US20200016387A1 - Dilator - Google Patents

Dilator Download PDF

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Publication number
US20200016387A1
US20200016387A1 US16/580,437 US201916580437A US2020016387A1 US 20200016387 A1 US20200016387 A1 US 20200016387A1 US 201916580437 A US201916580437 A US 201916580437A US 2020016387 A1 US2020016387 A1 US 2020016387A1
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US
United States
Prior art keywords
shaft
spirally
arranged protruding
distal end
dilator
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.)
Abandoned
Application number
US16/580,437
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English (en)
Inventor
Yukihiro FUSEYA
Hideaki Maki
Daiki Takahashi
Akira Sawai
Marina KITAI
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
Assigned to ASAHI INTECC CO., LTD. reassignment ASAHI INTECC CO., LTD. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MAKI, HIDEAKI, SAWAI, AKIRA, FUSEYA, Yukihiro, KITAI, Marina, TAKAHASHI, DAIKI
Publication of US20200016387A1 publication Critical patent/US20200016387A1/en
Abandoned legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/02—Devices for expanding tissue, e.g. skin tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A61M25/0053—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00902—Material properties transparent or translucent
    • A61B2017/00915—Material properties transparent or translucent for radioactive radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B2017/3454—Details of tips
    • A61B2017/3456—Details of tips blunt
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B2017/3454—Details of tips
    • A61B2017/3458—Details of tips threaded
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/006—Catheters; Hollow probes characterised by structural features having a special surface topography or special surface properties, e.g. roughened or knurled surface
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M2025/0687—Guide tubes having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids

Definitions

  • the disclosed embodiments relate to a dilator.
  • a dilator is known, for example, as a device for expanding a hole opened on the wall of an organ such as stomach and liver, a narrowed segment in a body cavity such as bile duct and pancreatic duct, and the like.
  • Such a dilator usually includes a shaft having a tapered portion for expanding a pre-opened hole, the tapered portion having an outer diameter gradually increasing from the distal end toward the proximal end.
  • a needle is allowed to advance through the distal end of the endoscope to open a hole on the wall of an organ and the like.
  • a guide wire is inserted into the hole through a through-hole of the needle, and then the needle is withdrawn.
  • the dilator is delivered to the hole along the guide wire, and pushed into the hole to expand the hole by the aforementioned tapered portion.
  • a dilator including a contrast maker disposed in the vicinity of a hole-expanding tapered portion is disclosed as a technology for determining the position of a dilator inside the body, according to JP 2017-51328.
  • the position of a contrast maker can be perceived under X-ray imaging, enabling the position of the tapered portion inside the body to be approximately detected during the procedure.
  • An object of the disclosed embodiments is to provide a dilator allowing accurate detection of the completion of hole expansion in a target object.
  • a dilator includes: a hollow shaft having a tapered portion that is smaller at a distal end than at a proximal end; and a body portion having a distal end located at a proximal end of the tapered portion, and extending toward a proximal end side in an axis direction of the shaft.
  • a spirally-arranged protruding portion is provided on an outer peripheral surface of the tapered portion and has gaps between adjacent portions of the spirally-arranged protruding portion along the axis direction of the shaft.
  • a proximal end of the spirally-arranged protruding portion is located at the proximal end of the tapered portion.
  • distal end side refers to a direction along the axis direction of the shaft in which the tapered portion is located with respect to the body portion.
  • proximal end side refers to a direction along the axis direction of the shaft which is opposite to the distal end side.
  • distal end refers to an end of any member or part at the distal end side
  • proximal end refers to an end of any member or part at the proximal end side.
  • FIG. 1 is a schematic partial cutaway side view of the entirety of a dilator of the disclosed embodiments
  • FIG. 2 is an enlarged schematic partial cutaway side view of a portion of a dilator of the disclosed embodiments
  • FIG. 3 is a schematic distal view of FIG. 2 ;
  • FIG. 4 is an enlarged schematic side view of a portion of a dilator of the disclosed embodiments
  • FIG. 5 is an enlarged schematic side view of a portion of a dilator of the disclosed embodiments
  • FIG. 6 is an enlarged schematic side view of a portion of a dilator of the disclosed embodiments.
