KR102371076B1 - Thrombus removal device - Google Patents

Abstract

An apparatus for removing a thrombus according to an embodiment of the present invention provides an apparatus for removing a thrombus for removing a thrombus, comprising: a suction catheter; a balloon catheter disposed within the suction catheter; and a thrombus removal unit provided at the distal end of the balloon catheter, wherein the thrombus removal unit is movable by the balloon catheter, and the thrombus may be sucked through the suction catheter.

Description

Thrombus Removal Device {THROMBUS REMOVAL DEVICE}

A thrombus removal device is disclosed.

When treating acute myocardial infarction in patients with ST-Elevation Myocardial Infarction (STEMI), the shorter the ischemic time, the lower the rate of cardiac necrosis. In the course of treating acute myocardial infarction, reperfusion injury may occur in the process of resuming blood flow to a blood vessel blocked by a thrombus. Although there are spontaneously recoverable injuries during reperfusion injuries, typical no-reflow/slow-reflow injuries and lethal reperfusion injuries cause additional damage to the myocardium.

In general, non-reflow/slow-reflow injury is large in lesions with high thrombosis, and lethal reperfusion injury is large in lesions with low thrombosis. In particular, lethal reperfusion injury has a problem in that when blood flow is suddenly resumed, the myocardium cannot respond to this sudden change, resulting in inflammation or necrosis. In an emergency situation, the thrombus removal device should be simple, respond flexibly to the reaction of blood vessels, and the interventional methods need to complement each other in order to effectively prevent the above two types of damage.

The above-mentioned background art is possessed or acquired by the inventor in the process of deriving the disclosure of the present application, and it cannot necessarily be said to be a known technology disclosed to the general public prior to the present application.

US Patent Publication No. 9,149,609 B2 (registered on Aug. 6, 2015)

An object of the present embodiment is to provide an effective thrombus removal device without delaying ischemic postconditioning while simultaneously performing thrombus removal and repeated balloon dilatation of a target lesion to pulverize the thrombus.

An apparatus for removing a thrombus according to an embodiment of the present invention provides an apparatus for removing a thrombus for removing a thrombus, comprising: a suction catheter; a balloon catheter disposed within the suction catheter; and a thrombus removal unit provided at the distal end of the balloon catheter, wherein the thrombus removal unit is expandable by the balloon catheter, the balloon catheter is movable, and the thrombus removed by the thrombus unit is sucked It can be aspirated through a catheter.

According to one side, the thrombus removal unit may be a balloon expandable and contractible by the inflow or outflow of the working fluid therein.

According to one side, the suction catheter, the suction catheter body is made of a flexible material and insertable into a blood vessel; and a suction catheter tip provided at an end of the catheter body.

According to one side, the opening of the suction catheter tip may be expandable.

According to one side, the balloon catheter, the suction catheter body, at least a portion of the balloon catheter shaft is disposed; and a guide wire for moving the balloon catheter shaft, wherein the balloon may be disposed at an end of the balloon catheter shaft.

According to one side, the balloon catheter shaft and the guide wire may be movable integrally.

According to one side, the suction catheter body may include a groove in the lumen or body in which at least a portion of the balloon catheter shaft or the guide wire may be disposed.

According to one side, the thrombus removal apparatus may further include a suction device connected to one end of the suction catheter to provide negative pressure to the inside of the suction catheter.

According to one side, the thrombus removal apparatus may further include a balloon inflation device, which provides a working fluid enabling expansion and contraction of the balloon to the balloon.

According to one side, the thrombus removal apparatus may further include a control unit for controlling operations of the suction catheter, the balloon catheter, the suction device, and the balloon inflation device.

According to one side, the control unit may position the balloon on the tip of the suction catheter in a reduced state, and open the tip of the suction catheter by inflation of the balloon through the balloon inflation device.

According to one side, the control unit moves the balloon to the target lesion site blocked by the thrombus, expands and contracts the balloon through the balloon inflation device, and at the same time provides negative pressure through the suction device to remove the thrombus can do.

The thrombus removal apparatus according to an embodiment may simplify the interventional treatment step and shorten the treatment time in the STEMI patient.

The thrombus removal apparatus according to an embodiment can maximize the effect of ischemic postconditioning by simultaneously performing the thrombus removal and balloon dilatation of the target lesion so that the ischemic post-treatment is not delayed.

The thrombus removal device according to an embodiment has a thrombus crushing effect by repeatedly expanding and deflating the target lesion, thereby effectively removing the thrombus while minimizing the risk of distal embolism.

