JP6349797B2 - Tip deflection movable catheter and tip deflection movable catheter manufacturing method - Google Patents

Description

  The present invention relates to a tip deflection movable catheter capable of freely deflecting a tip portion and a manufacturing method thereof.

  In catheters (including electrode catheters, ablation catheters, catheter sheaths, etc.) that are inserted through blood vessels, body cavities, body lumens, etc., to target tissues such as various organs (for example, the heart), the insertion and target tissues In order to facilitate access, etc., the direction of the distal end (tip) of the catheter inserted into the body is operated, and the operation section provided at the proximal end (base end) of the catheter disposed outside the body is operated. A tip deflection movable catheter which can be deflected by doing so is known.

  In the tip deflection movable catheter, as a structure for deflecting the direction of the distal end by the operation of the operation unit, for example, as described in Patent Document 1, a pull ring is embedded in the vicinity of the distal end of the catheter. A structure is known in which an operation wire (flat wire) is connected to a pull ring, the operation wire is extended to an operation unit, and the operation wire is advanced and retracted by operation of the operation unit. The distal deflection movable catheter is preferably not only flexible, but also has strength and flexibility that realizes good operability while preventing kinks and the like. A technique for reinforcing a tube by embedding a blade layer (braided wire assembly) formed by braiding the tube in the tube is described.

Special table 2009-537244 gazette

  However, in the conventional technique in which the pull ring is installed inside the blade layer while avoiding the blade layer, there is a problem that a portion of the tube cross section that can be used as a main lumen used as an insertion path for a catheter or the like becomes small. In order to ensure the size, there is a problem that the attaching portion of the pull ring becomes thick. In addition, there may be a method of removing a part of the blade layer at the distal end and installing a pull ring. However, in such a technique, a part of the wire constituting the blade layer protrudes from the broken part of the blade layer. Depending on the situation, there arises a problem that the tip deflection movable catheter is exposed on the surface.

  The present invention has been made in view of such a situation, and an object thereof is a tip deflection movable catheter in which a pull ring is attached to a catheter tube having a blade layer, avoiding a thickened distal end, and It is an object of the present invention to provide a tip deflection movable catheter that can prevent a problem that a wire constituting a blade layer is exposed to the surface, and a manufacturing method thereof.

In order to achieve the above object, a tip deflection movable catheter according to the present invention includes:
A main lumen and a wire lumen are formed, a blade layer surrounding the main lumen and the wire lumen from the outer peripheral side is embedded, and the distal end of the tube, which is the distal end, is inserted into the body, and the proximal end A catheter tube whose proximal end is located outside the body;
A pull ring provided to cover a pull ring installation portion which is a part of the distal end of the tube and includes a blade breaking portion where the blade layer is interrupted at least in a circumferential direction;
An operation wire that is passed through the wire lumen and connected at one end to the pull ring at the blade break;
A cover ring provided on the cover ring installation part which is another part of the tube distal end adjacent to the proximal end side of the pull ring installation part and the blade layer is continuous in the circumferential direction;
A tip tip for covering the pull ring installation portion, the cover ring installation portion, the pull ring and the cover ring, and connecting the pull ring and the cover ring to the distal end of the tube;
An operation portion provided at the proximal end of the tube and connected to the other end of the operation wire;
Have

  In the tip deflection movable catheter according to the present invention, since the pull ring is installed in the pull ring installation section including the blade disconnection section, the distal end of the catheter can be prevented from becoming thick. Further, there is a cover ring installation part adjacent to the pull ring installation part in which the blade layer is continuous in the circumferential direction, and the cover ring installation part is provided by covering the cover ring. Therefore, the wire that may protrude from the cut surface of the blade layer formed by the wire can be prevented from being exposed to the catheter surface by blocking the outer peripheral side by the pull ring and the cover ring.

  Further, for example, the pull ring and the cover ring may be separate, and may be arranged side by side so as to contact each other along the extending direction of the catheter tube.