  • FIG. 7 is a schematic partial cutaway side view of a portion of a dilator of the disclosed embodiments.
  • FIG. 8 is an enlarged schematic side view of a portion of a dilator of the disclosed embodiments.
  • a dilator including a hollow shaft having a tapered portion and a body portion.
  • An outer diameter of the tapered portion is smaller at a distal end of the shaft than at a proximal end of the shaft.
  • a distal end of the body portion is located at a proximal end of the tapered portion, and the body portion extends toward a proximal end side in an axis direction of the shaft (along a longitudinal axis of the shaft).
  • a spirally-arranged protruding portion is provided on an outer peripheral surface of the tapered portion, and has gaps between adjacent portions of the spirally-arranged protruding portion along the axis direction of the shaft.
  • a proximal end of the spirally-arranged protruding portion is located at the proximal end of the tapered portion.
  • FIG. 1 shows a schematic partial cutaway side view of the entirety of a dilator of the disclosed embodiments.
  • a dilator 1 generally includes a shaft 11 , a spirally-arranged protruding portion 21 , and a connector (proximal portion) 31 .
  • the shaft 11 is a hollow member having a through-hole 11 H.
  • a guide wire (not shown) and the like, for example, can be inserted through the through-hole 11 H.
  • the through-hole extends continuously from a distal end of the shaft to a proximal end of the shaft 11 .
  • the shaft 11 has a tapered portion 111 and a body portion 112 .
  • the tapered portion 111 is a part having an outer diameter that is smaller at a distal end than at a proximal end. Specifically, the tapered portion 111 is connected to a distal end of the body portion 112 described below, and extends from that distal end toward the distal end side, and has a shape that is tapered toward the distal end side.
  • the body portion 112 is a part having a distal end located at a proximal end 111 P of the tapered portion 111 , and it extends toward the proximal end side in the axis direction of the shaft 11 (along a longitudinal axis of the shaft 11 ). Specifically, the body portion 112 is connected at its distal end to the proximal end 111 P of the aforementioned tapered portion 111 , and is also connected at its proximal end to the connector 31 described below.
  • the body portion 112 has a substantially constant outer diameter from the distal end thereof through the proximal end. It is noted that the body portion 112 may be integrally formed with the tapered portion 111 , or may be formed as a separate body. The body portion 112 may be integrally formed with the tapered portion 111 by casting or the like.
  • Materials for the tapered portion 111 and the body portion 112 as described above preferably have antithrombogenicity, flexibility, and biocompatibility because they are to be inserted into a body cavity.
  • the materials include resin materials such as polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluororesin; metal materials such as stainless steel and superelastic alloys (nickel-titanium alloys); and the like. It is noted that the tapered portion 111 and the body portion 112 may have various types of coating in their surface side portions.
  • the coating examples include a protective film(s) (representative example: a plating film(s)) located at the surfaces of the tapered portion 111 and the body portion 112 ; an underlying film for improving adhesiveness of the tapered portion 111 and the body portion 112 with the spirally-arranged protruding portion 21 ; and the like.
  • a protective film(s) representedative example: a plating film(s) located at the surfaces of the tapered portion 111 and the body portion 112 ; an underlying film for improving adhesiveness of the tapered portion 111 and the body portion 112 with the spirally-arranged protruding portion 21 ; and the like.
  • the spirally-arranged protruding portion 21 is disposed on an outer peripheral surface 111 A of the tapered portion 111 , and has gaps 21 G between adjacent portions of the spirally-arranged protruding portion 21 along the axis direction of the shaft 11 .
  • the above spirally-arranged protruding portion 21 can be formed, for example, as a single-thread or multi-thread protruded portion protruded radially and outwardly from the outer peripheral surface 111 A of the tapered portion 111 (the outermost surface, outermost portion of the dilator 1 ), the single-thread or multi-thread protruded portion being continuous or discontinuous in the axis direction.
