WO2022127718A1 - 用于胃肠内窥镜检查的内窥镜附件 - Google Patents

用于胃肠内窥镜检查的内窥镜附件 Download PDF

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Publication number
WO2022127718A1
WO2022127718A1 PCT/CN2021/137253 CN2021137253W WO2022127718A1 WO 2022127718 A1 WO2022127718 A1 WO 2022127718A1 CN 2021137253 W CN2021137253 W CN 2021137253W WO 2022127718 A1 WO2022127718 A1 WO 2022127718A1
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Prior art keywords
axial
forward edge
accessory
axial segment
endoscope
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PCT/CN2021/137253
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English (en)
French (fr)
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宾穆勒·肯尼斯·F
哈克斯科特
谢磊
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南微医学科技股份有限公司
宾穆勒·肯尼斯·F
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Application filed by 南微医学科技股份有限公司, 宾穆勒·肯尼斯·F filed Critical 南微医学科技股份有限公司
Priority to DE212021000483.0U priority Critical patent/DE212021000483U1/de
Priority to JP2023600127U priority patent/JP3244386U/ja
Publication of WO2022127718A1 publication Critical patent/WO2022127718A1/zh
Priority to US18/208,651 priority patent/US20230320569A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00089—Hoods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00087—Tools
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00094—Suction openings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00091—Nozzles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
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    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00269—Type of minimally invasive operation endoscopic mucosal resection EMR
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    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/00296—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means mounted on an endoscope
    • A—HUMAN NECESSITIES
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    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
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    • A61B2018/00982—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes

Definitions

  • the present disclosure relates to endoscopy, and more particularly, to endoscopic devices for gastrointestinal surgery.
  • Achalasia is a condition of the esophagus in which the lower esophageal sphincter does not function properly to move food into the stomach or instead obstructs the passage of food to the stomach. Achalasia can cause a person's inability to swallow, weight loss and reflux, among other symptoms.
  • POEM peroral endoscopic myotomy
  • POEM is an endoscopic treatment method by which myotomy is performed on the muscle fibers of the lower esophageal sphincter.
  • the endoscope is inserted through the incision into the esophageal mucosa and then through the submucosa between the mucosa and the muscularis intestinal until it reaches the lower esophageal sphincter.
  • Myotomy of the lower esophageal sphincter is performed by incising the muscle fibers of the lower esophageal sphincter with the knife of the endoscope after the endoscope reaches the lower esophageal sphincter.
  • accessories eg, covers
  • embodiments of endoscopy systems including endoscopes and the accessories.
  • an accessory for an endoscope includes a proximal portion and a distal portion.
  • the proximal portion is configured to be coupled to the insertion tube of the endoscope.
  • the distal portion is coupled to the proximal portion and extends axially from the proximal portion to the forward edge.
  • the distal portion includes a first axial segment extending axially forward from the proximal portion, and a second axial segment extending axially forward from the first axial segment.
  • the first axial segment extends a first axial length forward from the proximal portion toward the edge.
  • the first axial segment defines the channel and extends circumferentially completely around the axis of the channel.
  • the second axial section extends from the first axial section forward to the edge for a second axial length. Over most of the second axial length, the second axial segment extends circumferentially about the axis by 180 degrees or less.
  • the second axial segment may extend on average less than 180 degrees circumferentially about the axis.
  • the forward edge may be concave and/or may be axially recessed relative to a plane extending transversely across the channel and with the forward edge on the first and second axial segments of the first axial length All intersect.
  • an endoscopic system includes an endoscope and accessories as previously described.
  • the endoscope includes an insertion tube and a knife extendable from the distal end of the insertion tube.
  • the accessory is coupled to the insertion tube at the distal end.
  • the axis may be disposed radially between the blade and a portion of the second axial segment extending the second axial length to the forward edge.
  • a cover for an endoscope includes a coupling portion and a cover portion.
  • the coupling portion is configured to be coupled to an insertion tube of an endoscope having a blade extendable therefrom.
  • the cover portion extends axially from the coupling portion to the forward edge.
  • the cover portion defines a channel having an axis and a transverse recess extending through the channel transverse to the axis.
  • the transverse notch may be an axially forward region at the forward edge and an axially rearward region of a plane extending through the channel and intersecting the forward edge on the opposite side of the forward edge.
  • Figure 1 is a schematic illustration of an endoscope inserted into the submucosa during a transoral endoscopic myotomy.
  • FIG. 2 is a cross-sectional view along line 2-2 of FIG. 1 .
  • FIG 3 is an upper front perspective view of the endoscope of the first embodiment with the cover.
  • FIG. 4 is an upper front perspective view of an endoscope with a cover shown in a faded manner.
  • FIG. 5 is a plan view of the endoscope having the cover of FIG. 1 .
  • FIG. 6 is a left side view of the endoscope having the cover of FIG. 1 .
  • FIG. 7 is a front view of the cover of the endoscope shown in a faded manner.
  • FIG. 8 is a left side view of the cover of the endoscope shown in a faded manner.
  • FIG. 9 is a top view of the cover of the endoscope shown in a faded manner.
  • Figure 10 is a front view of the cover shown in Figure 7 labeled with various dimensions.
  • Fig. 11 is a left side view of the cover shown in Fig. 8 labeled with various sizes.
  • Figure 12 is a top plan view of the cover shown in Figure 9 labeled with various dimensions.
  • 13 is an upper front perspective view of the endoscope with the second embodiment of the cover.
  • FIG 14 is an upper front perspective view of the endoscope of the third embodiment with the cover.
  • Figure 15 is a front view of a fourth embodiment of the cover.
  • FIG. 16 is a left side view of the fourth embodiment of the cover of FIG. 15 .
  • FIG. 17 is a top view of a fourth embodiment of the cover of FIG. 15 .
  • Figure 18 is a top view of the fifth embodiment of the cover.
  • FIGS. 3-18 are detailed schematic views of an endoscope with the cover shown in FIGS. 3-18 performing POEM.
  • endoscopic systems, components, and surgical procedures for performing POEM are disclosed with specific reference to POEM, it should be readily understood that the endoscopic systems and components described herein may also be used in other surgical procedures, such as other endoscopic submucosal dissections (also referred to as "" ESD”) or other endoscopic gastrointestinal surgery.
  • the endoscopic system and assembly more specifically, include an endoscope having a knife, one or more water sources, a camera head, and accessories.
  • This appendage referred to herein as the cover, includes extended sides that, during POEM or other procedures, allow for more efficient and/or effective cutting of tissue, such as the submucosa of the lower esophageal sphincter and muscle fibers.
  • FIG. 1 schematic diagrams of the esophagus 100 with an endoscope 110 inserted therein during a POEM procedure are shown.
  • the esophagus 100 extends from the pharynx (not labeled) to the stomach 102 .
  • the esophageal sphincter 104 is located at the bottom of the esophagus 100 adjacent to the stomach 102 .
  • the esophagus 100 generally includes a mucosa 100a, a submucosa 100b, and a muscularis intestinal 100c.
  • the mucosa 100a is the innermost layer of the esophagus 100 .
  • the submucosa 100b is an intermediate layer of tissue located between the mucosa 100a and the muscularis basement 100c.
  • the muscularis basement 100c which may also be referred to as "MP" is lateral to and adjacent to the submucosa 100b.
  • Muscularis basement 100c is the muscle that provides mobility to move food down through the esophagus 100 to the stomach 102 .
  • the lower esophageal sphincter 104 includes muscle tissue and is located at the lower end of the esophagus 100 adjacent to the stomach 102.
  • the endoscope 110 generally includes an insertion tube 112 having a distal end 114 .
  • the insertion tube 112 may be generally cylindrical and terminate at the distal end 114 .
