WO2025211069A1 - Dispositif médical - Google Patents

Dispositif médical

Info

Publication number
WO2025211069A1
WO2025211069A1 PCT/JP2025/007168 JP2025007168W WO2025211069A1 WO 2025211069 A1 WO2025211069 A1 WO 2025211069A1 JP 2025007168 W JP2025007168 W JP 2025007168W WO 2025211069 A1 WO2025211069 A1 WO 2025211069A1
Authority
WO
WIPO (PCT)
Prior art keywords
medical device
main body
expansion
expansion member
coil
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/JP2025/007168
Other languages
English (en)
Japanese (ja)
Inventor
裕司 伊藤
祥吾 西村
篤史 常住
翔也 田中
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Asahi Intecc Co Ltd
Original Assignee
Asahi Intecc Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Asahi Intecc Co Ltd filed Critical Asahi Intecc Co Ltd
Publication of WO2025211069A1 publication Critical patent/WO2025211069A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators

Definitions

  • This disclosure relates to medical devices.
  • a medical device for removing the leads is used.
  • One known example of such a medical device is one in which a coil is attached to the outer periphery of a stylet wire (see, for example, Patent Document 1).
  • the lead can be removed from the body by expanding the coil inside the lead lumen and then pulling out the medical device while fixing the outer periphery of the expanded coil to the lumen wall of the lead.
  • One aspect of the medical device of the present disclosure is (1) an elongated main body; an expansion member that covers the outer periphery of the body and is expandable radially outward; the expansion member is a coil in which a wire is wound around the outer periphery of the main body, The maximum width of the wire in the first portion of the coil is smaller than the maximum width of the wire in the second portion of the coil located closer to the base end than the first portion.
  • the maximum width of the wire may gradually increase from the distal end side toward the proximal end side of the coil.
  • the expansion member can be gradually expanded from the distal end toward the proximal end.
  • the pitch of the wires in the first portion may be greater than the pitch of the wires in the second portion. According to this configuration, the maximum width of the expansion member at the first region when the expansion member is expanded can be made larger than the maximum width of the expansion member at the second region.
  • the catheter may have a radiopaque marker located distal to the first portion. According to this configuration, the position of the distal end can be easily grasped from the first portion under X-ray fluoroscopy.
  • the tip of the expansion member In the medical device according to (10) to (19), In the longitudinal direction of the main body, the tip of the expansion member may be located within 10 mm from the tip of the main body toward the base end. According to this configuration, the distal end of the expansion member is disposed near the distal end of the main body, so that the expansion member can be expanded at the distal end of the medical device.
  • the reinforcing body may be a braided body in which wires are woven. This configuration allows the main body to be reinforced while maintaining flexibility.
  • a pushing member that is movable along the longitudinal direction of the main body and pushes the proximal end of the expansion member toward the distal end;
  • the pushing member is a cylindrical body that covers the outer periphery of the main body, The area where the distal core shaft and the proximal core shaft are joined may be covered with the cylindrical body. This configuration can prevent bending stress from concentrating on the joint portion when the medical device is bent, thereby preventing the core shaft from bending at the joint portion.
  • the non-jointed portion may have a bending stiffness smaller than the bending stiffness of any of the joined portions. According to this configuration, for example, when a medical device is inserted into a portion of the lead that is highly curved, the non-bonded portion bends along the curve of the lead, thereby improving the ease with which the medical device can be passed through.
  • the expansion member may be a coil in which a wire is wound around the outer periphery of the main body. According to this configuration, the expansion member can be easily formed.
  • the non-expandable portion may have a lower X-ray transmittance than the expandable portion. According to this configuration, the position of the non-expansion portion of the expansion member can be easily ascertained under X-ray fluoroscopy.
  • One aspect of the medical device of the present disclosure is (34) An elongated main body; an expansion member that covers the outer periphery of the body and is expandable radially outward; a pushing member that is movable along the longitudinal direction of the main body and pushes the proximal end of the expansion member toward the distal end,
  • the stiffness of the proximal end of the pusher member is greater than the stiffness of the distal end of the pusher member. According to this configuration, the pushing ability of the pushing member can be improved, and the pushing force can be reliably transmitted from the base end to the tip side of the pushing member.
