WO2017084203A1 - 一种双套管式造瘘管 - Google Patents

一种双套管式造瘘管 Download PDF

Info

Publication number
WO2017084203A1
WO2017084203A1 PCT/CN2016/070718 CN2016070718W WO2017084203A1 WO 2017084203 A1 WO2017084203 A1 WO 2017084203A1 CN 2016070718 W CN2016070718 W CN 2016070718W WO 2017084203 A1 WO2017084203 A1 WO 2017084203A1
Authority
WO
WIPO (PCT)
Prior art keywords
tube
drainage
outer tube
wall
channel
Prior art date
Application number
PCT/CN2016/070718
Other languages
English (en)
French (fr)
Inventor
陈勇
苟欣
何卫阳
Original Assignee
陈勇
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201510785503.9A external-priority patent/CN105343985B/zh
Priority claimed from CN201520911817.4U external-priority patent/CN205287205U/zh
Application filed by 陈勇 filed Critical 陈勇
Publication of WO2017084203A1 publication Critical patent/WO2017084203A1/zh

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the invention belongs to the field of medical instruments, and particularly relates to a double cannula type fistula tube.
  • Percutaneous nephrolithotomy is a modern minimally invasive technique for the treatment of urinary calculi. It is one of the most commonly used treatments for urological treatment of renal and ureteral calculi. It has the advantages of small trauma, high stone clearance rate and small renal damage. , but there is also a risk of serious bleeding and infection.
  • the ostomy channel is established through the puncture and dilation between the skin and the renal pelvis, and then placed into the sheath tube (skin sheath) and operated by the intraductal channel. Place the renal ostomy channel to drain urine and pressure to stop bleeding.
  • the diameter of the renal fistula tube must be smaller than the diameter of the sheath tube and the renal parenchymal fistula channel, it can be placed in the kidney. Therefore, there is a certain gap between the renal parenchymal fistula channel and the renal fistula tube, and the renal fistula tube directly compresses the renal fistula.
  • the effect of hemostasis in the wound of the channel is limited, which can lead to continuous hemorrhage in the renal parenchymal fistula. If the bleeding penetrates into the kidney, it can cause severe hematuria. If the blood clot blocks the fistula, it can cause severe renal colic.
  • the most widely used renal fistula tube is actually a shortened length double-chamber latex or silicone catheter.
  • the front side has a drainage side hole 01 connected with the intra-tube drainage channel 02, and the drainage side of the catheter is provided at the front end of the catheter.
  • An air bag 03 is disposed behind the hole 01.
  • the air bag 03 communicates with a water injection pipe 04 which extends along the wall of the urinary tube to the rear end of the urinary tube and forms a branch branch with the rear end of the drainage channel 02.
  • the catheter After the balloon is filled with water through the water injection pipe to fill it, the catheter is pulled back to make the balloon located at the renal mouth of the renal parenchymal ostomy channel, thereby achieving pressure hemostasis and preventing the drainage tube from coming out.
  • the above-mentioned renal fistula tube solves the problem of renal drainage in the kidney, it plays a certain role in stopping bleeding and fixing the fistula, but exists in clinical application.
  • the balloon at the front end of the renal ostomy tube is easily displaced into the pelvis and renal pelvis of the large hydronephrosis, which cannot effectively block the inner mouth of the renal parenchymal fistula (the renal pelvis side); 2) the diameter of the renal fistula is smaller than the renal parenchyma The diameter of the ostomy channel can not directly compress the channel to stop bleeding; 3) the outer part of the renal parenchymal ostomy channel (outside of the renal parenchyma) is not closed, the renal parenchymal fistula wound and the intrarenal urine can pass between the ostomy channel and the ostomy tube The gap continues to overflow into the perirenal space and is prone to infection.
  • the surgeon often uses the renal fistula balloon to pull back to the skin side and fix the fistula tube through the skin suture thread to compress and stop the ostomy tube, but the kidney and skin.
  • the vigorous pulling will lead to severe pain in the postoperative period, and the treatment effect of this method is very limited.
  • the renal parenchymal damage and the rupture of the water sac cause the ostomy tube to occur.
  • the continuous improvement of the renal fistula tube for percutaneous nephrolithotomy which has good drainage, hemostasis and fixation, is an important technical development direction today.
  • different researchers have designed a variety of renal fistulas with hemostatic effects.
  • CN202010364U published by the Chinese Patent Office on October 19, 2011 discloses a new type of drainage tube.
  • the front end of the elastic drainage tube is designed with an elastic head having a diameter larger than the outer diameter of the main body of the drainage tube, and a drainage tube has a inside.
  • a thimble that can extend through the draft tube channel to its front end.
  • the ejector pin is used to lengthen the elastic drainage tube, and the diameter of the drainage tube body is reduced, and then the diameter of the front end of the drainage tube is reduced to insert the drainage tube into the renal ostomy channel, and the released head is restored to the original diameter. And just located in the renal parenchymal fistula channel, thereby pressing the wound to achieve hemostasis.
  • the patented design has a certain hemostatic effect, there is no problem of the fistula tube fixing structure, and it is difficult to avoid the slippage of the ostomy tube.
  • CN102599942B published by the Chinese Patent Office on April 23, 2014 discloses a minimally invasive percutaneous nephrolithoscopic expansion hemostasis tube with an elastic spherical balloon positioned at the front end of the drainage catheter and positioned for fixation.
  • the non-elastic cylindrical balloon which directly compresses and stops bleeding in the renal parenchymal fistula channel can have better hemostasis and fixation effect.
  • the diameter of the renal ostomy channel used in clinical practice can vary greatly. The diameter of the cross-sectional circle after the expansion of the non-elastic balloon is difficult to match, and it is necessary to prepare a variety of non-elastic airbags of various diameter specifications for the application.
  • the present invention provides a double cannulated fistula having an effective hemostatic effect.
  • a double cannulated fistula tube comprising an inner drainage tube, an outer tube, an air bag and a liquid injection channel;
  • the length of the outer tube is smaller than the length of the inner drainage tube, and the two ends of the outer tube are respectively provided with through holes for the inner drainage tube to pass through, and the outer tube is sleeved through the through hole On the inner drainage tube, the outer tube can slide along the axial direction of the inner drainage tube;
  • the air bag includes a first air bag, and the first air bag is disposed at a front end of an outer wall of the inner drainage tube;
  • the liquid injection channel includes a first liquid injection channel; the first liquid injection channel is disposed on a wall of the inner drainage tube and is in communication with the first air bag.
  • the air bag further includes a second air bag, the second air bag is disposed at a front end of the outer wall of the outer tube, the first air bag is located at a front of the second air bag, and the liquid injection channel further includes a second liquid injection a passage; the second liquid injection passage is disposed on a pipe wall of the outer pipe and communicates with the second air bag.
  • the ostomy tube further includes a drainage hole, the drainage hole including a first drainage hole and a a first drainage hole; the first drainage hole is disposed on a tube wall of the inner drainage tube and located in front of the first air bag, and the first drainage hole is in communication with an interior of the inner drainage tube; The second drainage hole is disposed on the tube wall of the outer tube and located behind the second air bag, and the second drainage hole is in communication with the drainage channel of the outer tube.
  • the front end of the outer tube is conical.
  • the wall of the rear end of the inner drainage tube is provided with a direction indicating that the outer tube moves forward along the inner drainage tube A scale of the distance between the front end of the outer tube and the first airbag is described.
  • the shape of the first airbag after filling is spherical, and the shape of the second airbag after filling is tapered.
  • a check valve is disposed at the inlet ends of the first liquid injection channel and the second liquid injection channel.
  • the radial cross section of the drainage channel of the outer tube is annular or half moon shaped.
  • the outer tube and the inner drainage tube are concentric tubes.
  • An inlet end of the first liquid injection channel extends out of the inner drainage tube, and a branch branch is formed between the rear end of the inner drainage tube; an outlet end of the drainage channel of the outer tube and the second
  • the inlet ends of the injection passages each extend out of the outer tube, and respectively form a branch branch between the rear end of the outer tube and the outer tube.
  • the number of the first drainage hole and the second drainage hole are both plural, and the plurality of the first drainage holes are spaced apart from the tube wall of the inner drainage tube, and each of the first drainage holes
  • the shapes are all elliptical; a plurality of the second drainage holes are spirally spaced apart from the tube wall of the outer tube, and each of the second drainage holes has a shape of a long spindle.
  • a drainage strip for supporting the tube wall of the outer tube and a tube wall of the inner drainage tube is provided in the drainage channel of the outer tube, the number of the support strips is plural, and at least each of the support strips One end is fixed to the outer tube or the wall of the inner drainage tube, and the plurality of support strips are radially distributed around the axis of the inner drainage tube.
