WO2014080862A1 - 組織切除装置 - Google Patents

組織切除装置 Download PDF

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Publication number
WO2014080862A1
WO2014080862A1 PCT/JP2013/081020 JP2013081020W WO2014080862A1 WO 2014080862 A1 WO2014080862 A1 WO 2014080862A1 JP 2013081020 W JP2013081020 W JP 2013081020W WO 2014080862 A1 WO2014080862 A1 WO 2014080862A1
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WO
WIPO (PCT)
Prior art keywords
tissue
pair
slot
flow line
sealing portion
Prior art date
Application number
PCT/JP2013/081020
Other languages
English (en)
French (fr)
Inventor
宮本 学
萬壽 和夫
昌太郎 竹本
高橋 慎治
三日市 高康
聡子 鈴木
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 EP13856141.0A priority Critical patent/EP2923656A4/en
Priority to JP2014512964A priority patent/JP5608837B1/ja
Priority to CN201380028616.3A priority patent/CN104334097B/zh
Publication of WO2014080862A1 publication Critical patent/WO2014080862A1/ja
Priority to US14/542,050 priority patent/US20150150620A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/08Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A61B18/082Probes or electrodes therefor
    • A61B18/085Forceps, scissors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B17/07207Surgical 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/10Surgical instruments, devices or methods, e.g. tourniquets for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
    • A61B17/105Wound clamp magazines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3209Incision instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B18/1442Probes having pivoting end effectors, e.g. forceps
    • A61B18/1445Probes having pivoting end effectors, e.g. forceps at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00269Type of minimally invasive operation endoscopic mucosal resection EMR
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B2017/07214Stapler heads
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B2017/07214Stapler heads
    • A61B2017/07228Arrangement of the staples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B2017/07214Stapler heads
    • A61B2017/07278Stapler heads characterised by its sled or its staple holder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B2017/07214Stapler heads
    • A61B2017/07285Stapler heads characterised by its cutter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B2017/320052Guides for cutting instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/0063Sealing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A61B2090/309Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using white LEDs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36Image-producing devices or illumination devices not otherwise provided for
    • A61B90/361Image-producing devices, e.g. surgical cameras

