WO2015028926A1 - 完全转流型肠造瘘手术套件 - Google Patents

完全转流型肠造瘘手术套件 Download PDF

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Publication number
WO2015028926A1
WO2015028926A1 PCT/IB2014/064032 IB2014064032W WO2015028926A1 WO 2015028926 A1 WO2015028926 A1 WO 2015028926A1 IB 2014064032 W IB2014064032 W IB 2014064032W WO 2015028926 A1 WO2015028926 A1 WO 2015028926A1
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WO
WIPO (PCT)
Prior art keywords
tube
balloon
ostomy
intestine
fistula
Prior art date
Application number
PCT/IB2014/064032
Other languages
English (en)
French (fr)
Inventor
林建江
华汉巨
徐加鹤
Original Assignee
Lin Jianjiang
Hua Hanju
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lin Jianjiang, Hua Hanju filed Critical Lin Jianjiang
Priority to EP14839934.8A priority Critical patent/EP3040060B1/en
Priority to US14/911,249 priority patent/US10188542B2/en
Publication of WO2015028926A1 publication Critical patent/WO2015028926A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/4404—Details or parts
    • A61F5/4405—Valves or valve arrangements specially adapted therefor ; Fluid inlets or outlets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices

Definitions

  • the present application relies on and claims the benefit of priority to the benefit of the benefit of the benefit of the benefit of the benefit of the benefit of the benefit of the benefit of the entire disclosure of The present invention relates to a full-flow intestine fistula surgical kit. Background technique
  • a temporary ileal fistula tube is disclosed in Chinese Patent Application No. 201110343626.9.
  • the fistula tube is placed in the terminal ileum through the incision and passed through the abdominal wall, and the negative intestinal pressure is used to block the proximal intestinal contents.
  • the ostomy tube can be directly removed, and the ileal wall incision will heal itself, thus avoiding the operation of the iliac crest.
  • the technical structure is relatively complicated. His main disadvantage is that the diameter of the fistula tube is too small and requires negative pressure. In practical applications, the drainage will not be very smooth, and a specific negative pressure device is required, which is inconvenient to care. Summary of the invention
  • the invention provides a good flow conversion effect, controllable flow control effect, automatic closure of the sputum opening, and avoidance of secondary Surgery complete transfusion enterostomy surgery kit, which is specially designed to assist the sinus closure tube and other accessories to avoid sinus tract sinus after extraction.
  • the present invention provides a complete diversion enterostomy surgical kit comprising at least one ostomy tube, the ostomy tube comprising a tube body, the tube body being provided with a deformable balloon near the front end portion, a portion of the tube in front of the balloon forms a drainage section; a tube is disposed inside or inside the tube wall of the tube body, and a front end of the tube passes through the tube wall of the tube body
  • the lumen of the balloon is in communication, and the rear end of the capillary is connected to an interface with a one-way valve for injecting fluid into the balloon, the interface being provided with a measure for detecting the pressure of the balloon against the intestinal wall a pressure device; the balloon is filled with fluid through the interface to form a closed structure for blocking the contents of the intestine; and the drainage section is provided with a drainage port for guiding the contents of the intestine through the tube body.
  • the complete bypass type enterotomy surgical kit further comprises an annular fixing piece; the outer side of the tube wall of the tube body is provided with an annular groove, and the ostomy tube is matched with the annular groove
  • the annular fixing piece is fixed to the abdominal wall of the patient Connected.
  • the inner ring of the annular fixing piece has four diametrically extending claws, and a space between the ends of the four claws is slightly smaller than an outer diameter of the tubular body, and the annular fixing piece passes The manner in which the jaws are squeezed is caught in the annular groove.
  • the annular fixing piece is buckled above or inside the stoma chassis.
  • the tube body has a spring bracket that can be pumped.
  • the full-flow type enterotomy kit further includes an outer sleeve disposed at a rear end of the tube body and adapted to the tube body, the outer sleeve being used for the tube body Lead the patient's abdominal wall.
  • the full-flow intestine fistula surgical kit further comprises a sinus closure device, the sinus closure device comprising a drainage tube and a peripheral fixation ring integrally formed with the drainage tube, the drainage tube
  • the sinus closure device comprising a drainage tube and a peripheral fixation ring integrally formed with the drainage tube, the drainage tube
  • the outer side wall is provided with a scale.
  • the position of the outer peripheral fixing ring is zero scale, and the scales on the bow tubes on both sides of the outer peripheral fixing ring are sequentially marked with a millimeter extension.
  • the drainage tube is evenly distributed with a plurality of side holes along its length direction.
  • the outer side wall of the tube body of the fistula tube is provided with a scale.
  • the complete bypass intestine fistula surgical kit further comprises a sinus irrigation device,
  • the sinus irrigation device includes a graduated irrigation tube having a suction ear at the upper end.
  • the invention blocks the contents of the intestine by controlling the special balloon, and extracts the intestinal contents from the fistula tube, thereby temporarily protecting the distal anastomosis. After the distal anastomosis is healed, the ostomy tube is removed, and the fistula is automatically opened. Closed, avoiding secondary surgery.
  • the invention clamps the ostomy tube to the outside of the abdominal wall through the buckle structure, avoids the tube body retracting into the abdominal cavity, can clamp the tube body without suturing, is simple and easy to operate, has no influence on the patient and does not bring infection. risk.
  • the present invention is also designed with an additional sinus closure device, which solves the defects of sinus infection and difficulty in closure after ostomy tube removal, avoids secondary surgery and achieves autism.
  • the matching sinus flushing device is also convenient for home care to prevent blockage of the fistula.
  • the ostomy tube of the present invention is provided with a detachable spring, so that the ostomy tube having a larger diameter than the prior art can be used, and the ostomy tube is not damaged to the patient under the premise of providing better circulation effect. .
  • the ostomy tube of the present invention has a scale, which can be cut according to the thickness of the patient's abdomen, so that the drainage distance can be controlled within the shortest range, and the drainage effect is good.
  • the invention can measure the pressure of the balloon, and can ensure that the pressure of the intestinal wall is controlled by refilling the water after the expansion of the intestinal wall, and the sealing effect can still be fully achieved.
  • the present invention has been specially designed on the basis of the existing ostomy tube for fixing the ostomy tube, assisting the ostomy tube extraction, and removing various components such as the sinus tract after the ostomy tube is removed, thereby overcoming the existing Various defects in technology.
  • Figure 1 shows a full-flow intestine fistula surgical sleeve in accordance with an embodiment of the present invention.
  • Figure la shows a schematic perspective view of the annular fixing piece of Figure 1;
  • Figure 2 shows a schematic perspective view of the outer casing
  • Figure 3 shows a schematic view of the process of drawing the ostomy tube through the outer cannula to the abdominal wall of the patient;
  • Figure 4 shows the situation in which the annular fixation piece is stuck on the outside of the abdominal wall after the ostomy tube is pulled out of the abdominal wall;
  • Figure 5 is a schematic view showing the three-dimensional structure of the sinus closure device
  • Figure 6 shows a schematic view of the operation of the sinus closure device
  • Figure 7 shows a schematic view of the structure of the sinus flushing device. detailed description
  • the existing ostomy tube adopts a small-diameter, long-distance drainage ostomy tube, and the drainage effect is poor, and the ideal effect of protecting the distal rectal anastomosis cannot be obtained in practical application.
