JP3173369U - Thrombolysis removal device - Google Patents

Abstract

A thrombus dissolution removal apparatus capable of dissolving and removing a thrombus safely and reliably is provided.
SOLUTION: A long shaft member 12 whose distal end is fed into a blood vessel, a flexible distal end guide portion 13 disposed at the distal end of the shaft member 12, and a wire mesh knitted in a cylindrical shape The cylindrical portion 15 is contracted within the delivery catheter 18 and expands when released from the catheter 18 into the blood vessel, and the binding portions 16A and 16B are used to bind the wires at the end of the cylindrical portion 15. Filter sections 17A and 17B. The filter portion 14 is expanded at a position where the filter portion 14 covers the thrombus, and the thrombus is dissolved by maintaining the state in which the filter portion 14 is in contact with the thrombus for a predetermined time.
[Selection] Figure 1

Description

  The present invention relates to a thrombolysis removal apparatus for dissolving and removing a thrombus in a blood vessel of a living body.

  Thrombosis causes local anemia (ischemia) by occluding blood vessels in blood vessels, and if the symptoms progress, it can lead to the development of an infarction that necrotizes cellular tissue, resulting in the lives of patients. The condition is at risk of threatening. Therefore, in order to eliminate clogging of a thrombus that narrows a blood vessel, a thrombolytic therapy for dissolving a thrombus with a drug has been conventionally performed. In this method, a drug that dissolves a thrombus is injected into an occluded blood vessel or a blood vessel in the vicinity thereof to dissolve the thrombus, thereby ensuring blood flow in the occluded blood vessel.

  However, since thrombolytic agents act not only on occluded blood vessels but also on the whole body, there is a risk that blood coagulation may be hindered to cause bleeding if there are places where blood vessels are damaged, such as where blood vessels are damaged.

  Therefore, in recent years, a method for surgically securing blood flow has been implemented with the progress of endovascular treatment. For example, there are a vasodilation method in which a blood vessel is expanded with a micro delivery catheter with a balloon, a stent placement method in which a reticular tube called a stent is placed in a blood vessel, and a vascular wall is supported from the inside to prevent stenosis.

  However, the conventional methods for ensuring surgical blood flow have the following problems.

  First, in vasodilation in which a blood vessel is dilated using a micro delivery catheter with a balloon, there is a problem that the burden on the patient is large because the blood flow at the lesion site is completely blocked by the balloon. Further, depending on the strength of the blood vessel, the blood vessel may be damaged by inflating the balloon from the inside. Furthermore, this method is also known to have a high possibility of causing restenosis.

  Further, in stent placement in which blood flow is secured with a stent, there is a possibility that cells will proliferate mainly from small wounds on the inner wall of the blood vessel that occur during the placement of the stent, resulting in restenosis. Therefore, drug-eluting stents with a surface-coated drug that suppresses cell growth have been developed, but there is a possibility that delayed stent thrombosis may be caused by delaying the regeneration of the inner wall of the blood vessel by suppressing cell growth. There is. Because of the high mortality from myocardial infarction caused by this thrombosis, it is necessary to take an antiplatelet agent for a long period of time. There is a problem that there are various side effects in addition to the tendency to bleed easily and bleeding.

  In view of the above situation, an object of the present invention is to provide a thrombolysis and removal apparatus capable of dissolving and removing a thrombus safely and reliably.

  In order to solve the above problems, the present invention provides a long shaft member whose distal end is fed into a blood vessel, a flexible distal end guide portion disposed at the distal end of the shaft member, and a tubular shape. It consists of a wire mesh, and is composed of a cylindrical portion that contracts within the delivery catheter and expands when released from the catheter into the blood vessel, and a binding portion that binds the wire at the end of the cylindrical portion. A filter part, expanding the filter part at a position where the filter part covers the thrombus, and maintaining the state where the filter part is in contact with the thrombus for a predetermined time, thereby dissolving the thrombus A thrombolytic removal device is provided.

  Here, the binding portion is constituted by a ring-shaped member that is slidable in the axial direction with respect to the shaft member, and a stopper member having an outer diameter larger than an inner diameter of the binding portion is fixed to the shaft member, It is preferable to regulate the slidable range of the binding portion. In this case, the stopper member may be provided inside the filter portion. The stopper member is preferably made of a radiopaque metal material.

