WO2016064077A1

WO2016064077A1 - Catheter assembly

Info

Publication number: WO2016064077A1
Application number: PCT/KR2015/008569
Authority: WO
Inventors: Hoon Bum Lee; Moon Seo Park
Original assignee: Catholic Kwandong University Industry Foundation
Priority date: 2014-10-20
Filing date: 2015-08-17
Publication date: 2016-04-28
Also published as: KR20160046215A

Abstract

Disclosed is a catheter assembly, including: an external tube member inserted into a blood vessel; a first internal tube member inserted into the blood vessel through the external tube member; a first balloon portion provided at an end of the first internal tube member so as to be expandable, and configured to block a movement of an embolus within the blood vessel; and an outlet tube configured to discharge blood including the blocked embolus to the outside. According to the present disclosure, when an embolus, such as thrombus or atherom, is removed by using a balloon, it is possible to perform a corresponding procedure in an environment, in which it is difficult to directly cut a blood vessel, such as a brain blood vessel, and easily remove the embolus according to the procedure.

Description

CATHETER ASSEMBLY

The present invention relates to a catheter assembly, and more particularly, to a catheter assembly capable of safely destroying and collecting an embolus, such as a thrombus or atherom.

Recently, the incidence of cardiovascular (coronary arteries) diseases represented by angina pectoris, cardiac infarction, and sudden death has sharply increased. For example, cardiac infarction may occur generally when thrombotic infarct E1 occurs as illustrated in FIG. 2 in coronary arteries B narrowed due to atherosis E by a thrombus or atherom as illustrated in FIG. 1 or an embolus E2 having a larger diameter than a diameter of a blood vessel narrowed due to atherosis E flowing in as illustrated in FIG. 3 and a blood flow of coronary arteries suddenly decreasing.

A treatment of the cardiovascular disease has significantly developed for the last decade. In addition to a medication treatment, various treatments, such as coronary artery bypass graft for connecting a narrowed blood vessel region and a stent treatment, have been developed as a surgical method to give hope to patients with narrowed coronary arteries due to arteriosclerosis and suffer pain, and there comes a new turning point in the treatment of a heart disease.

Particularly, a treatment of coronary arteries stenosis disease includes a medication treatment and a non-surgical angioplasty performed by an internal medicine department, and a surgical treatment (coronary artery bypass surgery) performed by a cardiothoracic surgery department. The medication treatment cannot fundamentally solve a stricture region and a patient needs to continuously take an antianginal medicine, and even when a patient takes a medicine, the patient may continue to suffer a pain in the chest due to angina pectoris as a result of the limitation found in the medication treatment.

By contrast, the coronary arteries angioplasty may fundamentally treat a narrowed blood vessel by a non-surgical method, be effective to relieve a symptom of angina pectoris, and not require a decrease in an antianginal medicine taken. The coronary arteries angioplasty has significantly developed after being reported in the Gruentzig and the like in 1979, and the coronary arteries balloon angioplasty using a balloon was widely performed in 1980's, but acute closure of 2 to 8% and re-stenosis of 35 to 55% were generated immediately after the treatment.

In order to overcome the problems, various methods have been studied, and among them, the most effective method is a coronary stent procedure. The stent procedure is a procedure for widening a stricture region by locating a tube-shaped thin metal mesh to the stricture region and then expanding the stricture region, and is most widely performed now. It is reported that a success rate of the coronary stent procedure is 95% or more, and a re-stenosis rate is about 15 to 25%, which is, however, different depending on a severity of a lesion and a reporter. And it is reported that the stent procedure has an excellent effect in all of the cases, such as a stenosis lesion, a chronic total occlusion lesion, a myocardial infraction-related lesion, and a stricture lesion after coronary artery bypass surgery, as well as a primary lesion, compared to the coronary arteries balloon angioplasty.

Further, it has been known that a portion, into which the mesh is inserted, relieves ischemic symptoms in a stable state in the long term, and research to decrease restenosis by coating a mesh and an internal side of the mesh with anticoagulant steroids, inserting the mesh, and making the mesh be gradually discharged into tissue has been conducted as an effort to increase a success rate of the stent procedure and decrease restenosis.

In the meantime, Fogarty catheter has been used as the direct surgical treatment. Fogarty catheter is used in a surgical method of inserting a catheter into a portion adjacent to a blood vessel, in which an embolus is formed, by cutting the blood vessel by a predetermined length, raking out the embolus through the cut portion, and removing the embolus by using a balloon. However, in the Fogarty catheter, the blood vessel is required to be cut within a relatively short distance from the portion, in which the embolus is formed, so that there is a problem in that it is difficult to apply the Fogarty catheter to a portion, such as a blood vessel in the brain, which is difficult to be directly cut.

The present invention provides a catheter assembly, which is capable of removing a pre-formed or inflow embolus for a blood vessel, on which it is difficult to perform a direct surgical treatment, and a method of using the same.

Further, the present invention provides a catheter assembly capable of safely collecting a thrombus and atherom by isolating the thrombus and the atherom so as to prevent the thrombus and the atherom from moving from a blood vessel, in which the thrombus and the atherom are originally located, to another portion in a process of decomposing or separating the thrombus and the atherom by using ultrasonic waves.

Furthermore, the present invention provides a catheter assembly capable of locally applying a medicine to a limited portion even when a medicine for anticoagulating or decomposing an embolus, such as a thrombus and/or atherom, is inserted, thereby improving an effect of a medicine per unit capacity and minimizing a side effect caused due to an unnecessary application of a medicine to other organs.

