WO2011050705A1 - 一种肛肠手术器械及扩肛器 - Google Patents

一种肛肠手术器械及扩肛器 Download PDF

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Publication number
WO2011050705A1
WO2011050705A1 PCT/CN2010/078058 CN2010078058W WO2011050705A1 WO 2011050705 A1 WO2011050705 A1 WO 2011050705A1 CN 2010078058 W CN2010078058 W CN 2010078058W WO 2011050705 A1 WO2011050705 A1 WO 2011050705A1
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WO
WIPO (PCT)
Prior art keywords
barrel
light source
assembly
anal
stapler
Prior art date
Application number
PCT/CN2010/078058
Other languages
English (en)
French (fr)
Inventor
乔伟
曲直
Original Assignee
北京中法派尔特医疗设备有限公司
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
Priority claimed from CN2009202201387U external-priority patent/CN201519170U/zh
Priority claimed from CN201020570951XU external-priority patent/CN201814611U/zh
Application filed by 北京中法派尔特医疗设备有限公司 filed Critical 北京中法派尔特医疗设备有限公司
Priority to US13/501,590 priority Critical patent/US20130032628A1/en
Priority to EP10826068.8A priority patent/EP2494913B1/en
Publication of WO2011050705A1 publication Critical patent/WO2011050705A1/zh

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Classifications

    • 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
    • A61B1/32—Devices for opening or enlarging the visual field, e.g. of a tube of the body
    • 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
    • A61B1/06—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 with illuminating arrangements
    • A61B1/0661—Endoscope light sources
    • A61B1/0669—Endoscope light sources at proximal end of an endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0293—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors with ring member to support retractor elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • 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
    • A61B1/31—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 for the rectum, e.g. proctoscopes, sigmoidoscopes, colonoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00902—Material properties transparent or translucent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/1067—Anus

Definitions

  • This invention relates to the field of medical device technology, and more particularly to surgical instruments for use in surgical procedures for treating anorectal diseases.
  • the invention also relates to an anal expander in the above surgical instrument. Background technique
  • ⁇ is a common disease.
  • Ten men and nine babes say that the incidence rate is high, accounting for about 85% of all anorectal diseases.
  • the "anal tube vascular pad” has been established, and the tube is called “anal pad theory”. It is considered that the anal pad is an annular tissue band 1.5-2.0 cm wide above the dentate line of the human anal canal. Thick and soft, a highly specific vascular pad, is the normal tissue of the human body, but due to diarrhea, constipation, increased abdominal pressure, etc., pathological hypertrophy occurs, and it is called sputum after moving down.
  • the blood supply to the temporal region of the upper rectal artery is blocked, and the corpus callosum atrophy after surgery.
  • the operation is popular around the world for its painless postoperative operation, surgical operation, and anal incontinence.
  • the medical instruments used in PPH surgery include an anastomat and an analter, a threader and the like, which must be used at the same time, so the anal sac is an essential tool in surgery.
  • the existing anal spreader Due to the poor view of the anus during the operation, the existing anal spreader has inconvenient or even unsafe factors in use.
  • the field of view of the operation is maintained by the anal sphincter.
  • the diameter is about 4cm and the depth is more than 8cm.
  • the visual field is very unclear. The doctor sometimes needs extra headlights to illuminate the surgical field. Even then Sometimes it is still not very clear. Due to the small space and unclear vision, it is difficult to make a purse string.
  • the analectifier is made of a transparent material and is provided with a light source. During operation, the doctor can completely illuminate the surgical field, especially the deep field of view, through the illuminating light source on the analter, thereby greatly improving the convenience and safety of the operation.
  • an anal expander comprising a cylindrical barrel body having a flared rim on the top of the barrel, further comprising a peripheral light source assembly for illuminating the surgical field, A peripheral light source assembly is coupled to the flared rim.
  • the wall of the barrel is a transparent body that conducts light and transmits light.
  • the wall of the barrel is a two-layer structure of light guiding and light transmission, and the gap between them forms an optical path.
  • the bottom end of the barrel wall of the barrel is provided with a contracted optical path exit.
  • the front end of the illuminating light source of the peripheral light source assembly is provided with a wedge-shaped concentrating head, and the concentrating head is engaged in a wedge-shaped hole on the flared rim.
  • the barrel is provided with an optical fiber, and the optical fiber is connected to the peripheral light source assembly through a light source interface at the flared edge.
  • the optical fibers are wound laterally or longitudinally on the barrel.
  • the invention also provides an anorectal surgical instrument, including a disposable ankle anastomat and an auxiliary expansion
  • the anal device and the hook-up device are the analgesic device according to any one of the above.
  • the disposable ankle stapler comprises a cone-shaped abutment assembly at the front end of the stapler, a cartridge assembly at the rear of the staple holder assembly, a gun body assembly in the middle of the stapler, and a rear portion of the stapler.