  • the spirally-arranged protruding portion 21 is arranged so that adjacent portions of the spirally-arranged protruding portion 21 are spaced apart in the axis direction. This enables the tapered portion 111 to be moved forward due to the screw action of the spirally-arranged protruding portion 21 by a rotational operation of the shaft 11 , leading to smooth expansion of a hole with the tapered portion 111 . It is noted that the spirally-arranged protruding portion 21 may be integrally formed with the shaft 11 , or may be formed as a separate body. The spirally-arranged protruding portion 21 may be integrally formed with the tapered portion 111 of the shaft 11 by casting or the like.
  • a proximal end 21 P of the spirally-arranged protruding portion 21 is located at the proximal end 111 P of the tapered portion 111 . That is, the spirally-arranged protruding portion 21 is disposed on the outer peripheral surface 111 A of the tapered portion 111 .
  • the spirally-arranged protruding portion 21 preferably does not serve as a blade (it does not have a shape where a living body tissue may be cut). That is, the spirally-arranged protruding portion 21 preferably does not have a sharp edge at an end portion on a radially outer side of the shaft in a cross-section (for example, in a cross-section perpendicular to the spiral direction of the spirally-arranged protruding portion).
  • Such end portions can include, for example, a part having a shape including an obtuse edge or a curve (for example, a curve constituting a part of a circle or an ellipse), and the like. This enables the dilator 1 to expand a hole pre-formed in a target object (for example, the wall of the digestive tract such as the patient's stomach) without damaging living body tissues at the inner surface of the hole.
  • a material of the spirally-arranged protruding portion 21 there is no particular limitation for a material of the spirally-arranged protruding portion 21 as long as the effects of the disclosed embodiments are not impaired.
  • the following materials can be used: for example, metal materials such as stainless steel and superelastic alloys (nickel-titanium alloys), biocompatible resin materials such as polyamide resin and fluororesin, or the like.
  • a radiopaque material can preferably be included.
  • radiopaque materials include, for example, gold, platinum, tungsten, or alloys including these elements (for example, platinum-nickel alloys and the like), and the like.
  • a radiopaque material may be combined with a material other than the radiopaque material such as a radiopaque material to be coated on a non-radiopaque material.
  • a material of the spirally-arranged protruding portion 21 contains a radiopaque material as described above, the position of the spirally-arranged protruding portion 21 can be perceived under radiographic imaging. This enables the completion of hole expansion to be detected more accurately.
  • the connector 31 as shown in FIG. 1 is a part with which an operator pushes the dilator 1 into the body, and/or performs a rotation operation.
  • the above connector 31 has a distal end connected to the proximal end of the body portion 112 and a through-hole 31 H in communication with the through-hole 11 H of the shaft 11 .
  • a guide wire or the like can be inserted through the through-hole 31 H of the connector 31 .
  • the length of each portion of the dilator 1 in the axis direction is usually as follows: 1,600 mm to 2,500 mm for the entire shaft 11 , and 5 mm to 100 mm for the tapered portion 111 .
  • the outer diameter of each portion of the shaft 11 is usually as follows: 0.6 mm to 2.3 mm for the distal end of the tapered portion 111 , and 1.2 mm to 4.0 mm for the proximal end 111 P of the tapered portion 111 and for the body portion 112 .
  • the inner diameter of the through-hole 11 H of the shaft 11 is usually 0.4 mm to 1.0 mm.
  • each portion of the dilator 1 can be as follows: 2,000 mm for the entire shaft 11 , and 30 mm for the tapered portion 111 .
  • the outer diameter of each portion of the shaft 11 can be as follows: 1.1 mm for the distal end of the tapered portion 111 , and 1.9 mm for the proximal end 111 P of the tapered portion 111 and for the body portion 112 .
  • the inner diameter of the through-hole 11 H of the shaft 11 can be 0.7 mm.
