driving member so as to be movable forward or backward or rotatable; A first driving unit provided at a rear end of the cutting tool holding member to rotationally drive the cutting tool holding member in the housing; A second driving unit provided at a rear end of the first driving unit and elastically supported by the second elastic body in the housing to oscillate the first driving unit back and forth; A tilting wire operating portion provided in the housing for operating the tilting wire driving member in the longitudinal direction; An outer catheter manipulation part provided in the housing for manipulating the outer catheter fixing member in a longitudinal direction; And a cutting tool operating portion provided in the housing for driving the cutting tool holding member back and forth.

Preferably, in the present invention, the inner catheter is further provided with a plurality of grooves parallel to the tilting direction on the outer peripheral surface of the distal end, more preferably, the grooves are perpendicular to the rotation axis direction of the inner catheter.

Preferably, in the present invention, the centering member is inflated or contracted by relative back and forth movement between the inner catheter and the outer catheter.

Preferably, in the present invention, the centering member is composed of a plurality of flexible strips formed by a plurality of incision grooves that are fixed at the distal end of the outer catheter to the inner catheter and are longitudinally incised at the outer circumferential surface of the outer catheter .

Preferably, in the present invention, the cutting tool is characterized in that the drilling tip is composed of a flexible tube fixed to the tip and a coil spring wound on the flexible tube.

Preferably, the tilting wire according to the present invention is characterized in that at least two tilting wires are rotationally symmetrical with respect to the radial direction of the inner catheter.

Preferably, in the present invention, the distal end portion of the inner catheter further includes a head having a curved front end.

Preferably, in the present invention, the housing further includes a second driving unit for oscillating the first driving unit back and forth.

A surgical apparatus for removing a chronic stricto stricture lesion in a blood vessel according to the present invention comprises: an inner catheter; A cutting tool having a drilling tip inserted into the inner catheter for striking the stenosis by rotation and / or vibration; An outer catheter having a centering member which is provided on an outer circumferential surface of the inner catheter so as to be inflatable and supported on an inner wall of the blood vessel; And a drive unit for driving the outer catheter, wherein the perforating means can be safely introduced to the target site by using the inner catheter, and the drilling tip can be rotated And / or perforation is performed while vibrating in the direction of the axis of rotation, so that the removal of the chronic complete stricture lesion of the blood vessel can be effectively achieved.

In addition, since the surgical apparatus of the present invention can stably center the perforation means in the perforation process in the perforating process, accurate puncturing can be performed on the perforated material, so that accurate and safe procedures can be performed.

1 is an enlarged view of only an inner catheter, a cutting tool and an outer catheter in the surgical apparatus according to the present invention,
2 is a drawing showing a preferred example of an inner catheter in a surgical device according to the present invention,
3 (a) and 3 (b) illustrate a tilting operation of the inner catheter in the surgical apparatus according to the present invention,
4 (a), 4 (b) and 4 (c) schematically show a procedure of removing a stenosis in a blood vessel using the surgical apparatus according to the present invention,
Figure 5 shows a preferred embodiment of a drive unit for driving an inner catheter, a cutting tool and an outer catheter in a surgical device according to the present invention.

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. It is to be understood that the invention is not to be interpreted as limited to the embodiments set forth herein, but includes all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

Meanwhile, in the present invention, the terms first and / or second etc. may be used to describe various components, but the components are not limited to the terms. The terms may be referred to as a second element only for the purpose of distinguishing one element from another, for example, to the extent that it does not depart from the scope of the invention in accordance with the concept of the present invention, Similarly, the second component may also be referred to as the first component.

It is to be understood that when an element is referred to as being "connected" or "connected" to another element, it may be directly connected or connected to the other element, but it should be understood that there may be other elements in between something to do. On the other hand, when it is mentioned that an element is "directly connected" or "directly contacted" to another element, it should be understood that there are no other elements in between. Other expressions for describing the relationship between components, such as "between" and "between" or "adjacent to" and "directly adjacent to" should also be interpreted.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. Singular expressions include plural expressions unless the context clearly indicates 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.