  • the fistula tube further includes a tube plug disposed at a rear end of the outer tube and located between the outer tube and the inner drainage tube.
  • the outlet end of the drainage channel of the outer tube is provided with a liquid collecting bag or a vacuum suction device; the rear end of the inner drainage tube is provided with a liquid collecting bag.
  • the invention has the beneficial effects that the invention fully considers the drainage, hemostasis and fixation of the fistula tube, and also considers the drainage problem of the intraoperative perfusion solution accumulated in the extrarenal perirenal space, postoperative extravasation urine and blood.
  • the ostomy tube used after percutaneous nephrolithotomy it provides a good intrarenal External drainage effect, effective hemostasis and a double-tube ostomy tube that can be properly fixed.
  • the channel adjusts a volume of the first balloon and the second balloon after the liquid is injected, so that after the percutaneous nephrolithotomy, the first balloon is positioned at the inner mouth of the renal parenchymal fistula channel, the first The front end of the second balloon is located at the outer mouth of the renal parenchyma or slightly enters, and the first balloon and the second balloon which are filled in the renal parenchyma through the renal parenchyma can completely close the inner and outer ports of the renal parenchymal fistula, and the renal parenchymal fistula
  • the bleeding of the channel wound only accumulates in the gap between the wall of the ostomy channel and the wall of the inner drainage tube, and the pressure increases with the increase of blood accumulation in the gap, and the wound of the renal parenchymal fistula is compressed, and the bleeding stops
  • the exact hemostatic effect can be obtained, which can not only prevent venous oozing of the renal parenchymal fistula, but also effectively control severe renal artery bleeding, and also avoid the direct application of the balloon in the prior art.
  • the risk of renal parenchymal injury may be caused by oppression of the ostomy channel.
  • the operator may further adjust the position between the outer tube and the inner drainage tube or the volume of the first balloon and the second balloon by postoperatively. Controlling bleeding, which increases clinical treatments, has changed the current state of treatment of postoperative renal sinus hemorrhage with hemostatic drugs and intervention or open surgery.
  • a gap may be formed between the wall of the outer tube located at the rear of the second balloon and the surrounding adipose tissue, which is increased
  • the large drainage area helps the peripheral effusion of the kidney to accumulate in the gap, and is also beneficial to prevent the surrounding adipose tissue from clogging the second drainage hole, so that the renal peripheral effusion can be fully drained.
  • the ostomy tube can be properly fixed and it is not easy to shift out.
  • the ostomy tube can be double-fixed by the mutual cooperation between the first air bag and the second air bag, and the first air bag and the second air bag rarely rupture due to the necessity of vigorous traction, and the patient also There will be no drama related to sputum traction The pain is not even needed to fix the suture at the skin ostomy wound, avoiding the pain caused by the suture pulling the skin.
  • the ostomy tube of the present invention can be designed to meet the requirements of two or three diameter specifications which are basically matched with the current clinical use of the renal ostomy channel, which greatly saves application cost, reduces resource waste, and is convenient for clinical use.
  • Figure 1 is a schematic view showing the structure of a renal fistula in the prior art
  • FIG. 2 is a schematic structural view of a double-tube type ostomy tube according to the present invention.
  • FIG. 3 is a schematic structural view of a double cannulated fistula outer tube provided with a second air bag according to the present invention
  • Figure 4 is a schematic view showing the structure of a double-tube type ostomy tube with a drainage hole
  • Figure 5 is a longitudinal sectional view of Figure 4.
  • Figure 6 is a cross-sectional view taken along line A-A of Figure 4.
  • 01 drainage side hole
  • 02 in-pipe drainage channel
  • 03 airbag
  • 04 water injection pipeline
  • the invention provides a double cannula type ostomy tube with effective hemostasis effect in the present hemostatic problem existing during percutaneous nephrolithotomy, as shown in FIG. 2, the ostomy tube includes an internal drainage tube 1, the outer tube 2, the air bag 3 and the liquid injection channel 4;
  • the length of the outer tube 2 is smaller than the length of the inner drainage tube 1, and the two ends of the outer tube 2 are respectively provided There is a through hole through which the inner drainage tube 1 passes, and the outer tube 2 is sleeved on the inner drainage tube 1 through the through hole, and the outer tube 2 can be drained in the axial direction thereof Slide on tube 1;
  • the airbag 3 includes a first airbag 31, and the first airbag 31 is disposed at a front end of an outer wall of the inner drainage tube 1;
  • the liquid injection channel 4 includes a first liquid injection channel 41; the first liquid injection channel 41 is disposed on the wall of the inner drainage tube 1 and is in communication with the first air bag 31.
  • the outer tube 2 by arranging the outer tube 2 on the inner drainage tube 1, the outer tube 2 can slide along the axial direction of the inner drainage tube 1, the diameter of the outer tube 2 Compared with the ostomy channel, the diameter of the ostomy channel is slightly larger, so that the wall of the outer tube 2 can press the subcutaneous fat tissue and the muscle tissue in the ostomy channel of the human body wall, thereby reducing the bleeding of the tissue.
  • the present invention is further provided with a second airbag 32 at the front end of the outer wall of the outer tube 2, as shown in FIG.
  • An air bag 31 is located in front of the second air bag 32, and the second air bag 32 is disposed.
  • the pipe wall of the outer tube 2 is provided with a second liquid injecting channel 42, and the second liquid injecting channel 42 is The second air bag 32 is in communication.
  • the distance between the first airbag 31 and the second airbag 32 can be adjusted by the outer tube 2 sliding on the inner drainage tube 1 along the axial direction thereof, the first liquid injection channel 41 and the second liquid injection passage 42 are capable of injecting liquid into the first airbag 31 and the second airbag 32, respectively, and adjusting a volume of the first airbag 31 and the second airbag 32 after the liquid is injected.
  • the distance between the first airbag 31 and the second airbag 32 is adjusted by the positional relationship between the inner draft tube 1 and the outer tube 2, through the first liquid injection passage 41 and the
  • the second infusion channel 42 adjusts the volume of the first balloon 31 and the second balloon 32 after the liquid is injected, so that the first balloon 31 is positioned in the renal parenchyma after percutaneous nephrolithotomy
  • the front end of the second balloon 32 is located at the outer mouth of the renal parenchyma or slightly enters, and the first balloon 31 and the second balloon 32 which are in a liquid-filled state inside and outside the renal parenchyma make the renal parenchyma
  • the inner and outer ports of the channel can be completely closed, and the hemorrhage of the renal parenchymal fistula channel only accumulates in the gap between the wall of the ostomy channel and the wall of the inner drainage tube 1, and the pressure increases with the increase of blood accumulation in the gap, and the renal parenchyma
  • the ost the hemorr
  • the exact hemostatic effect can be obtained, which can not only prevent venous oozing of the renal parenchymal fistula, but also Effectively control severe renal arterial hemorrhage, and also avoid the risk of renal parenchymal injury that may be caused by the direct compression of the balloon 3 of the ostomy tube in the prior art.
  • the outer tube 2 and the inner drainage tube 1 of the invention are all made of medical silica gel material (high temperature vulcanized silica gel), which has certain physical and mechanical properties against pressure and deformation, and has good biocompatibility. The local inflammatory response is small.
  • the outer tube 2 can be designed to have a total length of 12 cm, an outer diameter of 9.0 mm, and an inner diameter of 8.0 mm.
  • the inner drainage tube 1 can be designed to have a total length of 35 cm, an outer diameter of 4.0 mm, and an inner diameter of 3.2 mm; the outer tube 2
  • the spacing between the inner wall and the outer wall of the inner drainage tube 1 is 2.0 mm.
  • the diameter of the outer tube 2 is slightly larger than the diameter of the conventional ostomy channel in the present invention, the skin incision required during the operation is correspondingly increased, but this does not significantly impair the minimally invasive surgery because of subcutaneous fat.
  • the tissue and the muscle tissue have certain expandability.
  • the relatively large diameter of the outer tube 2 is placed into the ostomy channel, which not only does not damage the tissue, but may be caused by the compression of the tube wall of the outer tube 2 The above tissue bleeding stopped.
  • the first airbag 31 and the second airbag 32 are both formed of an elastic material, the first airbag 31 has a capacity of 2-10 mL, and the second airbag 32 has a capacity of 5-20 mL.
  • the outer tube 2 can slide along the inner axial direction of the inner drainage tube 1, and the inner wall of the outer tube 2 and the outer wall of the inner drainage tube 1 are not disposed. There are gaps to make specific limits.
