JP6498978B2 - Protective cover and method for manufacturing medical device set - Google Patents

Description

  The present invention relates to a protective cover for protecting a member to be protected provided at a distal end portion of a medical long body, and a method for manufacturing a medical device set having the protective cover.

  In recent medical treatments, various forms of treatment and examination are performed using an elongated hollow tubular medical device called a catheter. Such treatment methods include the method of administering a drug directly to the affected area using the length of the catheter, and the use of a catheter attached to the tip of a balloon that expands by pressurization to push the stenotic part in the body cavity. There are a method of opening, a method of scraping and opening the affected part using a catheter with a cutter attached to the tip, and a method of closing an aneurysm, bleeding site or feeding blood vessel using a catheter. In addition, in order to maintain the stenosis in the body cavity in an open state, there is a treatment method in which a tubular stent having a meshed side surface is implanted into the body cavity using a catheter and placed. Furthermore, there is a case of sucking liquid that has become excessive for the body.

  When the catheter is stored, the distal end portion of the catheter is covered with a hollow protective cover, and a protected member such as a balloon provided at the distal end portion is protected (for example, see Patent Document 1 below).

JP 2001-79093 A

  In the manufacturing process of a medical device set including a catheter and a protective cover that covers the protected member at the distal end of the catheter, the protected member is accommodated in the protective cover by inserting the protected member into the protective cover. . At this time, the outer surface of the member to be protected and the inner surface of the protective cover rub against each other. On the other hand, when using a catheter in which the member to be protected is covered with a protective cover, the member to be protected is exposed by pulling out the member to be protected from the protective cover. At this time, the outer surface of the member to be protected and the inner surface of the protective cover rub against each other.

  In this way, when the protective cover is attached to and removed from the protected member, friction is generated between the outer surface of the protected member and the inner surface of the protective cover. Therefore, there is a concern that the outer surface of the member to be protected such as a balloon or a stent is damaged by friction, or when the medicine is provided on the outer surface of the member to be protected, the medicine is peeled off by friction.

  The present invention has been made in consideration of such problems, and the protective cover is attached to and removed from the protected member without generating friction between the outer surface of the protected member and the inner surface of the protective cover. It is an object of the present invention to provide a protective cover and a method for manufacturing a medical device set.

  In order to achieve the above object, the protective cover of the present invention is a protective cover for protecting a protected member provided at the distal end portion by covering the distal end portion of the medical elongated body, and the protected member A hollow cover body that has an opening at one end in the axial direction and that can expand and contract in the radial direction with elastic deformation, and can be fitted to the cover body, An operating member for operating expansion / contraction of the cover main body, wherein the cover main body is expanded by fitting the operating member to the cover main body and contracted by releasing the fitting.

  According to the protective cover configured as described above, when the protected member is covered with the protective cover in the manufacturing process, the cover body is disposed after the protected member is disposed in the storage portion in a state where the cover body is expanded by the operation member. When the fitting of the operation member with respect to is released, the cover body is reduced in diameter by its own elastic restoring force, and the inner surface of the storage portion comes into contact with the outer surface of the protected member. Thereby, a to-be-protected member can be covered with a protective cover, without generating friction to the outer surface of a to-be-protected member, and the inner surface of a storage part. Further, when removing the protective cover from the distal end portion of the medical elongated body, after the inner surface of the storage portion is separated from the outer surface of the protected member by fitting the operating member to the cover body, the protected member is removed. Take it out of the cover body. Thereby, the protective cover can be removed without generating friction between the outer surface of the member to be protected and the inner surface of the storage portion.

  In the protective cover, the operation member can be fitted to an inner surface forming a lumen of the cover main body, and the operation member is attached to the cover main body as the operation member is fitted to the cover main body. May be spread from the inside.

  With this configuration, it is possible to reliably expand the diameter of the cover body with a simple operation.

  In the protective cover, the cover main body is fixedly disposed on a peripheral wall portion surrounding the lumen of the cover main body in a range excluding a part in a circumferential direction, and a portion of the peripheral wall portion that does not surround the lumen. And an elastic part having elastic elasticity that is fixed to the peripheral wall part.

  With this configuration, a cover body that can expand and contract in the radial direction with elastic deformation can be constructed with a simple configuration.

  In the protective cover, the operation member has a holding portion that can hold and release a stylet that is inserted into the medical elongated body and protrudes from a distal end of the medical elongated body. The stylet may be fixedly held by being pressed from the outside by the cover body when positioned inside the storage unit, and the stylet may be released when positioned outside the storage unit.

  With this structure, when the cover body is moved relative to the operation member in the axial direction in a state in which the stylet is inserted into the holding portion in the assembly process of attaching the protective cover to the distal end portion of the medical elongated body, the holding is performed. The part holds the stylet fixed. Thereby, a to-be-protected member can be easily arrange | positioned inside a storage part. Further, when the protective cover is removed from the distal end portion of the medical elongated body, when the operation member is released from the cover body, the holding portion fixes and holds the stylet. Therefore, the stylet can be smoothly removed from the medical long body.

  The protective cover may further include a connecting portion that connects the cover body and the operation member so as to be relatively movable in the axial direction.

  With this configuration, the cover main body and the operation member can be handled integrally, so that an operation for removing the protective cover from the distal end portion of the medical elongated body can be performed quickly and smoothly.

  The present invention also provides a method for manufacturing a medical device set, comprising: a medical elongated body provided with a protected member at a distal end portion; and a protective cover that protects the protected member by covering the distal end portion. The protective cover includes a hollow cover main body having a storage portion for storing the protected member, having an opening at one end in the axial direction, and capable of expanding and contracting in a radial direction with elastic deformation, and the cover An operating member that can be fitted to the main body and operates expansion / contraction of the cover main body, and the manufacturing method expands the cover main body by the operating member so that the inner diameter of the storage portion is A providing step of providing the protective cover in a state larger than an outer diameter of the protected member; and after the providing step, the protected member is disposed on the inner side of the storage portion, and the cover main body is disposed on the cover body. By releasing the engagement of the operating member, to contract the cover body, having a shrinkage step of contacting the inner surface of the cover body and the outer surface of the object to be protected member.