  • the pusher member may include a reinforcing coil surrounding the proximal end of the pusher member. This configuration makes it possible to increase the rigidity of the base end portion of the pushing member.
  • the proximal end of the pushing member may be provided with a pushing loop member. According to this configuration, the pushing member can be easily pushed toward the distal end side using forceps, tweezers, or the like.
  • the tip of the push-in loop member may be located radially inside an imaginary cylindrical surface formed by extending the outer circumferential surface of the reinforcing coil.
  • the core shaft has a first straight portion having a constant outer diameter that extends from a base end of the first tapered portion toward the base end side, The outer periphery of the first straight portion may be covered with the expanded portion. This configuration allows the expansion section to be expanded while maintaining the flexibility of the distal end of the medical device.
  • a pushing member that is movable along the longitudinal direction of the main body and pushes the proximal end of the expansion member toward the distal end;
  • the core shaft has a second tapered portion located on the proximal side of a proximal end of the first straight portion and gradually increasing in diameter toward the proximal side, and a second straight portion having a constant outer diameter and extending from the proximal end of the second tapered portion toward the proximal side,
  • the outer periphery of the second straight portion may be covered with the pushing member.
  • One aspect of the medical device of the present disclosure is (64) An elongated main body; an expansion member covering the outer periphery of the body and expandable radially outward; When the expansion member is in an expanded state, at least a portion of the expansion member is plastically deformed. According to this configuration, even if the pusher member is retracted after the expansion member is expanded, for example, the expansion member can be prevented from coming off the lumen wall of the lead.
  • the expansion member may be a coil in which a wire is wound around the outer periphery of the main body. According to this configuration, even if the pusher member is retracted after the expansion member is expanded, for example, the expansion member can be prevented from coming off the lumen wall of the lead.
  • distal side means the direction along the longitudinal direction of the main body, in the direction in which the medical device is pushed in (e.g., the distal direction of a lead).
  • Proximal side means the direction along the longitudinal direction of the main body, in the opposite direction to the distal side.
  • distal refers to the distal end of any component.
  • Proximal end refers to the proximal end of any component.
  • distal portion refers to the region between the distal end of any component and a position midway between the distal and proximal ends of that component.
  • Proximal end refers to the region up to the proximal end of any component, located proximal to the midway position.
  • dial direction refers to the direction perpendicular to the longitudinal direction of the main body.
  • FIG. 9 is a schematic cross-sectional view taken along line IX-IX in FIG. 8.
  • 1 is a schematic cross-sectional view showing one embodiment of a push-in loop member.
  • FIG. 2 is a schematic cross-sectional view showing an enlarged view of the fixing mechanism of FIG. 1 .
  • FIG. 12 is a schematic cross-sectional view showing a state when fixed by the fixing mechanism of FIG. 11 .
  • 2 is an enlarged schematic side view of the gripping member of FIG. 1;
  • FIG. FIG. 2 is a schematic cross-sectional view showing one embodiment of a gripping member.
  • FIG. 2 is a partially enlarged schematic cross-sectional view showing the first embodiment in use, in which the expansion member is not expanded within the lead.
  • FIG. 2 is a partially enlarged schematic cross-sectional view showing the state of the first embodiment during use, in which the expansion member is expanded within the lead.
  • FIG. 2 is a partially enlarged schematic cross-sectional view showing the state of the first embodiment during use, in which the expansion member is expanded within the lead.
  • FIG. 1 is a schematic diagram showing a method for measuring expansion force.
  • FIG. 10 is a conceptual diagram showing the distribution of the expansion force of the expansion member.
  • FIG. 10 is a schematic side view of the second embodiment, showing the expansion member in an unexpanded state.
  • FIG. 21 is a schematic side view showing an enlarged view of the expansion member of FIG. 20. 21 is a schematic cross-sectional view showing an enlarged portion of the expansion member of FIG. 20.
  • FIG. 1 is a schematic diagram showing a method for measuring expansion force.
  • FIG. 10 is a conceptual diagram showing the distribution of the expansion force of the expansion member.
  • FIG. 10 is a schematic side view of the second embodiment, showing the expansion member
  • FIG. 10 is a schematic side view showing an enlarged view of a portion of the third embodiment.
