WO2018019072A1 - 一种吻合器的缝合钉成形钉高调节机构及包括该调节机构的吻合器 - Google Patents

一种吻合器的缝合钉成形钉高调节机构及包括该调节机构的吻合器 Download PDF

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Publication number
WO2018019072A1
WO2018019072A1 PCT/CN2017/090327 CN2017090327W WO2018019072A1 WO 2018019072 A1 WO2018019072 A1 WO 2018019072A1 CN 2017090327 W CN2017090327 W CN 2017090327W WO 2018019072 A1 WO2018019072 A1 WO 2018019072A1
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WO
WIPO (PCT)
Prior art keywords
staple
height
nail
cartridge
forming
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2017/090327
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English (en)
French (fr)
Inventor
聂红林
杨光
张析量
石秀凤
李安华
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SHANGHAI YISI MEDICAL TECHNOLOGY Co Ltd
Yisi Suzhou Medical Technology Co Ltd
Original Assignee
SHANGHAI YISI MEDICAL TECHNOLOGY Co Ltd
Yisi Suzhou Medical Technology Co Ltd
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Application filed by SHANGHAI YISI MEDICAL TECHNOLOGY Co Ltd, Yisi Suzhou Medical Technology Co Ltd filed Critical SHANGHAI YISI MEDICAL TECHNOLOGY Co Ltd
Priority to BR112019001587-6A priority Critical patent/BR112019001587A2/pt
Priority to EP17833375.3A priority patent/EP3492022A4/en
Priority to JP2019504760A priority patent/JP2019523070A/ja
Priority to US16/320,319 priority patent/US11540828B2/en
Publication of WO2018019072A1 publication Critical patent/WO2018019072A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/0725—Stapler heads with settable gap between anvil and cartridge, e.g. for different staple heights at different shots
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07257—Stapler heads characterised by its anvil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07271—Stapler heads characterised by its cartridge
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07278—Stapler heads characterised by its sled or its staple holder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07285—Stapler heads characterised by its cutter

Definitions

  • the present application relates to a surgical instrument, and in particular to a staple forming nail height adjusting mechanism applied to an open stapler and a stapler including the same.
  • surgical staplers are more and more widely used in clinical operations, including linear staplers and ring staplers.
  • the surgical stapler generally works by closing the two interlocking handle assemblies (usually one handle with the pedestal assembly and the other handle with the staple cartridge assembly) to hold the tissue and then the staples in the cartridge assembly. Introduce the shape and stitch the tissue together.
  • a cutting knife is also provided, and the rows of staples are inserted into the body tissue while cutting the tissue between the rows of staples to cut the stitched tissue.
  • a surgical stapler having the above functions includes a first handle portion and a second handle portion.
  • the first handle portion includes a detachable cartridge assembly, a locking rod, and a drive assembly, wherein the cartridge assembly generally includes a staple cartridge, a plurality of staples, and a plurality of pusher blocks, the upper surface of the staple cartridge being a tissue contacting surface, the tissue contacting surface There are multiple rows of holes, and the holes are pre-installed in the holes.
  • the second handle portion includes an abutment seat that includes a staple forming surface having a plurality of rows of staple forming grooves. The first handle portion and the second handle portion can be coupled together and locked by a locking lever located at the first handle portion to close the tissue requiring suturing.
  • the drive assembly in the first handle includes a wedge-shaped pusher that pushes the pusher block when the drive assembly is moved distally from the proximal end of the stapler, thereby causing the staple in the staple cartridge to be pushed out of the staple cartridge
  • the hole penetrates the closed tissue and reaches the nail forming groove on the forming surface of the nail holder, and is extruded into a "B" shape.
  • the drive assembly also includes a cutting knife for cutting tissue between the rows of staple lines after the tissue is stitched by the staples.
  • the staple height after the stapler multi-row staple is formed is fixed and unadjustable.
  • the nail height after the staple is formed is too high, the bleeding of the suture may be caused, which may endanger the safety of the patient; If the nail height after the nail is formed is too low, the tissue at the cutting edge will be necrotic due to ischemia, which will cause the staple to fall off and an anastomotic leakage occurs.
  • the present application provides a novel stapler staple height adjusting mechanism, such that the stapler including the staple forming nail height adjusting mechanism can adjust the stapler for different characteristics of the tissue.
  • the staples of the staples are high, thereby improving the formation rate of the staples, reducing the incidence of suture bleeding, anastomotic leakage and the like.
  • the present invention adopts the following technical solutions:
  • a surgical stapler includes a first handle portion and a second handle portion; the first handle portion includes a staple cartridge holder at a distal end, a cartridge assembly, a drive assembly, the staple cartridge assembly including a staple, The drive assembly can drive the staple away from the cartridge assembly to the abutment to be extruded; the second handle portion includes a distal abutment; the stapler further includes an adjustment mechanism, the adjustment structure The distance between the drive assembly and the anvil is adjusted to adjust the formed staple height of the staple of the stapler.
  • the cartridge assembly is detachable from the cartridge holder.
  • the cartridge assembly also includes a staple cartridge and a pusher block disposed corresponding to the staple.
  • first handle portion further includes a locking lever located in the middle, and the distal ends of the first handle portion and the second handle portion are locked by the locking lever.
  • the abutment seat is provided with a nail groove piece, and the nail groove piece comprises a nail forming surface.
  • the driving component comprises a push button, a pusher connected to the push button and a wedge-shaped distal end, and the push button pushes the push piece, and the distal wedge-shaped push piece drives the push block to move in the direction of the abutment one by one.