Definitions

  • the present invention relates to a tissue excision device, and more particularly, to a tissue excision device used for so-called full-thickness excision in which a part of a luminal tissue is excised over the entire thickness direction.
  • Patent Document 1 describes a surgical stapler having a pair of jaws. A cartridge loaded with staples is attached to one of the pair of jaws, and an anvil member having a plurality of staple pockets is attached to the other jaw. When the jaw is closed with the tissue sandwiched between the pair of jaws, a part of the tissue can be incised through the entire layer by the built-in cutter while the tissue is sutured by the staple.
  • a tissue excision device includes a pair of gripping members that hold tissue, and a cartridge that is replaceably attached to the pair of gripping members.
  • the cartridge includes a longitudinal axis and the longitudinal direction.
  • a cartridge body that has a slot extending along an axis, guides a cutting member that cuts tissue by the slot, and defines a moving range of the cutting member, and is provided on both sides of the slot so as to sandwich the slot.
  • a pair of sealing portions each extending in parallel with the slot, and a tissue sealing portion provided on the distal end side of the slot and on an extension line of the slot.
  • the tissue sealing portion is held between the pair of grasping members and is located on the distal side of the slot. Tissues may be joined.
  • the pair of sealing portions extend to the tip side from the slot, and the tissue sealing portion is It may be provided between the pair of sealing portions.
  • the pair of sealing portions are a pair of staple rows composed of a plurality of staples arranged in the cartridge body. It may be.
  • the tissue sealing portion is a sealing staple disposed on the distal end side of the slot in the cartridge body. May be.
  • the tissue sealing portion is held between the pair of grasping members and is located on the distal side of the slot.
  • a pair of electrodes capable of contacting the tissue may be used.
  • the tissue sealing portion is held between the pair of grasping members and positioned on the distal end side with respect to the slot.
  • a pair of heating elements capable of contacting the tissue may be used.
  • an insertion portion that extends along the longitudinal axis, a pair of gripping members that are provided at the distal end of the insertion portion and grip tissue, and along a predetermined flow line
  • a cutting member that cuts the luminal tissue held between the pair of jaws by moving, and a pair of seals provided on both sides of the flow line so as to sandwich the flow line, and extending in parallel with the flow line, respectively.
  • a tissue sealing portion provided on the distal end side of the flow line and on an extension line of the flow line.
  • the tissue sealing portion is held between the pair of grasping members and positioned on the distal side with respect to the flow line.
  • the tissues to be joined may be joined.
  • the pair of sealing portions extend to the tip side from the flow line, and the tissue sealing portion is , And may be provided between the pair of sealing portions.
  • the pair of sealing portions are a pair of staples arranged on both sides of the flow line. It may be a staple row.
  • the tissue sealing portion may be a sealing staple disposed on the distal end side of the flow line. .
  • the tissue sealing portion is held between the pair of grasping members and more distal than the flow line. It may be a pair of electrodes that can be in contact with the tissue located. In the tissue excision apparatus according to the fourteenth aspect of the present invention, according to the eighth aspect, the tissue sealing portion is held between the pair of gripping members and more distal than the flow line. It may be a pair of heating elements that can be in contact with the tissue located.
  • tissue excision device since the tissue sealing portion is arranged in the cartridge, the tissue between the pair of sealing portions on the distal end side (front side) of the cutting line of the cutting member is the tissue sealing portion. Is securely stitched and sealed. Further, in a state where the tissue is drawn into the narrow gap between the pair of gripping members and gripped, the tissue is first sutured by the pair of sealing portions and the tissue sealing portion, and then the pair of gripping members after the cutting member cuts the tissue Holding by is released. Therefore, in a series of procedures using the tissue excision apparatus, tissue excision can be performed without causing any state in which the contents of the luminal tissue may leak to the outside.
  • FIG. 1 is a diagram illustrating an overall configuration of a tissue excision apparatus according to a first embodiment of the present invention. It is a figure which shows 1 operation
  • FIG. 1 is a diagram illustrating an overall configuration of a tissue excision apparatus 1 according to the present embodiment.
  • the tissue excision apparatus 1 is provided at the distal end and includes a treatment unit 10 for performing treatment on a target tissue.
  • the tissue excision apparatus 1 further includes a first operation unit 30 for operating the treatment unit 10, a long insertion unit 40 provided between the treatment unit 10 and the first operation unit 30, and an insertion
  • the observation part 50 inserted in the part 40, the 2nd operation part 60 for operating the observation part 50, and the 3rd operation part 70 for operating a treatment part are provided.
  • 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, and a tissue using a cartridge 13 loaded with a staple 13A. Suture and detach.
  • the basic structure of the treatment part 10 is well-known as described in the above-mentioned patent document 1, for example.
  • the first operation unit 30 has a known configuration and includes two dial knobs 31 and 32 and a lock lever 33.
  • the dial knobs 31 and 32 are connected to a bending portion 41 described later by an operation member (not shown) such as a wire.
  • the third operation unit 70 is provided with a first trigger 34 for opening and closing the pair of jaws 11 and 12 and a second trigger 35 for performing a suturing and incising operation.
  • the insertion portion 40 has flexibility and is formed in a tubular shape extending along the longitudinal axis.
  • the treatment portion 10 is attached to the distal end side of the insertion portion 40, and the first operation portion 30 is attached to the proximal end side of the insertion portion 40.
  • the insertion portion 40 has a bending portion 41 having a known structure having a plurality of node rings or bending pieces on the tip side, and is bent by operating the dial knobs 31 and 32 of the first operation portion 30. be able to.
  • the curved state can be fixed by operating the lock lever 33.
  • 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, and a general endoscopic treatment tool 100 or the like equipped with the forceps portion 101 is inserted into the forceps port 42, so that the first jaw 11 can protrude from the base end side.
  • the observation unit 50 is inserted into the insertion unit 40 so as to be able to advance and retreat, and includes an illumination unit 51 including an LED or the like at the tip and an imaging unit 52 such as a CCD. Further, a bending portion 53 having the same structure as that of the bending portion 41 is provided on the distal end side.
  • 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. Thereby, for example, as shown in FIG. 2, the distal end portion of the observation unit 50 is protruded and the bending portion 53 is appropriately bent, whereby the tissue or the like held by the treatment portion 10 can be preferably observed.
  • 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. 3 is a partially enlarged view showing a state where the first jaw 11 and the cartridge 13 are viewed from the second jaw 12 side.
  • the cartridge 13 includes a cartridge main body 14 having a longitudinal axis, a slot 14A for moving a cutter (cutting member) 20 extending along the longitudinal axis, and cutting the tissue, and both sides of the slot 14A in the width direction.
  • a pair of first staple rows (a pair of sealing portions) 15 extending in parallel with the slot 14A, and a second staple (tissue seal) disposed in front of the slot 14A (on the tip side of the slot 14A) and on an extended line of the slot 14A Stop portion, sealing staple) 16.
  • a plurality of staples 15A are arranged in the cartridge main body 14 in the first staple row 15, and extend to the tip side by a predetermined length, for example, 5 millimeters (mm) from the slot 14A.
  • the second staple 16 is disposed between the two first staple rows 15.
  • FIG. 3 shows an example in which two second staples 16 are arranged, the number of arranged second staples 16 is not particularly limited, and may be one or three or more.
  • the staples arranged as the second staples may be the same staple 15A as the first staple row or may be different.
  • the cutter 20 is inserted into the slot 14A from the inside of the cartridge 13 and moves in the slot 14A while protruding toward the second jaw 12.
  • the cutter 20 enters the slot 14A in a state where the protruding end of the cutter 20 enters a groove provided in an anvil member described later so that the tissue sandwiched between the pair of jaws 11 and 12 can be cut over all layers. Move along.
  • the blade span of the cutter 20 required for this is longer than the thickness of the two target tissues held in the folded state and longer than the distance between the pair of jaws 11 and 12 in the closed state.
  • FIG. 4A is a diagram showing a mechanism for ejecting staples from the cartridge 13.
  • a driver 17 made of resin or the like is disposed below the staple 15A.
  • a wedge 18 having a slope 18 ⁇ / b> A on the tip side is disposed.
  • the wedge 18 pushes the driver 17 in contact with the inclined surface 18A upward.
  • the staple 15A is sequentially ejected from the proximal end side by being pushed by the driver 17 and penetrates the tissue, and the penetrated end portion is pressed against the anvil member 21 provided in the second jaw 12 and folded back. .
  • the driver 17 is disposed in each of the two first staple rows 15, but in the region on the tip side of the slot 14A, as shown in FIG. 4B, the two first staple rows 15 and the second staple rows 15 are arranged.
  • a driver 19 that pushes up the staple 16 is disposed. Therefore, when the wedge 18 pushes up the driver 19, the staple 15A and the second staple 16 in the first staple row 15 are pushed up and ejected together.
  • tissue excision apparatus 1 First, the surgeon introduces the tissue excision apparatus 1 into the stomach from the patient's mouth and observes the tumor using the observation unit 50. Then, as shown in FIG. 5, a rough excision region R surrounding the tumor Tm is set.
  • the excision region R is preferably set so that the shortest distance from the tumor Tm is 5 millimeters (mm) or more so as not to damage the tumor Tm at the time of tissue excision.