  • FIG. 10 is a schematic cross-sectional view showing the fourth embodiment, illustrating the expansion member in an unexpanded state.
  • FIG. 25 is a schematic cross-sectional view showing an enlarged non-expandable portion of FIG. 24 .
  • FIG. 10 is a schematic cross-sectional view showing one embodiment of a non-expandable portion.
  • FIG. 10 is a schematic side view showing an enlarged view of the expansion member of the fifth embodiment, illustrating the expansion member in an unexpanded state.
  • FIG. 28 is a schematic side view showing the expansion member of FIG. 27 in an expanded state.
  • FIG. 28 is a schematic side view showing the expansion member of FIG. 27 in an expanded state.
  • FIG. 28 is a schematic side view showing the expansion member of FIG. 27 in an expanded state.
  • FIG. 13 is a schematic side view showing one aspect of the sixth embodiment.
  • FIG. 13 is a schematic side view showing one aspect of the sixth embodiment.
  • FIG. 13 is a schematic side view showing one aspect of the sixth embodiment.
  • FIG. 13 is a schematic side view showing a fixing mechanism of the seventh embodiment.
  • FIG. 13 is a schematic cross-sectional view showing a fixing mechanism of an eighth embodiment.
  • FIG. 13 is a schematic side view of the expansion member of the ninth embodiment, showing the expansion member in an unexpanded state.
  • FIG. 36 is a schematic side view showing the expansion member of FIG. 35 in an expanded state.
  • FIG. 19 is a schematic cross-sectional view showing the expansion member of the tenth embodiment, illustrating the expansion member in an unexpanded state.
  • FIG. 38 is a schematic cross-sectional view showing the expansion member of FIG. 37 in an expanded state.
  • FIG. 23 is a schematic cross-sectional view showing the expansion member of the eleventh embodiment, illustrating the expansion member in an unexpanded state.
  • FIG. 40 is a schematic cross-sectional view showing the expansion member of FIG. 39 in an expanded state.
  • the medical device disclosed herein is, for example, a device for removing a lead placed in the body.
  • the medical device is inserted into the lumen of the lead and pushed through the lumen of the lead until the tip is positioned near the tip of the lead.
  • the pushing member is manually moved toward the distal end of the medical device by the operator (physician).
  • the tip of the pushing member pushes the base end of the expansion member toward the distal end, compressing the expansion member along the longitudinal direction. As the expansion member is compressed, it expands radially outward in the medical device.
  • the expansion member When the expansion member expands, it begins from the distal end of the expansion member, and then the expansion progresses toward the proximal end of the expansion member.
  • the distal end of the expansion member that expanded first abuts against the inner circumference of the lead, fixing the distal end of the medical device to the distal end of the lead. Then, the portion of the expansion member proximal to the distal end abuts against the inner circumference of the lead in the same manner as the distal end.
  • the operator pulls the medical device temporarily fixed to the lead toward the proximal end (toward the hand), thereby removing the lead.
  • a medical device 1 generally includes a main body 11, a tip fixation portion 21, an expansion member 31, a pushing member 41, a fixing mechanism 51, and a gripping member 61.
  • the main body 11 is a long member.
  • the main body 11 can be formed, for example, from a core shaft (hereinafter also referred to as "core shaft 11") made of a metal such as a stainless steel alloy formed into a linear shape.
  • the main body 11 may be formed, for example, so that its outer diameter varies along the longitudinal direction.
  • the portion of the main body 11 located inside the expansion member 31 is the small diameter portion 111, which has a constant outer diameter.
  • the portion of the main body 11 located more proximal than the small diameter portion 111 is the large diameter portion 112, which has a larger outer diameter than the small diameter portion 111.
  • the main body 11 extends from the tip of the expansion member 31 to the tip of the gripping member 61.
  • the material used to form the main body 11 should preferably be flexible, anti-thrombogenic, and biocompatible.
  • examples of such materials include stainless steel alloys such as SUS304 and superelastic alloys such as Ni-Ti alloys.
  • the core shaft 11 may have a distal core shaft 11A and a proximal core shaft 11B joined to the proximal end of the distal core shaft 11A and extending toward the proximal end.