  • a target object is punctured with an introducer needle to open a hole.
  • a guide wire (not shown) is inserted into a through-hole of the introducer needle, and then the introducer needle is withdrawn.
  • the proximal end of the guide wire is inserted into the through-hole 11 H, 31 H of the dilator 1 , and the dilator 1 is then inserted.
  • the dilator 1 is pushed in while rotating the shaft 11 to expand the hole at a punctured portion.
  • the tapered portion 111 can be moved forward to the distal end side due to the screw action and the like of the spirally-arranged protruding portion 21 by a rotation operation of the shaft 11 , leading to smooth hole expansion with the tapered portion 111 .
  • the screwing-in resistance of the shaft 11 suddenly decreases when the proximal end 111 P of the tapered portion 111 passes through a punctured portion and hole expansion in a target object is completed (when the hole expansion at the punctured portion is completed) because the spirally-arranged protruding portion 21 is not disposed on the outer peripheral surface 112 A of the body portion 112 . This can allow an operator to accurately detect when the hole expansion is completed.
  • the dilator 1 having the aforementioned configuration can reduce the screwing-in resistance of the shaft 11 when expansion of a hole in a target object is completed, allowing an operator to accurately detect when the hole expansion is completed by means of a sensuous communication received by the operator.
  • a dilator 2 of the disclosed embodiments can include a spirally-arranged protruding portion 210 having an outer shape (outer profile) that falls within the outer shape (outer profile) of the body portion 112 when viewed in the axis direction of the shaft 11 in a state where the tapered potion 111 and the body potion 112 extend in a substantially linear fashion. That is, the shape (the outer shape) of an outer peripheral surface 210 A of a spirally-arranged protruding portion 210 viewed from the distal end side along the axis of the shaft 11 preferably falls in a region within a virtual cylinder C.
  • the virtual cylinder C is defined by virtual lines extending from the outer peripheral surface 112 A (the outer shape) of the body portion 112 toward the distal end side.
  • the outer shape of the spirally-arranged protruding portion 210 formed as described above can reduce the screwing-in resistance of the shaft 11 more noticeably (and thus can allow an operator to reliably perceive it) when expansion of a hole in a target object is completed. Therefore, the completion of hole expansion can be more accurately detected.
  • FIG. 4 is an enlarged schematic side view of a portion of a dilator 3 of the disclosed embodiments.
  • a coating 70 may be formed for the purposes of, for example, improving slidability and preventing pinching of a living body tissue.
  • Materials which can be used to form the coating 70 include, for example, biocompatible resin materials such as polyamide resin and fluororesin, hydrophilic coating materials, and the like.
  • the above coating 70 may be configured to have a thickness of, for example, 0.1 ⁇ m to 300 ⁇ m.
  • the outer peripheral surface (the outer surface) of the coating 70 corresponds to an outer peripheral surface of a shaft 11 (an outer peripheral surface 111 A of the tapered portion 111 and an outer peripheral surface 112 A of a body portion 112 ) or an outer peripheral surface 21 A of a spirally-arranged protruding portion 21 .
  • FIG. 5 shows an enlarged schematic side view of a portion of a dilator 4 according to the disclosed embodiments.
  • a dilator 4 generally includes a shaft 12 , a spirally-arranged protruding portion 22 , and the connector 31 (see FIG. 1 ).
  • the dilator 4 differs from the dilator 1 in the configurations of the shaft 12 and the spirally-arranged protruding portion 22 . It is noted that the configurations other than those of the shaft 12 and the spirally-arranged protruding portion 22 and the operating modes of the dilator 4 are similar to those of the dilator 1 . Therefore, the same reference symbol is given to the same part, and detailed description thereof will be omitted.
  • the shaft 12 is a hollow member having a through-hole 12 H.
  • the shaft 12 has a tapered portion 121 and a body portion 122 .
  • the tapered portion 121 is a part where the outer diameter is smaller at the distal end than at the proximal end.
