WO2015141046A1 - 医療機器用ハンドルおよび医療機器 - Google Patents

医療機器用ハンドルおよび医療機器 Download PDF

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Publication number
WO2015141046A1
WO2015141046A1 PCT/JP2014/077643 JP2014077643W WO2015141046A1 WO 2015141046 A1 WO2015141046 A1 WO 2015141046A1 JP 2014077643 W JP2014077643 W JP 2014077643W WO 2015141046 A1 WO2015141046 A1 WO 2015141046A1
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WO
WIPO (PCT)
Prior art keywords
handle
switching
members
rotating
rotating plate
Prior art date
Application number
PCT/JP2014/077643
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English (en)
French (fr)
Japanese (ja)
Inventor
小林　洋平
Original Assignee
日本ライフライン株式会社
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Filing date
Publication date
Application filed by 日本ライフライン株式会社 filed Critical 日本ライフライン株式会社
Publication of WO2015141046A1 publication Critical patent/WO2015141046A1/ja

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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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0136—Handles therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00839—Bioelectrical parameters, e.g. ECG, EEG
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe

Definitions

  • the present invention relates to a medical device such as an electrode catheter or a sheath introducer used for, for example, examination (diagnosis) or treatment of arrhythmia, and a medical device handle applied to such a medical device.
  • a medical device such as an electrode catheter or a sheath introducer used for, for example, examination (diagnosis) or treatment of arrhythmia
  • a medical device handle applied to such a medical device.
  • the electrode catheter is inserted into the body (for example, the inside of the heart) through a blood vessel, and is used for arrhythmia examination and treatment.
  • the shape near the tip (distal end) of the catheter tube inserted into the body is attached to the proximal end (proximal end, rear end, hand side) placed outside the body. Depending on the operation of the part, it changes (deflects, curves, bends) in one direction or both directions.
  • a sheath introducer catheter sheath
  • a sheath sheath tube
  • an operation unit including a rotating plate rotatably mounted on the handle body (Rotary operation unit) is used.
  • a proximal end side of an operation wire for bending the vicinity of the distal end of a tubular member such as a catheter tube or a sheath tube is extended from the inside of these tubular members.
  • the rotary plate is fixed to the handle body by twisting a knob provided on the handle body, so that the rotation position of the rotary plate (the curved state near the tip) ) Is fixed (held).
  • the present invention has been made in view of such problems, and an object thereof is to provide a medical device handle and a medical device capable of improving operability.
  • the handle for a medical device is a handle attached to the proximal end side of a flexible tubular member, and is used in a rotating operation for bending the handle body and the vicinity of the distal end of the tubular member.
  • a rotation operation unit is rotatably attached to the handle body, and at least a part of the rotation operation unit is configured to be elastically displaceable along the orthogonal direction of the rotation axis, and the rotation axis of the rotation plate is orthogonal. According to the position state along the direction, the rotation operation is possible and the rotation position of the rotation plate is arbitrarily set, and the rotation operation is disabled and the rotation position of the rotation plate is fixed. And a switching mechanism for switching between them.
  • the medical device of the present invention comprises a flexible tubular member and a handle as the medical device handle of the present invention mounted on the proximal end side of the tubular member.
  • the rotating plate is configured such that at least a part thereof can be elastically displaced along the orthogonal direction of the rotation axis, and the position state of the rotating plate along the orthogonal direction of the rotation axis Accordingly, a switching mechanism is provided for switching between the free state and the locked state. As a result, while the rotary plate is being rotated, the rotary plate is elastically displaced in the direction orthogonal to the rotation axis, thereby switching between the free state and the locked state according to the position state.
  • the vicinity of the distal end of the tubular member is in a desired curved state.
  • the work to be held in can be done with one hand.
  • the handle main body may be constituted by, for example, first and second handle members facing each other along the rotation axis.
  • the rotating plate is disposed opposite to each other between the first and second handle members, for example, and is positioned on the first handle member side and the second handle member side.
  • the second rotating member is configured by a pair of divided members that are arranged side by side along the orthogonal direction of the rotation axis and at least one of which is provided with the second switching member.
  • the elastic displacement can be performed along a direction orthogonal to the rotation axis.
  • the direction in which the operator grips the rotating plate (second rotating member) during the rotation operation (direction in which a force is applied with the finger) and the direction of the elastic displacement (with the finger during the switching operation). Therefore, it is not necessary to apply a force in an extra direction, and the operability is further improved.
  • the strength in the locked state (lock strength) is increased as compared with the case where the second switching member is provided only in one of the pair of split members, the reliability of the product during the switching operation is increased. Will improve.
  • the first switching member in the second handle member and the second switching member in each divided member are engaged with each other.
  • the first switching member in the second handle member and the second in each divided member are brought into the locked state.
  • the switching members may be disengaged from each other to enter the free state. That is, the locked state may be set in the non-pressed state, and the free state may be set in the pressed state. In this case, since the switching between the free state and the locked state is realized by a simple operation, the operability is further improved. Conversely, compared with the case where the non-pressed state is the free state and the pressed state is the locked state, the operation in the operation of holding the vicinity of the distal end of the tubular member in a desired curved state. More improved.
  • the rotation operation unit has a spring member that realizes the elastic displacement of the divided member.
  • the elastic displacement in the divided member can be realized with a simple configuration.
  • the spring member includes a rod-like spring member that extends along the rotation axis and connects the first rotation member and the divided member to each other, and the rod-like spring member extends along a direction orthogonal to the rotation axis.
  • the elastic displacement of the divided member is realized by partially elastically deforming.
  • the elastic displacement in the divided member can be realized with a simpler and space-saving configuration while securing the role as the connecting member between the first rotating member and the divided member.
  • the rod-shaped spring member is inserted and arranged in the rotating plate and the elastic displacement mechanism is completed only by the rotating plate, such an elastic displacement mechanism does not hinder the rotation operation, and the operability is improved. Further improvement is realized.
  • the pair of divided members have a non-slip shape that fits together. In such a case, when the divided members are engaged with each other, sliding (mutual displacement) along the boundary direction between them is prevented, and malfunction during rotation operation is avoided.
  • the pair of divided members it is desirable to arrange one second switching member one by one at a position that is substantially point-symmetric with each other along the direction of the elastic displacement.
  • the second switching member is disposed along the direction of the elastic displacement (the direction orthogonal to the rotation axis), so that the second switching member is located at a position excluding such a direction.
  • the engagement state between the first and second switching members becomes better.
  • the second switching members are arranged one by one at positions that are substantially point-symmetric to each other, the first and the second switching members are compared with the case where a plurality of second switching members are arranged on each divided member.
  • the engagement failure between the two switching members (such as a phenomenon that the locked state cannot be set) is less likely to occur (desirably not occur).
  • the first handle member is also provided with a first switching member, and the first and second handle members have the same shape.
  • the first switching member in the first handle member is not actually used, the first and second handle members have the same shape, for example, manufacture using the same mold. Therefore, the manufacturing becomes easy and the manufacturing cost is reduced.
  • the first and second switching members may be shaped to fit each other, for example (first configuration example).
  • One of the first and second switching members may be a ring-shaped member and the other may be a convex member (second configuration example).