  • the pusher block pushes the staples out of the staple cartridge holes, penetrates the tissue closed by the first handle portion and the second handle portion, reaches the staple forming groove on the nail forming surface of the abutment seat, and is extruded into "B. "Glyph.”
  • the adjusting mechanism is disposed at the bottom of the staple cartridge, and includes a staple cartridge gasket and an adjusting gasket.
  • the upper surface of the cartridge holder gasket is matched with the bottom surface of the push piece, and the adjusting gasket is disposed under the nail cartridge gasket.
  • the bottom surface of the adjusting washer is matched with the upper surface of the bottom of the nail holder.
  • the adjusting pad is kept unchanged in the vertical direction, and the horizontal direction can be moved left and right.
  • the pin holder spacer is kept unchanged in the horizontal direction and can be moved up and down in the vertical direction.
  • the lower surface of the cartridge holder gasket includes one or more first height adjustment regions, and each of the first height adjustment regions includes at least two step surfaces having unequal heights.
  • each of the second height adjusting regions includes at least one step. surface.
  • the lower surface of the cartridge holder pad includes two first height adjustment zones
  • the upper surface of the adjustment pad includes two second height adjustment zones, the two second height adjustment zones The distance between them is the same as the distance between the two first height adjustment zones.
  • each of the first height adjustment regions includes three unequal step surfaces, which are a first step surface, a second step surface, and a third step surface, wherein the first step surface is the highest, that is, the staple chamber
  • the width of the seat gasket is the smallest at the first step surface
  • the third step surface is the lowest, that is, the width of the nail holder gasket at the third step surface is the largest, and the height of the second step surface and the cartridge holder gasket are at the second.
  • the width of the step surface is centered.
  • the height of the cartridge holder gasket is the lowest in the vertical direction, and the height of the pusher sheet located above it is also the lowest, and the pushing sheet is The distance between the nail seats is the largest. Pushing the pusher block under the action of the driving component causes the staple in the nail hole to be pushed out of the staple cartridge, and the distance between the beam of the staple and the nail forming surface of the nail groove of the second handle portion is the largest, and the staple is The height H1 is also the highest after forming. In this case, it is suitable to match the thicker tissue.
  • the height of the cartridge holder gasket rises in the vertical direction, and the height of the pusher sheet located above it is also raised, correspondingly The distance between the pusher and the anvil is increased.
  • Pushing the pusher block under the action of the driving component causes the staple in the nail hole to be pushed out of the staple cartridge, and the distance between the beam of the staple and the forming surface of the nail on the second handle portion is shortened, resulting in the staple
  • the height H2 after forming is lowered, that is, H2 ⁇ H1. In this case, it is suitable for anastomosis of a tissue of moderate thickness.
  • the height of the cartridge holder gasket is the highest in the vertical direction, and the height of the pusher sheet above the nail cartridge is also the highest.
  • the distance between the anvils is minimal. Pushing the pusher block under the action of the driving component causes the staple in the nail hole to be pushed out of the staple cartridge. At this time, the distance between the beam of the staple and the forming surface of the nail on the second handle portion is the smallest, and the forming height of the staple is formed.
  • H3 is further reduced, that is, H3 ⁇ H2 ⁇ H1. In this case, it is suitable to match the thinner tissue.
  • the stapler includes a plurality of rows of staples, respectively correspondingly including the plurality of rows of staples Set multiple rows of push nail blocks.
  • the driving assembly includes a push piece that simultaneously pushes the plurality of rows of push blocks while pushing, thereby pushing the plurality of rows of staples.
  • the stapler includes a plurality of rows of staples, and correspondingly includes a plurality of rows of pusher blocks disposed corresponding to the plurality of rows of staples.
  • the driving assembly includes a plurality of push pieces, each of which corresponds to a row of push nail blocks, which pushes a row of push nail blocks corresponding thereto when pushing, thereby pushing a row of the staples corresponding thereto.
  • the drive assembly further includes a cutting blade for cutting tissue in the middle of the plurality of rows of staple lines.
  • the drive assembly includes two pushers that are disposed between two pushers.
  • the cutting blade is disposed at the proximal end of the two pushers so that when the push button is pushed distally, the tissue is cut after the staple is stitched.
  • a stapler comprising the above-described staple forming nail height adjusting mechanism.
  • the present application can adjust the forming height of the staple of the stapler to improve the formation rate of the staple, reduce the bleeding of the suture, and the anastomotic leakage. It can achieve an efficient match to all human tissues.
  • FIG. 1 is a side view of a surgical stapler in accordance with an embodiment of the present application, wherein the first handle and the second handle are in a disengaged state.
  • FIG. 2 is an exploded perspective view of the distal end of the surgical stapler of FIG. 1.
  • FIG. 3 is a side elevational view of the staple cartridge spacer of the surgical stapler of FIG. 1 with the distal end portion A of the cartridge holder gasket enlarged.
  • Figure 4 is a side elevational view of the adjustment pad of the surgical stapler of Figure 1 with the distal end portion B of the adjustment pad enlarged.
  • Figure 5 is a partially enlarged schematic view of the distal end of the surgical stapler shown in Figure 1, wherein the pusher pushes the pusher block to push the staples out of the staple cartridge holes, and the staples reach the staple forming grooves on the forming surface of the stapled staples. Medium, extruded into a "B" shape.
  • FIG. 6 is a side elevational view of the staple cartridge gasket and the adjustment gasket of the surgical stapler of FIG. 1 with the stepped surface of the adjustment gasket mated with the first stepped surface of the cartridge holder gasket.