An exemplary embodiment of the present invention provides a catheter assembly, including: a hollow external tube member inserted into a blood vessel; and a second balloon portion provided at an end of the external tube member so as to be radially expandable, and configured to block a movement of an embolus within the blood vessel, wherein the external tube member includes a second outlet tube discharging blood including the blocked embolus entering from a second outlet hole positioned at a distal portion based on the second balloon portion to the outside.

The external tube member may include a second inlet tube communicated so as to supply a fluid to the blocked embolus through an opened second inlet hole.

The second outlet tube may have a larger diameter of a cross section than that of the second inlet tube.

The second outlet tube and the second inlet tube may be implemented by adjusting pressure in the same tube member.

The second balloon portion may be expanded by an injection of a physiological saline solution.

The catheter assembly may include; a first internal tube member provided so as to pass through the external tube member in an axial direction of the first internal member, wherein the first internal tube member includes a first outlet tube, through which the blood including the blocked embolus is discharged from a first outlet hole positioned at the distal portion based on the second balloon portion and the second outlet hole to the outside.

The first internal tube member may include a first balloon portion which is provided at the distal portion based on the first outlet hole so as to be radially expandable and blocks a movement of the embolus within the blood vessel.

The first internal tube member may include a first inlet tube communicated so as to supply a fluid through an opened first fluid inlet hole to the blocked embolus.

The fluid supplied to the blocked embolus may be at least one of a physiological saline solution, blood, and a medicine for anticoagulation or dissolution of an embolus.

The embolus may be at least one of a blood clot and atherom.

The medicine may be at least one of streptokinase, urokinase, tissue-type plasminogen activator, warfarin, hirudin, paclitaxel, sirolimus, everolimus, zotarolimus, a non-steroidal antiphlogistic, and steroid.

The first outlet tube may have a relatively larger diameter of a cross-section than that of the first inlet tube.

The first outlet tube and the first inlet tube may be implemented by adjusting pressure in the same tube member.

The first balloon portion may be formed of a material having relatively less intensity than that of another portion so as to be easily expandable compared to another portion of the same member.

The first balloon portion may be expanded by an injection of a physiological saline solution.

The first internal tube member may include a transducer for irradiating ultrasonic waves of a frequency band for treatment.

Another exemplary embodiment of the present invention provides a catheter assembly, including: a hollow external tube member inserted into a blood vessel; a first internal tube member provided so as to pass through the external tube member in an axial direction of the external tube member; and a first balloon portion provided at an end of the first internal tube member so as to be radially expandable, and configured to block a movement of an embolus within the blood vessel, wherein the first internal tube member includes a first outlet tube, through which blood including the blocked embolus is discharged from a first outlet hole positioned at a distal portion based on the first balloon portion to the outside.

Another exemplary embodiment of the present invention provides a method of using a catheter assembly, including: a first operation of inserting an external tube member into a blood vessel of a patient and making the external tube member approach a target embolus; a second operation of inserting a first internal tube member into the blood vessel through the external tube member, and locating the first internal tube member at the other side of the external tube member while passing through the embolus; a third operation of expanding a first balloon portion of the first internal tube member to block a flow of blood including the embolus; and a fourth operation of discharging the blood including the blocked embolus to the outside through an outlet tube of at least one of the first internal tube member and the external tube member.

The first operation may include: 1a of inserting a second internal tube into the blood vessel; and operation 1b of inserting the external tube member in a state where the inserted second internal tube member is inserted into the external tube member.

Another exemplary embodiment of the present invention provides a method of using a catheter assembly, including: a first operation of inserting a first internal tube member into a blood vessel of a patient and positioning the first internal tube member at the other side of an external tube member while passing through a target embolus; a second operation of inserting the external tube member into the blood vessel with the first internal tube member as a core to approach the embolus; a third operation of blocking a flow of the blood including the embolus by expanding a first balloon portion of the first internal tube member; and a fourth operation of discharging the blood including the blocked embolus through an outlet tube of at least one of the first internal tube member and the external tube member.

The first operation may include: operation 1a of inserting a second internal tube into the blood vessel; and operation 1b of inserting the first internal tube member in a state where the inserted second internal tube member is inserted into the first internal tube member.

The second operation may include making a medicine enter through an inlet tube of the first tube member before and after the first internal tube member passes through the embolus so that at least one of the medicines for anticoagulation or dissolution of the embolus flows into each of both sides of the embolus within the blood vessel.

The third operation may include blocking a blood flow at the front and the rear of the embolus from external sides of the first balloon portion and a second balloon portion by expanding the second balloon portion of the external tube member.

The third operation further may include making at least one of the medicines for anticoagulation or dissolution of the embolus flow into both sides of the embolus through the external tube member and an inlet tube of the first internal tube member.

The method of using a catheter assembly may include: a fifth operation of, when the embolus having a size, which fails to be discharged to the outside through the outlet tubes of the first internal tube member and the external tube member exists, capturing the embolus having the size, which fails to be discharged between the first balloon portion and the second balloon portion, by pulling the first internal tube member; and a sixth operation of drawing out the captured embolus by simultaneously pulling the first internal tube member and the external tube member.

According to the present invention, when an embolus, such as thrombus or atherom, is removed by using a balloon, it is possible to perform a corresponding procedure in an environment, in which it is difficult to directly cut a blood vessel, such as a brain blood vessel, and easily remove the embolus according to the procedure.

