WO2023066033A1 - Urethral catheterization device, and urethral catheterization assembly comprising same - Google Patents

Urethral catheterization device, and urethral catheterization assembly comprising same Download PDF

Info

Publication number
WO2023066033A1
WO2023066033A1 PCT/CN2022/123868 CN2022123868W WO2023066033A1 WO 2023066033 A1 WO2023066033 A1 WO 2023066033A1 CN 2022123868 W CN2022123868 W CN 2022123868W WO 2023066033 A1 WO2023066033 A1 WO 2023066033A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
distal end
positioning ring
urinary
limiting
Prior art date
Application number
PCT/CN2022/123868
Other languages
French (fr)
Chinese (zh)
Inventor
薛文俊
陈安然
Original Assignee
上海康路联医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海康路联医疗科技有限公司 filed Critical 上海康路联医疗科技有限公司
Publication of WO2023066033A1 publication Critical patent/WO2023066033A1/en

Links

Images

Classifications

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

Definitions

  • the embodiments of the present application relate to the technical field of medical devices, and in particular to a catheterization device and a catheterization assembly including the catheterization device.
  • Indwelling catheterization is an irreplaceable bladder emptying method in clinical practice, and is widely used in urinary retention, dysuria, and urine drainage.
  • the total length of the catheter in front of the catheter balloon and the bullet-shaped end is 2-3 cm, which can cause bladder and urinary tract irritation.
  • Urinary tract irritation is a symptom, mainly common in urinary tract infection, urinary tract tuberculosis, urinary stones and other diseases, including frequent urination, urgency, painful urination and endless urination. It is caused by irritation of the bladder neck and bladder triangle. Most of them are caused by urinary tract infection, non-infectious inflammation and physical and chemical factors.
  • the drainage port of the traditional urinary catheter is located at the tip of the catheter, that is, when the patient is standing upright or lying flat, the position of the drainage port is higher than the opening of the bladder urethra, that is, there is a certain amount of urine that cannot flow out of the catheter.
  • This residual urine predisposes to the formation of periureteral stones and increases the risk of urinary tract infections.
  • the present application provides a catheterization device and a catheterization assembly including the catheterization device, so as to overcome the above problems or at least partly solve the above problems.
  • An embodiment of the present application provides a urinary catheterization device, which includes: a catheter that can pass through the urethra and has a main lumen that axially passes through the catheter; and a positioning structure that communicates with the main lumen, Extending axially from the distal end of the catheter and expanding radially outward, the positioning structure includes: a positioning ring, which can produce elastic deformation; a connecting part, which respectively connects the positioning ring and the distal end of the catheter, and the connecting part includes spaced At least one hollow unit; wherein, the positioning structure can be elastically deformed to enter the bladder through the urethra under a stressed state, and can be elastically restored to be positioned at the neck of the bladder under a non-stressed state.
  • the positioning structure is a horn-shaped structure expanding outward from the distal end of the catheter.
  • the at least one hollow unit is regularly arranged along the circumference of the side wall of the horn-shaped structure.
  • connection part is formed of film, wire, strip, woven mesh material or any combination of the above materials.
  • the hollowed out area of the hollowed out unit is larger than the caliber of the ureteral orifice.
  • the hollow unit is roughly elongated and extends from the distal end to the proximal end of the trumpet-shaped structure.
  • the hollowed-out units are approximately trapezoidal or petal-shaped, and the hollowed-out units are separated by radiating strips extending from the distal end to the proximal end of the trumpet-shaped structure.
  • the urinary catheterization device further includes a pull wire, the distal end of which passes through the main lumen and is connected to the positioning structure, and the proximal end extends to the proximal end of the catheter; the proximal end of the pull wire is provided with a reminder mark, It is used to prompt the pulling wire to pull the distance of the positioning structure to the proximal end.