  • each of the first and second switching members may be a ring-shaped member (third configuration example).
  • the rotational position of the rotating plate can be set to an arbitrary continuous (non-discrete) position.
  • the pitch is limited according to the shape to be fitted, and the rotational position of the rotating plate is set to a discrete position.
  • tubular member examples include a sheath tube and a catheter tube.
  • medical device to which the present invention is applied examples include a sheath introducer or various catheters (electrode catheter or the like).
  • the rotating plate and the switching mechanism having the above-described configuration are provided, the operation of holding the vicinity of the distal end of the tubular member in a desired curved state is performed with one hand. Can be realized by the operation. Therefore, it is possible to improve work efficiency and improve operability.
  • FIG. 3 is a plan view illustrating a configuration example of a handle member illustrated in FIG. 2.
  • FIG. 3 is a plan view illustrating a configuration example of a rotating member illustrated in FIG. 2.
  • FIG. 3 is a schematic diagram showing schematic structure of the sheath introducer which concerns on a comparative example. It is sectional drawing showing the detailed structural example of the handle shown in FIG.
  • FIG. 10 is a plan view illustrating a configuration example of a handle member according to Modification Example 1.
  • FIG. 10 is a plan view illustrating a configuration example of a rotating member according to Modification Example 1.
  • FIG. 10 is a plan view illustrating a configuration example of a handle member according to Modification 2.
  • FIG. 12 is a plan view illustrating a configuration example of a rotating member according to Modification 2.
  • FIG. 10 is a schematic diagram illustrating a schematic configuration example of an electrode catheter as a medical device according to Modification Example 5.
  • FIG. 10 is a plan view illustrating a configuration example of an electrode catheter as a medical device according to Modification Example 5.
  • Embodiment (example when medical device is sheath introducer) 2.
  • Modified example Modified example 1 (example in which the shapes of the first and second switching members are opposite combinations)
  • Modification 2 (example in which each of the first and second switching members is a ring-shaped member)
  • Modifications 3 and 4 examples in which the first and second switching members are a combination of a ring-shaped member and a convex member)
  • Modification 5 (example when the medical device is an electrode catheter) 3.
  • Other variations (example when the medical device is sheath introducer) 2.
  • Modified example Modified example 1 (example in which the shapes of the first and second switching members are opposite combinations)
  • Modification 2 (example in which each of the first and second switching members is a ring-shaped member)
  • Modifications 3 and 4 examples in which the first and second switching members are a combination of a ring-shaped member and a convex member)
  • Modification 5 (example when
  • FIG. 1 schematically shows a schematic configuration example of a sheath introducer 1 as a medical device according to an embodiment of the present invention.
  • the sheath introducer 1 introduces the sheath tube 2 into the body prior to the insertion of the catheter tube 6 such as an electrode catheter into the patient's body, so that the catheter tube 6 is inserted into the blood vessel. It is a device for securing a passage.
  • the sheath introducer 1 includes a sheath tube 2 (sheath shaft) as a sheath main body (long portion), and a handle 3 attached to the proximal end side of the sheath tube 2.
  • the sheath tube 2 is formed of a flexible tubular structure (hollow tubular member) and has a shape that extends along its own axial direction (Z-axis direction). Specifically, the length of the sheath tube 2 in the axial direction is several times to several tens of times longer than the length of the handle 3 in the axial direction (Z-axis direction).
  • the sheath tube 2 may be composed of a tube having the same characteristics in the axial direction, but the distal end portion having relatively high flexibility and the distal end portion are integrated in the axial direction. It is preferable to have a proximal end portion that is formed and is relatively stiffer than the distal end portion.
  • a catheter tube 6 can be inserted. Further, distal ends of operation wires 41a and 41b (not shown in FIG. 1) to be described later are fixed to the distal end side of the sheath tube 2. The proximal ends of the operation wires 41a and 41b are extended from the sheath tube 2 into the handle 3 (on a rotating plate 32 described later).
  • the sheath tube 2 is made of a synthetic resin such as polyolefin, polyamide, polyether polyamide, or polyurethane.
  • the axial length of the sheath tube 2 is about 500 to 800 mm, and the length of the flexible portion near the tip of the sheath tube 2 is about 20 to 150 mm.
  • the outer diameter of the sheath tube 2 (the outer diameter of the XY cross section) is about 2.0 to 5.0 mm (preferably about 2.6 to 4.3 mm).
  • the (inner diameter of the XY cross section) is about 1.6 to 4.3 mm (preferably about 2.0 to 2.8 mm).
  • a plurality of electrodes (here, three ring electrodes 61 and one distal electrode 62) are arranged at a predetermined interval. Yes. Specifically, the ring electrode 61 is fixedly disposed on the outer peripheral surface of the catheter tube 6, while the tip electrode 62 is fixedly disposed at the forefront of the catheter tube 6.
  • the handle 3 is a portion that is gripped (gripped) by an operator (doctor) when the sheath introducer 1 is used.
  • the handle 3 has a handle main body 31 (gripping part) mounted on the proximal end side of the sheath tube 2 and a rotation operation part including a rotating plate 32.
  • the rotating plate 32 is a member that is attached to the handle main body 31 so as to be rotatable about a rotation axis (Y-axis direction) perpendicular to the longitudinal direction (Z-axis direction).
  • this rotation operation portion is a portion used in the operation (rotation operation) of bending (deflecting) the vicinity of the distal end of the sheath tube 2.
  • FIG. 2 shows an example of a detailed configuration of the handle 3 in an exploded perspective view
  • R shown in FIG. 2 represents a rotating shaft of the rotating plate 32.
  • FIG. 3 shows a cross-sectional configuration example taken along the line II-II in the handle 3 shown in FIG.
  • symbol P1 is shown collectively.
  • the handle main body 31 includes a handle member 311 (first handle member) and a handle member 312 (first handle members) facing each other along the rotation axis R (Y-axis direction) of the rotating plate 32. 2 handle members).
  • Each of these handle members 311 and 312 extends along the axial direction (Z-axis direction) of the handle main body 31, and the rotating plate 32 is sandwiched therebetween.
  • the axial length of the handle body 31 is preferably such that the operator can hold it with one hand, but is not particularly limited.
  • FIG. 4 shows a planar configuration example of the handle members 311 and 312.
  • the handle members 311 and 312 have the same shape.
  • these handle members 311 and 312 protrude toward the rotating plate 32 in the vicinity of the center region thereof (near the rotation axis R and the region near the rotating plate 32).
  • the connecting pins 311p and 312p are shaped.
  • the connecting pin 311p is a member for connecting the handle member 311 and the rotary plate 32 or the like (specifically, a rotary member 321 and an intermediate member 33 described later in the rotary plate 32) to each other.
  • the connecting pin 312p is a member for connecting the handle member 312 and the rotating plate 32 and the like (specifically, a rotating member 322 and an intermediate member 33 described later in the rotating plate 32) to each other.
  • Each of the connecting pins 311p and 312p is formed with a guide groove g1 for inserting (extending) the sheath tube 2 and the like along the axial direction of the handle body 31.
  • These handle members 311 and 312 are each provided with a switching member Ex1 along a predetermined circumference centering on the connecting pins 311p and 312p.