According to the invention, a blood flow is blocked at the front and the rear of a location, at which coronary arteries stenosis disease is generated, so that it is possible to safely separate and/or decompose a thrombus and atherom by using ultrasonic waves, and collect the separated and decomposed residues.

Further, according to the present invention, a medicine is locally applied to a limited portion by inserting a medicine for anticoagulating or decomposing an embolus, such as a thrombus and/or atherom, within a blood vessel blocked from the outside, so that it is possible to improve an effect of a medicine per unit capacity and minimize a side effect, such as intentional bleeding, by preventing a medicine from being discharged to other organs.

FIGS. 1 to 3 are schematic diagrams for describing a cardiac disease or a cerebrovascular disease.

FIG. 4 is a perspective diagram illustrating a second internal tube member according to an exemplary embodiment of the present invention.

FIG. 5 is a plan view illustrating a catheter including a first internal tube member according to an exemplary embodiment of the present invention.

FIG. 6 is a schematic diagram illustrating the catheter including the first internal tube member according to an exemplary embodiment of the present invention.

FIG. 7 is a schematic diagram illustrating a mutual relationship between an external tube member, the first internal tube member, and the second internal tube member according to an exemplary embodiment of the present invention.

FIG. 8 is a schematic diagram illustrating the first internal tube member according to an exemplary embodiment of the present invention.

FIGS. 9 and 10 are schematic diagrams illustrating a first internal tube member according to another exemplary embodiment of the present invention.

FIG. 11 is a schematic diagram illustrating the first internal tube member according to another exemplary embodiment of the present invention.

FIG. 12 is a schematic diagram illustrating the external tube member according to an exemplary embodiment of the present invention.

FIGS. 13 and 14 are schematic diagrams illustrating a catheter assembly including a transducer for treatment or diagnosis.

FIGS. 15 to 19 are schematic diagrams sequentially illustrating a method of removing an embolus and the like having a small size by using a catheter assembly according to an exemplary embodiment of the present invention.

FIGS. 20 to 24 are schematic diagrams sequentially illustrating a method of removing an embolus and the like having a middle size by using a catheter assembly according to an exemplary embodiment of the present invention.

FIGS. 25 to 29 are schematic diagrams sequentially illustrating a method of removing an embolus and the like having a small size by using a catheter assembly according to an exemplary embodiment of the present invention.

FIGS. 30 to 32 are schematic diagrams illustrating exemplary embodiment, in which an embolus is sucked in an emergency situation.

FIGS. 33 and 34 are schematic diagrams illustrating a first internal tube member according to yet another exemplary embodiment of the present invention.

Hereinafter, an exemplary embodiment of the present invention will be described in detail with reference to the accompanying drawings. Unless there is a special definition or mention, terms indicating a direction used in the present specification are based on a state illustrated in the drawing. Further, the same reference numeral designates the same member throughout each exemplary embodiment. In the meantime, for convenience of the description, a thickness or a size of each constituent element illustrated in the drawings may be exaggerated, and it does not mean that the constituent element needs to be actually configured with a corresponding size or a ratio between the elements.

A first internal tube member according to an exemplary embodiment of the present invention will be described with reference to FIGS. 4 to 10. FIG. 4 is a perspective diagram illustrating a second internal tube member according to an exemplary embodiment of the present invention, and FIG. 5 is a plan view illustrating a catheter including a first internal tube member according to an exemplary embodiment of the present invention. Further, FIG. 6 is a schematic diagram illustrating the catheter including the first internal tube member according to an exemplary embodiment of the present invention, FIG. 7 is a schematic diagram illustrating a mutual relationship between an external tube member, the first internal tube member, and the second internal tube member according to an exemplary embodiment of the present invention, and FIG. 8 is a schematic diagram illustrating the first internal tube member according to an exemplary embodiment of the present invention. Further, FIGS. 9 and 10 are schematic diagrams illustrating a first internal tube member according to another exemplary embodiment of the present invention.

An external tube member according to an exemplary embodiment of the present invention will be described with reference to FIG. 4. A general catheter or a catheter or a cannula having a large diameter used for a stent treatment may correspond to the external tube member according to the exemplary embodiment of the present invention. Each of the tube-shaped members in the present exemplary embodiment is not limited to a medical appliance for a specific purpose. That is, various medical appliances may correspond to the external tube member as long as the medical appliances have the similar configurations or perform the similar functions as that of the external tube member in the present exemplary embodiment.

The external tube member 10 is formed in a tube shape having a predetermined length. The external tube member 10 is inserted into a blood vessel of a patient to enable various medical appliances including a first internal tube member and a second internal tube member to be described below to pass through a blood vessel without damage to the blood vessel.

Further, dye required for angiography or other medications may be injected through the external tube member 10 as necessary.

The second internal tube member will be described with reference to FIG. 5. The second internal tube member 20 is formed in a tube shape having a smaller cross-sectional diameter than that of the external tube member 10. The second internal tube member 20 may be used for guiding the external tube member and the first internal tube member when the external tube member and the first internal tube member are inserted into the blood vessel, and may be used for blocking a blood flow by forming a balloon inside the blood vessel as necessary. This will be described in detail below.