  • the bending rigidity of the proximal core shaft 11B may be greater than the bending rigidity of the distal core shaft 11A. This allows the medical device 1 to be pushed forward so that the distal end of the medical device 1 can easily follow the inner lumen of the lead that curves inside the body, while maintaining the pushability of the medical device 1.
  • the distal core shaft 11A may be formed from a Ni-Ti alloy
  • the proximal core shaft 11B may be formed from a stainless steel alloy.
  • the rigidity of a Ni-Ti alloy is less than that of a stainless steel alloy. This allows for the excellent pushability and tracking ability described above to be achieved.
  • the joint portion 11a where the distal core shaft 11A and the proximal core shaft 11B are joined may be covered by the tubular body 41.
  • the joint portion 11a between the distal core shaft 11A and the proximal core shaft 11B may always be located in the inner cavity 41h of the tubular body 41. Covering the joint portion 11a with the tubular body 41 can prevent bending stress from concentrating on the joint portion 11a when the medical device 1 is bent. As a result, bending of the core shaft at the joint portion 11a can be prevented.
  • the tip fixing portion 21 is the portion where the tip of the main body 11 and the tip of the expansion member 31 are integrally fixed. As shown in Figure 3, the tip fixing portion 21 can be specifically formed, for example, so that its tip has a generally hemispherical shape that is convexly curved toward the tip. This can reduce resistance when the medical device 1 advances through the lumen of the lead, for example. As a result, the medical device 1 can be smoothly inserted into the lumen of the lead.
  • the tip fixing portion 21 can be formed, for example, by melting a portion of the material that forms the core shaft 11 and/or the expansion member 31 (e.g., a coil), or by joining the core shaft 11 and the expansion member 31 using brazing or soldering material.
  • brazing and soldering materials include alloys such as Sn-Pb alloy, Pb-Ag alloy, Sn-Ag alloy, and Au-Sn alloy.
  • the expansion member 31 is a member that covers the outer periphery of the main body 11 and is expandable radially outward. As shown in Figure 3, the expansion member 31 may specifically be formed, for example, as a coil (hereinafter also referred to as "coil 31") in which a wire w1 is wound around the outer periphery of the main body 11. This makes it easy to form the expansion member 31.
  • coil 31 a coil in which a wire w1 is wound around the outer periphery of the main body 11. This makes it easy to form the expansion member 31.
  • the wire w1 forming the coil 31 can be, for example, at least one of a solid wire and a twisted wire.
  • a solid wire refers to a single, single wire.
  • a twisted wire refers to a bundle of wires formed by twisting multiple single wires together in advance.
  • the coil 31 can be formed by winding the wire w1 in at least one of a single-strand and multiple-strand configuration.
  • the wire w1 may have, for example, a circular cross section.
  • the wire w1 may also have a rectangular cross section. In the medical device 1, the wire w1 is a single wire with a circular cross section.
  • the coil 31 is a four-strand coil formed by winding four wires w1 together.
  • the wires w1 may have radiopaque portions (e.g., radiopaque wires w11). All of the wires w1 forming the coil 31 may be radiopaque wires w11. Only some of the wires w1 may be radiopaque wires w11. In this embodiment, only one of the four wires w1 is formed from a radiopaque wire w11 (for convenience, in Figure 4, only the single radiopaque wire w11 is shown painted black). Examples of radiopaque materials include metals such as gold, platinum, tungsten, and lead, as well as materials containing these metals. This makes it easy to determine the position of the expansion member 31 under X-ray fluoroscopy.
  • radiopaque materials include metals such as gold, platinum, tungsten, and lead, as well as materials containing these metals. This makes it easy to determine the position of the expansion member 31 under X-ray fluoroscopy.
  • the pitch p1 of the wires w1 in the first region 31A is greater than the pitch p2 of the wires w1 in the second region 31B. This allows the maximum width D1 of the expansion member 31 at the first region 31A when expanded to be greater than the maximum width D2 of the expansion member 31 at the second region 31B when not inserted into a lumen such as a lead 80.
  • the "maximum width of the expansion member” refers to the maximum radial dimension of the expansion member.