  • Figure 7 is a front elevational view of the distal end of the surgical stapler of Figure 1, wherein the staple cartridge spacer and the adjustment pad are in the engaged state shown in Figure 6, i.e., the stepped surface of the adjustment pad and the cartridge holder The first step surface fits.
  • Figure 8 is a side elevational view of the staple cartridge spacer and adjustment pad of the surgical stapler of Figure 1 with the stepped surface of the adjustment pad mated with the second stepped surface of the cartridge holder.
  • Figure 9 is a front elevational view of the distal end of the surgical stapler of Figure 1, wherein the staple cartridge spacer and the adjustment pad are in the engaged state shown in Figure 8, i.e., the stepped surface of the adjustment pad and the cartridge holder The second step surface fits.
  • Figure 10 is a side elevational view of the staple cartridge spacer and adjustment pad of the surgical stapler of Figure 1 with the stepped surface of the adjustment pad mated with the third stepped surface of the cartridge holder.
  • Figure 11 is a front elevational view of the distal end of the surgical stapler of Figure 1, wherein the staple cartridge spacer and the adjustment pad are in the engaged state shown in Figure 10, i.e., the stepped surface of the adjustment pad and the cartridge holder The third step surface fits.
  • FIG. 1 there is shown a side view of a surgical stapler in accordance with one embodiment of the present application, with the first handle and the second handle being in a disengaged state for clarity.
  • a surgical stapler according to an embodiment of the present application including the first The handle portion 1, the second handle portion 2, the first handle portion 1 and the second handle portion 2 can be assembled together, as shown in Fig. 1, the middle of the second handle portion 2 is provided with a rotating shaft 23, the first handle portion 1 The corresponding portion is provided with a groove into which the rotating shaft 23 is fitted and pivotable in the groove, so that the distal ends of the first handle portion 1 and the second handle portion 2 can be opened or closed.
  • the first handle portion 1 includes a staple cartridge holder 12 at the distal end, a cartridge assembly, a locking lever 13 in the middle, a drive assembly, and an adjustment mechanism;
  • the second handle portion 2 includes an abutment seat 21, specifically see FIG.
  • the nail base 21 has a nail groove piece 211, and the nail groove piece 211 includes a nail forming surface. The distal ends of the first handle portion 1 and the second handle portion 2 are locked by the locking lever 13 on the first handle portion 1.
  • the cartridge assembly can be detached from the cartridge holder 12.
  • the cartridge assembly specifically includes a staple cartridge 11, a plurality of pusher blocks 16, and a plurality of staples 3 disposed corresponding to the pusher blocks 16.
  • the driving assembly specifically includes a push button 14, a pusher 15 connected to the push button 14 and having a wedge-shaped distal end, the push button 14 is horizontally pushed to push the pusher 15, and the distal wedge-shaped pusher 15
  • the pusher block 16 is driven one by one to move in the direction of the abutment 21, and the pusher block 16 pushes the staple 3 out of the staple cartridge hole, penetrates the tissue closed by the first handle portion 1 and the second handle portion 2, and reaches the ground.
  • the nail forming groove on the nail forming surface of the nail holder 21 is extruded into a "B" shape.
  • the distance between the pusher 15 and the abutment 21 determines the height of the staples after the staples 3 are formed. The closer the pusher 15 is to the abutment 21, the smaller the staple height after the staples 3 are formed. vice versa.
  • the drive assembly further includes a cutting blade (not shown in the drawings) for cutting tissue in the middle of the plurality of rows of staple lines.
  • a cutting can be provided between the two pushers 15. The knife, the cutting knife is disposed at the proximal end of the two pushers 15, so that when the push button 14 is pushed distally, the tissue is cut after the staples 3 are stitched.
  • the adjustment mechanism is placed at the bottom of the staple cartridge 11 and includes a staple cartridge spacer 121 and an adjustment spacer 122.
  • the upper surface of the cartridge holder 121 is engaged with the bottom surface of the pusher sheet 15, and the adjustment spacer 122 is disposed below the cartridge holder 121.
  • the bottom surface of the adjustment spacer 122 is matched with the upper surface of the bottom of the cartridge holder 12.
  • the lower surface of the staple cartridge spacer 121 includes one or more first height adjustment zones, and each of the first height adjustment zones includes at least two step faces of unequal height.
  • a region corresponding to the height adjustment region on the cartridge holder 121 is disposed on an upper surface of the adjustment pad 122, and the second height adjustment region includes at least one step surface 1221.
  • the lower surface of the cartridge holder 121 includes two first height adjustment zones, each of which includes three unequal heights.
  • the step faces are respectively a first stepped surface 1211, a second stepped surface 1212, and a third stepped surface 1213, wherein the first stepped surface 1211 is the highest, that is, the width of the staple cartridge spacer 121 at the first stepped surface 1211 is the smallest.
  • the third stepped surface 1213 is the lowest, that is, the width of the staple cartridge spacer 121 at the third stepped surface 1213 is the largest, and the height of the second stepped surface 1212 and the width of the staple cartridge spacer 121 at the second stepped surface 1212 are both centered. .
  • the upper surface of the adjustment pad 122 includes two second height adjustment zones, and the distance between the two second height adjustment zones is The distance between the two first height adjustment zones is the same.
  • Each of the second height adjustment zones includes a stepped surface 1221.
  • the adjusting spacer 122 remains unchanged in the vertical direction, and the horizontal direction can be moved left and right.
  • the staple cartridge spacer 121 remains unchanged in the horizontal direction and can be moved up and down in the vertical direction.