  • the invention designs a sputum tube with a special balloon and a special structure, an auxiliary sputum tube lead-out, and various accessories for avoiding sinus tract failure after the ostomy tube is removed.
  • the ostomy tube constitutes a complete surgical kit.
  • the respective components constituting the full-flow intestine fistula surgical kit of the present invention will be described in detail below with reference to the accompanying drawings.
  • the complete bypass enterostomy surgical kit constituting the present invention comprises at least one fistula catheter 1, as shown in Fig. 1, which shows a complete bypass intestine fistula operation according to a specific embodiment of the present invention.
  • the fistula tube 1 shown in the figure comprises a tube body 11 made of a synthetic material having a total length of 15 cm (specifically, different models are required according to the abdominal wall of the patient), an inner diameter of 7.5 mm, and an outer diameter of 10 mm.
  • the tube body 11 is provided near the front end portion.
  • the tube body 11 can be made of a soft, thin silica gel.
  • the balloon 12 can be made of a material that is deformable and has a high degree of compliance with low surface tension, such as by day.
  • the balloon 12 of the present invention has a diameter of 3.5 cm, and the balloon 12 is filled with water/gas to exert pressure on the intestinal tube, and the balloon is easily deformed by pressure deformation to extend forward and backward, thereby reducing the pressure on the intestinal tube and simultaneously blocking the closed intestinal tube.
  • the effect is sufficient to ensure the effectiveness and safety of the balloon to block the intestine.
  • the contents of the intestine gradually exert pressure on the intestinal wall, causing the intestine to gradually expand, and the balloon 12 extending before and after filling can also expand with the intestine due to sufficient extension performance. And extending up and down, continue to maintain pressure on the intestinal wall, delay the blocking time.
  • the protection period of intubation ostomy is generally about three weeks in clinical application. After three weeks, the healing of distal rectal anastomosis is examined. For example, the rectal anastomosis has healed, and the ostomy tube can be successfully removed. If the distal anastomosis is healed. Poor, the pressure of the balloon 12 can be controlled by refilling the water, so that the balloon 12 can continue to close the intestinal tube to transfer the contents of the intestine, so that the effect of the transfusion of the fistula can be controlled, and the healing of the distal anastomosis can be fully ensured. It is the biggest feature of this ostomy tube - controllability.
  • ostomy tube Distinguished from all similar ostomy tubes used to protect the rectal anastomosis. After the fistula is removed, the sinus sinus is smoothly closed by the ostomy closing device to avoid the occurrence of sinus failure due to the use of wide-diameter ostomy. This is the second feature of the ostomy tube. .
  • the portion of the tube body 11 located in front of the balloon 12 forms a drainage section 13, and the drainage section 13 has a slanted drainage port 14 for facilitating insertion, for guiding the contents of the intestine through the drainage port 14.
  • the tube wall of the drainage section 13 is provided with a fusiform side hole 15 for assisting drainage.
  • the oblique drainage port 14 may be blocked by the intestinal mucosa, and the auxiliary fusiform side hole 15 can maintain smooth drainage. The effect of preventing the ileal wall from premature expansion due to unsmooth drainage and increased pressure, so that the ostomy tube 1 loses its protective effect.
  • the oblique drainage opening 14 can enlarge the drainage cross section on the one hand, and on the other hand, when the tubular body 11 is inserted, only 0.5 cm in size is cut on the ileal wall.
  • the ostomy tube with an outer diameter of lcm can be smoothly inserted into the intestine, and the smaller the incision of the ileum, the faster the healing rate after extubation, and the lower the probability that the intestinal fistula will not heal after extubation.
  • the inside of the tube wall of the tube body 11 or the tube body 11 is provided with a thin tube 16, and the front end of the thin tube 16 communicates with the inner cavity of the balloon 12 through the tube wall of the tube body 11, and the rear end of the thin tube 16 is connected with a single tube.
  • the balloon 12 is filled with an interface 17 of a fluid (gas or liquid, such as air or water), and the interface 17 is provided with a pressure gauge (not shown) for detecting the pressure of the balloon against the intestinal wall.
  • the one-way valve disposed in the interface 17 may be any valve having a one-way function, and the figure is clear, and the structure of the one-way valve is not specifically drawn.
  • the balloon 12 is fluidized through the interface 17 to form a closed structure between the intestinal tube and the intestinal tube for blocking the contents of the intestine, as shown in Figs.
  • the full-flow type enterotomy surgical kit of the present invention further includes an annular fixing piece 2, as shown in FIGS. 1 and 1a, wherein FIG. 1a shows the annular fixing piece 2 of FIG. Schematic diagram of three-dimensional structure.
  • the outer side of the tube wall of the tube body 11 is provided with an annular groove 18, and the ostomy tube 1 is fixedly connected to the abdominal wall of the patient through the annular fixing piece 2 which cooperates with the annular groove 18.
  • the fistula tube 1 is dragged back into the abdominal cavity, and the present invention adopts a snap structure of the annular fixing piece 2 and the annular groove 18,
  • the tube body 11 of the fistula tube 1 is caught outside the abdominal wall by the annular fixing piece 2, and the tube body 11 is prevented from being retracted into the abdominal cavity.
  • the tubular body 11 is sewn by means of sutures on the outside of the abdominal wall, which obviously aggravates the suffering of the patient, and the suture portion is also easily infected.
  • the invention adopts the buckle structure of the annular fixing piece 2 and the annular groove 18, and the tube body 11 can be caught without sewing, which is simple and easy to operate, has no influence on the patient and does not bring the risk of infection.
  • the outer side wall of the tube body 11 is provided with a scale, and the tube body 11 can be selected according to the thickness of the abdominal wall (measured during the operation), or the tube body 11 can be used according to the thickness of the abdominal wall according to the scale on the tube body 11.
  • the scissors and other tools are cut to a suitable length, and the scale on the tube 11 can also guide the buckle position of the annular fixing piece 2, to prevent the buckle from being too loose or the buckle being too tight to squeeze the abdominal wall to cause itching.
  • the annular fixing piece 2 may be a simple annular sheet-like structure, and the inner diameter of the annular fixing piece 2 is slightly smaller than the outer diameter of the pipe body 11, so that it can be caught in the annular groove 18 by extrusion.
  • the annular fixing piece 2 may also be in the form of a structure in which the inner ring has four diametrically extending claws 21, and the space between the ends of the four claws 21 is slightly smaller than that of the tube body 11. The diameter can also be caught in the annular groove 18 by squeezing the claws 21.
  • FIG. 1 is that the four claws 21 are more susceptible to elastic deformation, and thus are relatively easy to be stuck to the outside of the tubular body 11, It is also easier to remove from the tube body 11.
