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WO2013073523A1 - 医療機器 - Google Patents

医療機器 Download PDF

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Publication number
WO2013073523A1
WO2013073523A1 PCT/JP2012/079368 JP2012079368W WO2013073523A1 WO 2013073523 A1 WO2013073523 A1 WO 2013073523A1 JP 2012079368 W JP2012079368 W JP 2012079368W WO 2013073523 A1 WO2013073523 A1 WO 2013073523A1
Authority
WO
WIPO (PCT)
Prior art keywords
gripping member
medical device
jaw
shaft
axis
Prior art date
Application number
PCT/JP2012/079368
Other languages
English (en)
French (fr)
Inventor
宮本　学
Original Assignee
オリンパスメディカルシステムズ株式会社
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 オリンパスメディカルシステムズ株式会社 filed Critical オリンパスメディカルシステムズ株式会社
Priority to CN201280035366.1A priority Critical patent/CN103687553B/zh
Priority to EP12849904.3A priority patent/EP2781195B1/en
Priority to JP2013526254A priority patent/JP5420802B2/ja
Publication of WO2013073523A1 publication Critical patent/WO2013073523A1/ja
Priority to US13/915,995 priority patent/US8820608B2/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/70—Manipulators specially adapted for use in surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/70—Manipulators specially adapted for use in surgery
    • A61B34/71—Manipulators operated by drive cable mechanisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07257—Stapler heads characterised by its anvil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07271—Stapler heads characterised by its cartridge
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A61B2017/2932—Transmission of forces to jaw members
    • A61B2017/2939—Details of linkages or pivot points
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A61B2017/2932—Transmission of forces to jaw members
    • A61B2017/2939—Details of linkages or pivot points
    • A61B2017/294—Connection of actuating rod to jaw, e.g. releasable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A61B2017/2932—Transmission of forces to jaw members
    • A61B2017/2939—Details of linkages or pivot points
    • A61B2017/2941—Toggle linkages