The thrombus removal apparatus according to an embodiment may complement interventional procedures used to prevent non-reflow/slow-reperfusion injury and lethal reperfusion injury.

The thrombus removal apparatus according to an exemplary embodiment may ultimately reduce the size of myocardial infarction due to the above-described effect, thereby minimizing the occurrence of complications after myocardial infarction.

Effects of the thrombus removal device according to an embodiment are not limited to those mentioned above, and other effects not mentioned will be clearly understood by those skilled in the art from the following description.

1 is a diagram schematically illustrating a thrombus removal apparatus according to a first embodiment.
2 is a view showing a balloon and a catheter tip of the thrombus removal device according to the first embodiment.
3 is a diagram schematically illustrating a process in which the balloon of the thrombus removal device according to the first embodiment opens the catheter tip.
4 shows the thrombus removal apparatus according to the first embodiment. 4A shows an initial state in which the thrombus removal device according to the first embodiment is inserted. Figure 4 (b) shows a state in which the catheter tip of the thrombus removal device according to the first embodiment is opened. Figure 4 (c) shows a state in which the balloon catheter of the thrombus removal device according to the first embodiment moves. 4(d) shows a thrombus removal process of the thrombus removal apparatus according to the first embodiment.
5 shows an apparatus for removing a thrombus according to a second embodiment. 5( a ) shows an initial state in which the thrombus removal device according to the second embodiment is inserted. Figure 5 (b) shows a state in which the catheter tip of the thrombus removal device according to the second embodiment is opened. 5( c ) shows a state in which the balloon catheter of the thrombus removal device according to the second embodiment moves. 5( d ) shows a thrombus removal process of the thrombus removal apparatus according to the second embodiment.

Hereinafter, embodiments will be described in detail with reference to the accompanying drawings. However, since various changes may be made to the embodiments, the scope of the patent application is not limited or limited by these embodiments. It should be understood that all modifications, equivalents and substitutes for the embodiments are included in the scope of the rights.

The terms used in the examples are used for the purpose of description only, and should not be construed as limiting. The singular expression includes the plural expression unless the context clearly dictates otherwise. In this specification, terms such as "comprise" or "have" are intended to designate that a feature, number, step, operation, component, part, or a combination thereof described in the specification exists, but one or more other features It should be understood that this does not preclude the existence or addition of numbers, steps, operations, components, parts, or combinations thereof.

Unless defined otherwise, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by one of ordinary skill in the art to which the embodiment belongs. Terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with the meaning in the context of the related art, and should not be interpreted in an ideal or excessively formal meaning unless explicitly defined in the present application. does not

In addition, in the description with reference to the accompanying drawings, the same components are given the same reference numerals regardless of the reference numerals, and the overlapping description thereof will be omitted. In describing the embodiment, if it is determined that a detailed description of a related known technology may unnecessarily obscure the gist of the embodiment, the detailed description thereof will be omitted.

In addition, in describing the components of the embodiment, terms such as first, second, A, B, (a), (b), etc. may be used. These terms are only for distinguishing the elements from other elements, and the essence, order, or order of the elements are not limited by the terms. When it is described that a component is "connected", "coupled" or "connected" to another component, the component may be directly connected or connected to the other component, but another component is between each component. It will be understood that may also be "connected", "coupled" or "connected".

Components included in one embodiment and components having a common function will be described using the same names in other embodiments. Unless otherwise stated, descriptions described in one embodiment may be applied to other embodiments as well, and detailed descriptions within the overlapping range will be omitted.

As used herein, the term "ischemia" refers to a condition in which blood flow is temporarily blocked in a blood vessel, and "ischemic time" is the amount of time that has elapsed until blood flow is restored in a damaged tissue portion. tell the time The shorter the ischemia time, the lower the tissue damage rate, and it is considered as the most important factor for life and prognosis in STEMI patients.

As used herein, the term “reperfusion” refers to the resumption of blood flow. "Reperfusion Injury" refers to tissue damage that occurs when a blocked blood vessel is re-opened, and can be mainly found in the heart.

As used herein, the term "no-reflow/slow-reflow injury" refers to a sharp decrease in the blood flow rate of a blood vessel (eg, a coronary artery) as a sequelae that occurs during reperfusion treatment. It is caused by thrombus or arteriosclerotic plaques in the target lesion site falling off to the distal part and occluding microvessels.

