WO2021115420A1 - 负压清石鞘 - Google Patents

负压清石鞘 Download PDF

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Publication number
WO2021115420A1
WO2021115420A1 PCT/CN2020/135631 CN2020135631W WO2021115420A1 WO 2021115420 A1 WO2021115420 A1 WO 2021115420A1 CN 2020135631 W CN2020135631 W CN 2020135631W WO 2021115420 A1 WO2021115420 A1 WO 2021115420A1
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WO
WIPO (PCT)
Prior art keywords
negative pressure
sheath
inner sheath
water inlet
section
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PCT/CN2020/135631
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English (en)
French (fr)
Inventor
刘启明
郑琴
Original Assignee
刘启明
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.)
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Publication date
Priority claimed from CN201922209604.8U external-priority patent/CN211433155U/zh
Priority claimed from CN202022644851.3U external-priority patent/CN213910503U/zh
Application filed by 刘启明 filed Critical 刘启明
Publication of WO2021115420A1 publication Critical patent/WO2021115420A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems

Definitions

  • the embodiments of the present disclosure relate to the field of medical devices, and more specifically, to a negative pressure stone cleaning sheath.
  • the treatment of urinary calculi through natural channels or percutaneous renal channels has become the main treatment method, such as transurethral bladder stone lithotripsy and transurethral ureteroscopy.
  • Specific surgical methods such as lower lithotripsy and lithotripsy and percutaneous renal stone lithotripsy.
  • the use of holmium laser under ureteroscopy or nephroscope for lithotripsy treatment will achieve significant clinical results.
  • the holmium laser vaporizes the stones into fine particles through the "drilling effect" by "micro-blasting", so that the stones are naturally discharged from the body.
  • Holmium laser lithotripsy is especially suitable for the treatment of ureteral stones, bladder stones and complex stones in the kidney.
  • the holmium laser is highly recognized and favored by experts in urology, and it is also the gold standard for urinary lithotripsy.
  • Percutaneous nephrolithotomy is a modern minimally invasive surgical technique in which the nephroscope passes through the skin-kidney channel (a channel that penetrates into the renal pelvis and calyx through the skin) to carry out internal lithotripsy and lithotripsy.
  • skin-kidney channel a channel that penetrates into the renal pelvis and calyx through the skin
  • percutaneous nephrolithotomy is often used in the treatment of kidney stones larger than 2 cm in the urology department. During the operation, the instruments need to be combined with perfusion and suction.
  • the common clinical percutaneous nephroscopy can be briefly divided into 4 types according to the size of the channel:
  • PCNL Percutaneous nephrolithotomy
  • lithotripsy equipment can use holmium laser or ballistic lithotripsy, or ultrasound negative pressure Crushed stone (EMS, etc.).
  • F represents the circumference, and the unit is mm.
  • mPCNL minimally invasive percutaneous nephrolithotomy
  • conventional F16-18 channel can use standard uretero-nephroscope
  • lithotripsy equipment can use holmium laser or ballistic lithotripsy.
  • Super-mini-PCNL (SMP) percutaneous nephrolithotomy can use SMP nephroscope, lithotripsy equipment uses holmium laser.
  • Needle-shaped percutaneous nephrolithotomy (ultra mini-PCNL, UMP), conventional F11-13 channel, can use UMP nephroscope, lithotripsy equipment uses holmium laser.
  • the existing negative pressure stone cleaning sheath has a split structure between the back section of the inner sheath and the water inlet pipe and the negative pressure pipe. Many parts are assembled manually after the production is completed, and the assembly efficiency is slow, resulting in higher production costs, and there will be problems such as structural instability after the parts are assembled.
  • PCNL and mPCNL use a single sheath, and the perfusion and suction are intermittently and alternately. It is difficult to ensure that the visual field is continuously clear, and it takes time to wait for the efficiency of lithotripsy. There is a certain impact; and the pressure in the renal pelvis is too high during the lithotripsy process, which is easy to retrograde infection, leading to sepsis, sepsis and other complications.
  • SMP nephroscope and UMP nephroscope are designed with a separate outer sheath water inlet channel, it is also necessary to purchase a more expensive matching nephroscope, and the outer sheath of the channel is a metal sheath, and the renal channel cannot be placed with a balloon fistula after the operation. Once the channel has bleeding, it is difficult to suppress the bleeding and other shortcomings.
  • nephroscopes and cystoscopes in clinical treatment of bladder stones have inherent shortcomings such as low stone removal efficiency, difficulty in forming circulating water during surgery, and blurred vision during intraoperative lithotripsy.
  • the present disclosure provides a negative pressure stone cleaning sheath, comprising an inner sheath component and an outer sheath sleeved with the inner sheath component, wherein the negative pressure stone cleaning sheath has a main channel, a water inlet channel, and a negative pressure channel.
  • the main channel is defined by the inner sheath assembly and extends along the longitudinal direction of the inner sheath assembly.
  • the water inlet channel is jointly defined by an inner sheath assembly and an outer sheath assembly, and is arranged around the main channel, wherein both the water inlet channel and the main channel are open at the front end of the negative pressure stone cleaning sheath.
  • the negative pressure channel is defined by the inner sheath assembly and communicates with the main channel.
  • the inner sheath assembly has an inner tube portion and an outer tube portion, the inner tube portion defines the main channel and separates the main channel from the water inlet channel, and the outer tube Partly surrounding the inner cylinder part and spaced apart from the inner cylinder part to define a part of the water inlet channel therebetween, wherein the outer sheath is sleeved on the outer cylinder part, and It is spaced apart from the inner cylinder part to define another part of the water inlet channel therebetween.
  • the inner sheath assembly has a water inlet branch pipe communicating with the water inlet channel and a negative pressure branch pipe defining the negative pressure channel.
  • the inner sheath assembly includes an inner sheath anterior segment and an inner sheath posterior segment, and the interior of the inner sheath anterior segment communicates with the interior of the inner sheath posterior segment to form the main channel, wherein
  • the front section of the inner sheath and the part of the rear section of the inner sheath that define the main channel together constitute the inner cylinder part, wherein the water inlet branch pipe, the negative pressure branch pipe and the outer cylinder part are all provided in the The posterior segment of the inner sheath is described, and the posterior segment of the inner sheath is integrally formed.
  • the inner diameter of the front section of the inner sheath is the same as the inner diameter of the rear section of the inner sheath.
  • the inner diameter of the posterior section of the inner sheath at the end that meets the anterior section of the inner sheath is the same as the inner diameter of the anterior section of the inner sheath. From the connecting end of the front section of the inner sheath to the other end of the rear section of the inner sheath, the inner diameter of the rear section of the inner sheath gradually increases.
  • the inner wall of the posterior section of the inner sheath is provided with a first groove that matches with the end of the anterior section of the inner sheath, and the anterior section of the inner sheath is connected to the posterior section of the inner sheath.
  • the end surface of the end of the inner sheath is engaged with the bottom of the first groove, and the outer peripheral surface of the end of the front section of the inner sheath that is connected with the rear section of the inner sheath is engaged with the side wall of the first groove.
  • the inner wall of the rear section of the inner sheath is further provided with a second groove, and the second groove is connected to the end of the front section of the inner sheath that is connected to the rear section of the inner sheath.
  • a first gap is provided between the outer peripheral surface
  • a second gap is provided between the inner wall of the outer sheath and the outer peripheral surface of the front section of the inner sheath, and the first gap and the second gap together form the water inlet channel.
  • a negative pressure side hole is opened on the posterior segment of the inner sheath, and the negative pressure branch pipe communicates with the main channel through the negative pressure side hole.
  • the diameter of the negative pressure side hole is not less than the inner diameter of the posterior section of the inner sheath.
  • the rear section of the inner sheath is also provided with an inner sheath water inlet side hole
  • the water inlet branch pipe is connected to the water inlet channel through the inner sheath water inlet side hole
  • the A control valve is provided on the water inlet branch pipe.
  • the posterior section of the inner sheath has a negative pressure section and a weight reduction section
  • the negative pressure branch pipe and the water inlet branch pipe are both arranged on the negative pressure section
  • the tube wall of the weight reduction section The thickness is less than or equal to the thickness of the pipe wall of the negative pressure section.
  • the weight reduction section is located on a side of the negative pressure section away from the front section of the inner sheath.
  • the inner tube portion of the inner sheath assembly is a hollow inner sheath main tube
  • the outer tube portion of the inner sheath assembly has an inner diameter greater than an outer diameter of the inner sheath main tube and
  • the front water inlet sleeve is located outside the main pipe of the inner sheath.
  • a side wall of the front water inlet casing is provided with a water inlet side hole, and the water inlet branch pipe is connected to the front water inlet casing through the water inlet side hole.
  • the inner sheath assembly includes a middle section negative pressure suction sleeve and the negative pressure branch pipe.
  • the middle section negative pressure suction sleeve has an inner diameter larger than the outer diameter of the inner sheath main pipe and surrounds the inner sheath.
  • the main pipe wherein the side wall of the inner sheath main pipe is provided with an inner sheath side hole, and the side wall of the middle section negative pressure suction sleeve is provided with a negative pressure suction side hole, and the negative pressure branch pipe passes through the negative pressure suction side hole and
  • the inner sheath side hole is connected to the inner sheath main pipeline.
  • the outer sheath adopts a matched tearable outer sheath; or adopts multiple pieces of metal sheath, and the multiple pieces of metal sheath are assembled into a tube.
  • the diameter of the inner sheath side hole is not less than the inner diameter of the inner sheath main pipe, and the diameter of the negative pressure suction side hole is larger than the diameter of the inner sheath main pipe.
  • the inner diameter of the negative pressure branch pipe is larger than the inner diameter of the inner sheath main pipe.
  • a negative pressure control through hole is opened on the negative pressure branch pipe, and the area of the negative pressure control through hole is smaller than the inner surface area of the thumb.
  • the stone cleaning sheath is an adjustable negative-pressure stone cleaning sheath that is continuously perfused in an assembled cycle.
  • the adjustable negative-pressure stone cleaning sheath includes: an inner sheath main pipe, an inner sheath side hole, and a middle negative Pressure suction casing, negative pressure suction side hole, negative pressure branch pipe, negative pressure control through hole, front water inlet casing, water inlet side hole, water inlet branch pipe and outer sheath; wherein, the inner sheath main pipe is hollow inside Straight pipe; outside the inner sheath main pipe and located in the middle section, there is a coaxial middle section negative pressure suction sleeve.
  • the middle section negative pressure suction sleeve is cylindrical, and the inner diameter of the middle section negative pressure suction sleeve is larger than the outer diameter of the inner sheath main pipe.
  • the inner sheath main pipe is provided with an inner sheath side hole on the side wall, and a negative pressure suction side hole is opened on the side wall of the middle section of the negative pressure suction sleeve and opposite to the inner sheath side hole;
  • the negative pressure branch pipe It is connected to the inner sheath main pipe through the negative pressure suction side hole and the inner sheath side hole; a negative pressure control through hole is opened on the side wall of the negative pressure branch pipe; it is arranged outside the inner sheath main pipe and before the middle section negative pressure suction sleeve There is a sealed and coaxial front water inlet casing.
  • the inner diameter of the front water inlet casing is larger than the outer diameter of the inner sheath main pipe.
  • the side wall of the front water inlet casing is provided with a water inlet side hole, and the water inlet branch pipe passes through the inlet
  • the water side hole is connected to the front water inlet sleeve;
  • the outer sheath is sealed and spliced to the front end of the coaxial front water inlet sleeve;
  • the inner diameter of the outer sheath is larger than the outer diameter of the inner sheath main pipe, and the outer wall of the inner sheath main pipe is connected to
  • An annular water inlet channel is formed between the front water inlet sleeve and the inner wall of the outer sheath;
  • the water inlet branch pipe is connected to the water inlet pipe, and normal saline is poured from the water inlet branch pipe into the front water inlet sleeve, and flows forward through the water inlet channel to
  • the outer sheath adopts a matched tearable outer sheath; or adopts multiple pieces of metal sheath, and the multiple pieces of metal sheath are assembled into a tube.
  • the diameter of the inner sheath side hole is not less than the inner diameter of the inner sheath main pipe; the diameter of the negative pressure suction side hole is larger than the diameter of the inner sheath main pipe.
  • the front end of the front water inlet sleeve is sleeved on the outer side wall of the end of the outer sheath, and the inner diameter of the front water inlet sleeve is equal to the outer diameter of the outer sheath, or the outer diameter of the front water inlet sleeve Equal to the inner diameter of the outer sheath.