The surgical device of the present invention includes an inner catheter 110, a cutting tool 120, an outer catheter 130, and a drive unit 200.

Referring to FIG. 1, the inner catheter 110 according to the present invention has a through hole formed therein so that the cutting tool 120 can move back and forth or rotate along the inner catheter 110.

The inner catheter 110 functions to guide the cutting tool 110 to a target site as a portion where insertion is performed along the inside of the blood vessel. While the inner catheter 110 moves along the blood vessel to the target site, 110 are drawn into the inner catheter 110 and are not exposed to the outside.

Such an inner catheter 110 may be provided by a flexible tube of a synthetic resin material, and may be provided by a tube coated with a synthetic resin, preferably with a coil spring or a metal wire braided braid.

FIG. 2 is a view showing a preferred example of an inner catheter in a surgical apparatus according to the present invention, in which a metal wire is braided so that a tubular mesh 110b is used as a core, and the mesh core is coated with a synthetic resin And an inner catheter 110 made of a coating layer 110a, and a coil spring other than a metal wire mesh may be used.

Preferably, in the present invention, as illustrated in FIG. 1, the inner catheter 110 is characterized in that a plurality of grooves 112 are additionally formed in parallel to the tilting direction on the outer peripheral surface of the tip. The groove 112 may be formed perpendicular to the longitudinal direction of the inner catheter 110 to facilitate tilting in a direction in which the groove 112 is formed. The inner catheter 110 is provided with a tilting wire 111 for tilting operation and the distal end portion of the inner catheter 110 can be tilted in a specific direction by the operation of the tilting wire 111. For example, the tilting wire 111 is slidably inserted into the inner catheter 110 in a state in which the distal end of the tilting wire 111 is adjacent to the distal end of the inner catheter 110 and is capable of tilting the distal end of the inner catheter 110 .

1 shows that a tilting wire 111 is provided inside the recess 112 of the inner catheter 110. As shown in FIG. A head 113 having a rounded curved front end is fixed to the distal end of the inner catheter 110. The head 113 is inserted into the blood vessel to move the blood vessel to the target site Can be prevented.

3 (a) and 3 (b) illustrate a tilting operation of the inner catheter in the surgical apparatus according to the present invention.

3 (a), the inner catheter 110 has a plurality of grooves 112 formed on one side of a radial direction of the inner catheter 110, A tilting wire 111 is provided. The tip of the tilting wire 111 is fixed to the distal end of the inner catheter 110 and can be slidably inserted into the inner catheter 110.

As shown in FIG. 3 (b), when the rear end 111a of the tilting wire 111 is pulled, the inner catheter 110 can be tilted in the direction in which the tilting wire 111 is positioned. The operation of the tilting wire 111 is performed in the drive unit, though it will be described later in detail.

In this embodiment, the tilting direction of the inner catheter 110 by the tilting wire 111 is made only in a specific direction. However, after the entire inner catheter 110 is rotated about the axial direction, the tilting wire 111 is manipulated So that the inner catheter 110 can rotate 360 degrees within the blood vessel.

In this embodiment, the inner catheter is provided with only one tilting wire so that the tilting is performed only in the direction in which the tilting wire is positioned. However, in the inner catheter, two or more tilting wires are radiated to the inner catheter It can be clearly understood that the distal end portion of the inner catheter can be tilted in any direction without rotating the inner catheter itself by the operation of the plurality of tilting wires.

Referring again to FIG. 1, the cutting tool 120 is inserted into the inner catheter 110 and is capable of moving forward or backward along the inner catheter 110, and a drilling tip 122 for hitting the lesion is provided at the distal end do.