  • the inventors have found that one of the important reasons for the serious infection of patients after percutaneous nephrolithotomy is that the urinary fluid in the peripheral space of the kidney (including intraoperative perfusion) is rarely considered in the design of the renal fistula. Drainage problems of fluid, postoperative extravasation of urine and blood, etc.)
  • a space is provided between the inner wall of the outer tube 2 of the present invention and the outer wall of the inner drainage tube 1, and the space forms a drainage channel 5 of the outer tube.
  • the radial cross section of the drainage channel 5 of the outer tube is annular or half-moon shaped; at the same time, it cooperates with the drainage channel 5 of the outer tube and the inner drainage tube 1, the ostomy tube further includes a drainage hole 6, the drainage The hole 6 includes a first drainage hole 61 and a second drainage hole 62; the first drainage hole 61 is disposed on the tube wall of the inner drainage tube 1 and is located in front of the first air bag 31, the first The drainage hole 61 communicates with the inside of the inner drainage tube 1; the second drainage hole 62 is disposed on the tube wall of the outer tube 2, and is located behind the second air bag 32, and the second drainage hole 62 is in communication with the drainage channel 5 of the outer tube.
  • the first drainage hole 61 is located in the renal collecting system after the operation, and the internal drainage tube 1 is used to drain the urine in the kidney; the second drainage hole 62 is located in the renal peripheral space after the operation.
  • the drainage channel 5 of the outer tube further drains the renal peripheral fluid.
  • the front end of the outer tube 2 is designed to reduce the resistance of the outer tube 2 during sliding.
  • Conical type The through hole provided at the front end of the outer tube 2 for the inner drainage tube 1 to pass through is circular, specifically disposed at the top of the cone, the diameter of the through hole is 4.8 mm, only the inner drainage tube 1 is The slightly larger diameter allows both the outer tube 2 to slide outside the inner drainage tube 1, and also prevents the renal peripheral adipose tissue from being embedded to prevent the outer tube 2 from sliding forward.
  • the injected liquid may overflow. Therefore, the first injection channel 41 and the inlet end of the second liquid injection channel 42 are each provided with a check valve 7. The liquid is injected into the first airbag 31 and the second airbag 32 through the one-way valve 7, and the injection liquid overflow can be effectively prevented.
  • the shape of the second airbag 32 after filling is tapered, and the shape of the first airbag 31 after filling is spherical. Under the expansion of the second airbag 32 having a conical shape after filling, a gap may be formed between the wall of the outer tube 2 located at the rear of the second airbag 32 and the surrounding fat tissue. Increasing the drainage area, contributing to the accumulation of the renal peripheral fluid to the gap, is also beneficial to prevent the surrounding adipose tissue from clogging the second drainage hole 42, and the renal peripheral fluid can be fully drained.
  • the renal and surrounding anatomical structures are usually evaluated by B-ultrasound, intravenous pyelography or CT imaging before percutaneous nephrolithotomy, and B-ultrasound or/and X-ray are used during surgery.
  • the filming method is used as a guide for renal puncture and ostomy.
  • the above method can be used to know the atrophy and thinning of the renal and renal parenchyma of the patient, and can accurately measure the thickness of the renal parenchyma at the ostomy or the length of the renal parenchyma.
  • the tube wall of the rear end of the inner draft tube 1 is provided with a scale 8 for indicating that the outer tube 2 slides along the inner drainage tube 1
  • the distance between the second airbag 32 on the outer tube 2 and the first airbag 31 on the inner drainage tube 1 is spaced apart.
  • the distance between the rear end of the scale 8 and the rear end of the first airbag 31 is 15 cm.
  • the length of the renal parenchymal fistula channel generally does not exceed 3 cm, so that the scale 8 can be set on the wall of the tube at the rear end of the inner balloon 3115 cm from the first balloon, that is, the outer tube 2 is completely
  • the length of 12 cm plus the reserved renal parenchymal fistula channel length is 3 cm, marked 2.5 mm apart at intervals, and the scale is 3 cm in length.
  • the inlet end of the first liquid injection passage 41 extends out of the inner drainage tube 1 and a branch branch is formed between the rear end of the inner drainage tube 1 and the rear end of the inner drainage tube 1
  • the outlet end of the drainage channel 5 of the outer tube and the inlet end of the second liquid injection channel 42 both extend out of the outer tube 2, and respectively form a bifurcation branch tube with the rear end of the outer tube 2 .
  • the number of the first drainage hole 61 and the second drainage hole 62 are both plural; a plurality of the first drainage holes 61 are spaced apart from the wall of the inner drainage tube 1, each of the A shape of the drainage holes 61 is elliptical; a plurality of the second drainage holes 62 are spirally spaced apart from the wall of the outer tube 2, and each of the second drainage holes 62 has a long shape.
  • the drainage channel 5 of the outer tube is provided with a support strip 9 for supporting the tube wall of the outer tube 2 and the tube wall of the inner drainage tube 1.
  • the number of the support strips 9 is plural.
  • At least one end of the support bar 9 is fixed to the outer tube 2 or the wall of the inner drainage tube 1, and the plurality of the support bars 9 are radially distributed around the axis of the inner drainage tube 1
  • a plurality of the support bars 9 are annularly distributed around the axis of the inner drainage tube 1.
  • the fistula tube further includes a tube plug 10 disposed at a rear end of the outer tube 2 and located between the outer tube 2 and the inner drainage tube 1.
  • a tube plug 10 disposed at a rear end of the outer tube 2 and located between the outer tube 2 and the inner drainage tube 1.
  • the outlet end of the drainage channel 5 of the outer tube is provided with a liquid collection bag or a vacuum suction device; the rear end of the inner drainage tube 1 A liquid collection bag is provided.
  • Negative pressure aspirator such as the high-pressure drainage bottle from B. Braun, Germany, can form and maintain a negative pressure of 60-80 kPa. It is compact and lightweight, and can be carried around without affecting patient activities.
  • the invention fully considers the drainage, hemostasis and fixation of the fistula tube, and also considers the intraoperative perfusion solution accumulated in the extrarenal perirenal space, the drainage of postoperative extravasation urine and blood, and the percutaneous nephrolithotomy
  • the improvement of the ostomy tube used after the crushed stone provides a double-tube ostomy tube with good internal and external drainage effect, effective hemostasis, and sufficient fixation.
  • the ostomy tube can be designed to meet the requirements of two or three diameter specifications that are basically matched with the current renal ostomy channel, which greatly saves application cost, reduces resource waste, and is convenient for clinical use.
  • the renal collecting system kidney
  • the check valve 7 is filled with water into the first air bag 31 via the first water injection passage 41, and after being filled, the inner drainage tube 1 is gently pulled back, so that the first air bag 31 is located in the renal parenchyma. ⁇
  • the inside of the channel is closed and closed.
  • the peeling sheath is removed and the outer tube 2 sleeved outside the inner drainage tube 1 is slid forward in the loose tissue of the kidney, and is marked according to the scale 8 on the tube wall of the inner drainage tube 1.
  • the position at which the front end of the outer tube 2 is located that is, the distance between the front end of the outer tube 2 and the first airbag 31 is determined.
  • the second air bag 32 is filled with water through the one-way valve 7 through the second liquid injection passage 42 to close the outer opening of the renal parenchymal fistula channel.
  • the outlet end of the inner drainage tube 1 is connected to a urine collection bag, and the outlet end of the drainage channel 5 of the outer tube is connected to a liquid collection bag or a vacuum suction device.
  • the first air bag 31 and the second air bag 32 cooperate with a completely closed kidney
  • the parenchymal ostomy channel functions to stop bleeding and fix, and the perirenal effusion can gradually infiltrate into the gap between the outer tube 2 and the renal peripheral adipose tissue behind the second balloon 32 under the action of vacuum suction, and then enter The second drainage hole 62 is then sucked out through the drainage channel 5 of the outer tube.
  • the relative position of 1 such as drainage bleeding or renal parenchyma may increase the amount of liquid injecting the second airbag 32 or shorten the spacing between the first airbag 31 and the second airbag 32, so that the The second air bag 32 is further inflated and pushed forward to force the renal parenchyma around the outer mouth of the fistula channel, and further shortens the wound of the renal parenchymal fistula channel to complete the hemostasis effect on the basis of closing the renal parenchymal fistula channel.
  • the fistula tube can be properly fixed and is not easily displaced.
  • the ostomy tube can be double-fixed by the mutual cooperation between the first airbag 31 and the second airbag 32, and the first airbag 31 and the second airbag 32 rarely appear because strong traction is not required.
  • the rupture occurs, the patient does not have severe pain associated with traction of the fistula, and even does not need to fix the suture at the skin ostomy wound, thereby avoiding the pain caused by the suture pulling the skin.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