  • the adjusting washer 122 is moved left and right in the horizontal direction such that the second height adjusting area cooperates with the first height adjusting area, that is, the step surface 1221 on the adjusting washer 122 and the three step surfaces 1211 - of the cartridge holder 121
  • One of the 1213 fits to adjust the height of the staple cartridge spacer 121 in the vertical direction, thereby adjusting the distance between the pusher 15 and the abutment 21 and thus adjusting the staple height after the staple 3 is formed.
  • FIG. 6-11 respectively show that when the stepped surface 1221 of the adjusting washer 122 is engaged with the first stepped surface 1211, the second stepped surface 1212 or the third stepped surface 1213 of the cartridge holder 121, the surgical stapler is in operation.
  • the height of the cartridge holder 121 in the vertical direction is the lowest, and the pusher is located above it.
  • the height of 15 is also the lowest, and the distance between the pusher 15 and the anvil 21 is the largest.
  • the pusher 15 pushes the pusher block 16 under the action of the drive assembly so that the staple 3 in the staple cartridge hole is pushed out of the staple cartridge 11, at this time the cross member of the staple 3 and the staple on the staple groove 211 of the second handle portion 2.
  • the distance of the forming surface is the largest, and the height H1 of the staple 3 is also the highest. In this case, it is suitable to match the thicker tissue.
  • the height of the cartridge holder 121 is the highest in the vertical direction, and the pusher is located above it.
  • the height of 15 is also the highest, and the distance between the pusher 15 and the anvil 21 is the smallest.
  • the pusher 15 pushes the pusher block 16 under the action of the drive assembly to cause the staples 3 in the staple cartridge hole to be pushed out of the staple cartridge 11, at which time the cross member of the staple 3 and the second handle portion 2 are formed on the staple groove 211.
  • the distance is the smallest, and the forming height H3 of the staple 3 is further lowered, that is, H3 ⁇ H2 ⁇ H1. In this case, it is suitable to match the thinner tissue.
  • the stapler in the example of the present application is a linear stapler, but the application is not limited to use in a linear stapler, and is equally applicable to ring and other types of staplers.
