阅读说明：本技术 网篮导管及其制造方法以及医疗用处置器具 (Basket catheter, method for producing the same, and medical treatment instrument ) 是由 高寺雅之 于 2018-05-21 设计创作，主要内容包括：本发明的目的在于提供易将近位侧的旋转扭矩传递至网篮部,并能够去除捕捉到的异物的网篮导管。网篮导管(1)具有远位侧和近位侧,并具有外筒部件(2)；内筒部件(3),其配置在该外筒部件(2)的内腔；以及可扩张的网篮部(10),其配置在内筒部件(3)的远位侧,具有多条弹性丝线(15),内筒部件(3)具有将线材呈螺旋状卷绕而形成的中空线圈体(4)。在上述网篮导管(1)中,优选多条弹性丝线(15)与内筒部件(3)通过筒状的连接件(20)连接。(The invention aims to provide a basket guide pipe which can easily transmit the rotation torque of a near side to a basket part and can remove the captured foreign matters. The basket catheter (1) has a distal side and a proximal side, and has an outer cylinder member (2); an inner cylinder member (3) disposed in the inner cavity of the outer cylinder member (2); and an expandable basket section (10) which is disposed on the distal side of the inner tubular member (3) and has a plurality of elastic wires (15), wherein the inner tubular member (3) has a hollow coil body (4) formed by spirally winding the wires. In the basket duct (1), the plurality of elastic threads (15) and the inner tube member (3) are preferably connected by a tubular connector (20).)

1. A basket catheter having a distal side and a proximal side, wherein,

The basket conduit has:

an outer cylinder member;

an inner cylinder member disposed in the inner cavity of the outer cylinder member; and

An expandable basket part disposed on the distal side of the inner cylinder member and having a plurality of elastic wires,

The inner tube member has a hollow coil body formed by spirally winding a wire material.

2. The basket conduit of claim 1,

The hollow coil body has at least a first layer and a second layer arranged outside the first layer,

The winding direction of the wire is opposite to the second layer in the first layer.

3. The basket conduit of claim 1 or 2,

The hollow coil body is composed of a first layer, a second layer arranged outside the first layer, and a third layer arranged outside the second layer,

the winding direction of the wire is opposite to the second layer in the first layer and opposite to the third layer in the second layer.

4. The basket conduit of any of claims 1 to 3,

Another wire extending in the proximal-distal direction is disposed in the lumen of the hollow coil body, and one end and the other end of the other wire are fixed to the hollow coil body.

5. The basket conduit of any of claims 1 to 4,

The inner barrel component also has a metal tube connected to the proximal end of the hollow coil body.

6. the basket conduit of any of claims 1 to 5,

The elastic silk threads are connected with the inner cylinder component through a cylindrical connecting piece.

7. The basket conduit of claim 6,

the connecting member has a plurality of thread insertion passages into which proximal end portions of the elastic threads are inserted from a distal side, and the thread insertion passages are arranged in a circumferential direction.

8. The basket conduit of claim 7,

The connecting piece is provided with a fixing hole communicated with the outside and the thread insertion passage on the peripheral wall.

9. The basket conduit of any of claims 6 to 8,

The connector has a small diameter portion having an outer diameter on a proximal side smaller than an outer diameter on a distal side,

The small diameter portion is inserted into a distal side of an inner cavity of the inner cylinder member.

10. the basket conduit of claim 9,

The inner diameter of the connecting piece at the small-diameter part is larger than the inner diameter of the far end of the inner cylinder part.

11. A medical treatment tool comprising:

The basket conduit of any one of claims 1 to 10; and

and an auxiliary treatment tool inserted through the inner cavity of the inner cylinder member.

12. The medical treatment tool according to claim 11, wherein,

The auxiliary treatment device is a balloon catheter, a micro-catheter, a forceps, a laser probe, a fiberscope, a liquid electric impact crushing probe or a guide wire.

13. A method for manufacturing a basket conduit, comprising:

Preparing a plurality of elastic threads that form an expandable basket portion, and a tubular connector that connects an inner tubular member to the plurality of elastic threads and has a plurality of thread insertion passages arranged in a circumferential direction;

inserting a proximal end of the elastic thread into the thread insertion path from a distal side; and

And a step of joining the elastic thread to the connecting member.

14. The method of manufacturing a basket conduit according to claim 13,

The connecting piece is provided with a fixing hole communicated with the outside and the thread insertion passage on the peripheral wall,

In the joining process of the elastic thread and the connecting member, an adhesive is injected into the fixing hole.

15. The method of manufacturing a basket conduit according to claim 13 or 14,

The method further includes a step of reducing an outer diameter of a proximal end of the elastic thread before the step of inserting the elastic thread into the thread insertion passage.

16. The method for manufacturing a basket duct according to any one of claims 13 to 15, further comprising:

Preparing the inner tube member having a hollow coil body formed by spirally winding a wire material; and

And inserting the proximal end of the connector into the distal end of the inner cavity of the inner tube member.

Technical Field

The present invention relates to a catheter capable of capturing foreign matter in a basket and a medical treatment instrument including the catheter.

Background

for the treatment of stones occurring in bile ducts and urinary tracts, basket catheters (forceps) or balloon catheters for removing stones, which are woven from shape memory alloy wires such as SUS strands and Ni — Ti into a cage shape, are used. In the basket catheter, a plurality of metal wires of a basket section for capturing foreign matter are fixed at two positions on the distal end and the proximal side of the distal end, and the wires are bent or twisted in a spiral shape between the fixing points at the two positions, thereby forming a cage shape. The basket portion is housed in, for example, a resin sheath when delivered to the affected area, and is exposed from the distal end of the sheath to be deployed in a cage shape when capturing foreign matter. In order to remove foreign matter accurately in a short time, it is necessary to efficiently transmit a rotational torque generated by the operation of the handle on the hand side to the basket portion, and to change the position of the metal wire forming the basket, thereby facilitating the collection or hooking of foreign matter.