  • the inner diameter of the negative pressure branch pipe is larger than the inner diameter of the inner sheath main pipe.
  • the area of the negative pressure control through hole is smaller than the area of the inner surface of the thumb.
  • the seal between the front section water inlet sleeve and the middle section negative pressure suction sleeve is welded between the two, or a coaxial partition is arranged between the two, and the partition is a circular ring. shape.
  • the length of the front end of the inner sheath main pipe protruding from the front end of the middle section negative pressure suction sleeve is 4-30 cm; the length of the inner sheath main pipe protruding from the end of the middle section negative pressure suction sleeve is 0 to 30 cm. 10cm.
  • a coaxial tail step is provided at the tail of the inner sheath main pipe and located on the outer wall of the inner sheath main pipe.
  • the tail step is ring-shaped and has an inner diameter equal to the inner sheath main pipe.
  • the outer diameter of the inner sheath is connected with the main pipe of the inner sheath as a whole; the end of the main pipe of the inner sheath is covered with a waterproof cap; the center of the waterproof cap has a through hole.
  • the inner sheath main pipe, the middle section negative pressure suction sleeve, the negative pressure branch pipe, the front water inlet casing, the water inlet branch pipe and the tail step are made of metal materials or polymer materials.
  • the negative pressure scavenging sheath includes an inner sheath
  • the inner sheath includes an inner sheath anterior segment and an inner sheath posterior segment
  • one end of the inner sheath anterior segment is located inside one end of the inner sheath posterior segment
  • the front section of the inner sheath is sealed with the rear section of the inner sheath, the inside of the front section of the inner sheath and the inside of the rear section of the inner sheath form a communicating main channel
  • the front section of the inner sheath is sheathed with an outer sheath
  • the rear section is provided with a water inlet branch pipe and a negative pressure branch pipe
  • the negative pressure branch pipe is in communication with the main channel, between the rear section of the inner sheath and the front section of the inner sheath, the outer sheath and the front section of the inner sheath
  • a water inlet channel is arranged between, the water inlet branch pipe is communicated with the water inlet channel, and the rear section of
  • the inner diameter of the front section of the inner sheath is the same as the inner diameter of the rear section of the inner sheath.
  • the inner diameter of one end of the posterior section of the inner sheath is the same as the inner diameter of the anterior section of the inner sheath; from one end of the posterior section of the inner sheath to the other end of the posterior section of the inner sheath, the inner diameter The inner diameter of the posterior section of the sheath gradually increases.
  • the inner wall of the posterior section of the inner sheath is provided with a ring of first grooves that matches with one end of the anterior section of the inner sheath, and the end surface of one end of the anterior section of the inner sheath is in contact with the first recess.
  • the bottom of the groove is attached to each other, and the outer peripheral surface of one end of the front section of the inner sheath is attached to the side wall of the first groove.
  • the inner wall of the rear section of the inner sheath is further provided with a second groove connected to the first groove, and the second groove is between the outer peripheral surface of the front section of the inner sheath
  • a first gap is provided between the outer sheath, and the outer peripheral surface of one end of the outer sheath is attached to the inner wall of the rear section of the inner sheath.
  • a second gap is provided between the inner wall of the outer sheath and the outer peripheral surface of the front section of the inner sheath. The first gap and the second gap form a connected water inlet channel.
  • the rear section of the inner sheath is provided with a negative pressure side hole
  • the negative pressure branch pipe communicates with the main channel through the negative pressure side hole
  • the negative pressure branch pipe is provided with a negative pressure control Through hole.
  • the diameter of the negative pressure side hole is not less than the inner diameter of the posterior section of the inner sheath.
  • the rear section of the inner sheath is further provided with an inner sheath side hole, the water inlet branch pipe is communicated with the water inlet channel through the inner sheath side hole, and the water inlet branch pipe is Equipped with control valve.
  • the posterior section of the inner sheath has a negative pressure section and a weight reduction section
  • the negative pressure branch pipe and the water inlet branch pipe are both arranged on the negative pressure section
  • the tube wall of the weight reduction section The thickness is less than or equal to the thickness of the pipe wall of the negative pressure section.
  • the weight reduction section extends toward the middle of the rear section of the inner sheath relative to the negative pressure section.
  • Figure 1 is a cross-sectional view of an embodiment of a negative pressure stone cleaning sheath
  • Figure 2 is a schematic diagram of the inner sheath main pipe of an embodiment of the negative pressure stone cleaning sheath
  • Figure 3 is a schematic diagram of the middle section of the negative pressure suction sleeve of an embodiment of the negative pressure stone cleaning sheath;
  • FIG. 4 is a schematic diagram of a negative pressure branch pipe of an embodiment of a negative pressure stone cleaning sheath
  • Figure 5 is a schematic diagram of the front water inlet casing of an embodiment of the negative pressure stone cleaning sheath
  • Figure 6 is a schematic diagram of the water inlet branch pipe of an embodiment of the negative pressure stone cleaning sheath
  • Figure 7 is a schematic diagram of the outer sheath of an embodiment of the negative pressure stone cleaning sheath
  • Fig. 8 is a schematic diagram of a step at the tail of the inner sheath of an embodiment of the negative pressure stone cleaning sheath
  • Fig. 9 is a schematic diagram of an embodiment of a negative pressure stone clearing sheath connected to a nephroscope.
  • Figure 10 is a cross-sectional view of an embodiment of a negative pressure stone cleaning sheath
  • Figure 11 is a schematic structural view of the posterior section of the inner sheath of an embodiment of the negative pressure stone cleaning sheath
  • Figure 12 is a schematic diagram of an embodiment of a negative pressure stone cleaning sheath after the combination of a negative pressure stone cleaning sheath and a nephroscope;
  • Figure 13 is a cross-sectional view of an embodiment of a negative pressure stone cleaning sheath.
  • the features defined with “first”, “second”, etc. may explicitly or implicitly include one or more of these features.
  • the terms “installation”, “connection”, and “connection” should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection. Connected, or integrally connected; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the internal communication between two components.
  • the specific meaning of the above-mentioned terms in the present disclosure can be understood through specific situations.
  • the negative pressure stone clearing sheath proposed in the present disclosure can be used for stone clearing in urinary calculi lithotripsy surgery.
  • the negative pressure stone cleaning sheath proposed in the present disclosure includes an inner sheath component and an outer sheath sleeved with the inner sheath component.
  • the negative pressure clear stone sheath has a main channel, a water inlet channel, and a negative pressure channel.
  • the main channel is defined by the inner sheath assembly and extends along the longitudinal direction of the inner sheath assembly.
  • the water inlet channel is jointly defined by an inner sheath assembly and an outer sheath assembly, and is arranged around the main channel, wherein both the water inlet channel and the main channel are open at the front end of the negative pressure stone cleaning sheath.
  • a negative pressure channel, the negative pressure channel is defined by the inner sheath assembly and communicated with the main channel.
  • the length of the outer sheath is set such that the end of the outer sheath and the end of the inner sheath assembly extend to approximately the same position. Moreover, since the inner sheath component and the outer sheath are connected together by a sleeve, the length of the outer sheath is adjusted by the overlap length between the inner sheath component and the outer sheath, so that the end of the outer sheath and the inner sheath component The ends of the outer sheath are aligned, or the end of the outer sheath extends farther than the end of the inner sheath assembly, or the end of the inner sheath assembly extends farther than the end of the outer sheath. In this way, convenient adjustments can be achieved for different surgical situations.
  • the inner sheath assembly has a water inlet branch pipe communicating with the water inlet channel and a negative pressure branch pipe defining the negative pressure channel.
  • the negative pressure branch pipe is provided with a negative pressure control through hole, and the negative pressure branch pipe is connected with a negative pressure suction device so that a negative pressure is formed in the main channel.
  • the inlet branch pipe is connected to a water source, such as an inlet pipe.
  • normal saline can be injected from the water inlet branch to the front water inlet, and flow forward through the water inlet channel to the front end of the negative pressure clear stone sheath, and flow out from the open opening of the water inlet channel and from the main channel.
  • the open opening flows into the main channel, thereby forming a liquid circulation.
  • the operator can adjust the negative pressure by pressing the negative pressure control through hole intermittently with the thumb to control the liquid circulation.
  • the inner sheath assembly can be a one-piece structure, or it can be assembled from multiple components. Details will be introduced below in conjunction with the various embodiments shown in the drawings.
  • the outer sheath may be a matching type of tearable outer sheath, and the tearable outer sheath is an existing commercial product.
  • the outer sheath adopts multiple pieces of metal sheaths, and the multiple pieces of metal sheaths are assembled into a tubular shape.
  • the outer sheath adopts the currently commonly used clinically tearable outer sheath, or adopts a multi-piece metal sheath that can be broken apart, which is flexible to master, does not change the current routine operation habits of the surgeon, and does not increase the risk of accidents after changing the operation method.
  • a fistula tube with a balloon or a urinary catheter can be used to increase the safety of the passage.
  • the inner sheath assembly has an inner tube part and an outer tube part, the inner tube part defines the main channel and separates the main channel from the water inlet channel, and the outer tube part surrounds
  • the inner cylinder part is arranged and spaced apart from the inner cylinder part to define a part of the water inlet channel therebetween, wherein the outer sheath is sleeved on the outer cylinder part and is connected to the The inner cylinder part is spaced apart to define another part of the water inlet channel therebetween.
  • Adjustable negative pressure stone cleaning sheath includes: inner sheath main pipe, inner sheath side hole, middle negative pressure suction sleeve, negative pressure suction side hole, negative pressure branch pipe, negative pressure control through hole, front water inlet sleeve, water inlet Side hole, water inlet branch pipe and outer sheath; among them, the main pipe of the inner sheath is a straight pipe with a hollow inside; outside the main pipe of the inner sheath and located in the middle section, there is a coaxial middle section negative pressure suction sleeve, and the middle section negative pressure suction sleeve In a cylindrical shape, the inner diameter of the middle section negative pressure suction sleeve is larger than the outer diameter of the inner sheath main pipe; the side wall of the inner sheath main pipe is provided with an inner sheath side hole, and the side wall of the middle section negative pressure suction sleeve is connected to the inner sheath side The opposite position of the hole is provided with a negative pressure suction side hole
  • the outer sheath adopts matching various types of tearable outer sheaths, and the tearable outer sheath is an existing commercial product; or multiple pieces of metal sheaths are used, and multiple pieces of metal sheaths are assembled into a tube.
  • the outer sheath adopts the currently commonly used clinically tearable outer sheath, or adopts a multi-piece metal sheath that can be broken apart, which is flexible to master, does not change the current routine operation habits of the surgeon, and does not increase the risk of accidents after changing the operation method.
  • a fistula tube or urinary catheter with a balloon can be used to increase the safety of the passage.
  • the front end of the front water inlet sleeve is sleeved on the outer side wall of the end of the outer sheath.
  • the inner diameter of the front water inlet sleeve is equal to the outer diameter of the outer sheath, or the front water inlet
  • the outer diameter of the sleeve is equal to the inner diameter of the outer sheath.
  • a coaxial partition is set between the two.
  • the coaxial partition is arranged between the front section of the water inlet casing and the middle section of the negative pressure suction casing.
  • the partition is in the shape of a ring.
  • the plane of the partition is perpendicular to the axis of the inner sheath main pipe.
  • the inner diameter of the partition is equal to the inner sheath.
  • the outer diameter of the main pipeline makes the front section water inlet casing and the middle section negative pressure suction casing not communicate.
  • the middle section negative pressure suction sleeve, the partition and the front section water inlet sleeve are fixedly connected together, such as welding, bonding or threaded connection, so as to realize the airtightness between the middle section negative pressure suction sleeve and the front section water inlet sleeve to prevent water leakage.
  • the diameter of the inner sheath side hole is not less than the inner diameter of the inner sheath main pipe, and the area of the inner sheath side hole is no less than the inner cross-sectional area of the inner sheath main pipe, which improves the efficiency of stone removal.
  • the specific solution is to make the inner sheath side hole as close as possible to the diameter of the inner sheath main pipe, and use a larger diameter middle section negative pressure suction sleeve to cover the inner sheath main pipe to increase the strength.
  • the middle section negative pressure suction sleeve is in contact with the inner sheath
  • the corresponding part of the side hole is provided with a negative pressure suction side hole, which is connected to the negative pressure branch pipe.