一种双套管式造瘘管，其包括内引流管(1)、外管(2)、气囊(3)和注液通道(4)；所述外管(2)的长度小于所述内引流管(1)的长度，所述外管(2)的两端分别设有供所述内引流管(1)穿过的通孔，所述外管(2)通过所述通孔套设于所述内引流管(1)上，所述外管(2)可沿其轴向在所述内引流管(1)上滑动；所述气囊(3)包括第一气囊(31)，所述第一气囊(31)设于所述内引流管(1)的外壁的前端；所述注液通道(4)包括第一注液通道(41)；所述第一注液通道(41)设于所述内引流管(1)的管壁上，且与所述第一气囊(31)连通。

Description

一种双套管式造瘘管 技术领域
本发明属于医疗器械领域，具体涉及一种双套管式造瘘管。
背景技术
经皮肾镜取石术是治疗泌尿系结石的现代微创技术，为目前泌尿外科治疗肾与输尿管结石最常用的治疗方法之一，其具有创伤小、结石清除率高、肾功能损害小等优点，但也存在严重出血和感染风险。经皮肾镜取石术中需经皮肤与肾盏之间穿刺扩张建立造瘘通道，然后置入鞘管(剥皮鞘)并利用管内通道进行手术操作，在术后常规经鞘管将肾造瘘管置入肾造瘘通道以起到引流尿液和压迫止血的作用。由于肾造瘘管的直径必须小于鞘管和肾实质造瘘通道的直径才能置入肾内，因而在肾实质造瘘通道和肾造瘘管之间存在一定的空隙，肾造瘘管直接压迫肾造瘘通道创面止血的效果有限，可导致肾实质造瘘通道持续出血，出血若渗入肾内可导致严重血尿，血凝块若阻塞造瘘管可引发剧烈肾绞痛，出血若渗入肾外周间隙可形成巨大血肿，常并发严重感染。严重的肾造瘘通道出血可危及患者生命安全，若保守治疗无效则需行肾动脉栓塞术止血或开放性肾修补或切除术，这不但会加重患者创伤和治疗费用负担，还会导致肾功能的缺失。此外，经皮肾镜取石术中需经造瘘通道向肾内高压灌注大量生理盐水以保证手术视野清晰，但这些灌注液常混合含有大量细菌的感染尿液，会沿造瘘通道外溢至肾周间隙内，可在广泛而密闭的腹膜后间隙内形成严重感染，且极易吸收入血形成尿源性脓毒血症，甚至导致患者休克、死亡。
目前临床上使用最广泛的的肾造瘘管实际为缩短长度的双腔乳胶或硅胶尿管，如图1所示，其前端有引流侧孔01与管内引流通道02连接，在尿管前端引流侧孔01后设有一个气囊03，气囊03与一条注水管道04连通，该注水管道04沿尿管管壁延伸至尿管后端引出，而与引流通道02后端形成分叉支管。通过注水管道给气囊注水使其充盈后，回拉尿管使气囊位于肾实质造瘘通道肾内口处，从而实现压迫止血和防止引流管脱出。上述肾造瘘管虽然解决了肾内尿液引流的问题，起到了一定止血和固定造瘘管的作用，但在临床应用中存在 以下问题：1)肾造瘘管前端气囊易位移至宽大积水的肾盂肾盏内，不能切实封堵压迫肾实质造瘘通道内口(肾盏侧)；2)由于肾造瘘管直径小于肾实质造瘘通道直径，并不能直接压迫通道止血；3)肾实质造瘘通道外口(肾实质外侧)未封闭，肾实质瘘道创面出血和肾内尿液可通过造瘘通道与造瘘管之间的空隙持续外溢至肾周间隙，易引发感染。为防止上述情况出现，手术医师常采用将肾造瘘管气囊用力回拉牵引向皮肤侧并通过皮肤缝合丝线方式将造瘘管固定，以起到压迫止血和防止造瘘管移位作用，但肾及皮肤的大力牵拉会导致患者术后出现严重的疼痛，而且此处理方式止血效果十分有限，肾实质损伤和水囊破裂导致造瘘管脱出的情况也时有发生。
针对上述存在的情况，对经皮肾镜取石术所用肾造瘘管持续改进，使其具有良好的引流、止血、固定作用，是现今一个重要的技术发展方向。为解决肾造瘘通道出血问题，不同研究者设计了多种具备止血作用的肾造瘘管。如中国专利局2011年10月19日公告的CN202010364U号专利公开了一种新型引流管，其设计的弹性引流管的前端设置有直径大于引流管本体外径的弹性封头，引流管内部有一根可贯穿引流管通道至其前端的顶针。使用时依靠顶针来拉长弹性引流管，缩小引流管本体的直径后，再缩小引流管前端封头的直径，以将引流管放入到肾造瘘通道内，释放后的封头恢复原本直径且刚好位于肾实质造瘘通道内，从而压迫创面实现止血。该专利设计虽然具有一定的止血效果，但是无造瘘管固定结构，存在难以避免造瘘管滑脱移位的问题。另外，中国专利局2014年4月23日公告的CN102599942B号专利公开了一种微创经皮肾镜用扩张止血造瘘管，其引流导管前端设有位于肾盂内起固定作用的弹性球形气囊和定位于肾实质造瘘通道内起直接压迫止血作用的非弹性圆柱形气囊，可有较好止血和固定效果。然而，临床上采用的肾造瘘通道直径可以变化很大，非弹力气囊扩张后截面圆的直径难以与之恰好匹配，不得不制备很多种直径规格的非弹力气囊才便于开展应用。在其使用中一旦选择失误，要么不能满意压迫通道止血，要么撕裂肾实质瘘道加重出血。此外，严重扩张积水的肾脏，其实质组织常萎缩变薄变软，这时在肾实质造瘘通道内使用气囊扩张后，可能将肾实质瘘道壁创面顶起外翻或内翻，非但不能压迫止血，反而可引发严重出血。上述情况在中国专利局2013年5月29日公告的CN 202950710 U和2014年5月14日公告 的CN 203591512 U等专利公开的肾造瘘通道内弹性气囊使用中更易发生。
发明内容
为了解决现有技术存在的上述问题，针对目前经皮肾镜碎石术过程中存在的止血问题，本发明提供了具有切实有效的止血作用的一种双套管式造瘘管。
本发明所采用的技术方案为：
一种双套管式造瘘管，其包括内引流管、外管、气囊和注液通道；
所述外管的长度小于所述内引流管的长度，所述外管的两端分别设有供所述内引流管穿过的通孔，所述外管通过所述通孔套设于所述内引流管上，所述外管可沿其轴向在所述内引流管上滑动；
所述气囊包括第一气囊，所述第一气囊设于所述内引流管的外壁的前端；
所述注液通道包括第一注液通道；所述第一注液通道设于所述内引流管的管壁上，且与所述第一气囊连通。
所述气囊还包括第二气囊，所述第二气囊设于所述外管的外壁的前端，所述第一气囊位于所述第二气囊的前方；所述注液通道还包括第二注液通道；所述第二注液通道设于所述外管的管壁上，且与所述第二气囊连通。
所述外管的内壁和所述内引流管的外壁之间设有间隔，所述间隔形成外管的引流通道；所述造瘘管还包括引流孔，所述引流孔包括第一引流孔和第二引流孔；所述第一引流孔设于所述内引流管的管壁上，且位于所述第一气囊的前方，所述第一引流孔与所述内引流管的内部连通；所述第二引流孔设于所述外管的管壁上，且位于所述第二气囊的后方，所述第二引流孔与所述外管的引流通道连通。
所述外管的前端为圆锥型。
所述内引流管的后端的管壁上设有指示所述外管沿所述内引流管前移时所 述外管前端与所述第一气囊的间隔距离的刻度。
所述第一气囊充盈后的形状为球形，所述第二气囊充盈后的形状为锥形。
所述第一注液通道和所述第二注液通道的进口端均设有单向阀。
所述外管的引流通道的径向截面为环形或半月形。
所述外管和所述内引流管为同心管。
所述第一注液通道的进口端延伸出所述内引流管，且与所述内引流管的后端之间形成分叉支管；所述外管的引流通道的出口端和所述第二注液通道的进口端均延伸出所述外管，且分别与所述外管的后端之间形成分叉支管。
所述第一引流孔和所述第二引流孔的数量均为多个，多个所述第一引流孔呈间隔设于所述内引流管的管壁上，每个所述第一引流孔的形状均为椭圆形；多个所述第二引流孔呈螺旋状间隔设于所述外管的管壁上，每个所述第二引流孔的形状均为长梭形。
所述外管的引流通道内设有用于支撑所述外管的管壁和所述内引流管的管壁的支撑条，所述支撑条的数量为多个，每个所述支撑条的至少一端固定于所述外管或所述内引流管的管壁上，多个所述支撑条以所述内引流管的轴心为中心呈放射状分布。