  • the embodiments in FIG. 1 to FIG. 11 are only representative embodiments of the present application, and those skilled in the art can easily understand that the scope of protection of the present application is not limited to the scope defined by the embodiments. Combinations, modifications, and variations of the various embodiments are intended to fall within the scope of the present application.

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Abstract

一种吻合器的缝合钉成形钉高调节机构，该吻合器包括第一手柄部分（1）、第二手柄部分（2），第一手柄部分（1）包括位于远端的钉仓座（12）、钉仓组件、驱动组件和该缝合钉成形钉高调节机构，第二手柄部分（2）包括位于远端的抵钉座（21）。钉仓组件包括缝合钉（3），驱动组件可将缝合钉（3）驱动离开钉仓组件，到达抵钉座（21）从而被挤压成形。该调节结构调节驱动组件与抵钉座（21）之间的距离以调节吻合器的缝合钉（3）的成形钉高。还公开了一种吻合器，其包括缝合钉成形钉高调节机构。

Description

一种吻合器的缝合钉成形钉高调节机构及包括该调节机构的吻合器 技术领域
本申请涉及一种外科器械，具体地涉及一种应用于开放式吻合器的缝合钉成形钉高调节机构以及包括该调节机构的吻合器。
背景技术
目前，外科吻合器越来越广泛地应用于临床手术中，包括直线型吻合器及环形吻合器。外科吻合器的工作原理一般为：通过二个相互配合的手柄组件(通常一个手柄含抵钉座组件，另一个手柄含钉仓组件)闭合以夹持组织，然后将钉仓组件中的缝合钉推出成形，将组织缝合在一起。在有些吻合器中，还装有一把切割刀，多排的缝合钉钉入到身体组织的同时切割这些多排缝合钉之间的组织，从而将缝合好的组织切断开。
具有上述功能的外科吻合器包括第一手柄部分和第二手柄部分。第一手柄部分包括可以拆卸的钉仓组件、锁定杆、驱动组件，其中钉仓组件一般包括钉仓、若干缝合钉、若干推钉块，钉仓的上表面为组织接触面，组织接触面上有多排孔，孔内预安装缝合钉。第二手柄部分包括抵钉座，抵钉座包含一个钉成形面，钉成形面上有多排钉成形槽。第一手柄部分和第二手柄部分可连接在一起，并通过位于第一手柄部分的锁定杆锁定，从而闭合需要缝合的组织。第一手柄中的驱动组件包含楔形的推片，当驱动组件由吻合器的近端向远端运动时，楔形的推片会推动推钉块，从而使钉仓中的缝合钉被推出钉仓孔，穿透被闭合的组织，到达抵钉座钉成形面上的钉成形槽中，挤压成“B”字形。一般情况下，驱动组件还包括一个切割刀，用于在组织被缝合钉缝合后，在多排钉线中间切割组织。
在很多技术方案中，吻合器多排缝合钉成形后的钉高是固定不可调整的。但由于人体各部分组织厚度不同，人与人之间也存在一定差异，在某些情况下，如果缝合钉成形后的钉高太高，则会引起缝合口出血，危及患者生命安全；如果缝合钉成形后的钉高太低，则会导致切割边缘的组织因缺血而坏死，进而导致缝合钉脱落，发生吻合口瘘。
因此，非常需要改进的外科吻合器，使其可调整缝合钉成形后的钉高。
申请内容
针对现有技术中的上述不足，本申请提供一种新型的吻合器的缝合钉成形钉高调节机构，使得含有该缝合钉成形钉高调节机构的吻合器，能针对不同特性的组织调节吻合器的缝合钉的成形钉高，从而提高缝合钉成形良率，降低缝合口出血、吻合口瘘等现象的发生率。
解决上述技术问题，本发明采用如下技术方案：
一种外科吻合器，包括第一手柄部分、第二手柄部分；所述第一手柄部分包括位于远端的钉仓座、钉仓组件、驱动组件，所述钉仓组件包括缝合钉，所述驱动组件可将缝合钉驱动离开钉仓组件，到达抵钉座从而被挤压成形；所述第二手柄部分包括位于远端的抵钉座；所述吻合器还包括调节机构，所述调节结构调节驱动组件与抵钉座之间的距离以调节吻合器的缝合钉的成形钉高。
在一个实施方式中，所述钉仓组件可从钉仓座上拆卸下来。所述钉仓组件还包括钉仓以及与所述缝合钉对应设置的推钉块。
进一步地，所述第一手柄部分还包括位于中间的锁定杆，所述第一手柄部分、第二手柄部分的远端闭合后可通过所述锁定杆锁定。
进一步地，所述抵钉座上设有钉槽片，所述钉槽片包含钉成形面。
进一步地，所述驱动组件包括推钮、与推钮连接并且远端为楔形的推片，推动推钮进而推动推片，远端楔形的推片逐个驱动推钉块向抵钉座的方向运动，推钉块推动缝合钉从钉仓孔内推出，穿透由第一手柄部分及第二手柄部分闭合的组织，到达抵钉座的钉成形面上的钉成形槽中，挤压成“B”字形。
所述调节机构置于钉仓底部，包括钉仓座垫片、调节垫片，所述钉仓座垫片的上表面与推片的底面配合，调节垫片置于钉仓座垫片的下方，调节垫片的底面与钉仓座底部的上表面配合。所述调节垫片在垂直方向保持不变，水平方向可以左右移动，所述钉仓座垫片在水平方向保持不变，在垂直方向上可上下移动。所述钉仓座垫片下表面包括一个或多个第一高度调节区，每个第一高度调节区至少包括两个不等高的台阶面。在水平方向上移动调节垫片，使其上表面与钉仓座垫片上的其中一个台阶面接触，从而调节钉仓座垫片的高度，进而调节位于钉仓座垫片上方的推片的高度，使得推片与抵钉座之间的距离发生变化，而推片与抵钉座之间的距离决定了缝合钉成形后的钉高，推片越靠近抵钉座，缝合钉成形后的钉高越小，反之亦然。