  • the inner diameter of the negative pressure branch pipe is larger than the inner diameter of the inner sheath main pipe to ensure smooth stone removal.
  • the diameter of the negative pressure suction side hole is larger than the diameter of the main pipe of the inner sheath.
  • a negative pressure control through hole is opened on the negative pressure branch pipe connected with the negative pressure suction casing in the middle section.
  • the thumb can be used to easily adjust the negative pressure at any time to ensure a clear vision and high stone removal efficiency.
  • the area of the negative pressure control through hole is smaller than the area of the inner surface of the thumb.
  • the length of the front end of the inner sheath main pipe extending from the front end of the water inlet sleeve can be selected in a variety of ways. Choosing the short one can improve efficiency, the shorter the more efficient; the longer can reach deeper and obese patients.
  • the length of the front end of the inner sheath main pipe protruding from the front end of the middle section negative pressure suction sleeve is 4 to 30 cm.
  • the inner diameter of the main tube of the inner sheath can be selected in many ways. Choose the thicker to improve the efficiency of stone removal. The thicker the more efficient; for specific use, if the large stone is used, the thicker can be used to remove the stone; the small stone of 2cm can be selected to reduce the renal passage. Damage; the inner diameter of the main tube of the inner sheath is 1-12mm.
  • the end of the inner sheath main tube extends out of the middle section of the negative pressure sleeve.
  • the length of the end is designed with different sizes according to the changes of the nephroscope.
  • the end of the inner sheath main tube extends from the middle section of the negative pressure suction cannula to different lengths, which can be matched with different ureteroscopes or nephroscopes; if the commonly used clinical ureter lens section is 9cm thin and the rear part is thicker, the inner sheath main
  • the length of the end of the pipe protruding from the middle section of the negative pressure suction sleeve can be selected to be 10cm to avoid water leakage and reduce the difficulty of waterproof cap; if some other nephroscopes are as thick as before and after, the end of the inner sheath main pipe extends out of the middle section of negative pressure
  • the length of the end of the suction sleeve can be selected to be short to reduce the resistance to entry and exit.
  • the end of the main tube of the inner sheath is hermetically connected to the nephroscope or soft lens.
  • the present disclosure further includes a tail step and a waterproof cap; the tail of the main tube of the inner sheath is located inside The outer wall of the sheath main pipe is provided with a coaxial tail step.
  • the tail step is ring-shaped, with an inner diameter equal to the outer diameter of the inner sheath main pipe and is connected to the inner sheath main pipe as a whole; the end of the inner sheath main pipe is covered with a waterproof cap; There is a through hole in the center; thus, the waterproof cap is prevented from slipping off through the tail step, and the main pipe of the inner sheath is prevented from leaking.
  • the waterproof cap is made of elastic material, such as rubber, and the inner diameter of the through hole is smaller than that of the nephroscope or The outer diameter of the soft lens, the nephroscope or soft lens extends into the main tube of the inner sheath through the through hole in the center of the waterproof cap, and the waterproof cap is elastically sleeved on the outer wall of the nephroscope or soft lens to achieve sealing, and the nephroscope or soft lens The main pipe of the inner sheath can be entered and exited from the through hole.
  • the inner diameter of the main tube of the inner sheath is larger than the outer diameter of the nephroscope or soft mirror.
  • the inner sheath main pipeline, the middle section negative pressure suction casing, the negative pressure branch pipe, the partition, the front water inlet casing, the water inlet branch pipe and the tail step are made of metal or polymer materials, which can be mass-produced. Metal materials, such as stainless steel, can be used repeatedly; or polymer materials, such as plastic, can be sterilized at one time.
  • the present disclosure can adopt dual irrigation methods during the operation: the nephroscope is mainly filled with water, and the front section water inlet sleeve is assisted, or the front section water inlet sleeve is mainly filled with water, and the nephroscope assisted to meet different needs: 1.
  • the front section water inlet sleeve is mainly filled with water , Nephroscope is assisted to adapt to clear stones; 2.
  • Nephroscope is mainly filled with water, and the anterior water inlet cannula is assisted to adapt to distant stones such as ureter or calyx.
  • the present disclosure uses various inner sheath main tubes with different inner diameters to cooperate with various uretero-nephroscopes, which can adapt to various urinary stones such as kidney stones, bladder stones, ureteral stones, and urethral stones.
  • Figures 1-9 show the specific structure of the adjustable negative pressure stone cleaning sheath with the above-mentioned assembled cyclic uninterrupted perfusion.
  • the assembled cyclically uninterruptedly perfused adjustable negative pressure stone cleaning sheath of this embodiment includes: the inner sheath main pipe 1, the inner sheath side hole 11, the middle section negative pressure suction sleeve 2, the negative pressure suction side Hole 21, negative pressure branch pipe 3, negative pressure control through hole 31, partition 4, front water inlet sleeve 5, water inlet side hole 51, water inlet branch pipe 6, outer sheath 7, tail step 8 and waterproof cap.
  • the inner sheath main pipe 1, the middle section negative pressure suction sleeve 2, the negative pressure branch pipe 3, the partition 4, the front water inlet casing 5, and the water inlet branch pipe 6 constitute the inner sheath assembly described above, and the inner sheath main pipe 1 constitutes the foregoing
  • the inner cylinder part of the inner sheath assembly and the front water inlet sleeve 5 constitute the outer cylinder part 9 described above.
  • the inner sheath main pipe 1 is a straight pipe with a hollow inside; outside the inner sheath main pipe 1 and located in the middle section, a coaxial middle section negative pressure suction sleeve 2 is sleeved.
  • the middle section negative pressure suction sleeve 2 is cylindrical, and the middle section
  • the inner diameter of the negative pressure suction sleeve 2 is greater than the outer diameter of the inner sheath main pipe 1; the inner sheath side hole 11 is opened on the side wall of the inner sheath main pipe 1, and the side wall of the negative pressure suction sleeve 2 is connected to the inner sheath side in the middle section.
  • the opposite position of the hole 11 is provided with a negative pressure suction side hole 21; the negative pressure branch pipe 3 is connected to the inner sheath main pipe 1 through the negative pressure suction side hole 21 and the inner sheath side hole 11.
  • the negative pressure branch pipe 3 is provided with a negative pressure side wall.
  • Pressure control through hole 31; outside the inner sheath main pipe 1 and in front of the middle section negative pressure suction sleeve 2 is provided with a coaxial front water inlet casing 5, the inner diameter of the front water inlet casing 5 is larger than that of the inner sheath main pipe 1 Outer diameter; a coaxial partition 4 is set between the front section of the inlet casing 5 and the middle section of the negative pressure suction casing 2.
  • the partition 4 is annular, and the plane of the partition 4 is perpendicular to the axis of the inner sheath main pipe 1 ,
  • the inner diameter of the partition 4 is equal to the outer diameter of the inner sheath main pipe 1, so that the front water inlet casing 5 and the middle negative pressure suction casing 2 are not connected;
  • the front water inlet casing 5 is provided with water inlet on the side wall
  • the side hole 51, the water inlet branch pipe 6 is connected to the front water inlet casing 5 through the water inlet side hole 51;
  • the outer sheath 7 is sealed and spliced to the front end of the coaxial front water inlet casing 5, and the outer diameter of the outer sheath 7 is equal to the front inlet
  • the inner diameter of the outer sheath 7 is greater than the outer diameter of the inner sheath main pipe 1, and an annular water inlet is formed between the outer wall of the inner sheath main pipe 1 and the inner walls of
  • the inner sheath main pipe 1 is a straight pipe with a hollow inside, and the inner sheath side hole 11 is opened on the side wall.
  • the inner diameter of the middle section negative pressure suction sleeve 2 is larger than the outer diameter of the inner sheath main pipe 1.
  • a negative pressure is provided on the side wall of the middle section negative pressure suction sleeve 2 opposite to the inner sheath side hole 11 Attract the side hole 21.
  • a negative pressure control through hole 31 is opened on the side wall of the negative pressure branch pipe 3.
  • the inner diameter of the front water inlet sleeve 5 is larger than the outer diameter of the inner sheath main pipe 1, and the side wall of the front water inlet sleeve 5 is provided with a water inlet side hole 51.
  • the water inlet branch pipe 6 is shown in FIG. 6, and the water inlet branch pipe 6 is connected to the front water inlet casing 5 through the water inlet side hole 51.
  • the outer sheath 7 is shown in FIG. 7.
  • the tail step 8 is ring-shaped.
  • the application of the present disclosure in percutaneous renal channel lithotripsy or transurethral bladder lithotripsy has the following advantages. 1. Improve the clarity of the intraoperative visual field: Keep the visual field clear. Under continuous perfusion and negative pressure suction, stone fragments, pus, blood clots, etc. can be quickly removed during lithotripsy, so that the operation can be kept in a clear field of vision Proceed; 2. Solve the problem of stone reflux and escape: under negative pressure suction, lithotripsy can avoid stone reflux and escape, reduce the difficulty of clearing stones and the risk of bleeding when looking for stones; 3. Effectively reduce intracavitary pressure and reduce the risk of surgery: Continuous suction and perfusion at the same time can form an uninterrupted liquid circulation.
  • the pressure in the cavity can be observed and adjusted at any time to maintain a low pressure in the cavity, reduce the probability of fever, and improve the safety of the operation; 4. Improve the efficiency of stone cleaning, and when crushing stone Small stones are sucked out at the same time under negative pressure to improve the stone removal rate and reduce the operation time; 5. Avoid the use of stone removal equipment. When encountering larger stones but smaller than the diameter of the inner sheath, the stones are retracted to the negative pressure side under negative pressure. The hole automatically escapes, eliminating the need to use stone capsules, stone-removing forceps and other equipment, reducing equipment consumption and patient burden.
  • the size of a kidney stone is about 3cm, suitable for percutaneous nephrolithotomy.
  • the back section is a circle with a diameter of 4mm.
  • the lithotripsy equipment uses a holmium laser. Choose a holmium laser fiber with a diameter of 0.5mm.
  • the dimensions of the adjustable negative pressure stone cleaning sheath with assembled cyclic continuous perfusion are as follows: the main pipe of the inner sheath uses a stainless steel pipe with a thickness of 0.25mm outside diameter of 5mm, and the inlet casing of the front section and the suction casing of the middle section are both selected. Stainless steel pipe with outer diameter of 6.5mm and thickness of 0.25mm.
  • the length of the front end of the inner sheath main tube protruding from the front end of the water inlet sleeve is 14cm: In this example, because the STOZE ureter lens section is 9cm thin and the rear part is thicker, the end of the inner sheath main tube is extended to avoid water leakage.
  • the length of the end of the negative pressure suction sleeve in the middle section is 10cm.
  • the skin puncture point is generally selected to be 10 to 12 cm next to the spine, 12 subcostal or 11 intercostal behind the posterior axillary line.
  • the guide wire is fed into the renal calyx, renal pelvis, and ureter through the puncture needle. The soft part of the front end of the guide wire should completely enter the renal pelvis or calyces.
  • the channel is gradually expanded using the percutaneous nephrolithic expansion kit, the F16 tearable outer sheath is indwelled, the percutaneous renal channel is established, and the uretero-nephroscope is observed through the channel without error.
  • the percutaneous nephrolithic expansion kit the F16 tearable outer sheath is indwelled, the percutaneous renal channel is established, and the uretero-nephroscope is observed through the channel without error.
  • the percutaneous nephrolithic expansion kit the F16 tearable outer sheath is indwelled, the percutaneous renal channel is established, and the uretero-nephroscope is observed through the channel without error.
  • the operating method of the assembled cyclic and uninterrupted perfusion adjustable negative pressure stone cleaning sheath of the present disclosure includes the following steps.
  • the outer sheath and the front water inlet sleeve can be peeled off to ensure that there is no water leakage at the splicing.
  • the uretero-nephroscope is also connected to another inlet pipe to infuse physiological saline and then extend into the inner sheath main pipe through the through hole in the center of the waterproof cap, as shown in Figure 9, reaching the head of the inner sheath main pipe, and the renal pelvis and kidney can be observed To ensure accurate location.
  • the surgeon can fix the stone removal sheath kit with one hand to prevent the loss of the passage, and press the negative pressure control through hole of the negative pressure branch pipe with the thumb to adjust the negative pressure in the main tube of the inner sheath, and the thumb can press the negative pressure to control the through hole. It forms a seal. Under the suction of the negative pressure suction device, the negative pressure in the main tube of the inner sheath increases, the thumb does not press the negative pressure control through hole, and the outside atmospheric pressure enters, the negative pressure in the main tube of the inner sheath decreases, ensuring a clear view Under the condition of low pressure in the renal pelvis.