所述造瘘管还包括管塞，所述管塞设于所述外管后端，且位于所述外管和所述内引流管之间。
所述外管的引流通道的出口端设有液体收集袋或负压吸引器；所述内引流管的后端设有液体收集袋。
本发明的有益效果为：本发明在充分考虑造瘘管的引流、止血和固定作用外，还考虑到了肾外肾周间隙内积聚的术中灌注液、术后外渗尿液和血液的引流问题，通过对经皮肾镜碎石术后所用造瘘管的改进，提供了具有良好的肾内 外引流效果、切实有效的止血作用和能够充分妥善固定的一种双套管式造瘘管。
1)通过所述外管和所述内引流管之间的位置关系调整所述第一气囊和所述第二气囊之间的距离，通过所述第一注液通道和所述第二注液通道调整所述第一气囊和所述第二气囊注入液体后体积的大小，使在经皮肾镜碎石术后，所述第一气囊定位于肾实质造瘘通道内口处，所述第二气囊的前端位于肾实质瘘道外口处或稍进入，通过肾实质瘘道内外呈充液状态的第一气囊和第二气囊使肾实质造瘘通道内外口可完全封闭，且肾实质造瘘通道创面出血仅积聚于造瘘通道壁与所述内引流管管壁之间的间隙内，随该间隙内积血增多压力逐渐增高，肾实质造瘘通道创面受压，出血停止。通过上述的止血方式可获得确切的止血效果，不但可以阻止肾实质造瘘通道创面静脉性渗血，还可以有效控制严重的肾动脉性出血，同时也避免了现有技术中造瘘管的气囊直接压迫造瘘通道创面止血方式可能导致的肾实质损伤风险。
2)通过观察被引流的液体的量，可以准确判断肾内外出血状况，尤其是可以早期发现肾外周间隙内形成的血肿，而予以及时治疗处理，这是以往造瘘管所不具备的。
3)造瘘管使用中，操作者可以在术后再通过调整所述外管与所述内引流管之间的位置或所述第一气囊和所述第二气囊的充液体积的大小来进一步控制出血，这增加了临床治疗手段，改变了以往只能用止血药物和介入或开放手术等方式处理术后肾瘘道出血的现状。
4)在充盈后的形状为锥形的所述第二气囊的扩张作用下，位于所述第二气囊的后方的所述外管的管壁与周围脂肪组织间可形成一定空隙，这既增大了可引流面积，有助于肾外周积液向该间隙积聚，也有利于防止周围脂肪组织堵塞所述第二引流孔，进而肾外周积液可被充分引流。
5)造瘘管可妥善固定，不易移位脱出。通过所述第一气囊和所述第二气囊之间的相互配合，可使得造瘘管双重固定，而且由于不需要大力牵引，所述第一气囊和所述第二气囊极少出现破裂，患者也不会出现与造瘘管牵引相关的剧 烈疼痛，甚至不需要在皮肤造瘘伤口处缝线固定，避免了缝线牵拉皮肤产生的疼痛。
6)本发明的造瘘管只需设计成与目前临床采用肾造瘘通道基本匹配的两三个直径规格即可满足使用，这极大地节省了应用成本，减少资源浪费，并方便临床使用。
附图说明
图1是现有技术中肾造瘘管的结构示意图；
图2是本发明一种双套管式造瘘管的结构示意图；
图3是本发明一种双套管式造瘘管外管设有第二气囊时的结构示意图；
图4是本发明一种双套管式造瘘管带引流孔的结构示意图；
图5是图4中的纵剖视图；
图6是图4中A-A的剖视图。
图中：
01、引流侧孔；02、管内引流通道；03、气囊；04、注水管道；
1、内引流管；2、外管；3、气囊；31、第一气囊；32、第二气囊；4、注液通道；41、第一注液通道；42、第二注液通道；5、外管的引流通道；6、引流孔；61、第一引流孔；62、第二引流孔；7、单向阀；8、刻度；9、支撑条；10、管塞。
具体实施方式
本发明针对目前经皮肾镜碎石术过程中存在的止血问题，提供了具有切实有效的止血作用的一种双套管式造瘘管，如图2所示，所述造瘘管包括内引流管1、外管2、气囊3和注液通道4；
所述外管2的长度小于所述内引流管1的长度，所述外管2的两端分别设 有供所述内引流管1穿过的通孔，所述外管2通过所述通孔套设于所述内引流管1上，所述外管2可沿其轴向在所述内引流管1上滑动；
所述气囊3包括第一气囊31，所述第一气囊31设于所述内引流管1的外壁的前端；
所述注液通道4包括第一注液通道41；所述第一注液通道41设于所述内引流管1的管壁上，且与所述第一气囊31连通。
采用上述技术方案，通过将所述外管2套设于所述内引流管1上，所述外管2可沿其轴向在所述内引流管1上滑动，所述外管2的直径相较于造瘘通道直径稍大，因此所述外管2的管壁能够压迫人体体壁造瘘通道内的皮下脂肪组织和肌肉组织，进而可使上述组织出血减少。
除了在所述内引流管1的外壁的前端设置所述第一气囊31外，本发明还在所述外管2的外壁的前端设置有第二气囊32，如图3所示，所述第一气囊31位于所述第二气囊32的前方，配合所述第二气囊32，所述外管2的管壁上设置有第二注液通道42，所述第二注液通道42与所述第二气囊32连通。能够通过所述外管2在沿其轴向在所述内引流管1上滑动，进而调整所述第一气囊31和所述第二气囊32之间间隔的距离，所述第一注液通道41和所述第二注液通道42能够分别为所述第一气囊31和所述第二气囊32注入液体，调整所述第一气囊31和所述第二气囊32注入液体后体积的大小。因此，通过所述内引流管1和所述外管2之间的位置关系调整所述第一气囊31和所述第二气囊32之间的距离，通过所述第一注液通道41和所述第二注液通道42调整所述第一气囊31和所述第二气囊32注入液体后体积的大小，从而在经皮肾镜碎石术后使所述第一气囊31定位于肾实质造瘘通道内口处，所述第二气囊32的前端位于肾实质瘘道外口处或稍进入，通过肾实质瘘道内外呈充液状态的第一气囊31和第二气囊32使肾实质造瘘通道内外口可完全封闭，且肾实质造瘘通道创面出血仅积聚于造瘘通道壁与所述内引流管1管壁之间的间隙内，随该间隙内积血增多压力逐渐增高，肾实质造瘘通道创面受压，出血停止。通过上述的止血方式可获得确切的止血效果，不但可以阻止肾实质造瘘通道创面静脉性渗血，还可以 有效控制严重的肾动脉性出血，同时也避免了现有技术中造瘘管的气囊3直接压迫造瘘通道创面止血方式可能导致的肾实质损伤风险。
本发明的所述外管2和所述内引流管1均用医用硅胶材料制成(高温硫化硅胶)，其具备一定抗压、抗形变的物理机械特性，且具备良好的生物相容性，局部炎性反应小。所述外管2可设计为全长12cm，外直径9.0mm，内直径8.0mm，所述内引流管1可设计为全长35cm，外直径4.0mm，内直径3.2mm；所述外管2的内壁和所述内引流管1的外壁之间的间距2.0mm。虽然本发明中所述外管2的直径较常规造瘘通道直径稍大，导致在手术的过程中所需皮肤切口也相应增大，但这并不明显损害手术的微创性，因为皮下脂肪组织和肌肉组织具有一定可扩张性，本发明中相对较大直径的所述外管2置入造瘘通道，不但不会损伤上述组织，反而由于所述外管2管壁的压迫作用可使上述组织出血停止。
所述第一气囊31和所述第二气囊32均采用弹性材料成型，所述第一气囊31的容量为2-10mL，所述第二气囊32的容量为5-20mL。
在上述结构中所述外管2可沿其轴向在所述内引流管1上滑动即可，并未对所述外管2的内壁和所述内引流管1的外壁之间的是否设有间隙做具体的限定。但是本发明人发现经皮肾镜碎石术术后患者出现严重感染的重要原因之一，是由于迄今为止的肾造瘘管设计中很少有考虑到肾外周间隙内积液(包括术中灌注液、术后外渗尿液和血液等)的引流问题。
因此，如图4-6之一所示，本发明的所述外管2的内壁和所述内引流管1的外壁之间设有间隔，所述间隔形成外管的引流通道5，所述外管的引流通道5的径向截面为环形或半月形；同时与所述外管的引流通道5和所述内引流管1相配合，所述造瘘管还包括有引流孔6，所述引流孔6包括第一引流孔61和第二引流孔62；所述第一引流孔61设于所述内引流管1的管壁上，且位于所述第一气囊31的前方，所述第一引流孔61与所述内引流管1的内部连通；所述第二引流孔62设于所述外管2的管壁上，且位于所述第二气囊32的后方，所述第二引流孔62与所述外管的引流通道5连通。