  • the switching member Ex1 has a shape that fits with a switching member Ex2 to be described later, and in this example, has a female screw shape. The details of the switching member Ex1 will be described later.
  • Such a handle main body 31 is made of, for example, a synthetic resin such as polycarbonate, acrylonitrile-butadiene-styrene copolymer (ABS), acrylic, polyolefin, polyoxymethylene, or the like.
  • a synthetic resin such as polycarbonate, acrylonitrile-butadiene-styrene copolymer (ABS), acrylic, polyolefin, polyoxymethylene, or the like.
  • the rotation operation unit described above includes the intermediate member 33, connecting members 341 and 342, rod-like spring members 35a and 35b, etc. in addition to the rotating plate 32.
  • the rotary plate 32 corresponds to a portion where the operator actually operates during the above-described rotation operation, and has a substantially disk shape. Specifically, in this example, as indicated by arrows d1a and d1b in FIG. 1, an operation of rotating the rotating plate 32 bidirectionally in the ZX plane (rotating the rotation axis R) with respect to the handle main body 31. Centered rotation operation) is possible. As will be described in detail later, a part of the rotating plate 32 is configured to be elastically displaceable along a direction orthogonal to the rotation axis R (a predetermined direction in the ZX plane).
  • a pair of knobs 32 a and 32 b are provided integrally with the rotating plate 32 on the side surface of the rotating plate 32.
  • the knob 32a and the knob 32b are arranged at positions that are point-symmetric with respect to the rotation axis R.
  • Each of these knobs 32a and 32b corresponds to a portion operated (pressed) by a finger of one hand, for example, when the operator rotates the rotary plate 32.
  • the knobs 32 a and 32 b are not spherical but are U-shaped having a thickness along the rotation axis R.
  • the curvature of the U-shaped curved surface is reduced (curvature) while suppressing (holding) the entire width (length in the X-axis direction) of the sheath introducer 1.
  • the radius can be increased), and the pressure applied to the finger during operation (degree of pain) can be reduced.
  • the rotating plate 32 includes a rotating member 321 (first rotating member) and a handle member 311, 312 which are arranged to face each other along the rotation axis R between the handle members 311 and 312.
  • the rotating member 322 (second rotating member) is used.
  • These rotating members 321 and 322 also have a substantially disk shape.
  • the rotating member 321 is disposed on the handle member 311 side, and the rotating member 322 is disposed on the handle member 312 side.
  • only the rotating member 322 among these rotating members 321 and 322 is configured to be elastically displaceable as described above. Further, as will be described later, these rotating members 321 and 322 are connected to each other and rotate integrally with each other.
  • Such a rotating plate 32 (rotating members 311 and 312) is made of, for example, the same material (synthetic resin or the like) as the above-described handle main body 31 (handle members 311 and 312).
  • a pair of knobs 321a and 321b which are parts of the pair of knobs 32a and 32b described above, are provided on the side surface of the rotating member 321.
  • a hole 321 h (through hole) through which the connecting pin 311 p described above is formed is formed near the center of the rotating member 321.
  • the rotating member 321 is fixed to the handle main body 31 (handle member 311) by the connecting pin 311p, and can rotate around the connecting pin 311p.
  • a pair of adjustment fasteners 321pa and 321pb are provided on the surface of the rotating member 321 on the rotating member 322 side.
  • These adjustment fasteners 321pa and 321pb are members (wire fasteners) for individually fixing the base ends of the aforementioned operation wires 41a and 41b by screwing or the like. Specifically, as shown in FIG. 2, the operation wire 41 a passes through a guide path g ⁇ b> 32 on the knob 321 a side of the intermediate member 33 described later, and the base end thereof is fixed to the adjustment fastener 321 pa. ing. On the other hand, the operation wire 41b passes through the guide path g32 on the knob 321b side of the intermediate member 33, and the base end thereof is fixed to the adjustment fastener 321pb. In addition, in these adjustment fasteners 321pa and 321pb, it is possible to arbitrarily adjust the pull-in lengths near the base ends when the base ends of the operation wires 41a and 41b are fixed.
  • Each of these operation wires 41a and 41b is made of a super elastic metal material such as stainless steel (SUS) or nickel titanium (NiTi), and has a diameter of about 100 to 500 ⁇ m (for example, 200 ⁇ m). .
  • a metal material for example, may be comprised with the high intensity
  • a pair of knobs 322a and 322b which are parts of the pair of knobs 32a and 32b, are also provided on the side surface of the rotating member 322. That is, as shown in FIG. 3, the knob 32 a on the rotating plate 32 is configured by the knob 321 a on the rotating member 321 and the knob 322 a on the rotating member 322. Similarly, a knob 32 b in the rotating plate 32 is configured by the knob 321 b in the rotating member 321 and the knob 322 b in the rotating member 322. Further, as shown in FIG. 2, a hole 322 h (through hole) through which the connecting pin 312 p described above passes is also formed near the center of the rotating member 322.
  • FIG. 5 shows a planar configuration example of such a rotating member 322.
  • the rotating member 322 is a pair of divided members arranged side by side along a direction orthogonal to the rotation axis R (a predetermined direction in the ZX plane: for example, the X-axis direction). It is comprised by 322d1 and 322d2.
  • the dividing member 322d1 is disposed on the knob 322b side, and the dividing member 322d2 is disposed on the knob 322a side.
  • Each of these dividing members 322d1 and 322d2 has a substantially semi-disc shape.
  • each of the divided members 322d1 and 322d2 the above-described elastic displacement is possible along the orthogonal direction of the rotation axis R (predetermined direction in the ZX plane) (shown in FIGS. 2 and 5). (See symbols m1 and m2). Such elastic displacement is made in accordance with the presence / absence and magnitude of the pressing in the gap direction with respect to each of the divided members 322d1 and 322d2, as indicated by reference numerals Fa and Fb in FIGS. It has become.
  • these division members 322d1 and 322d2 have anti-slip shapes S1 and S2 that fit each other.
  • the non-slip shapes S1 and S2 are configured by a combination of a semicircular convex portion and a concave portion fitted to the semicircular convex portion, respectively.
  • Such a rotation member 322 is provided with a switching member Ex2 along a predetermined circumference centered around the hole 322h. Specifically, in the pair of divided members 322d1 and 322d2, one switching member Ex2 is arranged at a position that is substantially point-symmetric with respect to the vicinity of the hole 322h (in this example, along the X-axis direction). Yes.
  • Such a switching member Ex2 has a shape that fits with the switching member Ex1 described above, and in this example, has a male screw shape.
  • the switching member Ex1 first switching member
  • the rotating member 322 a pair of divided members 322d1 and 322d2
  • the following switching mechanism is configured by the switching member Ex2 (second switching member).
  • This switching mechanism is a mechanism used when switching between the “locked state” and the “free state (unlocked state)”.
  • the “free state” means that the rotation plate 32 (in this example, the rotation member 322) corresponds to the position state along the direction orthogonal to the rotation axis R (a predetermined direction in the ZX plane). This means that the rotational position of the rotary plate 32 can be arbitrarily set.
  • the “locked state” means a state in which such a rotation operation becomes impossible and the rotational position of the rotating plate 32 is fixed.
  • switching members Ex1, Ex2 switching members
  • the intermediate member 33 is disposed between the rotating members 321 and 322, and functions as a spacer between the rotating members 321 and 322.