  • the uretero-nephroscope can be retracted into the main tube of the inner sheath, and the stone fragments will also enter the main tube of the inner sheath with the action of water flow and negative pressure, and the ureter-nephroscope can be retracted inside.
  • the sheath is behind the inner sheath side hole of the main tube, the stones will be sucked out of the body along with the negative pressure branch tube.
  • the adjustable negative pressure stone removal sheath of the present disclosure can be used to quickly remove the stones.
  • this embodiment discloses a negative pressure stone cleaning sheath.
  • the negative pressure stone cleaning sheath includes an inner sheath assembly 10 and an outer sheath 7 connected to the inner sheath assembly 10.
  • the inner sheath assembly 10 includes a front section 11 of the inner sheath and a rear section 12 of the inner sheath, and the outer sheath 7 is sleeved on the outside of the front section 11 of the inner sheath.
  • One end of the front section of the inner sheath 11 is located inside one end of the rear section of the inner sheath 12, and the front section of the inner sheath 11 and the back section of the inner sheath 12 are hermetically connected.
  • the inner sheath anterior segment 11 and the inner sheath posterior segment 12 are both hollow structures.
  • the inner diameter of the inner sheath anterior segment 11 is the same as the inner diameter of the inner sheath posterior segment 12.
  • the inner wall of the rear section 12 of the inner sheath is provided with a first groove 13 which is matched with one end of the front section 11 of the inner sheath.
  • the end surface of one end of the inner sheath 11 is attached to the bottom of the first groove 13, and the outer peripheral surface of one end of the front section of the inner sheath 11 is attached to the side wall of the first groove 13.
  • a negative pressure branch pipe 40 is provided on the rear section 12 of the inner sheath in this embodiment.
  • the negative pressure branch pipe 40 communicates with the main channel 30, and the negative pressure branch pipe 40 is used to connect a negative pressure suction device.
  • a negative pressure side hole 14 is opened in the rear section 12 of the inner sheath, and the negative pressure branch pipe 40 communicates with the main channel 30 through the negative pressure side hole 14.
  • the diameter of the negative pressure side hole 14 is not less than the inner diameter of the rear section 12 of the inner sheath; the inner diameter of the negative pressure branch pipe 40 is not less than the inner diameter of the rear section 12 of the inner sheath.
  • the negative pressure branch pipe 40 is provided with a negative pressure control through hole 31.
  • the diameter of the negative pressure control through hole 31 is smaller than the area of the inner surface of the thumb.
  • the rear section 12 of the inner sheath is also provided with a water inlet branch pipe 6 in this embodiment.
  • the inner wall of the inner sheath rear section 12 is also provided with a second groove 15 connected to the first groove 13.
  • the second groove 15 is connected to the inner sheath front section 11
  • a first gap is provided between the outer circumferential surfaces.
  • the outer peripheral surface of one end of the outer sheath 7 is attached to the inner peripheral surface of the posterior section 12 of the inner sheath.
  • a second gap is provided between the inner wall of one end of the outer sheath 7 and the outer peripheral surface of the front section 11 of the inner sheath.
  • a connected water inlet channel 60 is formed, and the water inlet branch pipe 6 communicates with the water inlet channel 60.
  • an inner sheath side hole 16 is opened on the inner sheath rear section 12, and the water inlet branch pipe 6 communicates with the water inlet channel 60 through the inner sheath side hole 16.
  • the negative pressure clearing stone sheath it can be filled with physiological saline from the water inlet branch pipe 6, and the physiological saline enters the water inlet channel 60 through the inner sheath side hole 16 and flows to the front end of the inner sheath front section 11 through the water inlet channel 60, and It flows into the main channel 30 from the front end of the front section 11 of the inner sheath.
  • a control valve 50 is also provided on the water inlet branch pipe 6, and the perfused physiological saline can be switched on and off by the control valve 50, and the flow rate of the physiological saline perfused in the water inlet branch pipe 6 can be adjusted.
  • the rear section of the inner sheath 12, the water intake branch pipe 6, and the negative pressure branch pipe 40 are integrally formed in this embodiment.
  • the rear section of the inner sheath 12, the water intake branch pipe 6, and the negative pressure branch pipe 40 are arranged in an integrated structure, which reduces zero cost. Components, reduce the probability of failure and defective products, and reduce the difficulty of manufacturing.
  • the stability of the negative pressure stone cleaning sheath structure is also increased.
  • the negative pressure branch tube 40 and the inner sheath posterior section 12 are an integral structure.
  • the connection between the negative pressure branch tube 40 and the inner sheath posterior section 12 can be made into a smooth arc structure, and the gravel inside the inner sheath posterior section 12 enters the negative pressure.
  • the branch pipe 40 is more smooth and will not form eddy currents or blockages.
  • the rear section 12 of the inner sheath has a negative pressure section 121 and a weight-reducing section 122, wherein the negative pressure branch pipe 40 and the water inlet branch pipe 6 are both arranged on the negative pressure section 121.
  • the wall thickness of the weight-reducing section 122 is less than or equal to that of the negative pressure section 121.
  • the weight-reducing section 122 can be made to be oriented relative to the negative pressure section 121. The middle part of the posterior section 12 of the inner sheath extends.
  • this embodiment may also be provided with a tail step 8 and a waterproof cap (not shown in the figure) at the end of the other end of the posterior section 12 of the inner sheath.
  • a through hole is provided in the middle of the waterproof cap. The tail step 8 can prevent the waterproof cap from falling off and prevent the inner sheath assembly 10 from leaking.
  • the back section of the inner sheath of the negative pressure stone cleaning sheath is integrated with the water inlet branch pipe and the negative pressure branch pipe, and the back section of the inner sheath, the water inlet branch pipe and the negative pressure branch pipe are set into an integrated structure, which reduces parts and failures. And the probability of defective products, reducing the difficulty of manufacturing.
  • the stability of the negative pressure stone cleaning sheath structure is also increased.
  • the negative pressure branch pipe and the back section of the inner sheath are an integrated structure.
  • the connection between the negative pressure branch pipe and the back section of the inner sheath can be made into a smooth arc structure.
  • the gravel inside the back section of the inner sheath enters the negative pressure branch pipe more smoothly. Will form a vortex or blockage.
  • the waterproof cap can be made of elastic materials. For example, rubber, the inner diameter of the through hole is smaller than the outer diameter of the nephroscope or soft lens.
  • the nephroscope or soft lens extends into the inner sheath assembly 10 through the through hole in the center of the waterproof cap.
  • the waterproof cap is elastically sleeved on the outer wall of the nephroscope or soft lens. On the upper side, sealing is achieved, and the nephroscope or soft scope can enter and exit the inner sheath assembly 10 through the through hole.
  • the outer sheath 7 of this embodiment adopts a tearable outer sheath commonly used in clinical practice at present, or adopts a multi-piece metal sheath that can be broken apart, which is flexible and does not change the current routine operation habits of the surgeon, and does not increase accidents that occur after changing the operation mode. Risk, and after the operation, a fistula or urinary catheter with a balloon can be used to increase the safety of the passage.
  • the negative pressure stone clearing sheath can adopt double irrigation methods during the operation: the nephroscope is mainly filled with water and the water inlet branch pipe 6 is assisted, or the water inlet branch pipe 6 is mainly filled with water and the nephroscope assisted to meet different needs. Among them:
  • Inlet branch pipe 6 is mainly filled with water, assisted by nephroscope, suitable for clearing stones.
  • the nephroscope is mainly irrigated with water intake branch pipe 6, which is suitable for distant stones such as ureter or renal calyx.
  • the negative pressure stone cleaning sheath of this embodiment can be made of metal materials or polymer materials, and can be mass-produced. Metal materials, such as stainless steel, can be used repeatedly; or polymer materials, such as plastic, can be sterilized at one time.
  • the minimally invasive percutaneous nephrolithotomy, the conventional F16 channel, and the thin STOZE ureter-nephroscope can be selected.
  • the back section of the mirror body is a circle with a diameter of 4mm.
  • the lithotripsy equipment uses holmium. For laser, choose 0.5mm diameter holmium laser fiber.
  • the length of the front end of the front section 11 of the inner sheath that protrudes from the water inlet branch pipe 6 is 14 cm, and the outer sheath 7 is a tearable outer sheath 7.
  • the skin puncture point is generally selected to be 10 to 12 cm next to the spine, 12 subcostal or 11 intercostal behind the posterior axillary line.
  • the guide wire is fed into the renal calyx, renal pelvis, and ureter through the puncture needle. The soft part of the front end of the guide wire should completely enter the renal pelvis or calyces.
  • the percutaneous nephrolithic expansion kit is used to gradually expand the channel, and the F16 tearable outer sheath 7 is indwelled.
  • the percutaneous renal channel is established, and the uretero-nephroscope is observable through the channel. .
  • the negative pressure stone clearing sheath can specifically include the following operation steps during the operation.
  • the outer sheath 7 and the posterior section 12 of the inner sheath can be peeled off by splicing at the body part to ensure that there is no water leakage at the splicing place.
  • the uretero-nephroscope is also connected to another water inlet pipe to infuse physiological saline and then extend through the through hole in the center of the waterproof cap to the main channel 30 inside the inner sheath assembly 10, and reach the front head of the front section 11 of the inner sheath, making the ureter and kidney
  • the mirror can observe the renal pelvis and calyces to ensure accurate position.
  • the surgeon can fix the negative pressure stone cleaning sheath with one hand to prevent the loss of the passage, and press the negative pressure control through hole 31 of the negative pressure branch tube 40 with the thumb to adjust the negative pressure in the inner sheath assembly 10, and the thumb presses the negative pressure
  • the through hole 31 is controlled to form a seal.
  • the negative pressure in the inner sheath assembly 10 increases, and the thumb does not press the negative pressure control through hole 31.
  • the outside atmospheric pressure enters, and the negative pressure in the inner sheath assembly 10 The pressure is reduced to ensure a low pressure in the renal pelvis under conditions of clear vision.
  • the F12 nephrostomy tube is indwelled through the channel of the tearable outer sheath 7, and the balloon is filled with 3ml of water. After exiting the tearable outer sheath 7 outside the body, it is torn into two halves, the renal ostomy tube is fixed, and the operation is over. It should be noted that the above F represents the circumference, and the unit is mm.
  • the inner diameter of one end of the inner sheath posterior section 12 of this embodiment is the same as the inner diameter of the inner sheath anterior section 11, from one end of the inner sheath posterior section 12 to the other end of the inner sheath posterior section 12, the inner sheath posterior section 12
  • the inner diameter of the tube is gradually increased, so as to be suitable for different nephroscopes and meet the needs of different nephroscopes.

