JP2017176344A - Protective sheath - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a protective sheath causing an operator to quickly recognize deformation or fall of a stent, thereby capable of contributing to achievement of a quick procedure.SOLUTION: A protective sheath 30 includes: a tube 40 having a storage chamber formed thereon for storing a distal end of a balloon catheter; and a stylet 50 (a core member) for holding the balloon catheter. The protective sheath further includes an identification part 60 that, when a stent 14 is deformed or fallen from the balloon 13 by an operation of removing the tube from the distal end of the balloon catheter, causes the operator to recognize deformation or fall of the stent.SELECTED DRAWING: Figure 2B

Description

  The present invention relates to a protective sheath that is removably attached to a balloon catheter and covers and protects a stent mounted on the balloon.

  Conventionally, a medical instrument such as a catheter has been used in order to reduce a burden on a patient associated with a surgical operation (see Patent Document 1). For example, in percutaneous transaneous coronary angioplasty (PTCA) used for myocardial infarction or angina pectoris, the stent is transported to the stenosis in the blood vessel using a balloon catheter, and the stent is placed in the stenosis. When reached, expand the balloon. Then, the occurrence of restenosis of the lesioned part is suppressed by placing the expanded stent with the expansion of the balloon in the stenotic part.

  In order to cover and protect the stent mounted on the balloon, a cylindrical protective sheath is detachably attached to the distal end portion of the balloon catheter. In the procedure of placing the stent, the protective sheath is removed from the distal end portion of the balloon catheter, and the balloon catheter is inserted into the living body lumen.

JP 2014-140462 A

  When removing the protective sheath from the tip of the balloon catheter, excessive force will act on the protective sheath, causing the stent to stretch before the operator notices it, or the stent to be bitten. There is. Further, when the protective sheath is pulled out, there is a possibility that the stent mounted on the balloon may fall off the balloon.

  In such a case, if the surgeon cannot recognize the deformation or dropout of the stent, or if it takes time to recognize it, it will not be possible to quickly perform the procedure by replacing the balloon catheter.

  Accordingly, an object of the present invention is to allow an operator to quickly recognize the deformation or dropout of a stent when the stent is deformed or dropped from the balloon during the operation of removing the protective sheath from the distal end portion of the balloon catheter. As a result, it is to provide a protective sheath that can contribute to achieving a quick procedure.

  In order to achieve the above object, the present invention is a protective sheath that is removably attached to a balloon catheter including a wire lumen through which a guide wire is inserted and a balloon, and covers and protects a stent mounted on the balloon. The protective sheath includes an opening through which the distal end portion of the balloon catheter where the stent is disposed and a housing chamber that accommodates the distal end portion of the balloon catheter is formed. A core member extending outside the chamber beyond the opening and holding the balloon catheter by being inserted into the wire lumen of the balloon catheter. The protective sheath further includes an identification unit for recognizing an operator to deform or drop the stent when the stent is deformed or dropped from the balloon during the operation of pulling out the tube from the tip of the balloon catheter. And having.

  According to the protective sheath configured as described above, when the stent is deformed or detached from the balloon in accordance with the operation of removing the protective sheath from the distal end portion of the balloon catheter, the identifying portion can deform or drop the stent. Can be recognized quickly. The surgeon stops using the balloon catheter in which the stent has failed before he / she notices it. As a result, the balloon catheter can be exchanged quickly to contribute to the achievement of a quick procedure.

It is a figure which shows the state with which the protective sheath was mounted | worn with the front-end | tip part of the balloon catheter. It is sectional drawing which shows the identification part of the protective sheath in 1st Embodiment, and is a figure which shows the state before a stent deform | transforms. It is sectional drawing which shows the identification part, and is a figure which shows the state after a stent deform | transforms with the operation | work which pulls out a tube from the front-end | tip part of a balloon catheter. It is sectional drawing which shows the identification part of the protective sheath in 2nd Embodiment, and is a figure which shows the state before a stent falls out of a balloon. It is sectional drawing which shows the identification part, and is a figure which shows the state after a stent fell from the balloon with the operation | work which pulls out a tube from the front-end | tip part of a balloon catheter, and the stent was hooked on the stylet extended outside the tube. It is. It is sectional drawing which shows the identification part of the protective sheath in 3rd Embodiment, and is a figure which shows the state before a stent falls out of a balloon. It is sectional drawing which shows the identification part, and is a figure which shows the state after a stent fell from the balloon with the operation | work which pulls out a tube from the front-end | tip part of a balloon catheter, and the stent was hooked on the stylet extended outside the tube. It is. It is sectional drawing which shows the identification part of the protective sheath in 4th Embodiment, and is a figure which shows the state before a stent deform | transforms. It is sectional drawing which shows the identification part, and is a figure which shows the state after a stent deform | transforms with the operation | work which pulls out a tube from the front-end | tip part of a balloon catheter.

  Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In addition, the following description does not limit the meaning of the technical scope and terms described in the claims. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may differ from actual ratios. In the following description, the hand operation side of the medical device is referred to as “proximal end side”, and the side inserted into the living body lumen is referred to as “distal end side”.

(First embodiment)
FIG. 1 is a view showing a state where a protective sheath 30 is attached to the distal end portion of the balloon catheter 10. FIG. 2A is a cross-sectional view showing the identification portion of the protective sheath 30 in the first embodiment, showing a state before the stent is deformed, and FIG. 2B is a cross-sectional view showing the identification portion, and the balloon catheter 10. It is a figure which shows the state after a stent deform | transforms with the operation | work which pulls out a tube from the front-end | tip part.

  With reference to FIG. 1, the medical device according to the embodiment includes a balloon catheter 10 and a protective sheath 30.

  The balloon catheter 10 includes a hub 11 disposed at a proximal end portion, an elongated shaft portion 12 and an expandable balloon 13 disposed at a distal end portion of the shaft portion 12. The stent 14 is mounted on the balloon 13.

  The hub 11 has a connection port 11 a to which an indeflator for supplying a fluid for expanding the balloon 13 is connected. Examples of the expansion fluid that expands the balloon 13 include, but are not limited to, an X-ray contrast medium, a physiological saline, and an electrolyte solution.

  The shaft portion 12 includes a proximal shaft 15, an intermediate shaft 16, and a distal shaft 17 from the proximal end side. The proximal shaft 15 has a lumen that communicates with the connection port 11 a of the hub 11. The proximal shaft 15 is joined to the hub 11 in a liquid-tight state. The intermediate shaft 16 has a lumen that communicates with the lumen of the proximal shaft 15. The intermediate shaft 16 is joined to the proximal end shaft 15 in a liquid-tight state. The tip shaft 17 has a double tube structure of an outer tube and an inner tube 18 (see FIG. 2A), and a balloon expansion lumen is formed between the inner tube 18 and the outer tube. The balloon expansion lumen communicates with the lumen of the intermediate shaft 16 and is joined to the intermediate shaft 16 in a liquid-tight state. An expansion fluid is supplied into the balloon 13 via the balloon expansion lumen. A wire lumen 19 for inserting a guide wire is formed in the inner tube 18 of the tip shaft 17. The wire lumen 19 communicates with a distal end opening 20 formed at the distal end of the inner tube 18 of the distal shaft 17 and a guide wire port 21 formed at the boundary between the intermediate shaft 16 and the distal shaft 17. When the balloon catheter 10 is inserted into the living body lumen, the guide wire is led out from the distal end opening 20 via the wire lumen 19, and the guide wire is made to precede the balloon catheter 10. Thereby, the balloon catheter 10 can be guided to the treatment site. As the shaft portion 12, for example, a rapid exchange (RX) type having a structure in which a guide wire passes through only a tip portion, an over-the-wire type in which a guide wire passes to a hub, or the like can be used. The shaft portion 12 has a length of about 100 mm to 2000 mm and an outer diameter of about 0.3 mm to 3.0 mm.

  The balloon 13 is fixed to the outer periphery in the vicinity of the distal end portion of the shaft portion 12, and is arranged in a folded state (or a contracted state). The interior of the balloon 13 communicates with the balloon expansion lumen of the distal shaft 17 and further communicates with the connection port 11a of the hub 11 via the lumen of the intermediate shaft 16 and the lumen of the proximal shaft 15. The expansion fluid that has flowed in from the connection port 11 a of the hub 11 flows into the balloon 13. The balloon 13 is expanded by introducing an expansion fluid.

  The constituent material of the balloon 13 is preferably flexible, for example, polyolefin, cross-linked polyolefin, polyester, polyester elastomer, polyvinyl chloride, polyurethane, polyurethane elastomer, polyphenylene sulfide, polyamide, polyamide elastomer, fluororesin, etc. High polymer materials, silicone rubber, latex rubber. The polyester is, for example, polyethylene terephthalate. The constituent material of the balloon 13 is not limited to the form in which the polymer material is used alone, and for example, a film in which the polymer material is appropriately laminated can be applied.

  The stent 14 functions as an in-vivo indwelling object that holds the lumen in an appropriate size by being placed in close contact with the inner surface of the stenosis, which is a lesioned part. The stent 14 has a cylindrical shape and expands as the balloon 13 expands. For example, the stent 14 is configured by stretching a linear member in a mesh shape. When the stent 14 is expanded, each mesh shape can be deformed to expand the diameter. The stent 14 is, for example, a drug eluting stent (DES) having an outer surface coated with a drug.