  • the positioning ring includes at least one easy-to-break part and at least two connecting sections separated by the easy-to-break part, and the easy-to-break part can prompt the connecting section to produce elastic deformation under the action of external force.
  • the cross-sectional area of the easy-to-break portion is smaller than the cross-sectional area of the connecting section.
  • the easy-to-break portion is a roughly V-shaped groove formed by adjacent connecting segments.
  • the easy-to-fold portion is a double-fold surface formed by butting edges of adjacent connecting sections.
  • the urinary catheterization assembly includes: the above-mentioned urinary catheterization device; , and maintain the positioning ring in a contracted state.
  • the delivery member is passed through the main lumen of the catheter and the inside of the positioning structure, and when the positioning ring is shrunk in the catheter, the positioning ring abuts against the limiting part.
  • the distal end or the proximal end of the positioning ring abuts against the limiting part.
  • the distal end of the delivery element is made of flexible material, and when the positioning ring is shrunk in the catheter, the distal end of the delivery element is exposed outside the catheter.
  • the delivery member is provided with a guide channel axially penetrating through its interior for use with a guide instrument.
  • the delivery part also has a receiving part extending in the axial direction, which is connected with the limiting part.
  • the positioning ring is shrunk in the catheter, and the catheter is placed On the receiving portion, the limiting portion surrounds the catheter in a circumferential direction, and the positioning ring is limited in the limiting portion.
  • the distal end of the delivery member has a first limiting portion, which includes two arc-shaped first limiting units, and the two arc-shaped first limiting units form a non-continuous ring; each The distal end of the first limiting unit has an oblique extension, which extends radially inward from the distal end of the first limiting unit, and when the delivery member delivers the urinary catheter, the positioning ring is limited to the oblique into the extension.
  • each first limiting unit is flexibly connected to the receiving portion, and the other end forms a ring with a gap with another first limiting unit, and the gap becomes larger when the delivery member is withdrawn proximally , the other end of each first limiting unit is separated in a direction away from the axis of the catheter.
  • a second limiting part between the distal end and the proximal end of the delivery member, which includes an annular second limiting unit with a gap, and the second limiting unit is fixedly connected with the receiving part .
  • the inner side of the fixed connection between the second limiting unit and the receiving part has a protrusion
  • the outer side of the conduit is provided with a groove
  • the protrusion cooperates with the groove to limit the circumference of the conduit. turn.
  • the hardness of the protrusion is greater than the hardness of the portion close to the notch.
  • the urinary catheter assembly further includes: a sheath tube connected to the distal end of the catheter and communicated with the catheter, the inner diameter of the sheath tube is greater than or equal to the outer diameter of the catheter, and the sheath tube is used to accommodate the deflated positioning ring; a pusher, which can push the positioning ring accommodated in the sheath tube to the distal end along the main lumen, so that the positioning ring is separated from the sheath tube and extended.
  • the distal end of the catheter extends upward in an arc from the bottom to form a receiving portion, and an opening is provided above the receiving portion.
  • a drainage hole is further provided at the distal end of the catheter, and the distal end of the drainage hole is farther away from the distal end of the opening than the proximal end of the opening.
  • the urinary catheterization device further includes a push rod, and the push rod is used to penetrate into the catheter and push the positioning ring out of the catheter.
  • the catheterization device further includes a receiving part, the receiving part includes a receiving channel and a stabilizing part, and the receiving channel is used to compress the positioning ring in a circumferential direction, so that the positioning ring gradually moves axially and shrinks therein,
  • the stabilizing portion serves to keep the positioning ring in a compressed state from the circumferential direction.