  • the body portion 122 is a part having a distal end located at a proximal end 121 P of the tapered portion 121 , and it extends toward the proximal end side in the axis direction of the shaft 12 .
  • the shaft 12 is formed by winding a wire around the axis of the above shaft 12 .
  • the above shaft 12 is formed as a coil body 12 C in which a single wire is spirally wound around (coiled) so that adjacent portions of the wire are brought into close contact with each other in the axis direction as shown in FIG. 5 .
  • the coil body 12 C serves as the aforementioned tapered portion 121 and the aforementioned body portion 122 , depending on the shape of the outer peripheral surface thereof. It is noted that in FIG. 5 , the common inscribed lines of the coil body 12 C are shown by dotted lines, and the through-hole 12 H is formed in a region surrounded by the common inscribed lines.
  • the spirally-arranged protruding portion 22 is disposed on an outer peripheral surface 121 A of the tapered portion 121 , and has gaps 22 G between adjacent portions of the spirally-arranged protruding portion 22 along the axis direction of the shaft 12 . Further, a proximal end 22 P of the spirally-arranged protruding portion 22 is located at the proximal end 121 P of the tapered portion 121 .
  • the spirally-arranged protruding portion 22 is formed by winding a wire around on the outer peripheral surface of the shaft 12 (the outer peripheral surface 121 A of the tapered portion 121 ).
  • the above spirally-arranged protruding portion 22 is, for example, formed as a coil body 22 C in which a single wire is spirally wound around so that adjacent portions of the wire are spaced apart from each other.
  • the inner periphery of the coil body 22 C is brought into close contact with the outer periphery of the coil body 12 C, and both the coil body 22 C and the coil body 12 C are joined to each other, for example, by soldering or welding each end of the both, fixing each end of the both via an adhesive, or fusing each end of the both via coating.
  • the number of wires used for the shaft 12 and the spirally-arranged protruding portion 22 may be one or more. It is noted that the winding directions of wires of the shaft 12 and the spirally-arranged protruding portion 22 are preferably opposite to each other as shown in FIG. 5 . That is, preferably, one of the coil body 12 C and the coil body 22 C is S-twisted, and the other is Z-twisted. By this configuration, the direction of a force axially applied to a wire of the shaft 12 can be directed as opposed to the direction of a force axially applied to a wire of the spirally-arranged protruding portion 22 , preventing decreases of torquability and pushability due to separation of adjacent portions of a wire of the shaft 12 .
  • materials for a wire of the aforementioned coil body 12 C for example, materials similar to those listed as materials of the tapered portion and the body portion in the dilator 1 can be exemplified.
  • materials for a wire of the aforementioned coil body 22 C for example, materials similar to those listed as materials of the spirally-arranged protruding portion 21 in the dilator 1 can be exemplified.
  • the dilator 4 includes the shaft 12 and the spirally-arranged protruding portion 22 which are formed with the coil body 12 C, 22 C, respectively. This configuration can improve the flexibility and torquability of the shaft 12 and the spirally-arranged protruding portion 22 .
  • a dilator 5 of the disclosed embodiments includes a distal tip 41 having a substantially tubular and hollow shape that is attached to the distal end of the shaft 12 as shown in FIG. 6 .
  • the distal tip 41 has a surface 41 A that is flatter (smoother) than the outer peripheral surface of the coil 12 C (an uneven surface due to the presence of a wire), and has a through-hole 41 H that is in communication with the through-hole 12 H of the shaft 12 .
  • the distal tip 41 may be formed so as to have a surface that is smoothed by applying a soldering material such as silver-tin solder, gold-tin solder, or the like to a distal end portion 123 of the coil body 12 C. This can improve the insertability of the shaft 12 into a hole opened with an introducer needle, enabling the procedure to be performed smoothly.
  • FIG. 7 shows a schematic partial cutaway side view of a portion of a dilator 6 of the disclosed embodiments.
  • a dilator 6 generally includes a shaft 13 , a spirally-arranged protruding portion 23 , and the connector 31 (see FIG. 1 ).