  Alternatively, one of the bundling portions is formed of a ring-shaped member that is slidable in the axial direction with respect to the shaft member, and the other of the bundling portions is fixed to the shaft member, and the one bundling portion slides. The possible range may be restricted. In this case, it is preferable that the bundling portion is made of a radiopaque metal material.

  According to the thrombolysis and removal apparatus of the present invention, there is no risk of damaging the blood vessel because there is no stress on the blood vessel, such as pressing the blood vessel from the inside. Further, there is no need to block the blood flow, and the burden on the patient can be reduced because the thrombus is dissolved by the natural fibrinolytic action of blood. Therefore, the thrombus can be dissolved and removed safely and reliably.

1 is an overall schematic view of a thrombolysis and removal apparatus according to an embodiment of the present invention. It is a cross-sectional schematic diagram for demonstrating the fundamental motion of the thrombolysis removal apparatus shown in FIG. It is a schematic diagram which shows an example of the state of the lesioned part which uses the thrombolysis removal apparatus shown in FIG. It is a schematic diagram for demonstrating the operation | movement at the time of using the thrombus dissolution removal apparatus shown in FIG.

  Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. In the present specification, the side operated by the operator outside the living body in the thrombus dissolution removing apparatus is referred to as the proximal end, and the side that is sent out into the living body and acts in the living body is referred to as the distal end.

  FIG. 1 is an overall schematic view of a thrombolysis and removal apparatus according to an embodiment of the present invention. As shown in FIG. 1, the thrombus dissolution removing device 1 of the present invention includes a shaft (shaft member) 12, a tip guide portion 13, and a filter portion 14. Then, it is inserted through the delivery catheter 18 and delivered to the lesion site in the blood vessel.

  The shaft 12 is a long wire in which a tip guide portion 13 and a filter portion 14 are disposed at the tip thereof. It is composed of a thin and flexible wire material to advance in the blood vessel, and the distal end of the shaft 12 is fed into the blood vessel, and the movement of the thrombolysis removing device 1 is controlled by operating the proximal end (not shown). . As the material of the shaft 12, a metal such as a nickel titanium alloy or stainless steel is suitable.

  A flexible tip guide portion 13 is disposed at the tip portion of the shaft 12. The distal end guide portion 13 is positioned at the head of the thrombus dissolution removing device 1 and is formed flexibly so as not to damage the blood vessel in which the thrombus dissolution removal device 1 travels. Preferably, the wire is a coiled wire or a knitted wire. Further, the material of the distal end guide portion 13 is preferably a radiopaque metal (for example, platinum, tungsten, etc.) whose position and posture can be confirmed under fluoroscopy.

  A filter portion 14 for dissolving and removing the thrombus is disposed on the proximal end side of the distal end guide portion 13. The filter unit 14 includes a cylindrical part 15 in which a wire having elasticity or shape memory property is knitted into a cylindrical shape whose diameter can be expanded and contracted, and a bundling part 16 that bundles the wires at the end of the cylindrical part 15. .

  The wire constituting the cylindrical portion 15 is a thin and flexible wire made of an alloy having elasticity or shape memory (preferably nickel titanium). A part or all of this wire may be plated with a radiopaque metal material (for example, gold, platinum, tungsten, or an alloy thereof). The cylindrical portion 15 forms 12 to 48 (preferably 16) of such wires and braids them into a tubular shape (for example, by braid knitting). By knitting in a cylindrical shape in this way, the diameter can be freely expanded or reduced. Although specifically described later, the cylindrical portion 15 contracts in the delivery catheter 18 and expands when released from the delivery catheter 18 into the blood vessel.

  The bundling portion 16 is a ring-shaped member for bundling the wires constituting the cylindrical portion 15 at both ends and attaching the cylindrical portion 15 to the shaft 12 so as to be slidable. As shown in FIG. 1, it is comprised from the front end side binding part 16A which bundles the front end side of the cylindrical part 15, and the base end side binding part 16B which binds the base end side.