  • the tip of the pushing loop member 412m may be positioned radially inside an imaginary cylindrical surface f that is an extension of the outer peripheral surface of the reinforcing coil 411. This prevents the tip of the pushing loop member 412m from getting caught on the lumen wall 80a of the lead 80 and impeding the advancement of the medical device when the medical device is pushed into the lead 80.
  • the main body 11 may have a first marker 511 at a location distal to the tip of the fixing mechanism 51.
  • the main body 11 may also have a second marker 512 at a location proximal to the base end of the fixing mechanism 51.
  • the first and second markers 511, 512 are not particularly limited as long as the operator can identify their positions.
  • the color of the first and second markers 511, 512 may be different from the color of other parts (e.g., the pushing member 41, the gripping member 61, etc.) so that the positions of the markers can be visually confirmed.
  • the tactile feel of the first and second markers 511, 512 may be different from the tactile feel of other parts.
  • the first marker 511 and the second marker 512 may each be a metal oxide coating formed on the surface of the main body 11.
  • the metal oxide coating can be formed, for example, by forming the main body 11 from a metal material such as a stainless steel alloy or a nickel-titanium alloy, and heat-treating the surface of this metal material in an oxidizing atmosphere.
  • the color of the metal oxide coating may be different from the color of the metal of the main body 11.
  • the tactile feel of the metal oxide coating may be different from the tactile feel of the metal of the main body 11. This makes it easy to form the first and second markers 511, 512.
  • the expansion member 31 is expanded radially outward, and the expansion member 31 is fixed to the lead 80. Specifically, while the tip of the pushing member 41 abuts against the base end of the expansion member 31, the pushing member 41 is further moved toward the tip along the longitudinal direction of the main body 11. At this time, as shown in FIG. 16, the expansion member 31 begins to expand radially outward from the first portion 31A. As shown in FIG. 17, by moving the pushing member 41 further toward the tip, the second portion 31B expands. When the expansion member 31 is in an expanded state, the outer periphery of the expansion member 31 (first portion 31A) abuts against the inner periphery (inner cavity wall 80a) of the lead 80 distal to the second electrode 82.
  • the medical device 1 is equipped with a pushing member 41.
  • the pushing member 41 can compress the expansion member 31 along the longitudinal direction of the main body 11, ensuring reliable expansion of the expansion member 31.
  • the non-expandable portion 322 has a joint portion 322a and a non-joint portion 322b.
  • the tip and base ends of the non-expandable portion 322 are fixed to the main body 11 at the joint portions 322a.
  • the portion of the non-expandable portion 322 between the tip and base ends of the non-expandable portion 322 is the non-joint portion 322b, which is not fixed to the main body 11.
  • the non-expandable portion 322 does not expand radially outward.
  • the coil 32 of the non-expandable portion 322 is not compressed along the longitudinal direction of the main body 11. For this reason, the non-expandable portion 322 does not expand radially outward, even when the pushing member 41 is moved, for example.
  • the joining method for the joint 322a is not particularly limited.
  • the joint 322a of the medical device 2 uses a solder material containing gold.
  • the fourth portion 32D is fixed (joined) to the main body 11 using a solder material containing gold.
  • the distal end of the expansion portion 321 begins to expand radially outward before the proximal end of the expansion portion 321.
  • the distal end of the expansion portion 321 can be fixed distal to the lead 80, allowing the hollow lead 80 implanted in the body to be smoothly removed.
  • the medical device 2 has a non-expandable portion 322 (fourth portion 32D) provided in the expansion member 32, and the non-expandable portion 322 has a non-bonded portion 322b.
  • the non-expandable portion 322 has a non-bonded portion 322b, which improves the flexibility of the non-expandable portion 322.
  • FIG. 23 is a schematic side view showing an enlarged portion of the third embodiment.
  • the medical device 3 generally includes a main body 11, a distal fixation portion 21, an expansion member 31, a radiopaque marker 35, a pushing member 41, and a fixing mechanism 51 and a gripping member 61 (not shown).
  • the third embodiment differs from the first embodiment in that it includes the radiopaque marker 35.