Definitions

  • the present invention relates to a medical device. In more detail, it is related with the medical device provided with the clamp mechanism.
  • This application claims priority based on provisional application 61 / 560,432 filed in the United States on November 16, 2011, the contents of which are incorporated herein by reference.
  • Patent Literature 1 describes a surgical stapler including a pair of jaws. A staple magazine loaded with staples is attached to one of the pair of jaws. On the other side, an anvil member having a plurality of staple pockets is attached. When the jaw is closed with the tissue sandwiched between the pair of jaws, the tissue can be sutured by staple.
  • a medical device When a medical device is provided with a flexible insertion portion, it is necessary to use a flexible member such as a wire as the operation member.
  • a flexible member such as a wire
  • Such an operation member cannot easily increase the amount of force acting on the treatment portion because of a small breaking load and a transmission loss caused by friction with the insertion portion.
  • the medical stapler has a particularly large amount of force acting on the treatment portion, such as several hundred to a thousand newtons. For this reason, it has been difficult for the stapler to generate a force necessary for the treatment portion using a flexible operation member. If the force is insufficient, the tissue may fall off between the pair of jaws when the cutter is moved forward, or adequate stapling may not be realized due to insufficient compression of the tissue. Therefore, there is a problem that it is difficult to perform a stable procedure.
  • the present invention provides a medical device that generates a large gripping force between a pair of jaws and can securely grip a tissue between the pair of jaws.
  • the medical device is rotatably attached to a first gripping member and a second gripping member that are close to and away from each other, and a rotation shaft that is fixed to the first gripping member.
  • a rotating body and a first end are rotatably connected to a first rotating shaft provided on the second gripping member, and a second end is provided on the rotating body apart from the rotating shaft.
  • an open / close link rotatably connected to the second rotary shaft, and an operation member for rotating the rotating body.
  • the first end is rotatably connected to the first rotation shaft, and the second end is rotatable to the third rotation shaft provided on the first gripping member.
  • a grip member link coupled to the.
  • the first grasping member may be fixed to a tissue to be treated.
  • the second gripping member may approach the first gripping member by moving to the proximal end side of the first gripping member.
  • the medical device may further include a holding portion that holds the base end portion of the second gripping member at a predetermined position when the first gripping member and the second gripping member approach each other.
  • the medical device may further include a positioning unit that positions the first gripping member and the second gripping member in a predetermined positional relationship when the first gripping member and the second gripping member approach each other. .
  • the positioning portion is provided on the first abutting surface provided on the first gripping member and the second gripping member, and the first gripping member and the second gripping member approach each other. Sometimes it may have a second contact surface in contact with the first contact surface.
  • the medical device may further include an operation unit to which the operation member is connected and an operation for rotating the rotating body is input.
  • a cartridge containing staples may be attached to the first gripping member in a replaceable manner, and the first gripping member and the second gripping member may function as a stapler.
  • a large gripping force can be generated between the pair of jaws, and the tissue can be securely gripped between the pair of jaws. Therefore, suturing and tissue excision with staples can be suitably performed.
  • FIG. 3 is a cross-sectional view taken along line AA in FIG. 2.
  • FIG. 3 is a cross-sectional view taken along line BB in FIG. 2.
  • FIG. 4 is a cross-sectional view taken along the line CC in FIG. 3. It is a figure for demonstrating the force which acts on each part when closing a pair of jaw of the treatment part of the medical device which concerns on 1st embodiment of this invention.
  • FIG. 1 is a diagram illustrating an overall configuration of a medical device 1 according to the present embodiment.
  • the medical device 1 includes a clamp mechanism according to this embodiment.
  • the medical device 1 is provided at a distal end, a treatment unit 10 for performing treatment on a target tissue, a first operation unit 30 for operating the treatment unit 10, and a space between the treatment unit 10 and the first operation unit 30.
  • a treatment unit 10 for performing treatment on a target tissue
  • a first operation unit 30 for operating the treatment unit 10
  • a space between the treatment unit 10 and the first operation unit 30 are provided with an insertion portion 40, an observation portion 50 inserted through the insertion portion 40, and a second operation portion 60 for operating the observation portion 50.
  • the treatment section 10 includes a first jaw (first gripping member) 11 and a second jaw (second gripping member) 12 as a pair of jaws that can be opened and closed.
  • the treatment section 10 is an object that sutures and separates tissue using the cartridge 13 loaded with the staple 13A.
  • the basic structure is known, for example, as described in Patent Document 1 described above. The characteristic part in the treatment part 10 of this embodiment is demonstrated in detail later.
  • the first operation unit 30 has a known configuration and includes two dial knobs 31 and 32 and a lever 33.
  • the dial knob 31 is connected to the treatment section 10 by an operation member (described later) such as a wire. By rotating the dial knob 31, the pair of jaws 11 and 12 can be opened and closed.
  • the insertion part 40 is formed in a flexible tubular shape.
  • the insertion section 40 has the treatment section 10 attached to the distal end side and the first operation section 30 attached to the proximal end side.
  • the insertion portion 40 has a curved portion 41 having a known structure having a plurality of node rings or curved pieces on the distal end side.
  • the bending portion 41 can be bent by operating the dial knob 32 of the first operation portion 30.
  • An operation member is inserted into the lumen of the insertion portion 40 so as to be able to advance and retract in the axial direction.
  • a forceps port 42 is provided on the proximal end side of the insertion portion 40.
  • a general endoscopic treatment tool 100 or the like provided with the forceps 101 can be inserted into the forceps port 42 and protruded from the proximal end side of the first jaw 11.
  • the observation unit 50 is inserted into the insertion unit 40 so as to be able to advance and retreat.
  • the observation unit 50 includes an illumination unit 51 including an LED or the like at the tip, and an imaging unit 52 such as a CCD.
  • a bending portion 53 having the same structure as the bending portion 41 is provided on the distal end side of the observation portion 50. The distal end portion of the observation unit 50 can be protruded from the opening 43 provided on the distal end side of the insertion portion 40.
  • the second operation unit 60 is connected to the base end of the observation unit 50 that has come out from the base end side of the insertion unit 40.
  • the second operation unit 60 is provided with a dial knob 61, a button 62, and the like similar to those of the first operation unit 30.
  • the second operation unit 60 can perform a bending operation of the bending unit 53, an operation of the illumination unit 51 and the imaging unit 52, and the like.
  • the video signal acquired by the imaging means 52 is sent to an image processing unit (not shown) through the universal cable 63 and displayed on a display or the like (not shown).
  • a known endoscope apparatus or the like can be used by appropriately setting dimensions and the like.
  • FIG. 2 is an enlarged view of the treatment section 10.
  • FIG. 3 is a cross-sectional view of the treatment portion 10 in the longitudinal direction.
  • a cartridge 13 loaded with a plurality of rows of staples 13A in the longitudinal direction is mounted on the first jaw 11 in a replaceable manner.
  • a cutter 22 and a wedge 23 capable of moving back and forth between the rows of staples 13 ⁇ / b> A are attached to the first jaw 11.
  • the forward / backward operation of the cutter 22 can be performed by the lever 33 of the first operation unit 30.
  • An anvil member 14 that bends the tip of the staple 13 ⁇ / b> A is attached to the second jaw 12.
  • FIGS. 4 and 5 are sectional views taken along lines AA and BB in FIG. 2, respectively.
  • the first jaw 11 and the second jaw 12 are connected by a pair of parallel links (gripping member links) 15 and 16, respectively. That is, the first jaw 11 and the second jaw 12 are connected by four parallel links.
  • the 1st jaw 11 and the 2nd jaw 12 can approach and space apart, maintaining a mutually parallel state.
  • FIG. 6 is a cross-sectional view taken along the line CC of FIG.
  • a pulley (rotary body) 17 for opening and closing the first jaw 11 and the second jaw 12 is disposed on the proximal end side of the treatment portion 10.
  • the pulley 17 is rotatably attached to a rotation shaft 17A provided on the first jaw 11.
  • a wire (operation member) 18 is wound around the pulley 17. The end of the wire 18 is connected to the dial knob 31 of the first operation unit 30 through the insertion unit 40.
  • the pulley 17 and the second jaw 12 are connected by a pair of open / close links 19 having a substantially semicircular arc shape.
  • One end 19 ⁇ / b> A of the opening / closing link 19 is rotatable about a connecting shaft (first rotating shaft) 20 between the parallel link 15 and the second jaw 12 disposed on the distal end side of the two parallel links. It is connected to.
  • the other end 19 ⁇ / b> B is rotatably connected to a rotation shaft (second rotation shaft) 25 provided on the pulley 17.
  • a protrusion (holding portion) 21 that comes into contact with the second jaw 12 when the pair of jaws 11 and 12 are closed is provided at the base end portion of the first jaw 11.
  • the protrusion 21 is a screw type. By adjusting the screwing length between the protrusion 21 and the first jaw 11, the amount of protrusion from the first jaw 11 can be adjusted within a certain range.
  • the surgeon inserts the distal end side of the medical device 1 provided with the treatment unit 10 into a natural opening such as a patient's mouth.
  • the surgeon introduces the treatment unit 10 to the vicinity of the treatment target tissue while observing the treatment unit 10 and its surroundings with the observation unit 50.
  • the operator places the tissue to be sutured between the first jaw 11 and the second jaw 12.
  • the surgeon rotates the dial knob 31 of the first operation unit 30 in a predetermined direction, and pulls the wire 18 in the direction of the arrow A1 shown in FIG.
  • the pulley 17 rotates clockwise in FIG.
  • the end 19 ⁇ / b> B of the opening / closing link 19 rotates around the rotation shaft 17 ⁇ / b> A of the pulley 17.
  • the end 19A and the connecting shaft 20 also move to the proximal end side.
  • part of the parallel links 15 and 16 and the 2nd jaw 12 moves to a base end side.
  • the second jaw 12 moves close to the first jaw 11 fixed to the tissue to be treated while moving in a proximal direction while maintaining a parallel state with the first jaw 11 and approaches the pair of paired jaws. Joe is closed.
  • the clamp mechanism of this embodiment that closes the pair of jaws 11 and 12 connected by the parallel links 15 and 16 by the rotation of the pulley 17 that is operated and input via the wire 18 is a so-called toggle mechanism (a boost mechanism, a boost mechanism). ).
  • FIG. 7 and FIG. 8 are diagrams for explaining the forces acting on each part when the pair of jaws 11 and 12 are closed.
  • the wire 18 is pulled from the initial state shown in FIG. 7 and the second jaw 12 approaches the first jaw 11 as shown in FIG.
  • a straight line 11 connecting the rotation shaft 17A, the connection point (third rotation shaft) 15A between the parallel link 15 and the first jaw 11, and a straight line 12 connecting the axes of the connection shaft 20 and the connection shaft 25.
  • O be the intersection of A line segment connecting the rotation shaft 17A and the intersection point O is defined as OA.
  • a line segment connecting the connection point 15A and the intersection point O is defined as OB.
  • the length of the parallel link 15 is L1.