Preferably, in the present invention, the cutting tool 120 may be composed of a flexible tube whose tip is fixed to the drilling tip 122 and a coil spring 121 which is wound around the flexible tube. In the present invention, the drilling tip 122 is not limited to a particular shape, but a tip is formed at the distal end of the drilling tip 122 so as to be in contact with the stenotic material and to be perforated.

The cutting tool 120 is inserted into the inner catheter 110 in the course of the movement of the inner catheter 110 to the target site so that the cutting tool 120 is moved by the cutting tool 120 It is possible to prevent damage to the inner wall of the blood vessel.

On the other hand, after the inner catheter 110 reaches the target site, the cutting tool 120 is moved forward and backward, and forward and backward oscillation and rotation operation are performed, so that perforation of the stenosis can be performed.

The outer catheter 130 has a centering member that is provided on the outer circumferential surface of the inner catheter 110 in an expandable manner and is supported on the inner wall of the blood vessel.

In particular, in the present invention, the centering member can be expanded or contracted by relative back and forth movement between the inner catheter and the outer catheter.

Specifically, as illustrated in FIG. 1, in the present invention, the centering member has a distal end portion of the outer catheter 130 fixed to the inner catheter 110, and is provided with a plurality of incision grooves 132 cut longitudinally from the outer circumferential surface of the outer catheter. By a plurality of flexible strips 133 formed by a plurality of flexible strips 133. [

The outer catheter 130 has a stopper 131 at its distal end and is fixed to the outer circumferential surface of the inner catheter 110.

A plurality of flexible strips 133 are provided on the outer catheter 130 in the longitudinal direction so that when the outer catheter 130 is pushed in the state where the inner catheter 110 is fixed, Extends in a radial direction and is fixedly supported on the inner wall surface of the blood vessel so that the inner catheter 110 is positioned at the center of the blood vessel so that the cutting tool can be stably supported during the drilling operation of the stenosis.

4 (a), 4 (b) and 4 (c) are schematic views illustrating a procedure for removing stenosis in a blood vessel using the surgical apparatus according to the present invention.

4A, the inner catheter 110 is inserted into the blood vessel 10 to the target site where the stenosis 20 is present. In this process, the inner catheter 110 is tilted along the blood vessel And the centering member of the outer catheter 130 is kept folded in the inner catheter 110.

Next, as shown in FIG. 4 (b), when the inner catheter 110 is inserted to the target site where the stenosis 20 is present, the outer strip 133 is extended by pushing the outer catheter 130 The inner catheter 110 is firmly supported and positioned at the center of the blood vessel by the outer catheter 130.

Referring to FIG. 4C, in the state where the cutting tool 110 is moved forward by a predetermined length, the cutting tool 110 is rotated in one direction, And the operator can slowly advance the cutting tool 110 in accordance with the progress of the perforation so as to perform the perforation operation on the stenosed product 20. [

Next, the inner catheter 110, the cutting tool 120, and the driving unit 200 for driving the outer catheter 130 will be described.

5 is a view showing a preferred embodiment of a driving unit for driving an inner catheter, a cutting tool and an outer catheter in the surgical apparatus according to the present invention.

The driving unit 200 according to the present invention includes a housing 201, an outer catheter fixing member 210, an inner catheter fixing member 220, a tilting wire driving member 230, a cutting tool fixing member 240, 260 includes a tilting wire operating unit 270, an outer catheter operating unit 280, and a cutting tool operating unit 290. The first and second driving units 250,

The housing 201 accommodates the respective components of the driving unit to constitute the entire outer appearance, and the outer shape of the housing 201 can have various forms that can be conveniently handled and used by the practitioner.

The outer catheter fixing member 210 is positioned at the distal end of the housing 201 and is fixed to the distal end of the outer catheter 130 and elastically supported by the first elastic body 211, Do.

5, the outer catheter fixing member 210 is provided with a hole formed therethrough at the center thereof, and the outer catheter 130 is press-fitted and fixed through the hole to move the outer catheter fixing member 210 forward or backward Thus, the outer catheter 130 is movable back and forth with respect to the inner catheter.

