WO2019174091A1 - 一种内窥镜端帽 - Google Patents

一种内窥镜端帽 Download PDF

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Publication number
WO2019174091A1
WO2019174091A1 PCT/CN2018/082737 CN2018082737W WO2019174091A1 WO 2019174091 A1 WO2019174091 A1 WO 2019174091A1 CN 2018082737 W CN2018082737 W CN 2018082737W WO 2019174091 A1 WO2019174091 A1 WO 2019174091A1
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WO
WIPO (PCT)
Prior art keywords
endoscope
end cap
sleeve
protruding member
type
Prior art date
Application number
PCT/CN2018/082737
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English (en)
French (fr)
Inventor
张澍田
冀明
翟惠虹
双建军
韦建宇
冷德嵘
李常青
沈正华
刘春俊
Original Assignee
南京微创医学科技股份有限公司
首都医科大学附属北京友谊医院
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Application filed by 南京微创医学科技股份有限公司, 首都医科大学附属北京友谊医院 filed Critical 南京微创医学科技股份有限公司
Priority to US16/976,007 priority Critical patent/US11864721B2/en
Priority to AU2018413522A priority patent/AU2018413522B2/en
Priority to JP2020546968A priority patent/JP2021514792A/ja
Priority to EP18910025.8A priority patent/EP3766404A4/en
Priority to CA3091868A priority patent/CA3091868A1/en
Publication of WO2019174091A1 publication Critical patent/WO2019174091A1/zh

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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
    • A61B1/31—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
    • 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
    • A61B1/00082—Balloons
    • 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
    • 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
    • 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
    • A61B1/00085—Baskets
    • 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
    • A61B1/0011—Manufacturing of endoscope parts
    • 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
    • A61B1/00131—Accessories for endoscopes
    • 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
    • A61B1/00131—Accessories for endoscopes
    • A61B1/00137—End pieces at either end of the endoscope, e.g. caps, seals or forceps plugs
    • 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
    • A61B1/00147—Holding or positioning arrangements
    • A61B1/00148—Holding or positioning arrangements using anchoring means
    • 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
    • A61B1/00064—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
    • A61B1/00101—Insertion part of the endoscope body characterised by distal tip features the distal tip features being detachable

Definitions

  • the invention relates to a medical endoscopy device, in particular an endoscope end cap.
  • Colonoscopy is an endoscopy for the small intestine
  • colonoscopy is an endoscopy for the distal part of the colon and small intestine. Colonoscopy and colonoscopy are the most effective techniques for assessing the health of the intestines.
  • Colorectal adenoma (especially villous adenoma) is the most precancerous disease of colorectal cancer (CRC). Screening and finding colorectal adenoma and endoscopic resection are the most effective in preventing CRC.
  • the current measure of colonoscopy is recognized as the "gold standard" for the detection of colorectal cancer and its precancerous lesions, adenomas.
  • the colon has three physiological characteristics: the colonic band, the colonic bag and the intestinal lining.
  • the sac-like bag that is, the colonic bag, has a large amount of intestinal fat in the vicinity of the colonic band.
  • the outer part of the intestinal fat is wrapped by the peritoneum, sometimes containing too much fat, can be twisted, or even caught in the intestine, causing intussusception. .
  • the lumen of the colon is not smooth and flat, there are many annular wrinkles, intestinal cavity feces or fecal water; at the same time combined with the adenoma's own characteristics (such as size, shape, number, colorectal anatomy, etc.), making colonoscopy Intestinal adenomas are easily missed when examined for intestinal adenomas.
  • the soft intestinal wall when performing colonoscopy, the soft intestinal wall may be close to the colonoscopy lens, disturbing the imaging, and some small adenomas existing in the annular wrinkles or intestinal feces or fecal water may be missed;
  • colonoscopy may also have "bumps” and "rapid slippage” in the intestine, which increases the rate of missed detection, so the quality of colonoscopy is not ideal.
  • Colorectal cancer is the second most common cancer in Europe and North America after lung cancer.
  • the incidence of colorectal cancer in China has also increased year by year.
  • Colonoscopy is the gold standard for bowel examination and the most effective way to prevent the incidence of colorectal cancer.
  • the current penetration rate of colonoscopy in China is not high, the time of each examination is limited, it is easy to cause missed detection, early detection, early treatment, early prevention, and the incidence of colorectal cancer is relatively advanced compared with Japan. The country is much higher and needs the attention of all medical staff.
  • PCT Patent WO 2011/148172 describes a cover for a medical endoscopic instrument having a plurality of movable, outwardly inclined covering elements of a covering element, the protruding elements being similar to the brush head bristles;
  • the protruding component is poured onto the endoscope surface; when the mirror is retracted, the bristles are opened to assist the stretching of the wrinkles, and the colonoscopy is better completed; however, due to the limited supporting force of the brush bristles on the cavity, Can not expand the endoscope field very well.
  • PCT patent WO 2014/123563 describes an endoscope sleeve comprising a tubular member and spaced apart projecting elements that are bendable in both the proximal and distal directions towards the tubular member. Due to the limited degree of curvature of the protruding elements, the entry resistance to some of the intestinal curved parts may be large; in addition, it is difficult to effectively open the folds in the intestine for the presence of some of the colon intussusception and the colonic band.
  • the object of the present invention is to design an endoscope end cap, especially when cooperating with a colonoscopy, not only the resistance of the lens is small, but also the space ratio of the colonoscope in the cavity during the period of the decapitation examination is extended. Stretching the shortened and folded intestine cavity, so that the folds and bends of the intestine can be displayed at the colonoscope lens to the greatest extent, thereby expanding the visibility of the colonoscope, shortening the time of the devitalization examination, and improving the quality of the single colonoscopy. To reduce the patient's discomfort, the risk of operation and the cost of time, thereby preventing and reducing the incidence of colorectal cancer.
  • the endoscope end cap of the present invention includes a sleeve member, a projecting member, and a movable sleeve.
  • the sleeve member is made of elastic material and can be elastically deformed. After being stretched, it is sleeved at the end of the endoscope and closely matched with the outer diameter of the endoscope to ensure that the end cap does not fall off or slip out when entering and exiting the body cavity.
  • the protruding member surrounds the sleeve member, and after being normally opened, the human body channel can be supported or the inner wall of the natural cavity can be opened, and the back portion of the intestinal pleat wall can be pulled out and displayed under the endoscope field view, thereby Greatly improve the detection rate of endoscopy.
  • the movable sleeve is at the proximal end of the end cap and has an inner diameter slightly larger than the sleeve member and is movable back and forth along the axial direction of the endoscope as the
  • the movable sleeve moves proximally along the axial direction of the endoscope, and the protruding member extends proximally under the pulling of the movable sleeve;
  • the endoscope is axially stretched, has a radially contracted state, and has a small outer circumference, so that the resistance is small, which is advantageous for the endoscope to enter the patient.
  • the movable sleeve When the endoscope is taken out of the human body and the mirror is retracted, the movable sleeve is squeezed by the human tissue and moves distally along the axial direction of the endoscope, so that the protruding element is normally opened and restored to the original state, thereby expanding the patient's digestion.
  • the inner wall of the channel; at this time, the protruding member is compressed along the axial direction of the endoscope, and is radially expanded, and the outer circumference is large, so that the resistance is large; since the digestive tract is opened, the endoscope field is enlarged.
  • the range improves the detection rate of the endoscope and greatly reduces the rate of missed detection of the endoscope.
  • the protruding element is in direct contact with the inner wall of the digestive tract, the lesion or polyp behind the inner wall of the digestive tract is removed by the action of the mirror. Pull out, so that the doctor only needs to inject a small amount of gas to assist in the examination, which can alleviate the pain of the patient.
  • the colonic lumen is enlarged and subjected to the frictional force of the endoscope end cap, the curved part of the colon is straightened, and the fold is flattened, so that some are hidden in the curved part of the colon.
  • the adenoma in the fold or under the excrement is exposed to the eye of the endoscope, which improves the effect of endoscopy and helps to reduce the time of endoscopic retraction.