As used herein, the term "lethal reperfusion injury" refers to the death of myocardial cells due to the rapid resumption of blood flow as a sequelae that occurred during reperfusion treatment.

As used herein, the term "ischemic postconditioning" refers to a method of protecting the myocardium from reperfusion injury by gently resuming blood flow by performing periodic repetition of myocardial ischemia and reperfusion immediately after reperfusion.

1 to 4 show the thrombus removal device 10 according to the first embodiment, and FIG. 5 shows the thrombus removal device 20 according to the second embodiment.

The thrombus removal apparatus 10 according to the first embodiment may be a monorail type, and the thrombus removal apparatus 20 according to the second embodiment may be an over the wire type.

In the case of the monorail type, the guide wire or balloon catheter shaft may be inserted and connected at an intermediate position of the suction catheter, for example, at about 1/3 position from the front. In contrast, in the case of the over the wire type, a guide wire or a balloon catheter shaft may be inserted into the rear end of the suction catheter.

1 is a view schematically showing a thrombus removal apparatus 10 according to a first embodiment. Referring to FIG. 1 , the thrombus removal device 10 according to the first embodiment includes a suction catheter 100 , a balloon catheter 200 , and a thrombus removal unit (opening of the balloon and the tip of the suction catheter) 300 . can

The thrombus removal unit 300 may be an opening of a balloon and a suction catheter that can be expanded and contracted by inflow or outflow of a working fluid therein. The thrombus removal unit 300 is in a reduced state as the thrombus removal unit 300 is contracted (opening of the tip of the suction catheter) to minimize damage to the blood vessel B while moving to the target lesion, and the thrombus removal unit 300 is in a reduced state. ) at the position of the thrombus (T), the balloon located at the end of the thrombus removal unit (the opening of the tip of the suction catheter) expands, and the opening of the suction catheter is expanded so that the thrombus can be sucked and negative pressure is applied. At the same time, ischemic postconditioning and vasodilation are performed simultaneously while crushing the thrombus (T) by repeating expansion and contraction. At this time, the pulverized blood clot can be effectively removed through a suction catheter with negative pressure applied.

The suction catheter 100 may include a suction catheter body 110 made of a flexible material and insertable into a blood vessel, and a suction catheter tip 120 provided at an end of the catheter body.

For example, the opening of the suction catheter tip 120 may have a deformable shape.

The balloon catheter 200 may include a balloon catheter shaft 210 at least partially disposed in the suction catheter body 110 and a guide wire 220 for moving the balloon catheter shaft 210 . For example, all or at least a portion of the balloon catheter shaft 210 may be disposed within a wall or lumen of the suction catheter body.

The balloon 300 may be disposed at the distal end of the balloon catheter shaft 210 .

In addition, the balloon catheter 200 may include a guide wire 220 for moving the balloon catheter shaft 210 . The balloon catheter shaft and the guide wire may be integrally movable within a wall or lumen of the suction catheter body.

The thrombus removal apparatus 10 according to the first embodiment may include a suction device 400 connected to one end of the suction catheter 100 to provide negative pressure to the inside of the suction catheter 100 .

In addition, the thrombus removal apparatus 10 according to the first embodiment may include a balloon inflation device 500 that provides a working fluid enabling expansion and contraction of the balloon 300 to the balloon 300 . .

FIG. 2 is a view showing a balloon 300 and a catheter tip 120 that are a thrombus removal unit of the thrombus removal device 10 according to the first embodiment.

Referring to FIG. 2 , when the balloon 300 is in a contracted state, it may pass through the opening of the reduced catheter tip 120 while moving to the outside of the suction catheter 100 . When the balloon 300 is inflated, the catheter tip 120 may be expanded.

3 is a diagram schematically illustrating a process in which the balloon 300 of the thrombus removal device 10 according to the first embodiment opens the catheter tip 120 .

Referring to FIG. 3 , the balloon 300 in a contracted state in the blood vessel passes through the opening of the catheter tip 120 along the guide wire 220 (shown in a longitudinal section). Thereafter, the balloon 300 in a contracted state in the blood vessel (B) expands without completely passing through the opening of the catheter tip 120 to expand the catheter tip 120 . Then, even when the inflated balloon 300 is contracted, the dilated catheter tip 120 may still be maintained in an open state without contracting again.

4 shows an operating state of the thrombus removal device 10 according to the first embodiment. In the thrombus removal device 10 according to the embodiment, the suction catheter tip 120 may be opened by the balloon 300 .