  • a handle assembly and an adjustment nut member at the tail of the stapler, the cartridge assembly including a staple cartridge, a pusher tab, and a staple cartridge sleeve, the staple cartridge, the pusher tab, and the staple cartridge sleeve are all made of a transparent material .
  • the outer casing of the magazine sleeve is provided with a pair of enlarged operation holes.
  • the anorecting device provided by the invention is further improved on the basis of the prior art, and the existing anisal device is connected at the flared edge according to the problem that the visual field is unclear and the operation is inconvenient and the safety and reliability are low.
  • There is a peripheral light source component and its illuminating light source can emit visible light with sufficient intensity. Since the barrel body is made of transparent material, visible light can illuminate the entire surgical field through the barrel wall or optical path of the barrel body, especially the deep field of view, which is equivalent to making the tube The body has a luminous function to ensure the safety of the operation.
  • the light source assembly is disposed outside the barrel, it is easy to operate and control without adversely affecting the use of the analyzer.
  • the disposable ankle anastomat of the anorectal surgical instrument provided by the invention has a transparent staple cartridge, which enables the operator to clearly see the extent of the anastomosis of the tissue to be resected into the anastomat and the tissue lifting condition, and judges that it should not enter. Whether the part has been eliminated, to ensure that the scope of resection is accurate and complete, and improve the success rate of surgery.
  • Figure 1 is an outline view of a first embodiment of an anorectal device provided by the present invention
  • Figure 2 is a structural view of the anastomosis device shown in Figure 1;
  • Figure 3 is an outline view of a second embodiment of the expander provided by the present invention.
  • Figure 4 is a structural view of the analgia shown in Figure 3;
  • Figure 5 is an outline view of a third embodiment of the analgia provided by the present invention.
  • Figure 6 is a schematic structural view of the peripheral light source assembly shown in Figure 5;
  • Figure 7 is a cross-sectional view of the barrel shown in Figure 5;
  • Figure 8 is a partial enlarged view of the I portion of Figure 7;
  • Figure 9 is a schematic view showing the structure of the anal expansion device shown in Figure 5 after removing the peripheral light source assembly;
  • Figure 10 is an outline view of a disposable ankle stapler provided by the present invention
  • Figure 11 is a partial enlarged view of the staple cartridge sleeve of Figure 10;
  • Figure 12 is an exploded perspective view showing the internal structure of the stapler shown in Figure 10;
  • Figure 13 is a schematic view of the cooperation of the disposable ankle stapler and the anal expansion device provided by the present invention.
  • the core of the invention is to provide an anal expander.
  • the analectifier is made of a transparent material and is provided with a light source. During operation, the doctor can completely illuminate the operation area, especially the deep field of view, through the illumination source on the analyzer, thereby greatly improving the convenience and safety of the operation.
  • Another core of the present invention is to provide an anorectal surgical instrument equipped with the above-described anal expansion device.
  • FIG. 1 is an external view of a first embodiment of the expander according to the present invention
  • FIG. 2 is a structural view of the expander shown in FIG.
  • the outer contour of the device 10 is in the shape of an inverted hat.
  • the body 10-1 is equivalent to the cap body, and has a clear scale on the surface for the doctor to observe and operate.
  • the flared flared edge 10-2 is equivalent to the brim.
  • a plurality of hollow portions are evenly opened, the light source assembly 20 is located outside the flared edge 10-2, and the optical fiber 30 is laterally wound around the outer wall of the barrel 10-1 and passes through the light source interface on the flared edge 10-2. 40 and light source components 20 connections.
  • the optical fiber 30 is specifically a luminescent plastic fiber having a diameter of 0.25-0.5 mm.
  • the light source assembly 20 is mainly composed of a casing and an illuminating light source and a battery located inside the casing, and the illuminating light source adopts a cold light source, such as a size of 2x2, 2x3, 2x4, 2x5mm and high brightness LEDs with a diameter of 03 ⁇ 05mm, the battery can be used with a button battery with a working voltage between 1.5 ⁇ 5V.
  • FIG. 3 is an external view of a second embodiment of the expander according to the present invention.
  • FIG. 4 is a structural view of the expander shown in FIG.
  • the analtenary 10 provided by the present invention comprises a transparent cylindrical body 10-1, and the top of the barrel 10-1 has an elastic flared edge 10-2, and the entire anus is enlarged.
  • the outer contour of the device 10 is in the shape of an inverted hat.
  • the body 10-1 is equivalent to the cap body, and has a clear scale on the head for the doctor to observe and operate.
  • the flared flaring edge 10-2 is equivalent to the brim edge.
  • the medical rubber material is made of a plurality of hollow portions, and the light source assembly 20 is located outside the flared edge 10-2.
  • the optical fiber 30 is longitudinally arranged on the outer wall of the barrel 10-1 and is flared.
  • the light source interface 40 on the rim 10-2 is coupled to the light source assembly 20.