  • FIG. 1 is a schematic view of the stage of retracting the body cavity after assembly of the endoscope end cap.
  • 2A is a schematic view of the endoscope end cap entering the mirror stage.
  • 2B is a schematic view of the endoscope end cap retracting stage.
  • Figure 3 is a right side view of the everted endoscope end cap.
  • FIG. 4A is a front elevational view of the everted endoscope end cap shown in FIG. 3.
  • FIG. 4B is a cross-sectional view of the eversion type endoscope end cap shown in FIG. 3.
  • Fig. 5 is a side view of the everted endoscope end cap in a die-out state.
  • Figure 6 is a cross-sectional view of the everted endoscope end cap in a die-out state.
  • Figure 7 is a right side view of the combined everted endoscope end cap.
  • Figure 8A is a front view of the combined eversion type endoscope end cap shown in Figure 7
  • Figure 8B is a cross-sectional view of the front view of the combined eversion type endoscope end cap shown in Figure 7.
  • Figure 9 is a schematic view of an umbrella endoscope end cap.
  • Figure 10 is a cross-sectional view of the umbrella endoscope end cap of Figure 9.
  • 11A and 11B are a left side view and a right side view, respectively, of the umbrella endoscope end cap shown in Fig. 9.
  • 12A and 12B are left and right side views, respectively, of another umbrella endoscope end cap.
  • Figure 13 is a schematic illustration of a mesh type endoscope end cap.
  • 14A and 14B are a left side view and a front view, respectively, of the mesh type endoscope end cap shown in Fig. 13.
  • Figure 15 is a schematic illustration of another mesh type endoscope end cap.
  • 16A and 16B are a left side view and a front view, respectively, of the endoscope end cap of Fig. 15.
  • Figure 17 is a schematic illustration of another mesh type endoscope end cap.
  • 18A and 18B are a left side view and a front view, respectively, of the mesh type end cap shown in Fig. 17.
  • Figure 19 is a schematic illustration of a mesh type endoscope end cap incorporating an end cap.
  • 20A and 20B are respectively a left side view and a front view of the mesh type endoscope end cap of the combined end cap shown in Fig. 19.
  • Figure 21 is a right side elevational view of the end cap with a protruding everted endoscope end cap.
  • Fig. 22A is a front elevational view of the everted endoscope end cap shown in Fig. 21;
  • Figure 22B is a cross-sectional view of the eversion type endoscope end cap shown in Figure 21.
  • an endoscope end cap 101 constructed and operative in accordance with an embodiment of the present invention is illustrated that is mounted on an endoscope shaft 103 and inserted into a body lumen 102, including but not limited to, a colon or stomach.
  • a body lumen 102 including but not limited to, a colon or stomach.
  • Endoscopes have image capture devices and working lumens for viewing body lumens, as is well known in the art.
  • the distal end of the endoscope end cap 101 is the end corresponding to the end of the endoscope shaft 103, which is the end farthest from the endoscope expert/colonoscopy expert, and is also the end of the instrument deepest in the patient's body. .
  • the distal movement of the endoscope is into the mirror, i.e., further into the body cavity of the patient, and the proximal movement of the endoscope is a retrospective towards the operator.
  • the endoscope end cap 101 comprises a sleeve member 1, a projecting element 2 and a movable sleeve 3, wherein the inner diameter of the sleeve member 1 is smaller than the endoscope shaft and can be
  • the sleeve is sleeved at the distal end of the endoscope shaft and closely cooperates with the endoscope shaft 103 to ensure that the endoscope end cap 101 does not fall off or slip out when entering and exiting the human body cavity;
  • the sleeve member 1 may be a trapezoidal shape, a tapered shape and a cylindrical shape, the cross-sectional shape of which may be circular, elliptical, triangular, polygonal, etc.; one end of the protruding element 2 is connected to the sleeve member 1 and the other end is connected to the movable sleeve 3;
  • the moving sleeve 3 is at the proximal end of the projecting member 2, the inner diameter
  • the projecting element 2 gradually closes toward the endoscope and even abuts against the outer surface of the shaft of the endoscope, so that the endoscope end cap of the sleeve member 1, the projecting element 2 and the movable sleeve 3 101 in the direction parallel to the axial direction of the endoscope shaft 103, substantially forming a smooth cylindrical body-like structure, such a structure, because of the small radial dimension when entering the mirror, the resistance is small, which is beneficial to the endoscope Entering the intestines, and because the end caps are in contact with the digestive tract, they are smooth and angular, so they will not scratch the intestines and reduce the damage and pain caused to the patients.
  • the movable sleeve 3 is moved by the intestinal tract to move distally along the endoscope, so that the protruding member 2 protrudes outward.
  • the force received by the endoscope end cap 101 is that the pulling force is larger than the insertion force; in the process of the movable sleeve 3 gradually approaching the sleeve member 1, the protruding member 2 changes from a cylindrical shape to a lantern shape.
  • the outer circumference of the projecting element 2 continues to increase during this process; at this time, the movable sleeve 3 is gradually moved toward the sleeve member 1 until it abuts against the sleeve member 1, and when the projecting member 2 After the outer circumference reaches the maximum value, as the force is gradually increased, the protruding member 2 is gradually bent toward the distal end, and the outer circumference of the protruding member 2 is gradually decreased.
  • the intestine is expanded under the support of the protruding element 2, which enlarges the field of view of the endoscope and improves the accuracy of the endoscopy; in addition, the movable sleeve 3 abuts when the mirror is retracted.
  • the two members provide a good supporting force to the protruding member, so that the endoscope end cap 101 is for the intestinal tract.
  • the support is enhanced, and the endoscopic field of view is well expanded, so that the doctor can directly observe some adenomas in a hidden position, and it is not necessary to spend more time focusing on the inspection of a hidden area, which can improve the quality of colonoscopy. It also helps to shorten the time for degenerative examination. The doctor only needs to inject a small amount of gas to assist the examination, which reduces the risk of operation and time, reduces the pain of the patient and helps the patient recover as soon as possible.
  • the endoscope end cap 101 of the present invention can be integrally molded from silicone rubber, rubber or plastic at a time, and the parts are manufacturable and low in cost.
  • the protruding member 2 can also be woven from a memory alloy such as nickel-titanium wire. At this time, the protruding member has a stronger effect of straightening and flattening the intussusbow and the curved portion of the intestine, and can be effectively hidden in the intestine.
  • the inlaid, or wrinkled adenoma is exposed to the colonoscope lens, significantly improving the quality of the colonoscopy.
  • the endoscope end cap 101 of the present invention may further include an end cap 4 which is assembled with the sleeve member 1 and assembled to the endoscope shaft 103, and the end cap 4 is internally
  • the endoscope end cap 101 acts as a further limit and secures it to the endoscope shaft 103, which better prevents the endoscope end cap 101 from coming from the endoscope shaft when entering or retracting the mirror. Slip off.
  • the inner diameter of the movable sleeve 3 is slightly larger than the inner diameter of the sleeve member 1, ensuring that it can freely move axially around the periphery of the endoscope shaft 103.
  • the end cap 4 can be of a very transparent material so as not to affect the visibility and field of view of the endoscope.
  • the protruding member 2 has a tendency to bend distally after being stressed, and at this time, the sleeve member 1 supports the protruding member 2, that is, the protruding member 2 receives A portion of the distal force is applied to the tubular member 1; and the tubular member 1 is coupled to the endoscope shaft 103 in such a manner that it is sleeved over the distal end of the endoscope shaft 103, and such a connection may be There is a risk of slipping off the endoscope shaft after a large force.
  • the end cap 4 After the end cap 4 is assembled with the sleeve member 1 and then connected to the endoscope shaft 103, the end cap 4 securely fixes the sleeve member 1 to the distal end of the endoscope. On the basis of not affecting the existing function of the endoscope end cap 101, the possibility of slipping off from the endoscope is further reduced.