  By making the pull ring and the cover ring separate, the shape of each ring becomes simple, and thus such a pull ring and cover ring are easy to manufacture. Further, by arranging the pull ring and the cover ring so as to be in contact with each other, it is possible to reliably prevent the wire constituting the blade layer from moving toward the catheter surface.

For example, the pull ring and the cover ring may be integrated.
If the pull ring and the cover ring are integrated, it is possible to reliably prevent the wire constituting the blade layer from moving toward the catheter surface, and such a tip deflection movable catheter can be easily attached to the catheter tube.

For example, the thickness of the cover ring may be smaller than the thickness of the pull ring.
By making the thickness of the cover ring thinner than the pull ring, a space for the tip to cover the cover ring can be secured.

For example, the inner diameter of the cover ring may be larger than the inner diameter of the pull ring and smaller than the outer diameter of the pull ring.
Since the inner diameter of the cover ring is larger than the pull ring, the blade layer can be covered from the outer peripheral side without deforming the main lumen. Further, since the inner diameter of the cover ring is smaller than the outer diameter of the pull ring, a gap is not formed between the cover ring and the pull ring, and it is possible to reliably prevent the wire constituting the blade layer from moving toward the catheter surface.

Further, for example, the outer diameter of the cover ring installation portion may be larger than the outer diameter of the pull ring installation portion and smaller than the outer diameter of the outer surface of the catheter tube closer to the proximal end than the cover ring installation portion.
By making the outer diameter of the cover ring installation part larger than the outer diameter of the pull ring installation part, it becomes easy to have a structure in which the blade layer is present in the cover installation part. Can be more reliably prevented from going to. Moreover, it can prevent that a bulge arises in the distal end of a catheter by making the outer peripheral diameter of a cover ring installation part smaller than the outer peripheral diameter of a catheter tube outer surface.

A method of manufacturing a tip deflection movable catheter according to the present invention is a method of manufacturing a tip deflection movable catheter in which a distal end is inserted into a body and a proximal end is disposed outside the body,
A step of preparing a tube body in which a main lumen and a wire lumen are formed, and a blade layer surrounding the main lumen and the wire lumen from an outer peripheral side is embedded;
A pull ring installation portion provided at one end portion of the tube base body with a blade breakage portion where the blade layer is interrupted at least in a circumferential direction, and the other end side of the tube base body with respect to the pull ring installation portion Forming a covering installation part that is adjacent to the blade layer and the blade layer is continuous in the circumferential direction;
Passing an operation wire having one end connected to the pull ring through the wire lumen;
Installing a cover ring over the cover ring installation part, and installing the pull ring over the pull ring installation part; and
Covering the pull ring installation part, the cover ring installation part, the pull ring and the cover ring with a tip, and connecting the pull ring and the cover ring to the one end of the tube body;
Providing an operation part to which the other end of the operation wire is connected to the other end of the tube body;
Have

  According to such a manufacturing method, it is possible to manufacture a tip deflection movable catheter that can prevent the distal end of the catheter from becoming thick and can prevent the problem that the wire constituting the blade layer is exposed to the surface.

FIG. 1 is a plan view showing an external configuration of a tip deflection movable catheter according to an embodiment of the present invention. 2 is a cross-sectional view taken along line II-II shown in FIG. FIG. 3 is a sectional view taken along line III-III shown in FIG. 4 is a cross-sectional view taken along line IV-IV shown in FIG. FIG. 5 is a cross-sectional view taken along the line V-V shown in FIGS. 3 and 4. FIG. 6 is a partial cross-sectional view showing an installation portion forming step in the manufacturing process of the distal deflection movable catheter according to one embodiment of the present invention. FIG. 7 is a partial cross-sectional view showing the wire insertion and ring installation steps in the manufacturing process of the distal deflection movable catheter according to one embodiment of the present invention.