  • the dilator 6 differs from the dilator 1 in the configurations of the shaft 13 and the spirally-arranged protruding portion 23 . It is noted that the configurations other than those of the shaft 13 and the spirally-arranged protruding portion 23 and the operating modes of the dilator 6 are similar to those of the dilator 1 . Therefore, the same reference symbol is given to the same part, and detailed description thereof will be omitted.
  • the shaft 13 is a hollow member having a through-hole 13 H.
  • the shaft 13 has a tapered portion 131 , a body portion 132 , and a distal end portion 133 . It is noted that the tapered portion 131 and the body portion 132 have the same configurations as the tapered portion 111 and the body portion 112 of the dilator 1 , and the descriptions thereof will be applied.
  • the distal end portion 133 is a part having a proximal end located at a distal end 131 D of the tapered portion 131 of the shaft 13 and extending toward the distal end side in the axis direction of the shaft 13 .
  • the distal end portion 133 has, for example, a substantially constant outer diameter from the distal end thereof through the proximal end as shown in FIG. 7 .
  • the distal end portion 133 may be integrally formed with the tapered portion 131 , or may be formed as a separate body. In FIG. 7 , the distal end portion 133 is integrally formed with the tapered portion 131 by casting or the like.
  • materials for the distal end portion 133 for example, materials similar to those listed as materials for the tapered portion 111 and the body portion 112 in the dilator 1 can be exemplified.
  • the spirally-arranged protruding portion 23 is disposed on outer peripheral surfaces 133 A and 131 A of the distal end portion 133 and the tapered portion 131 , and has gaps 23 G along the axis direction of the shaft 13 . It is noted that the spirally-arranged protruding portion 23 is formed as a continuous single thread in the dilator 6 . Moreover, the spirally-arranged protruding portion 23 is integrally formed with the distal end portion 133 and the tapered portion 131 by casting or the like.
  • the distal end of the spirally-arranged protruding portion 23 is preferably located at the distal end of the tapered portion 131 or the outer peripheral surface 133 A of the distal end portion 133 .
  • the distal end of the spirally-arranged protruding portion 23 is located at the distal end of the distal end portion 133
  • the proximal end is located at the proximal end 131 P of the tapered portion 131 .
  • the distal end portion 133 included in the dilator 6 can be pre-inserted into a hole before expanding the hole with the tapered portion 131 , leading to stable and reliable hole expansion with the tapered portion 131 .
  • FIG. 8 shows an enlarged schematic side view of a portion of a dilator 7 according to the disclosed embodiments.
  • a dilator 7 generally includes a shaft 14 , a spirally-arranged protruding portion 24 , and the connector 31 (see FIG. 1 ).
  • the dilator 7 differs from the dilator 6 in the configurations of the shaft 14 and the spirally-arranged protruding portion 24 . It is noted that the configurations other than those of the shaft 14 and the spirally-arranged protruding portion 24 and the operating modes of the dilator 7 are similar to those of the dilator 6 . Therefore, the same reference symbol is given to the same part, and detailed description thereof will be omitted.
  • the shaft 14 is a hollow member having a through-hole 14 H.
  • the shaft 14 has a tapered portion 141 , a body portion 142 , and a distal end portion 143 .
  • the tapered portion 141 is a part where the outer diameter is smaller at the distal end than at the proximal end.
  • the body portion 142 is a part having a distal end located at a proximal end 141 P of the tapered portion 141 and extending toward the proximal end side in the axis direction of the shaft 14 .
  • the distal end portion 143 is a part having a proximal end located at a distal end 141 D of the tapered portion 141 and extending toward the distal end side in the axis direction of the shaft 14 .
  • the shaft 14 is formed by winding a wire around the axis of the shaft 14 .
  • the shaft 14 is formed with a coil body 14 C, and can serve as the tapered portion 141 , the body portion 142 , and the distal end portion 143 , depending on the shape of the outer peripheral surface thereof.