  • the optical fiber 30 is specifically a luminescent plastic fiber having a diameter of between 0.25 and 0.5 mm, and the light source assembly
  • the illuminating light source adopts a cold light source, such as a high-brightness light-emitting diode with a size of 2x2, 2x3, 2x4, 2x5mm and a diameter of 03 ⁇ 05mm, and the battery can adopt an operating voltage.
  • Button battery between 1.5 ⁇ 5V.
  • the optical fiber 30 is a bulk-emitting optical fiber. More preferably, the optical fiber 30 can be single stranded or reticulated.
  • the mesh optical fibers are each composed of a fine-diameter bulk light-emitting optical fiber and can constitute a flexible light band.
  • the optical fiber may be located not only on the outer wall of the barrel but also on the inner wall of the barrel or between the inner and outer walls.
  • the optical fibers may be wound laterally on the inner wall of the barrel or longitudinally on the inner wall of the barrel.
  • a thin groove is formed between the inner wall, the outer wall or the inner and outer walls of the barrel, and the optical fiber is embedded in the narrow groove.
  • FIG. 5 is an external view of a third embodiment of the anisotropic device according to the present invention
  • FIG. 6 is a peripheral light source assembly shown in FIG. Schematic diagram of the structure
  • Figure 7 5 is a cross-sectional view of the barrel shown in FIG. 5
  • FIG. 8 is a partial enlarged view of the portion I of FIG. 7
  • FIG. 9 is a schematic view showing the structure of the anisotropic device of FIG.
  • the anisotropic device provided by the present invention comprises a transparent cylindrical barrel 100, the top of the barrel 100 is a resilient flared rim 200, and the flared rim 200 has two flankes, one of which A wedge hole 201 is provided on the side wing.
  • the barrel 100 and the flared rim 200 are all made of a transparent material having a two-layer structure with a gap therebetween, and the gap therebetween forms an optical path 101.
  • the front end of the light source of the peripheral light source assembly 300 is provided with a wedge-shaped concentrating head 301, and a top surface of the concentrating head 301 has a beveled protrusion 311 near the root, and a corresponding hole 211 is formed in the top wall of the wedge-shaped hole 201.
  • the peripheral light source assembly 300 is mainly composed of a collecting head 301, a light emitting diode (not shown), a battery 302 and a power switch 303.
  • the two poles of the light emitting diode are connected to the positive and negative poles of the battery 302 through wires, and the light emitting diodes are from the rectangular shell.
  • the battery protrudes into the concentrating head 301, and the battery 302 is a button battery with an operating voltage between 1.5 and 5V, and is installed in a rectangular casing together with the power switch 303.
  • the operating end of the power switch 303 is from the casing. Exposed to the outside.
  • the visible light of the LED enters the optical path 101 of the barrel 100 from the optical path entrance 321 at the front end of the concentrating head 301, so that the light fills the inside of the transparent cylindrical body, and the visible light forms an optical path inside the cylindrical barrel, and the light is in the cylinder.
  • the inner wall of the barrel is transmissive and constantly reflected (the arrows indicate the direction of the light, and the dotted line indicates the path of the light) to illuminate the entire surgical field.
  • the bottom end of the cylindrical barrel 100 is provided with a contracted optical path exit 121 through which light is transmitted, thereby illuminating the deep field of view during surgery.
  • the wall of the barrel body can also be a transparent body for guiding light and transmitting light, and the peripheral light source assembly illuminates the surgical area along the wall of the barrel body, and the rest of the structure is basically the same as the third embodiment described above, Repeat the description.
  • the structure of the barrel has relatively low requirements on the processing technology, which is beneficial to the economy and the production efficiency.
  • anorectal surgical instrument including a disposable ankle anastomat and an anal incubator, a hook line and other accessories.
  • hook line Other accessories such as the device can refer to the prior art, and will not be described here. Only the improvements are described below. Disposable sputum stapler.
  • FIG. 10 is an external view of the disposable sputum stapler provided by the present invention
  • FIG. 11 is a partial enlarged view of the staple cartridge sleeve of FIG.
  • the disposable ankle stapler of the present invention includes an anvil assembly, a cartridge assembly, and a body assembly.
  • the anvil assembly is located at the front of the ankle stapler and is coupled to the body assembly by a connecting rod that passes through the cartridge assembly.
  • the abutment assembly includes a tapered abutment 1 having a circular recess for receiving the pad ring 2.
  • the cartridge assembly includes a staple cartridge 3, a pusher tab 4 at the rear of the staple cartridge 3, and a staple cartridge sleeve 5, both of which are mounted inside the staple cartridge sleeve 5,
  • the staple cartridge sleeve 5 is provided with a hooking hole 5-2 through which the purse string can be pulled out and the bundled tissue is pulled into the cavity of the cartridge assembly.
  • the cartridge assembly further includes an annular cutter (not shown) that is mounted inside the pusher tab 4 and that is movable along with the pusher tab 4.
  • annular cutter (not shown) that is mounted inside the pusher tab 4 and that is movable along with the pusher tab 4.