  • the configurations of the main body 11, the distal fixation portion 21, the expansion member 31, the pushing member 41, the fixing mechanism 51, and the gripping member 61 are the same as those of the first embodiment. Therefore, the same components are denoted by the same reference numerals, and detailed descriptions thereof will be omitted.
  • the manner of use of the medical device 3 is the same as that of the medical device 1.
  • FIG. 24 to 26 are schematic diagrams showing a fourth embodiment.
  • the medical device 4 generally comprises a main body 14, a tip fixation portion 21, an expansion member 32, a pushing member 44, a fixing mechanism 51, and a gripping member 61 (not shown).
  • the fourth embodiment differs from the second embodiment in that it comprises the main body 14 and the pushing member 44.
  • the configurations of the tip fixation portion 21, the fixing mechanism 51, and the gripping member 61 are the same as those of the second embodiment. Therefore, the same components are denoted by the same reference numerals and detailed descriptions thereof are omitted.
  • the configurations of the main body 14 and the pushing member 44, other than those described below, are the same as those of the first embodiment.
  • the usage of the medical device 4 is the same as that of the medical device 1.
  • the main body 14 is an elongated member.
  • the main body 14 is a core shaft (hereinafter also referred to as the "core shaft 14").
  • the small diameter portion 141 of the core shaft 14 has, in order from its tip toward its base end, a first tapered portion 141A, a first straight portion 141B, a second tapered portion 141C, and a second straight portion 141D.
  • the first tapered portion 141A is a portion whose diameter gradually increases toward the base end.
  • the first tapered portion 141A is positioned closer to the tip end than the tip of the expansion portion 321.
  • the tip end of the first tapered portion 141A is fixed to the tip fixing portion 21.
  • the outer periphery of the first tapered portion 141A is covered by the non-expandable portion 322.
  • the portion of the first tapered portion 141A that is covered by the non-expandable portion 322 may be the entire first tapered portion 141A, or may be only a portion of the first tapered portion 141A.
  • the first straight portion 141B is a portion with a constant outer diameter that extends from the base end of the first tapered portion 141A toward the base end.
  • the first straight portion 141B is arranged so that its tip is continuous with the base end of the first tapered portion 141A.
  • the outer periphery of the first straight portion 141B is covered with the expansion portion 321. This allows the expansion portion 321 to expand while maintaining the flexibility of the tip portion of the medical device 4.
  • the second tapered portion 141C is located closer to the base end than the base end of the first straight portion 141B and gradually widens in diameter toward the base end.
  • the second tapered portion 141C can be formed, for example, so that its tip is continuous with the base end of the first straight portion 141B.
  • the second straight portion 141D is a portion with a constant outer diameter that extends from the base end of the second tapered portion 141C toward the base end.
  • the second straight portion 141D is arranged so that its tip is continuous with the base end of the second tapered portion 141C.
  • the pushing member 44 is movable along the longitudinal direction of the main body 14 and pushes the base end of the expansion member 32 toward the tip.
  • the pushing member 44 is formed of a cylindrical body.
  • the outer periphery of the second straight portion 141D, or the outer periphery of the second tapered portion 141C and the second straight portion 141D, may always be covered by the pushing member 44.
  • both the second tapered portion 141C and the second straight portion 141D are covered by the pushing member 44.
  • the main body 14 has a second tapered portion 141C and a second straight portion 141D, and the outer periphery of the second straight portion 141D is covered with the pushing member 44, thereby ensuring the rigidity of the medical device 4 on the proximal side of the expansion member 32 while increasing the flexibility of the distal end of the medical device 4. As a result, the passability of the distal end of the medical device 4 can be improved.
  • the medical device 4 has the above-described configuration, which increases the flexibility of the tip of the medical device 4, thereby improving its pushability and tracking ability.
  • the main body of the medical device 4 tapers in one direction from the second straight portion 141D to the first tapered portion 141A. Therefore, the flexibility of the medical device 4 increases toward the tip of the main body 14, further improving its tracking ability.
  • the medical device 5 generally comprises a main body 11, a tip fixing portion 21, an expansion member 35, a pushing member 41, and a fixing mechanism 51 and a gripping member 61 (not shown).
  • the fifth embodiment differs from the first embodiment in that it comprises an expansion member 35.
