JP6269326B2 - Medical equipment - Google Patents

Description

  The present invention relates to a medical device such as a catheter.

  In recent years, long medical devices such as catheters and puncture needles for endoscopes used by inserting into body cavities such as blood vessels and forceps holes of endoscopes have been developed. These medical devices are common in that they are flexible and have a long sheath and a hub on the hand side. The sheath has one or more lumens (lumens) extending from the distal end to the proximal end, and various articles such as a medical solution, a contrast medium, a guide wire, a puncture needle, and other medical devices are supplied into the lumen. Is done. As the sheath, a single tube or a double tube is used depending on the type of medical device.

  The hub is generally made of a material that is thicker and harder than the sheath so that the user can easily handle the hub. The hub is hollow and communicates with the lumen of the sheath, and a connector for attaching a syringe is generally provided at the proximal end of the hub.

  With respect to this type of medical device, Patent Document 1 discloses a medical device (catheter) including a long sheath (catheter body) formed of a double tube and a hub provided at the proximal end of the sheath. ) Is described. The proximal end portion of the sheath is inserted and fixed inside the hub, and the vicinity of the fixed portion is held by a kink protector (protector). The protector is a cylindrical protective member that prevents the inner end of the sheath from being bent (kink) by bending the base end of the sheath, and is provided at the distal end of the hub. The protector is also called a connector cover or a strain relief, and has sufficient bending rigidity and hardness.

  The sheath is made mainly of a resin material such as polyurethane resin or polyamide resin. In order to improve visibility when placed on an instrument table or an operating table, the sheath is generally opaque and colored in various colors. On the other hand, Patent Document 2 and Patent Document 3 describe that a sheath is transparent so that a chemical solution passing through the inside can be visually confirmed from the outside.

JP 2012-223346 A JP 2003-190275 A JP 2006-110224 A

  When inserting this type of medical device into the body cavity, place a guiding catheter (parent catheter) or endoscope on the subject, and insert the medical device from the connector or the hand control unit at the proximal end of these. It is common to do. When the medical device is inserted deeply into the body cavity, the hub of the medical device may reach the vicinity of the connector of the guiding catheter or the proximal operation portion of the endoscope (hereinafter sometimes referred to as a body cavity introduction port).

  Here, in some conventional medical devices, the hub is made of a transparent resin material so that the tip of a syringe filled with a chemical solution can be visually confirmed to be normally attached to the hub. On the other hand, the protector includes an opaque resin material, and ensures the visibility of the medical device in a state of being placed on an instrument table or an operating table.

  In such a medical device, it can be visually confirmed that the drug solution is normally supplied from the syringe to the sheath and flowing toward the distal end, or the blood of the subject flows from the distal end opening of the sheath and the base of the sheath. It is required to quickly and visually discover that the fluid is flowing toward the end side (reverse blood). However, even if the sheath is transparent as in Patent Document 2 and Patent Document 3, if the sheath is inserted deeply into the body cavity until the hub or protector approaches the body cavity introduction port, the inside of the lumen is passed through the wall surface of the sheath. It becomes impossible to see. For this reason, when the sheath is inserted deeply into the body cavity and the tip reaches the vicinity of the target living tissue, when the drug solution is discharged or various manipulations are performed, the flow of the drug solution and the occurrence of reverse blood are visually observed. There is a problem that it cannot be confirmed.

  The present invention has been made in view of the above-described problems, and provides a medical device capable of visually confirming the internal state of the lumen of the sheath even when the sheath is inserted sufficiently deep into the body cavity. is there.

  According to the present invention, an elongated tubular sheath having a lumen, a hollow hub provided in communication with the lumen on the proximal end side of the sheath, and the sheath provided at a distal end portion of the hub A protector that holds the outer periphery of the base end of the protector, and the holding region held by the protector of the protector and the base end of the sheath both has visible light permeability and the lumen. A medical device characterized in that the internal state of the device can be visually recognized is provided.