  • This toggle mechanism will fail if the pulley 17 rotates more than a predetermined amount.
  • the protrusion length of the protrusion 21 is such that the second jaw 12 is slightly inclined when the proximal end portion of the second jaw 12 contacts the protrusion 21, and the height dimension D1 on the proximal end side of the treatment portion 10 is It is set to be slightly larger than the height dimension D2 on the distal end side.
  • the operator When the tissue is securely grasped between the pair of jaws 11 and 12, the operator operates the lever 33 to advance the cutter 22. Then, the tissue is sutured by the wedge 23 pressing the staple 13A in the cartridge 13 against the anvil member 14 to bend by a known mechanism. Further, the cutter 22 cuts the tissue between the staple rows where the tissue is sutured, and the target tissue is separated without causing perforation or the like.
  • a flexible insertion portion When a flexible insertion portion is provided as in the medical device 1 of this embodiment, it is necessary to use a flexible member such as a wire as the operation member.
  • a flexible member such as a wire
  • such an operation member cannot easily increase the amount of force acting on the treatment portion because of a small breaking load and a transmission loss caused by friction with the insertion portion.
  • a stapler such as the treatment unit 10 has a particularly large amount of force acting on the treatment unit, such as about several hundred to a thousand newtons. For this reason, it has been difficult to generate a force necessary for the treatment portion using a flexible operation member. If the force is insufficient, the tissue may fall off between the pair of jaws when the cutter is advanced, or adequate stapling may not be achieved due to insufficient compression of the tissue. As a result, there is a problem that it is difficult to perform a stable procedure.
  • the clamp mechanism including the pulley 17, the opening / closing link 19, and the parallel links 15 and 16 functions as a toggle mechanism. For this reason, even if a flexible member such as a wire is used as the operation member for rotating the pulley, it is possible to increase the reduction ratio in the vicinity of the treatment portion and generate a large gripping force between the pair of jaws. Therefore, it is possible to suitably perform suturing and tissue excision by stapling by securely grasping a tissue between a pair of jaws while providing a flexible insertion portion and allowing an approach to a target tissue from a natural opening. it can.
  • the reduction ratio is not large until the pair of jaws is closed. For this reason, the amount of operation of the operation member may be small at the beginning of tissue clamping, and the operational feeling is not impaired. Since the reduction ratio increases as the tissue is grasped and the tissue is compressed and thinned, the operator can always perform the operation with the minimum required pulling amount of the operation member.
  • the amount of operation force from the first operation unit 30 is transmitted to the open / close link 19 using the pulley 17 as an input node. For this reason, it is not necessary to receive the reaction force from the link by the toggle mechanism with the wire 18. Furthermore, since the pulley 17 is a rotating body, it is not necessary to provide another guide for regulating the behavior as long as sufficient rigidity is secured to the rotating shaft 17A. Therefore, it is easy to simplify the configuration of the connecting portion between the treatment section and the operation member and to make the configuration small.
  • the hard length of the distal end portion of the medical device 1 is not easily increased. As a result, the insertability into the body cavity and the size of the opening / closing stroke can be compatible at a high level.
  • the opening / closing link 19 is formed in an arc shape. For this reason, the distance between the end portions 19A and 19B can be adjusted to a desired value while preventing interference with the parallel links 15 and 16 when the treatment portion is opened and closed.
  • the pair of jaws close while the second jaw 12 on the movable side moves relative to the first jaw 11 on the fixed side relative to the base end side. For this reason, it is possible to suitably suppress dropping from between the jaws by applying a force to the grasped tissue so as to be pulled toward the proximal end side.
  • the clamp mechanism of the present embodiment is not limited to the above configuration.
  • the open / close link 19 and the parallel link 16 on the base end side may be connected to reverse the attachment relationship between the open / close link and the parallel link.
  • the second jaw 12 approaches the first jaw 11 while moving relatively to the distal end side, and the pair of jaws is closed.
  • This configuration is not necessarily suitable when the treatment section is a stapler.
  • the present invention can be applied without problems to a treatment unit without such restrictions.
  • the gripping force of the treatment part can be increased suitably.
  • FIG. 12 is an enlarged view of the treatment portion 72 of the endoscope treatment tool 71, which is the medical device of the present embodiment.
  • the treatment portion 72 is provided with a pair of a fixed jaw 73 and a movable jaw 74 that open and close.
  • the fixed side jaw 73 and the movable side jaw 74 are connected by a rotation shaft 75 so as to be relatively rotatable.
  • One end 19 ⁇ / b> A of the opening / closing link 19 is connected to the movable jaw 74 so as to be relatively rotatable on the tip side of the rotation shaft 75.
  • the pulley 17 is rotated by pulling the wire 18 in the direction of the arrow A2 via an operation unit (not shown). Then, the movable side jaw 74 rotates about the rotation shaft 75 and approaches the fixed side jaw 73, and the pair of jaws 73, 74 are closed as shown in FIG. At this time, with the rotation of the pulley 17, the connecting shaft 25 of the end portion 19B approaches a virtual straight line connecting the rotating shaft 17A of the pulley and the connecting shaft 20 of the end portion 19A. That is, the pair of jaws 73 and 74 includes a toggle mechanism having the same basic structure as the first embodiment. For this reason, a larger gripping force can be realized by the pair of jaws.
  • the clamp mechanism according to the present embodiment is not only a treatment part as in the first embodiment that opens and closes while maintaining a parallel state, but also a treatment part that is connected so as to be relatively rotatable with a single rotation shaft. Can be applied without any problem.
  • the base end portion of the movable jaw 74 is fixed to the rotating shaft 75. For this reason, when the distal end side of the movable side jaw 74 receives a reaction force from the grasped tissue and tries to move in the opening direction, the movable side jaw 74 does not approach the fixed side jaw 73. That is, the rotation shaft 75 functions as a holding portion that holds the base end portion in a predetermined position. As a result, by increasing the gripping force with the toggle mechanism, the distal ends of the pair of jaws can be reliably closed without being affected by the reaction force.
  • the treatment unit is a stapler as in the first embodiment.
  • the anvil member and the cartridge be positioned with high accuracy in a predetermined positional relationship.
  • the staple is pressed against the staple pocket of the anvil member.
  • a slight gap is required between the connecting shaft and the jaw in order to connect the link and the jaw so as to be rotatable. This gap becomes a cause of backlash (vibration with respect to the connecting shaft) when the pair of jaws are opened and closed.
  • the pair of jaws 81 and 82 may be provided with protrusions 83 and 84 as positioning portions.
  • the protrusion 83 provided on the jaw 81 includes a pair of protrusions of a first protrusion 83A and a second protrusion 83B formed on both sides of the jaw 81 in the width direction.
  • the upper surfaces (first contact surfaces) of the protrusions 83A and 83B are formed on inclined surfaces 83a and 83b, respectively.
  • the height of each of the protrusions 83A and 83B decreases as it approaches the width direction end.
  • the protrusions 84 provided on the jaw 82 are constituted by a pair of protrusions of a first protrusion 84A and a second protrusion 84B formed on both sides of the jaw 82 in the width direction.
  • the lower surfaces (second contact surfaces) of the protrusions 84A and 84B are formed on inclined surfaces 84a and 84b having inclination angles corresponding to the inclined surfaces 83a and 83b, respectively.
  • the protrusion length of each protrusion 84A, 84B becomes large as it approaches the end part in the width direction.
  • the positioning portion may be configured by a substantially conical protrusion 86 and a circular hole 87 into which at least a part of the protrusion 86 can enter.
  • the deviation is corrected by the protrusion 86 entering the hole 87 while the curved tapered surface 86 a of the protrusion 86 is in contact with the upper edge of the hole 87.
  • a protrusion 88 and an elongated hole 89 may be further provided.
  • the protrusion 88 is a substantially conical protrusion having a protrusion length longer than that of the protrusion 86.
  • the elongated hole 89 is an oblong elongated hole extending in the longitudinal direction of the jaw 81 in plan view.
  • the inner surface of the hole 87 or the long hole 89 may be perpendicular to the stitching surface 81A of the first jaw 81. Further, the inner surfaces of the holes 87 and the long holes 89 may be inclined so as to correspond to the tapered surfaces of the protrusions 86 and 88 and the like. In the latter case, there is an advantage that sliding when the pair of jaws approaches is smoother. The arrangement of the holes and the projections may be reversed to form the projections 86 and 88 on the first jaw 81.
  • a set of protrusions is formed so as to have inclined surfaces 83c and 84c inclined in a direction perpendicular to the inclined direction of the inclined surface 83a, such as the protrusions 83C and 84C shown in FIG. 14D. May be.
  • the protrusions 83D and 84D provided at the end portions in the width direction of the pair of jaws, the inclinations of the protrusions 83A and 84A and the inclined surfaces are reversed. Even if it does in this way, the positioning effect can be acquired without a problem.
  • the positioning part is not limited to the above-described projection set or projection / hole set.
  • the anvil member 93 attached to the second jaw 92 is urged by the urging member 94 such as a spring so as to always contact the surface 91 ⁇ / b> A on the proximal end side of the first jaw 91. Yes.
  • the position of the anvil member 93 is the same as that of the surface 91A. Hold in contact. For this reason, it can position suitably with respect to the cartridge 95.
  • the biasing member 94 positions the anvil member 93 in the longitudinal direction.
  • a similar biasing member may be arranged on both sides or one side of the anvil member in the width direction to position the anvil member 93 in the width direction. You may combine both.
  • various elastic bodies such as a leaf spring, a disc spring, a tension spring, a compression spring, and an elastomer can be appropriately selected and used as the biasing member.
  • a plurality of locking projections 98 may be provided to prevent the tissue sandwiched between the pair of jaws 96, 97 from slipping off due to body fluid or the like.
  • the locking protrusion 98 is formed so as not to protrude from the stitching surfaces 96A and 97A on which the anvil member and the cartridge are arranged. A part of the sandwiched tissue is deformed and enters between the adjacent locking projections 98 to be locked.
  • the locking protrusion 98 has a rising angle on the distal end side smaller than a rising angle on the proximal end side. For this reason, when the entering tissue tries to move to the distal end side, it bites into the tissue and suppresses the movement to the distal end side. That is, the tissue is prevented from falling off from the pair of jaws.
  • the locking protrusion 98 is not limited to the above.
  • a pin-like locking projection 99 as shown in FIG. 18 may be used.
  • the locking projections 99 interfere with each other during the suturing operation in which the stitching surfaces 96A and 97A are closest to each other by arranging the locking projections 99 alternately on the jaw 96 side and the jaw 97 side. It may be formed so as not to. In this case, the locking protrusion 99 may be formed to protrude to a certain degree higher than the stitching surface.
  • the tissue can be reliably grasped between the pair of jaws, and the suturing and tissue excision can be suitably performed by stapling. As a result, the surgeon can perform a stable procedure.