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Abstract

一种负压清石鞘,包括内鞘组件(10)和与内鞘组件(10)套接的外鞘(7),其中,该负压清石鞘具有主通道(30)、进水通道(60)、负压通道(20)。主通道(30)由内鞘组件(10)限定,且沿该内鞘组件(10)的纵向方向延伸。进水通道(60)由内鞘组件(10)和外鞘(7)共同限定,且围绕主通道(30)布置,其中,进水通道(60)和主通道(30)均在负压清石鞘的前端处敞开。负压通道(20)由内鞘组件(10)限定,且连通到主通道(30)。该负压清石鞘具有改善术中视野清晰度、解决结石返流及逃逸的问题、减少手术风险、提高清石效率等优点。

Description

负压清石鞘
本申请要求于2019年12月11日递交的第201922209604.8号中国专利申请以及于2020年11月16日递交的第202022644851.3号中国专利申请的优先权,在此全文引用上述中国专利申请公开的内容以作为本申请的一部分。
技术领域
本公开的实施例涉及医疗器械领域,更具体的说,涉及一种负压清石鞘。
背景技术
随着人们饮食结构和生活方式的改变,泌尿系结石的发病率也呈逐年上升趋势。从开腹手术到无创碎石,先后出现了开刀取石、体外震波碎石、腹腔镜下取石、输尿管镜下气压弹道碎石及钬激光碎石技术、经皮肾镜下激光或EMS碎石取石等多种微创治疗方式。当前,随着碎石的能量武器特别是钬激光的发展,经自然通道或经皮肾通道对泌尿系结石的治疗成为了主要的治疗手段,如经尿道膀胱结石碎石取石、经尿道输尿管镜下碎石取石、经皮肾通道肾结石碎石取石等具体手术方式。采用输尿管镜或肾镜下利用钬激光行碎石处理,会取得显著的临床效果。钬激光通过“钻孔效应”使结石“微爆破”汽化成细小颗粒,从而使结石自然排出体外。钬激光碎石尤其适用于输尿管结石、膀胱结石及肾内复杂结石的治疗。目前在泌尿外科上,钬激光深受泌尿外科专家们的认可和青睐,也是泌尿系碎石的金标准。
经皮肾镜碎石术是将肾镜通过皮肾通道(一条经皮肤穿入肾盂肾盏内的通道)进行体内碎石和取石的现代外科微创技术。目前泌尿科治疗大于2cm的肾结石多应用经皮肾镜碎石取石术,术中操作器械的同时,需要结合灌注和吸引。目前临床常见的经皮肾镜术按通道大小可简要分为4种:
1.经皮肾镜碎石取石术(percutaneous nephrolithotomy,PCNL),常规F20-24通道,可以用标准WOLF肾镜或输尿管肾镜,碎石设备可以用钬激光或者弹道碎石,或者超声负压碎石(EMS等)。其中F代表周长,单位为mm。
2.微创经皮肾穿刺取石术(minimally invasive percutaneousnephrolithotomy,mPCNL),常规F16-18通道,可以用标准输尿管肾镜,碎石设备可以用钬激 光或者弹道碎石。
3.超微经皮肾镜取石术(Super-mini-PCNL,SMP),常规F12-14通道,可以用SMP肾镜,碎石设备使用钬激光。
4.针状经皮肾镜取石术(ultra mini-PCNL,UMP),常规F11-13通道,可以用UMP肾镜,碎石设备使用钬激光。
目前在经皮肾镜碎石取石术中,一般采用普通的无负压的单鞘,或者将负压清石鞘与肾镜配合使用。但是发明人在实现本公开的过程中,发现现有技术中存在如下问题:现有的负压清石鞘的内鞘后段与进水管、负压管之间一般为分体式结构,零部件较多,各零部件生产完成后需要手工组装,组装效率较慢,导致生产成本较高,且各零部件组装后会存在结构不稳定等问题。
现有用于经皮肾通道造瘘行碎石清石术的方法中,PCNL及mPCNL使用单鞘,灌注和吸引为间断、交替进行,很难保证视野持续清晰,需要时间等待,对碎石效率有一定影响;且碎石过程肾盂内压力过高,容易逆行感染,导致脓毒血症、败血症等并发症。SMP肾镜及UMP肾镜虽然设计了单独的外鞘进水通路,但是也有需要另外购买较为昂贵的配套肾镜,且通道外鞘为金属鞘体,术后肾通道无法放置带气囊造瘘管,一旦通道有出血,难以压迫止血等缺点。
另外目前临床所有应用的肾镜、膀胱镜等在处理膀胱结石时候,存在清石效率低,术中难以形成循环水,术中碎石时候视野容易模糊等固有缺点。
发明内容
本公开提供一种负压清石鞘,包括内鞘组件和与所述内鞘组件套接的外鞘,其中,该负压清石鞘具有主通道、进水通道、负压通道。所述主通道由内鞘组件限定,且沿该内鞘组件的纵向方向延伸。所述进水通道由内鞘组件和外鞘组件共同限定,且围绕所述主通道布置,其中,所述进水通道和所述主通道均在所述负压清石鞘的前端处敞开。所述负压通道由内鞘组件限定,且连通到所述主通道。
在一示例性实施例中,所述内鞘组件具有内筒部分和外筒部分,所述内筒部分限定所述主通道且将所述主通道与所述进水通道分开,所述外筒部分围绕所述内筒部分设置,且与所述内筒部分间隔开,以在二者之间限定所述进水 通道的一部分,其中,所述外鞘套接于所述外筒部分,并与所述内筒部分间隔开,以在二者之间限定所述进水通道的另一部分。
在一示例性实施例中,内鞘组件具有与所述进水通道相连通的进水支管和限定所述负压通道的负压支管。
在一示例性实施例中,所述内鞘组件包括内鞘前段及内鞘后段,所述内鞘前段的内部与所述内鞘后段的内部相连通以形成所述主通道,其中所述内鞘前段与所述内鞘后段的限定所述主通道的部分共同构成所述内筒部分,其中,所述进水支管、所述负压支管及所述外筒部分均设于所述内鞘后段,且内鞘后段一体成型。
在一示例性实施例中,所述内鞘前段的内径与所述内鞘后段的内径相同。
在一示例性实施例中,所述内鞘后段在其与所述内鞘前段相接的端部处的内径与所述内鞘前段的内径相同,且从所述内鞘后段的与所述内鞘前段相接的端部至所述内鞘后段的另一端部,所述内鞘后段的内径逐渐增大。
在一示例性实施例中,所述内鞘后段的内壁设有与所述内鞘前段的端部相配合的第一凹槽,所述内鞘前段的与所述内鞘后段相接的端部的端面与所述第一凹槽的底部接合,所述内鞘前段的与所述内鞘后段相接的端部的外周面与所述第一凹槽的侧壁接合。
在一示例性实施例中,所述内鞘后段的内壁还设有第二凹槽,所述第二凹槽与所述内鞘前段的与所述内鞘后段相接的端部的外周面之间设有第一空隙,所述外鞘的内壁与所述内鞘前段的外周面之间设有第二空隙,第一空隙与第二间隙共同形成所述进水通道。
在一示例性实施例中,所述内鞘后段上开设有负压侧孔,所述负压支管通过所述负压侧孔与所述主通道相通。
在一示例性实施例中,所述负压侧孔的直径不小于所述内鞘后段的内径。
在一示例性实施例中,所述内鞘后段上还开设有内鞘进水侧孔,所述进水支管通过所述内鞘进水侧孔与所述进水通道相连通,所述进水支管上设有控制阀。
在一示例性实施例中,所述内鞘后段具有负压段及减重段,所述负压支管、进水支管均设置于所述负压段上,所述减重段的管壁厚度小于或等于所述负压段的管壁厚度。
在一示例性实施例中,所述减重段位于所述负压段的远离内鞘前段的一侧。
在一示例性实施例中,所述内鞘组件的所述内筒部分为内部中空的内鞘主管道,所述内鞘组件的所述外筒部分为内径大于内鞘主管道的外径且位于所述内鞘主管道外的前段进水套管。
在一示例性实施例中,所述前段进水套管的侧壁上开设有进水侧孔,所述进水支管通过进水侧孔连通至所述前段进水套管。
在一示例性实施例中,所述内鞘组件包括中段负压吸引套管和所述负压支管,所述中段负压吸引套管的内径大于内鞘主管道的外径,且围绕内鞘主管道,其中所述内鞘主管道的侧壁开设有内鞘侧孔,在中段负压吸引套管的侧壁开设有负压吸引侧孔,所述负压支管通过负压吸引侧孔和内鞘侧孔连通至内鞘主管道。
在一示例性实施例中,所述外鞘采用匹配的可撕脱外鞘;或者采用多片金属鞘,多片金属鞘组装成管状。
在一示例性实施例中,所述内鞘侧孔的直径不小于内鞘主管道的内径,且所述负压吸引侧孔的直径大于内鞘主管道的直径。
在一示例性实施例中,所述负压支管的内径大于内鞘主管道的内径。
在一示例性实施例中,所述负压支管上开设有负压控制通孔,所述负压控制通孔的面积小于拇指的内表面面积。
在一示例性实施例中,清石鞘为组装式循环不间断灌注的可调负压清石鞘,所述可调负压清石鞘包括:内鞘主管道、内鞘侧孔、中段负压吸引套管、负压吸引侧孔、负压支管、负压控制通孔、前段进水套管、进水侧孔、进水支管和外鞘;其中,所述内鞘主管道为内部中空的直管道;在内鞘主管道外且位于中段位置套有共轴的中段负压吸引套管,中段负压吸引套管为筒形,中段负压吸引套管的内径大于内鞘主管道的外径;所述内鞘主管道的侧壁开设有内鞘侧孔,在中段负压吸引套管的侧壁且与内鞘侧孔相对的位置开设有负压吸引侧孔;所述负压支管通过负压吸引侧孔和内鞘侧孔连通至内鞘主管道;所述负压支管的侧壁上开设有负压控制通孔;在内鞘主管道外且位于中段负压吸引套管前设置有密封连接且共轴的前段进水套管,前段进水套管的内径大于内鞘主管道的外径,前段进水套管的侧壁上开设有进水侧孔,进水支管通过进 水侧孔连通至前段进水套管;所述外鞘密封拼接于共轴的前段进水套管的前端;外鞘的内径大于内鞘主管道的外径,在内鞘主管道的外壁与前段进水套管和外鞘的内壁之间形成环形的进水通道;所述进水支管连接进水管,从进水支管灌注生理盐水至前段进水套管内,经进水通道向前流动至内鞘主管道的前端,从内鞘主管道的前端流入内鞘主管道内;所述负压支管通过负压管连接负压吸引器,内鞘主管道内形成负压;通过拇指间断按压负压控制通孔,调整负压大小。
在一示例性实施例中,所述外鞘采用匹配的可撕脱外鞘;或者采用多片金属鞘,多片金属鞘组装成管状。
在一示例性实施例中,所述内鞘侧孔的直径不小于内鞘主管道的内径;所述负压吸引侧孔的直径大于内鞘主管道的直径。
在一示例性实施例中,所述前段进水套管的前端套接在外鞘末端的外侧壁上,前段进水套管的内径等于外鞘的外径,或者前段进水套管的外径等于外鞘的内径。
在一示例性实施例中,所述负压支管的内径大于内鞘主管道的内径。
在一示例性实施例中,所述负压控制通孔的面积小于拇指的内表面面积。
在一示例性实施例中,所述前段进水套管与中段负压吸引套管之间的密封,通过二者焊接,或者在二者之间设置共轴的隔板,隔板为圆环形。
在一示例性实施例中,所述内鞘主管道的前端伸出中段负压吸引套管前端的长度为4~30cm;内鞘主管道伸出中段负压吸引套管末端的长度为0~10cm。
在一示例性实施例中,还包括尾部台阶和防水帽,在内鞘主管道的尾部且位于内鞘主管道的外壁设置有共轴的尾部台阶,尾部台阶为环形,内径等于内鞘主管道的外径并与内鞘主管道连接为一体;内鞘主管道的末端盖上防水帽;防水帽的中心具有通孔。
在一示例性实施例中,所述内鞘主管道、中段负压吸引套管、负压支管、前段进水套管、进水支管和尾部台阶采用金属材料或高分子材料。
在一示例性实施例中,负压清石鞘包括内鞘,所述内鞘包括内鞘前段及内鞘后段,所述内鞘前段的一端位于所述内鞘后段的一端内部,所述内鞘前段与所述内鞘后段密封连接,所述内鞘前段内部与所述内鞘后段内部形成相连通 的主通道,所述内鞘前段外套设有外鞘,所述内鞘后段上设有进水支管及负压支管,所述负压支管与所述主通道相通,所述内鞘后段与所述内鞘前段之间、所述外鞘与所述内鞘前段之间设有进水通道,所述进水支管与所述进水通道相连通,所述内鞘后段与所述进水支管、负压支管一体成型。
在一示例性实施例中,所述内鞘前段的内径与所述内鞘后段的内径相同。
在一示例性实施例中,所述内鞘后段的一端内径与所述内鞘前段的内径相同;从所述内鞘后段的一端至所述内鞘后段的另一端,所述内鞘后段的内径逐渐增大。