  According to the above manufacturing method, this allows the protected member to be covered with the protective cover without generating friction between the outer surface of the protected member and the inner surface of the storage portion.

  In the manufacturing method of the medical device set described above, by moving the protected member relative to the protective cover and the operation member in the axial direction between the providing step and the contracting step, You may have the arrangement | positioning step which arrange | positions the said to-be-protected member inside.

  Thereby, a to-be-protected member can be easily arrange | positioned inside a storage part.

  In the manufacturing method of the medical device set, the operation member has a holding portion capable of holding and releasing a stylet, and in the providing step, the holding is performed from the opening of the cover body into which the operation member is fitted. An insertion step of inserting the stylet that is inserted into the medical elongated body and protrudes from the distal end of the medical elongated body into the holding section; After the inserting step, the cover body is axially moved relative to the operation member, thereby pressing the holding portion from the outside with the cover body to fix and hold the stylet on the holding portion. And an arrangement step of arranging the protected member inside the storage portion, and the insertion step and the arrangement step include the providing step, It may be performed between the serial contraction step.

  As a result, the stylet is fixedly held by the holding portion with the relative movement of the operation member with respect to the cover main body, and the protected member of the medical elongated body with the stylet inserted is placed inside the storage portion. Be placed. Therefore, the protected member can be easily arranged inside the storage portion.

  According to the manufacturing method of the protective cover and medical device set of the present invention, the protective cover can be attached to and removed from the protected member without generating friction between the outer surface of the protected member and the inner surface of the protective cover. it can.

It is a schematic block diagram of the medical device set provided with the protective cover which concerns on 1st Embodiment of this invention. 2A is a perspective view of the cover body according to the first configuration example, FIG. 2B is a perspective view of the cover body according to the second configuration example, and FIG. 2C is a perspective view of the cover body according to the third configuration example. FIG. 2D is a perspective view of the cover body according to the fourth configuration example. 3A is a first explanatory view of the manufacturing method of the medical device set shown in FIG. 1, FIG. 3B is a second explanatory view of the manufacturing method of the medical device set shown in FIG. 1, and FIG. 3C is a medical view shown in FIG. It is 3rd explanatory drawing of the manufacturing method of a device set. 4A is a first diagram illustrating a method of removing the protective cover from the medical device set shown in FIG. 1, and FIG. 4B is a second diagram illustrating a method of removing the protective cover from the medical device set shown in FIG. is there. It is a schematic block diagram of the medical device set provided with the protective cover which concerns on 2nd Embodiment of this invention. It is sectional drawing of the front end side of the operation member of the protective cover shown in FIG. 7A is a first explanatory view of the manufacturing method of the medical device set shown in FIG. 5, FIG. 7B is a second explanatory view of the manufacturing method of the medical device set shown in FIG. 5, and FIG. 7C is the medical device shown in FIG. FIG. 7D is a fourth explanatory diagram of the method for manufacturing the medical device set shown in FIG. 5. 8A is a first diagram illustrating a method for removing the protective cover from the medical device set shown in FIG. 5, and FIG. 8B is a second diagram for explaining a method for removing the protective cover from the medical device set shown in FIG. is there. It is a schematic block diagram of the medical device set provided with the protective cover which has a connection part. It is a schematic block diagram of the medical device set provided with the protective cover which has the connection part which concerns on a modification.

  Hereinafter, preferred embodiments of a protective cover and a method for manufacturing a medical device set according to the present invention will be described with reference to the accompanying drawings.

[First Embodiment]
A medical device set 10A shown in FIG. 1 includes a medical long body 12 having a protected member 14 provided at a distal end portion thereof, and a protective cover 16A that protects the protected member 14 of the medical long body 12. .

  Examples of the protected member 14 include a balloon that can be expanded and contracted by an expansion fluid, a drug-eluting balloon in which a drug is applied to the outer surface of the balloon, a cutting balloon provided with a cutting member on the outer surface of the balloon, and an outer surface of the balloon. Self-expandable stents that are mounted on a balloon and expanded by a balloon, and drug-eluting stents in which a drug is applied to the outer surface of the stent. Therefore, the medical elongated body 12 can be configured as a balloon catheter, a cutting balloon catheter, a stent delivery catheter, or the like.

  In the case of this embodiment, the medical long body 12 is configured as a balloon catheter 13, and is a long and thin flexible catheter shaft 18 and a protected member 14 at the distal end of the catheter shaft 18. And a balloon 15 provided as. Although not shown, a hub is fixed to the proximal end portion of the catheter shaft 18.

  The balloon 15 is a member that can be expanded and contracted according to supply and discharge of the expansion fluid. The balloon 15 is delivered to a stenosis part in a living body lumen such as a blood vessel and expands the stenosis part from the inside by expanding. In FIG. 1, the balloon 15 is accommodated in the protective cover 16A in a contracted state.

  In the case of this embodiment, the medicine M is applied to the outer surface 15a of the balloon 15. The drug M has an effect of suppressing restenosis, for example, by attaching a stenosis part in a living body lumen to a treated site. Examples of such drugs M include anticancer agents, immunosuppressive agents, antibiotics, anti-rheumatic agents, antithrombotic agents, antihyperlipidemic agents, ACE inhibitors, calcium antagonists, integrin inhibitors, antiallergic agents, Antioxidant, GPIIbIIIa antagonist, retinoid, flavonoid, carotenoid, lipid improver, DNA synthesis inhibitor, tyrosine kinase inhibitor, antiplatelet agent, vascular smooth muscle growth inhibitor, anti-inflammatory agent, biomaterial, interferon, NO Production promoting substances are exemplified.