  • Located in the middle of the ankle stapler is a gun body assembly 6.
  • the gun body assembly 6 is provided with a movable handle 7 below, and an adjusting nut 8 is arranged at the tail of the ankle stapling device, and the 4 nail seat can be driven by rotating the adjusting nut 8. 1 Close to or away from the cartridge assembly.
  • the three components of the staple cartridge 3, the pusher tab 4 and the staple cartridge sleeve 5 are made of a transparent material, and the purpose of the manufacture is as follows: First, the staples installed in the staple cartridge can be clearly observed. Whether there is a deficiency, the second, so that the doctor can clearly observe the degree of the sputum tissue entering the cavity of the cartridge assembly and the degree of uniformity during the operation.
  • a pair of enlarged operating holes 5-1 are defined in the outer casing of the cartridge sleeve 5, and a tool plier can be used at the operating hole 5-1, through which the access to the anastomotic tissue can be further observed. How much can be adjusted by the forceps to adjust the sputum tissue to make the gap more secure, so as to avoid the corresponding complications.
  • FIG. 13 is a schematic diagram of the cooperation between the disposable ankle stapler and the anal dissipator provided by the present invention.
  • the peripheral light source is intentionally omitted in the figure. Component.
  • the doctor firstly fixed the three anesthesia with three atraumatic forceps at three points where the prolapse of the ankle was less and the anorectal valgus was slight, and the anal sac was placed on the suturing device, and the suturing device was placed.
  • the anal incubator and the suture are introduced into the anorectal with the anorectal introducer. After removal of the anorectal introducer, the prolapsed mucosa falls into the semicircular tubular opening of the suture. Press the power switch on the anus to open the illuminator. Since the cylindrical body of the analyzer is transparent, the dentate line in the anorectal can be observed through it.
  • the opening of the suture is rotated by the suturing device. Align the tendon tissue and complete the full circle of purse-string sutures at a position 3-4 cm above the dentate line.