Hereinafter, the present invention will be described based on embodiments shown in the drawings.
The catheter sheath 1 as the tip deflection movable catheter of the present embodiment includes, for example, a sheath for guiding an electrode catheter for detecting an electrocardiogram, an ablation catheter for cauterizing an affected part, and the like when performing catheter ablation. Used for other purposes. Other applications include a catheter sheath that guides a catheter for introducing a stent into the bile duct.

  As shown in FIG. 1, the catheter sheath 1 of the present embodiment includes a sheath body 2 constituted by a catheter tube 20 and the like, and an operation section 3 and a grip section 4 provided at the proximal end of the sheath body 2. The vicinity of the distal end of the sheath body 2 is a deflecting portion 2a that can be arbitrarily deflected in directions opposite to each other by 180 degrees, as indicated by arrows α and β.

  As shown in FIG. 2, which is a cross-sectional view of the central portion of the sheath body 2, the sheath body 2 has a hollow tube 20 in which a main lumen 21 and wire lumens 28a and 29a are formed except for a distal end where the deflecting portion 2a is provided. (Catheter tube) and a first wire 30 and a second wire 31 as operation wires passing through the wire lumens 28a and 29a. When using the catheter sheath 1, the tube distal end 20a, which is the distal end of the hollow tube 20, is inserted into the body, and the tube proximal end 20b, which is the proximal end, is disposed outside the body. The hollow tube 20 of the present embodiment is configured by a multilayer tube having an inner tube 22 and an outer tube 24.

  A main lumen 21 is formed along the axial direction of the sheath body 2 in the inner tube 22 disposed along the central axis of the sheath body 2. A blade layer 26 and two wire lumen tubes 28 and 29 are embedded in the outer tube 24 surrounding the outer periphery of the inner tube 22.

  The pair of wire lumen tubes 28 and 29 are embedded at a position symmetrical about 180 degrees with respect to the central axis of the sheath body 2. Wire lumens 28a and 29a are formed along the axial direction in the wire lumen tubes 28 and 29, and the first wire 30 and the second wire 31 are inserted into the respective wire lumens so as to be movable in the axial direction. It is.

  As shown in FIG. 2, the blade layer 26 is embedded in the outer tube 24 so as to have an elliptical cross section, and the first wire 30 and the first wire 30 are arranged in the major axis direction of the elliptical blade layer 26. Two wires 31 are arranged. In the minor axis direction of the elliptical blade layer 26, the blade layer 26 is embedded in the outer tube 24 near the inner tube 22, and in the major axis direction of the elliptical blade layer 26, the blade layer 26 is embedded. Is embedded in the outer tube 24 close to the outer periphery.

  The blade layer 26 is configured by braiding a wire (reinforcing wire). The blade layer 26 is disposed so as to surround the main lumen 21 and the wire lumens 28 a and 29 a from the outer peripheral side, and imparts kink resistance to the sheath body 2. Examples of the reinforcing wire constituting the blade layer 26 include, but are not limited to, a fine metal wire such as stainless steel.

  The main lumen 21 formed in the inner peripheral surface of the inner tube 22 along the axial direction has an electrode catheter, an ablation catheter, a stent delivery catheter, a catheter for other uses, a guide wire, and other medical devices as a shaft. It can be inserted freely in the direction. The inner peripheral surface of the main lumen 21 preferably has good sliding characteristics, and the inner tube 22 is made of, for example, polytetrafluoroethylene (PTFE), tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer (PFA), tetrafluoroethylene / It is made of a fluororesin such as hexafluoropropylene copolymer (FEP), tetrafluoroethylene / ethylene copolymer (ETFE), and polyvinylidene fluoride (PVDF).