  • the end cap 4 can also be extended axially distally to form a projection such that its end is located deeper into the body than the end of the endoscope, the projection being higher than the end surface of the endoscope; since the entire end cap is high
  • the transparent material does not obscure the field of view of the endoscope during endoscopy.
  • the protruding part can directly contact the lesion, and the covering object can be separated from the folds in the intestinal tract, etc., and because the protrusion has a certain distance from the lens, the imaging of the lens is not affected, and the lesion can be observed.
  • the structure is easier and more effective in diagnosing the condition.
  • the protrusion may be of a straight type, and its structure is as shown in FIG. 21, FIG. 22A and FIG.
  • the protrusion may also be conical, and the conical protrusion can be applied to more different occasions than the straight type protrusion. For example, surgery that requires tunneling, or a small opening with a small opening, the cone is more convenient for deeper penetration.
  • FIG. 3 is a right side view of an everted endoscope end cap comprising a sleeve member 1, a projecting member 2 and a movable sleeve 3.
  • 4A and 4B are a front view and a cross-sectional view, respectively, of an everted endoscope end cap.
  • 5 and 6 are respectively a right side view and a cross-sectional view of the eversion type endoscope end cap in a die-out state, which is a cylindrical structure in which the inner diameter of the left end is larger than the inner diameter of the right end; the right end is opened and pulled to the left to the left end.
  • the entire end cap is subjected to the manufacturing process shown in Figures 5 and 6, and the integrally formed structure includes the projecting member 2 connected to the proximal end of the sleeve member 1, and the projecting member 2 includes a plurality of lengths having a certain width.
  • a strip-like structure extending from the joint with the sleeve member 1 axially along the end cap to the movable sleeve 3, the width of the strip-shaped structure may be consistent, or Gradually changing.
  • the elongated structure of the protruding element 2 may further include an elongated fin 5 which is movable in an initial state of the endoscope end cap 101 and when it is inserted into the mirror.
  • the direction of the sleeve 3 is curved, and the long fins 5 are gradually bent toward the direction of the sleeve member 1 when the mirror is retracted, forming a ring shape around the sleeve member 1, and the body cavity can be turned by the elastic force of the rear fin 5 itself.
  • the support can be opened or the inner wall of the natural cavity can be opened, and the back part of the intestinal pleat wall can be pulled out and displayed under the endoscope field view, thereby greatly improving the detection rate of the endoscopy.
  • the movable sleeve 3 moves proximally along the axial direction of the endoscope, with the movable sleeve 3 oriented
  • the proximal movement can drive the protruding element 2 with or without the elongated fins 5 toward the endoscope shaft 103, so that the endoscope end cap 101 gradually closes toward the endoscope and even closes the endoscope
  • the endoscope end cap 101 formed by the sleeve member 1, the projecting member 2 and the movable sleeve 3 is in the axially parallel direction of the endoscope shaft 103, and is substantially smooth and angular.
  • the cylindrical structure which has little resistance when it enters the mirror, is beneficial to the endoscope entering the intestine, further reducing the patient's discomfort.
  • the movable sleeve 3 When the endoscope is pulled out from the human body, the movable sleeve 3 is moved by the intestinal tract to move distally along the endoscope, and the movable sleeve 3 gradually approaches the sleeve member 1.
  • the protruding member 2 In the middle, the protruding member 2 is changed from a cylindrical shape to a lantern shape and finally formed into a cake shape, and the outer circumference of the protruding member 2 is continuously increased in the process, and at this time, the movable sleeve 3 is gradually moved toward the sleeve member 1 until Abutting against the sleeve member 1, and when the outer circumference of the protruding member 2 reaches a maximum value, as the force is gradually increased, the protruding member 2 is gradually bent toward the distal end, and the outer circumference of the protruding member 2 is gradually decreased.
  • the long fins 5 are gradually bent toward the direction of the sleeve member 1, and the fins 5 are closely attached to the intestinal lumen, which further produces a supporting force to open the intestinal lumen, and can be used to pull the intussusception and the intestines.
  • Straight and flat expose the adenoma hidden in the intussusception or fold after exposure to the colonoscopy lens, enlarge the lumen surface area that can be observed by the lens, reduce the rate of missed detection, and improve the quality of colonoscopy.
  • the end cap is used with an endoscope.
  • the intestine is expanded under the support of the protruding element 2, which enlarges the field of view of the endoscope and improves the accuracy of the endoscopy; in addition, the movable sleeve 3 abuts against the sleeve member.
  • the two members provide a good supporting force to the protruding member 2, so that the endoscope end cap 101 is for the intestine
  • the support is enhanced, and the endoscopic field of view is well expanded, so that the doctor can directly observe some adenomas in a hidden position, and it is not necessary to spend more time focusing on the inspection of a hidden area, which can improve the quality of colonoscopy and also help.
  • doctors In order to shorten the time of degenerative examination, doctors only need to inject a small amount of gas to assist in the examination, which reduces the risk of operation and time, and also helps to shorten the time of degenerative examination and reduce the discomfort of patients.
  • the mold of the endoscope end cap 101 is simple, the manufacturability of the parts is strong, the cost is low, and the supporting force of the endoscope end cap 101 product after folding is enhanced to achieve a better supporting effect.
  • the endoscope end cap 101 can also be used in combination with the end cap 14, as shown in Figures 7, 8A and 8B, which are side, front and front views of a combined eversion type endoscope end cap, wherein The sleeve member 1 and the end cap 14 are assembled and assembled to the endoscope shaft, and the end cap 14 further restricts the endoscope end cap 101 and fixes it to the endoscope to prevent the end.
  • the cap slips off the endoscope when it is in or out of the mirror.
  • the inner diameter of the movable sleeve 2 is slightly larger than the inner diameter of the sleeve member 1, ensuring that it can move freely in the axial direction of the periphery of the endoscope shaft.
  • FIGS. 9, 10, and 11 show an umbrella endoscope end cap
  • FIG. 12 shows another umbrella endoscope end cap
  • 9 is a schematic view of an umbrella endoscope end cap
  • FIG. 10 is a front view of the umbrella endoscope end cap shown in FIG. 9,
  • FIG. 11 is a left end of the umbrella endoscope end cap shown in FIG. View and right view
  • Figure 12 is a left and right side view of another umbrella endoscope end cap.
  • the umbrella endoscope end cap 201 includes a sleeve member 21, a protruding member 22, and a movable sleeve 23.
  • the projecting member includes an umbrella-like projecting member 25 and a connecting rod 26 extending axially from a joint with the sleeve member 21, and one end of the connecting rod 26 is connected to one end of the movable sleeve 3, The other end of the connecting rod 26 is coupled to the axially extending end of the umbrella-like projecting member 25 such that the sleeve member 21, the projecting member 22 and the movable sleeve 23 form an umbrella-like structure.
  • the umbrella-like protruding member 25 in the umbrella endoscope end cap 201 may be a rectangle having a uniform width from the joint portion with the sleeve member 21 as shown in FIG. 11, or may be as shown in FIG. A trapezoidal structure in which the width is widened from the narrower direction from the joint with the sleeve member 21 is shown.
  • a plurality of protrusions may be disposed at the end of the umbrella-shaped protruding member to increase the frictional force, and the protrusions may be designed according to the work requirements, and may be point-like protrusions and intersecting prism-shaped protrusions.
  • the movable sleeve 23 moves proximally along the axial direction of the endoscope, and as the movable sleeve 23 moves toward the proximal end, the protruding member 22 can be driven toward the endoscope.
  • the shaft 103 is brought closer together such that the endoscope end cap 201 is gradually brought closer to the endoscope or even abuts against the outer surface of the shaft of the endoscope, and the sleeve member 21, the projecting member 22 and the movable sleeve 23 are formed.
  • the endoscope end cap 201 is formed in a direction parallel to the axial direction of the endoscope shaft 103, and basically forms a cylindrical structure without any angularity. This structure has little resistance when entering the mirror, which is advantageous for the endoscope. Entering the intestine further reduces the patient's discomfort.