  • the suture passes only through the mucosa and submucosa.
  • the circular fistula stapler is unscrewed to the maximum position, and the anastomat is introduced through the anastomosis device and the abutment is deepened to the upper end of the purse string, and then the purse string is tied and fastened to the center rod of the stapler.
  • Use the hook hook to pull the end of the purse string out of the hook line of the anastomat, and tie it to the end of the suture outside the stapler or fix it by applying a clamp.
  • the tool tongs can be used to adjust the sputum tissue in the cavity to ensure uniform sputum tissue gap in the cavity.
  • the stapler is completely closed, check whether the sputum tissue is suitable, then press the movable handle to fire and simultaneously remove the cavity. Prolapse the mucosa and finally exit the stapler.
  • an anorectal surgical instrument has an external light source assembly, and the body of the anorectal is made of a transparent material, and, in addition, a stapler, a pusher, and a staple cartridge are provided.
  • the components are also made of a transparent material.

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Description

一种肛肠手术器械及扩肛器
本申请要求于 2009 年 10 月 26 日提交中国专利局、 申请号为 200920220138.7、 发明名称为"具有透明釘仓的一次性痔吻合器"的中国专利申 请的优先权， 以及于 2009 年 10 月 26 日提交中国专利局、 申请号为 200920220139.1、 发明名称为"冷光源扩肛器"的中国专利申请的优先权， 还要 求于 2010年 10月 21 日提交中国专利局、 申请号为 201020570951.X、 发明名 称为"一种肛肠手术器械及扩肛器"， 其全部内容通过引用结合在本申请中。 技术领域
本发明涉及医疗器械技术领域，尤其涉及在治疗肛肠疾病的外科手术中使 用的手术器械。 本发明还涉及上述手术器械中的扩肛器。 背景技术
痔是一种常见病， 俗话有： 十男九痔的说法， 发病率很高， 约占所有肛肠 疾病的 85%。关于病因，从 1960年起，建立了 "肛管血管垫 "，筒称"肛垫学说"， 认为肛垫是人体肛管内齿状线上方宽 1.5-2.0cm的环状组织带，该区厚而柔软， 为一高度特定化的血管性衬垫， 是人体的正常组织， 但由于腹泻、 便秘、 腹压 增高等原因， 发生病理性肥大， 下移后称之为痔。
随着这种概念被广泛接受， 其治疗手段也随之发生了很大变化。 2000年 中华医学会外科学分会肛肠学组制订了《痔诊断暂行标准》，将痔分为 I-IV度， 4个档次。 目前认为 III、 IV度的中、 重度痔必须手术治疗， 同时以 "痔上粘膜 环切术 "（PPH手术）， 最为大家所接受。 此手术起源于 20世纪 90年代， 此手 术技术是指切除齿状线上 2-4cm处粘膜和粘膜下层，使得肛垫向上移起，起到 悬吊肛垫的作用， 明显緩解脱垂的症状。 同时由于粘膜下组织的切除， 阻断直 肠上动脉分支对痔区的血液供应， 术后痔体萎缩。 该手术以其术后无痛、 手术 操作筒单、 不发生肛门失禁等优点而风靡全球。
目前，在肛肠疾病的外科手术中， PPH手术所用到的医疗器械包含痔吻合 器以及扩肛器、 穿线器等配件， 它们必须同时配套使用， 所以扩肛器是手术中 的必备器械。 由于手术操作时肛门处视野不好，现有扩肛器在使用中存在不便利甚至不 安全的因素。 可以看到， 在所有的步骤中， 手术的视野均靠扩肛器维持， 直径 大约 4cm, 深度却在 8cm以上， 视野很不清楚， 医生有时还需要额外带头灯 去照亮手术视野， 即使这样， 有时仍不很清楚。 由于空间小， 视野不清， 很难 做好荷包线，很难检查该切除的组织是否完全进入到器身的釘仓内，也无法直 观判断是否有其他组织如女性的阴道、肠管的肌层进入到吻合口内。所以只能 靠医生的经验来判断。 一旦判断错误， 将带来严重并发症， 如大出血、 肛门阴 道瘘、 术后狭窄等。