  • Insertion tube 112 includes one or more passages (not shown) that extend through the insertion tube to one or more nozzles 114a in distal end 114 that supply "water” (including other fluids) solutions, eg, brine) and "air” (including other gases, eg, carbon dioxide).
  • Insertion tube 112 also includes a dedicated channel (not shown) extending therethrough to outlet 114b in distal end 114 that supplies suction and accommodates insertion of instruments.
  • Outlet 114b provides an outlet for instruments such as knife 116 extending from distal end 114 of endoscope 110 to engage the patient's tissue.
  • the inserted instrument will not be off-center from the axis of 114b.
  • the outlet 114b may be offset toward one side of the distal end 114, eg, its location is off-center relative to the axis 114c of the distal end 114 (labeled in Figures 11 and 12).
  • the knife 116 is likewise biased to one side of the distal end 114 of the endoscope 110, eg, off-center of the axis 114c.
  • the outlet 114b and the blade 116 may be located radially between the axis 114c and the outer circumference of the distal end 114 (eg, of the insertion tube 112).
  • the distal end 114 of the endoscope 110 may also include one or more light guide lenses (not shown) and an objective lens (not shown).
  • a light source emits light through the one or more light guide lenses to provide illumination in front of the distal end 114 of the insertion tube 112 .
  • the insertion tube 112 may include optical fibers (eg, glass fibers) or other means (not shown) extending through the insertion tube that divert light from the light source to the light guide lens for illumination purposes.
  • the insertion tube may further comprise other optical fibers or other optical transmission means (not shown) extending through the insertion tube which transfer light from the objective lens to the camera for imaging purposes.
  • the endoscope 110 also houses a knife 116 inserted through the outlet 114b, such as an electrosurgical knife specifically used for POEM and endoscopic submucosal dissection.
  • Knife 116 includes a tip (not shown) with electrodes, which may be of any suitable shape (eg, spherical, triangular, hooked), may be insulated or non-insulated, and/or may provide fluid injection. When used for fluid injection, the knife 116 may be an additional fluid source for the nozzle 114a.
  • endoscope 110 or an endoscope system including endoscope 110 may also be considered to include the various fluids and light sources described above (eg, water, air, suction, and/or light), cameras, An instrument (eg, knife 116) and/or its operational controls.
  • fluids and light sources eg, water, air, suction, and/or light
  • cameras e.g, An instrument (eg, knife 116) and/or its operational controls.
  • the endoscope 110 or the endoscope system including the endoscope 110 further includes a cover 120 .
  • Cap 120 is an accessory that is coupled to distal end 114 of endoscope 110 and is used to compress or otherwise engage tissue in a manner that facilitates viewing and cutting of tissue.
  • cover 120 includes extended sides (eg, extended ends, axially extending protrusions, flanged portions, or tips). Cover 120 may also be referred to as an attachment, distal attachment, or cover.
  • Cap 120 is tubular and generally includes a proximal portion 122 and a distal portion 130 coupled to and extending axially forward from proximal portion 122 (eg, parallel or substantially parallel to axis 114c).
  • the tubular cover 120 allows water, air, tissue, light, and/or instruments such as the knife 116 to pass therethrough to and/or away from the distal end 114 of the insertion tube 112 of the endoscope 110 .
  • the cap 120 extends axially between a rearward facing edge 122a (where the proximal portion 122 ends) and a forward edge 130a (where the distal portion 130 ends). As shown in FIGS.
  • the cap 120 may have an axial direction (ie, substantially parallel to the axis 114c of the insertion tube 112 and/or cap 120) from the rearmost portion of the rearward edge 122a to the forwardmost portion of the forward edge 130a. ) measured length L_cap.
  • the length L_cap of cover 120 may be approximately 10mm to 40mm, such as 15mm to 30mm (eg, 15mm to 20mm, 20mm to 25mm, or 25mm to 30mm), or another suitable distance.
  • the axial length L_cap of the cap 120 includes and may be equal to the sum of the length L_proximal of the proximal portion 122 and the length L_distal of the distal portion 130 .
  • the proximal portion 122 is configured to be coupled to the distal end 114 of the insertion tube 112 .
  • the proximal portion 122 may be generally tubular and configured to receive the distal end 114 of the insertion tube 112 of the endoscope 110 therein.
  • the proximal portion 122 of the cap 120 may be attached to the interior by one or more of a friction fit (eg, the inner surface of the proximal portion of the cap 120 frictionally engages and/or compresses the distal end 114 of the endoscope 110) or tape.
  • the insertion tube 112 of the speculum 110 is held.
  • the rearward edge 122a of the cover 120 comprises tape with a removable non-stick coating.
  • the proximal portion 122 may also enable the cap 120 to be coupled to the endoscope 110 in one or more orientations that the user may determine, eg, to orient the extended side of the cap 120 relative to the blade 116 (eg, closest or farthest away). knife 116).
  • the proximal portion 122 may also be referred to as a coupling portion.
  • the desired positioning of the extended side of the cover 120 relative to the knife 116 is determined by a steep notch or printed mark at the midpoint of the extended side of the cover 120 that is viewed from the outside in endoscopic imaging or visible inside.
  • the generally tubular proximal portion 122 includes an outer surface and an inner surface with a thickness extending therebetween.
  • the outer and inner surfaces are cylindrical and coaxial such that the thickness is constant both circumferentially around the proximal portion 122 and axially along the proximal portion 122 .
  • the inner surface has a diameter such that the distal end 114 of the endoscope 110 is received therein, eg, 6 mm to 20 mm (eg 7 mm to 12 mm, such as about 9 mm), depending on the insertion tube 112 of the endoscope 110 .
  • the proximal portion 122 eg, inner and/or outer surfaces
  • the length L_proximal of the proximal portion 122 extends axially from the rearward edge 122a of the cap 120 to the distal end 114 of the endoscope 110 (eg, the distance that it couples and/or overlaps with the insertion tube 112 of the endoscope 110 ) .
  • the length L_proximal of the proximal portion 122 may be between about 4 mm to 15 mm, such as 6 mm to 10 mm (eg, about 8 mm).
  • the distal portion 130 forms the extended side of the cover 120 .
  • the distal portion 130 of the cap 120 engages tissue (eg, tissue of the submucosa 100b ) and keeps the tissue away from the distal end 114 of the endoscope 110 .
  • tissue eg, tissue of the submucosa 100b
  • This provides a field of view for the camera while also allowing the knife 116 to be manipulated to engage and cut tissue (eg, in a POEM procedure, to engage and cut the submucosa 100b and/or the muscularislitis 100c, including the lower esophageal sphincter 104).
  • the distal portion 130 is generally tubular and defines a channel 130c through which water, air, suction and/or light passes to and/or away from the distal end 114 of the endoscope 110. Knife 116 also extends and retracts through channel 130c to cut tissue.
  • the distal portion 130 may also be referred to as a hood portion.
  • the length L_distal of the distal portion 130 extends axially from the proximal portion 122 (eg, from the distal end 114 of the endoscope 110 ) to the forward edge of the distal portion 130 that is axially farthest from the endoscope 110 130a.
  • the axial length L_distal of the distal portion 130 may have an axial length L_distal of, eg, about 5 mm to 25 mm, eg, 10 mm to 20 mm (eg, about 15 mm), or eg, 5 mm to 15 mm (eg, about 15 mm). 8mm to 10mm).
  • the axial length L_distal may include and equal the sum of the axial length L_short of the first axial segment 132 and the axial length L_long of the second axial segment 134 .
  • the length L_short may also be referred to as the first axial length and the length L_long may also be referred to as the second axial length.
  • the distal end portion 130 of the cap 120 forms an extension side by extending axially forward different distances from the proximal end portion 122 (eg, from the distal end 114 of the endoscope 110) to the forward edge 130a. More specifically, as will be discussed in further detail below, the distal portion 130 includes a first axial segment 132 and a second axial segment 134 , the second axial segment 134 being further from the proximal portion 122 than the first axial segment 132 . It extends distally axially to the forward edge 130a, forming an extension side.