  The outer tube 24 is preferably formed of a resin. For example, a polyamide-based elastomer such as a polyether block amide copolymer, polyamide, polyimide, polyamideimide, polyethylene terephthalate, polyethylene, polypropylene, polyurethane, ethylene / vinyl acetate copolymer It is composed of coalesced or polyvinyl chloride. The wire lumen tubes 28 and 29 are preferably formed of a resin having good sliding characteristics. For example, polytetrafluoroethylene (PTFE), tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer (PFA), tetrafluoro It is made of a fluororesin such as ethylene / hexafluoropropylene copolymer (FEP), tetrafluoroethylene / ethylene copolymer (ETFE), or polyvinylidene fluoride (PVDF). The first wire 30 and the second wire 31 are made of a metal such as stainless steel, for example, and may be a stranded wire or a single wire.

  The deflection directions α and β of the deflection unit 2a shown in FIG. 1 correspond to the 180-degree symmetrical mounting positions of the wire lumen tubes 28 and 29 described above. In the deflection part 2a, it is preferable that the hardness is set lower (softer) than the remaining part, and further, in the deflection part, the hardness is set to be gradually or stepwise reduced toward the tip. May be.

  As shown in FIG. 5, the distal end of the sheath body 2 is constituted by a pull ring 32, a cover ring 33, a distal end covering resin 34 as a tip, etc. in addition to the hollow tube 20 and the wires 30, 31. . At the tube distal end 20a of the hollow tube 20, the pull ring installation portion 20aa where the pull ring 32 is installed and the cover ring installation portion 20ab where the cover ring 33 is installed remove part of the outer tube 24, etc. Is formed.

  As shown in FIG. 4, the outer peripheral surface of the pull ring installation portion 20aa, which is a part of the tube distal end 20a, is processed into a cylindrical outer peripheral surface shape in accordance with the inner peripheral surface shape of the pull ring 32, and has an annular shape. The pull ring 32 is provided so as to cover the pull ring installation portion 20aa. The pull ring installation portion 20aa includes a blade break portion 25 where the blade layer 26 is interrupted in at least a part of the circumferential direction. The blade breaking portion 25 is formed in the major axis direction of the blade layer 26 whose cross section shown in FIG. 4 is elliptical, and a part of the blade layer 26 remains inside the pull ring 32 in the minor axis direction of the blade layer 26. May be.

  Further, in the blade disconnection portion 25 of the pull ring installation portion 20aa, part of the wire lumen tubes 28 and 29 disposed inside the blade layer 26 is also removed, and the wire lumens 28a and 29a are opened inside the pull ring 32. doing. The distal ends 30 a and 31 a of the first wire 30 and the second wire 31 are connected and fixed to the inner peripheral surface of the pull ring 32 at a position where the wire lumens 28 a and 29 a in the blade disconnection portion 25 are open. As shown in FIGS. 4 and 5, the distal ends 30 a and 31 a of the first wire 30 and the second wire 31 are fixed at 180 ° symmetrical positions with respect to the central axis of the sheath body 2 on the inner peripheral surface of the pull ring 32. Has been.

  As shown in FIG. 5, the cover ring installation part 20ab, which is another part of the tube distal end 20a, is provided on the proximal end side adjacent to the pull ring installation part 20aa. As shown in FIG. 3, the cover ring installation portion 20ab is processed into a cylindrical outer peripheral surface shape in accordance with the inner peripheral surface shape of the cover ring 33, and the annular cover ring 33 is formed on the cover ring installation portion 20ab. It is provided. In the cover ring installation portion 20ab, unlike the pull ring installation portion 20aa, the blade layer 26 is continuous in the circumferential direction, and a portion where the blade layer 26 is interrupted in a part of the circumferential direction, such as the blade breakage portion 25, is formed. Absent. In the covering installation portion 20ab, the wire lumen tubes 28 and 29 arranged inside the blade layer 26 are continuous in the circumferential direction, and the wire lumens 28a and 29a are closed in the circumferential direction.

  As shown in FIG. 5, it is preferable that the pull ring 32 and the cover ring 33 are arranged side by side so as to contact each other along the extending direction of the hollow tube 20. The cover ring 33 may be thinner than the pull ring 32 so that a part of the blade layer 26 in the longitudinal direction is accommodated therein and the distal end of the sheath body 2 is not thickened. preferable. The minimum inner diameter of the cover ring 33 is preferably larger than the minimum inner diameter of the pull ring 32 and smaller than the maximum outer diameter of the pull ring 32.