  • the structure of FIG. 1a can also omit the annular groove 18 on the outer side of the pipe body 11, and the friction between the four claws 21 and the pipe body 11 can be buckled.
  • the annular groove 18 is provided. The structural form of the buckle is better.
  • the annular fixing piece 2 can be fixed to the abdominal wall by snapping on the upper side or the inner side of the stoma chassis. 1. After the annular fixing piece 2 is caught in the annular groove 18, the annular fixing piece 2 faces the abdominal wall side.
  • the anti-allergic adhesive can be adhered to the abdominal wall and then fixed on the outer circumference of the annular fixing piece 2, and then trimmed to the appropriate size of the stoma chassis to protect the incision (as shown in Figure 4), and finally in the stoma chassis Attach the pocket to the contents of the intestines. 2.
  • the mouth chassis is attached first, and the ostomy chassis is attached to the abdominal wall, and then an annular fixing piece is stuck on the ostomy tube in the groove of the ostomy tube, and the bottom surface of the annular fixing piece 2 is made The bottom plate is bonded and fixed.
  • the stoma chassis is a commonly used laminating device in surgery, the structure of which is well known in the art and will not be described in detail.
  • the annular fixing piece 2 can be detachable and can be replaced together when the ostomy chassis is replaced.
  • the skin around the incision can be uniformly pressed to prevent the local compression depression from causing discomfort such as incision dermatitis.
  • the anti-allergic substance can prevent adverse reactions such as itching.
  • the tubular body 11 is provided with a detachable spring support 19, as shown in FIG.
  • the spring bracket 19 can ensure that after the tube body 11 passes through the abdominal wall, the entire tube body 11 is not squeezed and thinned by the abdominal wall tissue, thereby ensuring the shunting effect of the fistula tube 1.
  • the spring bracket 19 can be used.
  • the tube body 11 made of synthetic material loses its support, it will naturally become soft and thin, so that the ostomy tube 1 can be smoothly removed from the ileum, and the tube body 11 in the coarse state can be prevented from being placed in the intestine. The wall is brought out, damaging the intestinal wall.
  • the full-flow enterostomy surgical kit of the present invention may further include an outer sleeve 4 disposed at the rear end of the tubular body 11 and adapted to the tubular body 11, the outer sleeve 4 being used for
  • the tube body 11 is led out of the abdominal wall of the patient.
  • Fig. 2 it shows a three-dimensional structure of the outer sleeve 4, wherein the front end of the outer sleeve 4 is inclined so as to pass through the abdominal wall. .
  • the interface 17 of the end of the fistula tube 1 of the present invention has a large volume and is not easy to be removed from the abdominal wall.
  • FIG. 3 is a schematic view showing the process of the fistula tube 1 leading out of the abdominal wall F of the patient through the outer cannula 4.
  • Fig. 4 shows the case where the ostomy tube 1 is pulled out of the abdominal wall F, and after the removal of the cannula 4, the annular fixing piece 2 is caught on the outside of the abdominal wall F.
  • the enterostomy operation process of the present invention is as shown in Fig. 3, taking the ileum H of the terminal ileum H about 15 cm from the ileocecal valve, and using the absorption line for the concentric circular purse of about 1 cm and 1.5 cm in the ileum H (in the figure) Not shown), the pouch center electric knife cuts a small mouth as much as possible, and inserts the sacral canal 1 into the ileum H until the balloon 12 is fully inserted into the ileum H, and then tightens the inner and outer purses respectively.
  • the cannula 4 is withdrawn, and inside the abdominal cavity, the ileum H and the abdominal wall F are sutured together by an absorbable wire around the circumference of the fistula 1.
  • the annular fixing piece 2 is sleeved on the tubular body 11 to be engaged with the annular groove 18, and the annular groove 18 faces the abdominal wall with an anti-allergic adhesive, which can be adhered and fixed on the abdominal wall.
  • the mouth chassis 3 is attached to the outer periphery of the annular fixing piece 2, and finally the pocket contents are attached to the outside of the ostomy chassis 3.
  • the arrangement of the annular fixing piece 2 prevents the ostomy tube 1 from being retracted, and also protects the skin from erosive water and causes ostomy dermatitis.
  • the pressure of the balloon 12 is monitored. As the intestinal tube gradually expands, the blocking effect of the balloon 12 will gradually decrease. If there is a leak in the distal rectal anastomosis, it is necessary to continue to inject water into the balloon 12 to maintain the balloon 12. Closed, the pressure of the balloon 12 is controlled to delay the protection period.
  • the healing of the distal rectal anastomosis is examined. If the rectal anastomosis has healed, there is no need to continue the ostomy, and the ostomy tube 1 can be successfully removed.
  • the process is: evacuating the balloon 12, withdrawing the tube
  • the spring bracket 19 in the body 11 is softened and thinned, so that the intestinal wall is not damaged.
  • the ostomy tube 1 is successfully removed. Because the fistula tube 1 and the ileum are tightly fixed and sutured, it is easy to damage the intestine tube when the fistula tube 1 is withdrawn, causing bleeding or even perforation.
  • the material used for the fistula tube 1 is soft, through the spring bracket 19 Ensure that the ostomy tube does not collapse and deform during use, and ensure sufficient drainage effect.
  • the spring support 19 is pulled out, the ostomy tube is thinned under the pressing of the abdominal wall, which can ensure the smooth removal of the ostomy tube and avoid damage. Intestinal.
  • the abdominal wall F and the ostomy of the ileum H form a sinus.
  • the healing of the sinus requires a certain time. This condition occurs before the complete healing: the anterior abdominal wall of the sinus is healed first, and the sinus The wound inside the intestine of the intestine has not healed, and the contents flowing through the intestine will be partially retained in the sinus cavity, causing repeated infection of the sinus cavity.
  • the full-flow intestine surgery kit of the present invention further includes a sinus closure device 5, as shown in Figures 5-6, wherein Figure 5 shows the sinus closure device.
  • 5 is a schematic view of the three-dimensional structure
  • FIG. 6 is a schematic view showing the operation of the sinus closure device 5.
  • the sinus closure device 5 includes a drainage tube 51 and a peripheral fixing ring 52 integrally formed with the drainage tube 51.
  • the outer peripheral fixing ring 52 can be bonded to the stoma chassis for fixing effect.
  • the outer wall of the draft tube 51 has a scale.
  • the position of the outer peripheral fixing ring 52 is zero scale, and the scales on the drainage tube 51 on both sides of the outer peripheral fixing ring 52 are sequentially extended by a millimeter.
  • the outer peripheral fixing ring 52 and the drainage tube 51 are integrally formed with a stronger structure, avoiding slippage, and are convenient to manufacture and low in cost.
  • the sinus closure device 5 is specifically designed to assist in sinus closure, preventing the patient from requiring reoperation due to sinus failure.
  • the drainage tube 51 can be shortened by means of a tool such as scissors, according to the depth of the sinus (measured during the operation), with reference to the scale on the drainage tube 51. As shown in Fig.