  The stent 14 is made of a biocompatible material. Biocompatible materials include, for example, iron, titanium, aluminum, tin, tantalum or tantalum alloy, platinum or platinum alloy, gold or gold alloy, titanium alloy, nickel-titanium alloy, cobalt base alloy, cobalt-chromium alloy, Stainless steel, zinc-tungsten alloy, niobium alloy and the like.

  The drug coated on the outer surface of the stent 14 is, for example, a mixture of a biological bioactive substance and a biodegradable polymer. The place where the drug is coated is not limited to the outer surface of the stent 14, and may be the inner surface of the stent 14, or both the outer surface and the inner surface.

  The protective sheath 30 is detachably attached to the balloon catheter 10 and covers and protects the stent 14 mounted on the balloon 13. The protective sheath 30 includes a tube 40 having a cylindrical shape, and a stylet 50 (corresponding to the core member 50) extending from the inside of the tube 40 to the outside. The tube 40 is formed with an opening 41 through which the distal end portion of the balloon catheter 10 where the stent 14 is disposed can pass and an accommodation chamber 42 that communicates with the opening 41 and accommodates the distal end portion of the balloon catheter 10. The stylet 50 extends from the accommodation chamber 42 beyond the opening 41 to the outside, and holds the balloon catheter 10 by being inserted into the wire lumen 19 of the balloon catheter 10. Further, in the protective sheath 30 of the present embodiment, when the stent 14 is deformed or dropped from the balloon 13 with the operation of pulling the tube 40 from the distal end portion of the balloon catheter 10, the stent 14 is deformed or dropped. Is identified by the operator.

  The tube 40 is disposed along the balloon catheter 10 on the outer periphery of the stent 14, and prevents other medical devices and fingers from coming into contact with the drug covering the surface of the stent 14 before using the balloon catheter 10. . The tube 40 has an opening 41 at the base end. The accommodation chamber 42 inside the tube 40 communicates with the opening 41 on the proximal end side and is formed to extend toward the distal end side. Although the material which comprises the tube 40 is aluminum, for example, it is not restricted to this, A resin material may be sufficient.

  The stylet 50 is connected to the distal end side in the tube 40 at the distal end side. When the protective sheath 30 is attached to the distal end portion of the balloon catheter 10, the stylet 50 is inserted into the wire lumen 19 from the distal end opening 20 of the balloon catheter 10. The proximal end portion of the stylet 50 is led out of the balloon catheter 10 from the guide wire port 21 through the wire lumen 19. The stylet 50 is located substantially on the central axis of the protective sheath 30. Thereby, the balloon 13 can be disposed on the central axis of the protective sheath 30. Further, since the stylet 50 can be inserted into the wire lumen 19, the protective sheath 30 can be removably attached to the distal end portion of the balloon catheter 10. The constituent material of the stylet 50 is preferably flexible, and is, for example, a metal material such as stainless steel, a polymer material such as polyolefin, polyvinyl chloride, polyamide, or fluororesin, or a mixture thereof.

  When the stent 14 is deformed when the tube 40 is pulled out from the distal end portion of the balloon catheter 10, or when the stent 14 mounted on the balloon 13 is detached from the balloon 13, the identification unit 60 deforms or removes the stent 14. Can be recognized by the surgeon. The operator can quickly recognize that the stent 14 has been deformed or that the stent 14 has dropped from the balloon 13 by the action of the identification unit 60. As a result, the balloon catheter 10 can be exchanged quickly to perform the procedure quickly.

  In configuring the identification unit 60, there are specifically the following three forms. First, a configuration in which the identification unit 60 is configured by the cooperation of the tube 40 and the stylet 50, second, a configuration in which the identification unit 60 is configured by only the stylet 50, and third, an identification unit by only the tube 40 There is a form that constitutes 60.

  With reference to FIG. 2A and FIG. 2B, in 1st Embodiment, the form which comprises the identification part 60 by the cooperation of the 1st tube 40 and the stylet 50 is employ | adopted.

  The tube 40 has a deforming portion 43 that deforms into a state of projecting into the accommodation chamber 42 when a force exceeding a predetermined force is applied. The stylet 50 has a small diameter portion 51 formed at a position facing the deformed portion 43 of the tube 40 with a smaller diameter than other positions. The identification unit 60 includes a deformed portion 43 of the tube 40 and a small diameter portion 51 of the stylet 50.