Specifically, FIG. 4A shows an initial state in which the thrombus removal device 10 according to the first embodiment is inserted. Figure 4 (b) shows a state in which the catheter tip 120 of the thrombus removal device 10 according to the first embodiment is opened. 4(c) shows a state in which the balloon catheter 200 of the thrombus removal device 10 according to the first embodiment moves. FIG. 4(d) shows a thrombus T removal process of the thrombus removal apparatus 10 according to the first embodiment.

Referring to FIG. 4A , the thrombus removal apparatus 10 according to the first embodiment includes the suction catheter 100 , the balloon catheter 200 , the suction device 400 , and the balloon inflation device 500 . It may include a control unit (not shown) for controlling the operation of the.

Referring to FIG. 4( b ), the control unit positions the balloon 300 on the suction catheter tip 120 in a reduced state, and expands the balloon 300 through the balloon inflation device 500 . By the suction catheter tip 120 may be opened. This procedure is to minimize the wound on the vascular site that can be applied to the suction catheter to access the target lesion site.

Referring to FIG. 4C , the controller moves the balloon 300 to the target lesion site blocked by the thrombus T, and expands and contracts the balloon 300 through the balloon inflation device 500 . can Such repeated balloon inflation and deflation can break up the thrombus at the target lesion site. Since this process is ischemic postconditioning and has the same effect as vasodilation, the effect of performing three procedures at the same time can be obtained. During this process, the thrombus may be continuously removed by providing negative pressure through the suction device 500 .

Referring to FIG. 4( d ), the control unit positions the tip 120 of the suction catheter more proximal than the target lesion site, and repeats the expansion and contraction of the balloon 300 at the target lesion site to crush the thrombus. Ischemic postconditioning can be performed. At this time, angioplasty may be performed at the same time. During this process, a negative pressure may be provided through the suction device 400 to suck the pulverized thrombus T.

5 shows a thrombus removal device 20 according to the second embodiment.

The thrombus removal device 20 according to the second embodiment is an over-the-wire type, and the balloon catheter 2200 is inserted into the rear end of the suction catheter 2100, and other components are thrombus removal according to the first embodiment. Similar to device 10 .

Referring to FIG. 5A , the suction catheter 2100 of the thrombus removal apparatus 20 according to the second embodiment may be inserted into the target blood vessel B. At this time, the suction catheter tip 2120 may be in a reduced state.

The balloon catheter 2200 within the suction catheter 2100 may then be moved toward the catheter tip 120 of the suction catheter 100 . In this case, the balloon catheter 2200 is an over the wire type, and may be moved over the entire guide wire 2220 .

Thereafter, referring to FIG. 5B , the balloon 2300 of the balloon catheter 2200 in the suction catheter 2100 may be expanded while passing through the opening of the suction catheter tip 2120 . At this time, the inflated balloon 2300 may open the catheter tip 2120 of the suction catheter. Alternatively, the catheter tip 2120 of the suction catheter may be automatically opened or contracted regardless of the expansion and contraction of the balloon 2300 .

Then, referring to FIG. 5( c ), the inflated balloon 2300 may return to a contracted state again and may be positioned in the thrombus T located in the distal portion of the suction catheter 2100 . The balloon 2300 may be expanded and contracted through the balloon inflation device 2500 . In this case, the thrombus removal apparatus 20 may simultaneously provide a negative pressure through the suction device 2400 . Through the expansion and contraction of the balloon 2300 , the thrombus T in the blood vessel B may be removed from the blood vessel and the blood vessel B may be expanded.

Then, referring to FIG. 5(d), the balloon 2300 is moved to a position farther than the removed thrombus T, and while maintaining the expanded state, a negative pressure is provided through the suction device 2400, , the thrombus T may be aspirated.

Since the thrombus removal device according to an embodiment sucks the thrombus by applying negative pressure through the suction catheter at the same time during ischemic post-treatment, non-reperfusion/slow reperfusion injury and lethal reperfusion due to repeated balloon dilatation during ischemic post-treatment damage can be minimized.

These effects clinically can be expected to bring about a reduction in the incidence of heart failure and a reduction in mortality after STEMI, thereby reducing the overall medical cost of society.