  Moreover, about the covering installation part 20ab and the pull ring installation part 20aa formed by removing a part of the outer tube 24, the outer periphery of the covering installation part 20ab is the same as the inner peripheral diameter of the installed rings 32 and 33. The diameter is preferably larger than the outer peripheral diameter of the pull ring installation portion 20aa. Moreover, it is preferable that the outer periphery diameter of the covering installation part 20ab is smaller than the outer periphery diameter of the outer surface 20c of the hollow tube 20 adjacent to the proximal end side with respect to the covering installation part 20ab.

  The pull ring 32 is made of a metal such as stainless steel, for example, and a contrast ring may be attached to the distal end thereof. The contrast ring is made of a metal that can be easily detected by X-rays, for example, gold, platinum, iridium, tungsten, or the like. Note that the entire pull ring 32 may be made of metal that can be easily detected by X-rays or the like.

  Although the cover ring 33 is comprised, for example with metals, such as stainless steel, a material is not specifically limited.

  As shown in FIG. 5, the distal end of the sheath body 2 is provided with a distal end coating resin 34 as a tip. The distal end coating resin 34 covers the pull ring 32, the cover ring 33, the pull ring installation portion 20aa and the cover ring installation portion 20ab where the rings 32 and 33 are installed, and the rings 32 and 33 and the tube distal end The end 20a is connected. That is, the pull ring 32, the cover ring 33, the pull ring installation part 20aa, and the cover ring installation part 20ab are integrated by the distal end coating resin 34. The distal end coating resin 34 may partially enter the distal end lumen of the wire lumen tubes 28, 29, but does not prevent the wires 30, 31 from moving in the wire lumen in the axial direction. It has become.

  The distal end coating resin 34 is formed by a method of fusing resin pieces, for example, a polyamide-based elastomer such as a polyether block amide copolymer, polyamide, polyimide, polyamideimide, polyethylene terephthalate, polyethylene, polypropylene, polyurethane, It is made of resin such as ethylene / vinyl acetate copolymer and polyvinyl chloride.

  Proximal ends of the first wire 30 and the second wire 31 are connected to the operation section 3 provided at the sheath body 2 and the proximal end of the hollow tube 20 (tube proximal end 20b) shown in FIG. The operation unit 3 is provided on the tip (distal end) side of the grip unit 4. The operation unit 3 is provided with, for example, a rotary dial. By operating the rotary dial in the first rotation direction, the first wire 30 shown in FIGS. 2 to 5 is pulled, and the deflection unit 2a at the tip is shown in FIG. It is deflected as shown by arrow α. Further, by operating the rotary dial in the second rotation direction opposite to the first rotation direction, the second wire 31 shown in FIGS. 2 to 5 is pulled, and the tip deflection unit 2a is moved to the arrow β in FIG. Deflection as shown.

  Next, although the manufacturing method of the catheter sheath 1 which concerns on this embodiment is demonstrated, the manufacturing method of parts other than the distal end of the sheath main body 2, for example, the operation part 3 itself and the grip part 4 itself, and these and other parts are demonstrated. Since the joining method is a known method, detailed description thereof will be omitted, and portions different from the conventional manufacturing method will be described in detail.

  In the present embodiment, the method for manufacturing the catheter sheath 1 shown in FIG. 1 is particularly characterized in the method for manufacturing the distal end of the sheath body 2 shown in FIG.

  In the manufacturing method of the distal end of the sheath body 2, first, a tube body 40 that becomes the hollow tube 20 after processing and assembly is prepared. The tube body 40 has the same cross-sectional shape as the central portion of the sheath body 2 shown in FIG. 3 from one end to the other end. That is, the main lumen 21 and the wire lumens 28a and 29a are formed in the tube body 40, and the blade layer 26 surrounding the main lumen 21 and the wire lumens 28a and 29a from the outer peripheral side is embedded (FIG. 3). reference).