  • the intermediate member 33 is formed in a linear shape extending along the axial direction (Z-axis direction) of the handle 3, and the guide path g31 through which the sheath tube 2 and the like are inserted, and the operation wires 41a and 41b described above. And a pair of arcuate guide paths g32 that define the respective paths. These guide paths g31 and g32 are basically separated by a partition as shown in FIGS.
  • the intermediate member 33 is fixed to the handle body 31 so as not to rotate, unlike the rotating plate 32 (the rotating members 321 and 322).
  • the intermediate member 33 is made of a synthetic resin such as a fluororesin, a polyolefin, or polyoxymethylene.
  • the intermediate member 33 having such a configuration, a space for inserting a long component (such as the sheath tube 2) (a space formed by the guide path g31) is secured between the rotating members 321 and 322. It is possible. Further, the extending direction of such a long component is defined by the guide path g31 formed in the intermediate member 33 and the guide grooves g1 formed in the connection pins 311p and 312p in the handle main bodies 311 and 312. Thereby, this long component can be extended (linearly) along the central axis of the handle body 31 in the longitudinal direction (Z-axis direction).
  • a long component such as the sheath tube 2
  • the connecting members 341 and 342 are attached to the distal end side and the proximal end side of the handle members 311 and 312, thereby connecting the handle members 311 and 312 (sealing members). Member).
  • the handle main body 31 is fixed in a state where the rotating plate 32 (the rotating members 311 and 312) and the intermediate member 33 are sandwiched between the handle members 311 and 312, and the entire handle 3 shown in FIGS. Will be composed.
  • the connecting members 341 and 342 are formed with holes 341h and 342h through which the sheath tube 2 and the operation wires 41a and 41b are inserted.
  • Such connecting members 341 and 342 are also made of, for example, the same material (synthetic resin or the like) as the handle body 31 (handle members 311 and 312) described above.
  • the rod-like spring members 35a and 35b are spring members (elastic members) that realize the above-described elastic displacement (see symbols m1 and m2 in FIGS. 2 and 5) in the divided members 322d1 and 322d2 of the rotating member 322, respectively.
  • each of the rod-shaped spring members 35a and 35b is a rod-shaped member (for example, an elongated columnar member) extending along the rotation axis R (Y-axis direction), and rotates with the rotation member 321.
  • the member 322 also has a function of connecting the divided members 322d1 and 322d2 to each other. That is, each of the rod-like spring members 35a and 35b is a spring member and functions as a connecting member.
  • the rod-shaped spring member 35a connects the knob 321a of the rotating member 321 and the knob 322a of the dividing member 322d2.
  • the rod-shaped spring member 35b connects the knob 321b of the rotating member 321 and the knob 322b of the dividing member 322d1 to each other.
  • the rotating member 321 and the rotating member 322 are connected to each other at the knobs 321a and 321b.
  • the rotating members 321 and 322 can freely rotate integrally with each other around the rotation axis R. That is, the rotating member 321 and the rotating member 322 do not rotate separately (individually). For this reason, in the locked state described above, the rotating member 321 as well as the rotating member 322 provided with the switching member Ex2 become non-rotatable, while in the free state described above, the rotating member 321 can also rotate together with the rotating member 322.
  • gap spaces Gs21 and Gs22 are formed around (around) the rod-like spring member 35a in the knob 322a. Further, a gap space Gs11 is formed around the rod-shaped spring member 35a in the knob 321a. Although not shown, similar gap spaces are also formed around the rod-shaped spring member 35b in the knobs 321b and 322b. Since the gap spaces Gs11, Gs21, Gs22, etc. are formed, the details will be described later, but along the direction orthogonal to the rotation axis R of each divided member 322d1, 322d2 (predetermined direction in the ZX plane). During the elastic displacement, the rod-like spring members 35a and 35b are partially elastically deformed.
  • the spring properties of the bar-shaped spring members 35a and 35b are secured by utilizing the play portions (gap spaces Gs11, Gs21, Gs22, etc.) in the knobs 321a, 321b, 322a, 322b.
  • the rod-shaped spring members 35a and 35b are partially elastically deformed along the direction orthogonal to the rotation axis R (predetermined direction in the ZX plane), so that the elastic displacement in each of the divided members 322d1 and 322d2 is reduced. It has come to be realized.
  • Such rod-like spring members 35a and 35b are each made of, for example, a shape memory alloy such as a nickel-titanium (Ni-Ti) alloy.
  • the sheath tube 2 is inserted into the patient's body through the blood vessel prior to the catheter tube 6 in the electrode catheter or the like when examining or treating arrhythmia or the like. Thereby, an insertion path is secured in the blood vessel at the insertion destination, and insertion of the catheter tube 6 is assisted.
  • examples of a method for introducing the sheath tube 2 into the body include the following methods.
  • a dilator (not shown) is inserted into the inner hole of the sheath tube 2, and the sheath tube 2 integrated with the dilator is inserted into the blood vessel of the patient. Then, the sheath tube 2 is moved toward the target site (affected site) along a guide wire (not shown) inserted in advance while the operator rotates the rotating plate 32. At this time, the shape of the vicinity of the distal end of the sheath tube 2 inserted into the body changes in both directions according to the rotation operation of the rotating plate 32.
  • the rotary plate 32 when the rotary plate 32 is rotated in the direction of the arrow d1b in FIG. 1 (counterclockwise) by operating the knob 32b, the following is performed. That is, in the sheath tube 2, the operation wire 41b is pulled to the proximal end side (adjustment fastener 321pb side). Then, the vicinity of the distal end of the sheath tube 2 is curved along the direction indicated by the arrow d2b in FIG.
  • the swing deflection operation of the sheath tube 2 can be performed.
  • the handle body 31 by rotating the handle body 31 around the axis (within the XY plane in FIG. 1), the direction of the bending direction in the vicinity of the distal end of the sheath tube 2 while the sheath tube 2 is inserted into the patient's body is maintained. Can be set freely.
  • the distal end opening of the sheath tube 2 reaches the vicinity of the target site (affected site)
  • the above-described dilator and guide wire are removed.
  • tip part of the sheath tube 2 is detained in a patient's body.
  • the catheter tube 6 can be inserted into the body using the sheath tube 2 thus introduced into the body.
  • the distal end of the catheter tube 6 is inserted into the inner hole of the sheath tube 2 from the proximal end of the handle 3. Then, the operator operates the rotating plate of the catheter (arranged in the handle provided on the proximal end side of the catheter tube 6; not shown in FIG. 1) while performing the operation along the inner hole of the sheath tube 2. The catheter tube 6 is moved. Thereby, for example, as shown in FIG. 1, the vicinity of the distal end of the catheter tube 6 extends from the distal end opening of the sheath tube 2.
  • the catheter tube 6 is swung and deflected. Further, as necessary, the sheath tube 2 is swung and deflected by rotating the rotating plate 32 in the sheath introducer 1. As a result, the position of the distal end portion of the catheter tube 6 (for example, the ring-shaped electrode 61 and the one distal end electrode 62 in the electrode catheter) is adjusted and can reach the target site (affected site).