  • the movable sleeve 23 When the endoscope is pulled out from the human body, the movable sleeve 23 is moved by the intestinal tract to move distally along the axial direction of the endoscope, and the connecting rod 26 is opened to drive the umbrella-shaped protruding member 25 completely. Opened and formed into an umbrella shape, when the mirror is retracted, the inner wall of the patient's digestive tract can be opened, and the folds of the inner wall can be dragged out, which is displayed in the endoscope field, which expands the scope of the endoscope and improves the endoscope.
  • the increase will not change after a slight decrease.
  • the pull-out force is greater than the insertion force when entering the mirror.
  • the end cap cooperates with the endoscope during the use of the retracting mirror, and the intestine is expanded under the support of the protruding member 22, which expands the field of view of the endoscope, improves the accuracy of the endoscopy;
  • the sleeve 23 abuts against the sleeve member 21, and the two ends of the protruding member 22 are respectively connected to the two members, so that the two members provide a good supporting force to the protruding member 22, so that the endoscope
  • the support of the end cap 201 for the intestine is enhanced, and the endoscopic field of view is well expanded, so that the doctor can directly observe some adenomas in a concealed position, and does not have to spend more time focusing on the inspection of a hidden area.
  • the endoscope end cap 201 can also be used in combination with the end cap 24, wherein the sleeve member 21 and the end cap 24 are assembled and assembled to the endoscope shaft, the end cap 24 facing the endoscope end cap 201 Further limiting and securing it to the endoscope prevents the end cap from slipping off the endoscope shaft when it is in or out of the mirror.
  • the inner diameter of the movable sleeve 2 is slightly larger than the inner diameter of the sleeve member 1, ensuring that it can move freely in the axial direction of the periphery of the endoscope shaft.
  • Figure 13-16 shows the mesh type endoscope end cap.
  • Figure 17 and Figure 18 show another mesh type endoscope end cap.
  • Figure 19 and Figure 20 show the mesh type end cap assembly end cap. .
  • FIG. 13 and 15 are schematic views of a mesh type endoscope end cap
  • Fig. 14 is a left side view and a front view of the mesh type endoscope end cap corresponding to Fig. 13
  • Fig. 16 is a mesh type corresponding to Fig. 15. Left and front view of the end cap.
  • the mesh type endoscope end cap 301 structure includes a sleeve member 31, a projecting member 32, and a movable sleeve 33 in order from the distal end to the proximal end.
  • the protruding member may be a mesh-like protruding member, and the mesh-like protruding member 32 may be integrally formed by knitting, one end of which is connected to one end of the sleeve member 31, and the other end of which is connected to one end of the movable sleeve 33. .
  • the position of the mesh-like projecting member 32 connected to the sleeve member 31 may be different, in particular, the mesh-like projecting member 32 may be coupled to the proximal end of the sleeve member 31; the mesh-like projecting member 32 may also be coupled to The distal end of the sleeve member 31 such that the grid-like projection member 31 can wrap or semi-pack the sleeve member 31.
  • the mesh type endoscope end cap 301 enters the human body with the endoscope, that is, the endoscope end cap 301 in which the mesh-like convex member 32 is connected to the proximal end of the sleeve member 31 is more likely to enter the human body.
  • FIG. 17 is a schematic view of another mesh type endoscope end cap
  • FIG. 18 is a top view and a front view of the endoscope end cap of FIG.
  • the difference from the mesh type endoscope end cap shown in FIG. 13-16 is that the axial length of the sleeve member in the lantern type endoscope end cap is long, and the protruding member is connected to the distal end of the sleeve member. Therefore, the lantern-type endoscope sleeve member can be more stably fixed on the endoscope than the strawberry-type end cap sleeve member, and can provide greater support force to the grid-like protruding member to keep it open. The state is not easily deformed.
  • the grid-like protruding elements can be lantern type, strawberry type, water drop type, polygonal type, round type, mushroom type, cup type when being opened. Ball type, horn type, triangle type and wing type on the mesh.
  • FIG. 19 is a schematic view of a mesh type endoscope end cap combining end caps
  • FIG. 20 is a left side view and a front view of the mesh type endoscope end cap of the combined end cap shown in FIG.
  • the mesh type endoscope end cap of the combined end cap includes a sleeve member 31, a mesh-like projecting member 32, and a movable sleeve 33 and an end cap 34.
  • the combination endoscope end cap is assembled to the end of the endoscope by the adhesive combination of the sleeve member 31 and the end cap 34, and can be more firmly fixed on the endoscope than when the end cap 34 is not present.
  • the possibility of the end cap 301 slipping off the endoscope is greatly reduced, so that the function of the endoscope end cap can be better utilized.
  • the movable sleeve 33 moves proximally along the axial direction of the endoscope, and as the movable sleeve 33 moves toward the proximal end, the protruding member 32 can be driven toward the endoscope.
  • the shaft 103 is brought closer together such that the endoscope end cap 301 is gradually brought closer to the endoscope and even abuts against the outer surface of the shaft of the endoscope, and the sleeve member 31, the projecting member 32 and the movable sleeve 23 are formed.
  • the endoscope end cap 301 is substantially formed in a direction parallel to the axial direction of the endoscope shaft 103, and is formed into a cylinder-like structure that is smooth without any angularity. This structure has little resistance when entering the mirror, which is advantageous for the endoscope. Enter the intestines. Compared with the eversion type and the umbrella endoscope end cap, the meshing element has a smaller contact area with the digestive tract, and the corresponding resistance is smaller, which further reduces the patient's discomfort.
  • the movable sleeve 33 When the endoscope is pulled out from the human body, the movable sleeve 33 is pressed by the intestinal tract to move distally along the axial direction of the endoscope, and the protruding member 32 is contracted to the distal end to be retracted.
  • the inner wall of the patient's digestive tract is opened; because there are a large number of mesh gaps on the protruding convex element 2, part of the tissue will be squeezed into the mesh space due to the limited space when the mirror is retracted, thereby The action will gradually pull out the wrinkled lesions behind the inner wall, showing the endoscopic field of view, expanding the scope of the endoscope field of view, and improving the detection rate of endoscopy.
  • the movable sleeve 33 is forced to move until it abuts against the sleeve member, and the protruding member 32 is first changed into a spherical shape and then into a cake shape by the cylindrical body at the time of insertion, and the outer circumference of the protruding member will be in the process.
  • the force increases, it becomes larger; after that, as the force continues to increase, the outermost portion of the convex member of the cake gradually bends toward the distal end of the endoscope.
  • the outer circumference of the protruding member is subject to The force increases and becomes smaller. When the mirror is removed, the pull-out force is greater than the insertion force when entering the mirror.
  • the end cap cooperates with the endoscope during the use of the retracting mirror, and the intestine is expanded under the support of the protruding member 32, which expands the field of view of the endoscope, improves the accuracy of the endoscopy;
  • the sleeve 33 abuts against the sleeve member 31, and the two ends of the protruding member 32 are respectively connected to the two members, so that the two members provide a good supporting force to the protruding member 32, so that the endoscope
  • the end cap 301 has enhanced support for the intestine, which greatly expands the endoscopic field of view, so that the doctor can directly observe some adenomas in a concealed position, and does not have to spend more time focusing on the inspection of a hidden area.