  Next, as shown in FIGS. 6A and 6B, a pull ring installation portion 20 aa and a cover ring installation portion 20 ab are formed at one end 40 a of the tube body 40. 6 (a) and 6 (b) are cross-sectional views showing the steps of forming the installation portions 20aa and 20ab, and FIG. 6 (a) shows a vertical cross section along the major axis direction of the blade layer 26. (B) shows a longitudinal section along the minor axis direction of the blade layer 26.

  The pull ring installation part 20aa is formed by removing a part of the outer tube 24 at one end part 40a, a part of the blade layer 26, and a part of the wire lumens 28a and 29a by cutting or polishing. The As shown in FIG. 6A, by removing a part of the blade layer 26 in the major axis direction, a blade breakage portion 25 in which a part of the blade layer 26 is interrupted at least in a circumferential direction is formed. (See FIG. 4 for the state after assembly). In the blade breakage portion 25, part of the wire lumens 28a and 29a inside the blade layer 26 is also removed. As shown in FIG. 6B, the minor axis direction portion of the blade layer 26 is left without being removed.

  The cover ring installation part 20ab is formed adjacent to the proximal end side of the tube body 40 with respect to the pull ring installation part 20aa. The cover ring installation portion 20ab is formed by removing a part of the outer tube 24 at one end portion 40a by cutting or polishing. In the cover ring installation part 20ab, the blade layer 26 is left in a state of being continuous in the circumferential direction. The blade layer 26 of the cover ring installation part 20ab is preferably left entirely from the state before processing, but for example, it does not prevent part of the blade layer 26 adjacent to the pull ring installation part 20aa from being removed.

  Next, the pull ring 32 and the cover ring 33 are installed in the pull ring installation part 20aa and the cover ring installation part 20ab formed in the tube body 40. As the pull ring 32 is installed, the first and second wires 30 and 31 are passed through the wire lumens 28a and 29a. 7A and 7B are cross-sectional views showing the wire insertion and ring installation steps, and FIG. 7A shows a vertical cross-section along the major axis direction of the blade layer 26, and FIG. ) Shows a longitudinal section along the minor axis direction of the blade layer 26.

  As shown in FIGS. 7A and 7B, in the wire insertion and ring installation process, first, the cover ring 33 is installed over the cover installation part 20ab. The cover ring 33 is installed in the cover ring installation part 20ab by passing one end 40a of the tube base body 40 through the cover ring 33.

  Further, the pull ring 32 in which the distal ends 30a and 31a of the first and second wires 30 and 31 are fixed to the inner peripheral surface in advance is placed on the pull ring installation portion 20aa. When installing the pull ring 32, first, the proximal ends of the wires 30, 31 are inserted from the distal end side of the wire lumens 28a, 29a, and the wires 30, 31 are connected to the wire lumen 28a while the pull ring 32 is brought close to the pull ring installation portion 20aa. , 29a (the state shown in FIGS. 7A and 7B). Therefore, when the pull ring 32 is installed in the pull ring installation part 20aa, the arrangement of the wires 30, 31 on the wire lumens 28a, 29a is also completed. The fixing of the distal ends 30a and 31a of the wires 30 and 31 to the pull ring 32 can be performed using a brazing material such as a silver brazing material, but is not particularly limited.

  Next, the distal end coating resin 34 shown in FIG. 5 is formed, and the pull ring installation portion 20aa, the cover ring installation portion 20ab, the pull ring 32, and the cover ring 33 are covered with the distal end coating resin 34. The pull ring 32 and the cover ring 33 are connected to one end 40a. The distal end covering resin 34 is formed by attaching a resin piece that becomes the distal end covering resin 34 after fusion to one end portion 40a of the tube base body 40 on which the pull ring 32 and the cover ring 33 are installed. The heat shrinkable tube placed on the resin piece is heated to fuse the resin piece to the pull ring 32, the cover ring 33 and the tube base body 40.