The first elastic body 211 may be provided by a compression spring inserted between the housing 201 and the distal end of the outer catheter fixing member 210 so that the outer catheter fixing member 210 is elastically deformed backward The outer catheter fixing member 210 maintains a state in which the outer catheter fixing member 210 is in close contact with the rear catheter fixing member 210 when the operation force does not act on the outer catheter fixing member 210. [

The inner catheter fixing member 220 is fixed at the rear end of the outer catheter fixing member 210 to the housing 201 with the distal end of the inner catheter inserted through the outer catheter 130 fixed.

The tilting wire driving member 230 is provided so as to be movable back and forth with respect to the inner catheter fixing member 220, and the tilting wire connected to the inner catheter is fixed. Accordingly, tension can be generated in the tilting wire 111 (see FIG. 4) in accordance with the forward and backward movement of the tilting wire drive member 230, so that the inner catheter can be tilted.

The cutting tool fixing member 240 is fixed to a distal end of the cutting tool 120 inserted in the inner catheter and is positioned at the rear end of the tilting wire drive member 230 and is movable in the front and rear directions or rotatably, .

The first driving part 250 is provided at the rear end of the cutting tool fixing member 240 to rotationally drive the cutting tool fixing member 240 in the housing 201 to provide the cutting force of the drilling tip with respect to the stitching material. Can be provided by an electric motor.

The second driving unit 260 is provided at a rear end of the first driving unit 250 to vibrate the first driving unit 250 in the front-rear direction, and may be provided by a well-known electric motor.

The second driving unit 260 generates vibration in the forward and backward directions within a predetermined stroke range in the course of perforating the stenosed product by the rotation of the drilling tip (first driving unit), so that the frictional heat between the drilling tip and the stent There is an effect that the occurrence can be reduced.

The second driving unit 260 may be provided by an oscillating member provided at a rear end of the first driving unit 250 and an electric motor for rotationally driving the oscillating member. For example, the vibrating member may have a plurality of concavities and convexities, and the concavities and convexities may generate vibration in the front-rear direction of the first driving unit 250 in accordance with the rotation of the vibrating member. On the other hand, the second driving unit is not limited to this example, and vibration of the first driving unit can be generated by the vibration of the eccentrically positioned rotor, and such vibration means may have various modifications.

5, a tension spring 261 for elastically supporting the first driving part 250 and the housing 201 may be provided. The tension spring 261 elastically supports the first driving part 250 rearward The first driving part 250 and the second driving part 260 are positioned in close contact with each other so that the vibration can be smoothly transmitted to the first driving part 250.

The tilting wire operating portion 270 is provided in the housing 201 to operate the wire driving member 230 for tilting back and forth.

5, the tilting wire operating portion 270 includes a lever 271 whose middle portion is hinged to the housing 201 and whose lower end is rotatable with the tilting wire driving member 230, and the lever 271, Can be provided by a slide button 272 movable back and forth on one side of the outer circumferential surface of the housing 201 so as to be rotatable.

Therefore, the operator can operate the tilting wire drive member 230 back and forth by the operation of the slide button 272 before and after tilting the inner catheter.

On the other hand, when two or more tilting wires are provided for the tilting operation of the inner catheter, it can be understood that a plurality of tilting wire operating parts for tilting each tilting wire can be provided in the housing.

The outer catheter manipulation unit 280 may be provided by a lever that is hinged, and the outer catheter securing member 210 can be manipulated back and forth by manipulation of the lever.