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Abstract

一种内窥镜端帽，包括套管构件(1,21,31)、凸出元件(2,22,32)和可移动套管(3,23,33)。套管构件(1,21,31)与内窥镜的前端相连，套管构件(1,21,31)、凸出元件(2,22,32)和可移动套管(3,23,33)依次相连，可移动套管(3,23,33)在内窥镜外表面上可自由活动。内窥镜入镜检查时，端帽(101,201,301)呈平滑的没有棱角的类圆柱体结构，易进入且不会划伤消化道，退镜时，可移动套管(3,23,33)向远端移动并抵靠在套管构件(1,21,31)上为凸出元件(2,22,32)提供一个支撑力使其撑开肠道内壁，可提高单次内镜检查质量，降低患者的不适、操作的风险和操作时间。

Description

一种内窥镜端帽 技术领域
本发明涉及一种医疗内窥镜检查装置，特别是内窥镜端帽。
背景技术
在内窥镜检查过程中，柔性器械用于观察体腔，诸如胃肠道和许多其他体腔。该器械设置有光纤或电荷耦合器件(CCD)摄像机，这使得图像能够围绕弯曲传输以及能够生成图像在屏幕上显示。肠镜是用于小肠的内窥镜检查，而结肠镜是用于结肠和小肠远端部分的内窥镜检查，结肠镜和肠镜检查是评价肠子健康状态的最有效技术。
结直肠腺瘤(尤其是绒毛状腺瘤)是结直肠癌(colorectal cancer，CRC)最主要的癌前疾病，及时筛查和发现结直肠腺瘤并进行内镜下切除是预防CRC的最有效的措施，目前结肠镜检查被公认为是检测结直肠癌及其癌前病变即腺瘤的“金标准”。
然而，由于一些客观因素的存在，特别是肠道本身特殊的生理结构，肠道本身很多地方盘曲，结肠还有结肠带、结肠袋和肠脂垂三大生理特点，部分结肠壁缩成了许多囊状袋，即结肠袋，并且在结肠带附近有多数肠脂垂，肠脂垂的外面为腹膜所包裹，有时内含脂肪量过多，可发生扭转，甚或陷入肠内，引起肠套叠。因此结肠内腔并不是光滑平整的，存在许多环状皱褶、肠腔粪渣或粪水；同时结合腺瘤的自身特征(如大小、形态、数量、结直肠解剖部位等)，使得结肠镜在对肠道腺瘤检查时，肠道腺瘤很容易被漏检。如在进行肠镜退镜检 查时，柔软的肠道壁可能贴近肠镜镜头，扰乱成像，一些存在于环状皱褶或者肠腔粪渣或粪水下的小型腺瘤，可能漏检；退镜时，结肠镜在肠腔内还可能存在“颠簸”和“快速滑脱”现象，更加增加了漏检的比率，因此结肠镜检查质量并不理想。
结直肠癌在欧洲和北美地区是仅次于肺癌的第二大致死癌症，中国的结直肠癌发病率也有逐年增加的势头。结肠镜检查是肠道检查的金标准，也是预防结直肠癌发病率最有效的办法。但因为我国目前结肠镜检查的普及率不高，每次检查的时间有限，容易造成漏检，不能做到早检出，早治疗，早预防，造成结直肠癌的发病率相比日本等发达国家高出很多，需要得到各位医护人员的重视。
在做结肠镜早癌筛查时，如果及时将发现的息肉、腺瘤切除掉，可以大大降低其发展成癌变的风险，降低结直肠癌的发病率。因此，西方发达国家建议50岁以上的人群，每两年要做一次结肠镜检查。但传统的结肠镜检查，由于直肠，结肠的特殊结构，有很多的转弯及内壁褶皱组成，传统的检查，因视角原因，客观上无法看到褶壁的背面造成漏检；报道显示不同肠镜医师操作的腺瘤检出率从7％到53％不等，还具有很大的提高空间；
PCT专利WO2011/148172描述了一种用于医疗内窥器械的覆盖物，该覆盖物具有多个可动的、在外部倾斜的突出元件的覆盖物，突出元件类似于刷子的刷头刷毛；进境时，突出元件的向内窥镜表面倾倒；退镜时，张开刷毛，从而辅助拉伸褶皱，更好的完成结肠镜检查；然而由于刷头刷毛对腔道的支撑作用力有限，并不能很好的扩大内窥 镜视野。
PCT专利WO2014/123563描述了内窥镜套筒，该内窥镜套筒包括管状构件和隔开的凸出元件，凸出元件在朝管状构件的近侧和远侧方向上都可弯曲。由于凸出元件的弯曲程度有限，对于一些肠道弯曲部位的进境阻力可能较大；另外，对于一些结肠肠套叠和结肠带的存在的部位，很难有效打开肠道内的褶皱。
因此迫切需要一种可克服结肠镜检查术中出现的上述相关问题，提升结肠镜疾病检出率，同时又能缩短退镜时间的端帽。
发明内容
本发明的目的，是设计一种内窥镜端帽，特别是在配合结肠镜检查时，不仅入镜阻力小，而且在退镜检查过程时，扩大肠镜在腔道内的空间占比，拉伸短缩、折叠的肠腔，使得肠道褶皱部位和弯曲部位的能够最大程度的呈现在肠镜镜头处，从而扩大肠镜可视范围，缩短退镜检查时间，提高单次结肠镜检查质量，降低患者的不适、操作的风险和时间成本，进而达到预防并减少结直肠癌的发生概率。
本发明中的内窥镜端帽，包括套管构件、凸出元件和可移动套管。套管构件由弹性材料制成，可以发生弹性形变，撑大后套在内窥镜的末端，与内窥镜外径紧密配合，保证端帽进出人体腔道时不会脱落或滑出。凸出元件环绕在套管构件四周，正常撑开后可以将人体腔道支撑开或者可以拨开自然腔道内壁，并将肠道褶壁的背面部分拖出展示在内窥镜视野下，从而大大提高内窥镜检查的检出率。可移动套管在端帽的近端，其内径略大于套管构件，可以随受力的变化沿内窥镜的 轴向前后移动。
当内窥镜插入人体进行内镜检查时，可移动套管沿内窥镜轴向向近端运动，凸出元件在可移动套管的拉动下向近端延伸；此时凸出元件沿内窥镜轴向被拉伸，径向呈收缩状态，外周长小，因此受到的阻力小，有利于内窥镜进入患者体内。当内窥镜从人体中取出即退镜时，可移动套管受到人体组织的挤压，沿内窥镜轴向向远端运动，使凸出元件正常撑开恢复原状，从而撑开患者消化道内壁；此时凸出元件沿内窥镜轴向被压缩，径向呈撑开状态，外周长较大，因此受到的阻力较大；因为消化道被撑开，所以扩大了内窥镜视野范围，提高了内镜检出率，大大减少了内镜的漏检率；同时由于凸出元件与消化道内壁直接接触，从而随着退镜的动作，消化道内壁后面褶皱的病变或息肉被拖出，从而医生在做检查时只需要注入少量气体辅助观察，可以减轻的患者的疼痛感。
因此整个退镜动作运动过程中，由于结肠腔道被扩大，且受到内窥镜端帽的摩擦力作用，结肠的弯曲部位会被拉直，褶皱部位被拉平，从而使得一些隐藏于结肠弯曲部位、褶皱部位内或者排泄物下面的腺瘤暴露于内窥镜的视眼中，提高了内窥镜检查的效果，有利于降低内窥镜退镜时间。
附图说明：
图1为内窥镜端帽组装后从体腔退镜阶段的示意图。
图2A为内窥镜端帽入镜阶段的示意图。
图2B为内窥镜端帽退镜阶段的示意图。
图3为外翻型内窥镜端帽的右视图。
图4A为图3所示的外翻型内窥镜端帽的主视图。
图4B为图3所示外翻型内窥镜端帽的剖视图。
图5为出模状态的外翻型内窥镜端帽的侧视图。
图6为出模状态的外翻型内窥镜端帽的的剖视图。
图7为组合外翻型内窥镜端帽的右视图。
图8A为图7所示组合外翻型内窥镜端帽的主视图
图8B为图7所示组合外翻型内窥镜端帽主视图的剖视图。
图9为伞型内窥镜端帽的示意图。
图10为图9所示伞型内窥镜端帽的剖视图。
图11A和11B分别为图9所示伞型内窥镜端帽的左视图和右视图。