  In FIG. 1, a stylet 20 is inserted into the catheter shaft 18. The stylet 20 is, for example, a metal-made long flexible linear member, and is inserted into the catheter shaft 18 until the balloon catheter 13 is used, thereby preventing the balloon catheter 13 from being broken. . The tip of the stylet 20 projects from the catheter shaft 18.

  A ring-shaped gripping portion 22 is provided at the tip of the stylet 20. The grip portion 22 is a portion that the user (or an assistant thereof) grips when the stylet 20 is pulled out from the catheter shaft 18 after the protective cover 16A is detached from the balloon 15. By providing the grip portion 22, the stylet 20 can be easily pulled out. In the stylet 20, the gripping portion 22 may not be provided.

  The protective cover 16 </ b> A includes a cover body 24 and an operation member 26. The cover body 24 includes a storage portion 28 that stores the balloon 15 that constitutes the member to be protected 14, and an insertion guide portion 30 provided at one end of the storage portion 28, and can be expanded and contracted in the radial direction with elastic deformation. It is formed in a hollow shape. The protective cover 16 </ b> A has a first opening 24 a (opening) and a second opening 24 b formed at both ends in the axial direction, the first opening 24 a is formed in the storage portion 28, and the second guide guide 30 has a second opening. An opening 24b is formed.

  The storage portion 28 has a hollow cylindrical shape extending linearly, and its length is longer than that of the balloon 15. The inner diameter of the storage portion 28 is constant along the axial direction. In a state where the balloon 15 is stored in the storage unit 28, the inner surface 28 a of the storage unit 28 is in contact with the outer surface 15 a of the balloon 15.

  The insertion guide portion 30 has a tapered inner surface 31 that increases in diameter toward the second opening 24b side. When the operation member 26 is inserted into the protective cover 16A through the second opening 24b, the distal end portion of the operation member 26 is smoothly introduced into the storage portion 28 by the guide action of the tapered inner surface 31 of the insertion guide portion 30. Can do.

  The cover body 24 that can be expanded and contracted in the radial direction with elastic deformation can be realized by various configurations as described below.

  The cover main body 24A according to the first configuration example shown in FIG. 2A constitutes a peripheral wall portion 32 having a C-shaped cross section that constitutes most of the circumferential direction of the cover main body 24A, and the remaining circumferential portion of the cover main body 24A. And a stretchable portion 34 having stretchability.

  When the operation member 26 is inserted into the cover main body 24A, the storage portion 28 can be expanded substantially uniformly along the axial direction, and the outer surface 15a of the balloon 15 that is the protected member 14 and the inner surface 28a of the storage portion 28 can be expanded. It is necessary to form a gap G (see FIG. 4A) over the entire circumference in the circumferential direction. For this reason, it is preferable that the peripheral wall part 32 has moderate rigidity which can deform | transform in radial direction, but does not have elastic elasticity like rubber | gum.

  Examples of the constituent material of the peripheral wall 32 include polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polychlorinated salt, and the like. Examples thereof include polymer materials such as vinyl, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, and fluororesin, and mixtures thereof.

  The stretchable portion 34 is made of a material having elastic stretchability, and is disposed between both circumferential edges of the peripheral wall portion 32. Further, the stretchable portion 34 extends over the entire length of the cover body 24A along the axial direction of the cover body 24A. Both ends in the circumferential direction of the stretchable part 34 are fixed to both end edges in the circumferential direction of the peripheral wall part 32.

  Examples of the constituent material of the stretchable part 34 include various rubber materials such as natural rubber, butyl rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, and silicone rubber, and polyurethane, polyester, polyamide, olefin, and styrene. Examples thereof include various thermoplastic elastomers such as systems, or mixtures thereof.

  The cover main body 24B according to the second configuration example shown in FIG. 2B is obtained by adding one or more reinforcing bodies 36 to the cover main body 24A shown in FIG. 2A. In FIG. 2B, a plurality of reinforcing bodies 36 are embedded in the peripheral wall portion 32 at intervals in the circumferential direction and along the axial direction of the cover main body 24B. The reinforcing body 36 is made of a material (for example, a metal material) having higher rigidity than the peripheral wall portion 32.

  According to the cover main body 24B configured as described above, the reinforcement body 36 is provided, so that the expansion force due to the insertion of the operation member 26 is extended to the end opposite to the side where the operation member 26 is inserted. Easy to communicate. As a result, the cover main body 24 </ b> B can be reliably expanded along with the insertion of the operation member 26. The reinforcing body 36 may be fixed to the outer surface of the peripheral wall portion 32. Only one reinforcing body 36 may be provided.

  The cover main body 24C according to the third configuration example shown in FIG. 2C includes a peripheral wall portion 32 in which a cutout portion 33 extending in the axial direction is formed, and an outer surface of the peripheral wall portion 32 straddling the cutout portion 33 of the peripheral wall portion 32. And a plurality of stretchable portions 38 fixed to each other. The configuration of the peripheral wall portion 32 of the cover main body 24C is the same as that of the peripheral wall portion 32 of the cover main body 24A. The plurality of extendable portions 38 are arranged at intervals in the axial direction of the cover main body 24C. Each expansion / contraction part 38 is a member having elastic elasticity composed of the same material as the expansion / contraction part 34 shown in FIG. 2A.

  Note that only one stretchable part 38 may be provided. The elastic part 38 may be configured in a ring shape that goes around the peripheral wall part 32. In the cover main body 24C, in order to make it difficult to damage the outer surface 15a of the balloon 15 housed inside, the radially inner end edge of the end surface forming the cutout portion 33 of the peripheral wall portion 32 may be rounded.

  The cover main body 24D according to the fourth configuration example illustrated in FIG. 2D includes a peripheral wall portion 32 having the same configuration as the peripheral wall portion 32 illustrated in FIG. 2C and an expansion sleeve 40 (expansion / contraction portion) that covers the peripheral wall portion 32. The expansion / contraction sleeve 40 is a member having elastic elasticity and made of the same material as the expansion / contraction part 34 described above. When the operation member 26 is inserted, the peripheral wall portion 32 is expanded in the radial direction, and the extendable sleeve 40 extends in the circumferential direction, whereby the cover body 24D is expanded in the radial direction.