  Next, the operation unit 3 and the operation unit 3 to which the proximal ends of the first and second wires 30 and 31 are connected to the other end of the tube body 40 (corresponding to the proximal end 20b in FIG. 1). A grip portion 4 to be connected is provided to obtain the catheter sheath 1 shown in FIG.

  In the catheter sheath 1 as described above, the cover ring 33 provided in the covering installation portion 20ab where the blade layer 26 is continuous in the circumferential direction is arranged next to the pull ring 32. Even if the part is cut off and the pull ring 32 is provided, the problem that the reinforcing wire constituting the blade layer 26 protrudes from the cut surface of the blade layer 26 and is exposed to the outer peripheral surface of the sheath body 2 can be prevented. Moreover, since the catheter sheath 1 forms the blade disconnection part 25 and installs the pull ring 32, the distal end of the sheath body 2 can be made thin, and the catheter sheath 1 with excellent operability can be realized. Further, since the reinforcing wire can be prevented from being exposed by the cover ring 33, the thickness of the distal end coating resin 34 at the outer peripheral portions of the cover ring 33 and the pull ring 32 can be reduced. Has the advantage of thinning the distal end of the.

  The present invention is not limited to the above-described embodiment, and can be variously modified within the scope of the present invention.

  For example, in the above-described embodiment, the hollow tube 20 in which one main lumen 21 and two wire lumens 28a and 29a are formed is employed as the catheter tube, but the number of lumens formed in the catheter tube is particularly limited. Not. In the above-described embodiment, the wire lumen is formed by the wire lumen tubes 28 and 29. However, the present invention is not limited to this, and the wire lumen is attached to the outer tube 24 itself without providing the wire lumen tubes 28 and 29. It may be formed. In the above-described embodiment, the hollow tube 20 is configured by a multilayer tube, but may be configured by a single-layer tube.

  In the embodiment, the pull ring 32 and the cover ring 33 are separate bodies, but the pull ring 32 and the cover ring 33 may be formed integrally. When the pull ring 32 and the cover ring 33 are integrated, the attachment of the ring is only required once, so that such a catheter sheath is easy to assemble.

1 ... Catheter sheath (tip deflection movable catheter)
2 ... Sheath body 2a ... Deflection part 3 ... Operation part 20 ... Hollow tube (catheter tube)
DESCRIPTION OF SYMBOLS 21 ... Main lumen 20a ... Tube distal end 20aa ... Pull ring installation part 20ab ... Covering installation part 20c ... Outer surface 25 ... Blade disconnection part 26 ... Blade layer 28a, 29a ... Wire lumen 30, 31 ... Wire 32 ... Pull ring 33 ... Cover ring 34 ... Distal end coating resin (tip tip)
40 ... Tube element

Claims (7)