  • the surgeon projects the endoscope treatment tool 100 from the first jaw 11 and grasps one point of the stomach wall away from the tumor Tm from the inside of the stomach Sm with the forceps 101 as shown in FIG. . Since this one point is a part of the periphery of the region to be actually excised, it is preferable to set it at a position corresponding to the peripheral portion of the set excision region R, for example, a location about 30 mm away from the center of the tumor Tm. Can be selected.
  • this gripped point is referred to as a first gripping point P1.
  • the surgeon retracts the endoscope treatment tool 100 that grasps the first grasping point P1, and appropriately operates the first trigger 34, as shown in FIG.
  • a part of the stomach wall tissue ST is drawn into the gap between the two.
  • the observation unit 50 observes the tumor Tm, and care is taken so that the tumor Tm does not touch the pair of jaws.
  • the stomach wall tissue ST is drawn between the first jaw 11 and the second jaw 12 along two first pull-in lines L1 extending from the first gripping point P1. That is, the stomach wall tissue ST to be drawn is bent with the outer surface of the stomach facing inward so that the outer surfaces of the stomach come into contact with each other, one of the first lead lines L1 faces the first jaw 11, and the other is the second jaw 12. It is drawn in the state facing to.
  • the gap between the pair of jaws is a narrow slit, and the distance between them is about two sheets of the stomach wall tissue. It is not drawn in.
  • the operator When the stomach wall tissue ST is sufficiently retracted between the pair of jaws 11 and 12, the operator operates the second trigger 35. As a result, the wedge 18 moves forward in the cartridge 13 toward the tip, and pushes up the driver 17 disposed below each staple 15A of the first staple row 15 in order from the base end side. As a result, the staple 15A is sequentially pressed against the anvil member 21 (see FIG. 4A) provided on the second jaw 12 from the proximal end side toward the distal end side, and both end portions of the staple 15A penetrating the stomach wall tissue ST are formed. Wrapped. As a result, the folded stomach wall tissue ST is sutured so as to be integrated over the thickness direction on both sides of the first lead-in line L1.
  • the cutter 20 advances slightly toward the tip after the wedge 18, and the stomach wall tissue located between the rows of the first staple rows 15 in which the stomach wall tissue ST is sutured is substantially the first lead-in line L1. Cut along. As a result, a part of the stomach wall is cut over the entire layer as shown in FIG.
  • the stomach wall tissue located between the rows of the first staple rows 15 in front of the extension line of the flow line of the cutter 20 is sutured together by the second staple 16.
  • the operator After cutting and suturing along the first lead-in line L1, the operator removes the tissue excision device 1 out of the body cavity, replaces the cartridge 13 with a new cartridge loaded with staples, and introduces it again into the stomach. To do. And as shown in FIG. 9, the forceps part 101 of the treatment tool 100 for endoscopes 100 is set as the second gripping point P2 at the end opposite to the first gripping point P1 of the cutting line along the first lead-in line L1. Grip with
  • the surgeon retracts the endoscope treatment tool 100, and, as shown in FIG. 10, the stomach wall tissue ST grasped by the forceps portion 101 is moved into the pair of jaws 11 and 12 along the second pull-in line L2. Pull in. At this time, the stomach wall tissue ST is drawn so that the ridge line rg of the stomach wall tissue bent so that the outer surfaces come into contact with each other passes through the pair of jaws 11 and 12.
  • the stomach wall tissue ST is cut and sutured along the second lead-in line L2. Further, since the first lead-in line L1 and the second lead-in line L2 form a closed quadrilateral as shown in FIG. 5, the stomach wall tissue ST in the resection region R including the tumor Tm By the cutting line formed along the two lead-in lines L2, it is cut off from the stomach Sm as shown in FIG. In this way, a part of the stomach wall tissue ST is excised across the entire layer without leaving a hole in the stomach Sm.
  • the operator After completion of the resection, the operator removes the tissue resection device 1, collects the resected stomach wall tissue ST (resection piece), and ends the procedure. At this time, the excision piece may be grasped by the forceps 101 and the tissue excision apparatus 1 may be removed and the excision piece may be collected simultaneously.
  • the tissue excision apparatus 1 of the present embodiment since the second staple 16 as the tissue sealing portion is arranged in the cartridge 13, the tissue between the first staple rows 15 in front of the cutting line of the cutter 20. Are securely stitched and sealed by the second staple 16.
  • the tissue in a state where the tissue is drawn into and held in the narrow gap between the pair of jaws 11 and 12, the tissue is first sutured by the first staple row 15 and the second staple 16, and the pair of jaws is cut after the cutter cuts the tissue. Holding by is released. Therefore, in a series of procedures using the tissue excision apparatus 1, tissue excision can be performed without causing any state in which the contents of the luminal tissue may leak out.
  • the staple and the second staple in the first staple row are ejected by a common driver on the tip side from the slot 14A
  • the structure for ejecting the staple is limited to this.
  • the driver that pushes up the second staple may be separated from the driver in the first staple row.
  • a second wedge 23 may be provided in front of the cutter 20, and the driver 22 that pushes up the second staple 16 may be pushed up by the second wedge 23.
  • the second wedge 23 may be configured to push up the common driver 19, or the second wedge 23 may be configured to push up all the drivers.
  • the stapling direction of the first stapling row and the second stapling direction are parallel to each other.
  • It may be arranged so as to be orthogonal to the moving slot 14A. In this way, the tissue in front of the slot can be joined in a wider range, and the tissue can be excised more reliably.
  • FIG. 15 is a partially enlarged view showing the first jaw 11 and the distal end side of the cartridge 72 in the tissue excision device 71.
  • a linear or belt-like first electrode 73 is provided in front of the slot 14A in place of the second staple.
  • An insulator 74 is disposed around the first electrode 73 and is insulated from other metal parts in the treatment portion 10.
  • the anvil member 75 provided in the second jaw 12 is provided with a second electrode 76 having the same structure as the first electrode 73 at a position corresponding to the first electrode 73.
  • the first electrode 73 and the second electrode 76 are connected to a high frequency power source 77. On / off of energization can be switched by an operation unit (not shown).
  • the tissue excision device 71 When using the tissue excision device 71, as in the first embodiment, the tissue is sutured and cut using the first staple row 15 and the cutter 20, and then the first jaws 11 and 12 are opened without first opening them.
  • a high frequency current is supplied from a high frequency power source 77 to the tissue sandwiched between the electrode 73 and the second electrode 76.
  • a pair of electrodes of the first electrode 73 and the second electrode 76 function as a so-called bipolar electrosurgical instrument.
  • the intracellular and extracellular components of the tissue that is energized in contact with the first electrode 73 and the second electrode 76 are made uniform (liquid). Then, the tissues are joined between the pair of jaws 11 and 12, and the hole caused by the remaining unstitched tissue is sealed.
  • the tissue excision apparatus 71 of the present embodiment can perform tissue excision without causing any state in which the contents of the luminal tissue may leak to the outside. Moreover, since the tissue sealing portion is constituted by the first electrode 73 and the second electrode 76, the sealing portion is joined in a planar shape. As a result, the hole can be closed more reliably.
  • the structure of the tissue sealing portion that seals the tissue that has been contacted by energization is not limited to the bipolar mechanism described above.
  • a heating element such as a heater that generates heat when energized is attached to the cartridge and the anvil member instead of the first electrode 73 and the second electrode 76, and the tissue sandwiched between the pair of jaws is heated from both sides. Good.
  • these heat generating elements function as a so-called thermal coagulation treatment instrument, and therefore tissues can be joined together by appropriately setting the temperature and heating time.
  • the shape of the electrode is not limited to the above-described linear shape, belt shape, or the like, and may be a spot shape like the electrode 73A shown in FIG.
  • the number of times of suturing and cutting is not limited to two.
  • the jaw may not be cut twice depending on the size of the jaw.
  • the second suture and cutting are performed with a part of the lumen tissue pulled in such a way that the ridge line of the folded lumen tissue does not pass through the slit, The tissue to be excised is not cut off.
  • the luminal tissue targeted by the tissue excision apparatus of the present invention is not limited to the stomach.
  • the diameter of the intestine is smaller than that of the stomach, but the tissue excision method of the present invention can be suitably performed on the intestine and the like by appropriately setting the size of a device to be used such as a stapler.
  • the target disease for tissue resection is not limited to the tumor described in the embodiment, and is naturally applicable to other diseases such as a severe ulcer.
  • tissue sealing portion since the tissue sealing portion is arranged in the cartridge, the tissue between the pair of sealing portions in front of the cutting line of the cutting member is securely sutured by the tissue sealing portion. And sealed. Further, in a state where the tissue is drawn into the narrow gap between the pair of gripping members and gripped, the tissue is first sutured by the pair of sealing portions and the tissue sealing portion, and then the pair of gripping members after the cutting member cuts the tissue Holding by is released. Therefore, in a series of procedures using the tissue excision apparatus, tissue excision can be performed without causing any state in which the contents of the luminal tissue may leak to the outside.
  • first jaw first gripping member
  • Second jaw second gripping member
  • Cartridge body 14A Slot 15 A pair of first staple rows (a pair of sealing portions)
  • Second staple tissue sealing part, sealing staple
  • Cutter Cutting member