在一示例性实施例中,所述内鞘后段内壁上设有一圈与所述内鞘前段的一端相配合的第一凹槽,所述内鞘前段的一端的端面与所述第一凹槽的底部相贴合,所述内鞘前段的一端的外周面与所述第一凹槽的侧壁相贴合。
在一示例性实施例中,所述内鞘后段内壁上还设有一圈与所述第一凹槽相连的第二凹槽,所述第二凹槽与所述内鞘前段的外周面之间设有第一空隙,所述外鞘的一端外周面与所述内鞘后段的内壁相贴合,所述外鞘的内壁与内鞘前段的外周面之间设有第二空隙,所述第一空隙、第二空隙形成相连通的进水通道。
在一示例性实施例中,所述内鞘后段上开设有负压侧孔,所述负压支管通过负压侧孔与所述主通道相通,所述负压支管上开设有负压控制通孔。
在一示例性实施例中,所述负压侧孔的直径不小于所述内鞘后段的内径。
在一示例性实施例中,所述内鞘后段上还开设有内鞘侧孔,所述进水支管通过所述内鞘侧孔与所述进水通道相连通,所述进水支管上设有控制阀。
在一示例性实施例中,所述内鞘后段具有负压段及减重段,所述负压支管、进水支管均设置于所述负压段上,所述减重段的管壁厚度小于或等于所述负压段的管壁厚度。
在一示例性实施例中,所述减重段相对所述负压段向所述内鞘后段的中部延伸。
附图说明
为了更清楚地说明本公开实施例的技术方案,下面将对实施例的附图作简单地介绍,显而易见地,下面描述的附图仅仅涉及本公开的一些实施例,而 非对本公开的限制。
图1为负压清石鞘的一个实施例的剖面图;
图2为负压清石鞘的一个实施例的内鞘主管道的示意图;
图3为负压清石鞘的一个实施例的中段负压吸引套管的示意图;
图4为负压清石鞘的一个实施例的负压支管的示意图;
图5为负压清石鞘的一个实施例的前段进水套管的示意图;
图6为负压清石鞘的一个实施例的进水支管的示意图;
图7为负压清石鞘的一个实施例的外鞘的示意图;
图8为负压清石鞘的一个实施例的内鞘尾部台阶的示意图;
图9为负压清石鞘的一个实施例的连接肾镜的示意图。
图10为负压清石鞘的一个实施例的剖视图;
图11为负压清石鞘的一个实施例的内鞘后段的结构示意图;
图12为负压清石鞘的一个实施例的负压清石鞘与肾镜组合后的示意图;
图13为负压清石鞘的一个实施例的剖视图。
附图标记列表
1                内鞘主管道
2                中段负压吸引套管
3                负压支管
4                隔板
5                前段进水套管
6                进水支管
7                外鞘
8                尾部台阶
9                外筒部分
10               内鞘组件
11               内鞘侧孔
12               内鞘后段
13               第一凹槽
14               负压侧孔
15                第二凹槽
16                内鞘侧孔
17                内鞘前段
20                负压通道
21                负压吸引侧孔
30                主通道
31                负压控制通孔
40                负压支管
50                控制阀
51                进水侧孔
60                进水通道
121               负压段
122               减重段
具体实施方式
为使本公开实施例的目的、技术方案和优点更加清楚,下面将结合附图,对本公开实施例的技术方案进行清楚、完整地描述。显然,所描述的实施例是本公开的一部分实施例,而不是全部的实施例。基于所描述的本公开的实施例,本领域普通技术人员在无需创造性劳动的前提下所获得的所有其他实施例,都属于本公开保护的范围。
在本公开的描述中,需要理解的是,术语“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“中”、“内”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本公开和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本公开的限制。此外,术语“第一”、“第二”等仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”等的特征可以明示或者隐含地包括一个或者更多个该特征。在本公开的描述中,需要说明的是,除非另有明确的规定和限定,术语“安装”、“相连”、“连接”应做广义理解, 例如,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通。对于本领域的普通技术人员而言,可以通过具体情况理解上述术语在本公开中的具体含义。
本公开所提出的负压清石鞘可在泌尿系结石碎石手术中用于清石。
(一)
总体上,本公开提出的负压清石鞘包括内鞘组件和与所述内鞘组件套接的外鞘。该负压清石鞘具有主通道、进水通道、负压通道。所述主通道由内鞘组件限定,且沿该内鞘组件的纵向方向延伸。所述进水通道由内鞘组件和外鞘组件共同限定,且围绕所述主通道布置,其中,所述进水通道和所述主通道均在所述负压清石鞘的前端处敞开。负压通道,所述负压通道由内鞘组件限定,且连通到所述主通道。
外鞘的长度设置为,使得外鞘的末端与内鞘组件的末端大致延伸到相同的位置。而且,由于内鞘组件和外鞘采用套接的方式连接在一起,调整通过内鞘组件与外鞘之间的重叠长度而调节外鞘伸出的长度,从而使得外鞘的末端与内鞘组件的末端对齐,或外鞘的末端比内鞘组件的末端延伸得更远,或内鞘组件的末端比外鞘的末端延伸得更远。这样,可以针对不同手术情形实现便捷的调整。
在一实施例中,内鞘组件具有与所述进水通道相连通的进水支管和限定所述负压通道的负压支管。负压支管设置有负压控制通孔,且负压支管连接负压吸引器,以使得主通道内形成负压。进水支管连接水源,例如进水管。操作中,可以从进水支管灌注生理盐水至前段进水通到内,经进水通道向前流动至负压清石鞘的前端,从进水通道的敞开的开口流出,并从主通道的敞开的开口流入该主通道内,从而形成液体循环。操作者可以通过拇指间断按压负压控制通孔来调整负压大小,进而控制液体循环。
内鞘组件可以是一体式的结构,也可以由多个部件组装而成。具体将在下文中结合附图所示的各个实施例介绍。
在一实施例中,外鞘可以采用匹配的各种型号的可撕脱外鞘,可撕脱外鞘为已有的商品化的产品。或者,在一实施例中,外鞘采用多片金属鞘,多片金 属鞘组装成管状。外鞘采用目前临床常用的可撕脱外鞘,或者采用可掰开的多片金属鞘,灵活掌握,不改变目前术者常规操作习惯,不增加变更操作方式后意外发生的风险,并在手术结束后可使用带气囊造瘘管或导尿管,增加通道安全性。
在一实施例中,所述内鞘组件具有内筒部分和外筒部分,所述内筒部分限定所述主通道且将所述主通道与所述进水通道分开,所述外筒部分围绕所述内筒部分设置,且与所述内筒部分间隔开,以在二者之间限定所述进水通道的一部分,其中,所述外鞘套接于所述外筒部分,并与所述内筒部分间隔开,以在二者之间限定所述进水通道的另一部分。
(二)
下文结合附图1-9所示的实施例,进一步阐述本公开。
可调负压清石鞘包括:内鞘主管道、内鞘侧孔、中段负压吸引套管、负压吸引侧孔、负压支管、负压控制通孔、前段进水套管、进水侧孔、进水支管和外鞘;其中,内鞘主管道为内部中空的直管道;在内鞘主管道外且位于中段位置套有共轴的中段负压吸引套管,中段负压吸引套管为筒形,中段负压吸引套管的内径大于内鞘主管道的外径;内鞘主管道的侧壁开设有内鞘侧孔,在中段负压吸引套管的侧壁且与内鞘侧孔相对的位置开设有负压吸引侧孔;负压支管通过负压吸引侧孔和内鞘侧孔连通至内鞘主管道;负压支管的侧壁上开设有负压控制通孔;在内鞘主管道外且位于中段负压吸引套管前设置有密封连接且共轴的前段进水套管,前段进水套管的内径大于内鞘主管道的外径,前段进水套管的侧壁上开设有进水侧孔,进水支管通过进水侧孔连通至前段进水套管;外鞘密封拼接于共轴的前段进水套管的前端;外鞘的内径大于内鞘主管道的外径,在内鞘主管道的外壁与前段进水套管和外鞘的内壁之间形成环形的进水通道;进水支管连接进水管,从进水支管灌注生理盐水至前段进水套管内,经进水通道向前流动至内鞘主管道的前端,从内鞘主管道的前端流入内鞘主管道内;负压支管通过负压管连接负压吸引器,内鞘主管道内形成负压;通过拇指间断按压负压控制通孔,调整负压大小。
外鞘采用匹配的各种型号的可撕脱外鞘,可撕脱外鞘为已有的商品化的产品;或者采用多片金属鞘,多片金属鞘组装成管状。外鞘采用目前临床常用 的可撕脱外鞘,或者采用可掰开的多片金属鞘,灵活掌握,不改变目前术者常规操作习惯,不增加变更操作方式后意外发生的风险,并在手术结束后可使用带气囊造瘘管或导尿管,增加通道安全性。为了达到前段进水套管与外鞘拼接密封的目的,前段进水套管的前端套接在外鞘末端的外侧壁上,前段进水套管的内径等于外鞘的外径,或者前段进水套管的外径等于外鞘的内径。
为了实现前段进水套管与中段负压吸引套管之间的密封,采用焊接或在二者之间设置共轴的隔板。共轴的隔板设置在前段进水套管与中段负压吸引套管之间,隔板为圆环形,隔板所在的平面垂直于内鞘主管道的轴,隔板的内径等于内鞘主管道的外径,使得前段进水套管与中段负压吸引套管之间不连通。
中段负压吸引套管、隔板与前段进水套管固定连接在一起,如焊接、粘接或螺纹连接,从而实现中段负压吸引套管与前段进水套管之间密闭,防止漏水。
内鞘侧孔的直径不小于内鞘主管道的内径,内鞘侧孔的面积不小于内鞘主管道的内截面面积,提高清石效率。具体解决方案为尽量内鞘侧孔接近于内鞘主管道的管径,采用直径更大的中段负压吸引套管套在内鞘主管道外,增加强度,中段负压吸引套管在与内鞘侧孔相对应的部位开设负压吸引侧孔,接负压支管,负压支管的内径大于内鞘主管道的内径,确保清石顺畅。负压吸引侧孔的直径大于内鞘主管道的直径。
在连接中段负压吸引套管的负压支管上开设负压控制通孔,术中可采用拇指简便随时调整负压大小,确保视野清晰及清石效率高。负压控制通孔的面积小于拇指的内表面面积。
内鞘主管道的前端伸出前段进水套管前端的长度可多种选择,选择短的能够提高效率,越短越高效;长则能够到达更加深部及肥胖患者。内鞘主管道的前端伸出中段负压吸引套管前端的长度为4~30cm。
内鞘主管道的内径粗细可多种选择,选择粗的提高清石效率,越粗越高效;具体使用中若巨大结石选用粗的,高效清石;2cm小结石可选择细的,减少肾通道损伤;内鞘主管道的内径为1~12mm。
内鞘主管道的末端延伸出中段负压套管末端的长根据肾镜变化而设计有不同尺寸。内鞘主管道的末端伸出中段负压吸引套管末端的长度不同,可对应 配合不同的输尿管镜或者肾镜;若临床常用的输尿管镜头段9cm较细,后部较粗,则内鞘主管道的末端伸出中段负压吸引套管末端的长度可选择10cm,避免漏水,减少防水帽防水难度;若使用某些其他肾镜前后一样粗,则内鞘主管道的末端伸出中段负压吸引套管末端的长度可选择短,减少进出阻力,最短可使防水帽直接套于中段负压吸引套管尾部;内鞘主管道伸出中段负压吸引套管末端的长度为0~10cm。