  • the forward edge 130a may extend forward various distances to define a lateral notch 136 transverse to the channel 130c (eg, transverse to the axis 114c of the cover 120) at The entire forward edge 130a extends and the knife 116 can be inserted into the transverse recess 136 to cut tissue.
  • the forward edge 130a is optionally concave between the first axial segment 132 and the second axial segment 134 .
  • the first axial segment 132 of the distal portion 130 of the cap 120 includes the proximal portion 122 and/or the distal end of the endoscope 110 closest to the forward edge 130a, measured in the axial direction (eg, parallel to the axis 114c) 114 (see Figures 11 and 12) at the point or portion.
  • the first axial segment 132 of the cover 120 may extend substantially continuously (eg, completely) about the axis 114c to form the channel 130c.
  • the first axial section 132 of the cover 120 thus defines the volume of the cover 120 (eg, the cover of the channel 130c), which may be generally cylindrical or have another suitable shape.
  • the first axial segment 132 and thus the channel 130c may have an inner diameter of 6 mm to 12 mm (eg, 8 mm to 10 mm, such as 9 mm), which may be compatible with the inner diameter of the proximal portion 122 and/or the insertion tube at the distal end 114
  • the outer diameter of 112 is basically the same.
  • the diameter of the outer surface of the first axial section 132 may be 7mm to 18mm, preferably 7mm to 14mm (eg 10mm to 13mm, such as 12mm).
  • the first axial segment 132 may have a thickness of 0.5mm to 2mm.
  • the first axial segment 132 and/or the channel 130c defined thereby may have any other suitable axial displacement shape, such as by forming a constant (eg, straight or frustoconical) or curved manner to move axially away from the proximal portion 122 to progressively increase in size.
  • the cross-section of the first axial segment 132 and/or the channel 130c may be circular (as shown) or non-circular, such as oval, square, or otherwise having a straight segment or other suitable shape.
  • the length L_short of the first axial segment 132 is measured in the axial direction from the proximal end portion 122 of the cap 120 and/or the distal end 114 of the endoscope 110 to the closest proximal edge 130a of the cap 120 described above. The distance of the point or portion of the end portion 122 .
  • the first axial segment 132 may also be referred to as a short segment.
  • the length L_short of the first axial segment 132 may be, for example, 2 mm to 15 mm, such as 4 mm to 10 mm (eg 5 mm).
  • the forward edge 130a on the first axial segment 132 may have markings, which may be steep indentations or printed markings, for reference when the cover 120 is installed, at the location closest to the protruding hole of the knife 116 .
  • the markings may be individual and steep notches, eg less than 2mm in span, or 1mm or less than 5, 3, 2 or 1 degree, eg the notch forming the alignment slot 130b, may not be considered to define the first axial segment 132
  • the axial length L_ is short. The markings ensure that, after installation, the blade 116 is located on the opposite side of the extension of the second axial section 134 so that the blade 116 can be exposed to the notch for maximum exposure to facilitate surgical manipulation.
  • forward edge 130a may extend a constant axial distance equal to length L_short over circumferential span S_short of first axial segment 132 .
  • Circumferential span S_short can be defined by angular measurements around axis 114c.
  • the circumferential span S_short of the forward edge 130a may be 0 to 270 degrees, such as 0 to 180 degrees, 30 to 150 degrees (eg, 75 to 105 degrees), or 90 to 270 degrees (eg, 130 to 220 degrees).
  • the circumferential span S_short may be measured in a linear dimension, eg 0 mm to 10 mm (eg 4 mm to 8 mm).
  • the axial length of the forward edge 130a may gradually increase as the forward edge 130a moves from the singularity having the length L_short along its circumference toward the second axial segment 134.
  • the circumferential span S_short may also be referred to as the first circumferential span.
  • the second axial segment 134 of the distal end portion 130 of the cap 120 projects axially forward relative to the first axial segment 132 .
  • the second axial segment 134 includes the portion or point of the forward edge 130a that extends furthest from the proximal portion 122 and/or the distal end 114 of the endoscope 110, measured in the axial direction.
  • the second axial section 134 of the cover 120 forms an extended side, eg, by extending circumferentially not completely around the channel 130c.
  • the second axial segment 134 may be partially cylindrical, eg, having the same inner and/or outer radius as the first axial segment 132, or larger dimensions.
  • the second axial segment 134 may have another suitable shape, eg, increase and/or decrease with axial movement in a constant or curved fashion.
  • the second axial segment 134 may be partially circular (as shown) or non-circular in cross-section (ie, at a fixed axial position), such as partially oval, square, or otherwise having straight segments , or other suitable shapes (see, eg, Figures 15-17).
  • the distal portion 130 of the cap 120 may be symmetrical about a plane extending through the axis 114c of the insertion tube 112 and/or the cap 120, or may be asymmetrical.
  • the circumferential dimensions of the second axial segment 134 are discussed in further detail below.
  • the point or portion on the forward edge 130a of the second axial segment 134 has a length L_long (ie, the maximum axial length of the forward edge 130a) and may be referred to as the elongated side, first side or long side,
  • the length L_short on the forward edge 130a of the first axial segment 132 ie, the minimum axial length of the forward edge 130a
  • the elongated side may be located diametrically opposite the short side (eg, with the axis 114c therebetween).
  • the length L_long of the second axial segment 134 is the aforementioned point or portion measured in the axial direction from the forward edge 130a of the first axial segment 132 to the forward edge 130a furthest from the first axial segment 132 the distance.
  • the length L_long of the second axial segment 134 may be 2 mm to 15 mm, such as 3 mm to 10 mm (eg, about 3 mm to 5 mm) or 7 mm to 15 mm (eg, about 9 mm to 11 mm).
  • the length L_long of the second axial segment 134 is preferably no more than 10 mm, more preferably 2 mm to 5 mm.
  • the length L_distal of the distal end portion 130 and/or the length of the second axial segment 134 may be defined relative to the size or dimensions of the cover 120 and/or another portion of the endoscope 110.
  • the length L_long of the second axial section 134 may be between 0.25 and 1.5 times the diameter or other lateral dimension of the channel 130c and/or the outer surface of the first axial section 132 (eg, 0.25 to 0.75 times). (eg 0.4 to 0.6 times) or 0.75 to 1.5 times (eg 0.9 to 1.1 times)).
  • the forward edge 130a may extend a constant axial distance equal to the length L_long over the circumferential span S_long of the second axial segment 134 .
  • the circumferential span S_length may be defined by an angular measurement around the axis 114c of the distal portion 130 .
  • the circumferential span S_length of the forward edge 130a on the second axial segment 134 may be 0 to 180 degrees, such as 45 to 180 degrees (eg 60 to 120 degrees, such as 75 to 105 degrees) or 5 to 90 degrees (eg 5 to 45 degrees, such as 5 to 20 degrees).
  • the axial length may gradually decrease as the forward edge 130a moves circumferentially toward the first axial segment 132 from the singularity having the length L_long along its circumference.
  • the circumferential span S_long may also be referred to as the second circumferential span.
  • FIGS. 13 and 14 show that the length L_ of the second axial section 134 of the cover 120 is longer than the length L_ shown in FIGS. 3 to 13 . longer.
  • FIG. 13 also shows that the circumferential span S_length of the second axial section 134 of the cover 120 is smaller than the circumferential span S_length shown in FIGS. 3-12 .
  • FIGS. 15-17 shows that the distal portion 130 has a non-circular cross-sectional shape. More specifically, the second axial segment 134 transitions axially from the circular cross-sectional shape of the first axial segment 132 to having a flat side (eg, a bottom side as shown in FIGS. 16 and 17 ), such as Flat as shown in the figure.