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  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Surgical Instruments (AREA)

Abstract

　この医療機器は、互いに接近離間する第一把持部材および第二把持部材と、前記第一把持部材に対して固定された回転軸に回転可能に取り付けられた回転体と、第一の端部が前記第二把持部材に設けられた第一回動軸に回動可能に連結され、第二の端部が前記回転体に前記回転軸と離間して設けられた第二回動軸に回動可能に連結された開閉リンクと、前記回転体を回転させる操作部材と、を備え、前記回転体を所定の方向に回転させると、前記回転軸と前記第一回動軸の軸線とを結ぶ仮想直線に前記第二回動軸が接近しながら、前記第一把持部材と前記第二把持部材とが接近する。

Description

医療機器
　本発明は、医療機器に関する。より詳しくは、クランプ機構を備えた医療機器に関する。
　本願は、２０１１年１１月１６日に、米国に出願された仮出願第６１／５６０，４３２号に基づき優先権を主張し、その内容をここに援用する。
　従来、一対のジョーを開閉させるクランプ機構が、各種医療機器に用いられている。このような医療機器の一例として、特許文献１には、一対のジョーを備えた手術用ステイプラが記載されている。一対のジョーの一方には、ステイプルが装填されたステイプルマガジンが装着されている。他方には、複数のステイプルポケットを有するアンビル部材が取り付けられている。一対のジョーの間に組織を挟んでジョーを閉じると、ステイプルにより組織を縫合することができる。
　ステイプルを用いて縫合を行う際は、組織を充分に圧縮する必要がある。また、ステイプルをアンビル部材に押し当てて充分に変形させる必要がある。したがって、一対のジョーを比較的大きい力量で閉じる必要がある。
日本国特表２０１０－５２２０３５号公報
　医療機器において可撓性を有する挿入部を備える場合、操作部材もワイヤ等の可撓性のある部材を用いる必要がある。しかしながら、このような操作部材は、破断荷重が小さい、挿入部との摩擦により伝達ロスが生じる等の理由により、処置部に作用する力量を増加させるのは容易でなかった。医療用のステイプラは、処置部に作用する力量が数百から千ニュートン程度と特に大きい。このため、ステイプラでは可撓性の操作部材を用いて処置部に必要な力量を発生させるのは困難であった。力量が不足すると、カッターを前進させる際に組織が一対のジョーの間から脱落してしまったり、組織の圧縮が不充分なために適切なステープリングが実現できなかったりする恐れがある。したがって、安定した手技を行うことが難しいという問題がある。
　例えば、処置部付近にウォームギアやボールネジ等を配置し、減速比を大きくすることが考えられる。しかし、この構造では、常に減速比が大きいため、処置部において大きな力量が必要でない、組織の挟み始めにおいても操作部材のストロークが大きくなる。このため、特に手動の場合は操作が容易でないという問題がある。
　本発明は、一対のジョー間に大きな把持力を発生させ、一対のジョー間に確実に組織を把持することができる医療機器を提供する。
　本発明の第一の様態によれば、医療機器は、互いに接近離間する第一把持部材および第二把持部材と、前記第一把持部材に対して固定された回転軸に回転可能に取り付けられた回転体と、第一の端部が前記第二把持部材に設けられた第一回動軸に回動可能に連結され、第二の端部が前記回転体に前記回転軸と離間して設けられた第二回動軸に回動可能に連結された開閉リンクと、前記回転体を回転させる操作部材とを備える。前記回転体を所定の方向に回転させると、前記回転軸と前記第一回動軸の軸線とを結ぶ仮想直線に前記第二回動軸が接近しながら、前記第一把持部材と前記第二把持部材とが接近する。
　上記の医療機器において、第一の端部が前記第一回動軸に回動可能に連結され、第二の端部が前記第一把持部材に設けられた第三回動軸に回動可能に連結された把持部材リンクをさらに備えてもよい。前記回転体を所定の方向に回転させると、前記第一回動軸の軸線と前記第二回動軸の軸線とを結ぶ仮想直線と前記第三回動軸の軸線と前記回転軸の軸線とを結ぶ仮想直線との交点と、前記回転軸の軸線と間の距離が減少しながら、前記第一把持部材と前記第二把持部材とが接近してもよい。
　上記の医療機器において、前記第一把持部材は、処置の対象組織に対して固定されてもよい。前記第二把持部材は、前記第一把持部材の基端側に移動することにより前記第一把持部材に接近してもよい。
　上記の医療機器において、前記第一把持部材と前記第二把持部材とが接近したときに、前記第二把持部材の基端部を所定の位置に保持する保持部をさらに備えてもよい。
　上記の医療機器において、前記第一把持部材と第二把持部材とが接近したときに、前記第一把持部材と第二把持部材とを所定の位置関係に位置決めする位置決め部をさらに備えてもよい。
　上記の医療機器において、前記位置決め部は、前記第一把持部材に設けられた第一当接面と、前記第二把持部材に設けられ、前記第一把持部材と第二把持部材とが接近したときに前記第一当接面と接触する第二当接面とを有してもよい。
　上記の医療機器において、前記操作部材が接続され、前記回転体を回転させる操作が入力される操作部をさらに備えてもよい。
　上記の医療機器において、前記第一把持部材には、ステイプルを収容したカートリッジが交換可能に取り付けられ、前記第一把持部材および前記第二把持部材がステイプラとして機能してもよい。
　上記した医療機器によれば、一対のジョー間に大きな把持力を発生させ、一対のジョー間に確実に組織を把持することができる。したがって、ステイプルによる縫合および組織切除を好適に行うことができる。
本発明の第一実施形態に係る医療機器の全体構成を示す図である。 本発明の第一実施形態に係る医療機器の処置部の拡大図である。 本発明の第一実施形態に係る医療機器の処置部の長手方向における断面図である。 図２のＡ－Ａ線における断面図である。 図２のＢ－Ｂ線における断面図である。 図３のＣ－Ｃ線における断面図である。 本発明の第一実施形態に係る医療機器の処置部の一対のジョーを閉じる際に各部に作用する力を説明するための図である。 本発明の第一実施形態に係る医療機器の処置部の一対のジョーを閉じる際に各部に作用する力を説明するための図である。 本発明の第一実施形態に係る医療機器の処置部の一対のジョーが閉じられた状態を示す図である。 図９ＡのＤ－Ｄ線における断面図である。 本発明の第一実施形態に係る医療機器の変形例の処置部を示す図である。 本発明の第一実施形態に係る医療機器の変形例の処置部を示す図である。 本発明の第二実施形態に係る医療機器の処置部を示す図である。 本発明の第二実施形態に係る医療機器の処置部が閉じられた状態を示す図である。 本発明の第一実施形態に係る医療機器の他の変形例における一対のジョーを示す図である。 本発明の第一実施形態に係る医療機器の他の変形例における一対のジョーを示す図である。 本発明の第一実施形態に係る医療機器の他の変形例における一対のジョーを示す図である。 本発明の第一実施形態に係る医療機器の他の変形例における一対のジョーを示す図である。 本発明の第一実施形態に係る医療機器の他の変形例における処置部を示す模式図である。 本発明の第一実施形態に係る医療機器の他の変形例における処置部を示す模式図である。 本発明の第一実施形態に係る医療機器の他の変形例における一対のジョーを示す図である。 本発明の第一実施形態に係る医療機器の他の変形例における一対のジョーを示す図である。
　（第一実施形態）
　以下、本発明の第一実施形態に係る医療機器について、図１から図１１を参照して説明する。