  • the distal end portion of the catheter tube 6 for example, the ring-shaped electrode 61 and the one distal end electrode 62 in the electrode catheter
  • a catheter procedure (examination or treatment) is performed. After the procedure using the catheter is completed, the catheter tube 6 is removed from the body, and then the sheath tube 2 is removed from the body. As described above, examination and treatment of arrhythmia and the like are performed using the sheath introducer 1 and a catheter such as an electrode catheter.
  • FIG. 6 is a schematic diagram illustrating a schematic configuration of the sheath introducer 101 according to the comparative example.
  • FIG. 7 shows a cross-sectional configuration example taken along the line III-III in the handle 103 of the sheath introducer 101 shown in FIG.
  • the sheath introducer 101 of this comparative example is a device that assists the insertion of the catheter tube 6 by introducing the sheath tube 102 into the body prior to the catheter tube 6, as with the sheath introducer 1.
  • the sheath introducer 101 includes a sheath tube 102 and a handle 103 attached to the proximal end side of the sheath tube 102.
  • the handle 103 includes a handle body 91 including a pair of handle members 911 and 912 that are arranged to face each other, and a rotating plate 92 that is arranged between the handle members 911 and 912. It has.
  • the handle 103 also includes an O-ring 93 disposed between the handle member 911 and the rotating plate 92, and a washer 94 disposed between the handle member 912 and the rotating plate 92.
  • the handle 103 is further arranged so that its base 913a is fixed to the handle member 911 by an adhesive 914 and penetrates the rotary plate 92 along the rotation axis R of the rotary plate 92, and its tip is a male screw portion.
  • An adjustment pin 913 serving as 913b is provided.
  • a through hole 913h through which the sheath tube 102 and the like are inserted is formed on the axis (Y-axis direction) of the adjustment pin 913.
  • the handle 103 also has an adjustment knob 910 that has a female screw portion 910 b that is screwed with the male screw portion 913 b of the adjustment pin 913 and is rotatably attached to the handle member 912. On the adjustment knob 910, a knob 910a corresponding to a portion actually picked by the operator is provided.
  • the rotating plate 92 is fixed to the handle main body 91 by twisting the adjustment knob 910 provided on the handle main body 91 (handle member 912). (Curved state near the tip) is fixed (held).
  • a handle 103 has the following problems.
  • the adjustment knob 910 on the handle main body 91 (handle member 912) is fixed with the other hand while the rotating plate 92 is fixed at a desired rotation position with one hand. Need to twist. That is, in the case of the handle 103, an operation using both hands is required. Therefore, in this comparative example, work efficiency may be deteriorated, and operability may be reduced.
  • the shape near the distal end of the sheath tube and the shape near the distal end of the catheter tube are adjusted at the same time, so that the vicinity of the distal end of the electrode catheter is brought to an optimum position.
  • the sheath introducer 101 of the comparative example is used, as described above, both hands are used for the operation (rotation operation and rotation position fixing operation) on the sheath tube 102 side. Therefore, the operation on the catheter tube 6 side cannot be performed.
  • the shape near the distal end of the sheath tube 102 and the shape near the distal end of the catheter tube 6 cannot be adjusted at the same time. There is a risk that.
  • the rotating plate 32 has a direction orthogonal to the rotation axis R (in the ZX plane). (A predetermined direction) is partially elastically displaceable. Further, a switching mechanism (in this example, a switching member) that switches between the above-described free state and the locked state with respect to the rotational position of the rotating plate 32 in accordance with the position state of the rotating plate 32 along the orthogonal direction of the rotation axis R. Ex1, Ex2) are provided.
  • the rotary plate 32 is rotationally operated, and the rotary plate 32 is elastically displaced in the direction orthogonal to the rotation axis R, so that the free state and the locked state are changed according to the position state. Switching is realized.
  • switching members Ex1, Ex2 switching members
  • the operator's fingers press the knobs 322a and 322b (the pressing of the divided members 322d1 and 322d2 in the gap direction: see the signs Fa and Fb in FIG. 8B).
  • the free state is obtained as follows. That is, in this pressed state, for example, as shown in FIG. 8B, the divided members 322d1 and 322d2 of the rotating member 322 are elastically displaced along the direction orthogonal to the rotation axis R (in this example, the X-axis direction) (see FIG. 8B). (Refer to symbols m1 and m2 in 8B).
  • the switching member Ex1 in the handle member 321 and the switching member Ex2 in each of the divided members 322d1 and 322d2 are not engaged with each other (in this example, not fitted).
  • the engagement (fitting) state between the switching members Ex1, Ex2 in the locked state described above is released.
  • the rotating plate 32 can be rotated, and the rotating position of the rotating plate 32 is arbitrarily set (free state).
  • each of the divided members 322d1 and 322d2 is elastically displaced. Therefore, for example, as shown in FIG. 9B, the rod-like spring members 35a and 35b for realizing this elastic displacement are also partially (in this example, on the rotating member 322 side) toward the center of the rotating plate 32. The portion will be elastically deformed (see symbol ma in FIG. 9B).
  • the switching state between the free state and the locked state of the rotating plate 92 is performed according to the operation (twisting operation) along the rotation axis R direction of the rotating plate 92.
  • the rotation operation of the rotating plate 32 and the switching between the locked state and the free state relating to the rotational position of the rotating plate 32 are performed by the mechanism described above. Both operations can be performed.
  • the handle 3 can be operated with one hand (simple operation) to set the vicinity of the distal end of the sheath tube 2 in a desired curved state and hold the curved state. It becomes like this.
  • the shape near the distal end of the sheath tube 2 and the shape near the distal end of the catheter tube 6 can be adjusted simultaneously.
  • the rotation operation and the switching operation described above are performed as follows.
  • the operator holds the handle body 31 and holds the knobs 322a and 322b of the rotary plate 32 (the divided members 322d1 and 322d2 in the rotary member 322) with, for example, the fingers of the hand. Press (see symbols Fa and Fb in FIG. 10A).
  • the divided members 322d1 and 322d2 are elastically displaced toward the center of the rotating plate 32 (see symbols m1 and m2 in FIG. 10A), and the rotating plate 32 is set to a free state by the mechanism described above.
  • the operator rotates the rotary plate 32 using the knobs 322a and 322b while pressing the knobs 322a and 322b (while maintaining the free state) (see the arrow d1a in FIG. 10A).
  • the vicinity of the distal end of the sheath tube 2 is set to a desired curved state (see arrow d2a in FIG. 10A).
  • the divided members 322 d 1 and 322 d 2 of the rotating member 322 have anti-slip shapes S 1 and S 2 that fit with each other.
  • the non-slip shapes S1 and S2 are configured by a combination of a semicircular convex portion and a concave portion fitted to the semicircular convex portion, respectively.
  • the vicinity of the hole 322h is centered along the direction of elastic displacement of each of the divided members 322d1 and 322d2 (the direction orthogonal to the rotation axis R).
  • one switching member Ex2 is disposed at positions that are substantially point-symmetric with respect to each other.
  • the switching member Ex2 is first disposed along the direction of the elastic displacement described above, the switching member is compared with the case where the second switching member is disposed at a position excluding such a direction.
  • the engagement (fitting) state between Ex1 and Ex2 becomes better.