  • the length of the forward edge 130a may be gradually varied by moving circumferentially about the forward edge 130a, eg, to avoid sharp outer corners that might otherwise puncture, grab, or abrade tissue.
  • the second axial segment 134 may include a fillet transitioning from the maximum axial length L_long circumferential movement.
  • the second axial section 134 of the cover 120 forms an extension side. More specifically, over the axial length L_long of the second axial segment 134, the second axial segment 134 may extend circumferentially to the forward edge 130a by varying amounts about the axis 114c, eg, about the axis 114c The circumferential distance gradually decreases, moving axially away from the first axial segment 132 (eg, away from the distal end 114 of the insertion tube 112).
  • the second axial segment 134 may extend circumferentially about the axis 114c less than 360 degrees, preferably less than 180 degrees on average (eg, less than 135 degrees on average).
  • the second axial segment 134 may surround The axis 114c extends circumferentially by 180 degrees or less.
  • the forward edge 130a of the distal portion 130 may be concave, eg, axially recessed relative to a plane 140 that extends across the channel 130c (eg, across axis 114c) and intersects at Forward edge 130a on first axial segment 132 (ie, the short side of length L_short) and second axial segment 134, and not passing through cover 120 (as shown by plane 140) and/or at length is L_long (as shown by plane 140').
  • plane 140' intersects forward edge 130a on two opposite sides of distal portion 130.
  • forward edge 130a may be considered to define a transverse notch 136 .
  • the lateral notches are the axially forward region of the forward edge 130a and the axially rearward region of the planes 140, 140'.
  • Cap 120 may be coupled to insertion tube 112 in a direction in which knife 116 may extend into and/or through transverse recess 136 .
  • tissue is engaged by the forward edge 130a on the short side (ie, of length L_short) and the long side (ie, of length L_long) and is suspended across the forward edge 130a, and the knife from the forward edge 130a extends axially forward into and/or beyond transverse notch 136 to engage and cut tissue.
  • transverse notch 136 corresponds to the longitudinal position (eg, the vertical position as shown in FIGS. 7 , 8 , 10 and 11 ) of the knife 116 (eg, the outlet 114b of the distal end 114 of the insertion tube 112 ).
  • the distal portion 130 is preferably formed from a transparent material, such as polyvinylchloride (PVC), polyethylene, styrene, polycarbonate, acrylic, thermoplastic elastomer, or other transparent and/or colorless materials.
  • PVC polyvinylchloride
  • the material forming the distal portion 130 is elastically deformable such that the distal portion 130 can elastically flex under higher loading events when coupled to the endoscope 110 and/or inserted into a patient or deformed.
  • the distal portion 130 is preferably formed as a single (eg, one-piece) unitary component.
  • the distal portion 130 may be further formed with the proximal portion 122 as a single (eg, unitary) integral component, the distal portion 130 and the proximal portion 122 being formed of the same material during the same operation.
  • proximal portion 122 may be formed as a separate component and/or formed of a different material and coupled to distal portion 130 .
  • Cover 120 may also include one or more drain holes 142 configured as an outlet for water or air captured by cover 120 to escape, eg, in channel 130c.
  • the vent hole 142 is disposed in the first axial segment 132 at a distance from the proximal end portion 122 of the endoscope accessory and/or the distal end 114 of the endoscope that is less than the first distance from the distal end 130 of the cap 120
  • the length L_ of the axial segment 132 is short.
  • the vent hole 142 may also be provided partially in the first axial segment 132 , eg, at the interface of the first axial segment 132 and the proximal end portion 122 .
  • the cover 120 may include a plurality of drain holes 142 .
  • cover 120 may include a plurality of vent holes 142, eg, having a common axial location and/or locations through passage 130c, eg, spaced 180 degrees from each other. Additionally, in the case of two vent holes 142, the vent holes 142 may be located on opposite sides of the elongated side, and/or on points or portions thereof that are L_long in length. In an alternative configuration, as shown in FIG. 18 , the cover 120 may include one or more vent holes 142 in the extension side (eg, in the second axial segment 134 ) and/or in circumferential alignment with the extension side .
  • the diameter of the discharge hole 142 may be, for example, 0.5 mm to 4 mm (eg, about 3 mm).
  • the endoscope 110 with the cover 120 is shown when used in a POEM procedure.
  • the distal end 114 of the endoscope 110 (including the cap 120 coupled thereto) is inserted into the submucosa 100b between the mucosa 100a and the muscularis intestinal 100c.
  • the forward edge 130a of the cover 120 engages the tissue on the first axial segment 132 and the second axial segment 134 and suspends the tissue of the submucosa 100b therethrough.
  • the tissue of the submucosa 100b extending between the first axial segment 132 and the second axial segment 134 may be held under tension therebetween and/or may protrude into the lateral notches 136 .
  • the extended side of the cover 120 may be positioned between the mucosa 100a and the blade 116, or alternatively, may be positioned between the muscularislitis 100c and the blade 116.
  • the knife 116 is then extended to engage the submucosa 100b and manipulated to cut the submucosa 100b, eg, the tip of the knife 116 is pulled through the submucosa 100b to cut its tissue.
  • the endoscope 110 is then further inserted between the mucosa 100a and the muscularis intestinal 100c to suspend the various tissues of the submucosa 100b therethrough, and the knife 116 is again extended to engage the submucosa 100b and operate to cut the submucosa 100b.
  • the knife 116 may be retracted (eg, removed from the lateral notch 136) behind the forward edge 130a.
  • the process of cutting and further inserting the endoscope 110 is repeated until the lower esophageal sphincter 104 is reached, at which point myotomy (ie, resection) of the musculature of the lower esophageal sphincter 104 is performed.
  • a fluid solution may be injected through one or both of the nozzle 114a or the tip of the knife 116, which may serve to separate the tissue, clear any loose tissue, and clear or prevent smoke that might otherwise interfere with passing through the endoscope 110 field of view) and realize the role of "underwater” imaging.