  • the positioning ring of the embodiment of the present application can be positioned at the neck of the bladder in the expanded state, and fits closely with the inner wall of the neck of the bladder, reducing the space occupied by the fixed end of the traditional catheter distal end , reducing the irritation of the traditional catheter fixed end to the bladder wall.
  • the urine remaining in the bladder (for example near the bladder opening) can enter the catheter through the hollow unit.
  • the ureteral orifice will not be blocked, but can communicate with the hollow unit, thereby preventing the urine in the ureter from remaining at the bladder neck.
  • the easy-to-break part can promote the elastic deformation of the connecting section.
  • the easy-breaking part will first sag, and then drive the connecting section to deform, so that the positioning ring can be partially or completely closed in the catheter , so the positioning ring is easier to shrink into the catheter.
  • the urinary catheter assembly includes a urinary catheter and a delivery member, and the delivery member has a limiting portion for limiting the positioning ring in the limiting portion and maintaining the positioning ring in a contracted state.
  • Fig. 1A is a perspective view of an embodiment of a urinary catheterization device of the present application
  • Figure 1B is a side view of the catheterization device shown in Figure 1A;
  • Figure 1C is a left side view of the catheterization device shown in Figure 1B;
  • Fig. 2A is a perspective view of another embodiment of a urinary catheterization device of the present application.
  • Figure 2B is a side view of the catheterization device shown in Figure 2A;
  • Figure 2C is a left side view of the catheterization device shown in Figure 2B;
  • Fig. 2D is a structural schematic diagram of a positioning ring of another embodiment of a urinary catheterization device of the present application.
  • Fig. 3A and Fig. 3B are the schematic diagrams of the catheterization device in the state of bladder filling and contraction respectively;
  • 3C is a schematic diagram of the residual urine in the bladder passing through the hollow unit of the catheterization device
  • 4A and 4B are respectively a perspective view and a left side view of yet another embodiment of a catheterization device of the present application;
  • 4C to 4E are structural schematic diagrams of three embodiments of a positioning ring of a catheterization device of the present application.
  • Fig. 5A is a schematic diagram of an embodiment of a urinary catheter assembly of the present application.
  • Fig. 5B is a cross-sectional view of the state where the distal end of the positioning ring of the urinary catheter assembly shown in Fig. 5A is engaged to the state where the delivery member is closed to the proximal end of the catheter;
  • Fig. 5C is a cross-sectional view of the state where the positioning ring of the urinary catheter assembly shown in Fig. 5A is completely received in the catheter;
  • Fig. 5D is a cross-sectional view of the state where the proximal end of the positioning ring of the urinary catheter assembly is engaged to the state where the delivery member is retracted to the proximal end of the catheter;
  • Fig. 6A is a schematic diagram of another embodiment of a urinary catheter assembly of the present application.
  • Fig. 6B is a schematic diagram of the combination state of the delivery part and the urinary catheterization device of the urinary catheterization assembly shown in Fig. 6A;
  • Fig. 6C is a cross-sectional view of the first limiting unit of the urinary catheter assembly shown in Fig. 6A;
  • Fig. 6D is a cross-sectional view of the second limiting unit of the urinary catheter assembly shown in Fig. 6A;
  • Fig. 6E is a cross-sectional view of the combined state of the first limiting unit and the catheter of the urinary catheter assembly shown in Fig. 6A;
  • Fig. 6F is a cross-sectional view of the combined state of the second limiting unit and the catheter of the urinary catheter assembly shown in Fig. 6A;
  • Fig. 7 is a schematic diagram of another embodiment of a urinary catheter assembly of the present application.
  • 8A-8C are respectively a top view, a cross-sectional view and a side view of an embodiment of the catheter distal end of the present application;
  • Fig. 8D is a schematic diagram of the release state of the positioning structure of the present application from the catheter;
  • Fig. 8E is a schematic diagram of the release state of the positioning structure after the catheterization device of the present application enters the bladder through the urethra;