　図１は、本実施形態に係る医療機器１の全体構成を示す図である。医療機器１は、本実施形態に係るクランプ機構を備える。医療機器１は、先端に設けられ、対象組織に処置を行うための処置部１０と、処置部１０を操作するための第一操作部３０と、処置部１０と第一操作部３０との間に設けられた挿入部４０と、挿入部４０に挿通された観察部５０と、観察部５０を操作するための第二操作部６０とを備えている。処置部１０は、開閉可能な一対のジョーとして、第一ジョー（第一把持部材）１１および第二ジョー（第二把持部材）１２を有する。処置部１０は、ステイプル１３Ａが装填されたカートリッジ１３を用いて組織を縫合、および切離する物である。その基本構造は、例えば、上述の特許文献１に記載のように公知である。本実施形態の処置部１０における特徴箇所については、後に詳しく説明する。
　第一操作部３０は、公知の構成を有し、２つのダイヤルノブ３１および３２と、レバー３３とを有する。ダイヤルノブ３１は、ワイヤ等の操作部材（後述）により処置部１０と接続されている。ダイヤルノブ３１を回転させることにより、一対のジョー１１、１２を開閉操作することができる。
　挿入部４０は可撓性を有する管状に形成されている。挿入部４０は、先端側に処置部１０が、基端側に第一操作部３０がそれぞれ取り付けられている。挿入部４０は、複数の節輪または湾曲コマ等を有する公知の構造の湾曲部４１を先端側に有している。湾曲部４１は、第一操作部３０のダイヤルノブ３２を操作することにより、湾曲させることができる。挿入部４０の内腔には、操作部材が軸線方向に進退可能に挿通されている。挿入部４０の基端側には、鉗子口４２が設けられている。鉗子部１０１を備えた一般的な内視鏡用処置具１００等を鉗子口４２に挿入して、第一ジョー１１の基端側から突出させることができる。
　観察部５０は、挿入部４０に進退可能に挿通されている。観察部５０は先端にＬＥＤ等を含む照明部５１や、ＣＣＤ等の撮像手段５２を備えている。観察部５０の先端側に湾曲部４１と同様の構造の湾曲部５３を有している。観察部５０の先端部は、挿入部４０の先端側に設けられた開口４３から突没させることができる。
　第二操作部６０は、挿入部４０の基端側から外に出た観察部５０の基端に接続されている。第二操作部６０には、第一操作部３０と同様のダイヤルノブ６１やボタン６２等が設けられている。第二操作部６０は、湾曲部５３の湾曲操作や、照明部５１および撮像手段５２の操作等を行うことができる。撮像手段５２で取得された映像信号は、ユニバーサルケーブル６３を通って図示しない画像処理部に送られ、図示しないディスプレイ等に表示される。観察部５０および第二操作部６０としては、公知の内視鏡装置等を、寸法等を適宜設定して使用可能である。
　図２は、処置部１０の拡大図である。図３は処置部１０の長手方向における断面図である。図２に示すように、第一ジョー１１にはステイプル１３Ａが長手方向に複数列並んで装填されたカートリッジ１３が交換可能に装着されている。図３に示すように、第一ジョー１１には、ステイプル１３Ａの列間を進退可能なカッター２２およびクサビ２３が取り付けられている。カッター２２の進退操作は、第一操作部３０のレバー３３により可能である。第二ジョー１２には、ステイプル１３Ａの先端を屈曲させるアンビル部材１４が取り付けられている。
　図４および図５は、それぞれ図２のＡ－Ａ線およびＢ－Ｂ線における断面図である。図４および図５に示すように、第一ジョー１１と第二ジョー１２とは、それぞれ一対の平行リンク（把持部材リンク）１５および１６により接続されている。すなわち、第一ジョー１１と第二ジョー１２とは、４本の平行リンクにより接続されている。第一ジョー１１と第二ジョー１２とは、互いに平行な状態を保持しながら接近および離間可能である。
　図６は、図３のＣ－Ｃ線における断面図である。図３および図６に示すように、処置部１０の基端側には、第一ジョー１１と第二ジョー１２とを開閉操作するためのプーリ（回転体）１７が配置されている。プーリ１７は、第一ジョー１１に設けられた回転軸１７Ａに回転可能に取り付けられている。プーリ１７には、ワイヤ（操作部材）１８が巻き回されている。ワイヤ１８の端部は、挿入部４０を通って第一操作部３０のダイヤルノブ３１に接続されている。
　プーリ１７と第二ジョー１２とは、略半円弧状の一対の開閉リンク１９により接続されている。開閉リンク１９の一方の端部１９Ａは、２本の平行リンクのうち、先端側に配置された平行リンク１５と第二ジョー１２との連結軸（第一の回動軸）２０に回動可能に連結されている。他方の端部１９Ｂは、プーリ１７に設けられた回動軸（第二の回動軸）２５に対して回動可能に連結されている。
　図２に示すように、第一ジョー１１の基端部には、一対のジョー１１、１２が閉じられたときに第二ジョー１２に当接する突起（保持部）２１が設けられている。図３に示すように、突起２１はネジ式である。突起２１と第一ジョー１１との螺合長を調節することにより、第一ジョー１１からの突出量を一定範囲内で調節することができる。
　上記のように構成された医療機器１の使用時の動作について説明する。まず術者は、処置部１０が設けられた医療機器１の先端側を、患者の口等の自然開口に挿入する。術者は、観察部５０で処置部１０およびその周囲を観察しながら、処置部１０を処置対象組織の付近まで導入する。
　術者は、縫合する組織を第一ジョー１１と第二ジョー１２との間に位置させる。術者は、第一操作部３０のダイヤルノブ３１を所定の方向に回転させ、ワイヤ１８を図３に示す矢印Ａ１の方向に牽引する。すると、プーリ１７が図３における右回りに回転する。このため、開閉リンク１９の端部１９Ｂがプーリ１７の回転軸１７Ａを中心に回転移動する。当該回転移動に伴い、端部１９Ａおよび連結軸２０も基端側に移動する。これにより、平行リンク１５および１６と第二ジョー１２との連結部位は、基端側に移動する。その結果、第二ジョー１２は、第一ジョー１１と平行状態を保持しつつ、処置対象組織に対して固定された第一ジョー１１に対して基端側に相対移動しながら接近して一対のジョーが閉じられる。
　このとき、プーリ１７の回転に伴い、回動軸２５が回転軸１７Ａと連結軸２０とを結ぶ仮想直線に接近する。すなわち、ワイヤ１８を介して操作入力したプーリ１７の回転により平行リンク１５、１６で連結された一対のジョー１１、１２を閉じる本実施形態のクランプ機構は、いわゆるトグル機構（増力機構、倍力機構）として機能することがわかる。
　図７および図８は、一対のジョー１１、１２を閉じる際に各部に作用する力を説明するための図である。図７に示す初期状態から、ワイヤ１８を牽引して図８に示すように第二ジョー１２を第一ジョー１１に向かって接近させることを考える。ここで、回転軸１７Ａと、平行リンク１５と第一ジョー１１との連結点（第三回動軸）１５Ａとを結ぶ直線ｌ１と、連結軸２０と連結軸２５の軸線どうしを結ぶ直線ｌ２との交点をＯとする。回転軸１７Ａと交点Ｏとを結ぶ線分をＯＡとする。連結点１５Ａと交点Ｏとを結ぶ線分をＯＢとする。平行リンク１５の長さをＬ１とする。平行リンク１５が基端側において第一ジョー１２と平行な面となす角度をθとする。プーリ１７の半径をＲとする。このとき、一対のジョーの閉操作時におけるワイヤ１８の牽引力Ｆｉｎと第二ジョー１２に対して第一ジョー１１に接近させる方向に作用する力Ｆｏｕｔとの関係は、以下の式で表される。
Figure JPOXMLDOC01-appb-M000001
 　　　　　　　　　　　　　　　　　　
　したがって、ワイヤ１８を矢印Ａ１の方向に牽引すると、直線ｌ２が回転軸１７Ａに近づくにつれて線分ＯＡの長さが徐々に短くなってゼロに近づく。この結果、上記Ｆｏｕｔが増加するため、一対のジョーの把持力をさらに増加させることができる。