In fig. 10 to 11, a conventional basket duct is shown. As shown in fig. 10, the conventional basket catheter 100 includes a basket 110 that can be housed in the outer tube member 102, and the basket 110 and a handle (not shown) on the hand side are connected via wire members 104 and 105. The wire members 104, 105 transmit torque, and in fig. 10, the wire members 104, 105 are connected via a connecting pipe 106. As the thread member, a thread member in which a plurality of elastic threads constituting the basket portion are coaxially arranged in parallel as shown in fig. 11 is exemplified. For example, patent document 1 discloses a medical basket-type grasping forceps in which a plurality of strands are arranged coaxially in parallel on a proximal side of a proximal end of a cage-shaped portion, and an operation wire is connected to the proximal side.

patent document 1: japanese patent laid-open publication No. 2005-21195

When the grasping forceps (basket-type forceps) described in patent document 1 is inserted into a body lumen having a meandering shape, the proximal end portions (portions where a plurality of elastic wires are arranged in parallel in the axial direction) of the manipulation wire or the basket portion may come into contact with the inner wall of the endoscope tube, and an acute angle may be generated by the forceps raising table, whereby the inner cavity of the outer tube may be crushed and trapped, and may not be rotated in a desired angle or direction. In particular, in the curved portion of the small-diameter bile duct, the basket wire is disposed so as to be biased to the outside of the curved duct, and therefore the basket cannot be maintained in a sufficiently expanded state, which may result in a failure in removal of the calculus. Further, the calculus caught in the basket may not be released, and the catheter itself may not be pulled out (strangulated) from the bile duct, and as a result, the procedure to release the retention and the surgical operation may be shifted, which may increase the operation time and the invasion of the patient.

Disclosure of Invention

Therefore, an object of the present invention is to provide a basket catheter capable of easily transmitting a rotational torque on the proximal side to a basket portion to easily capture foreign matter, and allowing other auxiliary treatment instruments to be inserted into the lumen of the basket catheter to thereby allow for observation of foreign matter in the lumen, removal of captured foreign matter, and the like.

A basket catheter according to the present invention that can solve the above problems includes: an outer cylinder member; an inner cylinder member disposed in the inner cavity of the outer cylinder member; and an expandable basket section disposed on the distal side of the inner tubular member and having a plurality of elastic wires, the inner tubular member having a hollow coil body formed by spirally winding the wires. In the basket duct according to the present invention, since the inner tube member disposed on the proximal side of the basket portion has the hollow coil body formed by spirally winding the wire material, the rotational torque on the hand side is easily transmitted to the basket portion, and the foreign matter trapping operation is easily performed. Further, since the auxiliary treatment instrument provided separately from the basket catheter can be inserted into the lumen of the inner tubular member, it is possible to perform treatment such as observation of foreign matter in the lumen or removal of captured foreign matter. Therefore, prevention of strangulation, increase of options for surgery according to the disease, and promotion of minimally invasive treatment can be achieved.

In the basket duct, the hollow coil body preferably includes at least a first layer and a second layer arranged outside the first layer, and a winding direction of the wire rod is preferably opposite to that of the second layer in the first layer.

In the basket duct, the hollow coil body preferably includes a first layer, a second layer disposed outside the first layer, and a third layer disposed outside the second layer, and the winding direction of the wire is preferably opposite to that of the second layer in the first layer and opposite to that of the third layer in the second layer.

in the basket catheter, it is preferable that another wire extending in the proximal-distal direction is disposed in the lumen of the hollow coil body, and one end portion and the other end portion of the other wire are fixed to the hollow coil body.

In the basket duct, the inner tube member preferably further includes a metal tube connected to the proximal end of the hollow coil body.

In the basket duct, the plurality of elastic threads and the inner tube member are preferably connected by a tubular connector.

Preferably, the connecting member has a plurality of thread insertion passages through which proximal ends of the elastic threads are inserted from a distal side, and the plurality of thread insertion passages are arranged in a circumferential direction.

Preferably, the connector has a fixing hole in the peripheral wall, which communicates with the outside and the wire insertion passage.

Preferably, the connector has a small diameter portion having an outer diameter smaller on the proximal side than on the distal side, and the small diameter portion is inserted into the distal side of the inner cavity of the inner tube member.

Preferably, the inner diameter of the connecting member at the small diameter portion is equal to or larger than the inner diameter of the distal end of the inner cylinder member.

The present invention also provides a medical treatment tool including: the basket catheter and an auxiliary treatment tool inserted into the inner cavity of the inner cylinder member. The use of the auxiliary treatment tool enables observation of foreign matter in the lumen or removal of foreign matter captured by the basket catheter.

In the medical treatment instrument, the auxiliary treatment instrument is preferably a balloon catheter, a microcatheter, a forceps, a laser probe, a fiberscope, an electrohydraulic impact grinding probe, or a guide wire.

The invention also provides a method for manufacturing the basket conduit. The method for manufacturing the basket conduit is characterized by comprising the following steps: preparing a plurality of elastic threads which form an expandable basket portion, and a tubular connecting member which connects the inner tubular member and the plurality of elastic threads and has a plurality of thread insertion passages arranged in a circumferential direction; inserting the proximal end of the elastic thread into the thread insertion path from the distal side; and a step of joining the elastic thread to the connecting member. In the method of manufacturing a basket catheter according to the present invention, the inner tube member is used as the wire member for transmitting the rotation torque on the hand side to the basket portion, and the elastic wire is connected to the inner tube member via the tubular connector, so that a basket catheter in which the auxiliary treatment instrument can be inserted into the lumen can be obtained.

In the above manufacturing method, it is preferable that the connector has a fixing hole communicating with the outside and the thread insertion passage in the peripheral wall, and the adhesive is injected into the fixing hole in the step of joining the elastic thread and the connector.

In the above manufacturing method, it is preferable to have a step of reducing the outer diameter of the proximal end of the elastic thread before the step of inserting the elastic thread into the thread insertion passage.

In the above manufacturing method, it is preferable that the method further comprises: preparing an inner tube member having a hollow coil body formed by spirally winding a wire material; and inserting the proximal end of the connector into the distal end of the lumen of the inner tubular member.

According to the basket guide tube of the present invention, the rotational torque on the hand side is easily transmitted to the basket portion, and the foreign matter trapping operation is easily performed. Further, since the auxiliary treatment instrument provided separately from the basket catheter can be inserted into the lumen of the inner tubular member, it is possible to perform treatment such as observation of foreign matter in the lumen or removal of captured foreign matter.

according to the medical treatment instrument of the present invention, the auxiliary treatment instrument inserted into the inner cavity of the inner tubular member enables observation of foreign matter in the inner cavity or removal of captured foreign matter.

as described above, the basket catheter or the medical treatment instrument can prevent strangulation, increase options for operations according to a disease state, and promote minimally invasive treatment.