  According to the medical device of the present invention, it is possible to visually check the internal state of the lumen of the sheath through the protector even when the sheath is inserted sufficiently deep into the body cavity. Thereby, even in the state where the distal end of the sheath has reached the vicinity of the target biological tissue, it is possible to quickly know the poor injection of the chemical solution and the occurrence of reverse blood.

It is a side view which shows the catheter concerning embodiment of this invention. It is a longitudinal cross-sectional view which shows the internal structure of the front-end | tip part of a sheath. It is an enlarged view which shows typically the base end part (extension area | region) of a sheath. It is an enlarged view which shows typically the front-end | tip part of a sheath.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. In each drawing, corresponding constituent elements are denoted by common reference numerals, and redundant description is omitted as appropriate.

  FIG. 1 is a side view showing a catheter 100 which is an example of a medical device according to an embodiment of the present invention, and a partial length region of the proximal end portion 14 of the sheath 10 is omitted. FIG. 2 is a longitudinal sectional view showing the internal structure of the distal end portion 12 of the sheath 10, and a part of the proximal end side of the distal end portion 12 is not shown. FIG. 3 is an enlarged view schematically showing the extension region 15 in the proximal end portion 14 of the sheath 10, and FIG. 4 is an enlarged view schematically showing the distal end portion 12.

  First, the outline | summary of the medical device of this embodiment is demonstrated.

A medical device (catheter) 100 according to this embodiment includes a long tubular tubular sheath 10 having a lumen 20, a hollow hub 50, and a protector 60.
The hub 50 is provided on the proximal end side of the sheath 10 so as to communicate with the lumen 20 of the sheath 10. The protector 60 is provided at the distal end portion of the hub 50 and holds the outer periphery of the proximal end portion 14 of the sheath 10.
In the medical device (catheter) 100 of the present embodiment, the holding region 16 held by the protector 60 among the protector 60 and the base end portion 14 of the sheath 10 has visible light transmittance, and the lumen. The internal state of 20 can be visually recognized (see FIG. 3).

  Here, the internal state of the lumen 20 being visible means that when a colored passing material 200 such as blood is passed through the lumen 20, the passage of the passing material 200 is visually observed in a normal procedure environment. That can be recognized.

  Next, the medical device of this embodiment will be described in detail.

  The medical device of this embodiment is a catheter 100, for example. More specifically, the non-active catheter does not have an operation mechanism for bending the distal end 11 of the sheath 10. In addition to intravascular catheters and gastrointestinal catheters, various catheters that are inserted into various body cavities such as the abdominal cavity, thoracic cavity, or ureter can be used. Among these, the catheter 100 of the present embodiment is particularly preferably used for an intravascular catheter from the viewpoint that the blood flowing back from the target living tissue to the lumen 20 of the catheter 100 (reverse blood) can be visually confirmed.

  In addition, the present invention can be applied to various types of long medical devices used by being inserted into forceps holes of an endoscope. An example of such a medical device is an endoscope puncture needle (local injection needle). The puncture needle for endoscope is slidably inserted into an outer tube having a diameter larger than that of the inner tube, and a syringe is inserted at the proximal end of the inner tube. A device that is attached and discharges a liquid such as a drug solution from a puncture needle to a target biological tissue.

  The sheath 10 is a long and hollow resin tube and includes one or a plurality of lumens 20 therein. The sheath 10 has a length of about several tens of centimeters to several meters. In the present embodiment, the sheath 10 will be described roughly as a distal end portion 12 and a proximal end portion 14. The distal end portion 12 is a length region of about several centimeters to 1 meter, and the proximal end portion 14 is a remaining length region of the sheath 10.