Further, in the present exemplary embodiment, it is described that the second internal tube member 20 is formed in a tube shape, but the second internal tube member 20 may be replaced with a simple wire type in a relationship with the first internal tube member to be described below as necessary. That is, a case where the second internal tube member 20 is a simple wire type, for example, a generally used guide wire for guiding an insertion of the first internal tube member, is a general technology, so that a detailed description thereof will be omitted. First, referring to FIG. 6, the first internal tube member 31 in the present exemplary embodiment may be provided in a catheter 30 type. The catheter 30 may be of a type which is generally used. The first internal tube member 31 includes one or more independent tubes in accordance with a purpose, and serves as a passage so that a medicine, a physiological saline solution, or the like injected through a first adjusting unit 32, a second adjusting unit 33, and the like may flow into the blood vessel, and may provide a passage, through which blood within the blood vessel and foreign substances, such as other thrombi and atherom mixed in blood may be discharged to the outside as necessary.

Further, as illustrated in FIG. 7, a guide hole 313 passing from an end of the first internal tube member 31 through a lateral surface of the end may be formed. When the relatively soft first internal tube member 31 is directly inserted into the blood vessel through the external tube member 10, the first internal tube member 31 is rolled within the external tube member 10, so that it may be difficult to easily insert the first internal tube member 31. Because of this, the second internal tube member 20 is first inserted into the blood vessel, and then the external tube member 10 is inserted along the second internal tube member 20. Then, in a state where the second internal tube member 20, which is softer than the first internal tube member 31, is inserted into the guide hole 313 at the end of the first internal tube member 31, the first internal tube member 31 is inserted. In this case, the first internal tube member 31 may be easily inserted into the external tube member 10 along the second internal tube member 20 without being bent or rolled.

In the meantime, contrary to this, a guide wire 20 and the first internal tube member 31 may be first inserted in the aforementioned sequence, and then the external tube member 10 may be inserted based on the first internal tube member 31 as a core.

Further, a marker 311 is provided at the end side of the first internal tube member 31. The marker 311 is formed of a metal material detectable through diagnosis equipment, such as X-rays. The marker 311 may be used for determining a location, into which the end of the first internal tube member 31 is inserted, through an X-ray imaging device when the first internal tube member 31 is inserted into a blood vessel.

Referring to FIG. 8,

pressure adjusting tubes

316 and 316a are formed through the entire first internal tube member 31. A fluid is injected into the

pressure adjusting tubes

316 and 316a, so that the

pressure adjusting tubes

316 and 316a serve to adjust pressure. A physiological saline solution having high biofidelity may be injected. The first internal tube member 31 according to the present exemplary embodiment is formed in a single tube type. That is, an internal cross-section of one tube TB is divided into the pressure adjusting tube 316a and an internal space 315. The internal space 315 may be used as an inlet tube for transmitting a specific material into a blood vessel or an outlet tube for discharging a specific material from a blood vessel.

In the meantime, the first internal tube member 31 is provided with a first balloon portion 312a in a predetermined region thereof. For the first balloon portion 312a, a balloon BL is formed at an external side of the first balloon portion 312a. The balloon BL may be formed of a thin elastic synthetic resin membrane. Further, the balloon BL serves as a pressure adjusting tube between the tube TB and the balloon BL, and the pressure adjusting tube 316a in other portion is communicated with a space between the tube TB and the balloon BL.

The balloon BL is maintained in a contracted state by negative pressure at an initial stage as illustrated in FIG. 8A, and when a physiological saline solution is injected into the pressure adjusting tube 316a, as illustrated in FIGS. 8B, the balloon BL is gradually expanded by the injected physiological saline solution, and it is observed that an external diameter of the first balloon portion 312a is expanded at an external side of the first internal tube member 31.

Further, the internal space 315 may be used as the inlet tube or the outlet tube as described above. When the inlet function and the outlet function are simultaneously performed through the single tube similar to the present exemplary embodiment, a physiological saline solution, blood, and a medicine may flow into a blood vessel or a fluid or solid materials mixed with the fluid may be discharged to the outside by applying positive pressure or negative pressure through the internal space 315, and an effect of a medicine flowing into a blood vessel may be improved by alternately applying positive pressure and negative pressure. In this case, in order to apply negative pressure to an outlet hole 3151 (or an inlet hole) for communicating the internal space 315 with the blood vessel, an internal side of the tube TB of the first balloon portion 312a needs to be in a closed state. In this case, the internal side of the tube TB may be made of the same material as that of the tube TB or other materials, and a material thereof is not particularly limited.

An internal structure of the first internal tube member 31 is limited to the configuration and the disposition of the elements of FIG. 8, and may be changed in accordance with the change of the location of relevant elements, and is not limited to the aforementioned internal structure.

Further, various tubes may be further included in the first internal tube member 31. For example, as illustrated in FIG. 9, an independent inlet tube 317 and an independent outlet tube 315 may be provided as illustrated in FIG. 6. The inlet tube 317 serves as a passage through which a physiological saline solution, blood, medicines necessary for a treatment, or the like supplied from the outside may flow into a blood vessel through an inlet hole 3171.

The medicines may include thrombolytic agents, such as streptokinase, urokinase, tissue-type plasminogen activator, warfarin, and hirudin, paclitaxel, sirolimus, everolimus, zotarolimus, a non-steroidal antiphlogistic, steroid, and the like for decomposing and/or reducing atherom.

Further, the outlet tube 315 is provided as a passage, through which blood inside a blood vessel and foreign substances, such as an embolus, that is, a thrombus or atherom, mixed in blood may be discharged to the outside through an outlet hole 3151.