  • the length of the drainage tube 51 inserted into the sinus to the ileum H is just such that the peripheral fixation ring 52 abuts against the abdominal wall F, and the portion of the drainage tube 51 exposed to the outside of the abdominal wall F is not It needs to be too long, for example, only need to leave about 5mm, and the rest of the reference scale can be cut with scissors.
  • the peripheral fixation ring 52 is located at the middle of the drainage tube 51.
  • any one end can be selected to cut the drainage tube 51 into the sinus. Even if the length is cut due to the surgical strain, the other end can be re-operated.
  • This is also the advantage of setting the position of the peripheral fixing ring 52 to zero scale. Since the ileal H and the abdominal wall F are sutured together, the sinus position does not move, and the drainage tube 51 reaches the ileum H. Even if it is slightly tight, the ileum H is not pushed away from the abdominal wall F, of course, due to the outside of the drainage tube 51. According to the scale reference calculation, the drainage tube 51 does not have a problem that the insertion of the ileum is too long to affect the healing of the intestine.
  • the drainage tube 51 After the drainage tube 51 is inserted into the sinus, the drainage tube 51 is fixed to the outside of the abdominal wall of the patient through the peripheral fixation ring 52.
  • the diameter of the drainage tube is only 3 mm, and the sinus is slowly healed from 10 mm wide to 3 mm small caliber sinus, and drainage is maintained. Unobstructed, easy to close the sinus.
  • the key factor for the smooth closing of the sinus is to keep the sinus circulation smooth, and the peripheral fixing ring 52 can be fixedly bonded to the stoma chassis.
  • the drainage tube 51 is a silicone drainage tube having an inner diameter of 0.3 cm, and the drainage tube 51 is along the drainage tube 51.
  • a plurality of side holes 53 are distributed in the longitudinal direction, and the scale on the outer side wall of the drainage tube 51 can be used to trim the drainage tube 51 by calculating the sinus depth, so that the front end of the drainage tube 51 is placed at the bottom of the sinus without entering the ileum, and does not affect the intestine.
  • the rupture of the road is healed, and at the same time, the circulation is ensured, the formation of the dead space is avoided, the sinus is smoothly closed automatically, and the reoperation due to repeated infection of the sinus is avoided.
  • the invention adopts the sinus closure device 5 to insert the sinus tract, and the inner tissue of the sinus tract gradually crawls and grows to close the inner side of the sinus tract.
  • the oozing fluid during the sinus healing process can flow from the outside of the drainage tube 51 into the inside of the drainage tube 51 through the side hole 53 on the drainage tube 51, and the contents flowing through the intestinal tract can also enter the drainage tube 51 to flow out, and never It will accumulate in the inner side of the sinus to cause inflammation, so that the closed sinus can be gradually grown from the inside to the outside.
  • the drainage tube 51 can be removed, and the tissue gradually grows from the inside to the outside to close the entire sinus, so that the contents flowing through the intestinal tract are not retained in the sinus cavity, causing repeated infection.