  The hub 50 is a grip portion that is provided on the proximal end side of the sheath 10 and is gripped by a user such as a doctor with fingers. A connecting portion 52 is provided at the proximal end of the hub 50. The inside of the connecting portion 52 is open to communicate with the lumen 20. A spiral groove is formed on the outer periphery of the connecting portion 52, and a luer connector of a syringe (not shown) is screwed and attached. Thereby, a drug such as a drug solution or an embolic bead filled in the syringe can be supplied to the sheath 10, or a body fluid or an obstruction can be sucked from the body cavity through the sheath 10. In addition, an instrument such as a guide wire or a stent may be inserted into the opening of the connecting portion 52.

  A plurality of wings 54 are formed around the hub 50. By rotating the wing 54 around the axis of the hub 50, a torque for axially rotating the sheath 10 can be applied. Thereby, the sheath 10 inserted into the body cavity can be oriented in a desired direction.

  The hub 50 is made of a resin material. Examples of the resin material include polyamide resin (nylon) and polyolefin. The hub 50 is visible light transmissive. Thereby, it can be visually confirmed that the insertion depth of the syringe tip is normal. Further, it can be visually confirmed that the medicine is normally discharged from the syringe to the hub 50.

  A connecting recess 56 is formed at the tip of the hub 50, and the proximal end of the sheath 10 is fitted and fixed to the connecting recess 56. The connection recess 56 corresponds to the boundary between the sheath 10 and the hub 50.

  The protector 60 is a hollow tubular member provided at the distal end portion of the hub 50. A part (holding region 16) of the base end portion 14 of the sheath 10 is inserted through the protector 60. As shown in FIG. 1, a part of the proximal end side of the coupling recess 56 of the hub 50 is exposed slightly proximally than the protector 60. Thereby, the boundary between the sheath 10 and the hub 50 can be clearly seen through the hub 50 without using the protector 60. However, the present invention is not limited to this, and the entire connecting recess 56 of the hub 50 may be covered with the protector 60. The protector 60 has a predetermined bending rigidity, and functions as a strain relief that relieves bending stress concentrated on the nearest portion of the sheath 10 near the hub 50 and prevents kinking of the sheath 10.

  In the catheter 100 of the present embodiment, the protector 60 and the holding region 16 of the sheath 10 are both visible light transmissive.

  The sheath 10 has visible light permeability means that the sheath 10 is transparent or translucent and allows visible light to pass from the outside of the sheath 10 to the lumen 20 to such an extent that the internal state of the lumen 20 can be visually recognized. Say. When the sheath 10 has a multilayer structure, the sheath 10 having visible light transmission means that visible light is transmitted through the entire multilayer structure as described above. When the medical device is an endoscope puncture needle (local injection needle), the sheath 10 has a double (multiple) tube structure in which the inner tube is slidably inserted into the outer tube. May be. In this case, the sheath 10 has a visible light transmission property in a combined state in which the outer tube and the inner tube are combined, and at least the visible light is transmitted from the outside of the sheath 10 to the lumen 20 of the inner tube to visually recognize the inside. That is possible.

  Further, the protector 60 has visible light transparency means that the protector 60 is transparent or translucent, and allows visible light to pass from the outside to the inside of the protector 60 to the extent that the internal state of the hollow tubular protector 60 is visible. That means. When the protector 60 has a multilayer structure, the protector 60 having visible light transmission means that visible light is transmitted through the multilayer structure as described above.

  Thereby, according to the catheter 100 of the present embodiment, the medicine circulating inside the sheath 10 and the reverse blood reaching the protector 60 from the distal end 11 through the lumen 20 of the sheath 10 can be visually confirmed from the outside. it can. For this reason, it can be visually confirmed that the medicine is normally flowing toward the distal end side of the sheath 10 without clogging the connecting recess 56 which is a boundary between the sheath 10 and the hub 50. Further, before the reverse blood reaches the intermediate portion or the base end portion of the hub 50 beyond the protector 60, it can be visually confirmed immediately when the reverse blood reaches the protector 60 at the latest.