  • the switching member Ex2 is disposed along the direction of elastic displacement (the direction orthogonal to the rotation axis R)
  • the position of the concavo-convex shape (male shape and female shape) between the switching members Ex1 and Ex2 is determined. Match and make it easier to fit together. Further, in this case, it can be said that the amount of displacement at the time of elastic displacement is the largest, so that it can be easily fitted.
  • the switching member Ex2 when the switching member Ex2 is arranged along a direction other than the elastic displacement direction, the positions of the concavo-convex shape between the switching members Ex1 and Ex2 do not match each other, so that it becomes difficult to fit each other.
  • the outer edge portion (side surface) in the elastic displacement direction of the divided members 322d1 and 322d2 comes into contact with the switching member Ex1 before the switching member Ex2, and the switching is performed. There is also a possibility that the fitting between the members Ex1 and Ex2 becomes insufficient.
  • one switching member Ex2 is disposed at positions that are substantially point-symmetric with respect to each other, for example, as shown in FIG. 12, a plurality of switching members Ex2 are provided in each of the divided members 322d1 and 322d2 (in this example, 2).
  • the following advantages can be obtained as compared with the case where each piece is arranged. That is, an engagement (fitting) failure between the switching members Ex1 and Ex2 (a phenomenon that the rotating plate 32 cannot be set in a locked state or the like; a state where the rotating plate 32 is not engaged (fitted) is balanced) occurs. It becomes difficult (desirably it does not occur).
  • the switching members Ex2 are arranged one by one, even if the positions of the concave and convex shapes between the switching members Ex1 and Ex2 are shifted in the pressed state, the positions where they are fitted to each other by the elastic force (The misalignment is repaired), and poor fitting is avoided.
  • the switching members Ex2 are arranged one by one, even if the positions of the concave and convex shapes between the switching members Ex1 and Ex2 are shifted in the pressed state, the positions where they are fitted to each other by the elastic force (The misalignment is repaired), and poor fitting is avoided.
  • the switching members Ex2 are arranged one by one, even if the positions of the concave and convex shapes between the switching members Ex1 and Ex2 are shifted in the pressed state, the positions where they are fitted to each other by the elastic force (The misalignment is repaired), and poor fitting is avoided.
  • the switching members Ex2 are arranged one by one, even if the positions of the concave and convex shapes between the
  • a rotating plate 32 that is partly elastically displaceable along the direction orthogonal to the rotation axis R is provided, and the position along the direction orthogonal to the rotation axis R on the rotation plate 32 is provided.
  • Switching mechanisms switching members Ex1, Ex2 for switching between the free state and the locked state of the rotating plate 32 according to the state are provided.
  • the following erroneous operation can be prevented during the work of holding the vicinity of the distal end of the sheath tube 2 in a desired curved state. It becomes possible to do. That is, in the case of the comparative example, when the adjustment knob 910 is twisted with one hand, the rotational position of the rotating plate 92 held by the other hand may slightly vary due to camera shake or the like. (Incorrect operation may occur.) On the other hand, in the present embodiment, as described above, since the work at this time is completed by an operation with one hand, the occurrence of such an erroneous operation is avoided.
  • the rotating plate 32 is constituted by a pair of rotating members 321 and 322, and only one of the rotating members 321 and 322 (the rotating member 322) is elastically displaced along the direction orthogonal to the rotation axis R. Therefore, the following effects can also be obtained. That is, as compared with the case where both of the rotating members 321 and 322 undergo such elastic displacement, it becomes easier to determine which state is currently set between the above-described free state and locked state, and operability ( Convenience) can be improved. Specifically, whether or not the rotating member 322 is elastically displaced according to the relative positional relationship (relative position state) between the rotating member 321 and the rotating member 322, that is, a free state and a locked state.
  • the rotating member 322 is configured by a pair of divided members 322d1 and 322d2 that are arranged side by side along the direction orthogonal to the rotation axis R and each provided with a switching member Ex2, and in each divided member 322d1 and 322d2 Since the elastic displacement is enabled along the orthogonal direction of the rotation axis R, the following effects can be obtained. That is, the direction in which the operator holds the rotating plate 32 (rotating member 322) during the rotation operation (direction in which a force is applied by the finger) and the direction of the elastic displacement (direction in which the finger is pressed during the switching operation).
  • the rotary plate 32 is picked and gripped by, for example, the thumb and the index finger at the portions 32a and 32b, and the force is always applied along the direction orthogonal to the rotation axis R.
  • the rotating plate 32 is rotated while being added. Therefore, it is possible to perform the switching operation between the free state and the locked state by simply increasing the force applied in that state and pressing the knobs 322a and 322b, and a smooth switching operation can be realized. .
  • the rotating plate 32 is set in the locked state in the non-pressed state described above, and the rotating plate 32 is set in the free state in the pressed state described above. Switching is realized by a simple operation, and the operability can be further improved. Conversely, compared with the case where the non-pressed state is set to the free state and the pressed state is set to the locked state, the operation in the operation of holding the vicinity of the distal end of the sheath tube 2 in a desired curved state. It is possible to further improve the performance. Specifically, for example, when the handle 3 is not held with both hands (when held with one hand), when the curved shape near the distal end of the sheath tube 2 is determined, the hand is released from the handle 3 of the sheath introducer 1.
  • the rotating plate 32 is set to the locked state in the non-pressed state (the state where the hand is released from the handle 3), and the desired curved state is maintained. It can be said that operability becomes easy.
  • the switching member Ex1 is provided on the handle member 311 in addition to the handle member 312, and the handle members 311 and 312 have the same shape, the following effects can also be obtained. That is, although the switching member Ex1 in the handle member 311 is not actually used, the two handle members 311 and 312 have the same shape, which makes it possible to manufacture using the same mold, for example, and facilitate the manufacturing. And manufacturing cost can be reduced.
  • connection pins 311p and 312p and the switching member Ex1 are formed in the handle members 311 and 312, as in the above-described comparative example, a dedicated separate for ensuring their functions. There is no need to separately provide members (adjustment pins 913 and adjustment knobs 910). Therefore, in the handle 3 of the present embodiment, the number of parts can be reduced as compared with the handle 103 of the comparative example, the manufacturing cost can be reduced, and the work during the manufacturing (assembly) is simplified. Can be realized.
  • the rotation operation part in the handle 3 has a spring member that realizes the elastic displacement in each of the divided members 322d1 and 322d2, the elastic displacement in each of the divided members 322d1 and 322d2 can be realized with a simple configuration. It becomes possible.
  • such a spring member is constituted by rod-like spring members 35a and 35b extending along the rotation axis R and connecting the rotary member 321 and the divided members 322d1 and 322d2 to each other. ing. And since each said rod-shaped spring member 35a, 35b was elastically deformed partially along the orthogonal direction of the rotating shaft R, since the said elastic displacement in each division member 322d1, 322d2 was implement
  • the rod-like spring members 35a and 35b are inserted and arranged in the rotating plate 32, and a mechanism (elastic displacement mechanism) for applying an elastic displacement only by the rotating plate 32 is completed, such an elastic displacement mechanism is rotated. In this case, the operability can be further improved.