  • the sinus closure device 5 is specially designed.
  • the sinus can be smoothly closed, and the drainage tube 51 is fixed to the ostomy through the outer circumferential fixation ring 52.
  • the chassis is easy to use and can be used exclusively for this wide-caliber ostomy. This solution keeps the circulation smooth, gradually withdraws the tube, prevents the dead space from remaining, and automatically closes the sinus. It does not need to be returned again.
  • the complete diversion enterostomy surgical kit of the present invention further comprises a sinus irrigation device 6, as shown in Fig. 7, which shows a schematic view of the sinus irrigation device 6, which is washed
  • the device 6 includes a graduated irrigation tube 61 having an aspiration balloon 62 at the upper end.
  • the inner diameter of the tube 11 of the fistula tube is designed to be about 7.5 mm, the drainage of the intestinal fluid can usually ensure smooth flow, but if the patient has a poor diet, such as eating some food-residue diet such as vegetables, seeded Fruits and the like may easily cause obstruction of the tube body 11. In some special patients, the intestinal fluid is particularly thick and the obstruction of the tube body 11 may occur.
  • the sinus irrigation device 6 is a graduated irrigation tube 61 with an end suction ball 62, which injects water into the tube body. 11 rinsing, convenient for home care, can avoid re-admission.
  • the present invention is designed on the basis of the existing ostomy tube, and is specially designed for fixing the ostomy tube, assisting the sputum tube extraction and removing the sinus tube after the ostomy tube is removed, thereby overcoming various accessories.
  • the prior art There are various drawbacks of the prior art.

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Abstract

一种完全转流型肠造瘘手术套件，包括一个造瘘管（1），造瘘管（1）包括管体（11），管体（11）靠近前端部位设置有可变形的球囊（12）；管体（11）的管壁内部或管体（11）内设置有细管（16），细管（16）的前端穿过管体（11）的管壁与球囊（12）的内腔连通；球囊（12）经接口（17）充流体后与肠管之间形成用于阻断肠内容物的封闭结构；完全转流型肠造瘘手术套件进一步包括环形固定片（2）；管体（11）的管壁外侧开设有环形凹槽（18），造瘘管（1）通过与环形凹槽（18）相配合的环形固定片（2）与患者腹壁（F）固定连接。通过控制球囊（12）压力转流肠内容物，使肠内容物从造瘘管（1）引出，待远端吻合口愈合后拔除造瘘管（1），造瘘口自动闭合。

Description

完全转流型肠造痿手术套件 技术领域
本申请依赖并要求 2013年 8月 27日提交的中国专利申请 201310379014.4 的优先权， 在此通过参考将其全部内容并入本文。 本发明涉及一种完全转流 型肠造痿手术套件。 背景技术
直肠癌行低位吻合术后存在吻合口漏的风险， 一旦发生吻合口漏将带来 严重的并发症， 而临时性的回肠保护性造痿术能够起到保护吻合口漏发生， 降低吻合口漏带来的并发症的作用， 但是目前常用的回肠双腔造痿需要再次 行手术回纳， 而二次回纳同样存在着吻合口漏、 肠梗阻等并发症风险， 如何 去避免二次回纳手术， 避免二次回纳所带来的风险， 一直是肛肠外科医生探 索的一个方向。
中国发明专利申请 201110343626.9中公开了一种临时性回肠造痿管， 在 手术中将造痿管通过切口放置于末端回肠内并穿过腹壁引出体外， 利用负压 达到阻断近端肠内容物并引出体外的目的， 在造痿结束后， 造痿管可直接拔 除， 回肠壁切口将自行愈合， 从而避免还痿手术。但是该技术结构比较复杂， 他的主要缺点应该是造痿管直径太小， 需要负压， 实际应用中引流不会很通 畅， 且需要特定的负压装置， 护理不方便。 发明内容
技术问题
为了克服现有造痿管存在的引流距离长、 转流效果差且结构较复杂的缺 点， 本发明提供一种转流效果好、 转流效果可控型、 造痿口自动闭合， 避免 二次手术的完全转流型肠造痿手术套件， 其中专门设计了用于辅助造痿管拔 除后避免窦道不愈的窦道闭合管等配件。 技术解决方案
为解决上述技术问题， 本发明提供了一种完全转流型肠造痿手术套件， 至少包括一个造瘘管， 所述造痿管包括管体， 管体靠近前端部位设置有可变 形的球囊， 所述管体位于所述的球囊前的部分形成引流段； 所述管体的管壁 内部或管体内设置有细管， 所述细管的前端穿过所述管体的管壁与所述球囊 的内腔连通， 所述细管的后端连接带有单向阀门的用于向所述球囊注流体的 接口， 所述接口设置有用于检测球囊对肠壁的压力的测压仪； 所述球囊经所 述接口充流体后与肠管之间形成用于阻断肠内容物的封闭结构； 所述引流段 上设有将肠内容物通过所述管体引出的引流口； 其中， 所述完全转流型肠造 痿手术套件进一歩包括环形固定片； 所述管体的管壁外侧开设有环形凹槽， 所述造痿管通过与所述环形凹槽相配合的所述环形固定片与患者腹壁固定连 接。
优选地， 所述环形固定片的内环具有四个沿直径方向延伸的卡爪， 所述 四个卡爪的末端之间的空间略小于所述管体的外径， 所述环形固定片通过挤 压所述卡爪的方式卡在所述环形凹槽中。