　このトグル機構は、プーリ１７が所定量以上回転すると破綻してしまう。しかし、図９Ａに示すように、一対のジョー１１、１２が閉じられると、図９Ｂに示すように、第二ジョー１２の基端部が第一ジョー１１の突起２１と当接する。このため、プーリ１７は所定量以上回転できず、トグル機構の破綻が防止される。また、突起２１の突出長は、第二ジョー１２の基端部が突起２１と接触したときに第二ジョー１２がわずかに傾斜して、処置部１０の基端側における高さ寸法Ｄ１が、先端側における高さ寸法Ｄ２よりもわずかに大きくなるように設定されている。これにより、第二ジョー１２の基端側が所定の位置に保持される。更に、一対のジョーに充分閉じる力が作用しているにもかかわらず先端側のみが把持した組織から受ける反力に負けて開いてしまうことが抑制される。
　組織が一対のジョー１１、１２間に確実に把持されたら、術者はレバー３３を操作してカッター２２を前進させる。すると、公知の機構によりクサビ２３がカートリッジ１３内のステイプル１３Ａをアンビル部材１４に押し当てて湾曲させることにより組織が縫合される。さらに、組織を縫合したステイプルの列間の組織をカッター２２が切断し、穿孔等を生じさせずに対象組織が切離される。
　本実施形態の医療機器１のように可撓性を有する挿入部を備える場合、操作部材もワイヤ等の可撓性のある部材を用いる必要がある。しかしながら、このような操作部材は、破断荷重が小さい、挿入部との摩擦により伝達ロスが生じる等の理由により、処置部に作用する力量を増加させるのは容易でなかった。特に処置部１０のようなステイプラは、処置部に作用する力量が数百から千ニュートン程度と特に大きい。このため、可撓性の操作部材を用いて処置部に必要な力量を発生させるのは困難であった。力量が不足すると、カッターを前進させる際に組織が一対のジョーの間から脱落してしまったり、組織の圧縮が不充分なために適切なステープリングが実現できなかったりする可能性がある。この結果、安定した手技を行うことが難しいという問題がある。
　これを解決するために、処置部付近にウォームギアやボールネジ等を配置し、減速比を大きくすることも考えられる。しかし、この構造では、常に減速比が大きいため、処置部において大きな力量が必要でない、組織の挟み始めにおいても操作部材のストロークが大きくなる。このため、特に手動の場合は操作が容易でないという問題がある。
　本実施形態の医療機器１では、上述のように、プーリ１７、開閉リンク１９、および平行リンク１５、１６からなるクランプ機構がトグル機構として機能する。このため、プーリを回転させる操作部材としてワイヤ等の可撓性部材を用いても、処置部付近における減速比を大きくして一対のジョー間に大きな把持力を発生させることが可能である。したがって、可撓性の挿入部を備え、自然開口からの対象組織へのアプローチを可能としつつ、一対のジョー間に確実に組織を把持して、ステイプルによる縫合および組織切除を好適に行うことができる。
　一対のジョーが閉じるまでは、減速比が大きくない。このため、組織の挟み始め等においては、操作部材の操作量が少なくてよく、操作感が損なわれない。組織を把持し、組織が圧縮されて薄くなるにつれて減速比が大きくなるため、術者は常に必要最小限の操作部材の牽引量で操作を行うことができる。
　一対のジョーを完全に閉じた後は、ダイヤルノブ３１から手を離しても、トグル機構が機能することにより閉状態が維持される。プーリ１７を回転させない限り一対のジョーが開くことはない。したがって、ジョーの閉状態を維持するために操作部材に操作入力を加え続ける必要がない。このため、操作時の術者の負担を軽減することができる。
　第一操作部３０からの操作力量が、プーリ１７を入力節として開閉リンク１９に伝達される。このため、トグル機構によるリンクからの反力をワイヤ１８で受ける必要がない。さらに、プーリ１７は回転体であるため、回転軸１７Ａに充分な剛性を確保しておけば、他に挙動を規制するガイドを設ける必要もない。したがって、処置部と操作部材との連結部位の構成を簡素にして、小型に構成することも容易となる。
　プーリ１７およびワイヤ１８を用いた入力機構のため、処置部の開閉ストロークを大きくしても、医療機器１の先端部の硬質長が長くなりにくい。その結果、体腔内への挿入性と開閉ストロークの大きさとを高いレベルで両立することができる。
　開閉リンク１９が円弧状に形成されている。このため、処置部の開閉時における平行リンク１５、１６との干渉を防ぎつつ、端部１９Ａ、１９Ｂ間の距離を所望の値に調節することができる。
　可動側の第二ジョー１２が、固定側の第一ジョー１１に対して基端側に相対移動しながら一対のジョーが閉じる。このため、把持した組織に対して基端側に引き寄せるように力を作用させて、ジョー間から脱落することを好適に抑制することができる。
　本実施形態のクランプ機構は上記のような構成に限られない。図１０に示すように、開閉リンク１９と基端側の平行リンク１６とを連結して、開閉リンクと平行リンクとの取り付け関係を逆転させてもよい。この場合は、図１１に示すように第二ジョー１２が第一ジョー１１に対して先端側に相対移動しつつ接近して、一対のジョーが閉じられる。この構成は、処置部がステイプラである場合は必ずしも好適であるとは言えない。しかし、そのような制約のない処置部には問題なく適用することができる。その処置部の把持力を好適に増大させることができる。
　（第二実施形態）
　本発明の第二実施形態に係る医療機器について、図１２及び図１３を参照して説明する。本実施形態では、処置部が一対のジョーを有する把持鉗子に形成されている点が、第一実施形態と異なる。なお、以降の説明において、既に説明したものと同様の構成については、同一の符号を付して重複する説明を省略する。
　図１２は、本実施形態の医療機器である、内視鏡用処置具７１の処置部７２の拡大図である。処置部７２には、開閉する一対の固定側ジョー７３および可動側ジョー７４が設けられている。固定側ジョー７３と可動側ジョー７４とは、回動軸７５で相対回動可能に連結されている。開閉リンク１９の一方の端部１９Ａは、回動軸７５よりも先端側において、可動側ジョー７４と相対回動可能に連結されている。
　本実施形態の内視鏡用処置具７１では、図示しない操作部等を介してワイヤ１８を矢印Ａ２の方向に牽引してプーリ１７を回転させる。すると、可動側ジョー７４が回動軸７５を中心に回動して固定側ジョー７３に接近し、図１３に示すように一対のジョー７３、７４が閉じられる。このとき、プーリ１７の回転に伴い、端部１９Ｂの連結軸２５が、プーリの回転軸１７Ａと端部１９Ａの連結軸２０とを結ぶ仮想直線に対して接近する。すなわち、一対のジョー７３、７４は第一実施形態と同様の基本構造を有するトグル機構を備えている。このため、一対のジョーにより、より大きな把持力を実現することができる。
　このように、本実施形態に係るクランプ機構は、平行状態を保持しつつ開閉する第一実施形態のような処置部だけでなく、一つの回動軸で相対回動可能に連結された処置部に対しても問題なく適用することができる。
　なお、本実施形態においては、可動側ジョー７４の基端部は回動軸７５に固定されている。このため、可動側ジョー７４の先端側が把持した組織から反力を受けて開く方向に動こうとする際、固定側ジョー７３に接近することはない。すなわち、回動軸７５が、当該基端部を所定の位置に保持する保持部として機能する。その結果、トグル機構で把持力を増大させることで、当該反力の影響を受けずに一対のジョーの先端側を確実に閉じることができる。
　以上、本発明の各実施形態について説明した。しかしながら、本発明は上記の実施形態に限られず、その趣旨を逸脱しない範囲において、各構成要素に種々の変更を加えたり、削除したり、各実施形態の構成を組み合わせたりすることが可能である。