  The deforming portion 43 is formed so as to be plastically deformed in a state of projecting into the accommodating chamber 42. The deformable portion 43 can be formed, for example, by providing the concave portion 44 on the tube 40 and reducing the thickness of the tube 40.

  The specific configuration of the deforming portion 43 can be variously modified. The tube 40 can be formed from a material in which a linear member is formed in a mesh shape like a stent, and can be formed so as to be plastically deformed. Further, the deforming portion 43 may be configured from a mechanical configuration such as a push switch using a disc spring or the like. When the switch part is pushed against the elastic force of the disc spring, the tip part of the switch part may be protruded into the storage chamber 42.

  A marker indicating the position to be operated by the operator is attached to the outer peripheral surface of the tube 40 so that the operator operates the deformed portion 43 when the tube 40 is pulled out from the distal end portion of the balloon catheter 10. In the operation of pulling out the tube 40, it is preferable that when the operation is performed at a site other than the deforming portion 43, the stent 14 is more easily damaged than when the operation is performed at the deforming portion 43. This is because when the operator pulls out the tube 40 from the distal end portion of the balloon catheter 10, it becomes easy to recognize the correct operation position on the tube 40. In this case, the portions other than the deforming portion 43 are preferably formed from a flexible material having no rigidity so that the operator's force can easily act on the stent 14.

  The “predetermined force” that causes the deformation of the deformation portion 43 is set to a force that causes the stent 14 to be damaged or deformed when the tube 40 is pulled out from the distal end portion of the balloon catheter 10. The force at which the stent 14 is broken / deformed includes the material / thickness / mesh shape of the stent 14, the material / folded shape of the balloon 13 on which the stent 14 is mounted, the material / thickness of the inner tube 18 of the distal shaft 17, and the stylus. Since various factors such as the material of the let 50 and the clearance between the inner pipe 18 and the inner peripheral surface are involved, it cannot be uniquely determined. As an example of a “predetermined force” that causes deformation in the deformation portion 43, 5 [N] can be cited.

  Next, the operation of the protective sheath 30 will be described.

  As shown in FIG. 2A, when the tube 40 is pulled out from the distal end portion of the balloon catheter 10, the deformable portion 43 is not plastically deformed unless the force acting on the deformable portion 43 exceeds a predetermined force. The surgeon can remove the protective sheath 30 from the distal end portion of the balloon catheter 10 without causing damage or deformation of the stent 14. The surgeon removes the stylet 50 from the wire lumen 19, and thereafter places the stent 14 in the stenosis, which is the target site, according to a normal procedure.

  As shown in FIG. 2B, when the tube 40 is pulled out from the distal end portion of the balloon catheter 10, if the force acting on the deformation portion 43 exceeds a predetermined force, the deformation portion 43 Plastically deformed to protrude toward Between the plastically deformed deformed portion 43 and the small diameter portion 51, the stent 14 and the inner tube 18 of the distal shaft 17 are crushed. As a result, the crushed portion becomes a resistance, and the distal end portion of the balloon catheter 10 is prevented from coming off from the tube 40. Thereby, the identification unit 60 can make the operator recognize the deformation of the stent 14.

  The operator can quickly recognize that the stent 14 has been deformed because the tube 40 cannot be pulled out from the distal end portion of the balloon catheter 10 by the action of the identification unit 60. Since the protective sheath 30 itself cannot be removed, the situation in which the stent 14 cannot be delivered and the procedure is started without the stent 14 can be fundamentally prevented. That is, the surgeon will not use the balloon catheter 10 in which the stent 14 has a problem before he / she notices it. As a result, the balloon catheter 10 can be exchanged quickly to perform the procedure quickly.

  Thus, the protective sheath 30 of the first embodiment is provided with a structure intended to break the stent 14 when the protective sheath 30 is not gripped in the correct position and method. By destroying the stent 14 and making the balloon catheter 10 unusable, it is possible to make an operator sense unintentional deformation or dropping of the stent 14 due to removal of the protective sheath 30.

  As described above, the protective sheath 30 according to the first embodiment can be used when the stent 14 is deformed or dropped from the balloon 13 as the tube 40 is pulled out from the distal end portion of the balloon catheter 10. It has the identification part 60 which makes an operator recognize deformation | transformation or omission.

  With this configuration, according to this protective sheath 30, when the stent 14 is deformed or falls off the balloon 13 in accordance with the operation of removing the protective sheath 30 from the distal end portion of the balloon catheter 10, the stent 14 The operator can quickly recognize the deformation or dropout. The surgeon stops using the balloon catheter 10 in which the stent 14 has failed before he or she notices it. As a result, the exchange of the balloon catheter 10 and the like can be performed quickly, contributing to the achievement of a quick procedure.