  In FIG. 1, the operation member 26 is a member that can be fitted to the cover main body 24 and operates expansion / contraction of the cover main body 24. In the present embodiment, the operation member 26 includes a body portion 42 and a distal end insertion portion 44 provided at the distal end of the body portion 42, and the outer surface of the body portion 42 slides and fits on the inner surface of the cover body 24. Is possible.

  The outer diameter of the body portion 42 is larger than the inner diameter of the storage portion 28 of the cover main body 24 in a natural state (a state where no external force is acting), and the inner diameter (second inner diameter portion) of the insertion guide portion 30 of the cover main body 24. Smaller than the diameter of the opening 24b). The distal end insertion portion 44 has a tapered outer surface 45 that is continuous with the outer surface of the body portion 42 and has an outer diameter that decreases toward the distal direction.

  Next, with reference to FIGS. 3A to 3C, a method for manufacturing the medical device set 10 </ b> A configured as described above (particularly, an assembling process for attaching the protective cover 16 </ b> A to the distal end portion of the balloon catheter 13) will be described.

  In the case of the present embodiment, the method for manufacturing the medical device set 10A includes a providing step (FIG. 3A), an arranging step (3B), and a contracting step (FIG. 3C).

  As shown in FIG. 3A, in the providing step, the cover body 24 is expanded by the operation member 26 to provide the protective cover 16 </ b> A in which the inner diameter of the storage portion 28 is larger than the outer diameter of the balloon 15. In this case, specifically, the operation member 26 is inserted into the cover main body 24 through the second opening 24b. At this time, the operation member 26 can be smoothly inserted inside the storage portion 28 of the cover body 24 by the tapered inner surface 31 of the insertion guide portion 30 and the tapered outer surface 45 of the distal end insertion portion 44.

  Next, an arrangement step is performed. As shown in FIG. 3B, in the placement step, the balloon 15 is placed inside the storage portion 28 by moving the balloon 15 relative to the protective cover 16A and the operation member 26 in the axial direction. In this case, specifically, the distal end portion of the balloon catheter 13 and the stylet 20 are inserted into the storage portion 28 of the cover body 24 through the first opening 24a.

  At this time, since the balloon 15 is inserted into the storage portion 28 without the outer surface 15a of the balloon 15 being in contact with the inner surface 28a of the storage portion 28, when the balloon 15 is placed inside the storage portion 28, the balloon 15 An annular gap G is formed between the outer surface 15 a and the inner surface 28 a of the storage portion 28. For this reason, friction does not occur between the outer surface 15 a of the balloon 15 and the inner surface 28 a of the storage portion 28. Therefore, the medicine M applied to the outer surface 15a of the balloon 15 is not peeled off, and the outer surface 15a of the balloon 15 is not damaged.

  Next, a contraction step is performed. As shown in FIG. 3C, in the deflation step, the operation member 26 is detached from the cover body 24 in a state where the balloon 15 is disposed inside the storage portion 28, so that the cover body 24 is deflated, and the outer surface 15 a of the balloon 15 The inner surface of the cover main body 24 is brought into contact. In this case, specifically, the operation member 26 is pulled out from the cover body 24 by moving the operation member 26 relative to the cover body 24 in the direction opposite to the balloon 15. Thereby, the inner surface 28a of the storage part 28 moves toward the outer surface 15a side of the balloon 15 as the diameter of the cover main body 24 is reduced by the elastic restoring force of the cover main body 24 itself, and the inner surface 28a of the storage part 28 moves. It reaches a state in contact with the outer surface 15 a of the balloon 15.

  As described above, the medical device set 10A shown in FIG. 1 is completed.

  When using the medical device set 10 </ b> A, the protective cover 16 </ b> A is removed from the distal end portion of the balloon catheter 13 (medical long body 12). In the case of this embodiment, the method of removing the protective cover 16A includes an expansion step (FIG. 4A) and a removal step (FIG. 4B).

  In the expansion step, as shown in FIG. 4A, the inner surface 28 a of the storage portion 28 is separated from the outer surface 15 a of the balloon 15 by attaching the operation member 26 to the cover body 24. In this case, specifically, the operation member 26 is inserted inside the storage portion 28 of the cover main body 24 through the second opening 24b, so that the storage portion 28 is pushed out from the inside. Thereby, an annular gap G extending over the entire circumference in the circumferential direction is formed between the outer surface 15 a of the balloon 15 and the inner surface 28 a of the storage portion 28.

  Next, an extraction step is performed. As shown in FIG. 4B, in the removal step, the balloon 15 is moved out of the cover body 24 through the first opening 24 a by moving the balloon 15 in the axial direction relative to the cover body 24. At this time, since the outer surface 15a of the balloon 15 is brought out of the cover body 24 without contacting the inner surface 28a of the storage portion 28, the balloon 15 is disposed between the outer surface 15a of the balloon 15 and the inner surface 28a of the storage portion 28. There is no friction. Therefore, the medicine M applied to the outer surface 15a of the balloon 15 is not peeled off, and the outer surface 15a of the balloon 15 is not damaged.

  As described above, according to the protective cover 16A, when the protected member 14 is covered with the protective cover 16A in the manufacturing process, the cover main body 24 is expanded by the operation member 26 and the protected member 14 is placed in the storage portion 28. When the fitting of the operation member 26 to the cover body 24 is released, the cover body 24 is reduced in diameter by its own elastic restoring force, and the inner surface 28a of the storage portion 28 contacts the outer surface of the protected member 14. To do. As a result, the protected member 14 can be covered with the protective cover 16 </ b> A without causing friction between the outer surface of the protected member 14 and the inner surface 28 a of the storage portion 28.