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Abstract

 組織切除装置は、組織を保持する一対の把持部材と、前記一対の把持部材に交換可能に取り付けられるカートリッジとを備え、前記カートリッジは、長手軸と、前記長手軸に沿って延びるスロットとを有し、前記スロットにより組織を切断する切断部材を案内するとともに前記切断部材の移動範囲を規定するカートリッジ本体と、前記スロットを挟むように前記スロットの両側に設けられ、それぞれ前記スロットと平行に延びる一対の封止部と、前記スロットより先端側かつ前記スロットの延長線上に設けられた組織封止部と、を有する。

Description

組織切除装置
 本発明は、組織切除装置、より詳しくは、管腔組織の一部を厚さ方向全体にわたり切除する、いわゆる全層切除に用いる組織切除装置に関する。
 本願は、2012年11月20日に、米国に仮出願された米国特許出願第61/728,507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、胃癌等の治療において、腫瘍およびその周辺の組織を、胃壁の厚さ方向全体にわたり切除することが行われている。このような全層切除は、開腹手術あるいは腹腔鏡下手術により行われることが多い。
 また、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カートリッジが装着され、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しつつ、内蔵されたカッターにより組織の一部を全層にわたって切開することができる。

日本国特表2010-522035号公報
 従来全層切除は、開腹手術下や腹腔鏡手術下で行われてきたが、患者の侵襲をより小さくしたり、腫瘍を切除する際の再発のリスクを低減したりする観点から、これを口等の自然開口から行うことが検討されている。
 しかしながら、特許文献1に記載されたような従来の組織切除装置では、第一ステイプル列しか備えていないため、第一の引き込み線に沿って縫合および切断を行うと、切断部材の切断線の先端側(前方)であって第一ステイプル列間の組織が未縫合となり、穴のような状態となった部位が残存する。そのため、管腔組織の内圧が高まった等の場合に、一時的ではあるが当該部位から管腔組織の内容物が外部に漏れ出る恐れがある状態が生じてしまうという問題がある。

 本発明の第一の態様に係る組織切除装置は、組織を保持する一対の把持部材と、前記一対の把持部材に交換可能に取り付けられるカートリッジとを備え、前記カートリッジは、長手軸と、前記長手軸に沿って延びるスロットとを有し、前記スロットにより組織を切断する切断部材を案内するとともに前記切断部材の移動範囲を規定するカートリッジ本体と、前記スロットを挟むように前記スロットの両側に設けられ、それぞれ前記スロットと平行に延びる一対の封止部と、前記スロットの先端側かつ前記スロットの延長線上に設けられた組織封止部と、を有する。