优选地， 所述环形固定片卡扣在所述造口底盘的上方或内侧。
优选地， 所述管体内带有可抽拨的弹簧支架。
优选地， 所述完全转流型肠造痿手术套件进一歩包括一个设置于所述管 体的后端并与所述管体相适配的外套管， 所述外套管用于将所述管体引出患 者腹壁。
优选地，所述完全转流型肠造痿手术套件进一歩包括一个窦道闭合装置， 所述窦道闭合装置包括引流管和与所述引流管一体成型的外周固定环， 所述 引流管的外侧壁上带有刻度。
优选地， 所述外周固定环所在的位置为零刻度， 所述外周固定环两侧的 弓 I流管上的刻度依次以毫米延伸标注。
优选地， 所述引流管沿其长度方向均匀分布有多个侧孔。
优选地， 所述造痿管的管体的外侧壁上带有刻度。
优选地，所述完全转流型肠造痿手术套件进一歩包括一个窦道冲洗装置， 所述窦道冲洗装置包括一个带刻度的冲洗管， 所述冲洗管上端具有一个吸耳 球。
有益效果
本发明的完全转流型肠造痿手术套件具备如下有益效果：
本发明通过控制特制球囊阻断肠内容物， 使肠内容物从造痿管引出， 起 到临时保护远端吻合口的效果， 待远端吻合口愈合后拔除造痿管， 造痿口自 动闭合， 避免了二次手术。
另外， 本发明通过卡扣结构将造痿管卡住在腹壁外部， 避免管体缩回腹 腔， 无需缝合即可卡住管体， 简单易操作， 对患者没有任何影响并且不会带 来感染的风险。
另外， 本发明还设计有额外的窦道闭合装置， 解决了造痿管拔除后引起 的窦道感染、 闭合困难等缺陷， 避免了二次手术， 达到自闭效果。 配套的窦 道冲洗装置也方便家庭护理， 防止造痿管堵塞。
本发明的造瘘管设置有可拆卸的弹簧， 因而可采用比现有技术直径更大 的造痿管， 在提供更好的转流效果的前提下， 不会增加拔除造痿管对患者的 伤害。
另外本发明的造痿管带有刻度， 可以根据患者腹部厚度进行裁剪， 使得 引流距离可以控制在最短范围内， 引流效果好。
本发明可对球囊测压， 可以保证随着肠壁扩张后通过再次注水控制球囊 对肠壁压力， 仍能起到充分的阻断效果。
总之， 本发明在现有造痿管的基础上， 专门设计了用于固定造痿管、 辅 助造痿管引出以及造痿管拔除后避免窦道不愈的各种配件， 从而克服了现有 技术的种种缺陷。 附图说明
以下附图仅旨在于对本发明做示意性说明和解释， 并不限定本发明的范 围。 其中，
图 1显示的是根据本发明的一个具体实施例的完全转流型肠造痿手术套 件的造痿管的剖视示意图；
图 la显示的是图 1中环形固定片的立体结构示意图；
图 2显示的是外套管的立体结构示意图；
图 3显示的是造痿管通过外套管引出患者腹壁的过程示意图；
图 4显示的是造痿管引出腹壁之后， 撤除外套管后， 采用环形固定片卡 在腹壁外侧的情形；
图 5显示的是窦道闭合装置的立体结构示意图；
图 6显示的是窦道闭合装置的操作示意图；
图 7显示的是窦道冲洗装置的结构示意图。 具体实施方式
为了对本发明的技术特征、 目的和效果有更加清楚的理解， 现对照附图 说明本发明的具体实施方式。 其中， 相同的部件采用相同的标号。
正如背景技术部分所述， 现有造痿管采用的都是小口径、 长距离引流的 造痿管， 引流效果差， 实际应用中不能取得理想的保护远端直肠吻合口的效 果。 没有专用的宽口径造痿管， 而宽口径造痿管可能存在造痿口闭合困难、 拔管风险等缺陷。
因此， 本发明在现有造痿管的基础上， 设计了带有特制球囊及特制结构 的造痿管、 辅助造痿管引出以及造痿管拔除后避免窦道不愈的各种配件， 从 而与造痿管构成了整套的手术套件。 下面参照附图对构成本发明的完全转流 型肠造痿手术套件的各个配件进行逐一详细说明。
其中， 构成本发明的完全转流型肠造痿手术套件至少包括一个造痿管 1， 如图 1所示， 其显示的是根据本发明的一个具体实施例的完全转流型肠造痿 手术套件的造瘘管 1的剖视示意图。
图中所示造瘘管 1包括总长为 15cm (具体根据患者的腹壁厚道需要选用 不同的型号）、 内径 7.5mm， 外径 10mm的合成材料制成的管体 11， 管体 11 靠近前端部位设置有可变形的球囊 12。 管体 11 可以由质地软、 薄的硅胶制 成。球囊 12可由可变形且具有高度顺应性低表面张力的材料制成， 例如由天 然橡胶制成， 其具有良好的可伸展性， 确保球囊 12封闭肠管通路时具有良好 的安全性， 不会因为球囊 12 对肠壁的压力过大引起肠管缺血坏死， 且球囊 12具有抗酸、 抗碱、 耐 37 °C、 耐消化液成分等特点， 可放置体内二个月以上 不变性。 当然， 对于天然橡胶过敏患者， 可改用其他弹性材料制成的球囊。
本发明的球囊 12的直径为 3.5cm， 球囊 12充水 /气后对肠管产生压力， 球囊易受压变形向前后延伸， 降低对肠管的压力， 同时能起到阻断封闭肠管 的效果， 充分保障了球囊阻断肠管的有效性和安全性。 插管造痿术后， 随着 肠蠕动增加， 肠内容物逐渐对肠壁产生压力， 造成肠管的逐渐扩张， 而充水 后前后延伸的球囊 12因充分的延展性能亦可随着肠管扩张而向上下延伸，继 续保持对肠壁的压力， 延迟阻断时间。 插管造痿的保护期目前临床应用中一 般为三周左右， 三周后检查远端直肠吻合口愈合情况， 如直肠吻合口已经愈 合， 可顺利拔除造痿管， 如果远端吻合口愈合情况不佳， 也可通过再次注水 控制球囊 12压力， 使球囊 12继续封闭肠管转流肠内容， 使造痿管的转流效 果达到可控性， 可以充分保证远端吻合口的愈合， 这是本造痿管的最大特征 ——可控性。 区别于既往所有类似的用于保护直肠吻合口的造痿管。 造痿管 拔除后， 通过造瘘闭合装置， 使造痿窦道顺利闭合， 避免因采用宽径造痿引 起窦道不愈的发生， 这是本造痿管的第二特征一一自闭性。
管体 11位于球囊 12前的部分形成引流段 13， 引流段 13具有便于插入 的斜形引流口 14， 用于将肠内容物通过引流口 14引出。 引流段 13的管壁上 开设有具有协助引流效果的梭形侧孔 15， 当肠蠕动时， 斜行引流口 14可能 为肠粘膜覆盖堵塞， 辅助的梭形侧孔 15可以起到保持引流顺畅的效果， 防止 回肠肠壁因引流不通畅、 压力增高而过早扩张， 使造痿管 1 失去保护效果。 其中斜形引流口 14的倾斜角度为 30-60 ° ，斜形引流口 14可以一方面加大引 流横截面， 另一方面当管体 11插入时， 在回肠壁上只要切开 0.5cm大小的口 子即可将外径达到 lcm的造痿管顺利插入回肠内， 回肠的切口越小， 拔管后 的愈合速度越快， 拔管后肠痿不愈的概率越低。
管体 11的管壁内部或管体 11内设置有细管 16，细管 16的前端穿过管体 11的管壁与球囊 12的内腔连通， 细管 16的后端连接带有单向阀门的用于向 球囊 12注流体 （气体或液体， 例如空气或水） 的接口 17， 接口 17设置有用 于检测球囊对肠壁的压力的测压仪 （图中未示出）。 其中， 设置于接口 17中 的单向阀门可以是任何一种具备单向导通功能的阀门， 图中为显示清楚， 并 未具体画出单向阀门的结构。
球囊 12经接口 17充流体后与肠管之间形成用于阻断肠内容物的封闭结 构， 如图 3-4所示。
与现有技术不同的是， 本发明的完全转流型肠造痿手术套件进一歩包括 环形固定片 2， 如图 1和 la所示， 其中图 la显示的是图 1中环形固定片 2 的立体结构示意图。 对应的， 管体 11 的管壁外侧开设有环形凹槽 18， 所述 造痿管 1通过与环形凹槽 18相配合的所述环形固定片 2与患者腹壁固定连 接。 亦即， 肠造瘘手术完成之后， 为便于将造痿管 1 固定避免肠道蠕动将造 痿管 1拖回腹腔内部，本发明采用了环形固定片 2和环形凹槽 18的卡扣结构， 通过环形固定片 2将造痿管 1的管体 11卡住在腹壁外部， 避免管体 11缩回 腹腔。 现有技术中， 管体 11是通过在腹壁外部用缝线的方式缝住的， 这显然 会加重患者的痛苦， 而且缝线部位也很容易感染。 本发明采用环形固定片 2 和环形凹槽 18 的卡扣结构， 无需缝合即可卡住管体 11， 简单易操作， 对患 者没有任何影响并且不会带来感染的风险。