  Further, when removing the protective cover 16 </ b> A from the distal end portion of the medical elongated body 12, the inner surface 28 a of the storage portion 28 is separated from the outer surface of the protected member 14 by fitting the operation member 26 to the cover body 24. After that, the protected member 14 is taken out of the cover body 24. Thereby, the protective cover 16 </ b> A can be removed without causing friction between the outer surface of the protected member 14 and the inner surface 28 a of the storage portion 28.

  In particular, in the case of the present embodiment, the operation member 26 can be fitted to the inner surface forming the inner cavity of the cover main body 24, and the operation member 26 is covered by the fitting of the operation member 26 to the cover main body 24. The main body 24 is pushed from the inside. With this configuration, the diameter of the cover main body 24 can be reliably expanded by a simple operation.

  In the case of the present embodiment, the cover body 24 is fixedly disposed on the peripheral wall portion 32 that surrounds the lumen in the cover main body 24 in a range excluding a part in the circumferential direction, and the portion of the peripheral wall portion 32 that does not surround the lumen. Or it has the elastic part 34 which has elastic elastic property fixed to the surrounding wall part 32 ranging over the part. With this configuration, the cover body 24 that can be expanded and contracted in the radial direction with elastic deformation can be constructed with a simple configuration.

  According to the manufacturing method of the medical device set 10A, the protected member 14 can be covered with the protective cover 16A without generating friction between the outer surface of the protected member 14 and the inner surface 28a of the storage portion 28. In particular, in the case of the present embodiment, the protected member 14 is relatively moved in the axial direction with respect to the protective cover 16 </ b> A and the operation member 26 in the arrangement step, so that the protected member 14 is easily arranged inside the storage portion 28. be able to.

[Second Embodiment]
A medical device set 10B illustrated in FIG. 5 includes a balloon catheter 13 as an example of the medical long body 12 and a protective cover 16B according to the second embodiment. In the initial state of the medical device set 10B shown in FIG. 5, the stylet 52 is inserted through the lumen of the catheter shaft 18, and the distal end of the stylet 52 protrudes from the catheter shaft 18 in the distal direction and the protective cover 16B The operation member 54 is fixedly held. Unlike the stylet 20 shown in FIG. 1, the tip of the stylet 52 shown in FIG. 5 is not provided with a ring-shaped gripping portion.

  In the present embodiment, the operation member 54 is a hollow member (for example, a hollow cylindrical member) having a rod-like body portion 56 and a holding portion 58 provided at the distal end portion of the body portion 56. The holding part 58 is configured to hold and release the stylet 52.

  As shown in FIG. 6, the holding portion 58 has a plurality of slits 60 at intervals in the circumferential direction, and a plurality of holding arms 62 between the slits 60. That is, the plurality of holding arms 62 are arranged at intervals in the circumferential direction via the slit 60. The slit 60 extends in the axial direction of the operation member 54, penetrates the inside and outside of the holding portion 58 in the radial direction, and opens at the tip of the holding portion 58.

  The holding arm 62 is elastically deformable in the radial direction. The holding arm 62 has a first tapered outer surface 64 that increases in diameter from the distal end surface of the holding arm 62 toward the proximal direction, and is provided closer to the proximal end than the first tapered outer surface 64 and decreases in diameter toward the proximal direction. A second tapered outer surface 66. The outer diameter of the plurality of holding arms 62 in the natural state (the outer diameter at the base end position of the first taper outer surface 64) is slightly larger than the inner diameter of the storage portion 28 of the cover body 24 in the natural state.

  The base end of the second tapered outer surface 66 (the minimum outer diameter portion of the second tapered outer surface 66) is continuous with the body portion 56. In FIG. 6, the base end of the first taper outer surface 64 and the tip of the second taper outer surface 66 are directly connected, but the outer diameter in the axial direction is between the first taper outer surface 64 and the second taper outer surface 66. May be provided with a constant straight portion.

  The inner surface of the tip of each holding arm 62 is a contact surface 62 a that contacts the outer surface of the stylet 52. A plurality of contact surfaces 62a arranged in the circumferential direction form an insertion hole 68 through which the stylet 52 can be inserted. In the natural state of the holding arm 62, the diameter of the insertion hole 68 is substantially the same as or slightly larger than the outer diameter of the stylet 52.

  Next, with reference to FIGS. 7A to 7D, a method for manufacturing the medical device set 10 </ b> B configured as described above (in particular, an assembling process for attaching the protective cover 16 </ b> B to the distal end portion of the balloon catheter 13) will be described.

  In the case of this embodiment, the manufacturing method includes a providing step (FIG. 7A), an inserting step (FIG. 7B), an arranging step (7C), and a contracting step (FIG. 7D).

  As shown in FIG. 7A, in the providing step, the cover body 24 is expanded by the operation member 54 to provide the protective cover 16 </ b> B in which the inner diameter of the storage portion 28 is larger than the outer diameter of the balloon 15. In this case, the holding portion 58 is protruded from the first opening 24a of the cover body 24 to which the operation member 54 is attached. The operation member 54 can be inserted into the cover main body 24 through the first opening 24a or the second opening 24b. When the operation member 54 is inserted into the cover main body 24 through the second opening 24b, the operation member 54 is smoothly inserted by the tapered inner surface 31 of the insertion guide portion 30 and the first tapered outer surface 64 of the holding portion 58. be able to.

  Next, an insertion step is performed. As shown in FIG. 7B, in the insertion step, the stylet 52 protruding from the distal end of the catheter shaft 18 is inserted into the insertion hole 68 of the holding portion 58. In this case, since the holding part 58 is located outside the storage part 28, it is not pressed from the outside by the storage part 28. Therefore, the tip of the stylet 52 can be inserted into the insertion hole 68 (see FIG. 6) without any trouble.