  The visible light transmittance of the base end portion 14 of the sheath 10 is preferably 50% or more, more preferably 70% or more, and the visible light transmittance of the protector 60 is preferably 30% or more, more preferably 50% or more. Here, the visible light transmittance of each member means the transmittance of visible light from the outside of the member to the axial center (the lumen 20 in the case of the sheath 10). The catheter 100 of the present embodiment has a visible light transmittance of the proximal end portion 14 of the sheath 10 and the protector 60 in the above range, so that a colored passage 200 such as reverse blood passing through the lumen 20 can be seen from the outside. Visible.

  The protector 60 of the present embodiment is made of a resin material and is configured to be transparent or translucent. Specific resin materials include styrene resins such as olefin-styrene copolymers; polyolefins such as polyethylene, polypropylene and ethylene-vinyl acetate copolymers; polyesters such as polyethylene terephthalate; rubber materials such as silicone rubber; Examples thereof include vinyl chloride, polyurethane and polyamide. These resin materials can be used alone or in combination of two or more. In particular, the visible light transmittance of the protector 60 can be adjusted to the above range by using resin materials having different light transmittances mixed at a predetermined ratio. Moreover, the protector 60 may contain a pigment in the range which does not contain a pigment substantially or does not impair transparency or translucency.

  In the present embodiment, in the proximal end portion 14 of the sheath 10, the extension region 15 extending to the distal end side with respect to the protector 60 is also visible light transmissive. More specifically, the holding region 16 and the extension region 15 of the sheath 10 are translucent. And the front-end | tip part 12 located in the front end side rather than the extension area | region 15 among the sheaths 10 has visible light impermeability.

  Accordingly, when the passing region 200 such as reverse blood reaches the extension region 15 of the sheath 10 with the extension region 15 protruding from the parent catheter or endoscope, that is, the reverse blood reaches the protector 60. This can be immediately visually confirmed (see FIG. 3).

  As shown in FIGS. 2 to 4, the sheath 10 has a laminated structure, and is formed by laminating an inner layer 22 and an outer layer 26 in order from the axial center side. A reinforcing layer 24 is embedded in the outer layer 26. The reinforcing layer 24 is in contact with or close to the outer surface of the inner layer 22.

  The inner layer 22 is a cylindrical member having a lumen 20 therein. As shown in FIG. 2, the lumen 20 expands toward the proximal side at the distal end portion 12 of the sheath 10.

  Examples of the material of the inner layer 22 include a fluorine-based thermoplastic polymer material. Specific examples of the fluorine-based thermoplastic polymer material include polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), and perfluoroalkoxy fluororesin (PFA). These resin materials can be used alone or in combination of two or more.

  An example of the material for the outer layer 26 is a thermoplastic polymer. Examples of the thermoplastic polymer include polyurethane (PU) resin, polyimide (PI) resin, polyamideimide (PAI) resin, polyethylene terephthalate (PET) resin, polyethylene (PE) resin, and polyamide (PA) resin. , Nylon elastomer resin, ethylene-vinyl acetate resin (EVA), polyvinyl chloride (PVC) resin or polypropylene (PP) resin, or a combination thereof. The thermoplastic polymer includes a thermoplastic elastomer. These resin materials can be used alone or in combination of two or more.

  In this specification, the thermoplastic elastomer is a concept including a polymer alloy (polymer blend, block copolymerization, graft copolymerization, random copolymerization, etc.), a softening agent such as a plasticizer, and a mixture thereof. is there. The elastomer includes urethane elastomer, amide elastomer (nylon elastomer), styrene elastomer, olefin elastomer, and vinyl chloride elastomer. The urethane-based elastomer includes a thermoplastic polyurethane elastomer. The amide-based elastomer includes a thermoplastic polyamide elastomer or a thermoplastic polyether block amide copolymer.