　例えば、処置部が第一実施形態のようなステイプラである場合を考える。ステイプルにより好適な縫合を行うには、アンビル部材とカートリッジとが所定の位置関係に高精度に位置決めされることが必要である。更に、ステイプルがアンビル部材のステイプルポケットに押し当てられることが必要である。しかしながら、リンクを用いて一対のジョーを連結すると、リンクとジョーとを回動可能に連結するためには、連結軸とジョーとの間にわずかに隙間が必要である。この隙間が一対のジョーの開閉時にガタ（連結軸に対するぶれ）を生じさせる原因となる。
　そこで、図１４Ａに示すように、一対のジョー８１、８２のそれぞれに位置決め部としての突起部８３、８４を設けてもよい。ジョー８１に設けられた突起部８３は、ジョー８１の幅方向両側に形成された第一突起８３Ａおよび第二突起８３Ｂの一対の突起から構成される。各突起８３Ａ、８３Ｂの上面（第一当接面）は、それぞれ斜面８３ａおよび８３ｂに形成されている。幅方向端部に近づくにつれて各突起８３Ａ、８３Ｂの高さが低くなる。ジョー８２に設けられた突起部８４は、ジョー８２の幅方向両側に形成された第一突起８４Ａおよび第二突起８４Ｂの一対の突起から構成される。各突起８４Ａ、８４Ｂの下面（第二当接面）は、それぞれ斜面８３ａおよび８３ｂに対応した傾斜角の斜面８４ａおよび８４ｂに形成されている。幅方向端部に近づくにつれて各突起８４Ａ、８４Ｂの突出長が大きくなる。
　このようにすると、ジョー８１とジョー８２とが接近すると、斜面８３ａと斜面８４ａ、および斜面８３ｂと斜面８４ｂとがそれぞれ接触する。これにより、まずジョー８１とジョー８２とが平行な状態に位置決めされる。一対のジョー８１、８２の幅方向においてガタ等によるずれが生じている場合、ジョー８１とジョー８２とが接近するにつれて、斜面８３ａおよび８３ｂに平行に相対移動して当該ずれが修正される。最終的にずれのない所定の位置関係に位置決めされて一対のジョーが閉じられる。したがって、若干のガタが生じていても、カートリッジとアンビル部材とを確実に位置決めした状態で一対のジョーを閉じることができる。その結果、縫合を行うことができる。
　位置決め部の形状は上記のものには限られない。例えば、図１４Ｂに示すように、略円錐形の突起８６と、突起８６の少なくとも一部が進入可能な円形の穴８７とで位置決め部が構成されてもよい。この場合は、突起８６の曲面状のテーパー面８６ａが穴８７の上部のエッジに接触しつつ突起８６が穴８７内に進入することによりずれが修正される。
　この場合、さらに、図１４Ｃに示すように、突起８８と、長穴８９とを備えてもよい。突起８８は、突起８６よりも突出長の長い略円錐形の突起である。長穴８９は、平面視においてジョー８１の長手方向に延びる長円形の長穴である。このようにすると、第一実施形態のように、ジョー８２がジョー８１に対して長手方向に相対移動しながら接近するときに、まず突起８８が長穴８９に進入して幅方向のずれを修正および抑制する。その後突起８６が穴８７内に進入して確実に位置決めされる。したがって、より確実に位置決めを行うことができる。
　なお、穴８７や長穴８９の内側面は、第一ジョー８１の縫合面８１Ａに対して直角をなしてもよい。また、穴８７や長穴８９の内側面は、突起８６、８８等のテーパー面に対応するように傾斜させてもよい。後者の場合、一対のジョーが接近する際の摺動がより滑らかになるという利点がある。穴と突起の配置を逆転し、第一ジョー８１に突起８６、８８等を形成してもよい。
　斜面を有する突起部を形成する場合、突起の一組を、図１４Ｄに示す突起８３Ｃおよび８４Ｃのように、斜面８３ａの傾斜方向と直交する方向に傾斜する斜面８３ｃおよび８４ｃを有するように形成してもよい。このようにすると、幅方向のずれに加えて長手方向のずれも修正することができる。さらに高精度に位置決めすることができる。なお、図１４Ｄでは、一対のジョーの幅方向端部に設けられた突起８３Ｄおよび８４Ｄにおいて、突起８３Ａ、８４Ａと斜面の傾斜が逆に形成されている。このようにしても問題なく位置決め効果を得ることができる。
　位置決め部は、上述のような突起の組や突起と穴の組を備えるものに限られない。図１５に示す変形例では、第二ジョー９２に取り付けられたアンビル部材９３が、バネ等の付勢部材９４により常時第一ジョー９１の基端側の面９１Ａに当接するように付勢されている。このようにすると、図１６に示すように、第二ジョー９２が第一ジョー９１に対して相対移動しつつ一対のジョー９１、９２が閉じられたときも、アンビル部材９３の位置は面９１Ａと接触した状態に保持される。このため、カートリッジ９５に対して好適に位置決めすることができる。
　この例では、付勢部材９４がアンビル部材９３の長手方向の位置決めをしている。同様の付勢部材をアンビル部材の幅方向両側または片側に配置して、アンビル部材９３の幅方向の位置決めを行ってもよい。この両者を組み合わせてもよい。なお、本変形例においては、付勢部材として、板バネ、皿バネ、引張バネ、圧縮バネ、エラストマー等の各種の弾性体を、適宜選択して用いることができる。
　図１７に示すように、一対のジョー９６、９７で挟んだ組織が体液等により滑って脱落するのを防ぐために、複数の係止突起９８を設けてもよい。係止突起９８は、アンビル部材およびカートリッジが配置される縫合面９６Ａ、９７Ａから突出しないように形成されている。挟まれた組織の一部は変形して隣接する係止突起９８間に進入し、係止される。係止突起９８は、先端側の立ち上がり角度が基端側の立ち上がり角度よりも小さい。このため、進入した組織が先端側に移動しようとすると当該組織に食い込み、先端側への移動を抑制する。すなわち一対のジョーからの組織の脱落を抑制する。
　係止突起９８は、上記のものに限られない。図１８のようなピン状の係止突起９９であってもよい。また、図１８に示すようにジョー９６側とジョー９７側とで係止突起９９を互い違いに配置する等により、縫合面９６Ａと９７Ａとが最接近する縫合操作時において係止突起９９どうしが干渉しないように形成されてもよい。この場合、係止突起９９は、ある程度縫合面よりも高く突出するように形成されてもよい。
　上記した医療機器によれば、一対のジョー間に確実に組織を把持して、ステイプルによる縫合および組織切除を好適に行うことができる。その結果、術者は安定した手技を行うことができる。
　１　医療機器
　１０　処置部
　１１　第一ジョー
　１２　第二ジョー
　１３　カートリッジ
　１３Ａ　ステイプル
　１４　アンビル部材
　１５　平行リンク
　１５Ａ　連結点
　１６　平行リンク
　１７　プーリ
　１７Ａ　回転軸
　１８　ワイヤ
　１９　開閉リンク
　１９Ａ、１９Ｂ　端部
　２０　連結軸
　２１　突起
　２２　カッター
　２３　クサビ
　２５　回動軸
　３０　第一操作部
　３１、３２　ダイヤルノブ
　３３　レバー
　４０　挿入部
　４１　湾曲部
　４２　鉗子口
　４３　開口
　５０　観察部
　５１　照明部
　５２　撮像手段
　５３　湾曲部
　６０　第二操作部
　６１　ダイヤルノブ
　６２　ボタン
　６３　ユニバーサルケーブル
　７１　内視鏡用処置具
　７２　処置部
　７３　固定側ジョー
　７４　可動側ジョー
　７５　回動軸
　８１、８２　ジョー
　８１Ａ　縫合面
　８３、８４　突起部
　８３Ａ、８４Ａ　第一突起
　８３Ｂ、８４Ｂ　第二突起
　８３Ｃ、８３Ｄ、８４Ｃ、８４Ｄ　突起
　８３ａ、８３ｂ、８３ｃ、８４ａ、８４ｂ、８４ｃ　斜面
　８６、８８　突起
　８６ａ　テーパー面
　８７　穴
　８９　長穴
　９１　第一ジョー
　９１Ａ　面
　９２　第二ジョー
　９３　アンビル部材
　９４　付勢部材
　９５　カートリッジ
　９６、９７　ジョー
　９６Ａ、９７Ａ　縫合面
　９８、９９　係止突起
　１００　内視鏡用処置具
　１０１　鉗子部