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Abstract

内窥镜(110)的附件包括近端部分(122)和远端部分(130)，近端部分(122)配置为耦合至内窥镜(110)的插入管(112)；远端部分(130)耦合至近端部分(122)并从近端部分(122)轴向延伸至前向边缘(130a)。远端部分(130)包括从近端部分(122)轴向向前延伸的第一轴向段(132)，和从第一轴向段(132)轴向向前延伸的第二轴向段(134)，第一轴向段(132)从近端部分(122)向前向边缘(130a)延伸第一轴向长度(L_短)，且第一轴向段(132)限定通道(130c)，并且完全围绕通道(130c)的轴线(114c)周向地延伸；第二轴向段(134)从第一轴向段(132)向前向边缘(130a)延伸第二轴向长度(L_长)，且在大部分的第二轴向长度(L_长)上，第二轴向段(134)绕轴线(114c)周向延伸180度或更小。内窥镜(110)的附件使得在POEM或其他手术过程中可以更高效和/或有效地切割组织。

Description

用于胃肠内窥镜检查的内窥镜附件
相关申请的交叉引用
本申请要求于2020年12月14日提交的、申请号为63/125,389、发明名称为“用于胃肠内窥镜检查的内窥镜附件”的美国临时专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本公开涉及内窥镜检查，尤其涉及用于胃肠手术的内窥镜设备。
背景技术
失弛缓症(achalasia)是食管的下述状态：其中食管下括约肌不能正常运作以将食物移入胃中或者反而阻碍食物通向胃的通道。失弛缓症可能导致人无法吞咽、体重减轻和反流以及其他症状。
失弛缓症可以通过经口的内窥镜下肌切开术(peroral endoscopic myotomy，在下文中将其称为“POEM”)进行治疗。POEM是一种内窥镜治疗方法，通过该方法对食管下括约肌的肌肉纤维进行肌切开术。为了进行POEM，将内窥镜通过切口插入食管粘膜，然后穿过粘膜和固有肌层之间的粘膜下层，直到到达食管下括约肌。当内窥镜到达食管下括约肌后，通过用内窥镜的刀切开食管下括约肌的肌肉纤维来进行食管下括约肌的肌切开术。
发明内容
本文公开了用于内窥镜的附件(例如，盖)的实施方式和包括内窥镜和所述附件的内窥镜系统的实施方式。
在一个实施方式中，用于内窥镜的附件包括近端部分和远端部分。近端部分配置为耦合至内窥镜的插入管。远端部分耦合至近端部分并从近端部分轴向延伸至前向边缘。远端部分包括从近端部分轴向向前延伸的第一轴向段，和从第一轴向段轴向向前延伸的第二轴向段。第一轴向段从近端部分向前向边缘延伸第一轴向长度。第一轴向段限定通道，并 且完全围绕通道的轴线周向地延伸。第二轴向段从第一轴向段向前向边缘延伸第二轴向长度。在大部分的第二轴向长度上，第二轴向段绕轴线周向延伸180度或更小。
在第二轴向长度上，第二轴向段可以绕轴线周向地平均延伸小于180度。前向边缘可以是凹形的和/或可以相对于平面轴向凹陷，该平面横向延伸跨过通道并且与前向边缘在第一轴向长度的第一轴向段上和第二轴向段上均相交。
在一种实施方式中，内窥镜系统包括内窥镜和如前所述的附件。内窥镜包括插入管和可从该插入管的远端延伸的刀。附件在远端处与插入管耦合。
轴线可以径向地设置在刀与第二轴向段的一部分之间，该一部分延伸第二轴向长度至前向边缘。
在一个实施方式中，用于内窥镜的盖包括耦合部分和罩部分。耦合部分配置为耦合至内窥镜的插入管，其具有从其可延伸的刀。罩部分从耦合部分轴向地延伸至前向边缘。罩部分限定了具有轴线的通道和横向于所述轴线延伸穿过所述通道的横向凹口。
横向凹口可以是在前向边缘的轴向前向的区域，以及在延伸穿过通道并且在前向边缘的相对侧与前向边缘相交的平面的轴向后向的区域。
附图说明
当结合附图阅读时，根据以下详细描述可以最好地理解本公开。要强调的是，根据惯例，附图的各个特征未按比例绘制。相反，为了清楚起见，各种特征的尺寸被任意地扩大或缩小。
图1是在经口的内窥镜肌切开术的过程中插入粘膜下层的内窥镜的示意图。
图2是沿着图1的线2-2的剖视图。
图3是具有盖的第一实施例的内窥镜的上部正透视图。
图4是具有以淡化方式示出的盖的内窥镜的上部正透视图。
图5是具有图1的盖的内窥镜的俯视图。
图6是具有图1的盖的内窥镜的左视图。
图7是以淡化方式示出的内窥镜的盖的正视图。
图8是以淡化方式示出的内窥镜的盖的左视图。
图9是以淡化方式示出的内窥镜的盖的俯视图。
图10是标有各种尺寸的如图7所示的盖的正视图。
图11是标有各种尺寸的如图8所示的盖的左视图。
图12是标有各种尺寸的如图9所示的盖的俯视图。
图13是具有盖的第二实施例的内窥镜的上部正透视图。
图14是具有盖的第三实施例的内窥镜的上部正透视图。
图15是盖的第四实施例的正视图。
图16是图15的盖的第四实施例的左视图。
图17是图15的盖的第四实施例的俯视图。
图18是盖的第五实施例的俯视图。
图19是具有执行POEM的图3至图18所示的盖的内窥镜的详细示意图。
具体实施方式
本文公开了用于执行POEM的内窥镜系统、组件和手术过程。尽管具体参照POEM进行了披露，但应该容易理解，本文所述的内窥镜系统和组件也可以用于其他手术过程，例如其他内窥镜黏膜下剥离术(endoscopic submucosal dissection，也可以称为“ESD”)或其他内窥镜胃肠手术。该内窥镜系统和组件，更具体地，包括具有刀、一个或多个水源、摄像头和附件的内窥镜。该附件在本文中称为盖，其包括延伸的侧面，该侧面在POEM或其他手术过程中，可使得更高效和/或有效地切割组织，例如食管下括约肌的粘膜下层和肌肉纤维。
参考图1和图2，示出了在POEM手术过程期间具有内窥镜110插入其中的食管100的示意图。食管100从咽部(未标记)延伸至胃102。食管括约肌104位于食管100的底部，与胃102相邻。如图2的剖面图所示，食管100通常包括粘膜100a、粘膜下层100b和固有肌层100c。粘膜100a是食管100的最内层。粘膜下层100b是位于粘膜100a与固有肌层100c之间的组织的中间层。固有肌层(muscularis propria)100c，也可以称为“MP”，位于粘膜下层100b的外侧并与其相邻。固有肌层100c是提供移动性以使食物通过食管100向下运动到胃102的肌肉。如上所指的食管下括约肌104包括肌肉组织，并且位于食管100的下端，与胃102相邻。
另外参考图3至图6，内窥镜110通常包括具有远端114的插入管112。如图所示，插入管112可以是大致圆柱形的并且终止于远端114。插入管112包括一个或多个通道(未示出)，所述通道穿过所述插入管延伸至远端114中的一个或多个喷嘴114a，所述喷嘴114a供应“水”(包括其他流体溶液，例如，盐水)和“空气”(包括其他气体，例如，二氧化碳)。插入管112还包括专用通道(未示出)，所述专用通道穿过所述插入管延伸至远端114 中的出口114b，所述专用通道供应吸力并容纳器械的插入。出口114b为诸如刀116等器械提供了从内窥镜110的远端114延伸的出口，以与患者的组织接合。当出口114b中插入器械时，插入的器械不会偏离114b的轴线中心。如图所示，出口114b可朝着远端114的一侧偏置，例如，其位置相对于远端114的轴线114c(在图11和12中标记)偏离中心。因此，刀116同样地偏向内窥镜110的远端114的一侧，例如偏离轴线114c中心。如图所示，出口114b以及刀116可以在径向上位于轴线114c与(例如，插入管112的)远端114的外周之间。
内窥镜110的远端114也可以包括一个或多个导光透镜(未示出)和物镜(未示出)。光源通过所述一个或多个导光透镜发光以在插入管112的远端114的前方提供照明。例如，插入管112可以包括光纤(例如，玻璃纤维)或延伸穿过所述插入管的其他装置(未示出)，所述其他装置出于照明目的将光从光源转移到导光透镜。插入管可以进一步包括其他光纤或穿过所述插入管延伸的其他光学传输装置(未示出)，所述其他光学传输装置出于成像目的将光从物镜转移到摄像头。