  Since the binding portions 16A and 16B slide relative to the shaft 12 and the cylindrical portion 15 can expand and contract in diameter, the filter portion 14 expands and shortens in a natural state or a shape memory recovery temperature (expanded). (State) [see FIG. 2 (d)], can be freely deformed in the delivery catheter 18 to be reduced in diameter and expanded (contracted state) (see FIG. 2 (b)). The size of the delivery catheter 18 to be used is preferably about 2.7 Fr (diameter 0.9 mm), but it is desirable that the diameter of the delivery catheter 18 be reduced and expanded so as to be within this diameter.

  A stopper (stopper member) 17 fixed to the shaft 12 is disposed inside the filter portion 14. The outer diameter of the stopper 17 is made larger than the inner diameter of the bundling portion 16. Thereby, the slidable range in the axial direction of the shaft of the bundling portion 16 is restricted, and as a result, the moving range of the filter portion 14 is restricted to a certain range. In FIG. 1, the distal end side stopper 17 </ b> A and the proximal end side stopper 17 </ b> B are provided inside the filter portion 14 to regulate the movable range of the filter portion 14. The stopper 17 is made of a metal material having radiopacity (for example, gold, platinum, tungsten, or an alloy thereof) in order to serve as a marker under fluoroscopy. Alternatively, the metal material may be plated on another material.

  The basic movement of the thrombus dissolution removing device 1 having the above configuration will be described with reference to FIG.

  First, in order to insert the thrombolysis and removal apparatus 1 into a blood vessel, a guide wire (not shown) is advanced to the lesion site where the thrombus is present in the blood vessel, and then the delivery catheter 18 is passed through the guide wire. When the delivery catheter 18 reaches the lesioned part, the guide wire is retracted and removed from the delivery catheter 18.

  Next, the thrombus dissolution / removal device 1 is inserted from the proximal end of the delivery catheter 18 to advance toward the distal end of the delivery catheter 18. As shown in FIG. 2 (a), in the delivery catheter 18, the binding portions 16A and 16B are slid and the tubular portion 15 is elongated. It can proceed smoothly.

  Next, when the delivery catheter 18 is retracted with respect to the thrombolysis removal apparatus 1 or the thrombolysis removal apparatus 1 is advanced with respect to the delivery catheter 18, as shown in FIG. The part 14 is exposed. At this time, the cylindrical portion 15 released from the restraint of the delivery catheter 18 starts to expand from the exposed portion.

  Then, as shown in FIG. 2C, when the filter unit 14 is completely exposed from the delivery catheter 18, the filter unit 14 is expanded and shortened. The thrombus dissolution / removal device 1 according to the present invention is placed in a lesion where a thrombus adheres in this state to dissolve and remove the thrombus.

  Hereinafter, a specific method for dissolving a thrombus with the thrombus dissolution removing apparatus 1 will be described with reference to FIGS. 3 and 4.

  FIG. 3 is a schematic diagram showing an example of a state of a lesion using the thrombus dissolution removing device 1 of the present invention. As shown in FIG. 3, here, a state where a thrombus 102 is attached to a blood vessel 101 of a human body and a stenosis 103 is generated will be described as an example.

  Here, a thrombus is basically a blood clot formed of platelets and fibrin to prevent blood loss when a blood vessel is damaged, but it is caused by smoking, hypertension, obesity, etc. It is also formed when blood vessels are injured, when blood properties change due to hyperlipidemia or dehydration, or when blood flow becomes sluggish due to blood pressure or the like. Normally, once the hemostasis is completed and the damaged blood vessel is repaired, the formed thrombus disappears. In this way, blood originally has an action of dissolving and decomposing thrombus (fibrinolytic action). In the present invention, this fibrinolysis is used to dissolve and remove the thrombus 102 in the stenosis 103.

  First, as shown in FIG. 4A, the transport catheter 18 is first advanced to the stenosis portion 103, and the thrombus dissolution removing device 1 is inserted therethrough and transported to the stenosis portion 103.

  When the thrombolysis removal device 1 reaches the stenosis 103, the delivery catheter 18 is moved backward with respect to the thrombolysis removal device 1 or the thrombolysis removal device 1 is advanced with respect to the delivery catheter 18 to start from the distal end of the delivery catheter 18. The filter unit 14 is discharged into the blood vessel 101, and the delivery catheter 18 is retracted. As shown in FIG. 4B, the discharged filter part 14 is expanded and covers the thrombus 102 and is disposed at a position where it enters the thrombus 102.