In the method of manufacturing a basket catheter according to the present invention, the inner tube member is used as the wire member for transmitting the rotational torque on the hand side to the basket portion, and the elastic wire is connected to the inner tube member via the tubular connector, so that a basket catheter in which an auxiliary treatment instrument can be inserted into the lumen can be obtained.

Drawings

Fig. 1 shows a top view (partially sectional view) of a distal side of a basket catheter according to an embodiment of the present invention.

fig. 2 shows a cross-sectional view of the basket conduit shown in fig. 1 along line II-II.

Fig. 3 shows a top view (partially cross-sectional view) of the proximal side of the basket conduit according to the embodiment of the present invention.

Fig. 4 is a perspective view of a connector according to an embodiment of the present invention.

Fig. 5 shows a cross-sectional view of a connector according to an embodiment of the present invention along the axial direction.

Fig. 6 is a plan view (partially sectional view) showing a method of manufacturing a basket duct according to an embodiment of the present invention.

fig. 7 is a plan view (partially sectional view) showing a method of manufacturing a basket duct according to an embodiment of the present invention.

Fig. 8 is a plan view (partially sectional view) showing a method of manufacturing a basket duct according to an embodiment of the present invention.

fig. 9 is a plan view (partially sectional view) showing a method of manufacturing a basket duct according to an embodiment of the present invention.

Fig. 10 shows a top view of a prior art basket conduit.

Fig. 11 shows a cross-sectional view of the basket conduit shown in fig. 10 along line XI-XI.

Detailed Description

The present invention will be described more specifically based on the following embodiments, but the present invention is not limited to the following embodiments, and can be carried out by appropriately changing the embodiments within the scope conforming to the gist described above and below, and all of them are included in the technical scope of the present invention. Note that, in each drawing, hatching, component symbols, and the like may be omitted for convenience, and in such a case, the description and other drawings are referred to. In addition, the dimensions of the various components in the drawings are different from actual dimensions, since it is preferable to understand the features of the present invention.

1. basket catheter and medical treatment device

In the present invention, a Basket catheter (Basket catheter) is a medical treatment instrument having a distal side and a proximal side and having a cage-like Basket for catching a foreign body such as a calculus, and includes a Basket-type forceps. Hereinafter, the basket conduit may be simply referred to as a "conduit". First, the overall structure of the catheter will be described with reference to fig. 1. Fig. 1 shows a plan view (partially sectional view) of the distal side of a catheter 1 according to the present invention, and fig. 2 shows a sectional view of the catheter 1 shown in fig. 1 taken along line II-II.

in the present invention, the proximal side of the catheter 1 refers to a direction toward the hand of the user (operator) with respect to the extending direction of the catheter 1, and the distal side refers to a direction opposite to the proximal side (i.e., a direction toward the treatment target). The direction from the proximal side to the distal side of the catheter 1 is referred to as the axial direction or the proximal-distal direction.

The catheter 1 has: an outer cylinder member 2; an inner tube member 3 disposed in the inner cavity of the outer tube member 2; and an expandable basket section 10 disposed on the distal side of the inner tubular member 3 and having a plurality of elastic wires 15.

The outer cylinder member 2 prevents the elastic wire 15 of the basket portion 10 from damaging the jaw opening in the endoscope, the inside of the forceps channel, and the body tissue other than the foreign object, during the period from the jaw opening of the endoscope through the inside of the forceps channel to the vicinity of the foreign object.

The outer tubular member 2 may be a resin tube extruded by extrusion, a tubular body formed by arranging wires of a single wire or a twisted wire in a specific pattern, a metal tube, or a combination thereof. As a tubular body in which wires are arranged in a specific pattern, a tubular body having a mesh structure formed by simply crossing or knitting the wires, or a coil around which the wires are wound are shown. The kind of mesh structure is not particularly limited, and the number of turns and the density of the coil are not particularly limited. The coil may be wound at a constant density over the entire axial direction, or may be wound at a different density depending on the position in the axial direction. In order to improve the flexibility of the metal pipe, grooves may be formed spirally on the outer surface of the metal pipe. Preferably, the groove is formed on the outer surface of the metal pipe on the distal side from the axial center thereof. The groove may not be formed on the outer surface on the side closer to the axial center of the metal pipe.

The outer cylindrical member 2 is preferably made of resin or metal. Examples of the resin constituting the outer tube member 2 include polyamide resin, polyester resin, polyurethane resin, polyolefin resin, fluorine resin, vinyl chloride resin, silicone resin, and natural rubber. These may be used alone or in combination of two or more. Among them, polyamide resins, polyester resins, polyurethane resins, polyolefin resins, and fluorine resins are preferably used. Examples of the metal constituting the outer tubular member 2 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, a Ni — Ti alloy, a Co — Cr alloy, and a combination thereof. In particular, a wire rod made of a Ni — Ti alloy is excellent in shape memory and high elasticity. The wire rod may be a fiber material such as a polyarylate fiber, an aramid fiber, an ultra-high molecular weight polyethylene fiber, a PBO fiber, or a carbon fiber. The fibrous material may be monofilament or multifilament. Further, a member in which a reinforcing material such as a metal wire is disposed in a cylindrical body made of a resin may be used as the outer cylindrical member 2.

The outer cylinder member 2 may be formed of a single layer or a plurality of layers. Further, in the axial direction, a part of the outer cylindrical member 2 may be formed of a single layer, and the other part may be formed of a plurality of layers.

The inner tube member 3 is disposed in the inner cavity of the outer tube member 2. The inner tube member 3 has a hollow coil body 4 formed by spirally winding a wire material. As described above, since the inner tubular member 3 of the basket duct 1 of the present invention includes the hollow coil body 4, the torque on the hand side is easily transmitted to the basket unit 10, and the foreign matter trapping operation is easily performed. Further, since an auxiliary treatment instrument provided separately from the basket catheter 1 can be inserted into the lumen of the inner tubular member 3, it is possible to perform treatment such as observation of foreign matter in the lumen or removal of captured foreign matter. Therefore, prevention of strangulation, increase of options for surgery according to the disease, and promotion of minimally invasive treatment can be achieved.

A part of the inner tube member 3 in the proximal-distal direction of the catheter 1 may be the hollow coil body 4, or the entire inner tube member 3 in the axial direction may be the hollow coil body 4. When a part of the inner tubular member 3 is the hollow coil body 4, a part other than the hollow coil body 4 may be configured to be the same as the outer tubular member 2. Although not shown, the inner tube member 3 preferably further includes a metal pipe connected to the proximal end of the hollow coil body 4. By providing the hollow coil body 4, the torque on the hand side can be easily transmitted to the basket portion 10, and by providing the metal pipe, the elongation of the inner tube member 3 in the axial direction can be suppressed.