  Next, an arrangement step is performed. As shown in FIG. 7C, in the disposing step, the cover body 24 is moved relative to the operation member 54 in the axial direction, thereby pressing the holding portion 58 from the outside with the cover main body 24 to put the stylet 52 on the holding portion 58. The balloon 15 is placed inside the storage portion 28 while being fixedly held. FIG. 7C shows the cover main body 24 immediately before the operation member 54 is removed from the storage portion 28.

  Specifically, in the placement step, as the holding portion 58 enters the storage portion 28, the holding portion 58 is pushed inward by the storage portion 28 and elastically deformed, so that the plurality of holding arms 62 are styled. The let 52 is gripped. The holding portion 58 is smoothly introduced into the storage portion 28 by the taper action of the second taper outer surface 66.

  In the placement step, the outer surface 15a of the balloon 15 is not brought into contact with the inner surface 28a of the storage portion 28, and the balloon 15 is inserted into the storage portion 28. Therefore, when the balloon 15 is placed inside the storage portion 28, the balloon 15 Friction does not occur between the outer surface 15a and the inner surface 28a of the storage portion 28. Therefore, the medicine M applied to the outer surface 15a of the balloon 15 is not peeled off, and the outer surface 15a of the balloon 15 is not damaged.

  In the arrangement step, the position of the cover body 24 may be fixed and the operation member 54 may be moved in the axial direction.

  Next, a contraction step is performed. As shown in FIG. 7D, in the contraction step, the cover body 24 is contracted by detaching the operation member 54 from the cover body 24 in a state where the balloon 15 is disposed inside the storage portion 28, and the outer surface 15 a of the balloon 15. The inner surface of the cover body 24 (the inner surface 28a of the storage portion 28) is brought into contact.

  In this case, specifically, the operation member 54 is pulled out of the cover body 24 by moving the operation member 54 relative to the cover body 24 in the direction opposite to the balloon 15. Thereby, the inner surface 28a of the storage part 28 moves toward the outer surface 15a side of the balloon 15 as the diameter of the cover main body 24 is reduced by the elastic restoring force of the cover main body 24 itself, and the inner surface 28a of the storage part 28 moves. It reaches a state in contact with the outer surface 15 a of the balloon 15.

  As described above, the medical device set 10B shown in FIG. 5 is completed.

  When using the medical device set 10B, the protective cover 16B is removed from the distal end portion of the balloon catheter 13 (long medical body 12). In the case of this embodiment, the method for removing the protective cover 16B includes an expansion step (FIG. 8A) and a removal step (FIG. 8B).

  In the expansion step, as shown in FIG. 8A, the operation member 54 is attached to the cover body 24 to separate the inner surface 28 a of the storage portion 28 from the outer surface 15 a of the balloon 15. In this case, specifically, by inserting the operation member 54 inside the storage portion 28 of the cover main body 24 through the second opening 24b, the storage portion 28 is pushed out from the inside. Thereby, an annular gap G extending over the entire circumference in the circumferential direction is formed between the outer surface 15 a of the balloon 15 and the inner surface 28 a of the storage portion 28.

  Next, an extraction step is performed. As shown in FIG. 8B, in the removal step, the balloon 15 is moved out of the cover body 24 through the first opening 24a by moving the balloon 15 in the axial direction relative to the cover body 24. At this time, since the outer surface 15a of the balloon 15 is brought out of the cover body 24 without contacting the inner surface 28a of the storage portion 28, the balloon 15 is disposed between the outer surface 15a of the balloon 15 and the inner surface 28a of the storage portion 28. There is no friction. Therefore, the medicine M applied to the outer surface 15a of the balloon 15 is not peeled off, and the outer surface 15a of the balloon 15 is not damaged.

  As described above, according to the protective cover 16B, when the protected member 14 is covered with the protective cover 16B in the manufacturing process, the cover main body 24 is expanded by the operation member 54 and the protected member 14 is placed in the storage portion 28. When the fitting of the operation member 54 to the cover body 24 is released, the cover body 24 is reduced in diameter by its own elastic restoring force, and the inner surface 28 a of the storage portion 28 contacts the outer surface of the protected member 14. To do. Accordingly, the protected member 14 can be covered with the protective cover 16B without generating friction between the outer surface of the protected member 14 and the inner surface 28a of the storage portion 28.

  Further, when the protective cover 16B is removed from the distal end portion of the medical elongated body 12, the inner surface 28a of the storage portion 28 is separated from the outer surface of the protected member 14 by fitting the operation member 54 to the cover body 24. After that, the protected member 14 is taken out of the cover body 24. Thereby, the protective cover 16B can be removed without generating friction between the outer surface of the protected member 14 and the inner surface 28a of the storage portion 28.

  In particular, in the case of the present embodiment, in the assembly process of attaching the protective cover 16B to the distal end portion of the medical elongated body 12, the cover main body 24 is moved with respect to the operation member 54 with the stylet 52 inserted into the holding portion 58. When the relative movement is performed in the axial direction, the holding portion 58 holds the stylet 52 in a fixed manner. Thereby, the protected member 14 can be easily disposed inside the storage portion 28.

  Further, when the protective cover 16B is removed from the distal end portion of the medical elongated body 12, when the fitting of the operation member 54 to the cover body 24 is released, the holding portion 58 fixes and holds the stylet 52. Accordingly, it is possible to smoothly remove the stylet 52 from the medical long body 12.

  According to the manufacturing method of the medical device set 10B according to the present embodiment, the protected member 14 can be covered with the protective cover 16B without generating friction between the outer surface of the protected member 14 and the inner surface 28a of the storage portion 28. .

  In particular, in the case of the present embodiment, the stylet 52 is fixedly held by the holding portion 58 as the operation member 54 moves relative to the cover body 24, and the medical elongated body in a state in which the stylet 52 is inserted. Twelve protected members 14 are arranged inside the storage portion 28. Therefore, the protected member 14 can be easily disposed inside the storage portion 28.

  In the second embodiment, the same or similar operations and effects as those in the first embodiment can be obtained for the same or similar portions as those in the first embodiment.