内鞘主管道的末端密封连接肾镜或软镜,为了进一步实现肾镜或软镜与内鞘主管道的密封,本公开进一步包括尾部台阶和防水帽;在内鞘主管道的尾部且位于内鞘主管道的外壁设置有共轴的尾部台阶,尾部台阶为环形,内径等于内鞘主管道的外径并与内鞘主管道连接为一体;内鞘主管道的末端盖上防水帽;防水帽的中心具有通孔;从而通过尾部台阶防止防水帽滑脱,并防止内鞘主管道漏气。输尿管肾镜、SMP肾镜、UMP肾镜、F4.8超微经皮肾镜、膀胱软镜或输尿管软镜等,防水帽采用具有弹性的材料,如橡胶,通孔的内径小于肾镜或软镜的外径,肾镜或软镜通过防水帽中心的通孔伸入至内鞘主管道内,防水帽弹性套在肾镜或软镜的外壁上,从而实现密封,并且肾镜或软镜能够从通孔中进出内鞘主管道。
内鞘主管道的内径大于肾镜或软镜的外径。
内鞘主管道、中段负压吸引套管、负压支管、隔板、前段进水套管、进水支管和尾部台阶采用金属材料或高分子材料,能大规模生产。金属材料如不锈钢材料,可反复使用;或者高分子材料如塑料,能够一次性消毒。
本公开在术中能够采用双灌水途径:肾镜主要灌水,前段进水套管辅助,或者前段进水套管主要灌水,肾镜辅助,以适应不同需求:1、前段进水套管主要灌水,肾镜辅助,适应清石;2、肾镜主要灌水,前段进水套管辅助,适应输尿管或者肾盏等较远结石。
本公开采用各种不同内径的内鞘主管道配合各种输尿管肾镜,能够适应肾结石、膀胱结石、输尿管结石和尿道结石等各种泌尿系结石。
具体参见附图1-9,其展示了上述组装式循环不间断灌注的可调负压清石鞘的具体结构。
如图1所示,本实施例的组装式循环不间断灌注的可调负压清石鞘包括:内鞘主管道1、内鞘侧孔11、中段负压吸引套管2、负压吸引侧孔21、负压 支管3、负压控制通孔31、隔板4、前段进水套管5、进水侧孔51、进水支管6、外鞘7、尾部台阶8和防水帽。内鞘主管道1、中段负压吸引套管2、负压支管3、隔板4、前段进水套管5、进水支管6构成前文所述的内鞘组件,内鞘主管道1构成前文所述的内鞘组件的内筒部分,前段进水套管5构成前文所述的外筒部分9。
其中,内鞘主管道1为内部中空的直管道;在内鞘主管道1外且位于中段位置套有共轴的中段负压吸引套管2,中段负压吸引套管2为筒形,中段负压吸引套管2的内径大于内鞘主管道1的外径;内鞘主管道1的侧壁开设有内鞘侧孔11,在中段负压吸引套管2的侧壁且与内鞘侧孔11相对的位置开设有负压吸引侧孔21;负压支管3通过负压吸引侧孔21和内鞘侧孔11连通至内鞘主管道1,负压支管3的侧壁上开设有负压控制通孔31;在内鞘主管道1外且位于中段负压吸引套管2前设置有共轴的前段进水套管5,前段进水套管5的内径大于内鞘主管道1的外径;前段进水套管5与中段负压吸引套管2之间设置共轴的隔板4,隔板4为圆环形,隔板4所在的平面垂直于内鞘主管道1的轴,隔板4的内径等于内鞘主管道1的外径,使得前段进水套管5与中段负压吸引套管2之间不连通;前段进水套管5的侧壁上开设有进水侧孔51,进水支管6通过进水侧孔51连通至前段进水套管5;外鞘7密封拼接于共轴的前段进水套管5的前端,外鞘7的外径等于前段进水套管5的内径;外鞘7的内径大于内鞘主管道1的外径,在内鞘主管道1的外壁与前段进水套管5和外鞘7的内壁之间形成环形的进水通道;在内鞘主管道1的尾部且位于内鞘主管道1的外壁设置有共轴的尾部台阶8,尾部台阶8为环形,内径等于内鞘主管道1的外径并与内鞘主管道1连接为一体;内鞘主管道1的末端盖上防水帽;防水帽的中心具有通孔;进水支管6连接进水管,从进水支管6灌注生理盐水至前段进水套管5内,经进水通道向前流动至内鞘主管道1的前端,从内鞘主管道的前端流入内鞘主管道1内;负压支管3通过负压管连接负压吸引器,内鞘主管道1内形成负压;通过拇指间断按压负压控制通孔31,调整负压大小。
如图2所示,内鞘主管道1为内部中空的直管道,侧壁开设有内鞘侧孔11。
如图3所示,中段负压吸引套管2的内径大于内鞘主管道1的外径,在 中段负压吸引套管2的侧壁且与内鞘侧孔11相对的位置开设有负压吸引侧孔21。
如图4所示,负压支管3的侧壁上开设有负压控制通孔31。
如图5所示,前段进水套管5的内径大于内鞘主管道1的外径,前段进水套管5的侧壁上开设有进水侧孔51。
进水支管6如图6所示,进水支管6通过进水侧孔51连通至前段进水套管5。
外鞘7如图7所示。
如图8所示,尾部台阶8为环形。
本公开应用在经皮肾通道碎石清石术中或者经尿道膀胱结石碎石术中具有以下优势。1、改善术中视野清晰度:保持视野清晰,在持续性灌注与负压吸引下,碎石时候结石碎末,脓液,血凝块等,均可迅速清除,使手术保持在清晰视野下进行;2、解决结石返流及逃逸的问题:在负压吸引下碎石可避免结石返流及逃逸,减少清石难度及寻找结石时候出血风险;3、有效降低腔内压力减少手术风险:持续性吸引同时进行灌注,可形成不间断的液体循环,随时可观察调节腔内压力情况,使腔内保持低压状态,减少发热概率,提高手术安全性;4、提高清石效率,碎石时候小结石在负压下同时吸出,提高结石清除率,减少手术时间;5、避免取石器械的使用,遇到较大但小于内鞘直径的结石,结石在负压下边退镜边向负压侧孔自动逸出,可无需使用套石囊,取石钳等器械,降低器材消耗及病人负担。
举例来说,肾结石大小3cm左右,适合经皮肾镜碎石,选择微创经皮肾穿刺取石术(minimally invasive percutaneous nephrolithotomy,mPCNL),常规F16通道,选择用细的STOZE输尿管肾镜,镜身后段为圆形直径4mm,碎石设备用钬激光,选择0.5mm直径的钬激光光纤。在此条件下,组装式循环不间断灌注的可调负压清石鞘尺寸如下:内鞘主管道选用5mm厚度0.25mm外径不锈钢管,前段进水套管和中段负压吸引套管均选用外径6.5mm厚度0.25mm不锈钢管。内鞘主管道的前端伸出前段进水套管的前端的长度为14cm:在此例中因STOZE输尿管镜头段9cm较细,后部较粗,为避免漏水,内鞘主管道的末端伸出中段负压吸引套管末端的长度为10cm。
皮肤穿刺点一般选在脊柱旁开10~12cm,腋后线偏后12肋下或11肋间。 先在B超/透视下确定穿刺位点和方向。穿刺部位皮肤小切口。穿刺针进入肾被膜后,随呼吸上下移动,此时超声直视下针尖再进1.5-2cm,针尖可进入肾盏,观察有尿液溢出。将导丝经穿刺针送入肾盏、肾盂、输尿管。导丝前端软的部分要完全进入肾盂或肾盏。此前阶段均已经有商品化的产品在临床广泛应用,然后使用经皮肾盂穿刺扩张套件逐步扩张通道,留置F16的可撕脱外鞘,经皮肾通道建立完成,输尿管肾镜通过通道观察无误。此前均为目前临床常规应用方法及设备。
本公开的组装式循环不间断灌注的可调负压清石鞘的操作方法,包括以下步骤。
1.在通道穿刺前,将可撕脱外鞘的尾部剪短至适合尺寸,提前将可撕脱外鞘的尾部与清石鞘套件的前段进水套管拼接,并体外试验深度适合且不漏水,再卸下可撕脱外鞘。
2.如前所述完成经皮肾通道建立,留置可撕脱外鞘支撑通道于人体。
3.于人体部位拼接可撕脱外鞘与前段进水套管,确保拼接处不漏水。
4.在进水支管的端口接上进水管,灌注生理盐水,将负压支管通过负压管接上负压吸引器。
5.输尿管肾镜也接另一进水管道灌注生理盐水后通过防水帽中心的通孔伸入至内鞘主管道内,如图9所示,达内鞘主管道的头部,可观察肾盂肾盏,确保位置准确。
6.看清结石后从输尿管肾镜内通道,进入钬激光光纤,进行经皮肾镜下钬激光碎石手术。
7.术中术者可一手固定清石鞘套件防止通道丢失,并以拇指间断按压负压支管的负压控制通孔,调整内鞘主管道内的负压大小,拇指按压负压控制通孔,构成密封,在负压吸引器的抽吸下,内鞘主管道内的负压增大,拇指不按压负压控制通孔,外界大气压进入,内鞘主管道内的负压减小,确保视野清晰的条件下肾盂内低压。
8.细小的结石碎末或小血块可通过负压支管吸出。较大的碎块但直径小于内鞘内径的,输尿管肾镜可退于内鞘主管道内,结石碎块随着水流及负压作用也会随着进入内鞘主管道内,输尿管肾镜退于内鞘主管道的内鞘侧孔的后方时,结石则会随着负压支管吸出体外,钬激光粉碎结石后可用本公开的可调负 压清石鞘迅速清除结石。
9.清石完成后,卸开可撕脱外鞘与前段进水套管的连接。
10.通过可撕脱外鞘通道留置F12肾造瘘管,气囊注水3ml,退出可撕脱外鞘于体外后将其撕开为两半,固定肾造瘘管,手术结束。文中F代表周长,单位为mm。
(三)
下文结合附图10-12所示的实施例,进一步阐述本公开。
如图10至图12所示,本实施例公开一种负压清石鞘,该负压清石鞘包括内鞘组件10及与内鞘组件10相连的外鞘7。其中,内鞘组件10包括内鞘前段11及内鞘后段12,外鞘7套设于内鞘前段11的外部。内鞘后段的限定出主通道的筒部和内鞘前段共同构成前文所述的内鞘组件的内筒部分,前文所述的外筒部分属于内鞘后段的一部分,即内鞘后段包括外筒部分9。
内鞘前段11的一端位于内鞘后段12的一端内部,且内鞘前段11与内鞘后段12密封连接。内鞘前段11与内鞘后段12的内部均为中空结构,内鞘前段11的内径与内鞘后段12的内径相同,内鞘前段11与内鞘后段12连接后,内鞘前段11与内鞘后段12的内部形成相连通的主通道30,该主通道30可用于肾镜的插入。
为了实现内鞘前段11与内鞘后段12的密封连接,本实施例在内鞘后段12的内壁上设有一圈与内鞘前段11的一端相配合的第一凹槽13,内鞘前段11的一端的端面与第一凹槽13的底部相贴合,内鞘前段11的一端的外周面与第一凹槽13的侧壁相贴合。内鞘前段11与内鞘后段12连接时,直接将内鞘前段11的一端插入第一凹槽13即可。
为了实现负压清石,本实施例在内鞘后段12上设有负压支管40,负压支管40与主通道30相通,负压支管40用于连接负压吸引器。为了实现负压支管40与主通道30的连通,在内鞘后段12上开设有负压侧孔14,负压支管40通过负压侧孔14与主通道30相通。优选地,负压侧孔14的直径不小于内鞘后段12的内径;负压支管40的内径不小于内鞘后段12的内径。负压支管40上开设有负压控制通孔31,优选地,该负压控制通孔31的直径小于拇指的内表面的面积。当负压支管40连接负压吸引器后,在主通道30内会形成 负压,通过拇指间断的按压负压控制通孔31可调整负压的大小。
为了令清石效果更好,本实施例在内鞘后段12上还设有进水支管6。内鞘后段12的内壁上还设有一圈与第一凹槽13相连的第二凹槽15,内鞘前段11与内鞘后段12连接后,第二凹槽15与内鞘前段11的外周面之间设有第一空隙。外鞘7的一端外周面与内鞘后段12的内周面相贴合,外鞘7的一端的内壁与内鞘前段11的外周面之间设有第二空隙,第一空隙、第二空隙形成相连通的进水通道60,进水支管6与该进水通道60相连通。
为了实现进水支管6与进水通道60的连通,本实施例在内鞘后段12上开设有内鞘侧孔16,进水支管6通过该内鞘侧孔16与进水通道60相通。该负压清石鞘在使用时,可从进水支管6灌注生理盐水,生理盐水通过内鞘侧孔16进入进水通道60,并通过进水通道60流至内鞘前段11的前端,并从内鞘前段11的前端流入主通道30内部。
本实施例在进水支管6上还设有控制阀50,通过控制阀50可开关控制所灌注的生理盐水,并调节进水支管6内灌注生理盐水的流量。
本实施例的内鞘后段12与进水支管6、负压支管40一体成型,本实施例将内鞘后段12与进水支管6、负压支管40设置成一体化结构,减少了零部件,减少了故障和残次品发生的概率,降低了制造难度。进水支管6、负压支管40与内鞘后段12之间不需要再进行手工组装,直接可以使用机器批量生产,提高了生产效率。同时由于一体化的设计,还增加了负压清石鞘结构的稳定性。