Claims (9)

  1. 　互いに接近離間する第一把持部材および第二把持部材と、
    　前記第一把持部材に対して固定された回転軸に回転可能に取り付けられた回転体と、
    　第一の端部が前記第二把持部材に設けられた第一回動軸に回動可能に連結され、第二の端部が前記回転体に前記回転軸と離間して設けられた第二回動軸に回動可能に連結された開閉リンクと、
    　前記回転体を回転させる操作部材と、
    　を備え、
    　前記回転体を所定の方向に回転させると、前記回転軸と前記第一回動軸の軸線とを結ぶ仮想直線に前記第二回動軸が接近しながら、前記第一把持部材と前記第二把持部材とが接近する
    　医療機器。
  2. 　請求項１に記載の医療機器であって、
    　第一の端部が前記第一回動軸に回動可能に連結され、第二の端部が前記第一把持部材に設けられた第三回動軸に回動可能に連結された把持部材リンクをさらに備え、
    　前記回転体を所定の方向に回転させると、前記第一回動軸の軸線と前記第二回動軸の軸線とを結ぶ仮想直線と前記第三回動軸の軸線と前記回転軸の軸線とを結ぶ仮想直線との交点と、前記回転軸の軸線と間の距離が減少しながら、前記第一把持部材と前記第二把持部材とが接近する
    　医療機器。
  3. 　請求項２に記載の医療機器であって、
    　前記第一把持部材は、処置の対象組織に対して固定され、
    　前記第二把持部材は、前記第一把持部材の基端側に移動することにより前記第一把持部材に接近する
    　医療機器。
  4. 　請求項１に記載の医療機器であって、
    　前記第一把持部材と前記第二把持部材とが接近したときに、前記第二把持部材の基端部を所定の位置に保持する保持部をさらに備える
    　医療機器。
  5. 　請求項２に記載の医療機器であって、
    　前記第一把持部材と第二把持部材とが接近したときに、前記第一把持部材と第二把持部材とを所定の位置関係に位置決めする位置決め部をさらに備える
    　医療機器。
  6. 　請求項５に記載の医療機器であって、
    　前記位置決め部は、
    　　前記第一把持部材に設けられた第一当接面と、
    　　前記第二把持部材に設けられ、前記第一把持部材と第二把持部材とが接近したときに前記第一当接面と接触する第二当接面とを有する
    　医療機器。
  7. 　請求項１に記載の医療機器であって、
    　前記操作部材が接続され、前記回転体を回転させる操作が入力される操作部をさらに備える
    　医療機器。
  8. 　請求項２に記載の医療機器であって、
    　前記第一把持部材には、ステイプルを収容したカートリッジが交換可能に取り付けられ、前記第一把持部材および前記第二把持部材がステイプラとして機能する
    　医療機器。
  9. 　請求項５に記載の医療機器であって、
    　前記第一把持部材には、ステイプルを収容したカートリッジが交換可能に取り付けられ、前記第一把持部材および前記第二把持部材がステイプラとして機能する
    　医療機器。
PCT/JP2012/079368 2011-11-16 2012-11-13 医療機器 WO2013073523A1 (ja)

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EP12849904.3A EP2781195B1 (en) 2011-11-16 2012-11-13 Medical instrument
JP2013526254A JP5420802B2 (ja) 2011-11-16 2012-11-13 医療機器
US13/915,995 US8820608B2 (en) 2011-11-16 2013-06-12 Medical instrument

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US61/560,432 2011-11-16

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JP5420802B2 (ja) 2014-02-19
US8820608B2 (en) 2014-09-02
JPWO2013073523A1 (ja) 2015-04-02
EP2781195A4 (en) 2015-05-27
CN103687553B (zh) 2016-06-29
CN103687553A (zh) 2014-03-26
US20140021240A1 (en) 2014-01-23
EP2781195A1 (en) 2014-09-24

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