The hollow coil body 4 is formed by spirally winding one or more wire rods. The density (winding interval) of the hollow coil bodies 4 is not particularly limited, and may be close-wound, pitch-wound, or a combination thereof. The hollow coil bodies 4 preferably have adjacent wires in contact with each other at least in a part of the proximal-distal direction of the basket catheter 1, and more preferably have adjacent wires in contact with each other entirely in the proximal-distal direction. By bringing adjacent wires into contact with each other, the hollow coil body 4 having excellent torque transmission and responsiveness can be obtained.

in the case where the wire rod constituting the hollow coil body 4 is a single body formed of a single wire, the sectional shape of the wire rod in the axial direction may be a circle, an ellipse, a polygon, or a combination thereof.

In the case of a wire material having a plurality of wires spirally wound, the number of the wires is 2 or more, 3 or more, or 4 or more; or less than 20, less than 15, less than 12, less than 10, or less than 8.

the hollow coil body 4 is preferably formed as a hollow body without a core by twisting a plurality of wires. In the hollow coil body 4, the twisting direction of the wire is not particularly limited, and may be Z-twisting or S-twisting.

The wire forming the hollow coil body 4 is preferably made of resin or metal. As a material constituting the wire rod, a resin or a metal constituting the outer tube member 2 can be used. In order to stabilize the shape of the hollow coil body 4, the wire is preferably made of platinum and tungsten.

The hollow coil body 4 may be a single-layer coil or a multilayer coil having a plurality of layers. When the hollow coil body 4 has a plurality of layers, it is preferable that at least one of the winding direction and the winding interval of the wire material is different in each layer. When the hollow coil body 4 is a multilayer coil, the outer diameters of the wires of the respective layers may be the same or different. For example, the outer diameter of the outer layer of the hollow coil body 4 may be larger than the outer diameter of the inner layer, or may be smaller than the outer diameter of the inner layer.

Preferably, the hollow coil body 4 includes at least a first layer 4A and a second layer 4B disposed outside the first layer 4A, and the winding direction of the wire is opposite to that of the second layer 4B in the first layer 4A. Thus, the first layer 4A and the second layer 4B, which are opposite in the winding direction of the wire material, are brought into contact with each other, whereby the hollow coil body 4 can be suppressed from being elongated in the axial direction.

preferably, the hollow coil body 4 includes a first layer 4A, a second layer 4B disposed outside the first layer 4A, and a third layer 4C disposed outside the second layer 4B, and the winding direction of the wire is opposite to that of the second layer 4B in the first layer 4A and opposite to that of the third layer 4C in the second layer 4B. That is, the winding directions of the wires of the first layer 4A and the third layer 4C are preferably the same. Thus, the first layer 4A and the second layer 4B, and the second layer 4B and the third layer 4C, which are opposite to each other in the winding direction of the wire material, are brought into contact with each other, whereby the elongation of the hollow coil body 4 in the axial direction is further suppressed. In the case where the hollow coil body 4 is formed as a three-layer hollow body having no core by twisting a plurality of wires, the first layer 4A may be S-twisted, the second layer 4B may be Z-twisted, and the third layer 4C may be S-twisted, or the first layer 4A may be Z-twisted, the second layer 4B may be S-twisted, and the third layer 4C may be Z-twisted.

Preferably, another wire (hereinafter, sometimes referred to as "reinforcing wire") extending in the proximal-distal direction is disposed in the lumen of the hollow coil body 4, and one end and the other end of the other wire are fixed to the hollow coil body 4. By disposing the reinforcing wire in the inner cavity of the hollow coil body 4 in this manner, the axial extension of the hollow coil body 4 can be suppressed.

Preferably, another wire (reinforcing wire) extending in the proximal-distal direction is disposed in the inner cavity of the outer tubular member 2 and outside the hollow coil body 4, and one end and the other end of the other wire are fixed to the hollow coil body 4. By disposing the reinforcing wire outside the hollow coil body 4 in this manner, the hollow coil body 4 can be suppressed from extending in the axial direction.

Preferably, the reinforcing wire is made of a biocompatible resin or metal that does not easily elongate in the axial direction. Examples of the material constituting the reinforcing wire include materials constituting the wire forming the hollow coil body 4, and examples of the material include platinum, tungsten, titanium, gold, or an alloy thereof, and polyolefin resins such as stainless steel and polypropylene resin. In particular, from the viewpoint of improving flexibility of the catheter 1, improving delivery performance, and suppressing manufacturing cost, it is preferable to use a wire made of polypropylene resin as the reinforcing wire.

The shape of the reinforcing wire is not particularly limited, and may be, for example, a linear shape, a wave shape, a spiral shape, or a combination thereof.

The reinforcing wire may be directly fixed to the hollow coil body 4, or may be indirectly fixed to the hollow coil body 4 via another member. The reinforcing wire may be fixed to the inner surface or the outer surface of the hollow coil body 4, or may be fixed to the proximal end surface or the distal end surface of the hollow coil body 4.

In order to protect the outer tube member 2 and the inner tube member 3 from a fluid such as a contrast medium or a drug solution, a coating agent may be applied to the inner surfaces of the outer tube member 2 and the inner tube member 3. In addition, in order to improve the slidability of the guide wire with respect to the inner tubular member 3, a lubricant may be applied to the inner surface of the inner tubular member 3. Further, in order to improve the slidability of the inner cylindrical member 3 with respect to the outer cylindrical member 2, a lubricant may be applied to the inner surface of the outer cylindrical member 2. As the coating agent and the lubricant, known coating agents and lubricants can be used.

fig. 3 shows an example of the proximal structure of the catheter 1 shown in fig. 1. As shown in fig. 3, a gripping member 50 may be connected to the proximal end side of the inner cylindrical member 3 in order to improve the operability of the inner cylindrical member 3. As the holding member 50, for example, a cylindrical member capable of being inserted into the proximal end side of the inner tube member 3 is exemplified.