The cutting tool operating portion 290 is for driving the cutting tool holding member 250 forward and backward and can be provided by a lever hinged to the housing 201. [ The operator can manipulate the cutting tool operating portion 290 during the perforating operation of the stitching material to position the cutting tool so as to protrude out of the inner catheter (see FIG. 4 (b)),

Although the tilting wire operating unit 270, the outer catheter operating unit 280 and the cutting tool operating unit 290 are operated by a manual operation using a slide button or a lever in the present embodiment, And it is obvious that a plurality of elastic bodies for returning the operation buttons or levers to the home position can be added for the convenience of operation of the operation buttons or levers. On the other hand, each operation portion can be electrically driven by an electric type, not by a water operation.

The present invention described above is not limited to the above-described embodiment and the accompanying drawings, and various substitutions, modifications, and changes are possible within the scope without departing from the technical spirit of the present invention. It will be evident to those who have knowledge of.

110: Inner catheter 111: Wire for tilting
112: groove 113: head
120: cutting tool 130: outer catheter
131: stopper 132: incision groove
133: flexible strip 200: drive unit
201: housing 210: outer catheter fixing member
211: first elastic member 220: inner catheter fixing member
230: a wire fixing member for tilting 240: a cutting tool fixing member
250: first driving part 260: second driving part
261: second elastic body 270: tilting wire operating portion
280: Outer catheter operating part 290: Cutting tool operating part

Claims (9)

A surgical device for removing a chronic stricture lesion obstructing a lumen of a blood vessel,
An inner catheter having a through hole formed therein;
A cutting tool inserted into the inner catheter and capable of moving forward or backward along the inner catheter, and having a drilling tip that hits a lesion at its distal end;
An outer catheter having a centering member which is provided on an outer circumferential surface of the inner catheter so as to be inflatable and supported on an inner wall of the blood vessel;
And a drive unit for driving the inner catheter, the cutting tool, and the outer catheter,
The drive unit includes:
A housing;
An outer catheter fixing member having an end fixed to the outer catheter and elastically supported by the first elastic body in the housing so as to be movable back and forth;
An inner catheter fixing member fixed to the distal end of the inner catheter and fixed to the rear end of the outer catheter fixing member and fixed in the housing;
A tilting wire driving member which is movable back and forth with respect to the inner catheter fixing member and to which a tilting wire connected to the inner catheter is fixed;
A cutting tool holding member provided in the housing so that a distal end of the cutting tool is fixed and closely contacted with a rear end of the tilting wire driving member so as to be movable forward or backward or rotatable;
A first driving unit provided at a rear end of the cutting tool holding member to rotationally drive the cutting tool holding member in the housing;
A tilting wire operating portion provided in the housing for operating the tilting wire driving member in the longitudinal direction;
An outer catheter manipulation part provided in the housing for manipulating the outer catheter fixing member in a longitudinal direction;
And a cutting tool operating portion provided on the housing for driving the cutting tool holding member in the forward and backward directions. According to claim 1, The inner catheter is a surgical device for removing chronic stenosis lesions in the vessels, characterized in that a plurality of grooves are formed side by side in the tilting direction on the outer peripheral surface of the tip. The surgical device of claim 2, wherein the groove is perpendicular to the direction of the rotation axis of the inner catheter. The surgical apparatus for removing a lesion according to claim 1, wherein the centering member is inflated or contracted by relative movement of the inner catheter and the outer catheter. 5. The apparatus according to claim 4,
Wherein the distal end of the outer catheter is fixed to the inner catheter and is composed of a plurality of flexible strips formed by a plurality of incision grooves cut longitudinally from the outer circumferential surface of the outer catheter. Surgical device. The cutting tool according to claim 1,
Wherein the drilling tip is composed of a flexible tube fixed to the tip and a coil spring wound on the flexible tube. The tilting wire according to claim 1,
Wherein at least two of the inner catheters are rotationally symmetric with respect to the radial direction of the inner catheter. The surgical apparatus of claim 1, wherein the distal end of the inner catheter further includes a head having a curved distal end. The surgical apparatus for removing a lesion according to claim 1, wherein the housing further includes a second driving unit for oscillating the first driving unit back and forth.

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