 本発明の第二の態様に係る組織切除装置において、上記第一の態様によれば、前記組織封止部は、前記一対の把持部材間に保持されるとともに前記スロットよりも先端側に位置する組織を接合してもよい。
 本発明の第三の態様に係る組織切除装置において、上記第一の態様によれば、前記一対の封止部は、前記スロットよりも前記先端側まで延びており、前記組織封止部は、前記一対の封止部の間に設けられていてもよい。
 本発明の第四の態様に係る組織切除装置において、上記第一の態様によれば、前記一対の封止部は、前記カートリッジ本体内に配置された複数のステイプルから構成される一対のステイプル列であってもよい。
 本発明の第五の態様に係る組織切除装置において、上記第一の態様によれば、前記組織封止部は、前記カートリッジ本体内において前記スロットの前記先端側に配置された封止ステイプルであってもよい。
 本発明の第六の態様に係る組織切除装置において、上記第一の態様によれば、前記組織封止部は、前記一対の把持部材間に保持されるとともに前記スロットよりも先端側に位置する組織に接触可能な一対の電極であってもよい。
 本発明の第七の態様に係る組織切除装置において、上記第一の態様によれば、前記組織封止部は、前記一対の把持部材間に保持されるとともに前記スロットよりも先端側に位置する組織に接触可能な一対の発熱素子であってもよい。
 本発明の第八の態様に係る組織切除装置において、長手軸に沿って延びる挿入部と、前記挿入部の先端に設けられ、組織を把持する一対の把持部材と、所定の動線に沿って移動することにより前記一対のジョー間に保持された管腔組織を切断する切断部材と、前記動線を挟むように前記動線の両側に設けられ、それぞれ前記動線と平行に延びる一対の封止部と、前記動線の先端側かつ前記動線の延長線上に設けられた組織封止部と、を備える。
 本発明の第九の態様に係る組織切除装置において、上記第八の態様によれば、前記組織封止部は、前記一対の把持部材間に保持されるとともに前記動線よりも先端側に位置する組織を接合してもよい。
 本発明の第十の態様に係る組織切除装置において、上記第八の態様によれば、前記一対の封止部は、前記動線よりも前記先端側まで延びており、前記組織封止部は、前記一対の封止部の間に設けられていてもよい。
 本発明の第十一の態様に係る組織切除装置において、上記第八の態様によれば、前記一対の封止部は、前記動線の両側に配置された複数のステイプルから構成される一対のステイプル列であってもよい。
 本発明の第十二の態様に係る組織切除装置において、上記第八の態様によれば、前記組織封止部は、前記動線の前記先端側に配置された封止ステイプルであってもよい。
 本発明の第十三の態様に係る組織切除装置において、上記第八の態様によれば、前記組織封止部は、前記一対の把持部材間に保持されるとともに前記動線よりも先端側に位置する組織に接触可能な一対の電極であってもよい。
 本発明の第十四の態様に係る組織切除装置において、上記第八の態様によれば、前記組織封止部は、前記一対の把持部材間に保持されるとともに前記動線よりも先端側に位置する組織に接触可能な一対の発熱素子であってもよい。
 上記各態様の組織切除装置は、カートリッジに組織封止部が配置されているため、切断部材の切断線の先端側(前方)であって一対の封止部間の組織が、組織封止部により確実に縫合されて封止される。また、一対の把持部材の間の狭い間隙に組織を引き込み、把持した状態で、まず一対の封止部および組織封止部により組織が縫合され、切断部材が組織を切断した後に一対の把持部材による保持が解除される。したがって、組織切除装置を用いた一連の手技においては、管腔組織の内容物が外部に漏れ出る恐れがある状態を全く生じさせずに組織切除を行うことができる。
本発明の第一実施形態の組織切除装置の全体構成を示す図である。 同組織切除装置の使用時の一動作を示す図である。 同組織切除装置の第一ジョーおよびカートリッジを第二ジョー側から見た状態を示す部分拡大図である。 カートリッジからステイプルが射出される仕組みを示す図である。 カートリッジ内のドライバを示す図である。 切除領域および把持点を示す図である。 同組織切除装置の使用時の一動作を示す図である。 同組織切除装置の使用時の一動作を示す図である。 同組織切除装置の使用時の一動作を示す図である。 同組織切除装置の使用時の一動作を示す図である。 同組織切除装置の使用時の一動作を示す図である。 同組織切除装置の使用時の一動作を示す図である。 従来の組織切除装置を用いて縫合及び切断を行った後の状態を示す図である。 同実施形態の変形例におけるカッターを示す図である。 同実施形態の変形例における第一ジョーおよびカートリッジの先端側を示す部分拡大図である。 本発明の第二実施形態の組織切除装置における第一ジョーおよびカートリッジの先端側を示す部分拡大図である。 同組織切除装置における電気的なつながりを示す図である。 同実施形態の変形例における第一ジョーおよびカートリッジの先端側を示す部分拡大図である。
 以下、本発明の第一実施形態について、図1から図14を参照して説明する。
 図1は、本実施形態の組織切除装置1の全体構成を示す図である。組織切除装置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を備えている。また、組織切除装置1は、さらに、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長尺の挿入部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、処置部を操作するための第三操作部70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を有し、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。また、処置部10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。
 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、ロックレバー33とを有する。ダイヤルノブ31および32は、ワイヤ等の操作部材(不図示)により後述する湾曲部41と接続されている。第三操作部70には、一対のジョー11、12を開閉操作するための第一トリガー34と、縫合および切開操作を行うための第二トリガー35とが設けられている。
 挿入部40は可撓性を有し、長手軸に沿って延びる管状に形成されている。挿入部40の先端側に処置部10が取り付けられ、挿入部40の基端側に第一操作部30が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を先端側に有しており、第一操作部30のダイヤルノブ31および32を操作することにより、湾曲させることができる。湾曲状態は、ロックレバー33を操作することで固定することができる。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。また、挿入部40の基端側には、鉗子口42が設けられており、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おり、先端部にLED等を含む照明部51と、CCD等の撮像手段52とを備えている。また、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。これにより、例えば図2に示すように、観察部50の先端部を突出させて湾曲部53を適宜湾曲させることにより、処置部10に保持された組織等を好適に観察することができる。