In the meantime, the outlet tube 315 serves as the passage, through which a solid foreign substance, such as a thrombus or atherom, passes, unlike the inlet tube 317, so that the outlet tube 315 may be formed to have a larger diameter L2 based on a cross section than a diameter L1 of the inlet tube 317 based on a cross section. By contrast, the inlet tube 317 serves as the passage, through which a liquid physiological saline solution, blood, or medicines flow in, and a flow rate flowing into the inlet tube 317 per a unit time is adjustable with pressure, so that it is not necessary to form the inlet tube 317 to have the large diameter L1 based on the cross section.

The formed locations of the inlet tube 317, the inlet hole 3171, the outlet tube 315, and the outlet hole 3151 and relative location relations between the inlet tube 317, the inlet hole 3171, the outlet tube 315, and the outlet hole 3151 and a transducer 319 are not limited, and the inlet tube 317, the inlet hole 3171, the outlet tube 315, and the outlet hole 3151 may be variously formed and arranged according to the purpose of treatment. However, the inlet hole 3171 may be positioned at an upsteram side of blood and the ouelt hole 3151 may be positioned at a downsteam side of blood according to charactersitics of the functions of the inlet hole 3171 and the outlet hole 3151. Further, the aforementioned first internal tube member 31 may be implemented by various medical tools regardless of names, such as a catheter or a guide wire, as long as the medical tools have the identical or similar configuration and perform the identical or similar function as the first internal tube member 31. The first internal tube member 31 may be similar to the external tube member.

Further, as illustrated in FIG. 9, a guide hole 313 passing through a lateral surface of an end side from an end of the first internal tube member 31 may be formed. When the comparatively soft first internal tube member 31 is directly inserted into the blood vessel through the external tube member 10, the first internal tube member 31 may be rolled inside the external tube member 10, so that it may be difficult to easily insert the first internal tube member 31. Accordingly, after the second internal tube member (not illustrated) formed of a relatively soft material is first inserted into the external tube member 10, the first internal tube member 31 is inserted as the second internal tube member is inserted into the guide hole 313 at the end side of the first internal tube member 31. In this case, the first internal tube member 31 may be easily inserted into the external tube member 10 along the second internal tube member 20 without being bent or rolled.

Referring to FIG. 10, the medicines for anticoagulation or dissolution of an embolus may flow into a blood vessel B through an internal space of an external tube member 10a to be described below, in addition to the aforementioned internal space 315 (see FIG. 8) or inlet tube 317 (see FIG. 9). In this case, it is possible to efficiently apply the medicine compared to the related art by supplying the medicine from both sides of the thrombus and the atherom E. Further, it is possible to apply the medicine only to blood BL1 within the blood vessel B isolated by the first balloon portion 312a and the second balloon portion 312b, so that the required amount of medicine is remarkably decreased, thereby reducing concerns with unnecessary side effect.

A first internal tube member according to another exemplary embodiment of the present invention will be described with reference to FIG. 11. FIG. 11 is a schematic diagram illustrating a first internal tube member according to another exemplary embodiment of the present invention.

A pressure adjusting tube 317a may be integrally formed with a tube TB as described above, and may be accommodated in the tube TB by using a separate tube member. However, a relative position of the pressure adjusting tube 317a with respect to the tube TB is not limited. For example, the pressure adjusting tube 317a may be connected to the tube TB as illustrated in FIG. 11, and in addition, the pressure adjusting tube 317a may be positioned inside the tube TB or ousdie the tube TB. However, the pressure adjusting tube 317a is connected to a space between the balloon BL of a first balloon portion 312a` and the tube TB in every case.

In the present exemplary embodiment, similar to the aforementioned exemplary embodiment, when a physiological saline solution is supplied to the pressure adjusting tube 317a, the balloon BL is fully filled with the physiological saline solution, so that the balloon BL is expanded as illsutrated in FIG. 11B. In this case, it is observed that an external diameter of the first balloon portion 312a` is increased at the external side of the first internal tube member 31.

In addition, the first internal tube member 31 may include or omit various types of tube depending on the purpose of a treatment or when the configuration, in which the balloon is formed, is changed.

The external tube member according to an exemplary embodiment of the present invention will be described with reference to FIG. 12. FIG. 12 is a schematic diagram illustrating the external tube member according to an exemplary embodiment of the present invention.

As illustrated in FIG. 12, a second balloon portion 112 may be formed at one end of the external tube member 10. The external tube member 10 according to the present exemplary embodiment has a structure almost identical to that of the first internal tube member aforementioned with reference to FIG. 5. That is, when a physiological saline solution is supplied into the pressure adjusting tube 116a and pressure is increased, the physiological saline solution continuously flows into the pressure adjusting tube 116 between a balloon BL2 and a tube TB2 of the second balloon portion 112, so that the balloon BL2 is expanded. In this case, it is observed that an external diameter of the second balloon portion 112 is expanded at an external side of the external tube member 10.

A first internal tube member according to another exemplary embodiment will be described with reference to FIGS. 13 and 14. FIGS. 13 and 14 are schematic diagrams illustrating a catheter assembly including a transducer.

Further, the transducer 319 for irradiating ultrasonic waves may be provided at a predetermined point of the first internal tube member 31 according to the present exemplary embodiment. The transducer 319 is used for separating a thrombus and/or atherom inside a blood vessel from the blood vessel or decomposing a thrombus and/or atherom inside a blood vessel into smaller lumps by irradiating ultrasonic waves. The transducer 319 irradiates ultrasonic waves having more intensive intensity compared to a transducer for obtaining an image for the purpose of a diagnosis.