内窥镜110也容纳通过出口114b插入的刀116，例如专门用于POEM和内窥镜黏膜下剥离术的手术用电刀。刀116包括具有电极的尖端(未示出)，该尖端可以是任何合适的形状(例如球形、三角形、钩形)，可以是绝缘的或非绝缘的，和/或可以提供流体注射。当用于流体注射时，刀116可以是喷嘴114a的附加流体源。
尽管未示出，但是内窥镜110或包括内窥镜110的内窥镜系统也可以被认为包括上述各种流体和光源(例如，水、空气、抽吸力和/或光)、摄像头、器械(例如，刀116)和/或其操作控件。
另外参考图7至图12，内窥镜110或包括内窥镜110的内窥镜系统还包括盖120。盖120是耦合至内窥镜110的远端114并且用于挤压组织或以其他方便查看和切割组织的方式与组织接合的附件。如上文所涉及且在下文中进一步论述的，盖120包括延伸侧面(例如，延伸端、轴向延伸突出部分、凸缘部分或尖端)。盖120也可以被称为附件、远端附件或罩。
盖120是管状的并且通常包括近端部分122和耦合至近端部分122并从近端部分122轴向向前延伸的远端部分130(例如，平行于或大致平行于轴线114c)。管状的盖120使得水、空气、组织、光和/或诸如刀116之类的器械穿过其中到达和/或远离内窥镜110的插入管112的远端114。盖120在后向边缘122a(近端部分122终止于此)和前向边缘130a(远端部分130终止于此)之间轴向延伸。如图11至图12所示，盖120可以具有从 后向边缘122a的最后向部分至前向边缘130a的最前向部分轴向(即，大致平行于插入管112和/或盖120的轴线114c)测得的长度L_盖。盖120的长度L_盖可以是大约10mm至40mm，例如15mm至30mm(例如，15mm至20mm、20mm至25mm或25mm至30mm)，或另外合适的距离。如下文更详细地讨论的，盖120的轴向长度L_盖包括近端部分122的长度L_近端和远端部分130的长度L_远端并且可以等于它们的和。
近端部分122配置为耦合至插入管112的远端114。例如，近端部分122可以是大致管状的，并且用于在其中接收内窥镜110的插入管112的远端114。盖120的近端部分122可以通过摩擦配合(例如，盖120的近端部分的内表面摩擦地接合和/或压紧内窥镜110的远端114)或胶带中的一个或多个将内窥镜110的插入管112进行保持。在一个实施例中，盖120的后向边缘122a包含具有可去除的非粘性涂层的胶带。在将盖120安装到插入管112上的过程中，胶带被向后折叠到后向边缘122a上。胶带通过剥离非粘性涂层以暴露胶带的粘性表面，来被固定到插入管112的表面。近端部分122也可以使得盖120能够以用户可以确定的一种或多种方向耦合至内窥镜110，例如，以使盖120的延伸侧相对于刀116定向(例如，最接近或最远离刀116)。近端部分122也可以被称为耦合部分。盖120的延伸侧相对于刀116的期望定位由在盖120的延伸侧的中点处的陡峭的凹口或印刷标记来确定，该陡峭的凹口或印刷标记在内窥镜成像中从外部或内部可见。
大致为管状的近端部分122包括外表面和内表面，其厚度在其间延伸。在一个示例中，外表面和内表面是圆柱形的并且是同轴的，使得厚度在围绕近端部分122的周向上以及在沿着近端部分122轴向上均是恒定的。内表面具有使得内窥镜110的远端114被接收在其中的直径，例如6mm至20mm(例如7mm至12mm，如大约9mm)，这取决于内窥镜110的插入管112。虽然讨论的和图示的为圆柱形，但是近端部分122(例如，内表面和/或外表面)可以具有其他形状，例如，以促使耦合至其他内窥镜110和/或耦合机构。
近端部分122的长度L_近端从盖120的后向边缘122a轴向延伸至内窥镜110的远端114(例如，与内窥镜110的插入管112耦合和/或重叠的距离)。近端部分122的长度L_近端可以在大约4mm至15mm之间，例如6mm至10mm(例如，大约8mm)。
远端部分130形成盖120的延伸侧。在使用中，盖120的远端部分130接合组织(例如，粘膜下层100b的组织)并使组织保持远离内窥镜110的远端114。这为摄像头提供了视野，同时还允许操纵所述刀116以接合和切割组织(例如，在POEM过程中，接合和切割粘膜下层100b和/或固有肌层100c，包括食管下括约肌104)。远端部分130大致上是管状的，并且限定了通道130c，水、空气、抽吸力和/或光穿过通道130c到达和/或远离内 窥镜110的远端114。刀116也通过通道130c延伸和缩回以切割组织。远端部分130也可以称为罩部分。
远端部分130的长度L_远端从近端部分122(例如，从内窥镜110的远端114)轴向延伸至远端部分130的轴向距离内窥镜110最远的前向边缘130a。远端部分130的轴向长度L_远端可以具有下述轴向长度L_远端：例如大约5mm至25mm，例如10mm至20mm(例如，大约15mm)，或例如5mm至15mm(例如，大约8mm至10mm)。如以下将进一步详细讨论的，轴向长度L_远端可以包括第一轴向段132的轴向长度L_短和第二轴向段134的轴向长度L_长并且等于它们的总和。长度L_短也可以被称为第一轴向长度，长度L_长也可以被称为第二轴向长度。
盖120的远端部分130通过从近端部分122(例如，从内窥镜110的远端114)轴向向前延伸不同的距离至前向边缘130a而形成延伸侧。更具体地，如以下将进一步详细讨论的，远端部分130包括第一轴向段132和第二轴向段134，第二轴向段134从近端部分122比第一轴向段132更远地轴向延伸至前向边缘130a，从而形成延伸侧。此外，如以下进一步详细讨论的，前向边缘130a可以向前延伸不同的距离，以限定横向凹口136，所述横向凹口136横向于通道130c(例如，横向于盖120的轴线114c)在整个前向边缘130a延伸，并且刀116可以插入所述横向凹口136中以切割组织。例如，在侧视图中，如图6、图8和图11所示的视图，可选地，前向边缘130a在第一轴向段132和第二轴向段134之间是凹的。
盖120的远端部分130的第一轴向段132包括前向边缘130a的沿轴向方向(例如，平行于轴线114c)测量的最接近近端部分122和/或内窥镜110的远端114(参见图11和12)的点或部分。
盖120的第一轴向段132可以围绕轴线114c大致连续地(例如，完全地)延伸以形成通道130c。盖120的第一轴向段132从而限定了盖120(例如，通道130c的盖)的体积，该盖可以是大致圆柱形的或具有另外合适的形状。例如，第一轴向段132以及由此的通道130c可以具有6mm至12mm(例如8mm至10mm，诸如9mm)的内径，其可以与近端部分122的内径和/或远端114处的插入管112的外径基本相同。第一轴向段132的外表面的直径可以为7mm至18mm，优选地为7mm至14mm(例如10mm至13mm，如12mm)。第一轴向段132可以具有0.5mm至2mm的厚度。除了圆柱形，第一轴向段132和/或由此限定的通道130c可具有任何其他合适的轴向移动形状，例如通过以恒定的(例如，直的或截头圆锥形的(frustoconical))或弯曲的方式远离近端部分122轴向移动而逐 渐增大尺寸。此外，第一轴向段132和/或通道130c的横截面(即，在固定的轴向位置)可以为圆形(如图所示)或非圆形，例如卵形、正方形或其他具有笔直段或其他合适的形状。
第一轴向段132的长度L_短是在轴向上测量的从盖120的近端部分122和/或内窥镜110的远端114到上述盖120的前向边缘130a的最接近近端部分122的点或部分的距离。第一轴向段132也可以被称为短段。第一轴向段132的长度L_短可以为例如2mm至15mm，如4mm至10mm(例如5mm)。在第一轴向段132上的前向边缘130a上最接近刀116的伸出孔的位置可以具有标记，该标记可以为陡峭的凹口或印刷标记，用于在安装盖120时进行参照。标记可以为单独且陡峭的凹口，例如跨度小于2mm，或1mm或小于5、3、2或1度，例如形成对准槽130b的凹口，可以不认为是限定了第一轴向段132的轴向长度L_短。标记可以确保安装后，刀116位于第二轴向段134的延伸部分的对侧，从而刀116可以最大程度地暴露在凹口中，便于手术操作。