 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3は、第一ジョー11およびカートリッジ13を第二ジョー12側から見た状態を示す部分拡大図である。カートリッジ13は、長手軸と、長手軸に沿って延び、かつ、組織を切断するカッター(切断部材)20が移動するためのスロット14Aとを有するカートリッジ本体14と、スロット14Aの幅方向両側でそれぞれスロット14Aと平行に延びる一対の第一ステイプル列(一対の封止部)15と、スロット14Aの前方(スロット14Aよりも先端側)かつスロット14Aの延長線上に配置された第二ステイプル(組織封止部、封止ステイプル)16とを備えている。
 第一ステイプル列15には、複数のステイプル15Aがカートリッジ本体14内に整列配置されており、スロット14Aよりも所定の長さ、例えば5ミリメートル(mm)だけ先端側まで延びている。第二ステイプル16は、二列の第一ステイプル列15の間に配置されている。図3では、第二ステイプル16が二つ配置された例を示しているが、配置される個数には特に制限はなく、一つであっても、三つ以上であってもよい。第二ステイプルとして配置されるステイプルは、第一ステイプル列と同一のステイプル15Aであってもよいし、異なっていてもよい。
 カッター20は、カートリッジ13の内側からスロット14Aに挿通され、第二ジョー12に向かって突出した状態でスロット14A内を移動する。カッター20は、一対のジョー11、12間に挟まれた組織を全層にわたって切断できるように、カッター20の突出端が、後述するアンビル部材に設けられた溝内に進入した状態でスロット14Aに沿って移動する。このために必要なカッター20の刃渡りは、折り返された状態で保持される対象組織の2枚分の厚さよりも長く、かつ閉じた状態の一対のジョー11、12間の距離よりも長い。
 図4Aは、カートリッジ13からステイプルが射出される仕組みを示す図である。ステイプル15Aの下方には樹脂等で形成されたドライバ17が配置されている。カートリッジ13内には、先端側に斜面18Aを有するクサビ18が配置されている。第二トリガー35を操作してクサビ18を前進させると、斜面18Aと接触したドライバ17をクサビ18が上方に押し上げる。その結果、ステイプル15Aは、ドライバ17に押されることで基端側から順次射出されて組織を貫通し、貫通した端部が第二ジョー12に設けられたアンビル部材21に押し当てられて折り返される。
 ドライバ17は、2列の第一ステイプル列15のそれぞれに配置されているが、スロット14Aよりも先端側の領域には、図4Bに示すように、2列の第一ステイプル列15および第二ステイプル16を押し上げるドライバ19が配置されている。したがって、クサビ18がドライバ19を押し上げると、第一ステイプル列15のステイプル15Aと第二ステイプル16とが一緒に押し上げられて射出される。
 次に、組織切除装置1の使用時の動作について、胃(管腔組織)の悪性腫瘍(以下、単に「腫瘍」と称する。)を全層切除する場合を例に取り説明する。
 まず、術者は、組織切除装置1を患者の口等から胃内に導入し、観察部50を用いて腫瘍を観察する。そして、図5に示すように、腫瘍Tmを取り囲む大まかな切除領域Rを設定する。切除領域Rは、組織切除時に腫瘍Tmを損傷等しないように、腫瘍Tmとの最短距離が5ミリメートル(mm)以上になるように設定されるのが好ましい。
 次に、術者は、内視鏡用処置具100を第一ジョー11から突出させ、図6に示すように、鉗子部101で腫瘍Tmから離れた胃壁の一点を胃Smの内側から把持する。この一点は、実際に切除される領域の周縁の一部となるため、設定した切除領域Rの周縁部に相当する位置に設定するのが好ましく、例えば、腫瘍Tmの中心から30mm程度離れた箇所を選択することができる。以後、この把持された一点を、第一把持点P1と称する。
 続いて術者は、第一把持点P1を把持した内視鏡用処置具100を後退させ、第一トリガー34を適宜操作しながら、図7に示すように、第一ジョー11と第二ジョー12との間の間隙に胃壁組織STの一部を引き込む。引き込む際には、観察部50で腫瘍Tmを観察し、腫瘍Tmが一対のジョーに触れないように注意して行う。
 胃壁組織STは、第一把持点P1から延びる2本の第一引き込み線L1に沿って第一ジョー11と第二ジョー12との間に引き込まれる。すなわち、引き込まれる胃壁組織STは、胃の外面どうしが接触するように胃の外面を内側にして折り曲げられ、第一引き込み線L1の一方が第一ジョー11に対向し、他方が第二ジョー12に対向した状態で引き込まれていく。一対のジョーの間隙は狭いスリット状であり、その間隔が胃壁組織の略2枚分の厚さとなっているため、胃に隣接する他の臓器等の組織が、胃壁組織とともに一対のジョー間に引き込まれることはない。
 胃壁組織STが一対のジョー11、12間に充分に引きこまれたら、術者は第二トリガー35を操作する。これにより、カートリッジ13内においてクサビ18が先端に向かって前進し、第一ステイプル列15の各ステイプル15Aの下方に配置されたドライバ17を基端側から順に押し上げる。その結果、ステイプル15Aは、基端側から先端側に向かって順次第二ジョー12に設けられたアンビル部材21(図4A参照)に押し当てられ、胃壁組織STを貫通したステイプル15Aの両端部が折り返される。その結果、第一引き込み線L1の両側において、折り曲げられた胃壁組織STが厚さ方向にわたって一体となるように縫合される。
 さらに、クサビ18に少し遅れてカッター20(図4A参照)が先端に向かって前進し、胃壁組織STを縫合した第一ステイプル列15の列間に位置する胃壁組織を、概ね第一引き込み線L1に沿って切断する。その結果、図8に示すよう胃壁の一部が全層にわたって切断される。ここで、カッター20の動線(スロット14Aと実質的に同一)の延長線上の前方において第一ステイプル列15の列間に位置する胃壁組織は、第二ステイプル16により一体に縫合される。
 第一引込み線L1に沿った切断および縫合が終了した後、術者は組織切除装置1を体腔外に抜去してカートリッジ13を、ステイプルが装填された新しいカートリッジと交換し、再度胃内に導入する。そして、図9に示すように、第一引込み線L1に沿った切断線の第一把持点P1と反対側の端部を第二把持点P2として、内視鏡用処置具100の鉗子部101で把持する。
 次に、術者は内視鏡用処置具100を後退させ、図10に示すように、鉗子部101で把持した胃壁組織STを、第二引込み線L2に沿って一対のジョー11、12内に引き込む。このとき、外面どうしが接触するように折り曲げられた胃壁組織の稜線rgが一対のジョー11、12内を通るように胃壁組織STを引き込む。
 その後、上述と同様の操作で縫合および切断を行うと、第二引込み線L2に沿って胃壁組織STが切断および縫合される。さらに、第一引込み線L1と第二引込み線L2とが図5に示すように閉じた四角形を形成するため、腫瘍Tmを含む切除領域R内の胃壁組織STが、第一引込み線L1および第二引込み線L2に沿って形成された切断線によって、図11に示すように胃Smから切り離される。このようにして、胃Smに穴を残すことなく、胃壁組織STの一部が全層にわたって切除される。
 切除終了後、術者は組織切除装置1を抜去し、切除された胃壁組織ST(切除片)を回収して手技を終了する。このとき、切除片を鉗子部101で把持し、組織切除装置1の抜去と切除片の回収とを同時に行ってもよい。
 冒頭説明したように、従来全層切除は、開腹手術下や腹腔鏡手術下で行われてきたが、患者の侵襲をより小さくしたり、腫瘍を切除する際の再発のリスクを低減したりする観点から、これを口等の自然開口から行うことが検討されている。