  • the common inscribed lines of the coil body 14 C are shown by dotted lines, and the through-hole 14 H is formed in a region surrounded by the common inscribed lines.
  • the spirally-arranged protruding portion 24 is disposed on outer peripheral surfaces 143 A and 141 A of the distal end portion 143 and the tapered portion 141 , and has gaps 24 G along the axis direction of the shaft 14 . Further, a proximal end 24 P of the spirally-arranged protruding portion 24 is located at the proximal end 141 P of the tapered portion 141 .
  • the spirally-arranged protruding portion 24 is formed by winding a wire around on the outer peripheral surface of the shaft 14 (the outer peripheral surface 143 A of the distal end portion 143 and the outer peripheral surface 141 A of the tapered portion 141 ).
  • the above spirally-arranged protruding portion 24 is, for example, formed as a coil body 24 C in which a single wire is spirally wound around so that adjacent portions of the wire are spaced apart from each other.
  • the dilator 7 includes the shaft 14 and the spirally-arranged protruding portion 24 which are formed with the coil body 14 C, 24 C, respectively. This configuration can improve the flexibility and torquability of the shaft 14 and the spirally-arranged protruding portion 24 . Further, the distal end portion 143 included in the dilator 7 can be pre-inserted into a hole before expanding the hole with the tapered portion 141 , leading to stable and reliable hole expansion with the tapered portion 141 .
  • the dilators 1 to 7 are described in which the distal ends of the spirally-arranged protruding portions 21 and 22 are located at the distal ends of the tapered portions 111 and 121 in the aforementioned dilators 1 to 5 , and the distal ends of the spirally-arranged protruding portions 23 and 24 are located at the distal ends of the distal end portions 133 and 143 in the dilators 6 and 7 .
  • a dilator having a distal end portion may be configured such that the distal end of a spirally-arranged protruding portion is located at a part between the distal end of a distal end portion and the proximal end of a tapered portion, and a dilator without having a distal end portion may be configured such that the distal end of a spirally-arranged protruding portion is located at a part between the distal end and the proximal end of a tapered portion.
  • dilators 4 , 5 are described where the shaft 12 and the spirally-arranged protruding portion 22 are formed with the coil body 12 C, 22 C, respectively
  • dilator 7 is described where the shaft 14 and the spirally-arranged protruding portion 24 are formed with the coil body 14 C, 24 C, respectively.
  • a dilator formed with a coil body may be configured such that only either one of a shaft and a spirally-arranged protruding portion is formed with a coil body.
  • a dilator may include coil bodies each including a multi-thread coil formed with a plurality of wires, or a dilator may include intermittently-wound-around coil bodies.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Surgery (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)
  • Gasket Seals (AREA)
US16/580,437 2017-03-24 2019-09-24 Dilator Abandoned US20200016387A1 (en)

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JP2017012024 2017-03-24
JPPCT/JP2017/012024 2017-03-24
PCT/JP2018/011671 WO2018174240A1 (ja) 2017-03-24 2018-03-23 ダイレータ

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US16/580,437 Abandoned US20200016387A1 (en) 2017-03-24 2019-09-24 Dilator