图12A和12B分别为另一种伞型内窥镜端帽的左视图和右视图。
图13是网格型内窥镜端帽的示意图。
图14A和14B分别是图13所示网格型内窥镜端帽的左视图和主视图。
图15是另一种网格型内窥镜端帽的示意图。
图16A和16B分别是图15所示内窥镜端帽的左视图和主视图。
图17是另一种网格型内窥镜端帽的示意图。
图18A和18B分别是图17所示网格型端帽的左视图和主视图。
图19是组合端帽盖的网格型内窥镜端帽的示意图。
图20A和20B分别是图19所示组合端帽盖的网格型内窥镜端帽的左视图和主视图。
图21为端帽盖含突出的外翻型内窥镜端帽的右视图。
图22A为图21所示的外翻型内窥镜端帽的主视图。
图22B为图21所示外翻型内窥镜端帽的剖视图。
附图标号说明
1、21、31、套管构件，2、22、32、凸出元件，3、23、33、可移动套管，5、翅片，4、24、34、端帽盖，25、伞状凸出元件，26、连接杆，101、201、301、内窥镜端帽，102、体腔，103、内窥镜轴杆，7、突出。
具体实施方式
以下结合附图对本发明技术方案进行详细说明。应当理解，此处所描述的具体实施方式仅用以解释本发明，并不用于限定本发明。本申请的范围并不受这些实施方式的限定，乃以申请专利的范围为准。而为提供更清楚的描述及使熟悉该项技艺者能理解本申请的申请内容，图示内各部分并不一定依照其相对的尺寸而绘图，某些尺寸与其他相关尺度的比例会被凸显而显得夸张，且不相关或不重要的细节部分亦未完全绘出，以求图示的简洁。
如图1所示，其示意了根据本发明的实施方式构造及操作的内窥镜端帽101，其安装在内窥镜轴杆103上并插入体腔102内，包括但不限于，结肠或胃肠道的部位或其他体腔部位。内窥镜具有用于观察体腔的图像捕获装置和工作腔道，这是本领域所公知的。内窥镜端帽 101远端是与内窥镜轴杆103末端相应的端部，该端部是离内窥镜专家/结肠镜专家最远的端部，也是仪器最深入病人体内的端部。内窥镜的向远侧运动是入镜，即更远地进入到病人体腔内，内窥镜的向近侧运动是朝向操作者的退镜。
在本发明的非限制性实施方式中，内窥镜端帽101包括套管构件1，凸出元件2和可移动套管3，其中套管构件1的内径小于内窥镜轴杆，可以被撑大后套在内窥镜轴杆的远端末端，与内窥镜轴杆103紧密配合，保证内窥镜端帽101进出人体腔道时不会脱落或滑出；套管构件1可以是台梯形、锥形和柱形，其横截面的形状可以是圆形、椭圆形、三角形、多边形等；凸出元件2一端与套管构件1相连，另一端与可移动套管3相连；可移动套管3在凸出元件2的近端，其内径略大于套管构件1的内径，保证其能在内窥镜轴杆外围沿轴向前后自由移动。
如图2A所示为内窥镜插入人体即入镜时，受到肠道等的挤压，凸出元件2贴向内窥镜轴杆103，可移动套管3沿内窥镜轴向向近端移动；凸出元件2向内窥镜逐渐靠拢甚至紧贴在内窥镜的轴杆外表面上，使得套管构件1，凸出元件2和可移动套管3构成的内窥镜端帽101在与内窥镜轴杆103轴向平行的方向，基本形成平滑没有棱角的类圆柱体结构，此种结构在入镜时因为径向尺寸小，受到的阻力很小，有利于内窥镜进入肠道，且因为端帽与消化道接触部分都是平滑没有棱角的，所以不会刮伤肠道，减轻给患者造成的伤害和痛楚。
如图2B所示为内窥镜从人体腔中拔出即退镜时，可移动套管3 受肠道挤压沿内窥镜轴向向远端运动，使得凸出元件2向外凸出；此时内窥镜端帽101受到的力即拔出力较大，大于插入力；在可移动套管3逐渐靠近套管构件1的过程中，凸出元件2从筒状变成灯笼状最后成饼状，凸出元件2的外周长在这个过程中持续增加；此时，可移动套管3逐渐向套管构件1方向移动，直至与套管构件1相抵，而当凸出元件2的外周长达到最大值后，随着受力的逐渐增加，凸出元件2会逐渐向远端弯曲，凸出元件2的外周长再逐渐减小。退镜过程中，在凸出元件2的支撑下，肠道被撑开，扩大了内窥镜的视野范围，提高了内镜检查的准确率；此外退镜时可移动套管3抵靠在套管构件1上，而凸出元件2的两端分别与这两个部件相连，因此这两个部件对凸出元件提供了一个很好的支撑力，使得内窥镜端帽101对于肠道的的支撑性增强，很好的扩大内窥镜视野，从而医生可以直接观察到一些隐蔽位置的腺瘤，不必花费较多时间专注于某一块隐蔽区域的检查，既可提高结肠镜检查质量，也有助于缩短退镜检查时间，医生在做检查也只需注入少量气体辅助检查，减小了操作的风险和时间成本，减轻患者疼痛的同时有利于患者尽快恢复。
本发明的内窥镜端帽101可以由硅胶、橡胶或塑料一次一体成型，部件的可制造性强，成本低。其中凸出元件2也可以由记忆合金如镍钛丝编织而成，此时的凸出元件将肠套叠、肠道弯曲部位拉直和捋平的效果更强，能有效的将隐藏于肠套叠、或者褶皱后的腺瘤暴露于肠镜镜头下，显著提高结肠镜检查质量。
如图1所示，本发明的内窥镜端帽101还可以包括端帽盖4，端 帽盖4与套管构件1组装后装配到内窥镜轴杆103上，端帽盖4对内窥镜端帽101起进一步的限位作用，并且将其固定到内窥镜轴杆103上，可更好的防止内窥镜端帽101在入镜或退镜时从内窥镜轴杆上滑脱。可移动套管3的内径略大于套管构件1的内径，保证其能在内窥镜轴杆103外围沿轴向自由移动。
端帽盖4可以采用透明度很好的材料，这样不会影响内窥镜的能见度和视野。
在没有端帽盖4的情况下，在退镜时，当内窥镜端帽101受到的摩擦力较大时，可移动套管3会抵靠在管状构件1上，对套管构件1施加一个向远端方向的力；同时凸出元件2在受力后会有向远端弯曲的倾向，而此时的套管构件1对凸出元件2起支撑作用，即凸出元件2受到的向远端的力有一部分会施加到管状构件1上；而管状构件1与内窥镜轴杆103的连接方式为其撑大后套在内窥镜轴杆103的远端，这种连接可能受力较大后有从内窥镜轴杆上滑脱的风险。
将端帽盖4与套管构件1组装到一起后再连接到内窥镜轴杆103上，端帽盖4就会将套管构件1牢牢的固定到内窥镜的远端末端，在不影响内窥镜端帽101已有功能的基础上，进一步减小了其从内窥镜上滑脱的可能性。
端帽盖4还可以轴向向远端延长形成一个突出，使其末端位于较内窥镜末端更深入人体的部位，该突出高于内窥镜的端面；因为整个端帽盖采用的是高透明的材料，因此不会在做内窥镜检查时遮挡内窥镜的视野。在检查时，突出部分可以直接接触病变，并且可以将遮挡 物如肠道内的褶皱等隔开，同时由于突出与镜头存在一定的距离，所以不但不会对镜头成像产生影响，还能使得观察病变结构更加容易，能更有效的诊断病情。该突出可以是直筒型的，其结构如图21，图22A和图22B所示；突出还可以是圆锥形的，相较于直筒型的突出，圆锥形的突出能适用于更多不同的场合，比如需要打隧道的手术，或者开口比较小的创面，圆锥形便于更有效的深入。