  • Fig. 8F is a schematic diagram of the positioning structure of the present application being gradually shrunk into the catheter in the bladder;
  • Fig. 9A is a schematic diagram of the state of the auxiliary storage and positioning structure of the storage device in the catheter of the present application.
  • 9B-9C are perspective views of two embodiments of the receiving element, respectively.
  • Catheter device 10 catheter 100; main cavity 101; positioning structure 200; positioning ring 201; connecting part 202; film 2021; hollow unit 2022; Urine assembly 20; delivery member 30; limiting part 301; receiving part 302; first limiting unit 3011; obliquely extending part 3111; second limiting unit 3012; protrusion 3013; groove 102; Part 204; receiving part 801; arc-shaped opening 802; drainage hole 803; receiving part 805; 806: push rod; receiving channel 500;
  • the “near end” refers to the end of the catheterization device or catheterization assembly that is close to the operator when the operator operates the catheterization device or catheterization assembly. Described “ far-end” refers to operator when operating catheterization device or urinary catheterization assembly, urinary catheterization device or urinary catheterization assembly is away from the end of this operator.
  • the “bottom” and “above” refer to the relative positions of the relevant components based on the current page where the illustration is located.
  • the positioning ring shrinks in the main lumen, including the positioning ring partially or completely shrinks in the main lumen.
  • a urinary catheterization device 10 including: a catheter 100 that can be inserted into the urethra, and the catheter 100 has a main lumen 101 that runs through the catheter 100 ; a positioning structure 200 , which communicates with the main lumen 101, and extends axially from the distal end of the catheter 100 and expands radially outward.
  • the positioning structure 200 includes: a positioning ring 201, which can be elastically deformed under the action of an external force; a connecting part 202, whose proximal end and The distal end of the catheter 100 is circumferentially connected, for example, covers the outer circumference of the catheter 100 , extends axially to the distal end, and expands radially outward, so that the distal end thereof is connected to the positioning ring 201 .
  • the positioning ring 201 and the connecting portion 202 form a trumpet-like structure, and the cross section of the positioning ring 201 can be selected from circular, petal-shaped, quadrangular, triangular, irregular shapes or any other suitable shape .
  • the positioning ring 201 forms a trumpet mouth of a trumpet-shaped structure that expands outward from the distal end of the catheter 100 .
  • the positioning structure 200 can be elastically deformed to enter the bladder via the urethra under a stressed state, and elastically recover to be positioned at the neck of the bladder under a non-stressed state.
  • 202 partially or completely shrinks in the main lumen 101; in the expanded state, the positioning ring 201 resumes elastic deformation, breaks away from the main lumen 101, and drives the connecting part 202 to expand until it expands to the maximum extent.
  • the positioning ring 201 can be positioned at the neck of the bladder in the expanded state, and fits closely to the inner wall of the neck of the bladder, which reduces the space volume occupied by the fixed end of the traditional catheter 100 distal end, and reduces the traditional catheter 100. irritation of the bladder wall.
  • the connecting part 202 can be formed by a film 2021 (as shown in FIG. 1A ), a filament (as shown in FIGS. 4A-4D ), a strip (as shown in FIGS. 2A-2C ), a braided mesh (as shown in FIG. 1C ) or any combination of the above materials. .
  • the material of the film can be silica gel, polymer and its composite material, etc.
  • the film 2021 can also be provided with a liner to maintain or strengthen the shape of the film.
  • the liner is similar to the supporting role of the skeleton, including filamentous, strip-shaped, woven mesh materials, etc.
  • the hardness of the material of the liner can be greater than that of the film. hardness.
  • the material of the lining can be selected from polymer materials, such as polyurethane, nylon, peek, ppsu, nickel-titanium alloy wire and other alloy wires.
  • the connecting portion 202 may also be formed only of filament, strip, woven mesh material or a combination thereof without including a film.