  Further, the identification unit 60 includes a deformed portion 43 of the tube 40 and a small diameter portion 51 of the stylet 50. When a force exceeding a predetermined force is applied to the deformed portion 43 in accordance with the operation of pulling out the tube 40 from the distal end portion of the balloon catheter 10, the deformed portion 43 and the small diameter portion deformed into a state of projecting into the accommodating chamber 42. 51, the stent 14 is crushed and the tip of the balloon catheter 10 is prevented from coming off from the tube 40. Thereby, the identification unit 60 makes the operator recognize the deformation of the stent 14.

  With this configuration, the surgeon can quickly recognize that the stent 14 has been deformed because the tube 40 cannot be pulled out from the distal end portion of the balloon catheter 10 by the action of the identification unit 60. Can do. The surgeon stops using the balloon catheter 10 in which the stent 14 has failed before he or she notices it. As a result, the balloon catheter 10 can be exchanged quickly to perform the procedure quickly.

(Second Embodiment)
FIG. 3A is a cross-sectional view showing the identification portion 160 of the protective sheath 30 in the second embodiment, and shows a state before the stent 14 is detached from the balloon 13, and FIG. 3B is a cross-sectional view showing the identification portion 160. The figure which shows the state after the stent 14 fell from the balloon 13 with the operation | work which pulls out the tube 40 from the front-end | tip part of the balloon catheter 10, and the stent 14 was caught by the stylet 150 extended outside the tube 40. It is. In addition, the same code | symbol is attached | subjected to the member which is common in 1st Embodiment, and the description is abbreviate | omitted.

  The second embodiment is different from the first embodiment in that the configuration of the identification unit 160 is modified. More specifically, the second embodiment adopts a configuration in which the identification unit 160 is configured by only the stylet 150, and the configuration in which the identification unit 60 is configured by the cooperation of the tube 40 and the stylet 50. This is different from the first embodiment adopting the above.

  With reference to FIG. 3A and FIG. 3B, in 2nd Embodiment, the form which comprises the identification part 160 only by the 2nd above-mentioned stylet 150 is employ | adopted.

  When the stent 14 falls off the balloon 13, in most cases, the stylet 150 and the inner peripheral surface of the stent 14 come into contact with each other. The second embodiment focuses on this point. The stylet 150 has a resistance portion 151 having a larger coefficient of friction with respect to the inner peripheral surface of the stent 14 than a portion of the portion that extends to the outside of the tube 40. The identification unit 160 includes a resistance unit 151 of the stylet 150.

  Resistor 151 is formed by roughening the surface of stylet 150. For example, the friction coefficient can be increased by subjecting part of the stylet 150 to shot blasting. The specific method for increasing the friction coefficient is not limited to the shot blasting process, and the surface may be roughened by chemical treatment with a chemical, or the surface may be roughened by coating with a material having a high friction coefficient. Although the specific numerical value of the friction coefficient is not particularly limited, for example, μ = about 0.2 or more.

  The position where the resistance portion 151 is formed is preferably a position near the base end portion (right end in the drawing) of the stylet 150 or a position including the base end portion.

  Although the length which forms the resistance part 151 is not specifically limited, Forming longer than the axial direction length of the stent 14 is preferable. This is because the frictional resistance with the stent 14 dropped from the balloon 13 is increased, and the stent 14 is easily hooked on the resistance portion 151 and stopped.

  Next, the operation of the protective sheath 30 will be described.

  As shown in FIG. 3A, when the tube 40 is pulled out from the distal end portion of the balloon catheter 10, the stent 14 does not reach the resistance portion 151 of the stylet 150 unless the stent 14 falls off the balloon 13. The surgeon removes the stylet 150 from the wire lumen 19 and thereafter places the stent 14 in the stenosis that is the target site according to a normal procedure.

  When the stent 14 is detached from the balloon 13 when the tube 40 is pulled out from the distal end portion of the balloon catheter 10, the stent 14 is detached toward the distal end side in the tube 40 as the tube 40 is pulled out. When the tube 40 is further pulled out, the stent 14 slides down toward the proximal end of the stylet 150 so as to hang from the stylet 150. As shown in FIG. 3B, when the stent 14 slides down to the resistance portion 151 of the stylet 150, the stent 14 is caught by the resistance portion 151 having a higher coefficient of friction with respect to the inner peripheral surface of the stent 14. As a result, the stent 14 is prevented from falling off from the proximal end portion of the stylet 150. Thereby, the identification unit 160 can make the operator recognize the drop of the stent 14.