  • the configurations of the main body 11, the tip fixing portion 21, the pushing member 41, the fixing mechanism 51, and the gripping member 61 are the same as those of the first embodiment. Therefore, the same components are denoted by the same reference numerals, and detailed descriptions thereof will be omitted.
  • the configuration of the expansion member 35, other than the configuration of the expansion member 35 described below, is the same as that of the first embodiment.
  • the usage of the medical device 5 is the same as that of the medical device 1.
  • the expansion member 35 covers the outer periphery of the main body 11 and is expandable radially outward.
  • the expansion member 35 is a coil (hereinafter also referred to as "coil 35") in which a wire w1 is wound around the outer periphery of the main body, and the outer diameter D4 of the tip of the coil 35 is formed to be smaller than the outer diameter D5 of the base end of the coil 35.
  • the shape of the coil 35 may be formed, for example, so that the outer diameter gradually decreases from its base end to its tip.
  • the ratio (outer diameter ratio) of the outer diameter D4 at the tip of the coil 35 to the outer diameter D5 at the base end is not particularly limited.
  • the outer diameter ratio D4/D5 of the coil 35, the pitch of the wire w1, etc. can be selected so that when the coil 35 expands radially outward, the tip of the coil 35 first comes into contact with the lumen wall 80a of the lead 80.
  • the base end of the expansion member 35 When using the medical device 5, the base end of the expansion member 35 is pushed toward the tip side with the pushing member 41, causing the expansion member 35 to begin expanding from its tip, as shown in FIG. 28. The expansion of the expansion member 35 then progresses toward the base end, and as shown in FIG. 29, the base end portion of the expansion member 35 abuts against the inner circumference of the lead 80, just like the tip end. This allows the tip end of the expansion member 35 to be fixed to the distal lumen wall 80a of the lead 80.
  • the outer diameter D4 of the tip of the coil 35 is smaller than the outer diameter D5 of the base end of the coil 35. Therefore, the medical device 5 can be smoothly pushed through the lumen 80h of the lead 80.
  • the medical device 6 generally comprises a main body 11, a tip fixing portion 21, an expansion member 31, a reinforcing member 76, a pushing member 41, and a fixing mechanism 51 and a gripping member 61 (not shown).
  • the sixth embodiment differs from the first embodiment in that it comprises a reinforcing member 76.
  • the configurations of the main body 11, tip fixing portion 21, expansion member 31, pushing member 41, fixing mechanism 51, and gripping member 61 are the same as those of the first embodiment. Therefore, the same components are denoted by the same reference numerals, and detailed descriptions thereof will be omitted.
  • the manner of use of the medical device 6 is the same as that of the medical device 1.
  • the form of the reinforcing body 76 is not particularly limited.
  • Examples of the reinforcing body 76 include an inner coil 761, a braided body 762, and a resin tube 763 (hereinafter also referred to as the "resin tube 763").
  • Figure 30 shows a medical device 6A in which the reinforcing body 76 is an inner coil 761.
  • the inner coil 761 is a component in which the wire w5 is wound in a spiral shape on the outer peripheral surface of the main body 11.
  • the wire w5 may be tightly wound on the outer peripheral surface of the main body 11 so that there are no gaps between adjacent wires w5 along the longitudinal direction. By winding the wire w5, the reinforcing body 76 can be easily formed.
  • Figure 31 shows a medical device 6B in which the reinforcing body 76 is a braided body 762.
  • the braided body 762 is, for example, a member in which wires w6 are woven into a mesh.
  • Figure 32 shows a medical device 6C in which the reinforcing body 76 is a resin tube 763.
  • the resin tube 763 is, for example, a flexible member that surrounds the main body 11 so as to fit closely to it.
  • resins that can be used to form the resin tube 763 include polyurethane, polyamide elastomer, and polytetrafluoroethylene (PTFE).
  • PTFE polytetrafluoroethylene
  • the medical device 6 is equipped with a reinforcing body 76, which fills the gap between the main body 11 and the expansion member 31, thereby preventing the expansion member 31 from deforming radially inward.
  • the expansion member 31 can be prevented from twisting in the circumferential direction and expanding asymmetrically.
  • Seventh Embodiment 33 is a schematic diagram showing the seventh embodiment.