In the meantime, the present invention may also further include the aforementioned second transducer (not illustrated) for obtaining an image for a diagnosis separately from or integrally with the transducer 319 according to the present exemplary embodiment. The second transducer may be replaced with a micro camera and the like for directly obtaining an image.

The transducer 319 according to the exemplary embodiment may be inserted into the blood vessel B to just short of a thrombus and/or atherom E together with the first internal tube member 31, or pass through a thrombus and/or atherom E and be inserted into a location adjacent to the separated atherom E as illustrated in FIG. 13 to irradiate ultrasonic waves for treatment toward the thrombus and the like. Further, as illustrated in FIG. 14, the transducer 319 may be inserted into a location of the thrombus and/or atherom E and radially irradiate ultrasonic waves.

In this case, inlet hole 3171 and the outlet hole 3151 may be formed at the upstream side and the downstream side of blood, respectively, as described above. This is equally applied to a case where the

transducers

319a and 319 are included. Particularly, when the transducer 319a irradiates ultrasonic waves in the front direction as illustrated in FIG. 13, the transducer 319a may be positioned at the upstream side of bllod based on a blood clot and/or atherom E, and in this case, the inlet hole 3171 may be positioned at any place between the left sie and the right side of the transducer 319a positioned at the upstream side of the blood. In the meantime, the outlet hole 3151 is positioned at the downstream side of blood based on a blood clot and/or atherom E. That is, the reason is that the outlet hole 3151 may be positioned at an opposite side of the transducer 319a in order to discharge the separated blood clot and the like as illustrated in FIG. 13.

When the transducer 319 is a type radially irradiating ultrasonic waves as illustrated in FIG. 14, the transducer 319 is inserted up to a position adjacent to a blood clot and the like as described above. In this case, the inlet hole 3171 may be positioned at the upstream side of blood and the outlet hole 3151 may be positioned at the downstream side that is the other side of blood.

In the meantime, the catheter assembly according to the present invention may be differently used according to a size of an embolus and the like. Hereinafter, a method of processing an embolus will be described based on three cases where a size of an embolus to be removed is small, middle, and large.

A method of removing an embolus and the like having a small size by using the external tube member and the first tube member according to the exemplary embodiment of the present invention will be described with reference to FIGS. 15 to 19. FIGS. 15 to 19 are schematic diagrams sequentially illustrating a method of using the catheter assembly according to the exemplary embodiment of the present invention.First, as illustrated in FIG. 15, the external tube member 10 is inserted into a blood B, and makes the external tube member 10 approach target embolus E2. Next, as illustrated in FIG. 16, the first internal tube member 31 is inserted into the blood vessel B through the external tube member 10. In this case, an end of the first internal tube member 31 is inserted so as to pass through the embolus E2 and the like.

Next, as illustrated in FIG. 17, a flow of blood in a portion including the embolus E2 is blocked by expanding the first balloon portion 312a of the first internal tube member 31. In this case, the flow of the blood including the embolus E2 may be blocked from external sides of the first balloon portion 312a and the second balloon portion 112 by expanding the second balloon portion 112 of the external tube member as necessary. In this situation, medicines may be applied by various methods as described above.

Next, as illustrated in FIGS. 18 and 19, the first balloon portion 312a is pulled toward the external tube member 10 while the blood vessel B is contracted by forming negative pressure through the outlet tube 315 within the isolated blood vessel. In this case, the embolus E2 becomes close to the outlet hole 3151, so that the embolus E2 may be discharged to the outside through the outlet hole 3151.That is, the present exemplary embodiment is meaningful in a case where the embolus E2 is small enough to be discharged through the internal space of the first internal tube member 31.

A method of removing an embolus and the like having a middle size by using the external tube member and the first internal tube member according to the exemplary embodiment of the present invention will be described with reference to FIGS. 20 to 24. FIGS. 20 to 24 are schematic diagrams sequentially illustrating a method of using the catheter assembly according to the exemplary embodiment of the present invention.

When an embolus E3 having a size, which is difficult to be discharged through the internal space of the first internal tube member 31, is found, the corresponding embolus E3 may be removed by a process below.

For example, as illustrated in FIG. 20, the external tube member 10 is inserted into a blood vessel B of a patient to approach the target embolus E3. Next, as illustrated in FIG. 21, the first internal tube member 31 is inserted into the blood vessel B through the external tube member 10. In this case, an end of the first internal tube member 31 is inserted so as to pass through the embolus E3 and the like.

Next, as illustrated in FIG. 22, a part of the blood vessel including the embolus E3 is blocked from the outside by expanding the first balloon portion 312a and the second balloon portion 112 to restrict a flow of blood.

Subsequently, as illustrated in FIGS. 23 and 24, the first balloon portion 312a is pulled toward the external tube member 10. In this case, the embolus E3 is difficult to be discharged through the internal space of the first internal tube member 31, so that the embolus E3 is simply pulled toward the external tube member 10 by the first balloon portion, sucked through an internal space 114 of the external tube member, and then discharged to the outside.

A method of removing an embolus and the like having a large size by using the external tube member and the first internal tube member according to the exemplary embodiment of the present invention will be described with reference to FIGS. 25 to 29. FIGS. 25 to 29 are schematic diagrams sequentially illustrating a method of removing an embolus having a large size by using the catheter assembly according to the exemplary embodiment of the present invention.