In addition, an auxiliary gripping member 51 for gripping the outer cylindrical member 2 may be connected to the proximal end side of the outer cylindrical member 2 in order to facilitate adjustment of the relative position between the outer cylindrical member 2 and the inner cylindrical member 3. As the auxiliary gripping member 51, a tubular member capable of being inserted through the proximal end side of the outer tube member 2 in the lumen is exemplified. As the material of the gripping member 50 and the auxiliary gripping member 51, for example, synthetic resin such as ABS and polycarbonate, or foamed plastic such as polyurethane foam can be used. The inner cavity of the holding member 50 may communicate with the inner cavity of the inner tube member 3. The lumen of the gripping member 50 may function as a passage for a drug, a fluid in a body cavity, or the like, in addition to the insertion passage for the guide wire. Further, the lumen of the outer tube member 2, which is the lumen of the auxiliary grip member 51 communicating with the outside of the inner tube member 3, may function as a passage for a drug, a fluid in a living body cavity, or the like.

The inner tube member 3 and the gripping member 50, and the outer tube member 2 and the auxiliary gripping member 51 can be joined by a conventionally known joining means such as an adhesive or heat welding. The gripping member 50 is disposed on the side closer to the auxiliary gripping member 51. An annular resistance member 52 may be provided at the proximal end of the auxiliary gripping member 51. This can prevent the auxiliary gripping member 51 from being accidentally displaced with respect to the gripping member 50, and thus can fix the relative position of the outer cylindrical member 2 and the inner cylindrical member 3.

the basket catheter 1 has an expandable basket portion 10, and the basket portion 10 is disposed on the distal side of the inner cylindrical member 3 and has a plurality of elastic wires 15. The basket 10 is provided to catch foreign matter in the body. As shown in fig. 1, it is preferable that the plurality of elastic threads 15 of the basket unit 10 are fixed at both distal and proximal positions. Thereby, the catching part 16 for catching foreign matter between the fixing parts at two positions is formed. By exposing the elastic thread 15 from the outer cylindrical member 2, the elastic thread 15 expands outward in the radial direction, and foreign matter can be captured by the capturing portion 16.

The elastic thread 15 is a linear member having elasticity, and is preferably made of a shape memory alloy or a shape memory resin. The elastic wire 15 may be a single-stranded or stranded wire made of stainless steel such as SUS304 or SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, aluminum, gold, silver, a Ni — Ti alloy, a Co — Cr alloy, or the like, for example, and among these, a metal wire made of a Ni — Ti alloy is preferable. The number of the elastic threads 15 is not particularly limited, and is, for example, 3 or more, 4 or more, 5 or more, or 10 or more; or 20 or less and 15 or less are allowed.

In the catching part 16, the elastic wire 15 preferably has a bent portion (bent portion). In the bending portion, the elastic wire 15 may be bent or bent. In the catching part 16, the elastic thread 15 may be formed in a spiral shape. By forming the capturing portion 16 in this manner, foreign matter is easily captured.

Preferably the plurality of elastic threads 15 of the basket 10 are mutually fixed at the distal end. The distal ends of the plurality of elastic threads 15 may be secured by the tip 11. Further, although not shown, the plurality of elastic threads 15 may be fixed to each other by heat welding, silver brazing, or adhesion.

The distal end 11 preferably has a wire insertion hole 12 into which the distal ends of the plurality of elastic wires 15 are inserted from the proximal side (see fig. 6). Although not shown, the distal end 11 may have a plurality of wire insertion holes 12 into which distal ends of the elastic wires 15 are inserted from the proximal side.

The material constituting the distal end 11 is preferably a resin, a metal, or a combination thereof constituting the outer tube member 2, but the metal constituting the distal end 11 is preferably stainless steel or a Ni — Ti alloy.

Although not shown, a treatment instrument insertion path through which an auxiliary treatment instrument, which is a treatment instrument provided separately from the basket catheter 1, is inserted may be provided at the distal end head 11. Preferably, the treatment instrument insertion path extends in the axial direction of the inner cylinder member 3. Further, it is more preferable that the central axis of the treatment instrument insertion path of the distal end 11 overlaps with the central axis of the inner tube member 3. By providing the treatment instrument insertion path in the distal end head 11 in this manner, the distal end of the auxiliary treatment instrument can be easily disposed on the distal side of the distal end of the catheter 1. Therefore, even after the foreign matter is captured by the capturing unit 16, the medical fluid or the contrast agent can be made to flow to the distal side of the foreign matter by using the auxiliary treatment instrument. In order to facilitate insertion of the auxiliary treatment instrument, the treatment instrument insertion passage preferably extends along the axial direction of the inner cylindrical member 3.

preferably, the outer diameter of the distal end head 11 is larger than the inner diameter of the outer cylindrical member 2 in the radial direction of the inner cylindrical member 3. Even if the catching part 16 is accommodated in the outer cylindrical member 2, the top end 11 is hooked on the distal end of the outer cylindrical member 2, and thus the basket part 10 can be prevented from being excessively moved toward the proximal side of the outer cylindrical member 2. In addition, even when the operation is performed after the capture portion 16 is housed, the capture portion 16 can be exposed from the outer tube member 2 immediately, and therefore the operation can be performed efficiently.

As shown in fig. 1, a plurality of elastic threads 15 are preferably fixed on the proximal side. Specifically, the plurality of elastic threads 15 and the inner tube member 3 are preferably connected by a tubular connector 20. Fig. 4 and 5 show an embodiment of the tubular connector 20. Since the connector 20 is formed in a tubular shape, the connector 20 and the lumen of the inner tubular member 3 can communicate with each other, and the auxiliary treatment instrument inserted through the lumen of the inner tubular member 3 can reach the capturing portion 16 through the lumen 24 of the connector 20 to a position on the distal side of the capturing portion 16. Therefore, treatments such as observation of foreign matter in the lumen and removal of captured foreign matter can be performed, and the effects of prevention of strangulation, increase of options for surgery according to a disease state, and promotion of minimally invasive treatment can be obtained.

The material constituting the connector 20 is preferably biocompatible, and can be constituted of, for example, the materials listed as preferred materials constituting the tip 11.

The shape of the coupling 20 may be a cylindrical shape or a polygonal cylindrical shape, but the shape of the coupling 20 is preferably a cylindrical shape in order to improve the slidability of the coupling 20 with respect to the outer tube member 2.

Since the connector 20 is housed together with the catching part 16 in the outer tube member 2, the outer diameter of the connector 20 is smaller than the inner diameter of the outer tube member 2.