所述第一引流孔61，其术后位于肾集合系统内，通过所述内引流管1，进而引流肾内尿液；所述第二引流孔62，其术后位于肾外周间隙内，通过所述外管的引流通道5，进而引流肾外周积液。
通过观察被引流的液体的量，可以准确判断肾内外出血状况，尤其是可以早期发现肾外周间隙内形成的血肿，而予以及时治疗处理，这是以往造瘘管所不具备的。
由于造瘘管在使用的过程中，所述外管2具有相对所述内引流管1滑动的过程，为减小所述外管2在滑动过程中的阻力，所述外管2的前端设计为圆锥型。设于所述外管2的前端供所述内引流管1穿过的通孔为圆形，具体设于圆锥的顶部，所述通孔的直径为4.8mm，仅较所述内引流管1直径稍大，既允许外管2在内引流管1外滑动，也能阻止肾外周脂肪组织嵌入而妨碍所述外管2向前滑动。
考虑到通过所述第一注液通道41和所述第二注液通道42向所述第一气囊31和所述第二气囊32注入液体使之充盈的过程中，注入的液体有可能外溢。因此所述第一注液通道41和所述第二注液通道42的进口端均设有单向阀7。通过所述单向阀7向所述第一气囊31和所述第二气囊32注入液体，可有效防止注入液体外溢。
所述第二气囊32充盈后的形状为锥形，所述第一气囊31充盈后的形状为球形。在充盈后的形状为锥形的所述第二气囊32的扩张作用下，位于所述第二气囊32的后方的所述外管2的管壁与周围脂肪组织间可形成一定空隙，这既增大了可引流面积，有助于肾外周积液向该间隙积聚，也有利于防止周围脂肪组织堵塞所述第二引流孔42，进而肾外周积液可被充分引流。
本发明的造瘘管在使用时，通常在经皮肾镜碎石术之前通过B超、静脉肾盂造影或CT等影像学检查评估肾及周围解剖结构，在术中使用B超或/和X线摄片手段作为肾穿刺造瘘的引导，采用上述方式可以知晓患者病肾肾实质萎缩变薄情况，并可准确测量造瘘处肾实质厚度或肾实质瘘道长度。
考虑到所述第一气囊31和所述第二气囊32之间的距离或所述外管2前端和所述第一气囊31之间的距离需要通过所述外管2和所述内引流管1之间的相对滑动来调整，为了更准确的调整上述距离，所述内引流管1的后端的管壁上设有刻度8，用于指示所述外管2沿所述内引流管1滑动时，所述外管2上的所述第二气囊32与所述内引流管1上的第一气囊31之间间隔的距离。所述刻度8的后端与所述第一气囊31的后端之间的距离为15cm。根据肾实质解剖特点，肾实质造瘘通道长度一般不超过3cm，因此可在所述内引流管1后端距所述第一气囊3115cm处的管壁上开始设置刻度8，即外管2全长12cm加上预留肾实质造瘘通道长度3cm，每间隔2.5mm向前标记，刻度全长3cm。
为了在使用的过程中，便于操作者进行操作，所述第一注液通道41的进口端延伸出所述内引流管1，且与所述内引流管1的后端之间形成分叉支管；所述外管的引流通道5的出口端和所述第二注液通道42的进口端均延伸出所述外管2，且分别与所述外管2的后端之间形成分叉支管。
所述第一引流孔61和所述第二引流孔62的数量均为多个；多个所述第一引流孔61间隔设于所述内引流管1的管壁上，每个所述第一引流孔61的形状均为椭圆形；多个所述第二引流孔62呈螺旋状间隔设于所述外管2的管壁上，每个所述第二引流孔62的形状均为长径为3.5-4.5mm的长梭形；该种设置可有效减少所述第二引流孔62对所述外管2的管壁材料抗形变特性的损害，并增大引流面积，减少周围脂肪组织填塞的可能，以保证充分引流肾外周积液。
为了防止所述外管的引流通道5在外力作用下变形，确保引流过程的通畅。所述外管的引流通道5内设有用于支撑所述外管2的管壁和所述内引流管1的管壁的支撑条9，所述支撑条9的数量为多个，每个所述支撑条9的至少一端固定于所述外管2或所述内引流管1的管壁上，多个所述支撑条9以所述内引流管1的轴心为中心呈放射状分布，当所述外管的引流通道5为环形时，多个所述支撑条9以所述内引流管1的轴心为中心呈环形分布。
所述造瘘管还包括管塞10，所述管塞10设于所述外管2后端，且位于所述外管2和所述内引流管1之间。当外管2沿内引流管1前滑动至理想位置后 可通过将所述管塞10置入，使所述外管2和所述内引流管1的位置相对固定，不再滑动，即所述第一气囊31和所述第二气囊32位置也相对固定。
为了实现液体的充分引流，特别是肾外周间隙的积液的充分引流，所述外管的引流通道5的出口端设有液体收集袋或负压吸引器；所述内引流管1的后端设有液体收集袋。(负压吸引器如德国B.Braun公司的高负压引流瓶，能形成并维持60～80kPa的负压，小巧轻便，可随身携带，不影响患者活动。)
本发明在充分考虑造瘘管的引流、止血和固定作用外，还考虑到了肾外肾周间隙内积聚的术中灌注液、术后外渗尿液和血液的引流问题，通过对经皮肾镜碎石术后所用造瘘管的改进，提供了具有良好的肾内外引流效果、切实有效的止血作用、和能够充分妥善固定的双套管式造瘘管。
该造瘘管只需设计成与目前临床采用肾造瘘通道基本匹配的两三个直径规格即可满足使用，极大地节省了应用成本，减少资源浪费，并方便临床使用。
下面通过具体实例说明本发明造瘘管的使用：经皮肾镜碎石术术前术中，通过B超、C臂X线摄片和CT等影像学检查手段测量得知肾实质造瘘通道长度或穿刺点肾实质厚度。碎石取石结束后，先将双套管式肾造瘘管的所述内引流管1的前部经剥皮鞘置入肾收集系统内(肾盏)，再由所述第一注水通道41处设置的所述单向阀7经所述第一注水通道41向所述第一气囊31注水，使其充盈后轻轻回拉所述内引流管1，使所述第一气囊31位于肾实质造瘘通道内口处并将其封闭。然后撕掉取出剥皮鞘，将套于所述内引流管1外的所述外管2在肾外周疏松的脂肪组织内向前推移滑动，根据所述内引流管1的管壁上的刻度8标记，判明所述外管2前端所处的位置，即所述外管2前端和所述第一气囊31的距离。当所述第二气囊32锥形的尖部刚好到达肾实质造瘘通道外口处或稍进入时停止推动所述外管2，将所述外管2后留有的管塞10嵌入，使所述外管2和所述内引流管1两者相对位置固定。此后，通过所述单向阀7经所述第二注液通道42向所述第二气囊32注水，将肾实质造瘘通道外口封闭。所述内引流管1的出口端连接尿液收集袋，所述外管的引流通道5的出口端连接液体收集袋或负压吸引器。所述第一气囊31和所述第二气囊32配合完全封闭肾 实质造瘘通道起到止血和固定作用，肾周积液可在负压吸引的作用下逐渐渗入所述第二气囊32后方的所述外管2与肾外周脂肪组织之间的间隙，再进入所述第二引流孔62，后经所述外管的引流通道5吸出。术后观察液体引流的状况，可根据出血及肾实质厚薄情况，适当增减所述第一气囊31和所述第二气囊32内注液量和调整所述外管2和所述内引流管1的相对位置，如引流出血较多或肾实质菲薄，可增加所述第二气囊32的注液量或缩短所述第一气囊31和所述第二气囊32之间的间距，使所述第二气囊32更加膨大并向前推挤压迫造瘘通道外口周围肾实质，在封闭肾实质造瘘通道的基础上进一步缩短收紧肾实质造瘘通道的创面以达到完全止血效果。
在上述过程中，造瘘管可妥善固定，不易移位脱出。通过所述第一气囊31和所述第二气囊32之间的相互配合，可使得造瘘管双重固定，而且由于不需要大力牵引，所述第一气囊31和所述第二气囊32极少出现破裂，患者也不会出现与造瘘管牵引相关的剧烈疼痛，甚至不需要在皮肤造瘘伤口处缝线固定，避免了缝线牵拉皮肤产生的疼痛。
本发明不局限于上述最佳实施方式，任何人在本发明的启示下都可得出其他各种形式的产品，但不论在其形状或结构上作任何变化，凡是具有与本申请相同或相近似的技术方案，均落在本发明的保护范围之内。