在一个实施方式中，如图3所示为外翻型内窥镜端帽右视图，所述内窥镜端帽包括套管构件1、凸出元件2和可移动套管3。图4A和4B分别为外翻型内窥镜端帽的主视图和剖视图。图5，6分别为出模状态的外翻型内窥镜端帽的右视图以及剖视图，其整体为一个左端内径大于右端内径的筒状结构；将右端翻开后向左拉动至越过左端后停止，即可形成如图4A和4B所示的形态。该实施方式中，整个端帽经过图5和6所示的制造工艺，一体成型的结构包括凸出元件2与套管构件1的近端相连，凸出元件2包括若干个具有一定宽度的长条状结构，该长条状结构由与套管构件1的连接处沿端帽轴向延伸至与可移动套管3相连接，该长条状结构的宽度可以是前后一致的，也可以是逐渐变化的。进一步的，凸出元件2的长条状结构上还可包括长条状翅片5，该长条状翅片5在内窥镜端帽101制成的初始状态及入镜时，朝向可移动套管3的方向弯曲，在退镜时长条状翅片5逐渐朝向套管构件1的方向弯曲，在套管构件1四周形成环形，依靠翻开后翅片5自身的弹力可以将人体腔道支撑开或者可以拨开自然腔道内壁，并将肠道褶壁的背面部分拖出展示在内窥镜视野下，从而大大 提高内窥镜检查的检出率。
本实施方式的外翻型内窥镜端帽101，当内窥镜插入人体进行内镜检查时，可移动套管3沿内窥镜轴向向近端运动，随着可移动套管3向近端运动，可带动具有或不具有长条状翅片5的凸出元件2向内窥镜轴杆103方向靠拢，使得内窥镜端帽101向内窥镜逐渐靠拢甚至紧贴在内窥镜轴杆的外表面上，套管构件1，凸出元件2和可移动套管3构成的内窥镜端帽101在于内窥镜轴杆103轴向平行的方向，基本形成平滑没有棱角的类圆柱体结构，此种结构在入镜时受到的阻力很小，有利于内窥镜进入肠道，进一步降低了患者的不适。
当内窥镜从人体中拔出时即退镜时，可移动套管3受肠道挤压沿内窥镜轴向向远端运动，在可移动套管3逐渐靠近套管构件1的过程中，凸出元件2从筒状变成灯笼状最后成饼状，凸出元件2的外周长在这个过程中持续增加，此时，可移动套管3逐渐向套管构件1方向移动，直至与套管构件1相抵，而当凸出元件2的外周长达到最大值后，随着受力的逐渐增加，凸出元件2会逐渐向远端弯曲，凸出元件2的外周长再逐渐减小。在出境过程中，长条状翅片5逐渐朝向套管构件1的方向弯曲，翅片5紧贴肠腔，会进一步产生支撑力撑开肠腔，可以将肠套叠、肠道弯曲部位拉直和捋平，将隐藏于肠套叠、或者褶皱后的腺瘤暴露于肠镜镜头下，扩大镜头可以观察到的肠腔表面积，降低漏检率，提高结肠镜检查质量。
该端帽配合内窥镜使用。退镜过程中，在凸出元件2的支撑下，肠道被撑开，扩大了内窥镜的视野范围，提高了内镜检查的准确率； 此外可移动套管3抵靠在套管构件1上，而凸出元件2的两端分别与这两个部件相连，因此这两个部件对凸出元件2提供了一个很好的支撑力，使得内窥镜端帽101对于肠道的的支撑性增强，很好的扩大内窥镜视野，从而医生可以直接观察到一些隐蔽位置的腺瘤，不必花费较多时间专注于某一块隐蔽区域的检查，既可提高结肠镜检查质量，也有助于缩短退镜检查时间，医生在做检查也只需注入少量气体辅助检查，减小了操作的风险和时间成本，也有助于缩短退镜检查时间，减少患者的不适。并且该内窥镜端帽101的模具简单，零件的可制造性强，成本低，内窥镜端帽101产品翻折后的支撑力增强了，达到更好的支撑效果。
该内窥镜端帽101还可以和端帽盖14组合使用，如图7，8A和图8B所示为组合外翻型内窥镜端帽的侧视图、主视图和主视图的剖视图，其中套管构件1和端帽盖14组合后装配到内窥镜轴杆上，端帽盖14对内窥镜端帽起101起进一步限位作用，并且将其固定到内窥镜上，防止端帽在入镜或退镜时从内窥镜上滑脱。可移动套管2的内径略大于套管构件1的内径，保证其能在内窥镜轴杆外围沿轴向前后自由移动。
如图9-12所示，为本发明的另一种实施方式，图9、10、11所示为伞型内窥镜端帽，图12所示另一种伞型内窥镜端帽。其中图9为伞型内窥镜端帽的示意图，图10为图9所示的伞型内窥镜端帽的主视图，图11为图9所示的伞型内窥镜端帽的左视图和右视图，图 12为另一种伞型内窥镜端帽的左视图和右视图。伞型内窥镜端帽201包括套管构件21、凸出元件22和可移动套管23。凸出元件包括伞状凸出元件25和连接杆26，该伞状凸出元件25由与套管构件21的连接处沿轴向延伸，连接杆26一端与可移动套管3的一端相连，连接杆26的另一端与伞状凸出元件25的沿轴向延伸的一端连接，从而套管构件21、凸出元件22和可移动套管23三者之间形成类似伞状结构。
伞型内窥镜端帽201中的伞状凸出元件25可以是如图11所示的从与套管构件21的连接处向外延伸方向上，宽度一致的长方形，也可以是如图12所示的从与套管构件21的连接处向外延伸方向上，宽度由窄变宽的梯形结构。
在伞状凸出元件的末端可设置若干凸起以增加摩擦力，凸起可以根据工作需要设计相应的形状，可以为点状凸起和交叉棱形凸起等。
当内窥镜插入人体进行内镜检查时，可移动套管23沿内窥镜轴向向近端运动，随着可移动套管23向近端运动，可带动凸出元件22向内窥镜轴杆103方向靠拢，使得内窥镜端帽201向内窥镜逐渐靠拢甚至紧贴在内窥镜的轴杆外表面上，套管构件21，凸出元件22和可移动套管23构成的内窥镜端帽201在与内窥镜轴杆103轴向平行的方向，基本形成平滑没有任何棱角的类圆柱体结构，此种结构在入镜时受到的阻力很小，有利于内窥镜进入肠道，进一步降低了患者的不适。
当内窥镜从人体中拔出时即退镜时，可移动套管23受肠道挤压 沿内窥镜轴向向远端运动，连接杆26张开，带动伞状凸出元件25完全撑开，形成伞状，可在退镜时，撑开患者消化道内壁，并将内壁后面褶皱的病变拖出，展示在内窥镜视野内，扩大了内窥镜视野范围，提高了内镜检出率；此时，可移动套管23受力移动至抵靠在套管构件上，且伞状凸出元件25垂直于套管构件时，外周长最大；此后随着受到的力即拔出力的增加，在连接杆的作用下，伞状凸出元件难于向远端弯曲，仅末端部分还有向远端弯曲的可能性，此时随凸出元件的外周长随拔出力的增加会略微减少后不再变化。退镜检查时拔出力大于入镜时的插入力。
该端帽配合内窥镜使用退镜过程中，在凸出元件22的支撑下，肠道被撑开，扩大了内窥镜的视野范围，提高了内窥镜检查的准确率；此外可移动套管23抵靠在套管构件21上，而凸出元件22的两端分别与这两个部件相连，因此这两个部件对凸出元件22提供了一个很好的支撑力，使得内窥镜端帽201对于肠道的的支撑性增强，很好的扩大内窥镜视野，从而医生可以直接观察到一些隐蔽位置的腺瘤，不必花费较多时间专注于某一块隐蔽区域的检查，既可提高结肠镜检查质量，也有助于缩短退镜检查时间，医生在做检查也只需注入少量气体辅助检查，减小了操作的风险和时间成本，也有助于缩短退镜检查时间，减少患者的不适。
该内窥镜端帽201还可以和端帽盖24组合使用，其中套管构件21和端帽盖24组合后装配到内窥镜轴杆上，端帽盖24对内窥镜端帽起201进一步限位作用，并且将其固定到内窥镜上，防止端帽在入 镜或退镜时从内窥镜轴杆上滑脱。可移动套管2的内径略大于套管构件1的内径，保证其能在内窥镜轴杆外围沿轴向前后自由移动。
现参照图13-20给出了另一种实施方式。如图13-16为网格型内窥镜端帽，如图17和18为另一种网格型内窥镜端帽，如图19和20为网格型端帽装配端帽盖的示意图。