As shown in fig. 4, the connector 20 preferably has a plurality of thread insertion passages 21 (e.g., 21a, 21b, 21c, 21d) into which the proximal end of the elastic thread 15 is inserted from the distal side, and the plurality of thread insertion passages 21 are arranged in the circumferential direction. In this case, the wire insertion passage 21 is preferably provided in the peripheral wall of the connector 20. By arranging the elastic threads 15 in the circumferential direction and outside the lumen 24 of the connector 20 in the radial direction, that is, around the lumen 24, hooking to the elastic threads 15 can be suppressed when the auxiliary treatment instrument is advanced and retreated in the axial direction.

preferably, the inlet of the wire insertion path 21 is provided on the distal end surface of the connector 20. This facilitates insertion of the elastic thread 15 from the distal side.

One elastic thread 15 may be inserted into one thread insertion passage 21, or a plurality of elastic threads 15 may be inserted into the thread insertion passage 21, but in order to firmly fix the elastic threads 15 to the connecting member 20, it is preferable to insert one elastic thread 15 into one thread insertion passage 21. Therefore, the inner diameter of the thread insertion passage 21 is preferably larger than the outer diameter of the elastic thread 15, and the inner diameter of the thread insertion passage 21 is preferably 1.5 times or less, more preferably 1.2 times or less, and still more preferably 1.1 times or less the outer diameter of the elastic thread 15.

The number of the wire insertion passages 21 may be set in accordance with the number of the elastic wires 15, and may be, for example, 3 or more, 4 or more, 5 or more, or 6 or more, but may be, for example, 12 or less, or 10 or less, from the viewpoint of ease of manufacturing the connector 20.

The extending direction of the wire insertion passage 21 is not particularly limited, but at least a part of the wire insertion passage 21 preferably extends in the axial direction of the inner cylindrical member 3, and more preferably the entire wire insertion passage 21 extends in the axial direction of the inner cylindrical member 3. This facilitates insertion of the proximal end of the elastic thread 15 into the thread insertion passage 21, and prevents buckling of the elastic thread 15.

The wire insertion passage 21 may be provided to pass through the connection member 20 in the axial direction. Specifically, the inlet of the string insertion path 21 may be provided on the distal end surface of the connector 20, and the outlet may be provided on the proximal end surface of the connector 20. By providing the wire insertion passage 21 in this manner, the insertion passage can be made longer. Further, the wire insertion passage 21 may have a length equal to the entire length of the coupler 20 in the axial direction of the inner tubular member 3. Such a wire insertion passage 21 can be easily formed, and therefore, the productivity of the connector 20 can be improved.

On the other hand, the proximal end of the wire insertion passage 21 may be located on the distal side from the proximal end of the connector 20. That is, the length of the wire insertion passage 21 may be shorter than the entire length of the connection member 20. When the elastic thread 15 is inserted into the thread insertion path 21, the elastic thread 15 comes into contact with the end of the thread insertion path 21, whereby the length of the elastic thread 15 in a portion corresponding to the catching part 16 can be made constant. The length of the wire insertion passage 21 in the proximal-distal direction may be shorter than the entire length of the connector 20, may be 75% or less, may be 50% or less, or may be 5% or more, 10% or more, or 20% or more of the entire length of the connector 20, as long as the connector 20 can be connected to the elastic wire 15.

It is preferable that the plurality of wire insertion passages 21 are arranged at constant intervals in the circumferential direction of the connection member 20. The plurality of wire insertion passages 21 may be arranged in rotational symmetry about the central axis of the connector 20. By disposing the string insertion path 21 in this manner, the trap portion 16 is formed in a shape that is easy to trap foreign matter.

Preferably, the length of the coupling 20 in the axial direction is longer than the maximum outer diameter. This facilitates the length of the wire insertion passage 21 to be ensured.

As shown in fig. 4 and 5, the connector 20 preferably has a fixing hole 22 in a peripheral wall thereof, which communicates with the outside and the thread insertion passage 21. The elastic thread 15 can be more firmly fixed to the connecting member 20 by injecting the adhesive 30 from the fixing hole 22.

The fixing hole 22 may be provided with one or more for one insertion passage, but in order to prevent the strength of the connector 20 from being lowered, it is preferable that the fixing hole 22 is provided with one for one insertion passage. The axial direction of the fixing hole 22 preferably intersects with the axial direction of the wire insertion passage 21, and more preferably is orthogonal thereto.

The inner diameter of the fixing hole 22 may be larger than the inner diameter of the wire insertion passage 21 or smaller than the inner diameter of the wire insertion passage 21. In addition, the length of the fixing hole 22 in the axial direction may be shorter than the length of the wire insertion passage 21 in the axial direction.

Preferably, the fixing hole 22 is provided on the distal side from the proximal end of the wire insertion passage 21. When the proximal end of the wire insertion passage 21 is 0% and the distal end is 100% in the axial direction, the fixing hole 22 is preferably provided in a range of 25% to 75%, more preferably 40% to 60%. Accordingly, the adhesive 30 injected from the fixing hole 22 is easily spread in the string insertion path 21, and thus the elastic string 15 and the connector 20 can be firmly fixed.

As the adhesive 30 injected into the fixing hole 22, for example, a solder such as silver solder, or an acrylic, epoxy, urethane adhesive can be used.

The method of joining the coupling 20 and the inner tubular member 3 is not particularly limited, but as shown in fig. 4 and 5, the coupling 20 preferably has a small diameter portion 23 having an outer diameter smaller on the proximal side than on the distal side, and the small diameter portion 23 is preferably inserted on the distal side of the inner cavity of the inner tubular member 3. By providing such a small diameter portion 23 in the coupling 20, the inner tube member 3 and the coupling 20 can be easily connected.

Preferably, the length of the small diameter portion 23 is less than half of the entire length of the coupling 20 in the axial direction. By setting the length of the small diameter portion 23 in this manner, the inner tube member 3 can be firmly joined.

Preferably, the inner diameter of the coupling 20 is constant in the small diameter portion 23 and the non-small diameter portion on the distal side of the small diameter portion 23. By providing the inner diameter in this manner, the sliding property of the auxiliary treatment instrument inserted through the lumen 24 of the connector 20 becomes good.

The outer diameter of the small-diameter portion 23 is preferably 95% or less, more preferably 90% or less, even more preferably 80% or less, and further preferably 60% or more, even more preferably 65% or more of the outer diameter of the non-small-diameter portion. This makes it possible to secure the size of the insertion path of the treatment instrument and to easily connect the treatment instrument to the inner tube member 3.