尽管前向边缘130a中有任何单独且陡峭的凹口，但前向边缘130a可以在第一轴向段132的周向跨度S_短上延伸等于长度L_短的恒定轴向距离。可以通过围绕轴线114c的角度测量来定义周向跨度S_短。例如，前向边缘130a的周向跨度S_短可以是0至270度，如0至180度，30至150度(例如75至105度)或90至270度(例如130至220度)。替代地，可以以线性尺寸测量周向跨度S_短，例如为0mm至10mm(例如4mm至8mm)。或者，前向边缘130a从具有长度L_短的奇点沿其周向地向第二轴向段134移动时，前向边缘130a的轴向长度可以逐渐增加。周向跨度S_短也可以称为第一周向跨度。
盖120的远端部分130的第二轴向段134相对于第一轴向段132轴向向前突出。第二轴向段134包括前向边缘130a的在轴向方向测量的从内窥镜110的近端部分122和/或远端114起延伸得最远的部分或点。
盖120的第二轴向段134形成延伸侧，例如，通过不完全围绕通道130c沿周向延伸。第二轴向段134可以一部分是圆柱形，例如，具有与第一轴向段132相同的内半径和/或外半径，或者更大的尺寸。替代地，第二轴向段134可以具有另一种合适的形状，例如，以恒定或弯曲的方式轴向移动来增大和/或减小。此外，第二轴向段134可一部分具有圆形的(如图所示)或非圆形的横截面(即，在固定的轴向位置)，例如一部分为卵形、正方形或其他具有直段的形状，或其他合适的形状(参见，例如，图15至图17)。如图所示，盖120的远端部分130可以关于延伸穿过插入管112和/或盖120的轴线114c的平面对称，或者可以是不对称的。第二轴向段134的周向尺寸在下面将进一步详细讨论。
第二轴向段134的前向边缘130a上的点或部分具有长度L_长(即，前向边缘130a的最大轴向长度)，可以被称为伸长侧、第一侧或长侧，位于第一轴向段132的前向边缘130a上的长度为L_短(即，前向边缘130a的最小轴向长度)可以称为第二侧或短侧的点或部分的对面。例如，伸长侧可以与短侧位置径向相对(例如，轴线114c位于其间)。
第二轴向段134的长度L_长是在轴向上测量的从第一轴向段132的前向边缘130a到距第一轴向段132最远的前向边缘130a的上述点或部分的距离。第二轴向段134的长度L_长可以是2mm至15mm，如3mm至10mm(例如，大约3mm至5mm)或7mm至15mm(例如，大约9mm至11mm)。优选地，第二轴向段134的长度L_长优选地是不超过10mm，更优地是2mm至5mm。替代或除了以绝对术语定义之外，可以相对于盖120和/或内窥镜110的另一部分的大小或尺寸来定义远端部分130的长度L_远和/或第二轴向段134的长度L_长。例如，第二轴向段134的长度L_长可以是通道130c和/或第一轴向段132的外表面的直径或其他横向尺寸的0.25倍至1.5倍之间(例如，0.25至0.75倍(如0.4至0.6倍)或0.75至1.5倍(如0.9至1.1倍))。
前向边缘130a可以在第二轴向段134的周向跨度S_长上延伸等于长度L_长的恒定轴向距离。周向跨度S_长可以通过围绕远端部分130的轴线114c的角度测量来定义。例如，第二轴向段134上前向边缘130a的周向跨度S_长可以是0至180度，例如45至180度(例如60至120度，如75至105度)或5至90度(例如5至45度，如5至20度)。替代地，前向边缘130a从具有长度L_长的奇点沿其周向地向第一轴向段132移动时，轴向长度可以逐渐减小。周向跨度S_长也可以称为第二周向跨度。
盖120的替代实施例在图13和图14中示出，两张图均示出了盖120的第二轴向段134的长度L_长比图3至图13中示出的长度L_长更长。图13还示出了盖120的第二轴向段134的周向跨度S_长小于图3至图12所示的周向跨度S_长。盖120的又一实施例在图15至图17中示出，其中远端部分130具有非圆形的横截面形状。更具体地，第二轴向段134从第一轴向段132的圆形横截面形状轴向移动过渡至具有平坦侧(例如，如图16和图17所示的底侧)，例如是如图所示的平面形的。
前向边缘130a的长度可以围绕前向边缘130a沿周向移动逐渐变化，例如，以避免尖锐的外部拐角，否则其可能会戳破、抓住或磨损组织。例如，如图所示，第二轴向段134可以包括从最大轴向长度L_长周向移动过渡的圆角。
如上所述，盖120的第二轴向段134，例如通过不完全围绕通道130c和/或轴线114c周向地延伸，形成延伸侧。更确切地说，在第二轴向段134的轴向长度L_长上，第二轴向 段134可以围绕轴线114c以变化的量周向地延伸至前向边缘130a，例如，围绕轴线114c周向距离逐渐减小，轴向移动远离第一轴向段132(例如，远离插入管112的远端114)。例如，在第二轴向段134的长度L_长上，第二轴向段134可以绕轴线114c周向地延伸小于360度，优选地平均小于180度(例如，平均小于135度)。替代地或另外地，在第二轴向段134的长度L_长的大部分(例如，大于50％、55％、60％、70％或更多)上，第二轴向段134可以围绕轴线114c周向延伸180度或小于180度。替代地或另外地，远端部分130的前向边缘130a可以是凹形的，例如，相对于平面140轴向凹陷，该平面横跨通道130c(例如，跨过轴线114c)延伸，并且相交于在第一轴向段132(即长度为L_短的短侧)和第二轴向段134上的前向边缘130a，且没有穿过盖120(如平面140所示)和/或在长度为L_长(如平面140'所示)处。例如，平面140'在远端部分130的两个相对侧与前向边缘130a相交。
在前向边缘130a相对于平面140和/或平面140'轴向凹陷的情况下，前向边缘130a可以被认为是限定了横向凹口136。横向凹口是前向边缘130a的轴向向前的区域和平面140、140'的轴向向后的区域。盖120可以在刀116可以延伸至横向凹口136中和/或穿过横向凹口136的方向上耦合至插入管112。在使用中，组织被前向边缘130a在短侧(即具有长度L_短)和长侧(即具有长度L_长)上接合并跨前向边缘130a而悬置，而刀则从前向边缘130a轴向向前延伸至横向凹口136中和/或超出横向凹口136以接合和切割组织。应当注意，横向凹口136对应于刀116(例如，插入管112的远端114的出口114b)的纵向位置(例如，如图7、8、10和11所示的垂直位置)。
远端部分130优选地由透明材料形成，例如聚氯乙烯(polyvinylchloride，PVC)、聚乙烯、苯乙烯、聚碳酸酯、丙烯酸(acrylic)、热塑性弹性体或其他透明和/或无色材料。在一些实施例中，形成远端部分130的材料是可弹性变形的，使得远端部分130可以在耦合至内窥镜110和/或插入患者体内时，在更高的负载事件下弹性挠曲或变形。远端部分130优选地形成为单个的(例如，一体的)整体组件。远端部分130可以进一步形成有作为单个的(例如，一体的)整体组件的近端部分122，在相同操作期间，远端部分130和近端部分122由相同材料形成。替代地，近端部分122可以形成为单独的组件和/或由不同的材料形成并且耦合至远端部分130。