  The surgeon can quickly recognize that the stent 14 has dropped out by visual observation because the stent 14 is caught by the resistance portion 151 of the stylet 150 by the action of the identification unit 160. The surgeon stops using the balloon catheter 10 in which the stent 14 has failed before he or she notices it. As a result, the balloon catheter 10 can be exchanged quickly to perform the procedure quickly.

  As described above, in the protective sheath 30 of the second embodiment, the identification unit 160 includes the resistance unit 151 of the stylet 150. When the stent 14 is detached from the balloon 13 as the tube 40 is pulled out from the distal end portion of the balloon catheter 10, the stent 14 is caught by the resistance portion 151, and the stent 14 is prevented from falling off from the proximal end portion of the stylet 150. As a result, the identification unit 160 allows the operator to recognize the removal of the stent 14.

  With this configuration, the surgeon can quickly recognize that the stent 14 has fallen, and can quickly perform the procedure by quickly replacing the balloon catheter 10 or the like. Become.

(Third embodiment)
FIG. 4A is a cross-sectional view showing the identification portion 260 of the protective sheath 30 in the third embodiment, showing a state before the stent 14 is dropped from the balloon 13, and FIG. 4B is a cross-sectional view showing the identification portion 260. The figure which shows the state after the stent 14 fell from the balloon 13 with the operation | work which pulls out the tube 40 from the front-end | tip part of the balloon catheter 10, and the stent 14 was caught by the stylet 250 extended outside the tube 40. It is. In addition, the same code | symbol is attached | subjected to the member which is common in 1st, 2nd embodiment, and the description is abbreviate | omitted.

  As in the second embodiment, the third embodiment employs a form in which the identification unit 260 is configured by only the stylet 250. However, the specific configuration of the identification unit 260 is different from that of the second embodiment.

  Referring to FIGS. 4A and 4B, in the third embodiment, as in the second embodiment, a configuration in which the identification unit 260 is configured only by the second stylet 250 described above is adopted. Yes.

  The stylet 250 has a large-diameter portion 251 formed on a part of the portion extending outside the tube 40 so as to have a larger diameter than the other portions. The identification unit 260 includes a large diameter portion 251 of the stylet 250.

  The large-diameter portion 251 is formed by using a large-diameter material as the material of the stylet 250 and cutting the other portion into a small diameter. The specific method for increasing the diameter is not limited to this case. For example, the diameter may be increased by coating a material having good adhesion to the material of the stylet 250. Although the specific numerical value for increasing the diameter is not particularly limited, for example, the diameter is preferably about 0.33 to 0.38 mm with respect to the diameter φ0.30 mm of the stylet 250.

  The position where the large-diameter portion 251 is formed is preferably a position near the base end portion (right end in the drawing) of the stylet 250 or a position including the base end portion.

  The length for forming the large diameter portion 251 is not particularly limited, and there is no problem even if it is formed shorter than the axial length of the stent 14.

  Next, the operation of the protective sheath 30 will be described.

  As shown in FIG. 4A, when the tube 40 is pulled out from the distal end portion of the balloon catheter 10, the stent 14 does not reach the large-diameter portion 251 of the stylet 250 unless the stent 14 falls off the balloon 13. The surgeon removes the stylet 250 from the wire lumen 19, and thereafter places the stent 14 in the stenosis that is the target site according to a normal procedure.

  When the stent 14 is detached from the balloon 13 when the tube 40 is pulled out from the distal end portion of the balloon catheter 10, the stent 14 is detached toward the distal end side in the tube 40 as the tube 40 is pulled out. When the tube 40 is further pulled out, the stent 14 slides down toward the proximal end of the stylet 250 so as to hang from the stylet 250. As shown in FIG. 4B, when the stent 14 slides down to the large-diameter portion 251 of the stylet 250, the stent 14 comes into contact with the distal end surface 251a of the large-diameter portion 251 and changes from the normal diameter portion to the large-diameter portion 251. The stent 14 is caught on the stepped portion 252 to be transferred. As a result, the stent 14 is prevented from falling off from the proximal end portion of the stylet 250. Thereby, the identification unit 260 can make the operator recognize the drop of the stent 14.

  Since the stent 14 is hooked on the stepped portion 252 of the stylet 250 by the action of the identification unit 260, the surgeon can quickly recognize that the stent 14 has fallen off visually. The surgeon stops using the balloon catheter 10 in which the stent 14 has failed before he or she notices it. As a result, the balloon catheter 10 can be exchanged quickly to perform the procedure quickly.

  As described above, in the protective sheath 30 of the third embodiment, the identification unit 260 is configured by the large-diameter portion 251 of the stylet 250. When the stent 14 is detached from the balloon 13 as the tube 40 is pulled out from the distal end portion of the balloon catheter 10, the stent 14 is hooked on the stepped portion 252 that moves to the large diameter portion 251, and the stent 14 from the proximal end portion of the stylet 250. Prevents falling off. As a result, the identification unit 260 allows the operator to recognize the removal of the stent 14.