  • the elastic displacement mechanism is provided in a portion other than the rotating plate 32 (for example, the handle main body 31)
  • the relative positional relationship between the handle main body 31 and the rotating plate 32 is changed by the rotation operation. It will be caught by a member, and it will become an obstacle at the time of rotation operation.
  • the spring property can be arbitrarily adjusted (set) by adjusting the material and thickness of the rod-shaped portion, for example.
  • spring members other than rod-shaped spring member 35a, 35b (for example, a coil spring etc. which connect each division member 322d1,322d2).
  • FIG. 13A illustrates a planar configuration example of the handle members (handle members 311B and 312B) according to the first modification.
  • FIG. 13B illustrates a planar configuration example of a rotating member (rotating member 322B) according to Modification 1.
  • the handle members 311B and 312B shown in FIG. 13A correspond to the handle members 311 and 312 described in the above embodiment, in which a switching member Ex1B is provided instead of the switching member Ex1, and other configurations are as follows. It is the same. Specifically, the switching member Ex1B has a shape that fits with a switching member Ex2B described below. In this example, the switching member Ex1B has a male screw shape.
  • the rotating member 322B shown in FIG. 13B corresponds to the rotating member 322 described in the above embodiment, in which the switching member Ex2B is provided instead of the switching member Ex2, and the other configurations are the same. ing.
  • the switching member Ex2B has a shape that fits with the switching member Ex1B described above, and in this example, has a female screw shape.
  • the shape of the switching members Ex1B, Ex2B is the shape of the switching members Ex1, Ex2 in the above embodiment (switching member Ex1: female screw).
  • the shape and switching member Ex2: male screw shape) are the opposite combination.
  • FIG. 14A illustrates a planar configuration example of a handle member (handle members 311C and 312C) according to Modification 2.
  • FIG. 14B illustrates a planar configuration example of a rotating member (rotating member 322C) according to Modification 2.
  • the handle members 311C and 312C shown in FIG. 14A correspond to the handle members 311 and 312 described in the above embodiment, in which a switching member Ex1C is provided instead of the switching member Ex1, and other configurations are as follows. It is the same. Specifically, the switching member Ex1C is a ring-shaped member that circulates around the connection pins 311p and 312p (rotation axis R).
  • the rotating member 322C shown in FIG. 14B corresponds to the rotating member 322 described in the above embodiment, in which the switching member Ex2C is provided instead of the switching member Ex2, and the other configurations are the same. ing.
  • the switching member Ex2C is a ring-shaped member that circulates around the hole 322h (rotating axis R) in the rotating member 322C.
  • the switching members Ex1C and Ex2C are ring-shaped members that engage (contact) each other.
  • the switching members Ex1C and Ex2C are in contact with each other, and the friction state (coefficient of friction) between these contact surfaces is used, whereby the locked state of the rotating plate 32 is achieved.
  • Such switching members Ex1C and Ex2C can be made of a material such as a fluorine-based resin such as silicon or polytetrafluoroethylene, for example.
  • the rotational position of the rotating plate 32 can be set to an arbitrary continuous (non-discrete) position.
  • the rotational position of the rotating plate 32 is a shape that fits between these members (in these examples, the screw The rotation position of the rotating plate 32 is set to a discrete position.
  • first switching member and the “second switching member” in the present invention are, for example, combinations of the ring-shaped member and the convex member (such as a male screw-shaped member) described so far. May be.
  • the switching member Ex1B that is a convex member is used as the “first switching member” on the handle body 31 side, and the switching that is a ring-shaped member is used as the “second switching member” on the rotating plate 32 side.
  • the member Ex2C may be used (Modification 3).
  • a switching member Ex1C that is a ring-shaped member is used as the “first switching member” on the handle main body 31 side, and a switching that is a convex member is used as the “second switching member” on the rotating plate 32 side.
  • the member Ex2 may be used (Modification 4).
  • the same effect can be obtained by the same operation as in the above embodiment. Further, in these modified examples 3 and 4, since a ring-shaped member is used for one of the “first switching member” and the “second switching member”, the same as in the case of the modified example 2 above.
  • the rotational position of the rotating plate 32 can be set to an arbitrary continuous position.
  • a ring-shaped member is not used for the “second switching member” on the rotating plate 32 side (the ring-shaped member is divided member 322d1, (It is not necessarily divided into two semicircular shapes corresponding to the shape of 322d2).
  • a ring-shaped member is used as the “second switching member” on the rotating plate 32 side (the ring-shaped member has two half members corresponding to the shapes of the divided members 322d1 and 322d2). This is because the “second switching member” is easier to manufacture than the third modification example (divided into a circle).
  • the modification 3 and 4 have the same functional effect of the first and second switching members.
  • FIG. 15 schematically illustrates a schematic configuration example of the electrode catheter 5 as a medical device according to the fifth modification.
  • the electrode catheter 5 is inserted into the body (for example, the inside of the heart) through a blood vessel, and is used for arrhythmia examination or treatment.
  • the electrode catheter 5 includes a catheter tube 6 (catheter shaft) as a catheter main body (long portion) and a handle 3 attached to the proximal end side of the catheter tube 6.
  • the configuration of the handle 3 is basically the same as that of the handle 3 described in the embodiment.
  • the catheter tube 6 has a flexible tubular structure (hollow tube-like member) and has a shape extending along its own axial direction (Z-axis direction). Further, as in the case of the sheath tube 2, the distal ends of the operation wires 41a and 41b are fixed to the distal end side of the catheter tube 6. Each proximal end side of the operation wires 41 a and 41 b is also extended from the catheter tube 6 onto the rotary plate 32 as in the case of the sheath tube 2.
  • Such a catheter tube 6 is made of, for example, the same material (synthetic resin or the like) as the sheath tube 2.
  • the catheter tube 6 is also formed with a so-called single lumen structure in which one lumen (pore, through-hole) is formed so as to extend along the axial direction of the catheter tube 6 or a plurality of (for example, four) lumens. So-called multi-lumen structure.
  • region which consists of a multi-lumen structure may be provided.
  • Various thin wires (such as operation wires 41a and 41b and conductive wires (not shown)) are inserted through the lumen of the catheter tube 6 in a state where they are electrically insulated from each other.
  • a plurality of electrodes (here, three ring electrodes 61 and one distal electrode 62) are arranged at a predetermined interval. Specifically, the ring electrode 61 is fixedly disposed on the outer peripheral surface of the catheter tube 6, while the tip electrode 62 is fixedly disposed at the forefront of the catheter tube 6.
  • These electrodes are electrically connected to the inside of the handle 3 through a plurality of conductive wires (not shown) inserted into the lumen of the catheter tube 6 described above.
  • a conductive wire is made of a metal material such as copper and covered with an insulating resin, and has a diameter of about 50 to 200 ⁇ m (for example, 100 ⁇ m).
  • Each of the ring electrode 61 and the tip electrode 62 is made of a metal material having good electrical conductivity, such as aluminum (Al), copper (Cu), SUS, gold (Au), platinum (Pt). ing.
  • metal material having good electrical conductivity such as aluminum (Al), copper (Cu), SUS, gold (Au), platinum (Pt).
  • the outer diameters of the ring-shaped electrode 61 and the tip electrode 62 are not particularly limited, but it is desirable to be approximately the same as the outer diameter of the catheter tube 6 described above.