因此，如何改善手术操作时肛门处的视野范围， 以提高手术的便利性和安 全性， 是本领域技术人员目前需要解决的主要技术问题。 发明内容
本发明的目的是提供一种扩肛器。该扩肛器由透明材料制成，且设有发光 光源， 手术时医生可通过扩肛器上的发光光源完全照亮手术区域，特别是深部 视野， 从而大大提高手术的便利性和安全性。
本发明的目的是提供一种配置有上述扩肛器的肛肠手术器械。
为了实现上述目的， 本发明提供了一种扩肛器， 包括圆柱形筒身， 所述筒 身顶部为具有弹性的扩口边沿， 进一步包括用于照亮手术区域的外设光源组 件， 所述外设光源组件与所述扩口边沿连接。
优选地， 所述筒身的筒壁为导光和透光的透明实体。
优选地， 所述筒身的筒壁为导光和透光的双层结构， 其中间的空隙形成光 路通道。
优选地， 所述筒身的筒壁底端设有收缩的光路射出口。
优选地， 所述外设光源组件的发光光源前端设有楔形聚光头， 所述聚光头 卡接于所述扩口边沿上的楔形孔中。
优选地， 所述筒身上设有光导纤维， 所述光导纤维通过所述扩口边沿处的 光源接口与所述外设光源组件连接。
优选地， 所述光导纤维横向缠绕或纵向排列于所述筒身上。
本发明还提供一种肛肠手术器械，包括一次性痔吻合器以及配套使用的扩 肛器、 勾线器， 所述扩肛器具体为上述任一项所述的扩肛器。
优选地， 所述一次性痔吻合器包括位于吻合器前端的锥体形抵釘座组件、 位于抵釘座组件后部的釘仓组件、位于吻合器中部的枪身组件、位于吻合器后 部的手柄组件以及位于吻合器尾部的调节螺母部件， 所述釘仓组件包括釘仓、 推釘片以及釘仓套， 所述釘仓、推釘片以及釘仓套三个部件全部采用透明材料 制成。
优选地， 所述釘仓套的外套体上开设有一对加大的操作孔。
本发明所提供的扩肛器在现有技术的基础上作了进一步改进，针对现有扩 肛器因视野不清楚而导致操作不便、安全可靠性低的问题，在所述扩口边沿处 连接有外设光源组件， 其发光光源可发出足够强度的可见光， 由于筒身为透明 材质， 因此可见光能够通过筒身的筒壁或光路通道照亮整个手术区域， 特别 是深部视野， 相当于使筒身具有发光功能， 从而确保手术安全成功。 此外， 由 于光源组件设置在筒身外部， 既便于操作和控制， 又不会对扩肛器的使用效果 带来负面影响。
本发明所提供的肛肠手术器械的一次性痔吻合器具有透明釘仓，能使操作 者清晰地看到待切除的组织进入痔吻合器的吻合口的范围及组织提升情况，并 判断不该进入部分是否已排除，从而确保切除范围准确完整，提高手术成功率。 附图说明
图 1是本发明所提供扩肛器的第一具体实施方式的外形图；
图 2是图 1所示扩肛器的结构图；
图 3是本发明所提供扩肛器的第二具体实施方式的外形图；
图 4是图 3所示扩肛器的结构图；
图 5是本发明所提供扩肛器的第三具体实施方式的外形图；
图 6是图 5中所示外设光源组件的结构示意图；
图 7是图 5中所示筒身的剖视图；
图 8是图 7中 I部位的局部放大示意图；
图 9是图 5所示扩肛器去掉外设光源组件后的结构示意图；
图 10是本发明所提供一次性痔吻合器的外形图； 图 11是图 10中釘仓套的局部放大示意图；
图 12是图 10所示吻合器的内部结构分解示意图；
图 13是本发明所提供一次性痔吻合器与扩肛器的配合示意图。
图 1至图 4中：
10.扩肛器 10-1.筒身 10-2.扩口边沿 20.光源组件 30.光导纤维
40.光源接口
图 5至图 9中：
100.筒身 101.光路通道 121.光路射出口 200.扩口边沿 201.楔 形孔 211.卡孔 300.外设光源组件 301.聚光头 302.电池 303.电源 开关 311.斜面凸块 321.光路射入口
图 10至图 13中：
1.抵釘座 2.垫刀环 3.釘仓 4.推釘片 5.釘仓套 5-1.操作孔 5-2.勾线孔 6.枪身组件 7.活动手柄 8.调节螺母 具体实施方式
本发明的核心是提供一种扩肛器。该扩肛器由透明材料制成，且设有发光 光源， 手术时医生可通过扩肛器上的发光光源完全照亮手术区域，特别是深部 视野，从而大大提高手术的便利性和安全性。本发明的另一核心是提供一种配 置有上述扩肛器的肛肠手术器械。
为了使本技术领域的人员更好地理解本发明方案，下面结合附图和具体实 施方式对本发明作进一步的详细说明。
请参考图 1、 图 2, 图 1是本发明所提供扩肛器的第一具体实施方式的外 形图； 图 2是图 1所示扩肛器的结构图。
在第一种具体实施方式中， 本发明所提供的扩肛器 10, 包括透明的圆柱 形筒身 10-1 , 筒身 10-1顶部为具有弹性的扩口边沿 10-2, 整个扩肛器 10的外 轮廓呈倒置的礼帽形状， 筒身 10-1相当于帽身， 其上设有明显的刻度尺寸， 便于医生观察及手术， 喇叭形扩口边沿 10-2相当于帽沿， 其上均匀地开设有 几处镂空部位， 光源组件 20位于扩口边沿 10-2的外侧， 光导纤维 30横向缠 绕在筒身 10-1的外壁上， 并通过扩口边沿 10-2上的光源接口 40与光源组件 20连接。
光导纤维 30具体为直径在 0.25-0.5mm之间的发光塑料纤维， 光源组件 20 主要由壳体以及位于壳体内部的发光光源和电池构成， 发光光源采用冷光 源， 如尺寸为 2x2、 2x3、 2x4、 2x5mm及直径为 03 ~ 05mm的高亮度发光二 极管， 电池可采用工作电压在 1.5 ~ 5V之间的纽扣电池。