  The medical device set 10C shown in FIG. 9 differs from the medical device set 10A shown in FIG. 1 in the configuration of the protective cover 16C. Specifically, the protective cover 16C is obtained by adding a connecting portion 70 that connects the cover main body 24 and the operation member 26 to the protective cover 16A so as to be relatively movable in the axial direction.

  In FIG. 9, the connecting portion 70 includes a hollow cylindrical portion 72 extending from the insertion guide portion 30 of the cover main body 24 in the direction opposite to the storage portion 28, and a support pin 74 fixed in the cylindrical portion 72. The cylindrical portion 72 is preferably configured to be expandable / reducible in the radial direction so as not to hinder the function of the cover body 24 that can be expanded / reduced in the radial direction. In this case, an expansion / contraction part (the expansion / contraction part 34, the expansion / contraction part 38 or the expansion / contraction sleeve 40) made of an elastic material may be provided in a part of the cylindrical part 72 in the circumferential direction. Alternatively, a slit may be provided in a part of the cylindrical portion 72 in the circumferential direction, so that the cylindrical portion 72 may be configured to be able to expand and contract in the radial direction.

  The support pin 74 is inserted into an elongated guide hole 76 provided in the operation member 26 along the axial direction. The operation member 26 can move in the axial direction relative to the cover body 24 by an amount corresponding to the length of the guide hole 76.

  As described above, in the medical device set 10 </ b> C, since the connecting portion 70 configured as described above is provided, the cover main body 24 and the operation member 26 can be handled integrally. Therefore, the operation for removing the protective cover 16C from the distal end portion of the medical elongated body 12 (operation for inserting the operation member 26 into the cover main body 24) can be performed quickly and smoothly.

  The protective cover 16D in the medical device set 10D shown in FIG. 10 includes a connecting portion 80 having a configuration different from that of the connecting portion 70 of the protective cover 16C. The connecting portion 80 also connects the cover body 24 and the operation member 26 so as to be relatively movable in the axial direction. The connecting portion 80 extends from the insertion guide portion 30 of the cover body 24 in the direction opposite to the storage portion 28 and has a hollow cylindrical portion 82 in which a first screw portion 83 is formed, and a first screw formed on the operation member 26. A second screw portion 84 screwed with the portion 83;

  The cylindrical portion 82 is preferably configured to be expandable / reducible in the radial direction so as not to hinder the function of the cover body 24 that can be expanded / reduced in the radial direction. In this case, an expansion / contraction part (the expansion / contraction part 34, the expansion / contraction part 38 or the expansion / contraction sleeve 40) made of an elastic material may be provided in a part of the cylindrical part 82 in the circumferential direction. Alternatively, a slit may be provided in a part of the cylindrical portion 82 in the circumferential direction, so that the cylindrical portion 82 may be configured to be able to expand and contract in the radial direction.

  In FIG. 10, the first screw portion 83 is a female screw formed on the inner surface of the cylindrical portion 82, and the second screw portion 84 is a male screw formed on the outer surface of the operation member 26. A male screw is formed as the first screw portion 83 on the outer surface of the cylindrical portion 82, and an annular wall having a shape covering the cylindrical portion 82 is provided on the outer surface of the operation member 26, and the second screw portion 84 is provided on the inner surface of the annular wall. An internal thread may be formed.

  In the protective cover 16D, when the operation member 26 is rotated with respect to the cover body 24 about the longitudinal axis of the cover body 24, the cover body is engaged under the screwing action of the first screw portion 83 and the second screw portion 84. 24, the operating member 26 moves in the axial direction.

  Thus, in the medical device set 10 </ b> D, since the connecting portion 80 configured as described above is provided, the cover body 24 and the operation member 26 can be handled integrally. Therefore, the operation for removing the protective cover 16D from the distal end portion of the medical elongated body 12 (operation for inserting the operation member 26 into the cover main body 24) can be performed quickly and smoothly.

  In addition, in the protective cover 16B of the medical device set 10B shown in FIG. 5, the connection part 70 shown in FIG. 9 or the connection part 80 shown in FIG. 10 may be provided.

  In the cover body 24, the second opening 24b may not be provided. In this case, for example, the cover main body 24 is configured to have a length that accommodates the entire length of the operation member 26 (or the operation member 54), and the user can touch the operation member 26 (or the operation member 54) with a finger during operation. An operation element may be provided so as to penetrate the peripheral wall portion of the cover main body 24 and be exposed to the outside of the cover main body 24.

  In the above description, the present invention has been described with reference to preferred embodiments. However, the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the present invention. Yes.

DESCRIPTION OF SYMBOLS 10A-10D ... Medical device set 12 ... Medical long body 13 ... Balloon catheter 14 ... Protected member 15 ... Balloon 16A-16D ... Protective cover 20, 52 ... Stylet 24, 24A-24D ... Cover body 26, 54 ... Operation member 28 ... storage part 58 ... holding part 70, 80 ... connecting part

Claims (9)