  The hardness of the thrombus 102 varies depending on the passage of time after the occurrence, blood flow rate, red blood cell concentration, and other individual differences, but it is various such as a viscous liquid or a solidified jelly. The mesh of the filter unit 14 comes into contact with the thrombus 102 and enters the inside thereof to expose the blood flow to the inside of the thrombus 102. In this state, if the filter unit 14 is left in the constriction 103 for a predetermined time (preferably 30 to 40 minutes), the thrombus 102 is dissolved by the fibrinolytic action of blood. Since the tubular portion 15 is formed in a mesh shape, the filter portion 14 can promote dissolution of the thrombus 102 while ensuring blood flow. Depending on the state of the stenosis 103, the base of the thrombus dissolution / removal device 1 may be operated to lightly move the filter unit 14 in the stenosis 103 to secure blood flow and promote the dissolution of the thrombus 102. After the predetermined time has elapsed, the thrombus dissolution / removal device 1 is housed in the delivery catheter 18 and then removed from the living body.

  Thus, according to the thrombus dissolution removal apparatus 1 of the present invention, there is no risk of damaging the blood vessel because there is no stress on the blood vessel, such as pressing the blood vessel from the inside. Further, there is no need to block the blood flow, and the burden on the patient can be reduced because the thrombus is dissolved by the natural fibrinolytic action of blood.

  The thrombolysis removal apparatus 1 of the present invention is particularly suitable for the dissolution removal of a thrombus from a patient who suffered from an acute ischemic stroke.

  In the above description, the movement range of the bundling portion 16 is regulated by the two stoppers 17A and 17B fixed to the shaft portion 12 in the filter portion 14. However, the number of the stoppers may be one, or the filter It may be provided outside the portion 14. Moreover, the same effect as the said thrombus dissolution removal apparatus 1 can be acquired also by fixing any one of binding part 16A, 16B to the shaft 12, and slidably comprising the other, without providing a stopper.

  Moreover, although the example which forms the stopper 17 from a radiopaque material was shown above, you may make it form the ring-shaped member which comprises the binding part 16 from a radiopaque material.

  As mentioned above, although embodiment of this invention was described, this invention is not limited to the said embodiment, Based on the meaning of this invention, various deformation | transformation are possible, These are excluded from the scope of this invention. is not.

  The present invention relates to a thrombus dissolution removal apparatus for dissolving and removing a thrombus in a blood vessel of a living body, and has industrial applicability.

DESCRIPTION OF SYMBOLS 1 Thrombus dissolution removal apparatus 12 Shaft 13 Tip guide part 14 Filter part 15 Tubular part 16 Binding part 16A Tip side binding part 16B Base end side binding part 17 Stopper 17A Tip side stopper 17B Base end side stopper 18 Delivery catheter

Claims (6)

A long shaft member whose distal end is fed into the blood vessel;
A flexible tip guide portion disposed at the tip of the shaft member;
A mesh of wire knitted into a tubular shape, a tubular portion that contracts within the delivery catheter and expands when released from the catheter into the blood vessel, and a binding portion that binds the wire at the end of the tubular portion; A filter unit comprising:
With
A thrombus dissolution and removal apparatus, wherein the thrombus is dissolved by expanding the filter portion at a position where the thrombus is covered with the filter portion and maintaining the state where the filter portion is in contact with the thrombus for a predetermined time. . The bundling portion is composed of a ring-shaped member that can slide in the axial direction with respect to the shaft member,
The thrombolysis removal apparatus according to claim 1, wherein a stopper member having an outer diameter larger than an inner diameter of the binding portion is fixed to the shaft member, and a slidable range of the binding portion is regulated.   The thrombus dissolution removing device according to claim 2, wherein the stopper member is provided inside the filter portion.   The thrombus dissolution removing device according to claim 2 or 3, wherein the stopper member is made of a radiopaque metal material. One of the binding parts is composed of a ring-shaped member that is slidable in the axial direction with respect to the shaft member,
The thrombolysis removal device according to claim 1, wherein the other of the binding portions is fixed to the shaft member to regulate a slidable range of the one binding portion.   The thrombus dissolution removing device according to claim 5, wherein the binding portion is made of a radiopaque metal material.

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