  As shown in FIG. 4, a pigment 28 is dispersed in the outer layer 26 at the distal end portion 12 of the sheath 10. Thereby, the front-end | tip part 12 of the sheath 10 is visible light impermeability, and its visibility is high. That is, when the distal end portion 12 is visible light transmissive, the instrument table and the like can be seen through the distal end portion 12 in a state where the catheter 100 is placed on the instrument table and the like. Good visibility of the tip 12 is ensured by the tip 12 being impervious to visible light as in this embodiment. In particular, the visibility can be further enhanced by the color of the distal end portion 12 of the sheath 10.

  A marker 40 is provided in the vicinity of the distal end 11 of the sheath 10. The marker 40 has a ring shape and is embedded in the outer layer 26 in a state in which the marker 40 is caulked and fixed to the outer periphery of the distal end portion of the reinforcing layer 24. The marker 40 includes a material that does not transmit radiation such as X-rays, and is specifically made of a metal material such as platinum.

  The outer diameter of the sheath is the same across the extension region 15 and the distal end portion 12 of the sheath 10. In other words, the outer diameter of the sheath 10 is continuous at the boundary portion 13 between the visible light transmissive base end portion 14 and the visible light non-transmissive distal end portion 12. The outer end diameter of the distal end portion 12 of the sheath 10 is reduced toward the distal end 11 of the sheath 10.

The catheter 100 of this embodiment is an intravascular catheter used by being inserted into a blood vessel such as a celiac artery. The dimension of the catheter 100 of this embodiment is demonstrated.
The outer diameter of the distal end portion 12 of the sheath 10 can be, for example, 550 μm or more and 1000 μm or less. Moreover, the outer diameter of the base end part 14 of the sheath 10 can be 800 micrometers or more and 1100 micrometers or less. That is, the maximum outer diameter of the sheath 10 is about 1 mm in diameter, and preferably 1 mm or less.

  As shown in FIG. 1, the outer diameter (sheath outer diameter) of the distal end portion 12 of the sheath 10 of the present embodiment is reduced in multiple stages (three stages in the present embodiment). At each stage, the sheath 10 is continuously and smoothly reduced.

  The inner diameter of the lumen 20 of the sheath 10 can be 400 μm or more and 600 μm or less. The inner diameter of the lumen 20 increases toward the proximal side at the distal end portion 12 within the above-described inner diameter range.

  As shown in FIGS. 1 and 2, a hydrophilic coat layer 30 is provided on the outer surface of the sheath 10 from the distal end portion 12 to the extending region 15. The hydrophilic coat layer 30 terminates in the middle of the extension region 15 of the sheath 10. As a result, the pushability of the sheath 10 in the body cavity is ensured, and the handleability of the proximal end portion 14 of the sheath 10 is improved.

  The hydrophilic coat layer 30 includes a hydrophilic material such as polyvinyl alcohol (PVA) or polyvinyl pyrrolidone. These resin materials can be used alone or in combination of two or more. The hydrophilic coat layer 30 may be formed by hydrophilizing the surface of the outer layer 26, or may be formed by applying a hydrophilic resin material to the surface of the outer layer 26.

  As shown in FIG. 1, the hydrophilic coat layer 30 is formed slightly to the proximal end side of the visible light impermeable distal end portion 12 in the sheath 10, and is distal to the intermediate portion of the extension region 15. Terminate on the side. In other words, the hydrophilic coat layer 30 terminates at a position slightly beyond the boundary portion 13 between the distal end portion 12 and the proximal end portion 14 (extension region 15) toward the proximal end side. Even if a discontinuity occurs in the surface property of the outer layer 26 at the boundary portion 13 between the front end portion 12 where the pigment is mixed in the outer layer 26 and the base end portion 14 where the pigment is not substantially mixed, the hydrophilic coating layer Since 30 covers the boundary portion 13, discontinuity of the sliding resistance of the sheath 10 does not occur at the boundary portion 13.