The inner diameter of the coupling 20 at the small-diameter portion 23 is preferably equal to or larger than the inner diameter of the distal end of the inner tube member 3. Thus, when the treatment instrument is inserted into the lumen from the proximal side of the inner tubular member 3, the joint between the inner tubular member 3 and the connector 20 is less likely to be touched, and therefore, the treatment instrument can be smoothly moved from the distal side to the proximal side. Further, once a part of the auxiliary treatment instrument in the axial direction passes through the joint between the inner tubular member 3 and the coupling 20, the operation of pulling out the auxiliary treatment instrument from the inner tubular member 3 can be smoothly performed. Further, the inner diameter of the coupling 20 at the small diameter portion 23 may be smaller than the inner diameter at the distal end of the inner tube member 3. Further, it is preferable that the inner diameter of the connector 20 at the proximal end of the small diameter portion 23 is the same as the inner diameter of the distal end of the inner cylinder member 3. Since there is no difference in height between the connector 20 and the inner tube member 3, the treatment instrument can be inserted more smoothly.

The outer diameter of the connector 20 at the small diameter portion 23 is preferably equal to or smaller than the inner diameter of the distal end of the inner tube member 3. By setting the inner diameters of the coupler 20 and the inner tubular member 3 in this manner, the proximal side of the coupler 20 can be inserted toward the distal end side of the inner tubular member 3.

When the small diameter portion 23 is provided in the connector 20, the wire insertion passage 21 and the fixing hole 22 are preferably provided in a non-small diameter portion on the distal side of the small diameter portion 23. By forming the wire insertion passage 21 and the fixing hole 22 in this manner, the strength of the connector 20 can be prevented from being reduced.

The present invention also includes a medical treatment instrument including the basket catheter 1 and an auxiliary treatment instrument inserted into the lumen of the inner tube member 3. According to the medical treatment instrument of the present invention, the auxiliary treatment instrument inserted into the lumen of the basket catheter 1 enables the observation of foreign matter in the lumen or the removal of the captured foreign matter. Therefore, prevention of strangulation, increase of options for surgery according to the disease, and promotion of minimally invasive treatment can be achieved.

Examples of the auxiliary treatment instrument include a balloon catheter, a microcatheter, a forceps, a laser probe, a fiberscope, an electro-hydraulic impact crushing probe (EHL), and a guide wire. When the balloon catheter, forceps, laser probe, and EHL are used, the foreign matter caught by the basket portion 10 can be removed, and therefore, the occurrence of strangulation can be suppressed. The microcatheter can be used for injection of a contrast agent into a distal side of the basket catheter 1 than the distal end thereof, and for Wire assist (Wire backup) for delivering the basket catheter 1 to a site where a guide Wire is not easily passed. The fiberscope can be used for observing the state at the distal end side of the basket catheter 1. The guide wire can guide the delivery route, the delivery position of the basket catheter 1.

2. Method for operating medical treatment tool

The method of operating the medical treatment instrument of the present invention preferably includes a step of disposing an auxiliary treatment instrument in the inner cavity of the inner tubular member 3. Specifically, the distal end of the auxiliary treatment instrument is preferably inserted from the proximal side of the inner tube member 3. This step corresponds to a preliminary step of exposing the auxiliary treatment instrument from the distal end of the inner tube member 3.

The operation method includes a step of exposing the auxiliary treatment instrument from the distal end of the inner tube member 3 to the outside. Specifically, the proximal end of the treatment section provided on the distal side of the treatment instrument is preferably disposed on the distal side of the distal end of the inner tubular member 3. Thus, after capturing an object such as a foreign object by the basket catheter 1, the treatment such as observation of the foreign object or the inside of the lumen and removal of the captured foreign object can be performed by the auxiliary treatment tool. Further, the step of capturing the object by the basket unit 10 may be performed before the step of exposing the auxiliary treatment instrument to the outside from the distal end of the inner tube member 3.

Preferably, the above-described operation method further includes a step of holding the object by the basket unit 10, and a step of removing the object held by the basket unit 10 by using an auxiliary treatment tool (removal step). Even if the object such as a stone held by the basket unit 10 cannot be released, the object can be removed by using the auxiliary treatment instrument, and therefore, occurrence of strangulation can be suppressed. In order to remove the object, the auxiliary treatment instrument is preferably a balloon catheter, forceps, a laser probe, or an EHL. For example, when the auxiliary treatment instrument is a balloon catheter, the balloon is inflated to apply a load to the object from the inside and expand the intervals between the plurality of elastic threads 15, whereby the object hooked on the elastic threads 15 is pushed out of the basket portion 10, and thus the object can be removed. In the removal step, the object may be crushed using forceps, a laser probe, or an EHL of an auxiliary treatment instrument. In the removal step, the object is preferably gripped by a forceps of an auxiliary treatment instrument and released from the basket unit 10.

preferably, the operation method further includes a step of disposing the distal end of the auxiliary treatment instrument on the distal side of the distal end of the basket catheter 1. In this case, the auxiliary treatment instrument is preferably a microcatheter, a fiberscope, or a guide wire. The present invention can be preferably used when it is desired to confirm the state of an object or a treatment target site existing on the distal side of the distal end of the basket catheter 1, or when the basket catheter 1 is delivered to a site through which a guide wire is not easily passed.

When the auxiliary treatment instrument is a microcatheter, the contrast medium may be introduced from the distal end of the microcatheter. This enables the contrast medium to be injected over the object located at the distal end of the basket catheter 1, thereby enabling observation of the state of the object located at the distal end of the basket catheter 1 and the treatment target site.

3. Method for manufacturing basket conduit

The basket catheter 1 described in the section "1. basket catheter and medical treatment instrument" can be manufactured by the following method. The method for manufacturing the basket duct 1 of the present invention comprises: preparing a plurality of elastic threads 15 and a tubular connecting member 20, wherein the plurality of elastic threads 15 form an expandable basket portion 10, and the tubular connecting member 20 connects the inner tubular member 3 and the plurality of elastic threads 15 and has a plurality of thread insertion passages 21 arranged in a circumferential direction; inserting the proximal end of the elastic thread 15 into the thread insertion path 21 from the distal side; and a step of joining the elastic thread 15 to the joining member 20.

First, a plurality of elastic threads 15 and a cylindrical connector 20 having a plurality of thread insertion passages 21 are prepared.

The elastic wire 15 forms the expandable basket portion 10. As the elastic thread 15, a metal material or a resin in which a wire material is heated in a state of being bent into a desired shape and is subjected to shape memory is preferably used. The heating temperature and the heating time can be appropriately set according to the material of the wire rod. Through this step, the wire rod is processed into a shape suitable for capturing the object. As another method, a wire rod previously bent into a predetermined shape may be prepared.