  • the medical device 7 generally comprises a main body 11, a pushing member 41, a fixing mechanism 57, a gripping member 61, and a tip fixation portion 21 and an expansion member 31 (not shown).
  • the seventh embodiment differs from the first embodiment in that it comprises the fixing mechanism 57.
  • the configurations of the main body 11, tip fixation portion 21, expansion member 31, pushing member 41, and gripping member 61 are the same as those of the first embodiment. Therefore, the same components are denoted by the same reference numerals, and detailed descriptions thereof will be omitted.
  • the medical device 7 has a fixing tube 57, which allows the fixing tube 57 to be removably fixed to the pushing member 41 and the gripping member 61. As a result, when the medical device 7 is not in use, it is possible to prevent the pushing member 41 from accidentally moving toward the tip side, causing the expansion member 31 to expand.
  • the pushing member 48 is rotated relative to the main body 18 to separate the male threaded portion 18a and the female threaded portion 48a. This releases the pusher member 48 from the main body 18.
  • the expansion member 31 expands radially outward, and the tip of the expansion member 31 is fixed distally to the lead 80.
  • the medical device 8 can be pulled toward the base end, allowing the lead 80 to be withdrawn from the body.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Radiology & Medical Imaging (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Vascular Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif médical capable d'éliminer sans à-coups un fil creux implanté dans un corps.　Un dispositif médical 1 selon l'invention comprend : un corps long 11 ; et un élément d'expansion 31 qui recouvre une périphérie externe du corps 11 et peut être étendu vers l'extérieur dans une direction radiale. L'élément d'expansion 31 est une bobine 31 dans laquelle un fil w1 est enroulé autour de la périphérie externe du corps 11. La largeur maximale du fil w1 dans une première partie 31A de la bobine 31 est inférieure à la largeur maximale du fil w1 dans une seconde partie 31B de la bobine 31, la seconde partie 31B étant située plus près du côté d'extrémité de base que la première partie 31A.
PCT/JP2025/007168 2024-04-04 2025-02-28 Dispositif médical Pending WO2025211069A1 (fr)

Applications Claiming Priority (2)

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JP2024-060961 2024-04-04
JP2024060961 2024-04-04

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WO2025211069A1 true WO2025211069A1 (fr) 2025-10-09

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PCT/JP2025/007168 Pending WO2025211069A1 (fr) 2024-04-04 2025-02-28 Dispositif médical
PCT/JP2025/007169 Pending WO2025211070A1 (fr) 2024-04-04 2025-02-28 Tige médicale et dispositif médical

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Application Number Title Priority Date Filing Date
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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5011488A (en) * 1988-12-07 1991-04-30 Robert Ginsburg Thrombus extraction system
JPH0788192A (ja) * 1993-06-30 1995-04-04 Toshio Saeki 手術用ガイドワイヤ
JP2003533300A (ja) * 2000-05-17 2003-11-11 クック ヴァスキュラー インコーポレイテッド リード取出し装置
JP2023526334A (ja) * 2020-05-19 2023-06-21 エクストラク・オー．エス・リミテッド 心臓植込み型電子デバイスのリードを抜き出すための振動システムおよびデバイス

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5367503B2 (ja) * 2009-08-19 2013-12-11 朝日インテック株式会社 医療用ガイドワイヤ、その製造方法、及び医療用ガイドワイヤとマイクロカテーテル、又はバルーンカテーテルとガイディングカテーテルとの組立体
DE102011110136A1 (de) * 2011-08-15 2013-02-21 Olympus Winter & Ibe Gmbh Schaft eines laparoskopischen Instrumentes

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5011488A (en) * 1988-12-07 1991-04-30 Robert Ginsburg Thrombus extraction system
JPH0788192A (ja) * 1993-06-30 1995-04-04 Toshio Saeki 手術用ガイドワイヤ
JP2003533300A (ja) * 2000-05-17 2003-11-11 クック ヴァスキュラー インコーポレイテッド リード取出し装置
JP2023526334A (ja) * 2020-05-19 2023-06-21 エクストラク・オー．エス・リミテッド 心臓植込み型電子デバイスのリードを抜き出すための振動システムおよびデバイス

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