  The reinforcing layer 24 is a protective layer for improving the kink resistance of the sheath 10 and the pressure resistance of the inner layer 22. The reinforcing layer 24 is a coil in which one or a plurality of wires 25 are spirally wound, or a mesh in which a plurality of wires 25 are braided.

  The material of the wire 25 constituting the reinforcing layer 24 is higher in rigidity than the inner layer 22 and the outer layer 26, and for example, a metal material can be used. Specifically, tungsten, stainless steel (SUS), nickel titanium alloy, steel, titanium, or copper alloy can be used. In addition, a resin material can be used for the wire 25. These resin materials can be used alone or in combination of two or more.

  More specifically, the reinforcing layer 24 of the present embodiment is a mesh formed by braiding the wires 25. The reinforcing layer 24 is provided at least inside the base end portion 14 of the sheath 10. The opening area ratio of the reinforcing layer 24 at the proximal end portion 14 of the sheath 10 exceeds 50%. The reinforcing layer 24 of the present embodiment is configured such that multiple (for example, eight) wires 25 are wound on the outer periphery of the inner layer 22 in a right spiral, and the multiple (for example, eight) wires 25 are wound on the outer periphery of the inner layer 22 in a left spiral Each wire 25 can be knitted together and wound.

  Thereby, even if the wire 25 is a metal material and is non-transparent to visible light, the entire sheath 10 can be made transparent to visible light.

  As shown in FIGS. 3 and 4, the mesh openings 42 of the reinforcing layer 24 are gap portions of the wires 25 that intersect each other. The opening area ratio of the reinforcing layer 24 is a ratio of a gap portion (mesh opening 42) where the wire 25 does not exist in the peripheral area of the cylindrical reinforcing layer 24. The opening area ratio may be calculated theoretically based on the wire diameter and pitch of the wire 25, or may be obtained by calculating the area based on the image of the sheath 10 (reinforcing layer 24). The pitch of the wires 25 is an axial distance between the wires 25 wound in the same direction and adjacent to each other.

  The reinforcing layer 24 of the present embodiment is provided from the distal end portion 12 to the proximal end portion 14 of the sheath 10. The opening area ratio (base end opening ratio) of the reinforcing layer 24 (see FIG. 3) in the proximal end portion 14 of the sheath 10 is the opening area ratio (tip opening) of the reinforcing layer 24 (see FIG. 4) in the distal end portion 12 of the sheath 10. Ratio).

  By increasing the proximal end opening ratio, the reinforcing layer 24 does not impair the visibility inside the lumen 20 in the extension region 15 and the holding region 16 of the proximal end portion 14 of the sheath 10. The proximal end opening ratio is preferably 70% or more and 90% or less. Thereby, while being able to make visible light permeability high in the base end part 14 of the sheath 10, the kink resistance of the base end part 14 of the sheath 10 can be ensured.

  In the catheter 100 of this embodiment, the reinforcing layer 24 is continuously formed from the distal end portion 12 to the proximal end portion 14 by the same number of wires 25. However, the pitch of the wires 25 at the distal end portion 12 of the sheath 10 is smaller than the pitch of the wires 25 at the proximal end portion 14. In the intermediate region including the boundary portion 13, the pitch of the wires 25 gradually increases toward the proximal end side.

  Thus, the spring property of the reinforcing layer 24 can be increased by decreasing the pitch of the wires 25 at the distal end portion 12 of the sheath 10 and decreasing the distal end opening ratio. For this reason, the front-end | tip part 12 of the sheath 10 can be bent flexibly. The distal end opening ratio is smaller than the proximal end opening ratio, and is preferably 50% or more and 80% or less.

  The present invention is not limited to the above-described embodiment, and includes various modifications and improvements as long as the object of the present invention is achieved.

  It should be noted that the various components of the present invention need not be individually independent. A plurality of components are formed as one member, a component is formed of a plurality of members, one component is a part of another component, and one component is And a part of other components are allowed to overlap.