图13和15为网格型内窥镜端帽的示意图，图14为与图13对应的网格型内窥镜端帽的左视图和主视图，图16为与图15对应的网格型内窥镜端帽的左视图和主视图。
网格型内窥镜端帽301结构包括从远端至近端依次为套管构件31、凸出元件32和可移动套管33。凸出元件可以为网格状凸出元件，该网格状凸出元件32可以通过编织的方式一体成型，其一端与套管构件31的一端相连，另一端与可移动套管33的一端相连。
网格状凸出元件32连接在套管构件31上的位置可以不同，具体为网格状凸出元件32可以连接在套管构件31的近端；网格状凸出元件32也可以连接在套管构件31的远端，从而网格状凸出元件31可以将套管构件31包裹或者半包裹在内。在网格型内窥镜端帽301随内窥镜进入人体时，即网格状凸出元件32与套管构件31的近端连接的内窥镜端帽301更容易进入人体。
图17为另一种网格型内窥镜端帽的示意图，图18为图17内窥镜端帽的俯视图和主视图。与图13-16所示的网格型内窥镜端帽的区 别在于，灯笼型内窥镜端帽中套管构件的轴向长度较长，凸出元件连接在套管构件的远端，因此灯笼型内窥镜套管构件相较于草莓型端帽套管构件能更稳定的固定在内窥镜上，能对网格状凸出元件提供更大的支撑力，使其保持撑开状态不易变形。
需注意的是这里的网格型内窥镜端帽中，其网格状凸出元件在撑开时可以是灯笼型，草莓型，水滴型，多边型，圆型，蘑菇型，杯型，球型，喇叭型，三角型以及网格上加翼型等。
图19是组合端帽盖的网格型内窥镜端帽的示意图，图20是图19所示组合端帽盖的网格型内窥镜端帽的左视图和主视图。组合端帽盖的网格型内窥镜端帽包括套管构件31、网格状凸出元件32和可移动套管33和端帽盖34。
组合内窥镜端帽中因套管构件31与端帽盖34粘接组合后装配到内窥镜的末端，相较于没有端帽盖34存在时能更加牢固的固定在内窥镜上，使得端帽301从内窥镜上滑脱的可能性大大减小，因此能更好的发挥内窥镜端帽的作用。
当内窥镜插入人体进行内镜检查时，可移动套管33沿内窥镜轴向向近端运动，随着可移动套管33向近端运动，可带动凸出元件32向内窥镜轴杆103方向靠拢，使得内窥镜端帽301向内窥镜逐渐靠拢甚至紧贴在内窥镜的轴杆外表面上，套管构件31，凸出元件32和可移动套管23构成的内窥镜端帽301在与内窥镜轴杆103轴向平行的方向，基本形成平滑没有任何棱角的类圆柱体结构，此种结构在入镜时受到的阻力很小，有利于内窥镜进入肠道。且网格状相较于外翻型 与伞型内窥镜端帽，其凸出元件与消化道接触的面积更小，相应的受到的阻力更小，更进一步降低了患者的不适。
当内窥镜从人体中拔出时即退镜时，可移动套管33受肠道挤压沿内窥镜轴向向远端运动，凸出元件32向远端收缩撑起，可在退镜时，撑开患者消化道内壁；因撑开的凸出元件2上存在大量的网格空隙，在退镜时部分组织会因有限的空间而挤进网格空隙中，从而随着退镜的动作，会将内壁后面褶皱的病变逐渐拖出，展示在内窥镜视野内，扩大了内窥镜视野范围，提高了内镜检出率。
可移动套管33受力移动直至抵靠在套管构件上，凸出元件32会先由插入时的类圆柱体变成类球形再变至饼状，这个过程中凸出元件的外周长会随受力的增加而变大；此后，随着受力的持续增加，饼状的凸出元件最外侧会逐渐向内窥镜的远端弯曲，这个过程中，凸出元件的外周长随受力的增加而变小。退镜检查时拔出力大于入镜时的插入力。
该端帽配合内窥镜使用退镜过程中，在凸出元件32的支撑下，肠道被撑开，扩大了内窥镜的视野范围，提高了内窥镜检查的准确率；此外可移动套管33抵靠在套管构件31上，而凸出元件32的两端分别与这两个部件相连，因此这两个部件对凸出元件32提供了一个很好的支撑力，使得内窥镜端帽301对于肠道的支撑性增强，很好的扩大内窥镜视野，从而医生可以直接观察到一些隐蔽位置的腺瘤，不必花费较多时间专注于某一块隐蔽区域的检查，既可提高结肠镜检查质量，也有助于缩短退镜检查时间，医生在做检查也只需注入少量气体 辅助检查，减小了操作的风险和时间成本，也有助于缩短退镜检查时间，减少患者的不适。

Claims (17)

  1. 一种内窥镜端帽，其特征在于，所述内窥镜端帽可设于内窥镜远端，其包括：套管构件，凸出元件和可移动套管，所述凸出元件的一端与套管构件相连，所述凸出元件的另一端与可移动套管相连；设有所述内窥镜端帽的内窥镜退镜时，所述可移动套管向内窥镜远端移动，直至与套管构件相抵靠为凸出元件提供支撑力，使得凸出元件撑开，从而扩大内窥镜视野。
  2. 根据权利要求1所述的内窥镜端帽，其特征在于，当设有所述内窥镜端帽的内窥镜入镜时，所述可移动套管沿内窥镜轴向向近端运动，凸出元件向内窥镜逐渐靠拢，使得套管构件、凸出元件和可移动套管均构成的内窥镜端帽在与内窥镜轴杆平行的方向，基本形成平滑的没有棱角的类圆柱体结构。
  3. 根据权利要求1所述的内窥镜端帽，其特征在于，套管构件的内径小于内窥镜轴杆的直径。
  4. 根据权利要求1所述的内窥镜端帽，其特征在于，可移动套管的内径略大于套管构件的内径。
  5. 根据权利要求1或2所述的内窥镜端帽，其特征在于，端帽可以由硅胶、橡胶或塑料一次一体成型，其中凸出元件也可以由记忆合金镍钛丝编织而成。
  6. 根据权利要求1或2所述的内窥镜端帽，其特征在于，还包括端帽盖，所述端帽盖可与所述套管构件组装后装配到内窥镜轴杆上。
  7. 根据权利要求6所述的内窥镜端帽，其特征在于，所述端帽盖采 用透明度好的材料。
  8. 根据权利要求1所述的内窥镜端帽，其特征在于，所述凸出元件为长条状凸出元件。
  9. 根据权利要求8所述的内窥镜端帽，其特征在于，凸出元件上可以连接有长条状翅片，其中翅片靠近管套部件的一端与凸出元件相连，另一端在退镜时将人体腔道撑开。
  10. 根据权利要求1所述的内窥镜端帽，其特征在于凸出元件包括伞状凸出元件和连接杆。
  11. 根据权利要求10所述的内窥镜端帽，其特征在于退镜时，可移动套管沿内窥镜轴向向远端移动，伞状凸出元件受连接杆作用，仅末端部分向远端弯曲。
  12. 根据权利要求10所述的内窥镜端帽，其特征在于伞状凸出元件末端有若干凸起。
  13. 根据权利要求1所述的内窥镜端帽，其特征在于凸出元件为网格状结构。
  14. 根据权利要求13所述的内窥镜端帽，其特征在于，网格状凸出元件包括灯笼型，草莓型，水滴型，多边型，圆型，蘑菇型，杯型，球型，喇叭型，三角型以及网格上加翼型。
  15. 根据权利要求13所述的内窥镜端帽，其特征在于，凸出元件可以连接在套管构件的近端，也可以连接在套管构件的远端。
  16. 根据权利要求1所述的内窥镜端帽，其特征在于，其套管构件包括圆形，椭圆形，三角形，圆锥形，多边形等。
  17. 根据权利要求6所述的内窥镜端帽，其特征在于，所述端帽盖还可以包括突出，该突出可以是直筒型的，也可以是圆锥形的。
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