  • the catheter tube 6 is inserted into the patient's body through the blood vessel when examining or treating arrhythmia or the like. At this time, the shape of the vicinity of the distal end of the catheter tube 6 inserted into the body changes in both directions according to the rotation operation of the rotating plate 32 by the operator.
  • the rotary plate 32 when the rotary plate 32 is rotated in the direction of the arrow d1b in FIG. 15 (counterclockwise) by operating the knob 32b, the following is performed. That is, in the catheter tube 6, the operation wire 41b is pulled to the proximal end side (adjustment fastener 321pb side). Then, the vicinity of the distal end of the catheter tube 6 is curved along the direction indicated by the arrow d2b in FIG.
  • the catheter tube 6 can be swung and deflected.
  • the handle body 31 by rotating the handle body 31 around the axis (within the XY plane in FIG. 15), the direction of the bending direction in the vicinity of the distal end of the catheter tube 6 while the catheter tube 6 is inserted into the patient's body is maintained. Can be set freely.
  • the cardiac potential is measured using the electrode (tip electrode 62 or ring electrode 61) of the catheter tube 6 inserted into the patient's body. Then, based on the information on the electrocardiogram, an examination regarding the presence and degree of arrhythmia or the like at the examination site is performed.
  • Radio (Frequency) is energized.
  • the various members (handle members 311B, 311C, 312B, 312C, rotating members 322A, 322B, 322C, switching members Ex1B, Ex1C) described in Modifications 1 to 4 are also used. , Ex2B, Ex2C, etc.) may be applied.
  • each member described in the above embodiment and the like are not limited, and other shapes, arrangement positions, materials, and the like may be used.
  • the configuration of the tubular member (the sheath tube 2 or the catheter tube 6) is specifically described. However, it is not always necessary to include all the members, and other members are further included. It may be. Specifically, for example, a leaf spring that can be deformed in the bending direction may be provided inside the catheter tube 6 as a swinging member. Further, the configuration of the electrodes in the catheter tube 6 (arrangement, shape, number, etc. of the ring-shaped electrode 61 and the tip electrode 62) is not limited to those described in the above-described embodiment and the like.
  • the configuration of the handle 3 (the handle body 31 and the rotation operation unit) has been specifically described. However, it is not always necessary to include all the members, and other members may be further provided. You may have. Specifically, for example, the intermediate member 33 may not be provided depending on circumstances.
  • the configuration of the switching mechanism is not limited to that described in the above embodiment and the like (switching members Ex1, Ex2, etc.), and other configurations may be employed.
  • the rotating plate 32 is not limited to the case where only a part of the rotating plate 32 is configured to be elastically displaceable along the direction orthogonal to the rotation axis R as described in the above-described embodiment, and at least a part of the rotating plate 32 is elastically displaced.
  • the case where the second switching member (switching member Ex2 or the like) is provided in each of the pair of split members 322d1 and 322d2 is not limited thereto.
  • the second switching member may be provided only on one of the divided members 322d1 and 322d2.
  • the strength in the locked state (lock strength) is increased as compared with the case where the second switching member is provided only on one side. The reliability of the product at the time can be improved.
  • the shape of the shape near the tip of the tubular member is not limited to that described in the above embodiment.
  • the medical device of the type (bi-direction type) in which the shape near the tip of the tubular member changes in both directions according to the operation of the rotating plate 32 has been described as an example.
  • the present invention can be applied to, for example, a medical device of a type (single direction type) in which the shape near the tip of the tubular member changes in one direction according to the operation of the rotating plate 32. In this case, only one (one) operation wire and one adjustment fastener are provided.
  • the electrode catheter as a specific example of the medical device according to the present invention is an electrode catheter for testing for arrhythmia (so-called EP catheter) or an electrode catheter for treating arrhythmia (so-called ablation catheter). It is possible to apply.
  • the sheath introducer and the electrode catheter have been described as specific examples of the medical device according to the present invention, but the present invention is not limited thereto. That is, the medical device handle according to the present invention can be applied to other medical devices such as a guide catheter (guiding catheter), an angiographic catheter, and a microcatheter.
  • a guide catheter guiding catheter
  • an angiographic catheter angiographic catheter
  • a microcatheter a microcatheter
  • tip electrode rotating shaft
  • g1 guide groove
  • g31, g32 guideway Ex1, Ex1B, Ex1C, Ex2, Ex2B, Ex2C ... switching member

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Physics & Mathematics (AREA)
  • Plasma & Fusion (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Otolaryngology (AREA)
  • Biophysics (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)
PCT/JP2014/077643 2014-03-18 2014-10-17 医療機器用ハンドルおよび医療機器 WO2015141046A1 (ja)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017176604A (ja) * 2016-03-31 2017-10-05 日本ゼオン株式会社 先端可動カテーテル
CN111655322A (zh) * 2018-01-31 2020-09-11 株式会社钟化 导管用手柄以及具备该手柄的导管
CN114786759A (zh) * 2019-12-12 2022-07-22 国立大学法人滋贺医科大学 医疗设备用偏转操作装置
JPWO2022162889A1 (enrdf_load_stackoverflow) * 2021-01-29 2022-08-04
EP3950037A4 (en) * 2019-04-05 2022-11-30 Japan Lifeline Co., Ltd. CATHETER HANDLE AND STEERABLE DEFORMABLE TIP CATHETER

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6713808B2 (ja) * 2016-03-31 2020-06-24 日本ピストンリング株式会社 医療器具

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH07255855A (ja) * 1991-02-15 1995-10-09 Ingemar H Lundquist カテーテル及びその使用方法
JP3162588U (ja) * 2010-06-25 2010-09-09 日本ゼオン株式会社 先端可動カテーテル
WO2012117749A1 (ja) * 2011-03-03 2012-09-07 テルモ株式会社 ステントデリバリーシステム
JP2013192670A (ja) * 2012-03-19 2013-09-30 Japan Lifeline Co Ltd カテーテル用ハンドル

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH07255855A (ja) * 1991-02-15 1995-10-09 Ingemar H Lundquist カテーテル及びその使用方法
JP3162588U (ja) * 2010-06-25 2010-09-09 日本ゼオン株式会社 先端可動カテーテル
WO2012117749A1 (ja) * 2011-03-03 2012-09-07 テルモ株式会社 ステントデリバリーシステム
JP2013192670A (ja) * 2012-03-19 2013-09-30 Japan Lifeline Co Ltd カテーテル用ハンドル

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017176604A (ja) * 2016-03-31 2017-10-05 日本ゼオン株式会社 先端可動カテーテル
CN111655322A (zh) * 2018-01-31 2020-09-11 株式会社钟化 导管用手柄以及具备该手柄的导管
EP3950037A4 (en) * 2019-04-05 2022-11-30 Japan Lifeline Co., Ltd. CATHETER HANDLE AND STEERABLE DEFORMABLE TIP CATHETER
CN114786759A (zh) * 2019-12-12 2022-07-22 国立大学法人滋贺医科大学 医疗设备用偏转操作装置
JPWO2022162889A1 (enrdf_load_stackoverflow) * 2021-01-29 2022-08-04
WO2022162889A1 (ja) * 2021-01-29 2022-08-04 日本ライフライン株式会社 カテーテル

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