The present exemplary embodiment is meaningful in a case where an embolus E4 having a large size, which is difficult to be discharged through the internal spaces of the first internal tube member 31 and the external tube member 31, is found. That is, the embolus E4 having the large size may be removed by a process below.

First, as illustrated in FIG. 25, the external tube member 10 is inserted into a blood vessel B of a patient to approach the target embolus E4. Next, as illustrated in FIG. 26, the first internal tube member 31 is inserted into the blood vessel B through the external tube member 10. In this case, an end of the first internal tube member 31 is inserted so as to pass through the embolus E4 and the like.

Next, as illustrated in FIG. 27, a part of the blood vessel including the embolus E4 is blocked from the outside by expanding the first balloon portion 312a of the first internal tube member 31 and the second balloon portion 112 of the external tube member 10 to restrict a flow of blood.

Subsequently, as illustrated in FIG. 28, the first balloon portion 312a is pulled toward the external tube member 10. In this case, the embolus E4 is difficult to be discharged through the internal spaces of the first internal tube member 31 and the external tube member 10, so that the embolus E4 is simply positioned between the first balloon portion 312a and the second balloon portion 12 and captured by the first balloon portion 312a and the second balloon portion 112.

Then, as illustrated in FIG. 29, the embolus E4 having the large size captured between the first balloon portion 312a and the second balloon portion 112 is discharged to the outside by extracting the first internal tube member 31 and the external tube member 10 in an opposite direction to the insertion direction.

A method of removing an embolus and the like in an emergency sitaution will be described with reference to FIGS. 30 to 32. FIGS. 30 to 32 are schematic diagrams illustrating exemplary embodiment, in which an embolus is sucked in an emergency situation.

In emergency situations involving patients with blood vessel disorder in their brain blood vessel, , it is difficult to sequentially perform all of the operations by using a general catheter. Also, in some cases, it may be too late to effectively treat patients.

The catheter assembly according to the present exemplary embodiment may suck the embolus E2, which is to be rapidly discharged to the outside, and discharge the sucked embolus E2 to the outside during a process of inserting the external tube member 10 as illustrated in FIG. 30, and suck the embolus E3, which is to be rapidly discharged to the outside, and discharge the sucked embolus E2 to the outside during a process of inserting the first internal tube member 31 through the external tube member 10 as illustrated in FIG. 31, and the embolus E2 and the like may be discharged to the outside by using both the external tube member 10 and the first internal tube member 31 at the same time as illustrated in FIG. 32.

However, in a case of the present exemplary embodiment, when the embolus E2 and the like are to be discharged by simply forming negative pressure without ballooning the external tube member 10 and the first internal tube member 31, the catheter assembly sucks blood within the blood vessel B in both directions, thereby degrading efficiency. Accordingly, when a blood vessel in one direction is closed by expanding the second balloon portion 112 of the external tube member 10 or the first balloon portion 312a of the first internal tube member 31, and then the catheter assembly sucks the embolus E2 and the like, the catheter assembly sucks only blood in one direction, thereby increasing efficiency.

Then, a subsequent process of forming a balloon in the first internal tube member 31 or the external tube member 10 may be performed as described above.

A first internal tube member according to yet another exemplary embodiment will be described with reference to FIGS. 33 and 23. FIGS. 33 and 23 are schematic diagrams illustrating a first internal tube member according to yet another exemplary embodiment of the present invention.

A first internal tube member 31 according to the present exemplary embodiment may be formed in a type of dual tubes including an external tube OT and an internal tube IT. In this case, the internal tube IT serves as the aforementioned outlet tube 314. The outlet tube 314 also serves as a passage for discharging foreign substances within blood to the outside, so that the outlet tube 315 may be formed to have the largest cross-section area.

Further, a pressure adjusting tube 317a is provided between the external tube OT and the internal tube IT. The pressure adjusting tube 317a in the present exemplary embodiment is formed in one tube within the first internal tube member 31, but the pressure adjusting tube 317a is formed in the first balloon portion 312a by an external balloon OT` made of a thin elastic tube material, instead of an external tube OT` in other portion as described above. That is, the pressure adjusting tube 317a is communicated so that a fluid flows in a space between the balloon OT` and the internal tube IT as described above. Accordingly, when a physiological saline solution and the like flows in through the pressure adjusting tube 317a, the external balloon OT` is gradually expanded according to the inflow of the physiological saline solution into the external balloon OT`, and as a result, it is observed that an external diameter of the first balloon portion 312 is expanded.

In the meantime, as illustrated in FIG. 34, the external balloon OT` may be contracted before the physiological saline solution is injected to be in contact with the internal tube IT. When gas, such as air, exists between the external balloon OT` and the internal tube IT before the physiological saline solution is injected, gas, such as corresponding air, is injected into a human body together the injected physiological saline solution, thereby causing a risk.

In the above, the exemplary embodiments of the present invention have been described, but the technical spirit of the present invention is not limited to the aforementioned exemplary embodiments, and various modifications may be made within the scope of the technical spirit of the present invention embodied in the claims.