The method according to the embodiment may be implemented in the form of program instructions that can be executed through various computer means and recorded in a computer-readable medium. The computer-readable medium may include program instructions, data files, data structures, etc. alone or in combination. The program instructions recorded on the medium may be specially designed and configured for the embodiment, or may be known and available to those skilled in the art of computer software. Examples of the computer-readable recording medium include magnetic media such as hard disks, floppy disks and magnetic tapes, optical media such as CD-ROMs and DVDs, and magnetic such as floppy disks. - includes magneto-optical media, and hardware devices specially configured to store and execute program instructions, such as ROM, RAM, flash memory, and the like. Examples of program instructions include not only machine language codes such as those generated by a compiler, but also high-level language codes that can be executed by a computer using an interpreter or the like. The hardware devices described above may be configured to operate as one or more software modules to perform the operations of the embodiments, and vice versa.

Software may comprise a computer program, code, instructions, or a combination of one or more thereof, which configures a processing device to operate as desired or is independently or collectively processed You can command the device. The software and/or data may be any kind of machine, component, physical device, virtual equipment, computer storage medium or apparatus, to be interpreted by or to provide instructions or data to the processing device. , or may be permanently or temporarily embody in a transmitted signal wave. The software may be distributed over networked computer systems and stored or executed in a distributed manner. Software and data may be stored in one or more computer-readable recording media.

As described above, although the embodiments have been described with reference to the limited drawings, those skilled in the art may apply various technical modifications and variations based on the above. For example, the described techniques are performed in an order different from the described method, and/or the described components of the system, structure, apparatus, circuit, etc. are combined or combined in a different form than the described method, or other components Or substituted or substituted by equivalents may achieve an appropriate result.

Therefore, other implementations, other embodiments, and equivalents to the claims are also within the scope of the following claims.

10: thrombus removal device
100: suction catheter
110: suction catheter body
120: suction catheter tip
130: home
200: balloon catheter
210: balloon catheter shaft
220: guide wire
300: thrombus removal unit (balloon)
400: suction device
500: balloon inflation device
20: thrombus removal device
2100: suction catheter
2110: suction catheter body
2120: suction catheter tip
2130: home
2200: balloon catheter
2210: balloon catheter shaft
2220: guide wire
2300: thrombus removal unit (balloon)
2400: suction device
2500: balloon inflation device
B: blood vessels
T: blood clot
Not shown: control

Claims (12)

A thrombus removal device for removing a thrombus, comprising:
suction catheter;
a balloon catheter disposed within the suction catheter; and
a thrombus removal unit provided at the distal end of the balloon catheter;
a suction device connected to one end of the suction catheter to provide negative pressure to the inside of the suction catheter;
a balloon inflation device that provides a working fluid to the balloon that enables expansion and contraction of the balloon;
a control unit for controlling operations of the suction catheter, the balloon catheter, the suction device, and the balloon inflation device;
including,
The thrombus removal unit is movable by the balloon catheter, and the thrombus removed by the thrombus removal unit is sucked through the suction catheter,
The control unit moves the balloon to a position farther than the removed thrombus, and provides negative pressure through the suction device while maintaining the balloon in an inflated state so that the thrombus is sucked,
thrombus removal device.
According to claim 1,
The thrombus removal unit is a balloon expandable and contractible by the inflow or outflow of the working fluid therein,
thrombus removal device.
3. The method of claim 2,
The suction catheter,
a suction catheter body made of a flexible material and insertable into a blood vessel; and
a suction catheter tip provided at an end of the catheter body;
containing,
thrombus removal device.
4. The method of claim 3,
the opening of the suction catheter tip is expandable;
thrombus removal device.
4. The method of claim 3,
The balloon catheter,
a balloon catheter shaft at least partially disposed within the suction catheter body; and
a guide wire for moving the balloon catheter shaft;
including,
The balloon is disposed at the distal end of the balloon catheter shaft,
thrombus removal device.
6. The method of claim 5,
The balloon catheter shaft and the guide wire are integrally movable,
thrombus removal device.
6. The method of claim 5,
The suction catheter body includes a lumen or a groove formed in the body, wherein at least a portion of the balloon catheter shaft or the guide wire is disposed in the lumen or the groove,
thrombus removal device.
delete delete delete According to claim 1,
the control unit
The balloon is positioned in a deflated state at the tip of the suction catheter in the collapsed state, and the tip of the suction catheter is opened by inflation of the balloon through the balloon inflation device,
thrombus removal device.
2. The method of claim 1
The control unit is
moving the balloon to a target lesion site closed with a thrombus, repeatedly inflating and deflating the balloon through the balloon inflation device, and simultaneously providing negative pressure through the suction device to remove the thrombus,
thrombus removal device.

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