The above embodiment includes the following technical idea.
(1) A long tubular sheath having a lumen, a hollow hub provided in communication with the lumen on the proximal end side of the sheath, and a proximal end of the sheath provided at a distal end portion of the hub A protector that holds the outer periphery of the part, and the holding region held by the protector among the protector and the base end part of the sheath has both visible light permeability and an internal state of the lumen A medical device characterized by being visible.
(2) A reinforcing layer formed by braiding a wire is provided at least inside the base end portion of the sheath, and an opening area ratio of the reinforcing layer at the base end portion of the sheath exceeds 50%. The medical device according to (1) above, which is characterized.
(3) The reinforcing layer is provided from the distal end portion of the sheath to the proximal end portion, and an opening area ratio of the reinforcing layer at the proximal end portion of the sheath is set at the distal end portion of the sheath. The medical device according to (2) above, wherein the medical device has a larger opening area ratio than the reinforcing layer.
(4) A distal end of the base end portion of the sheath that extends to the distal end side of the protector has visible light permeability, and the distal end of the sheath is located on the distal end side of the extended region. The medical device according to any one of (1) to (3), wherein the portion has visible light impermeability.
(5) The medical device according to (4), wherein the holding region and the extension region of the sheath are translucent.
(6) The sheath outer diameter is the same diameter across the extension region and the tip of the sheath, and the sheath outer diameter decreases toward the distal end of the sheath at the tip of the sheath. The medical device according to (4) or (5) above.
(7) A hydrophilic coat layer is provided on the outer surface of the sheath from the tip portion to the extension region, and the hydrophilic coat layer is terminated in the middle of the extension region. The medical device according to any one of (4) to (6) above.
(8) The medical device according to any one of (1) to (7), wherein the medical device is a catheter.

DESCRIPTION OF SYMBOLS 10 Sheath 11 Distal end 12 Tip part 13 Boundary part 14 Base end part 15 Extension area 16 Holding area 20 Lumen 22 Inner layer 24 Reinforcement layer 25 Wire 26 Outer layer 28 Pigment 30 Hydrophilic coat layer 40 Marker 42 Mesh opening 50 Hub 52 Connection part 54 Wings 56 Connection recess 60 Protector 100 Catheter 200

Claims (8)

An elongated tubular sheath having a lumen, a hollow hub provided on the proximal end side of the sheath in communication with the lumen, and an outer periphery of the proximal end portion of the sheath provided at a distal end portion of the hub A protector for holding,
The holding region held by the protector among the base end portions of the protector and the sheath both have visible light permeability and can visually recognize the internal state of the lumen. .   A reinforcing layer formed by braiding a wire is provided at least inside the base end of the sheath, and an opening area ratio of the reinforcing layer at the base end of the sheath exceeds 50%. The medical device according to claim 1.   The reinforcing layer is provided from the distal end portion of the sheath to the proximal end portion, and an opening area ratio of the reinforcing layer at the proximal end portion of the sheath is equal to an opening area ratio of the reinforcing layer at the distal end portion of the sheath. The medical device according to claim 2, wherein the medical device is larger than an opening area ratio.   Of the base end portion of the sheath, an extension region extending to the distal end side of the protector has visible light permeability, and a distal end portion of the sheath located on the distal end side of the extension region is visible. The medical device according to any one of claims 1 to 3, wherein the medical device has light impermeability.   The medical device according to claim 4, wherein the holding region and the extension region of the sheath are translucent.   The sheath outer diameter is the same diameter over the extension region and the tip of the sheath, and the sheath outer diameter of the tip of the sheath decreases toward the distal end of the sheath. Item 6. The medical device according to Item 4 or 5.   A hydrophilic coat layer is provided on the outer surface of the sheath from the tip portion to the extension region, and the hydrophilic coat layer terminates in the middle of the extension region. Item 7. The medical device according to any one of Items 4 to 6.   The medical device according to any one of claims 1 to 7, which is a catheter.

Images