进一步地，调节垫片的上表面与钉仓座垫片上的第一高度调节区对应的区域设置第二高度调节区，在一个实施方式中，每个所述第二高度调节区至少包括一个台阶面。
在一个实施方式中，所述钉仓座垫片下表面包括两个第一高度调节区，所述调节垫片的上表面包括两个第二高度调节区，所述两个第二高度调节区之间的距离与所述两个第一高度调节区之间的距离相同。
在一个实施方式中，每个第一高度调节区包含三个不等高的台阶面，分别为第一台阶面、第二台阶面、第三台阶面，其中第一台阶面最高，即钉仓座垫片在第一台阶面处的宽度最小，第三台阶面最低，即钉仓座垫片在第三台阶面处的宽度最大，第二台阶面的高度及钉仓座垫片在第二台阶面处的宽度均居中。在水平方向上左右移动调节垫片，使得第二高度调节区与第一高度调节区配合，即使得调节垫片上的台阶面与钉仓座垫片的三个台阶面中的其中一个配合，从而调节钉仓座垫片在垂直方向的高度，因而调节推片与抵钉座之间的距离并因此调节缝合钉成形后的钉高。
进一步地，当调节垫片的台阶面与钉仓座垫片的第一台阶面配合时，钉仓座垫片在垂直方向的高度最低，位于其上方的推片的高度亦最低，推片与抵钉座之间的距离最大。在驱动组件的作用下推片推动推钉块使钉仓孔中的缝合钉被推出钉仓，此时缝合钉的横梁与第二手柄部分的钉槽片上的钉成形面的距离最大，缝合钉成形后高度H1也就最高。在这种情况下，适合对较厚的组织进行吻合。
进一步地，当调节垫片的台阶面与钉仓座垫片的第二台阶面配合时，钉仓座垫片在垂直方向的高度上升，位于其上方的推片的高度亦被升高，相应地，推片与抵钉座之间的距离变大。在驱动组件的作用下推片推动推钉块使钉仓孔中的缝合钉被推出钉仓，此时缝合钉的横梁与第二手柄部分钉槽片上钉成形面的距离变短，导致缝合钉成形后高度H2降低，即H2<H1。在这种情况下，适合对厚度适中的组织进行吻合。
进一步地，当调节垫片的台阶面与钉仓座垫片的第三台阶面配合时，钉仓座垫片在垂直方向的高度最高，位于其上方的推片的高度亦最高，推片与抵钉座之间的距离最小。在驱动组件的作用下推片推动推钉块使钉仓孔中的缝合钉被推出钉仓，此时缝合钉的横梁与第二手柄部分钉槽片上钉成形面的距离最小，缝合钉成形高度H3进一步降低，即H3<H2<H1。在这种情况下，适合对较薄的组织进行吻合。
在另一个实施方式中，所述吻合器包括多排缝合钉，相应地包括与所述多排缝合钉对应 设置的多排推钉块。此时，所述驱动组件包括一个推片，其在推动时可同时推动所述多排推钉块，进而推动多排缝合钉。
在又一个实施方式中，所述吻合器包括多排缝合钉，相应地包括与所述多排缝合钉对应设置的多排推钉块。此时，所述驱动组件包括多个推片，每个推片对应一排推钉块，其在推动时推动与其对应的一排推钉块，进而推动与其相应的一排缝合钉。
进一步地，所述驱动组件还包括切割刀，用于在多排钉线中间切割组织。例如，所述驱动组件包括两个推片，所述切割刀设置在两个推片之间。
进一步地，所述切割刀设置在两个推片的近端，从而在向远端推动推钮时，在组织被缝合钉缝合后再进行切割。
根据本申请的另一方面，还涉及一种吻合器，包括上述缝合钉成形钉高调节机构。
本申请通过一种独特的结构设计，可以调节吻合器的缝合钉的成形钉高，以针对不同特性的组织，提高缝合钉成形良率，减少缝合口出血、吻合口瘘等现象的发生，从而能对人体各组织实现高效的吻合。
附图说明
图1为根据本申请一个实施方式的外科吻合器的侧视图，其中第一手柄、第二手柄处于分离状态。
图2为图1所示的外科吻合器的远端部件分解示意图。
图3为图1所示的外科吻合器的钉仓座垫片的侧视图，其中放大显示钉仓座垫片的远端部分A。
图4为图1所示的外科吻合器的调节垫片的结构侧视图，其中放大显示调节垫片的远端部分B。
图5为图1所示的外科吻合器远端局部放大示意图，其中示意出推片推动推钉块将缝合钉从钉仓孔内推出，缝合钉到达抵钉座钉成形面上的钉成形槽中，挤压成“B”字形。
图6为图1所示的外科吻合器的钉仓座垫片及调节垫片的侧视图，其中调节垫片的台阶面与钉仓座垫片的第一台阶面配合。
图7为图1所示的外科吻合器远端的正视图，其中钉仓座垫片及调节垫片处于图6所示的配合状态，即调节垫片的台阶面与钉仓座垫片的第一台阶面配合。
图8为图1所示的外科吻合器的钉仓座垫片及调节垫片的侧视图，其中调节垫片的台阶面与钉仓座垫片的第二台阶面配合。
图9为图1所示的外科吻合器远端的正视图，其中钉仓座垫片及调节垫片处于图8所示的配合状态，即调节垫片的台阶面与钉仓座垫片的第二台阶面配合。
图10为图1所示的外科吻合器的钉仓座垫片及调节垫片的侧视图，其中调节垫片的台阶面与钉仓座垫片的第三台阶面配合。
图11为图1所示的外科吻合器远端的正视图，其中钉仓座垫片及调节垫片处于图10所示的配合状态，即调节垫片的台阶面与钉仓座垫片的第三台阶面配合。
具体实施方式
下面参照附图，对本申请的具体实施方式进行说明。为了突出本申请的相关细节，本申请的示例性实施方式中的本领域公知的部件及连接关系将不予详细描述或省略。在各附图中，用相同的附图标记表示同样的部件，附图不是按比例绘制的。通常远离操作者的一端为远端，靠近操作者的一端为近端。为了清楚描述，按照吻合器水平放置时的方位进行描述，但正如本领域公知，在实际使用时，可在任何方位上对吻合器进行操作。