 しかしながら、上記特許文献1に記載されたような従来の組織切除装置では、第一ステイプル列しか備えていないため、第一の引き込み線に沿って縫合および切断を行うと、図12に示すように、カッターの切断線の前方であって第一ステイプル列間の組織が未縫合となり、穴のような状態となった部位が残存する。そのため、管腔組織の内圧が高まった等の場合に、一時的ではあるが当該部位から管腔組織の内容物が外部に漏れ出る恐れがある状態が生じてしまうという問題がある。
 本実施形態の組織切除装置1によれば、カートリッジ13に組織封止部としての第二ステイプル16が配置されているため、カッター20の切断線の前方であって第一ステイプル列15間の組織が第二ステイプル16により確実に縫合されて封止される。また、一対のジョー11、12の間の狭い間隙に組織を引き込み、把持した状態で、まず第一ステイプル列15および第二ステイプル16により組織が縫合され、カッターが組織を切断した後に一対のジョーによる保持が解除される。したがって、組織切除装置1を用いた一連の手技においては、管腔組織の内容物が外部に漏れ出る恐れがある状態を全く生じさせずに組織切除を行うことができる。
 また、閉じた一対のジョー11、12間の比較的狭いスリット状の間隙に組織を引き込んでから縫合及び切断が行われるため、胃等の管腔組織に隣接する他の臓器や組織等が一緒に引き込まれそうになっても、間隙の入口で阻止される。したがって、管腔組織の外部が視認できない経自然開口的アプローチであっても、これらの臓器、組織等を誤って管腔組織とともに縫合したり切断したりすることなく手技を行うことができる。
 本実施形態では、スロット14Aよりも先端側において、第一ステイプル列のステイプルと第二ステイプルとが共通のドライバにより射出される例を説明したが、ステイプルを射出するための構造はこれには限定されない。例えば、第二ステイプルを押し上げるドライバを第一ステイプル列のドライバと別体としてもよい。具体的には、図13に示すように、カッター20の前方に第二クサビ23を設け、第二ステイプル16を押し上げるドライバ22を第二クサビ23で押し上げる構造としてもよい。あるいは、第二クサビ23で共通のドライバ19を押し上げる構成にしたり、第二クサビ23ですべてのドライバを押し上げる構造にしたりしてもよい。
 また、上述の例では、第一ステイプル列のステイプルの向きと第二ステイプルの向きとが平行であるが、図14に示す変形例のように、第二ステイプル16Aの長手方向が、カッター20の移動するスロット14Aと直交するように配置されてもよい。このようにすると、スロットの前方の組織をより広い範囲で接合することができ、より確実に組織切除を行うことができる。
 次に、本発明の第二実施形態について説明する。本実施形態の組織切除装置71と第一実施形態の組織切除装置1との異なるところは、組織吻合部の構成である。なお、以降の説明において、すでに説明したものと共通する構成については、同一の符号を付して重複する説明を省略する。
 図15は、組織切除装置71における第一ジョー11およびカートリッジ72の先端側を示す部分拡大図である。スロット14Aの前方には、第二ステイプルに代えて、線状または帯状の第一電極73が設けられている。第一電極73の周囲には、絶縁体74が配置され、処置部10における他の金属製部位と絶縁されている。
 図16に示すように、第二ジョー12に設けられたアンビル部材75には、第一電極73と対応する位置に、第一電極73と同様の構造を有する第二電極76が設けられており、第一電極73および第二電極76は、高周波電源77に接続されている。通電のオンオフは、操作部(不図示)で切り替え可能である。
 組織切除装置71を使用する際は、第一実施形態と同様に、第一ステイプル列15とカッター20とを用いて組織を縫合、切断した後、一対のジョー11、12を開かずに第一電極73と第二電極76とに挟まれた組織に高周波電源77から高周波電流を通電する。これにより、第一電極73および第二電極76の一対の電極が、いわゆるバイポーラ(双極性)のエレクトロサージカル器具(electrosurgical instrument)として機能する。その結果、日本国特開2009-247893等に記載のように、第一電極73および第二電極76に接触して通電された組織の細胞内成分と細胞外成分とが均一化(リキッド化)し、一対のジョー11、12間において組織どうしが接合されて、未縫合組織の残存により生じた穴が封止される。
 本実施形態の組織切除装置71においても、第一実施形態同様、管腔組織の内容物が外部に漏れ出る恐れがある状態を全く生じさせずに組織切除を行うことができる。
 また、組織封止部が第一電極73および第二電極76により構成されているため、封止部位が面状に接合される。その結果、さらに確実に穴を塞ぐことができる。
 本実施形態において、通電することにより接触した組織を封止する組織封止部の構成は、上述のバイポーラの機構に限定されない。例えば、通電により自身が発熱するヒータ等の発熱素子を第一電極73および第二電極76に代えてカートリッジおよびアンビル部材に取り付け、一対のジョー間に挟まれた組織を両側から加熱する構成としてもよい。この構成により、これら発熱素子がいわゆる熱凝固処置具として機能するため、温度や加熱時間を適切に設定することで、組織同士を接合することができる。
 また、電極の形状も上述の線状、帯状等に限られず、図17に示す電極73Aのようなスポット状であってもよい。
 以上、本発明の各実施形態について説明したが、本発明の技術範囲は上記実施形態に限定されず、本発明の趣旨を逸脱しない範囲において構成要素の組み合わせを変えたり、各構成要素に種々の変更を加えたり、削除したりすることが可能である。
 例えば、上記実施形態では、縫合および切断を2回行って組織を切除する例を説明したが、縫合および切断の回数は2回に限られない。例えば、腫瘍が大きい等により大きな切除領域が設定された場合、ジョーの大きさによっては、2回では切断しきれない場合がある。このような場合は、折り曲げられた管腔組織の稜線がスリット内を通らないように管腔組織の一部を引き込んだ状態で2回目の縫合および切断を行うと、2回目の縫合および切断後も切除する組織は切り離されない。その後、必要に応じて同様の縫合および切断を繰り返し、最後に管腔組織の稜線がスリット内を通るようにして縫合および切断を行うことで、任意の大きさの領域を全層切除することができる。ここで、組織片が切除される最後の縫合及び切断においては、スロットの前方に組織が存在しないため、組織封止部を有さない従来のカートリッジが用いられてもよい。
 加えて、本発明の組織切除装置の対象となる管腔組織は、胃に限定されるものではない。例えば、腸は胃に比べて径が小さいが、ステイプラ等の、使用するデバイスのサイズを適切に設定することにより、腸等でも本発明の組織切除方法を好適に行うことが可能である。
 また、組織切除の対象疾患も、実施形態で説明した腫瘍には限定されず、例えば重度の潰瘍等の他の疾患等にも適用できることは当然である。
上記各実施形態によれば、カートリッジに組織封止部が配置されているため、切断部材の切断線の前方であって一対の封止部間の組織が、組織封止部により確実に縫合されて封止される。また、一対の把持部材の間の狭い間隙に組織を引き込み、把持した状態で、まず一対の封止部および組織封止部により組織が縫合され、切断部材が組織を切断した後に一対の把持部材による保持が解除される。したがって、組織切除装置を用いた一連の手技においては、管腔組織の内容物が外部に漏れ出る恐れがある状態を全く生じさせずに組織切除を行うことができる。
1,71 組織切除装置
 11 第一ジョー(第一把持部材)
 12 第二ジョー(第二把持部材)
 14 カートリッジ本体
 14A スロット
 15 一対の第一ステイプル列(一対の封止部)
 16 第二ステイプル(組織封止部、封止ステイプル)
 20 カッター(切断部材)