  With this configuration, the surgeon can quickly recognize that the stent 14 has fallen, and can quickly perform the procedure by quickly replacing the balloon catheter 10 or the like. Become.

(Fourth embodiment)
FIG. 5A is a cross-sectional view showing the identification portion 360 of the protective sheath 30 in the fourth embodiment, showing a state before the stent 14 is deformed, and FIG. 5B is a cross-sectional view showing the identification portion 360, It is a figure which shows the state after the stent 14 deform | transforms with the operation | work which extracts the tube 340 from the front-end | tip part of the balloon catheter 10. FIG. In addition, the same code | symbol is attached | subjected to the member which is common in 1st-3rd embodiment, and the description is abbreviate | omitted.

  The fourth embodiment is different from the first to third embodiments in that the configuration of the identification unit 360 is modified. More specifically, the fourth embodiment employs a configuration in which the identification unit 360 is configured only by the tube 340, and the configuration in which the identification unit 60 is configured by the cooperation of the tube 40 and the stylet 50. The first embodiment is different from the second and third embodiments in which the identification units 160 and 260 are configured only by the stylets 150 and 250.

  With reference to FIG. 5A and FIG. 5B, in 4th Embodiment, the form which comprises the identification part 360 only with the tube 340 is employ | adopted.

  The tube 340 includes a deforming portion 343 that is deformed into a state of projecting into the housing chamber 42 when a force exceeding a predetermined force is applied. The identification unit 360 includes a deformation unit 343 of the tube 340.

  The deformable portion 343 is formed so as to be plastically deformed in a state of projecting into the storage chamber 42. The deformable portion 343 of the fourth embodiment is formed such that the weakened portion 344 formed of a concave portion is formed on the tube 340 and the weakened portion 344 is broken when a force exceeding a predetermined force is applied. The deforming portion 343 is plastically deformed in a state where the deforming portion 343 protrudes in a tongue shape toward the inside of the accommodation chamber 42 while being supported by the tube 340 in a portion where the fragile portion 344 is not formed. The deforming portion 343 is supported by the tube 340 on the base end side (right side in the drawing) and is deformed so as to protrude into the accommodation chamber 42 on the distal end side (left side in the drawing).

  The marker which shows the position which an operator should operate on the outer peripheral surface of the tube 340 is the same as that of 1st Embodiment. As in the first embodiment, it is preferable that the stent 14 be easily damaged when the tube 340 is pulled out at a site other than the deformed portion 343 as compared with when the tube 340 is operated at the deformed portion 343. is there. Furthermore, regarding the “predetermined force” that causes the deformation of the deformable portion 343, the force that deforms the stent 14 when the tube 340 is pulled out from the distal end portion of the balloon catheter 10 is set as in the first embodiment. As an example, 5 [N] can be mentioned.

  Next, the operation of the protective sheath 30 will be described.

  As shown in FIG. 5A, when the tube 340 is pulled out from the distal end portion of the balloon catheter 10, the deformable portion 343 is not plastically deformed unless the force acting on the deformable portion 343 exceeds a predetermined force. The surgeon can remove the protective sheath 30 from the distal end portion of the balloon catheter 10 without causing damage or deformation of the stent 14. The surgeon removes the stylet 350 from the wire lumen 19 and thereafter places the stent 14 in the stenosis that is the target site according to a normal procedure.

  As shown in FIG. 5B, when the tube 340 is pulled out from the distal end portion of the balloon catheter 10, if the force acting on the deformable portion 343 exceeds a predetermined force, the deformable portion 343 is placed in the storage chamber 42. It is plastically deformed so as to protrude toward the end, and bites into the stent 14. As a result, the deformed portion 343 bites into the stent 14 as a resistance, and the distal end portion of the balloon catheter 10 is prevented from coming off from the tube 340. Thereby, the identification unit 360 can make the operator recognize the deformation of the stent 14.

  Since the operator cannot remove the tube 340 from the distal end portion of the balloon catheter 10 by the action of the identification unit 360, the surgeon can quickly recognize that the stent 14 has been deformed. The surgeon stops using the balloon catheter 10 in which the stent 14 has failed before he or she notices it. As a result, the balloon catheter 10 can be exchanged quickly to perform the procedure quickly.