Claims

A catheter assembly, comprising:

a hollow external tube member inserted into a blood vessel; and

a second balloon portion provided at an end of the external tube member so as to be radially expandable, and configured to block a movement of an embolus within the blood vessel,

wherein the external tube member includes a second outlet tube discharging blood including the blocked embolus entering from a second outlet hole positioned at a distal portion based on the second balloon portion to the outside.
The catheter assembly of claim 1, wherein the external tube member includes a second inlet tube communicated so as to supply a fluid to the blocked embolus through an opened second inlet hole.
The catheter assembly of claim 2, wherein the second outlet tube has a larger diameter of a cross section than that of the second inlet tube.
The catheter assembly of claim 2, wherein the second outlet tube and the second inlet tube are implemented by adjusting pressure in the same tube member.
The catheter assembly of claim 1, wherein the second balloon portion is expanded by an injection of a physiological saline solution.
The catheter assembly of claim 1, further comprising:

a first internal tube member provided so as to pass through the external tube member in an axial direction of the first internal member,

wherein the first internal tube member includes a first outlet tube, through which the blood including the blocked embolus is discharged from a first outlet hole positioned at the distal portion based on the second balloon portion and the second outlet hole to the outside.
The catheter assembly of claim 6, wherein the first internal tube member includes a first balloon portion which is provided at the distal portion based on the first outlet hole so as to be radially expandable and blocks a movement of the embolus within the blood vessel.
The catheter assembly of claim 6, wherein the first internal tube member includes a first inlet tube communicated so as to supply a fluid through an opened first fluid inlet hole to the blocked embolus.
The catheter assembly of claim 2 or 8, wherein the fluid supplied to the blocked embolus is at least one of a physiological saline solution, blood, and a medicine for anticoagulation or dissolution of an embolus.
The catheter assembly of claim 9, wherein the embolus is at least one of a blood clot and atherom.
The catheter assembly of claim 10, wherein the medicine is at least one of streptokinase, urokinase, tissue-type plasminogen activator, warfarin, hirudin, paclitaxel, sirolimus, everolimus, zotarolimus, a non-steroidal antiphlogistic, and steroid.
The catheter assembly of claim 8, wherein the first outlet tube has a relatively larger diameter of a cross-section than that of the first inlet tube.
The catheter assembly of claim 8, wherein the first outlet tube and the first inlet tube are implemented by adjusting pressure in the same tube member.
The catheter assembly of claim 1, wherein the first balloon portion is formed of a material having relatively less intensity than that of another portion so as to be easily expandable compared to another portion of the same member.
The catheter assembly of claim 14, wherein the first balloon portion is expanded by an injection of a physiological saline solution.
The catheter assembly of claim 1, wherein the first internal tube member includes a transducer for irradiating ultrasonic waves of a frequency band for treatment.
A catheter assembly, comprising:

a hollow external tube member inserted into a blood vessel;

a first internal tube member provided so as to pass through the external tube member in an axial direction of the external tube member; and

a first balloon portion provided at an end of the first internal tube member so as to be radially expandable, and configured to block a movement of an embolus within the blood vessel,

wherein the first internal tube member includes a first outlet tube, through which blood including the blocked embolus is discharged from a first outlet hole positioned at a distal portion based on the first balloon portion to the outside.
A method of using a catheter assembly, comprising:

a first operation of inserting an external tube member into a blood vessel of a patient and making the external tube member approach a target embolus;

a second operation of inserting a first internal tube member into the blood vessel through the external tube member, and locating the first internal tube member at the other side of the external tube member while passing through the embolus;

a third operation of expanding a first balloon portion of the first internal tube member to block a flow of blood including the embolus; and

a fourth operation of discharging the blood including the blocked embolus to the outside through an outlet tube of at least one of the first internal tube member and the external tube member.
The method of claim 18, wherein the first operation includes:

operation 1a of inserting a second internal tube into the blood vessel; and

operation 1b of inserting the external tube member in a state where the inserted second internal tube member is inserted into the external tube member.
A method of using a catheter assembly, comprising:

a first operation of inserting a first internal tube member into a blood vessel of a patient and positioning the first internal tube member at the other side of an external tube member while passing through a target embolus;

a second operation of inserting the external tube member into the blood vessel with the first internal tube member as a core to approach the embolus;

a third operation of blocking a flow of the blood including the embolus by expanding a first balloon portion of the first internal tube member; and

a fourth operation of discharging the blood including the blocked embolus through an outlet tube of at least one of the first internal tube member and the external tube member.
The method of claim 20, wherein the first operation includes:

operation 1a of inserting a second internal tube into the blood vessel; and

operation 1b of inserting the first internal tube member in a state where the inserted second internal tube member is inserted into the first internal tube member.
The method of claim 18 or 20, wherein the second operation includes making a medicine enter through an inlet tube of the first tube member before and after the first internal tube member passes through the embolus so that at least one of the medicines for anticoagulation or dissolution of the embolus flows into each of both sides of the embolus within the blood vessel.
The method of claim 18 or 20, wherein the third operation includes blocking a blood flow at the front and the rear of the embolus from external sides of the first balloon portion and a second balloon portion by expanding the second balloon portion of the external tube member.
The method of claim 23, wherein the third operation further includes making at least one of the medicines for anticoagulation or dissolution of the embolus flow into both sides of the embolus through the external tube member and an inlet tube of the first internal tube member.
The method of claim 23, further comprising:

a fifth operation of, when the embolus having a size, which fails to be discharged to the outside through the outlet tubes of the first internal tube member and the external tube member exists, capturing the embolus having the size, which fails to be discharged between the first balloon portion and the second balloon portion, by pulling the first internal tube member; and

a sixth operation of drawing out the captured embolus by simultaneously pulling the first internal tube member and the external tube member.