A main lumen and a wire lumen are formed, a blade layer surrounding the main lumen and the wire lumen from the outer peripheral side is embedded, and the distal end of the tube, which is the distal end, is inserted into the body, and the proximal end A catheter tube whose proximal end is located outside the body;
A pull ring provided to cover a pull ring installation portion which is a part of the distal end of the tube and includes a blade breaking portion where the blade layer is interrupted at least in a circumferential direction;
An operation wire that is passed through the wire lumen and connected at one end to the pull ring at the blade break;
A cover ring provided on the cover ring installation part which is another part of the tube distal end adjacent to the proximal end side of the pull ring installation part and the blade layer is continuous in the circumferential direction;
A tip tip for covering the pull ring installation portion, the cover ring installation portion, the pull ring and the cover ring, and connecting the pull ring and the cover ring to the distal end of the tube;
An operation portion provided at the proximal end of the tube and connected to the other end of the operation wire;
Have
The tip deflection movable catheter, wherein the pull ring and the cover ring are separate bodies and are arranged side by side so as to contact each other along the extending direction of the catheter tube. A main lumen and a wire lumen are formed, a blade layer surrounding the main lumen and the wire lumen from the outer peripheral side is embedded, and the distal end of the tube, which is the distal end, is inserted into the body, and the proximal end A catheter tube whose proximal end is located outside the body;
A pull ring provided to cover a pull ring installation portion which is a part of the distal end of the tube and includes a blade breaking portion where the blade layer is interrupted at least in a circumferential direction;
An operation wire that is passed through the wire lumen and connected at one end to the pull ring at the blade break;
A cover ring provided on the cover ring installation part which is another part of the tube distal end adjacent to the proximal end side of the pull ring installation part and the blade layer is continuous in the circumferential direction;
A tip tip for covering the pull ring installation portion, the cover ring installation portion, the pull ring and the cover ring, and connecting the pull ring and the cover ring to the distal end of the tube;
An operation portion provided at the proximal end of the tube and connected to the other end of the operation wire;
Have
The pulling movable catheter according to claim 1, wherein the pull ring and the cover ring are integrated.   The tip deflection movable catheter according to claim 1 or 2, wherein a thickness of the cover ring is thinner than a thickness of the pull ring.   The distal deflection movable catheter according to any one of claims 1 to 3, wherein an inner diameter of the cover ring is larger than an inner diameter of the pull ring and smaller than an outer diameter of the pull ring.   The outer diameter of the cover ring installation part is larger than the outer diameter of the pull ring installation part and smaller than the outer diameter of the outer surface of the catheter tube on the proximal end side from the cover ring installation part. Item 5. The distal deflection movable catheter according to Item 4. A method of manufacturing a tip deflection movable catheter in which a distal end is inserted into a body and a proximal end is disposed outside the body,
A step of preparing a tube body in which a main lumen and a wire lumen are formed, and a blade layer surrounding the main lumen and the wire lumen from an outer peripheral side is embedded;
A pull ring installation portion provided at one end portion of the tube base body with a blade breakage portion where the blade layer is interrupted at least in a circumferential direction, and the other end side of the tube base body with respect to the pull ring installation portion Forming a covering installation part that is adjacent to the blade layer and the blade layer is continuous in the circumferential direction;
Passing an operation wire having one end connected to the pull ring through the wire lumen;
Installing the cover ring installation portion with a cover ring separate from the pull ring and installing the pull ring installation portion with the pull ring; and
Covering the pull ring installation part, the cover ring installation part, the pull ring and the cover ring with a tip, and connecting the pull ring and the cover ring to the one end of the tube body;
Providing an operation part to which the other end of the operation wire is connected to the other end of the tube body;
The pull ring and the cover ring are installed, and the pull ring and the cover ring are arranged side by side so as to contact each other along the extending direction of the tube body. Method. A method of manufacturing a tip deflection movable catheter in which a distal end is inserted into a body and a proximal end is disposed outside the body,
A step of preparing a tube body in which a main lumen and a wire lumen are formed, and a blade layer surrounding the main lumen and the wire lumen from an outer peripheral side is embedded;
A pull ring installation portion provided at one end portion of the tube base body with a blade breakage portion where the blade layer is interrupted at least in a circumferential direction, and the other end side of the tube base body with respect to the pull ring installation portion Forming a covering installation part that is adjacent to the blade layer and the blade layer is continuous in the circumferential direction;
Passing an operation wire having one end connected to the pull ring through the wire lumen;
Installing the cover ring installation part over the cover ring that is integral with the pull ring, and installing the pull ring installation part over the pull ring; and
Covering the pull ring installation part, the cover ring installation part, the pull ring and the cover ring with a tip, and connecting the pull ring and the cover ring to the one end of the tube body;
Providing an operation part to which the other end of the operation wire is connected to the other end of the tube body;
A method of manufacturing a tip deflection movable catheter having

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