进一歩， 管体 11外侧壁上带有刻度， 管体 11可依据不同腹壁厚度 （在 手术过程中测量获得）选用不同规格长度， 或者根据腹壁厚度依照管体 11上 的刻度将管体 11用剪刀等工具剪短至合适的长度， 同时管体 11上的刻度还 可以指导环形固定片 2的卡扣位置， 避免卡扣太松脱落或者卡扣太紧挤压腹 壁引起瘙痒。
具体来说， 环形固定片 2可以是简单的环形片状结构， 环形固定片 2的 内径略小于管体 11的外径， 因而可以通过挤压的方式卡在环形凹槽 18中。 或者， 如图 la所示， 环形固定片 2也可以是内环具有四个沿直径方向延伸的 卡爪 21的结构形式， 四个卡爪 21的末端之间的空间略小于管体 11的外径， 同样可以通过挤压卡爪 21的方式卡在环形凹槽 18中。图 la这种结构形式的 好处是四个卡爪 21更容易发生弹性变形， 因而相对容易卡到管体 11外侧， 也比较容易从管体 11上拆下。 在特殊情况下， 图 la这种结构还可以省略管 体 11外侧的环形凹槽 18，由四个卡爪 21与管体 11的摩擦力就可以进行卡扣 固定， 当然， 具有环形凹槽 18的结构形式卡扣的效果更好。
对应的， 环形固定片 2可通过卡扣在造口底盘的上方或内侧两种方式与 腹壁固定， 1、 环形固定片 2卡入环形凹槽 18后， 环形固定片 2面向腹壁的 一面带有抗过敏物质的粘合胶， 可以粘在腹壁上贴合固定， 然后在环形固定 片 2外周再贴修剪后的合适大小的造口底盘保护切口 （如图 4所示）， 最后在 造口底盘上贴造口袋接肠内容物。 2、 造痿管 1从腹壁引出之后， 先贴造口底 盘， 造口底盘与腹壁贴合后在造口底盘上卡上环形固定片于造痿管凹槽内， 环形固定片 2底面与造口底盘粘合固定。 造口底盘为外科手术中常用贴合器 件， 其结构乃为本领域所公知， 因此不再细述。
另外， 如前所述， 环形固定片 2可以为可脱卸式， 可以在更换造口底盘 时可一起更换。
环形固定片 2固定时切口周围皮肤可以均匀受压， 防止局部受压凹陷引 起切口皮炎等不适症状。环形固定片 2卡入环形凹槽 18后， 抗过敏物质可以 防止瘙痒等不良反应。
在本发明的另一个具体实施例中， 管体 11内带有可抽拨的弹簧支架 19， 如图 1所示。 弹簧支架 19可以保证管体 11穿过腹壁后， 整个管体 11不被腹 壁组织挤压变细， 保证造痿管 1的分流效果， 在需要拔除造痿管 1的时候， 可以将弹簧支架 19从管体 11中抽出，此时合成材料制成的管体 11失去支撑 会自然变软变细， 这样就可以将造痿管 1从回肠中顺利拔除， 可防止粗大状 态的管体 11将肠壁带出， 损伤肠壁。
进一歩的， 本发明的完全转流型肠造痿手术套件还可以进一歩包括一个 设置于管体 11的后端并与管体 11相适配的外套管 4，所述外套管 4用于将所 述管体 11引出患者腹壁， 如图 2所示， 其显示的是外套管 4的立体结构示意 图， 其中外套管 4的前端为斜形， 以便于穿过腹壁？。 本发明的造痿管 1的 末端的接口 17体积较大， 不容易脱出腹壁， 故专门设计外套管 4， 方便手术 操作， 防止接口 17在引出腹壁的过程中受损， 具体操作方式参照图 3-4。 下面参照附图 3-4详细说明本发明的完全转流型肠造痿手术套件的操作 流程。 其中， 图 3显示的是造痿管 1通过外套管 4引出患者腹壁 F的过程示 意图。 图 4显示的是造痿管 1引出腹壁 F之后， 撤除外套管 4后， 采用环形 固定片 2卡在腹壁 F外侧的情形。
在直肠癌手术过程中， 首先将直肠段需要进行的手术完成之后， 为了避 免人体消化后的肠内容物达到直肠段， 需要通过肠造痿手术， 在直肠的前端 将肠内容物截流引出体外， 使之不通过正常的消化路径由直肠到肛门排出， 以避免肠内容物与直肠的手术切口部位接触导致感染。
本发明的肠造痿手术过程是，如图 3所示，取末端回肠 H距离回盲瓣 15cm 左右的回肠 H，在回肠 H上用吸收线作 lcm、 1.5cm大小左右同心圆荷包（图 中未示出）， 荷包中心电刀切一尽量小的口子， 将造痿管 1 斜面插向回肠 H 中， 直至球囊 12全部插入回肠 H后分别收紧内外荷包。 然后从接口 17处注 水， 注意控制球囊 12对肠壁的压力在 30-40cmHg之间， 再在腹壁 F上做一 lcm左右切口， 将外套管 4从腹壁 F外穿入腹腔， 通过外套管 4将造痿管 1 引出腹壁？。
之后， 如图 4所示， 撤除外套管 4， 在腹腔内部， 围绕造痿管 1周边用 可吸收线绕管将回肠 H和腹壁 F缝合固定在一起。
然后， 在管体 11上套上环形固定片 2， 使之卡入环形凹槽 18， 环形凹槽 18面向腹壁的一面带有抗过敏物质的粘合胶， 可以粘在腹壁上贴合固定， 然 后在环形固定片 2外周再贴造口底盘 3， 最后在造口底盘 3外侧贴造口袋接 肠内容物。 环形固定片 2的设置既可以防止造痿管 1回缩， 又可以保护皮肤 不被粪水侵蚀， 引起造口皮炎。
术后注意监测球囊 12的压力， 随着肠管逐渐扩张， 球囊 12阻断效果会 逐渐下降， 如果远端直肠吻合口有漏的发生， 需继续向球囊 12注水， 保持球 囊 12的封闭性， 控制球囊 12压力以延迟保护周期。
直肠癌手术三周之后， 检查远端直肠吻合口愈合情况， 如直肠吻合口已 经愈合， 就不需要继续造痿了， 可顺利拔除造痿管 1， 其过程为： 抽空球囊 12， 抽出管体 11内的弹簧支架 19， 管体 11变软变细， 即可在不损伤肠壁的 情况下顺利拔除造痿管 1。 因造痿管 1 与回肠紧密固定缝合， 抽出造痿管 1 时容易将肠管损伤， 引起出血甚至穿孔等风险， 为避免拔管时的风险， 造痿 管 1所用材料较软， 通过弹簧支架 19保证造痿管在使用时不塌陷变形， 保证 充分的引流效果， 在拔除时， 将弹簧支架 19抽出后造痿管在腹壁挤压作用下 变细， 可以保障造痿管的顺利拔除， 避免损伤肠道。
造痿管 1拔除后， 腹壁 F与回肠 H的造痿口形成窦道， 窦道的愈合需要 一定的时间， 在完全愈合之前， 会出现这种情况： 窦道外侧腹壁创面先愈合， 而窦道内侧肠道创面还未愈合，流经肠道的内容物会有部分滞留在窦道腔内， 造成窦道腔的反复感染。
为避免上述这种情况的发生， 本发明的完全转流型肠造痿手术套件进一 歩包括一个窦道闭合装置 5， 如图 5-6所示， 其中， 图 5显示的是窦道闭合装 置 5的立体结构示意图， 图 6显示的是窦道闭合装置 5的操作示意图。 如图 5所示， 窦道闭合装置 5包括引流管 51和与引流管 51—体成型的外周固定 环 52， 外周固定环 52可以粘合在造口底盘上起固定效果。 引流管 51的外侧 壁上带有刻度， 例如， 外周固定环 52所在的位置为零刻度， 外周固定环 52 两侧的引流管 51上的刻度依次以毫米延伸标注。 外周固定环 52与引流管 51 一体成型的结构强度更大， 避免滑脱， 而且制造方便， 成本低廉。
参照图 5-6所示， 窦道闭合装置 5专门用于辅助窦道闭合， 防止患者因 窦道不愈而需要再次手术。 当造痿管 1拔除后， 可以根据窦道的深度 （在手 术过程中测量获得）， 参照引流管 51上的刻度， 利用剪刀之类的工具将引流 管 51剪短。 如图 6所示， 引流管 51剪短之后， 插入窦道直抵回肠 H的引流 管 51的长度正好使得外周固定环 52贴紧腹壁 F, 并且， 引流管 51暴露在腹 壁 F外侧的部分也不需要太长，例如只需要留下 5mm左右，其余的参照刻度 用剪刀剪掉即可。