盖120还可以包括一个或多个排放孔142，其被配置为被盖120捕获的例如在通道130c中待逃逸的水或空气的出口。如图所示，排放孔142设置在第一轴向段132中，距内窥镜附件的近端部分122和/或内窥镜的远端114的距离小于盖120的远端130的第一轴 向段132的长度L_短。排放孔142也可以部分设置在第一轴向段132中，例如，设置在第一轴向段132与近端部分122的交界部分。如图所示，盖120可以包括多个排放孔142。如图所示，盖120可以包括多个排放孔142，它们例如，具有共同的轴向位置和/或位置穿过通道130c，例如彼此间隔180度。此外，在两个排放孔142的情况下，排放孔142可位于伸长侧的两相对侧，和/或其上的长度为L_长的点或部分上。在替代的配置中，如图18所示，盖120可以包括在延伸侧中(例如，在第二轴向段134中)和/或与延伸侧周向对准的一个或多个排放孔142。通过使排放孔142移动远离第一轴向段132和第二轴向段134之间的过渡区域，可以帮助减少应力集中和潜在的故障点，例如，当盖120安装在内窥镜110上时，防止盖120从前向边缘到排放口142撕裂。排放孔142的直径可以例如为0.5mm至4mm(例如，大约3mm)。
参考图19，示出了在POEM手术中使用时的具有盖120的内窥镜110。内窥镜110的远端114(包括与其耦合的盖120)被插入在粘膜100a和固有肌层100c之间的粘膜下层100b中。盖120的前向边缘130a接合第一轴向段132和第二轴向段134上的组织，并使粘膜下层100b的组织穿过其悬置。在第一轴向段132和第二轴向段134之间延伸的粘膜下层100b的组织可以在其间保持在张力下和/或可以突出至横向凹口136中。如图所示，盖120的延伸侧可以设置在粘膜100a和刀116之间，或者替代地，可以设置在固有肌层100c和刀116之间。
然后，将刀116延伸以接合粘膜下层100b并操作以切割粘膜下层100b，例如，拉动刀116的尖端穿过粘膜下层100b以切割其组织。然后将内窥镜110进一步插入在粘膜100a和固有肌层100c之间以悬置穿过其的粘膜下层100b的不同组织，并且再次延伸刀116以接合粘膜下层100b并操作以切割粘膜下层100b。
在组织的切割与内窥镜110的进一步插入之间，刀116可以在前向边缘130a的后面缩回(例如，从横向凹口136中移出)。重复切割和进一步插入内窥镜110的过程，直到到达食管下括约肌104，在此点执行食管下括约肌104的肌肉组织的肌切开术(即，切除)。
在该过程中，流体溶液可以通过喷嘴114a或刀116的尖端中的一个或两个注入，这可以起到分离组织、清除任何疏松组织，清除或防止烟雾(否则可能妨碍穿过内窥镜110的视野)并且实现“水下”成像的作用。
尽管已经结合某些实施例描述了本公开，但是应当理解，本公开不限于所公开的实施例，相反，其旨在覆盖所附权利要求的范围内包括的各种修改和等同布置，该范围应被赋予最宽泛的解释，以涵盖法律允许的所有此类修改和等同结构。

Claims (25)

  1. 一种内窥镜的附件，包括：
    近端部分，其配置为耦合至所述内窥镜的插入管；以及
    远端部分，耦合至所述近端部分并从所述近端部分轴向延伸至前向边缘，所述远端部分包括从所述近端部分轴向向前延伸的第二轴向段；
    其中，所述第二轴向段从所述近端部分向所述前向边缘延伸第二轴向长度，并且在大部分的所述第二轴向长度上，所述第二轴向段绕轴线周向延伸360度或更小角度。
  2. 根据权利要求1所述的附件，其中，在所述近端部分和所述第二轴向段之间还包括第一轴向段，所述第一轴向段从所述近端部分向所述前向边缘延伸第一轴向长度，所述第二轴向段从所述第一轴向段向所述前向边缘延伸第二轴向长度；
    其中，在所述第一轴向长度上，所述第一轴向段限定通道，并且所述第一轴向段完全围绕所述通道的轴线周向地延伸。
  3. 根据权利要求2所述的附件，其中，在所述第二轴向长度上，所述第二轴向段绕所述轴线周向地延伸平均小于180度。
  4. 根据权利要求1-3中任一项所述的附件，其中，所述前向边缘是凹形的。
  5. 根据权利要求4所述的附件，其中，所述前向边缘相对于一平面轴向凹陷，所述平面横向延伸跨过所述通道并且与所述前向边缘在所述第一轴向长度处的所述第一轴向段上和所述第二轴向段上均相交。
  6. 根据权利要求5所述的附件，其中，所述平面在所述第二轴向长度处与所述前向边缘相交。
  7. 根据权利要求1-6中任一项所述的附件，其中，所述前向边缘在围绕所述轴线的0度至180度的第一周向跨度上延伸所述第一轴向长度。
  8. 根据权利要求7所述的附件，其中，所述前向边缘在围绕所述轴线的30度至150度的第一周向跨度上延伸所述第一轴向长度。
  9. 根据权利要求1-8中任一项所述的附件，其中，所述前向边缘在围绕所述轴线的0度至180度的第二周向跨度上延伸所述第二轴向长度。
  10. 根据权利要求9所述的附件，其中，所述前向边缘在围绕所述轴线的5度至90度的第二周向跨度上延伸所述第二轴向长度。
  11. 根据权利要求1-10中任一项所述的附件，其中，所述第二轴向长度是2mm至15mm。
  12. 根据权利要求11所述的附件，其中，所述第二轴向长度是小于或等于10mm。
  13. 根据权利要求12所述的附件，其中，所述第二轴向长度是2mm至5mm。
  14. 根据权利要求1-13中的任一项所述的附件，还包括排放孔，所述排放孔为一个或多个。
  15. 根据权利要求14所述的附件，其中所述一个或多个排放孔的定位在所述第一轴向段中且距所述近端部分的距离小于所述第一轴向长度，或者所述一个或多个排放孔的定位在所述近端部分与所述第一轴向段的交界处，或者所述一个或多个排放孔定位在所述第二轴向段中或与由所述第二轴向段形成的延伸侧周向对准。
  16. 根据权利要求1-15中任一项所述的附件，其中，所述第二轴向段从所述第一轴向段的圆形横截面形轴向移动过渡到平坦侧。
  17. 根据权利要求1-16中任一项所述的附件，其中，具有非粘性可移除涂层的胶带被固定到后向边缘，并且在安装到所述插入管上的过程中，所述胶带在所述后向边缘上向后折叠。
  18. 根据权利要求17所述的附件，其中，通过剥离非粘性涂层将所述胶带固定到所述插入管的表面。
  19. 一种内窥镜系统，包括：
    内窥镜，其具有插入管和能从所述插入管的远端延伸的刀；和
    根据前述权利要求中的任一项所述的附件，其在所述远端处与所述插入管耦合。
  20. 根据权利要求19所述的内窥镜系统，其中，所述轴线径向地设置在所述刀与所述第二轴向段的一部分之间，所述第二轴向段的一部分延伸所述第二轴向长度至所述前向边缘。
  21. 一种用于内窥镜的盖，包括：
    耦合部分，其配置为耦合至内窥镜的插入管，所述内窥镜具有能从所述插入管延伸的刀；以及
    罩部分，其从所述耦合部分轴向地延伸至前向边缘，所述罩部分限定了具有轴线的通道和横向于所述轴线延伸穿过所述通道的横向凹口。
  22. 根据权利要求21所述的盖，其中，所述横向凹口是所述前向边缘的轴向向前的区域，以及在延伸穿过所述通道并且在所述前向边缘的相对侧与所述前向边缘相交的平面的轴向后向的区域。
  23. 根据权利要求22所述的盖，其中，所述前向边缘相对于所述平面凹陷。
  24. 根据权利要求21-23中的任一项所述的盖，其中，所述耦合部分配置为以使得所述刀能延伸至所述横向凹口中的方向耦合至所述插入管。
  25. 根据权利要求21-24中的任一项所述的盖，其中，在包括所述前向边缘的轴 向长度上，所述罩部分围绕所述轴线周向地延伸平均小于180度。
PCT/CN2021/137253 2020-12-14 2021-12-10 用于胃肠内窥镜检查的内窥镜附件 WO2022127718A1 (zh)

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US20080275444A1 (en) * 2007-05-02 2008-11-06 Olympus Medical Systems Corp. Endoscopic treatment instrument and tissue incision method
CN102387737A (zh) * 2009-04-10 2012-03-21 住友电木株式会社 内窥镜用护罩以及装配有该内窥镜用护罩的内窥镜
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