Claims (10)

  1. 一种双套管式造瘘管，其特征在于：其包括内引流管(1)、外管(2)、气囊(3)和注液通道(4)；
    所述外管(2)的长度小于所述内引流管(1)的长度，所述外管(2)的两端分别设有供所述内引流管(1)穿过的通孔，所述外管(2)通过所述通孔套设于所述内引流管(1)上，所述外管(2)可沿其轴向在所述内引流管(1)上滑动；
    所述气囊(3)包括第一气囊(31)，所述第一气囊(31)设于所述内引流管(1)的外壁的前端；
    所述注液通道(4)包括第一注液通道(41)；所述第一注液通道(41)设于所述内引流管(1)的管壁上，且与所述第一气囊(31)连通。
  2. 根根据权利要求1所述的双套管式造瘘管，其特征在于：所述气囊(3)还包括第二气囊(32)，所述第二气囊(32)设于所述外管(2)的外壁的前端，所述第一气囊(31)位于所述第二气囊(32)的前方；所述注液通道(4)还包括第二注液通道(42)；所述第二注液通道(42)设于所述外管(2)的管壁上，且与所述第二气囊(32)连通。
  3. 根根据权利要求1所述的双套管式造瘘管，其特征在于：所述外管(2)的内壁和所述内引流管(1)的外壁之间设有间隔，所述间隔形成外管的引流通道(5)；所述造瘘管还包括引流孔(6)，所述引流孔(6)包括第一引流孔(61)和第二引流孔(62)；所述第一引流孔(61)设于所述内引流管(1)的管壁上，且位于所述第一气囊(31)的前方，所述第一引流孔(61)与所述内引流管(1)的内部连通；所述第二引流孔(62)设于所述外管(2)的管壁上，且位于所述第二气囊(32)的后方，所述第二引流孔(62)与所述外管的引流通道(5)连通。
  4. 根据权利要求1-3之一所述的双套管式造瘘管，其特征在于：所述内引流管(1)的后端的管壁上设有指示所述外管(2)沿所述内引流管(1)前移时所述外管(2)的前端与所述第一气囊(31)的间隔距离的刻度(8)。
  5. 根据权利要求1-3之一所述的双套管式造瘘管，其特征在于：所述第一气囊(31)充盈后的形状为球形，所述第二气囊(32)充盈后的形状为锥形。
  6. 根据权利要求2-3之一所述的双套管式造瘘管，其特征在于：所述第一注液通道(41)和所述第二注液通道(42)的进口端均设有单向阀(7)。
  7. 根据权利要求2所述的双套管式造瘘管，其特征在于：所述第一注液通道(41)的进口端延伸出所述内引流管(1)，且与所述内引流管(1)的后端之间形成分叉支管；所述外管的引流通道(5)的出口端和所述第二注液通道(42)的进口端均延伸出所述外管(2)，且分别与所述外管(2)的后端之间形成分叉支管。
  8. 根据权利要求3所述的双套管式造瘘管，其特征在于：所述第一引流孔(61)和所述第二引流孔(62)的数量均为多个；多个所述第一引流孔(61)呈间隔设于所述内引流管(1)的管壁上，每个所述第一引流孔(61)的形状均为椭圆形；多个所述第二引流孔(62)呈螺旋状间隔设于所述外管(2)的管壁上，每个所述第二引流孔(62)的形状均为长梭形。
  9. 根根据权利要求3所述的双套管式造瘘管，其特征在于：所述外管的引流通道(5)内设有用于支撑所述外管(2)的管壁和所述内引流管(1)的管壁的支撑条(9)，所述支撑条(9)的数量为多个，每个所述支撑条(9)的至少一端固定于所述外管(2)或所述内引流管(1)的管壁上，多个所述支撑条(9)以所述内引流管(1)的轴心为中心呈放射状分布。
  10. 根据权利要求1-3之一所述的双套管式造瘘管，其特征在于：所述造瘘管还包括管塞(10)，所述管塞(10)设于所述外管(2)后端，且位于所述外管(2)和所述内引流管(1)之间。
PCT/CN2016/070718 2015-11-16 2016-01-12 一种双套管式造瘘管 WO2017084203A1 (zh)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201510785503.9A CN105343985B (zh) 2015-11-16 2015-11-16 一种双套管式造瘘管
CN201520911817.4 2015-11-16
CN201520911817.4U CN205287205U (zh) 2015-11-16 2015-11-16 一种双套管式造瘘管
CN201510785503.9 2015-11-16