请参考图 3、 图 4, 图 3是本发明所提供扩肛器的第二具体实施方式的外 形图； 图 4是图 3所示扩肛器的结构图。
在第二种具体实施方式中， 本发明所提供的扩肛器 10, 包括透明的圆柱 形筒身 10-1 , 筒身 10-1顶部为具有弹性的扩口边沿 10-2, 整个扩肛器 10的外 轮廓呈倒置的礼帽形状， 筒身 10-1相当于帽身， 其上设有明显的刻度尺寸， 便于医生观察及手术， 喇叭形扩口边沿 10-2相当于帽沿， 选用医用橡胶材料 制成， 其上均勾地开设有几处镂空部位， 光源组件 20位于扩口边沿 10-2的外 侧， 光导纤维 30纵向排列在筒身 10-1的外壁上， 并通过扩口边沿 10-2上的 光源接口 40与光源组件 20连接。
光导纤维 30具体为直径在 0.25-0.5mm之间的发光塑料纤维， 光源组件
20 主要由壳体以及位于壳体内部的发光光源和电池构成， 发光光源采用冷光 源， 如尺寸为 2x2、 2x3、 2x4、 2x5mm及直径为 03 ~ 05mm的高亮度发光二 极管， 电池可采用工作电压在 1.5 ~ 5V之间的纽扣电池。
优选地， 所述光导纤维 30为体发光的光导纤维。 更优选地， 所述光导纤 维 30可以为单股或网状。 所述网状光导纤维均由细直径的体发光光导纤维组 成， 可以组成柔性光带。
上述光导纤维不仅可以位于筒身的外壁， 还可以位于筒身的内壁， 或内、 外壁之间。 例如光导纤维可横向缠绕在筒身的内壁上，也可以纵向排列在筒身 的内壁上。 具体地， 在筒身的内壁、 外壁或内、 外壁之间开有细槽， 光导纤维 嵌在细槽内， 较为理想的方式， 是在制作筒身的过程中， 以缠绕或排列的方式 直接复合在筒身的内、外壁之间， 此种方式对筒身的使用性能不会产生任何不 良影响， 但是对加工工艺有一定要求。
请参考图 5、 图 6、 图 7、 图 8、 图 9, 图 5为本发明所提供扩肛器的第三 具体实施方式的外形图； 图 6是图 5中所示外设光源组件的结构示意图； 图 7 是图 5中所示筒身的剖视图； 图 8是图 7中 I部位的局部放大示意图； 图 9是 图 5所示扩肛器去掉外设光源组件后的结构示意图。
在第三种具体实施方式中，本发明所提供的扩肛器包括透明的圆柱形筒身 100, 筒身 100顶部为具有弹性的扩口边沿 200, 扩口边沿 200具有两支侧翼， 其中一支侧翼上设有楔形孔 201。 筒身 100和扩口边沿 200全部由透明材料制 成中间具有空隙的双层结构， 其中间的空隙形成光路通道 101。 外设光源组件 300的发光光源前端设有楔形聚光头 301 , 并且聚光头 301顶面在靠近根部的 位置带有一斜面凸块 311 , 楔形孔 201的顶壁上开设有相应的卡孔 211 , 使用 时，将聚光头 301插入扩口边沿 200上的楔形孔 201中， 当聚光头 301与楔形 孔 201吻合到位时， 斜面凸块 311便弹入卡孔 211 中， 从而将外设电源组件 300固定在扩口边沿 200上。
外设光源组件 300主要由聚光头 301、 发光二极管（图中未示出） 、 电池 302和电源开关 303组成， 发光二极管的两极通过电线与电池 302的正、 负极 相连， 并且发光二极管自矩形壳体中伸出并突入聚光头 301内， 电池 302为工 作电压在 1.5 ~ 5V之间的纽扣电池，连同电源开关 303—起安装在一矩形壳体 中， 电源开关 303的操作端从壳体中向外露出。
发光二极管的可见光由聚光头 301 前端的光路射入口 321 进入筒身 100 的光路通道 101 , 从而使光线充满透明的圆柱形筒身内部， 可见光的光线在圆 柱形筒身内部形成光路， 光线在圆柱形筒身的内壁上经透射和不断的反射（图 中箭头表示光线方向， 虚线表示光线的反射路线） ， 从而照亮整个手术区域。 特别地， 圆柱形筒身 100的底端设有收缩的光路射出口 121 , 光线从该光路射 出口 121透射出去， 从而可以照亮手术时的深部视野。
当然， 筒身的筒壁也可以为导光和透光的透明实体， 由外设光源组件沿筒 身的筒壁照亮手术区域， 其余结构与上述第三种具体实施方式基本相同， 就不 再重复描述。这种结构形式的筒身对加工工艺的要求相对较低，有利于节约制 造成本并提高生产效率。
除了上述扩肛器， 本发明还提供一套肛肠手术器械， 包括一次性痔吻合器 以及扩肛器、 勾线器等配件， 有关扩肛器的具体结构可参考上文的具体描述， 勾线器等其它配件可参考现有技术， 这里不再赘述。 下面仅详细介绍作出改进 的一次性痔吻合器。
请参考图 10、 图 11、 图 12, 图 10是本发明所提供一次性痔吻合器的外 形图； 图 11为图 10中釘仓套的局部放大示意图； 图 12为图 10所示吻合器的 内部结构分解示意图。