A protective cover for protecting a protected member provided at the distal end portion by covering the distal end portion of the medical elongated body,
It has a storage part for storing the protected member, has a first opening at one end in the axial direction, has a second opening at the other end in the axial direction, and can be expanded or contracted in the radial direction with elastic deformation. A hollow cover body;
An operation member that can be fitted to the cover main body and operates expansion / contraction of the cover main body,
The first opening is an opening for inserting and removing the protected member from the storage unit via the first opening.
In the cover main body, the operation member moves from the second opening side toward the first opening side with respect to the cover main body, and one end of the operation member is between the first opening and the second opening. Expanded by fitting the operating member to the cover body accompanying insertion to the middle part of the cover, and contracted by releasing the fitting,
Protective cover characterized by that. The protective cover according to claim 1,
The operation member can be fitted to an inner surface forming a lumen of the cover body,
With the fitting of the operation member to the cover body, the operation member spreads the cover body from the inside,
Protective cover characterized by that. A protective cover for protecting a protected member provided at the distal end portion by covering the distal end portion of the medical elongated body,
A hollow cover main body having a storage portion for storing the protected member, having an opening at one end in the axial direction, and capable of expanding and contracting in the radial direction with elastic deformation;
An operation member that can be fitted to the cover main body and operates expansion / contraction of the cover main body,
The cover body is expanded by fitting the operation member to the cover body, and contracted by releasing the fitting,
The cover main body is fixedly disposed on a peripheral wall portion surrounding the lumen of the cover main body in a range excluding a part in the circumferential direction, and a portion of the peripheral wall portion that does not surround the lumen, or the peripheral wall portion straddling the portion And an elastic part having elastic elasticity fixed to,
Protective cover characterized by that. A protective cover for protecting a protected member provided at the distal end portion by covering the distal end portion of the medical elongated body,
A hollow cover main body having a storage portion for storing the protected member, having an opening at one end in the axial direction, and capable of expanding and contracting in the radial direction with elastic deformation;
An operation member that can be fitted to the cover main body and operates expansion / contraction of the cover main body,
The cover body is expanded by fitting the operation member to the cover body, and contracted by releasing the fitting,
The operation member has a holding portion that can be inserted into the medical elongated body and can hold and release a stylet protruding from the distal end of the medical elongated body,
The holding part is fixedly held by the cover body when pressed from the outside when positioned inside the storage part, and the stylet is released when positioned outside the storage part. To
Protective cover characterized by that. A protective cover for protecting a protected member provided at the distal end portion by covering the distal end portion of the medical elongated body,
A hollow cover main body having a storage portion for storing the protected member, having an opening at one end in the axial direction, and capable of expanding and contracting in the radial direction with elastic deformation;
An operation member that can be fitted to the cover main body and operates expansion / contraction of the cover main body,
The cover body is expanded by fitting the operation member to the cover body, and contracted by releasing the fitting,
A connecting portion that connects the cover body and the operation member so as to be relatively movable in the axial direction;
Protective cover characterized by that. In the protective cover of any one of Claims 1-5,
The storage portion has an inner surface that is in contact with the protected member in a state where the protected member is stored in the storage portion and has a constant inner diameter along the axial direction.
The cover main body further includes an insertion guide portion provided at one end of the storage portion,
The insertion guide portion is formed with a tapered inner surface that decreases in diameter toward the storage portion.
Protective cover characterized by that. A method for producing a medical device set, comprising: a medical elongated body provided with a protected member at a distal end portion; and a protective cover for protecting the protected member by covering the distal end portion,
The protective cover is
A hollow having a housing portion for housing the protected member, a first opening at one end in the axial direction, a second opening at the other end in the axial direction, and being radially expandable / contractable with elastic deformation Shaped cover body,
An operation member that can be fitted to the cover body and operates expansion / contraction of the cover body,
The manufacturing method includes:
The operating member is moved from the second opening side toward the first opening side with respect to the cover body, and one end of the operating member is inserted to an intermediate portion between the first opening and the second opening. a providing step of providing the protective cover was greater state than the outer diameter of an inner diameter the protected member of the housing portion by the cover body is expanded by,
After the providing step, the operation member is fitted to the cover body in a state in which the member to be protected is disposed inside the storage portion by inserting the member to be protected into the storage portion through the first opening. A contraction step of contracting the cover main body by releasing the contact and bringing the outer surface of the protected member into contact with the inner surface of the cover main body,
A method of manufacturing a medical device set characterized by the above. A method for producing a medical device set, comprising: a medical elongated body provided with a protected member at a distal end portion; and a protective cover for protecting the protected member by covering the distal end portion,
The protective cover has a housing portion that houses the protected member, and has a hollow cover body that has an opening at one end in the axial direction and can be expanded and contracted in a radial direction with elastic deformation, and the cover body. An operation member that can be fitted and operates to expand and contract the cover body,
The manufacturing method includes:
Providing the protective cover with the cover body expanded by the operation member so that the inner diameter of the storage portion is larger than the outer diameter of the protected member;
After the providing step, the cover body is contracted by releasing the fitting of the operation member to the cover body in a state where the protected member is disposed inside the storage portion, and the outer surface of the protected member And a shrinking step for contacting the inner surface of the cover body,
Arrangement that arranges the protected member inside the storage portion by moving the protected member relative to the protective cover and the operation member in the axial direction between the providing step and the contracting step. Having steps,
A method of manufacturing a medical device set characterized by the above. A method for producing a medical device set, comprising: a medical elongated body provided with a protected member at a distal end portion; and a protective cover for protecting the protected member by covering the distal end portion,
The protective cover has a housing portion that houses the protected member, and has a hollow cover body that has an opening at one end in the axial direction and can be expanded and contracted in a radial direction with elastic deformation, and the cover body. An operation member that can be fitted and operates to expand and contract the cover body,
The manufacturing method includes:
Providing the protective cover with the cover body expanded by the operation member so that the inner diameter of the storage portion is larger than the outer diameter of the protected member;
After the providing step, the cover body is contracted by releasing the fitting of the operation member to the cover body in a state where the protected member is disposed inside the storage portion, and the outer surface of the protected member And a shrinking step for contacting the inner surface of the cover body,
The operating member has a holding portion capable of holding and releasing a stylet,
In the providing step, a state in which the holding portion is protruded from the opening of the cover main body fitted with the operation member is provided,
The manufacturing method further includes:
An insertion step of inserting the stylet inserted into the medical elongated body and protruding from the distal end of the medical elongated body into the holding portion;
After the inserting step, the cover main body is moved relative to the operation member in the axial direction, thereby pressing the holding portion from the outside with the cover main body to fix and hold the stylet on the holding portion. And an arrangement step of arranging the protected member inside the storage portion,
The inserting step and the placing step are performed between the providing step and the contracting step.
A method of manufacturing a medical device set characterized by the above.

Images