US16/580,301 Active 2038-05-30 US11331459B2 (en) 2017-03-24 2019-09-24 Dilator
US16/579,946 Active 2038-11-08 US11389631B2 (en) 2017-03-24 2019-09-24 Dilator
US16/579,921 Abandoned US20200016384A1 (en) 2017-03-24 2019-09-24 Dilator
US17/029,623 Active 2041-01-29 US12453843B2 (en) 2017-03-24 2020-09-23 Dilator
US17/029,562 Pending US20210001097A1 (en) 2017-03-24 2020-09-23 Dilator
US17/830,621 Active US11819647B2 (en) 2017-03-24 2022-06-02 Dilator

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US16/579,946 Active 2038-11-08 US11389631B2 (en) 2017-03-24 2019-09-24 Dilator
US16/579,921 Abandoned US20200016384A1 (en) 2017-03-24 2019-09-24 Dilator
US17/029,623 Active 2041-01-29 US12453843B2 (en) 2017-03-24 2020-09-23 Dilator
US17/029,562 Pending US20210001097A1 (en) 2017-03-24 2020-09-23 Dilator
US17/830,621 Active US11819647B2 (en) 2017-03-24 2022-06-02 Dilator

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US11331459B2 (en) 2017-03-24 2022-05-17 Asahi Intecc Co., Ltd. Dilator
US11389631B2 (en) * 2017-03-24 2022-07-19 Asahi Intecc Co., Ltd. Dilator
US11819647B2 (en) 2017-03-24 2023-11-21 Asahi Intecc Co., Ltd. Dilator
US12453843B2 (en) 2017-03-24 2025-10-28 Asahi Intecc Co., Ltd. Dilator
US12521534B2 (en) * 2020-06-01 2026-01-13 Asahi Intecc Co., Ltd. Dilators
US20220039822A1 (en) * 2020-08-06 2022-02-10 Peking University Third Hospital (Third Clinical Medical College Of Peking University) Dilating incision device
USD1095831S1 (en) 2023-04-07 2025-09-30 Asahi Intecc Co., Ltd. Medical dilator

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US20220288365A1 (en) 2022-09-15
JP7431001B2 (ja) 2024-02-14
JP6588677B2 (ja) 2019-10-09
EP3769703B1 (en) 2023-07-12
US20200016384A1 (en) 2020-01-16
US20200016385A1 (en) 2020-01-16
KR20190127874A (ko) 2019-11-13
WO2018174241A1 (ja) 2018-09-27
EP3603550A1 (en) 2020-02-05
KR20190127875A (ko) 2019-11-13
KR102299776B1 (ko) 2021-09-09
KR20190100306A (ko) 2019-08-28
US12453843B2 (en) 2025-10-28
EP3603549A1 (en) 2020-02-05
JPWO2018174242A1 (ja) 2019-11-07
JPWO2018174243A1 (ja) 2019-03-28
CN110461258A (zh) 2019-11-15
EP3603551A1 (en) 2020-02-05
JPWO2018174240A1 (ja) 2019-06-27
US11331459B2 (en) 2022-05-17
JP6978583B2 (ja) 2021-12-08
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US11819647B2 (en) 2023-11-21
CN110139616B (zh) 2022-03-08
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US20210001098A1 (en) 2021-01-07
EP3603548A1 (en) 2020-02-05
EP3603548A4 (en) 2021-03-03
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EP3603550A4 (en) 2021-03-03
CN111970982A (zh) 2020-11-20
JPWO2018174241A1 (ja) 2019-11-07
CN110520070B (zh) 2022-12-13
JP2018167050A (ja) 2018-11-01
CN111970982B (zh) 2024-02-13
JP6445745B1 (ja) 2018-12-26
US11389631B2 (en) 2022-07-19
JP7344059B2 (ja) 2023-09-13
EP3769703A1 (en) 2021-01-27
CN110290755B (zh) 2022-07-22
JP6588678B2 (ja) 2019-10-09
EP3603549A4 (en) 2020-11-11
KR20190127876A (ko) 2019-11-13
WO2018174243A1 (ja) 2018-09-27
JP2019205932A (ja) 2019-12-05
US20210001097A1 (en) 2021-01-07
EP3769703A4 (en) 2021-12-01
CN110520070A (zh) 2019-11-29
KR102305196B1 (ko) 2021-09-28
CN110139616A (zh) 2019-08-16
JP6588676B2 (ja) 2019-10-09
WO2019181011A1 (ja) 2019-09-26
US20200016386A1 (en) 2020-01-16
WO2018174240A1 (ja) 2018-09-27
CN111885975A (zh) 2020-11-03
CN110290755A (zh) 2019-09-27
EP3769702A1 (en) 2021-01-27
JP2020006209A (ja) 2020-01-16

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