负压支管40与内鞘后段12为一体结构,负压支管40与内鞘后段12之间的连接处可以做成平滑的弧形结构,内鞘后段12内部的碎石进入负压支管40更加流畅,不会形成涡流或堵塞。
内鞘后段12具有负压段121及减重段122,其中,负压支管40、进水支管6均设置于负压段121上。为了减轻内鞘后段12的重量,优选地,令减重段122的管壁厚度小于或等于负压段121的管壁厚度,进一步的,还可令减重段122相对负压段121向内鞘后段12的中部延伸。
为了便于肾镜与内鞘后段12的密封连接,本实施例还可在内鞘后段12的另一端的端部设置有尾部台阶8及防水帽(图中未示出),防水帽设置于尾部台阶8的一侧,防水帽的中部设置有通孔,尾部台阶8可防止防水帽脱 落,防止内鞘组件10漏气。
其中,负压清石鞘的内鞘后段与进水支管、负压支管为一体成型,内鞘后段与进水支管、负压支管设置成一体化结构,减少了零部件,减少了故障和残次品发生的概率,降低了制造难度。进水支管、负压支管与内鞘后段之间不需要再进行手工组装,直接可以使用机器批量生产,提高了生产效率。同时由于一体化的设计,还增加了负压清石鞘结构的稳定性。
负压支管与内鞘后段为一体结构,负压支管与内鞘后段之间的连接处可以做成平滑的弧形结构,内鞘后段内部的碎石进入负压支管更加流畅,不会形成涡流或堵塞。
在进行结石手术时,输尿管肾镜、SMP肾镜、UMP肾镜、F4.8超微经皮肾镜、膀胱软镜或输尿管软镜等按需要选择使用,防水帽可采用具有弹性的材料,如橡胶,通孔的内径小于肾镜或软镜的外径,肾镜或软镜通过防水帽中心的通孔伸入至内鞘组件10内,防水帽弹性套在肾镜或软镜的外壁上,从而实现密封,并且肾镜或软镜能够从通孔中进出内鞘组件10内部。
本实施例的外鞘7采用目前临床常用的可撕脱外鞘,或者采用可掰开的多片金属鞘,灵活掌握,不改变目前术者常规操作习惯,不增加变更操作方式后意外发生的风险,并在手术结束后可使用带气囊造瘘管或导尿管,增加通道安全性。
该负压清石鞘在术中能够采用双灌水途径:肾镜主要灌水,进水支管6辅助,或者进水支管6主要灌水,肾镜辅助,以适应不同需求,其中:
1、进水支管6主要灌水,肾镜辅助,适应清石。
2、肾镜主要灌水,进水支管6辅助,适应输尿管或者肾盏等较远结石。
本实施例的负压清石鞘可采用金属材料或高分子材料制成,能大规模生产。金属材料如不锈钢材料,可反复使用;或者高分子材料如塑料,能够一次性消毒。
以下以一个具体的例子,对本实施例的负压清石鞘的工作原理做进一步说明。
当患者体内的肾结石大小为3cm左右时,可选择微创经皮肾穿刺取石术,常规F16通道,选择用细的STOZE输尿管肾镜,镜身后段为圆形直径4mm,碎石设备用钬激光,选择0.5mm直径的钬激光光纤。内鞘前段11伸出进水支 管6的前端的长度为14cm,外鞘7选用可撕脱外鞘7。
皮肤穿刺点一般选在脊柱旁开10~12cm,腋后线偏后12肋下或11肋间。先在B超/透视下确定穿刺位点和方向。穿刺部位皮肤小切口。穿刺针进入肾被膜后,随呼吸上下移动,此时超声直视下针尖再进1.5-2cm,针尖可进入肾盏,观察有尿液溢出。将导丝经穿刺针送入肾盏、肾盂、输尿管。导丝前端软的部分要完全进入肾盂或肾盏。此前阶段均已经有商品化的产品在临床广泛应用,然后使用经皮肾盂穿刺扩张套件逐步扩张通道,留置F16的可撕脱外鞘7,经皮肾通道建立完成,输尿管肾镜通过通道观察无误。此前均为目前临床常规应用方法及设备。
负压清石鞘的在手术时可以具体包括以下操作步骤。
1.在通道穿刺前,将可撕脱外鞘7的尾部剪短至适合尺寸,提前将可撕脱外鞘7的尾部与内鞘后段12相拼接,并体外试验深度适合且不漏水,再卸下可撕脱外鞘7。
2.如前所述完成经皮肾通道建立,留置可撕脱外鞘7支撑通道于人体。
3.于人体部位拼接可撕脱外鞘7与内鞘后段12,确保拼接处不漏水。
4.在进水支管6的端口接上进水管,灌注生理盐水,将负压支管40连接负压吸引器。
5.输尿管肾镜也接另一进水管道灌注生理盐水后通过防水帽中心的通孔伸入至内鞘组件10内部的主通道30,并达内鞘前段11的前端头部,令输尿管肾镜可观察肾盂肾盏,确保位置准确。
6.看清结石后从输尿管肾镜内通道,进入钬激光光纤,进行经皮肾镜下钬激光碎石手术。
7.术中术者可一手固定负压清石鞘防止通道丢失,并以拇指间断按压负压支管40的负压控制通孔31,调整内鞘组件10内的负压大小,拇指按压负压控制通孔31,构成密封,在负压吸引器的抽吸下,内鞘组件10内的负压增大,拇指不按压负压控制通孔31,外界大气压进入,内鞘组件10内的负压减小,确保视野清晰的条件下肾盂内低压。
8.细小的结石碎末或小血块可通过负压支管40吸出;较大的碎块但直径小于内鞘后段12内径的,输尿管肾镜可退于内鞘组件10内部,结石碎块随着水流及负压作用也会随着进入内鞘组件10内,输尿管肾镜退于内鞘组件10 的内鞘侧孔16的后方时,结石则会随着负压支管40吸出体外。
9.清石完成后,卸开可撕脱外鞘7与内鞘后段12的连接。
10.通过可撕脱外鞘7通道留置F12肾造瘘管,气囊注水3ml,退出可撕脱外鞘7于体外后将其撕开为两半,固定肾造瘘管,手术结束。需要说明的是,上述F代表周长,单位为mm。
这样的负压清石鞘应用在经皮肾通道碎石清石术中或者经尿道膀胱结石碎石术中还具有以下技术效果:
1、改善术中视野清晰度:保持视野清晰,在持续性灌注与负压吸引下,碎石时候结石碎末,脓液,血凝块等,均可迅速清除,使手术保持在清晰视野下进行。
2、解决结石返流及逃逸的问题:在负压吸引下可避免结石返流及逃逸,减少清石难度及寻找结石时候出血风险。
3、有效降低腔内压力减少手术风险:持续性吸引同时进行灌注,可形成不间断的液体循环,随时可观察调节腔内压力情况,使腔内保持低压状态,减少发热概率,提高手术安全性。
4、提高碎石效率:碎石时候细小的结石在负压作用下同时吸出,提高结石清除率,减少手术时间。
5、提高了对于较大结石的清石效率,避免取石器械的使用:遇到较大但小于内鞘前段11直径的结石,结石在循环灌注及负压双重作用下边退镜边向负压吸引侧孔自动逸出,可无需使用套石囊,取石钳等器械,降低器材消耗及病人负担。
(四)
下文结合附图13所示的实施例,进一步阐述本公开。这里仅描述附图13展示的实施例与附图10-12的实施例的区别。
如图13所示,本实施例的内鞘后段12的一端内径与内鞘前段11的内径相同,从内鞘后段12的一端至内鞘后段12的另一端,内鞘后段12的内径逐渐增大,以便适用于不同肾镜,满足不同肾镜的使用需求。
以上所述仅是本公开的示范性实施方式,而非用于限制本公开的保护范 围,本公开的保护范围由所附的权利要求确定。

Claims (20)

  1. 一种负压清石鞘,包括内鞘组件和与所述内鞘组件套接的外鞘,其中,该负压清石鞘具有:
    主通道,所述主通道由内鞘组件限定,且沿该内鞘组件的纵向方向延伸;
    进水通道,所述进水通道由内鞘组件和外鞘组件共同限定,且围绕所述主通道布置,其中,所述进水通道和所述主通道均在所述负压清石鞘的前端处敞开;
    负压通道,所述负压通道由内鞘组件限定,且连通到所述主通道。
  2. 如权利要求1所述的负压清石鞘,其中,所述内鞘组件具有内筒部分和外筒部分,所述内筒部分限定所述主通道且将所述主通道与所述进水通道分开,所述外筒部分围绕所述内筒部分设置,且与所述内筒部分间隔开,以在二者之间限定所述进水通道的一部分,
    其中,所述外鞘套接于所述外筒部分,并与所述内筒部分间隔开,以在二者之间限定所述进水通道的另一部分。
  3. 如权利要求1-2中任一项所述的负压清石鞘,其中内鞘组件具有与所述进水通道相连通的进水支管和限定所述负压通道的负压支管。
  4. 如权利要求2-3中任一项所述的负压清石鞘,其中,所述内鞘组件包括内鞘前段及内鞘后段,所述内鞘前段的内部与所述内鞘后段的内部相连通以形成所述主通道,其中所述内鞘前段与所述内鞘后段的限定所述主通道的部分共同构成所述内筒部分,
    其中,所述进水支管、所述负压支管及所述外筒部分均设于所述内鞘后段,且内鞘后段一体成型。
  5. 如权利要求4所述的负压清石鞘,其中,所述内鞘前段的内径与所述内鞘后段的内径相同。
  6. 如权利要求4-5中任一项所述的负压清石鞘,其中,所述内鞘后段在其与所述内鞘前段相接的端部处的内径与所述内鞘前段的内径相同,且从所述内鞘后段的与所述内鞘前段相接的端部至所述内鞘后段的另一端部,所述内鞘后段的内径逐渐增大。
  7. 如权利要求4至6中任一项所述的负压清石鞘,所述内鞘后段的内壁 设有与所述内鞘前段的端部相配合的第一凹槽,所述内鞘前段的与所述内鞘后段相接的端部的端面与所述第一凹槽的底部接合,所述内鞘前段的与所述内鞘后段相接的端部的外周面与所述第一凹槽的侧壁接合。
  8. 如权利要求4至7中任一项所述的负压清石鞘,其中,所述内鞘后段的内壁还设有第二凹槽,所述第二凹槽与所述内鞘前段的与所述内鞘后段相接的端部的外周面之间设有第一空隙,所述外鞘的内壁与所述内鞘前段的外周面之间设有第二空隙,第一空隙与第二间隙共同形成所述进水通道。
  9. 如权利要求4至8中任一项所述的负压清石鞘,其中,所述内鞘后段上开设有负压侧孔,所述负压支管通过所述负压侧孔与所述主通道相通。
  10. 如权利要求9所述的负压清石鞘,其中,所述负压侧孔的直径不小于所述内鞘后段的内径。
  11. 如权利要求1-10任一项所述的负压清石鞘,其中,所述内鞘后段上还开设有内鞘进水侧孔,所述进水支管通过所述内鞘进水侧孔与所述进水通道相连通,所述进水支管上设有控制阀。
  12. 如权利要求4-11任一项所述的负压清石鞘,其中,所述内鞘后段具有负压段及减重段,所述负压支管、进水支管均设置于所述负压段上,所述减重段的管壁厚度小于或等于所述负压段的管壁厚度。
  13. 如权利要求4-12任一项所述的负压清石鞘,其中,所述减重段位于所述负压段的远离内鞘前段的一侧。
  14. 如权利要求3所述的负压清石鞘,其中,所述内鞘组件的所述内筒部分为内部中空的内鞘主管道,所述内鞘组件的所述外筒部分为内径大于内鞘主管道的外径且位于所述内鞘主管道外的前段进水套管。
  15. 如权利要求14所述的负压清石鞘,所述前段进水套管的侧壁上开设有进水侧孔,所述进水支管通过进水侧孔连通至所述前段进水套管。
  16. 如权利要求14-15中任一项所述的负压清石鞘,所述内鞘组件包括中段负压吸引套管和所述负压支管,
    所述中段负压吸引套管的内径大于内鞘主管道的外径,且围绕内鞘主管道,
    其中所述内鞘主管道的侧壁开设有内鞘侧孔,在中段负压吸引套管的侧壁开设有负压吸引侧孔,所述负压支管通过负压吸引侧孔和内鞘侧孔连通至 内鞘主管道。
  17. 如权利要求1-16中任一项所述的负压清石鞘,其中,所述外鞘采用匹配的可撕脱外鞘;或者采用多片金属鞘,多片金属鞘组装成管状。
  18. 如权利要求16所述的负压清石鞘,其中,所述内鞘侧孔的直径不小于内鞘主管道的内径,且所述负压吸引侧孔的直径大于内鞘主管道的直径。
  19. 如权利要求16所述的负压清石鞘,其中,所述负压支管的内径大于内鞘主管道的内径。
  20. 如权利要求4-19中任一项所述的负压清石鞘,其中,所述负压支管上开设有负压控制通孔,所述负压控制通孔的面积小于拇指的内表面面积。
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