图 5中外周固定环 52位于引流管 51的中间位置， 手术过程中可以选择 任意一端剪短引流管 51插入窦道， 即便由于手术紧张剪错了长度， 还可以用 另一端重新操作。 这也是将外周固定环 52 所在的位置设为零刻度的好处之 由于之前回肠 H和腹壁 F是缝合固定在一起的，因此窦道位置不会移动， 引流管 51抵达回肠 H即便稍紧， 也不会将回肠 H推离腹壁 F, 当然由于有 引流管 51外侧的刻度参照计算， 引流管 51也不存在由于太长而插入回肠影 响肠道愈合的问题。
引流管 51插入窦道之后，通过外周固定环 52将引流管 51固定在患者腹 壁外侧， 引流管直径只有 3mm， 使窦道慢慢愈合从 10mm宽径变为 3mm小 口径窦道， 并且保持引流通畅， 易于窦道闭合。
本发明中， 窦道顺利闭合的关键因素就是保持窦道的引流通畅， 外周固 定环 52可固定黏合在造口底盘上， 引流管 51为硅胶引流管， 内径 0.3cm大 小， 引流管 51沿其长度方向均与分布有多个侧孔 53， 引流管 51外侧壁上的 刻度可用于通过计算窦道深度修剪引流管 51， 使引流管 51 前端置于窦道底 部而不进入回肠， 不影响肠道破口愈合， 同时保证引流通畅， 避免死腔形成， 使窦道顺利自动闭合， 避免因窦道反复感染而需要再次手术。
本发明采用窦道闭合装置 5插入窦道， 窦道内侧组织逐渐爬行生长先闭 合窦道内侧。 窦道愈合过程中的渗出液体， 可以通过引流管 51 上的侧孔 53 从引流管 51的外侧进入引流管 51 内部流出， 流经肠道的内容物也可以进入 引流管 51流出， 从而不会积聚在窦道内侧引发炎症， 从而可以从内到外逐渐 生长闭合窦道。 之后可以拔除引流管 51， 组织由内向外逐渐生长封闭整个窦 道， 这样就不会出现流经肠道的内容物滞留在窦道腔内， 引起反复感染。
本发明中， 由于造痿管的外径达到了 lcm， 区别于既往所用的造痿管， 临床应用中存在窦道闭合困难、 反复窦道感染， 甚至需要再次手术的可能， 为了使插管造痿达到自动闭合， 避免二次手术的目的， 专门设计了窦道闭合 装置 5， 通过设计带有刻度的引流管 51， 保证窦道的顺利闭合， 引流管 51通 过外周固定环 52固定于造口底盘，使用方便，可专门用于这种宽口径的造痿， 此方案可保持引流通畅， 逐渐退管， 防止死腔残留， 使窦道自动闭合， 不需 要再次回纳。
另外， 本发明的完全转流型肠造痿手术套件进一歩包括一个窦道冲洗装 置 6， 如图 7所示， 其显示的是窦道冲洗装置 6的结构示意图， 该窦道冲洗 装置 6包括一个带刻度的冲洗管 61， 冲洗管 61上端具有一个吸耳球 62。 本 发明中， 尽管造瘘管的管体 11 内径设计为 7.5mm左右， 引流肠液通常可以 保证引流通畅， 但是如果术后患者饮食不当， 如食用了一些带有食物残渣的 饮食如蔬菜、 带籽的水果等容易引起管体 11梗阻， 某些特殊患者肠液特别稠 厚也会发生管体 11梗阻情况， 窦道冲洗装置 6为带刻度的冲洗管 61上端接 吸耳球 62， 将水注入管体 11进行冲洗， 方便患者家庭护理， 可以避免再次 入院。
综上所述， 本发明在现有造痿管的基础上， 专门设计了用于固定造痿管、 辅助造痿管引出以及造痿管拔除后避免窦道不愈的各种配件， 从而克服了现 有技术的种种缺陷。
本领域技术人员应当理解， 虽然本发明是按照多个实施例的方式进行描 述的， 但是并非每个实施例仅包含一个独立的技术方案。 说明书中如此叙述 仅仅是为了清楚起见，本领域技术人员应当将说明书作为一个整体加以理解， 并将各实施例中所涉及的技术方案看作是可以相互组合成不同实施例的方式 来理解本发明的保护范围。
以上所述仅为本发明示意性的具体实施方式， 并非用以限定本发明的范 围。 任何本领域的技术人员， 在不脱离本发明的构思和原则的前提下所作的 等同变化、 修改与结合， 均应属于本发明保护的范围。

Claims

权 利 要 求 书
1. 一种完全转流型肠造痿手术套件， 至少包括一个造痿管 （1)， 所述造 痿管（1)包括管体（11)，管体（11)靠近前端部位设置有可变形的球囊（12)， 所述管体（11) 位于所述的球囊 （12) 前的部分形成引流段 （13); 所述管体
(11) 的管壁内部或管体（11) 内设置有细管 （16)， 所述细管 （16) 的前端 穿过所述管体 （11) 的管壁与所述球囊 （12) 的内腔连通， 所述细管 （16) 的后端连接带有单向阀门的用于向所述球囊（12)注流体的接口 （17)， 所述 接口 （17) 设置有用于检测球囊对肠壁的压力的测压仪； 所述球囊 （12) 经 所述接口 （17) 充流体后与肠管之间形成用于阻断肠内容物的封闭结构； 所 述引流段 （13) 上设有将肠内容物通过所述管体 （11) 引出的引流口 （14); 其特征在于， 所述完全转流型肠造痿手术套件进一歩包括环形固定片 （2); 所述管体 （11) 的管壁外侧开设有环形凹槽 （18)， 所述造痿管 （1) 通过与 所述环形凹槽 （18) 相配合的所述环形固定片 （2) 与患者腹壁固定连接。
2. 如权利要求 1所述的完全转流型肠造痿手术套件， 其特征在于， 所述 环形固定片 （2) 的内环具有四个沿直径方向延伸的卡爪 （21)， 所述四个卡 爪 （21) 的末端之间的空间略小于所述管体 （11) 的外径， 所述环形固定片
(2) 通过挤压所述卡爪 （21) 的方式卡在所述环形凹槽 （18) 中。
3. 如权利要求 1或 2所述的完全转流型肠造痿手术套件， 其特征在于， 所述环形固定片 （2) 卡扣在所述造口底盘 （3) 的上方或内侧。
4. 如权利要求 1-3之一所述的完全转流型肠造痿手术套件，其特征在于， 所述管体 （11) 内带有可抽拨的弹簧支架 （19)。
5. 如权利要求 1-4之一所述的完全转流型肠造痿手术套件，其特征在于， 所述完全转流型肠造痿手术套件进一歩包括一个设置于所述管体 （11) 的后 端并与所述管体（11) 相适配的外套管 （4)， 所述外套管 （4)用于将所述管 体 (11) 引出患者腹壁。
6. 如权利要求 1-4之一所述的完全转流型肠造痿手术套件，其特征在于， 所述完全转流型肠造痿手术套件进一歩包括一个窦道闭合装置 （5)， 所述窦 道闭合装置 （5)包括引流管 （51)和与所述引流管（51)—体成型的外周固 定环 （52)， 所述引流管 (51 ) 的外侧壁上带有刻度。
7. 如权利要求 6所述的完全转流型肠造痿手术套件， 其特征在于， 所述 外周固定环 （52) 所在的位置为零刻度， 所述外周固定环 （52) 两侧的引流 管 （51 ) 上的刻度依次以毫米延伸标注。
8. 如权利要求 7所述的完全转流型肠造痿手术套件， 其特征在于， 所述 引流管 （51 ) 沿其长度方向均匀分布有多个侧孔 （53 )。
9. 如权利要求 1-4之一所述的完全转流型肠造痿手术套件，其特征在于， 所述造痿管 （1 ) 的管体 （11 ) 的外侧壁上带有刻度。
10. 如权利要求 4-9 之一所述的完全转流型肠造痿手术套件， 其特征在 于， 所述完全转流型肠造痿手术套件进一歩包括一个窦道冲洗装置 （6)， 所 述窦道冲洗装置 （6) 包括一个带刻度的冲洗管 （61 )， 所述冲洗管 （61 ) 上 端具有一个吸耳球 （62)。
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EP3040060A1 (en) 2016-07-06
US20160193072A1 (en) 2016-07-07
CN103405297A (zh) 2013-11-27
CN104146809A (zh) 2014-11-19
EP3040060A4 (en) 2017-01-18
US10188542B2 (en) 2019-01-29
CN104146809B (zh) 2016-07-06

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