参见附图1，其示出了根据本申请一个实施方式的外科吻合器的侧视图，为了清楚起见，其中第一手柄、第二手柄处于分离状态。根据本申请一个实施方式的外科吻合器，包括第一 手柄部分1、第二手柄部分2，第一手柄部分1和第二手柄部分2可以组装到一起，如图1所示，第二手柄部分2的中间设有转轴23，第一手柄部分1的相应部位设有凹槽，转轴23嵌入凹槽中并可在凹槽中枢轴转动，从而可将第一手柄部分1、第二手柄部分2的远端打开或闭合。第一手柄部分1包括位于远端的钉仓座12、钉仓组件、位于中间的锁定杆13、驱动组件以及调节机构；第二手柄部分2包括抵钉座21，具体参见附图5，抵钉座21上有钉槽片211，钉槽片211包含钉成形面。第一手柄部分1、第二手柄部分2的远端闭合后可通过第一手柄部分1上的锁定杆13锁定。
在一个实施方式中，所述钉仓组件可从钉仓座12上拆卸下来。参见附图2、5、7，钉仓组件具体包括钉仓11、若干推钉块16、与所述推钉块16对应设置的若干缝合钉3。
参见附图1、2、5，驱动组件具体包括推钮14、与推钮14连接并且远端为楔形的推片15，水平推动推钮14进而推动推片15，远端楔形的推片15逐个驱动推钉块16向抵钉座21的方向运动，推钉块16推动缝合钉3从钉仓孔内推出，穿透由第一手柄部分1及第二手柄部分2闭合的组织，到达抵钉座21的钉成形面上的钉成形槽中，挤压成“B”字形。具体参见附图5，推片15与抵钉座21之间的距离决定了缝合钉3成形后的钉高，推片15越靠近抵钉座21，缝合钉3成形后的钉高越小，反之亦然。
在另一个实施方式中，驱动组件还包括切割刀(附图中未示处)，用于在多排钉线中间切割组织，例如参见附图7，可在两个推片15之间设置切割刀，切割刀设置在两个推片15的近端，从而在向远端推动推钮14时，在组织被缝合钉3缝合后再进行切割。
参见附图2，调节机构置于钉仓11底部，包括钉仓座垫片121、调节垫片122。所述钉仓座垫片121的上表面与推片15的底面配合，调节垫片122置于钉仓座垫片121的下方，调节垫片122的底面与钉仓座12底部的上表面配合。钉仓座垫片121下表面包括一个或多个第一高度调节区，每个第一高度调节区至少包括两个不等高的台阶面。调节垫片122的上表面与钉仓座垫片121上的高度调节区对应的区域设置第二高度调节区，每个所述第二高度调节区至少包括一个台阶面1221。
在附图2-11所示的实施方式中，具体如图3所示，钉仓座垫片121下表面包括两个第一高度调节区，每个第一高度调节区包含三个不等高的台阶面，分别为第一台阶面1211、第二台阶面1212、第三台阶面1213，其中第一台阶面1211最高，即钉仓座垫片121在第一台阶面1211处的宽度最小，第三台阶面1213最低，即钉仓座垫片121在第三台阶面1213处的宽度最大，第二台阶面1212的高度及钉仓座垫片121在第二台阶面1212处的宽度均居中。
在附图2-11所示的实施方式中，具体如图4所示，调节垫片122的上表面包括两个第二高度调节区，所述两个第二高度调节区之间的距离与所述两个第一高度调节区之间的距离相同。每个第二高度调节区包括一个台阶面1221。
如图5所示，调节垫片122在垂直方向保持不变，水平方向可以左右移动，钉仓座垫片121在水平方向保持不变，在垂直方向上可上下移动。在水平方向上左右移动调节垫片122，使得第二高度调节区与第一高度调节区配合，即使得调节垫片122上的台阶面1221与钉仓座垫片121的三个台阶面1211-1213中的其中一个配合，从而调节钉仓座垫片121在垂直方向的高度，因而调节推片15与抵钉座21之间的距离并因此调节缝合钉3成形后的钉高。
附图6-11分别显示了调节垫片122的台阶面1221与钉仓座垫片121的第一台阶面1211、第二台阶面1212或第三台阶面1213配合时，外科吻合器工作时的远端正视图，在图7、9、11的右侧显示成形后具有不同钉高的缝合钉3。
参见图6、7，当调节垫片122的台阶面1221与钉仓座垫片121的第一台阶面1211配合时，钉仓座垫片121在垂直方向的高度最低，位于其上方的推片15的高度亦最低，推片15与抵钉座21之间的距离最大。在驱动组件的作用下推片15推动推钉块16使钉仓孔中的缝合钉3被推出钉仓11，此时缝合钉3的横梁与第二手柄部分2的钉槽片211上的钉成形面的距离最大，缝合钉3成形后高度H1也就最高。在这种情况下，适合对较厚的组织进行吻合。
参见图8、9，当调节垫片122的台阶面1221与钉仓座垫片121的第二台阶面1212配合 时，钉仓座垫片121在垂直方向的高度上升，位于其上方的推片15的高度亦被升高，相应地，推片15与抵钉座21之间的距离变大。在驱动组件的作用下推片15推动推钉块16使钉仓孔中的缝合钉3被推出钉仓11，此时缝合钉3的横梁与第二手柄部分2钉槽片211上钉成形面的距离变短，导致缝合钉3成形后高度H2降低，即H2<H1。在这种情况下，适合对厚度适中的组织进行吻合。
参见图10、11，当调节垫片122的台阶面1221与钉仓座垫片121的第三台阶面1213配合时，钉仓座垫片121在垂直方向的高度最高，位于其上方的推片15的高度亦最高，推片15与抵钉座21之间的距离最小。在驱动组件的作用下推片15推动推钉块16使钉仓孔中的缝合钉3被推出钉仓11，此时缝合钉3的横梁与第二手柄部分2钉槽片211上钉成形面的距离最小，缝合钉3成形高度H3进一步降低，即H3<H2<H1。在这种情况下，适合对较薄的组织进行吻合。
需要说明的是，本申请示例中的吻合器为直线型吻合器，但本申请并不仅限于在直线型吻合器中使用，同样适用于环形及其他类型的吻合器。另外，附图1至附图11中的实施方案仅为本申请比较有代表性的实施例，本领域技术人员容易理解，本申请的保护范围不仅仅限定在各实施方式所限定的范围内，对各实施方式的组合、变形、变化均落在本申请的保护范围内。

Claims (18)

  1. 一种吻合器的缝合钉成形钉高调节机构，所述吻合器包括第一手柄部分、第二手柄部分；所述第一手柄部分包括位于远端的钉仓座、钉仓组件、驱动组件、所述缝合钉成形钉高调节机构，所述第二手柄部分包括位于远端的抵钉座；所述钉仓组件包括缝合钉，所述驱动组件可将缝合钉驱动离开钉仓组件，到达抵钉座从而被挤压成形；其特征在于：所述吻合器还包括，所述调节结构调节驱动组件与抵钉座之间的距离以调节吻合器的缝合钉的成形钉高。