The tubular connector 20 connects the inner tubular member 3 to the plurality of elastic threads 15 and has a plurality of thread insertion passages 21 arranged in a circumferential direction. In one thread insertion path 21, one or more elastic threads 15 can be inserted, but preferably one elastic thread 15 is inserted.

The connector 20 preferably has a fixing hole 22 in the peripheral wall thereof, which communicates with the outside and the wire insertion passage 21. This enables the connecting member 20 and the elastic thread 15 to be firmly fixed. The wire insertion passage 21 and the fixing hole 22 can be configured as described in section 1. basket catheter and medical treatment instrument ". The wire insertion passage 21 and the fixing hole 22 can be formed by drilling, etching, or laser processing.

The present invention may further include a step of preparing the tip 11. The plurality of elastic threads 15 can be fixed at the distal end by the tip 11.

In addition, the present invention preferably further includes a step of preparing the inner tubular member 3, and the inner tubular member 3 includes a hollow coil body 4 formed by winding a wire rod in a spiral shape. This facilitates transmission of the rotational torque on the hand side to the basket unit 10, thereby facilitating the foreign matter trapping operation.

The present invention also includes a method for manufacturing the basket catheter 1 including the step of fixing the distal ends of the plurality of elastic threads 15. As a method of fixing the distal ends of the plurality of elastic threads 15, in the case of having a step of preparing the tip 11, as shown in fig. 6, a method of inserting the distal ends of the elastic threads 15 (for example, 15a, 15b, 15c, 15d) into the thread insertion hole 12 provided in the tip 11, and joining the tip 11 into which the elastic threads 15 are inserted by caulking (pressure welding), welding by laser, welding, brazing, adhesion by an adhesive such as an acrylic, epoxy, or urethane adhesive, or the like is exemplified. The method is not limited to this method, and the distal end portions of the plurality of elastic threads 15 may be fixed by being thermally welded to each other.

next, as shown in fig. 7, the proximal end of the elastic thread 15 is inserted into the thread insertion passage 21 from the distal side. Therefore, the inner diameter of the thread insertion path 21 is preferably equal to or larger than the outer diameter of the proximal end of the elastic thread 15.

Although not shown, the above-described manufacturing method may have a step of reducing the outer diameter of the proximal end of the elastic thread 15 before the step of inserting the elastic thread 15 into the thread insertion passage 21. By reducing the outer diameter of the proximal end of the elastic thread 15 in this manner, the thread can be easily inserted into the thread insertion passage 21. As a method of reducing the outer diameter of the proximal end of the elastic thread 15, there are a method of cutting the proximal end of the elastic thread 15 with a cutter and a method of crushing the proximal end by pressing it. The outer diameter of the insertion portion inserted into the wire insertion passage 21 is preferably 95% or less, more preferably 90% or less, even more preferably 70% or less, of the outer diameter of the non-insertion portion that is not inserted, and is also allowable even if the outer diameter is 40% or more and 50% or more.

The above-described manufacturing method has a step of joining the elastic thread 15 to the connector 20. Examples of the method of joining the elastic thread 15 and the connector 20 include caulking (pressure bonding) of the connector 20 into which the elastic thread 15 is inserted, welding by laser or the like, welding, brazing, and adhesion by an adhesive. In order to suppress the generation of the unevenness of the joining strength, it is preferable to bond the elastic thread 15 and the connecting member 20 by soldering or an adhesive.

As shown in fig. 8, the connector 20 preferably has a fixing hole 22 in a peripheral wall thereof, which communicates with the outside and the thread insertion passage 21(21b and 21d are not shown), and the adhesive 30 is injected into the fixing hole 22 in the step of joining the elastic thread 15 to the connector 20. The fixing hole 22 provided in the connector 20 can be configured as described above. The binder 30 includes a solder such as silver solder, and an acrylic, epoxy, or urethane binder.

The above-described manufacturing method may also include a step of joining the coupling 20 to the inner tube member 3. As shown in fig. 9, the above-described manufacturing method preferably includes a step of inserting the proximal end of the connector 20 into the distal end of the lumen of the inner tube member 3. By inserting the coupling 20 into the inner tube member 3 in this manner, the inner tube member 3 and the coupling 20 can be easily joined. As shown in fig. 9, a small-diameter portion 23 preferably provided in the connector 20 may be inserted into the inner cavity of the inner tube member 3. As another mode, the distal end of the inner tube member 3 may be inserted into the proximal end of the lumen 24 of the connector 20. Further alternatively, the proximal end of the connector 20 and the distal end of the inner tube member 3 may be joined by welding, brazing, or bonding with an adhesive.

The above-described manufacturing method may include a step of connecting another tubular member (hereinafter, referred to as a "tube") to the proximal end of the inner tubular member 3. The pipe is provided to facilitate handling of the gripping member 50, and therefore is preferably higher in hardness than the inner tube member 3. The tube is preferably made of a metal material such as stainless steel. As a method of joining the tube and the inner tubular member 3, in addition to a method of inserting the distal end portion of the tube into the proximal end portion of the lumen of the inner tubular member 3, methods of welding, brazing, bonding with an adhesive, and the like by laser or the like are exemplified.

The above-described manufacturing method may further include a step of connecting the gripping member 50 to the proximal end of the inner tubular member 3, a step of connecting the auxiliary gripping member 51 to the proximal end of the outer tubular member 2, and a step of disposing the inner tubular member 3 in the inner cavity of the outer tubular member 2.

The present application claims priority based on japanese patent application No. 2017-161611, filed 24/8/2017. For reference, the entire contents of the specification of japanese patent application No. 2017-161611, filed 24.8.2017, are cited in the present application.

Description of the reference numerals

1 … basket catheter; 2 … outer barrel component; 3 … inner barrel component; 4 … hollow coil body; 4a … first layer; 4B … second layer; a third layer of 4C …; 10 … a basket part; 11 … tip; 12 … inserting the thread into the hole; 15. 15a, 15b, 15c, 15d … elastic thread; 16 … catching part; 20 … connection pieces; 21. 21a, 21b, 21c, 21d … wire insertion passages; 22 … fixing holes; 23 … small diameter section; 24 … lumen of connector; 30 … an adhesive; 50 … a gripping member; 51 … auxiliary holding member; 52 … resistance elements.