如图所示， 本发明所提供的一次性痔吻合器包括抵釘座组件、釘仓组件和 枪身组件。 所述抵釘座组件位于该痔吻合器前部， 通过穿过釘仓组件的连接杆 与枪身组件连接。 所述抵釘座组件包括呈锥体形的抵釘座 1 , 所述抵釘座 1内 设有圆形凹槽以容置垫刀环 2。 所述釘仓组件包括釘仓 3、 位于所述釘仓 3后 部的推釘片 4和釘仓套 5 , 所述釘仓 3和推釘片 4均安装在釘仓套 5的内部， 所述釘仓套 5上设有勾线孔 5-2, 通过该勾线孔 5-2可以将荷包线拉出并将打 好荷包的痔组织拉入釘仓组件的空腔内。进一步地， 所述釘仓组件还包括环形 切刀 （未示出）， 该环形切刀安装在推釘片 4内部， 并且该环形切刀能够随推 釘片 4一起运动。 位于该痔吻合器中部的是枪身组件 6, 所述枪身组件 6的下 方设有活动手柄 7, 在该痔吻合器尾部设有调节螺母 8, 通过旋转调节螺母 8 可以驱动 4氐釘座 1靠近或远离釘仓组件。
在此，所述釘仓 3、推釘片 4以及釘仓套 5三个部件均采用透明材料制成， 这样制作的目的是：第一，可以清楚地观察到安装在釘仓内的缝釘是否有缺失， 第二，使得医生在手术过程中比较清楚地观察到进入釘仓组件空腔中的痔组织 的多少及均勾程度。
釘仓套 5的外套体上开设有一对加大的操作孔 5-1 , 在该操作孔 5-1处可 使用工具钳，通过该操作孔 5-1可以进一步观察进入吻合口部痔组织的多少并 可以通过工具钳调整痔组织使其间隙均勾， 以达到手术更安全可靠的目的，避 免相应并发症的产生。
以下结合附图筒述本发明提供的肛肠手术器械的使用方法。
请参考图 13 , 图 13是本发明所提供一次性痔吻合器与扩肛器的配合示意 图， 为清楚地显示一次性痔吻合器与扩肛器的配合关系， 图中特意省略了外设 光源组件。
医生在使用中，首先在痔块脱垂较少且肛膜外翻较轻微的三个点用三把无 创伤钳固定撑开， 将扩肛器套在缝扎器上， 并将缝扎器套在肛肠导入器上， 使 扩肛器和缝扎器随肛肠导入器一起被导入肛肠中。移去肛肠导入器后，脱垂的 粘膜落入缝扎器的的半圆管形的开口中。按下扩肛器上的电源开关打开照明装 置， 由于扩肛器的圆柱形筒身是透明的， 可以透过它观察到肛肠内的齿状线， 通过旋转缝扎器使缝扎器的开口对准痔组织，在距离齿状线 3-4厘米以上位置 完成整圈的荷包缝合线， 缝合线仅穿过粘膜和粘膜下层。之后旋开圆形痔吻合 器至最大位置，通过扩肛器导入痔吻合器并使其抵釘座深入至荷包缝合线的上 端， 然后将荷包线打结系紧在吻合器的中心杆上。 用勾线器将荷包线的尾端从 痔吻合器的勾线孔中拉出，将拖至吻合器外的缝合线尾端打结或通过施夹钳固 定。 然后， 旋转吻合器尾部的调节螺母使 4氏釘座靠近釘仓组件， 并在此过程中 适度牽拉缝合线， 将脱垂的粘膜层完全置入痔吻合器的釘仓组件的空腔中， 同 时可使用工具钳调整空腔中的痔组织， 确保空腔中的痔组织间隙均匀，待完全 闭合吻合器后，检查痔组织是否合适，再按下活动手柄击发并同时切除空腔中 的脱垂粘膜， 最后退出吻合器。
根据本发明提供的肛肠手术器械， 由于扩肛器带有外设光源组件，且扩肛 器的筒身由透明材料制成， 此外， 由于痔吻合器釘仓、 推釘片和釘仓套三个部 件也采用透明材料制成， 手术时， 痔吻合器的头部深入至扩肛器的筒身内部， 当按下扩肛器上的电源开关打开照明装置时，可见光的光线不但会照亮整个手 术区域， 并且会透过釘仓套照亮其内的釘仓和推釘片， 因而可以使医生清楚地 观察到进入釘仓内缝釘的安装情况以及进入釘仓组件空腔内的痔组织的多少 和均匀情况，有助于医生作出是否击发的判断， 大大提高手术的安全性和成功 以上对本发明所提供的肛肠手术器械及扩肛器进行了详细介绍。本文中应 用于帮助理解本发明的核心思想。应当指出， 对于本技术领域的普通技术人员 来说， 在不脱离本发明原理的前提下， 还可以对本发明进行若干改进和修饰， 这些改进和修饰也落入本发明权利要求的保护范围内。

Claims

权 利 要 求
1、 一种扩肛器， 包括圆柱形筒身， 所述筒身顶部为具有弹性的扩口边沿， 其特征在于， 进一步包括用于照亮手术区域的外设光源组件， 所述外设光源组 件与所述扩口边沿连接。
2、 根据权利要求 1 所述的扩肛器， 其特征在于， 所述筒身的筒壁为导光 和透光的透明实体。
3、 根据权利要求 1 所述的扩肛器， 其特征在于， 所述筒身的筒壁为导光 和透光的双层结构， 其中间的空隙形成光路通道。
4、 根据权利要求 3所述的扩肛器， 其特征在于， 所述筒身的筒壁底端设 有收缩的光路射出口。
5、 根据权利要求 1至 4任一项所述的扩肛器， 其特征在于， 所述外设光 源组件的发光光源前端设有楔形聚光头，所述聚光头卡接于所述扩口边沿上的 楔形孔中。
6、 根据权利要求 1 所述的扩肛器， 其特征在于， 所述筒身上设有光导纤 维， 所述光导纤维通过所述扩口边沿处的光源接口与所述外设光源组件连接。
7、 根据权利要求 6所述的扩肛器， 其特征在于， 所述光导纤维横向缠绕 或纵向排列于所述筒身上。
8、 一种肛肠手术器械， 包括一次性痔吻合器以及配套使用的扩肛器、 穿 线器， 其特征在于， 所述扩肛器具体为上述权利要求 1至 7任一项所述的扩肛 器。
9、 根据权利要求 8所述的肛肠手术器械， 其特征在于， 所述一次性痔吻 合器包括位于吻合器前端的锥体形抵釘座组件、位于抵釘座组件后部的釘仓组 件、位于吻合器中部的枪身组件、位于吻合器后部的手柄组件以及位于吻合器 尾部的调节螺母部件，所述釘仓组件包括釘仓、推釘片以及釘仓套，所述釘仓、 推釘片以及釘仓套三个部件全部采用透明材料制成。
10、 根据权利要求 9所述的肛肠手术器械， 其特征在于， 所述釘仓套的外 套体上开设有一对加大的操作孔。
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