  2. 根据权利要求1所述的吻合器的缝合钉成形钉高调节机构，其特征在于：所述钉仓组件还包括钉仓以及与所述缝合钉对应设置的推钉块；所述驱动组件包括推钮、与推钮连接并且远端为楔形的推片；推动推钮进而推动推片，远端楔形的推片逐个驱动推钉块向抵钉座的方向运动，推钉块推动缝合钉从钉仓孔内推出，穿透由第一手柄部分及第二手柄部分闭合的组织，到达抵钉座被挤压成“B”字形。
  3. 根据权利要求2所述的吻合器的缝合钉成形钉高调节机构，其特征在于：所述调节机构置于钉仓底部，包括钉仓座垫片、调节垫片，所述钉仓座垫片的上表面与推片的底面配合，调节垫片置于钉仓座垫片的下方，调节垫片的底面与钉仓座底部的上表面配合；所述调节垫片在垂直方向保持不变，水平方向可以左右移动，所述钉仓座垫片在水平方向保持不变，在垂直方向上可上下移动；所述钉仓座垫片下表面包括一个或多个第一高度调节区，在水平方向上移动调节垫片，使其上表面与所述第一高度调节区接触，从而调节钉仓座垫片的高度，进而调节位于钉仓座垫片上方的推片的高度，使得推片与抵钉座之间的距离发生变化。
  4. 根据权利要求3所述的吻合器的缝合钉成形钉高调节机构，其中：所述每个第一高度调节区至少包括两个不等高的台阶面，在水平方向上移动调节垫片，使其上表面与钉仓座垫片上的其中一个台阶面接触，从而调节钉仓座垫片的高度。
  5. 根据权利要求4所述的吻合器的缝合钉成形钉高调节机构，其中：所述调节垫片的上表面与钉仓座垫片上的第一高度调节区对应的区域设置第二高度调节区。
  6. 根据权利要求5所述的吻合器的缝合钉成形钉高调节机构，其特征在于：所述钉仓座垫片下表面包括两个第一高度调节区，所述调节垫片的上表面包括两个第二高度调节区，所述两个第二高度调节区之间的距离与所述两个第一高度调节区之间的距离相同。
  7. 根据权利要求5所述的吻合器的缝合钉成形钉高调节机构，其特征在于：所述每个所述第二高度调节区至少包括一个台阶面。
  8. 根据权利要求7所述的吻合器的缝合钉成形钉高调节机构，所述每个第一高度调节区包含三个不等高的台阶面，分别为第一台阶面、第二台阶面、第三台阶面，其中所述第一台阶面最高，即所述钉仓座垫片在所述第一台阶面处的宽度最小，所述第三台阶面最低，即所述钉仓座垫片在所述第三台阶面处的宽度最大，所述第二台阶面的高度及所述钉仓座垫片在 所述第二台阶面处的宽度均居中；在水平方向上左右移动所述调节垫片，使得所述第二高度调节区与所述第一高度调节区配合，即使得所述调节垫片上的台阶面与所述钉仓座垫片的三个台阶面中的其中一个配合，从而调节钉仓座垫片在垂直方向的高度，因而调节所述推片与所述抵钉座之间的距离并因此调节缝合钉成形后的钉高。
  9. 根据权利要求8所述的吻合器的缝合钉成形钉高调节机构，其中当所述调节垫片的台阶面与所述钉仓座垫片的所述第一台阶面配合时，所述钉仓座垫片在垂直方向的高度最低，位于其上方的所述推片的高度亦最低，推片与抵钉座之间的距离最大，在所述驱动组件的作用下所述推片推动推钉块使钉仓孔中的缝合钉被推出钉仓，此时缝合钉的横梁与第二手柄部分的钉槽片上的钉成形面的距离最大，缝合钉成形后高度H1也就最高。
  10. 根据权利要求9所述的吻合器的缝合钉成形钉高调节机构，其中当所述调节垫片的台阶面与所述钉仓座垫片的所述第二台阶面配合时，所述钉仓座垫片在垂直方向的高度上升，位于其上方的所述推片的高度亦被升高，相应地，所述推片与所述抵钉座之间的距离变大，在所述驱动组件的作用下所述推片推动推钉块使钉仓孔中的缝合钉被推出钉仓，此时缝合钉的横梁与第二手柄部分钉槽片上钉成形面的距离变短，导致缝合钉成形后高度H2降低，即H2<H1。
  11. 根据权利要求10所述的吻合器的缝合钉成形钉高调节机构，当所述调节垫片的台阶面与钉仓座垫片的第三台阶面配合时，钉仓座垫片在垂直方向的高度最高，位于其上方的推片的高度亦最高，推片与抵钉座之间的距离最小，在所述驱动组件的作用下所述推片推动推钉块使钉仓孔中的缝合钉被推出钉仓，此时缝合钉的横梁与第二手柄部分钉槽片上钉成形面的距离最小，缝合钉成形高度H3进一步降低，即H3<H2<H1。
  12. 根据权利要求1-8中任一项所述的吻合器的缝合钉成形钉高调节机构，所述钉仓组件可从钉仓座上拆卸下来。
  13. 根据权利要求1-8中任一项所述的吻合器的缝合钉成形钉高调节机构，所述第一手柄部分还包括位于中间的锁定杆，所述第一手柄部分、第二手柄部分的远端闭合后可通过所述锁定杆锁定。
  14. 根据权利要求1-8中任一项所述的吻合器的缝合钉成形钉高调节机构，所述抵钉座上设有钉槽片，所述钉槽片包含钉成形面。
  15. 根据权利要求1-8中任一项所述的吻合器的缝合钉成形钉高调节机构，所述缝合钉有两排。
  16. 根据权利要求15所述的吻合器的缝合钉成形钉高调节机构，所述驱动组件包括切割刀，所述切割刀设置在两个推片之间。
  17. 根据权利要求16所述的吻合器的缝合钉成形钉高调节机构，所述切割刀设置在两个推片的近端，从而在向远端推动推钮时，在组织被缝合钉缝合后再进行切割。
  18. 一种吻合器，包括根据权利要求1-17任一项所述的吻合器的缝合钉成形钉高调节机构。
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US11540828B2 (en) 2023-01-03
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