Claims (14)


  1.  組織を保持する一対の把持部材と、
     前記一対の把持部材に交換可能に取り付けられるカートリッジとを備え、
     前記カートリッジは、
      長手軸と、前記長手軸に沿って延びるスロットとを有し、前記スロットにより組織を切断する切断部材を案内するとともに前記切断部材の移動範囲を規定するカートリッジ本体と、
      前記スロットを挟むように前記スロットの両側に設けられ、それぞれ前記スロットと平行に延びる一対の封止部と、
      前記スロットより先端側かつ前記スロットの延長線上に設けられた組織封止部と、
     を有する
    組織切除装置。

  2.  前記組織封止部は、前記一対の把持部材間に保持されるとともに前記スロットよりも先端側に位置する組織を接合する
    請求項1に記載の組織切除装置。

  3.  前記一対の封止部は、前記スロットよりも前記先端側まで延びており、
     前記組織封止部は、前記一対の封止部の間に設けられている
    請求項1に記載の組織切除装置。

  4.  前記一対の封止部は、前記カートリッジ本体内に配置された複数のステイプルから構成される一対のステイプル列である
    請求項1に記載の組織切除装置。

  5.  請求項1に記載の組織切除装置であって、
     前記組織封止部は、前記カートリッジ本体内において前記スロットの前記先端側に配置された封止ステイプルである
    請求項1に記載の組織切除装置。

  6.  前記組織封止部は、前記一対の把持部材間に保持されるとともに前記スロットよりも先端側に位置する組織に接触可能な一対の電極である
    請求項1に記載の組織切除装置。

  7.  前記組織封止部は、前記一対の把持部材間に保持されるとともに前記スロットよりも先端側に位置する組織に接触可能な一対の発熱素子である
    請求項1に記載の組織切除装置。

  8.  長手軸に沿って延びる挿入部と、
    前記挿入部の先端に設けられ、組織を把持する一対の把持部材と、
     所定の動線に沿って移動することにより前記一対のジョー間に保持された管腔組織を切断する切断部材と、
     前記動線を挟むように前記動線の両側に設けられ、それぞれ前記動線と平行に延びる一対の封止部と、
     前記動線の前方かつ前記動線の延長線上に設けられた組織封止部と、
     を備える組織切除装置。

  9.  前記組織封止部は、前記一対の把持部材間に保持されるとともに前記動線よりも先端側に位置する組織を接合する
    請求項8に記載の組織切除装置。

  10.  前記一対の封止部は、前記動線よりも先端側まで延びており、
     前記組織封止部は、前記一対の封止部の間に設けられている
    請求項8に記載の組織切除装置。

  11.   前記一対の封止部は、前記動線の両側に配置された複数のステイプルから構成される一対のステイプル列である
    請求項8に記載の組織切除装置。

  12.  前記組織封止部は、前記動線の前記先端側に配置された封止ステイプルである
    請求項8に記載の組織切除装置。

  13.  前記組織封止部は、前記一対の把持部材間に保持されるとともに前記動線よりも先端側に位置する組織に接触可能な一対の電極である
    請求項8に記載の組織切除装置。

  14.  前記組織封止部は、前記一対の把持部材間に保持されるとともに前記動線よりも先端側に位置する組織に接触可能な一対の発熱素子である
    請求項8に記載の組織切除装置。
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EP3009080A1 (en) * 2014-10-13 2016-04-20 Ethicon Endo-Surgery, Inc. Staple cartridge
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EP2923656A1 (en) 2015-09-30
CN104334097B (zh) 2017-02-22
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