  As described above, in the protective sheath 30 of the fourth embodiment, the identification unit 360 is configured by the deformed portion 343 of the tube 340. When a force exceeding a predetermined force is applied to the deformed portion 343 in accordance with the operation of pulling out the tube 340 from the distal end portion of the balloon catheter 10, the deformed portion 343 deformed so as to protrude into the accommodation chamber 42 is formed in the stent 14. And the tip of the balloon catheter 10 is prevented from coming off from the tube 340. Thereby, the identification unit 360 makes the operator recognize the deformation of the stent 14.

  With this configuration, the operator can quickly recognize that the stent 14 has been deformed, and can quickly replace the balloon catheter 10 and perform the procedure quickly. Become.

(Other modifications)
Regarding the identification unit, a configuration in which the identification unit 60 is configured by the cooperation of the tube 40 and the stylet 50 (first embodiment), and a configuration in which the identification units 160 and 260 are configured only by the stylets 150 and 250 (second and second). (3rd embodiment) and the form (4th Embodiment) which comprises the identification part 360 only by the tube 340, although demonstrated separately, it can combine suitably. For example, the configuration of the first embodiment and the configuration of the second embodiment are combined, the configuration of the first embodiment and the configuration of the third embodiment are combined, the configuration of the fourth embodiment and the configuration of the second embodiment. The configuration can be combined, or the configuration of the fourth embodiment and the configuration of the third embodiment can be combined.

10 balloon catheter,
11 Hub,
12 shaft part,
13 Balloon,
14 stent,
18 Inner tube of tip shaft,
19 Wire lumen,
20 tip opening,
30 protective sheath,
40, 340 tubes,
50, 150, 250, 350 Stylet (core member),
60, 160, 260, 360 identifier,
41 opening,
42 containment chamber,
43, 343 deformation part,
51 Small diameter part,
151 resistance section,
251 Large diameter part,
251a End surface on the tip side,
252 Stepped part,
344 Vulnerable part.

Claims (5)

A protective sheath that is removably attached to a balloon catheter including a wire lumen and a balloon through which a guide wire is inserted, and covers and protects the stent mounted on the balloon;
A tube formed with an opening through which the distal end of the balloon catheter where the stent is disposed and a distal end of the balloon catheter are accommodated, the opening being in communication with the opening;
A core member that holds the balloon catheter by extending from the housing chamber beyond the opening and being inserted into the wire lumen of the balloon catheter;
An identification unit for allowing an operator to recognize deformation or drop of the stent when the stent is deformed or dropped from the balloon in accordance with the operation of removing the tube from the distal end of the balloon catheter. sheath. The tube has a deforming portion that deforms into a state of projecting toward the storage chamber when a force exceeding a predetermined force is applied,
The core member has a small-diameter portion formed in a smaller diameter than other positions at a position facing the deformed portion of the tube,
The identification part is composed of the deformation part of the tube and the small diameter part of the core member,
When a force exceeding a predetermined force is applied to the deforming portion in accordance with the operation of pulling out the tube from the distal end portion of the balloon catheter, the deforming portion and the small diameter portion that are deformed to protrude into the housing chamber The stent is crushed between the tube and the distal end portion of the balloon catheter is prevented from coming off from the tube, whereby the identification portion allows the operator to recognize the deformation of the stent. The protective sheath as described. The core member has, in a part of a portion extending to the outside of the tube, a resistance portion having a large coefficient of friction with respect to the inner peripheral surface of the stent as compared with other portions.
The identification part is composed of the resistance part of the core member,
When the stent is detached from the balloon with the operation of pulling out the tube from the distal end portion of the balloon catheter, the stent is caught on the resistance portion, and the stent is prevented from falling off from the proximal end portion of the core member, The protective sheath according to claim 1, wherein the identification unit causes an operator to recognize the removal of the stent. The core member has a large-diameter portion formed in a larger diameter than the other part in a part of the portion extending to the outside of the tube,
The identification part is composed of the large diameter part of the core member,
When the stent is detached from the balloon in accordance with the operation of pulling out the tube from the distal end portion of the balloon catheter, the stent is caught at a stepped portion that moves to the large diameter portion, and the stent is removed from the proximal end portion of the core member. The protective sheath according to claim 1, wherein the sheath is prevented from falling off, thereby causing the operator to recognize that the stent has dropped out. The tube has a deforming portion that deforms into a state of projecting toward the storage chamber when a force exceeding a predetermined force is applied,
The identification unit is configured by the deformation unit of the tube,
When a force exceeding a predetermined force is applied to the deformed portion in accordance with the operation of pulling out the tube from the distal end portion of the balloon catheter, the deformed portion deformed into a state of protruding toward the housing chamber is applied to the stent. The protective sheath according to claim 1, wherein biting is prevented and the distal end portion of the balloon catheter is prevented from coming out of the tube, whereby the identification portion causes the surgeon to recognize the deformation of the stent.