Publications (1)

Publication Number Publication Date
WO2017084203A1 true WO2017084203A1 (zh) 2017-05-26

Family

ID=58718012

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2016/070718 WO2017084203A1 (zh) 2015-11-16 2016-01-12 一种双套管式造瘘管

Country Status (1)

Country Link
WO (1) WO2017084203A1 (zh)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107569763A (zh) * 2017-09-19 2018-01-12 广东宏健医疗器械有限公司 一种一体化负压引流管
CN107583175A (zh) * 2017-09-19 2018-01-16 广东宏健医疗器械有限公司 一种改进型负压引流管
CN108969871A (zh) * 2018-09-11 2018-12-11 上海市第五人民医院 一种便于操作的免造口双气囊小肠转流管及其套件
CN109222857A (zh) * 2018-09-28 2019-01-18 中国人民解放军第四军医大学 一种可变径脑部造瘘神经内镜工作通道
CN109331260A (zh) * 2018-11-26 2019-02-15 新沂市中医医院 一种带有支撑功能的肛肠引流装置
CN109331326A (zh) * 2018-11-20 2019-02-15 李艳星 一种胸腔引流管及引流装置
CN110025835A (zh) * 2019-05-16 2019-07-19 江阴市人民医院 一种可调节引流区域的引流装置
CN114984340A (zh) * 2022-05-31 2022-09-02 厦门大学 一种可拆换引流冲洗套管器

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080214999A1 (en) * 2000-02-01 2008-09-04 Kletchka Harold D Angioplasty device and method of making same
DE102008057177A1 (de) * 2008-11-13 2010-05-20 Urotech Gmbh Katheter zum Ableiten von Urin aus dem Nierenbereich eines Individuums
CN202538131U (zh) * 2012-03-31 2012-11-21 潘进洪 微创经皮肾镜用扩张止血造瘘管
CN102908714A (zh) * 2011-04-08 2013-02-06 劳伦斯.J.格兰斯 用于外渗药物递送的可调整的球囊导管
CN202950710U (zh) * 2012-12-12 2013-05-29 中南大学 一种经皮肾镜取石术用引流止血装置
CN203591512U (zh) * 2013-10-09 2014-05-14 株洲市瑞邦医疗器材制品有限责任公司 圆柱形肾造瘘管

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080214999A1 (en) * 2000-02-01 2008-09-04 Kletchka Harold D Angioplasty device and method of making same
DE102008057177A1 (de) * 2008-11-13 2010-05-20 Urotech Gmbh Katheter zum Ableiten von Urin aus dem Nierenbereich eines Individuums
CN102908714A (zh) * 2011-04-08 2013-02-06 劳伦斯.J.格兰斯 用于外渗药物递送的可调整的球囊导管
CN202538131U (zh) * 2012-03-31 2012-11-21 潘进洪 微创经皮肾镜用扩张止血造瘘管
CN202950710U (zh) * 2012-12-12 2013-05-29 中南大学 一种经皮肾镜取石术用引流止血装置
CN203591512U (zh) * 2013-10-09 2014-05-14 株洲市瑞邦医疗器材制品有限责任公司 圆柱形肾造瘘管

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107569763A (zh) * 2017-09-19 2018-01-12 广东宏健医疗器械有限公司 一种一体化负压引流管
CN107583175A (zh) * 2017-09-19 2018-01-16 广东宏健医疗器械有限公司 一种改进型负压引流管
CN108969871A (zh) * 2018-09-11 2018-12-11 上海市第五人民医院 一种便于操作的免造口双气囊小肠转流管及其套件
CN109222857A (zh) * 2018-09-28 2019-01-18 中国人民解放军第四军医大学 一种可变径脑部造瘘神经内镜工作通道
CN109222857B (zh) * 2018-09-28 2023-08-25 中国人民解放军第四军医大学 一种可变径脑部造瘘神经内镜工作通道
CN109331326A (zh) * 2018-11-20 2019-02-15 李艳星 一种胸腔引流管及引流装置
CN109331260A (zh) * 2018-11-26 2019-02-15 新沂市中医医院 一种带有支撑功能的肛肠引流装置
CN109331260B (zh) * 2018-11-26 2023-08-18 新沂市中医医院 一种带有支撑功能的肛肠引流装置
CN110025835A (zh) * 2019-05-16 2019-07-19 江阴市人民医院 一种可调节引流区域的引流装置
CN110025835B (zh) * 2019-05-16 2023-10-10 江阴市人民医院 一种可调节引流区域的引流装置
CN114984340A (zh) * 2022-05-31 2022-09-02 厦门大学 一种可拆换引流冲洗套管器

Similar Documents

Publication Publication Date Title
WO2017084203A1 (zh) 一种双套管式造瘘管
CN105343985B (zh) 一种双套管式造瘘管
JP6450886B2 (ja) 腎灌流を増加させるために負圧を誘発させるための尿管および膀胱カテーテルおよび方法
JP2018527974A (ja) 患者の膀胱において負圧を誘発するためのカテーテルデバイスおよび方法
US20090171241A1 (en) System and method for urinary tract cell collection, diagnosis, and chemotherapy
KR20190020293A (ko) 안전한 요로 카테터와 요로 카테터 제조 방법
Fu et al. Ultrasound-guided minimally invasive percutaneous nephrolithotomy in flank position for management of complex renal calculi
CN103111010A (zh) 一种双腔球囊管及其应用
WO2007103809A2 (en) System and method for urinary tract cell collection, diagnosis, and chemotherapy
US11752300B2 (en) Catheter device and method for inducing negative pressure in a patient's bladder
Gupta et al. Comparison of standard with tubeless percutaneous nephrolithotomy
Mishra et al. Mini versus ultra-mini percutaneous nephrolithotomy in a paediatric population
JP2005501647A (ja) 体内管の穴をシールするための装置及び方法
CN108671362A (zh) 一种用于扩张输尿管的双球囊管道套件
CN205287205U (zh) 一种双套管式造瘘管
CN208065565U (zh) 带球囊的输尿管导管
CN205494638U (zh) 可冲洗式单管双腔h型引流管
CN215914766U (zh) 多用途肛管
CN109260573A (zh) 防十二指肠乳头出血的胆道外引流管及其置入装置
KR102213798B1 (ko) 팔의 동맥으로 삽입되어 복강 출혈을 막는 카테터 및 그 이용방법
CN215537704U (zh) 一次性双腔输尿管导管
CN220404119U (zh) 一种经皮肾镜专用手术膜
CN220877506U (zh) 一种防漏三腔导尿管
RU2750183C2 (ru) Способ эндоскопического бездренажного малоинвазивного лечения нефролитиаза у детей
US20230024336A1 (en) All-purpose Drainage Catheter

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 16865386

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 16865386

Country of ref document: EP

Kind code of ref document: A1

122 Ep: pct application non-entry in european phase

Ref document number: 16865386

Country of ref document: EP

Kind code of ref document: A1

32PN Ep: public notification in the ep bulletin as address of the adressee cannot be established

Free format text: NOTING OF LOSS OF RIGHTS PURSUANT TO RULE 112(1) EPC (EPO FORM 1205A DATED 16.01.19)