  • the drainage port of the catheter 100 is located at the tip of the catheter 100, that is, when the patient is standing upright or lying flat, the position of the drainage port is higher than the opening of the bladder urethra, that is, there is a certain amount of urine that cannot flow out of the catheter 100, which is commonly referred to as Residual urine, residual urine can easily lead to the formation of periureteral stones and increase the risk of urinary tract infection.
  • the design of the hollow unit 2022 as shown in FIGS. 3A to 3C , when the bladder contracts, on the one hand, the urine remaining in the bladder (for example near the bladder opening) can enter the catheter 100 through the hollow unit 2022 . On the other hand, the ureteral opening will not be blocked, but can communicate with the hollow unit 2022, thereby preventing the urine in the ureter from remaining at the bladder neck opening.
  • the hollowed out area of the hollowed out unit 2022 is larger than the caliber of the ureteral orifice, so as to partially block the membrane 2021 due to the small hollowed out area.
  • the hollow unit 2022 can have various shapes, as shown in FIGS. 1A to 1C .
  • the hollow unit 2022 is roughly elongated, extending from the distal end to the proximal end of the trumpet-shaped structure 200 .
  • the hollowed-out units 2022 are approximately trapezoidal (as shown in Figures 2A to 2C) or petal-shaped (4A-4B), and each hollowed-out unit 2022 extends from the distal end to the proximal end of the trumpet-shaped structure 200.
  • the radiating strips are separated, and each hollow unit 2022 is formed by the positioning ring 201 at the distal end, the radiating strips of the connecting part 202 and the proximal part of the connecting part 202 .
  • the catheterization device 10 further includes a pull wire 300 , the distal end of which passes through the main lumen 101 and is connected to the positioning ring 201 or the connecting portion 202 , and the proximal end extends to the proximal end of the catheter 100
  • the proximal end of the traction wire 300 is provided with a reminder mark, which is used to prompt the distance that the traction wire 300 pulls the positioning structure 200 to the proximal end.
  • the wire 300 exposes the prompting mark, the prompting positioning ring 201 has been partially or completely shrunk in the catheter 100, and at this time, the pulling wire 300 and the catheter 100 can be kept moving toward the proximal end synchronously.
  • a pull ring 301 may be provided at the proximal end of the pull wire 300 , and the pull ring 300 is pulled through the pull ring 301 .
  • the positioning ring 201 may include at least one frangible part 2011, and at least two connecting sections 2012 separated by the frangible part 2011. Elastic deformation, for example, when a traction force is applied to the positioning ring 201, the frangible part 2011 is first dented, and then the connecting section 2012 is driven to deform, so that the positioning ring 201 can be partially or completely received in the catheter 100, the setting of the frangible part 2011, The stress concentration of the positioning ring 201 is reduced, and the aspect ratio of the positioning ring 201 is larger when shrinking, so the positioning ring 201 is easier to shrink into the catheter 100 . In one embodiment, as shown in FIGS.
  • the easy-to-break portion 2011 is formed by adjacent arc-shaped connecting segments 2012, and the cross-sectional area of the easy-to-break portion 2011 is smaller than other parts of the positioning ring 201, for example The cross-sectional area of the connecting segment is conducive to deformation.
  • the easy-to-break portion 2011 is approximately a V-shaped groove.
  • the easy-to-fold portion 2011 is a double-fold surface formed by butting edges of adjacent linear connecting segments 2012 .
  • a urinary catheter assembly 20 which includes a urinary catheter device 10 and a delivery member 30.
  • the delivery member 30 has a limiting portion 301 for positioning the positioning ring 201 ( For example, the distal end of the positioning ring 201) is limited in the limiting portion 301, and maintains the positioning ring 201 in a contracted state.
  • the delivery member 30 is installed inside the main lumen 101 and the positioning structure 200 of the catheter 100.
  • the positioning ring 201 is shrunk in the catheter 100, the distal end of the positioning ring 201 (as shown in FIG. 5C ) or the proximal end (as shown in FIG. 5D ) abuts against the limiting portion 301.
  • the limiting portion 301 is a groove.
  • the positioning ring 201 When the positioning ring 201 is shrunk into the catheter 100, a part of the positioning ring 201 is embedded in the groove, and the delivery member 30 and the pulling wire 300 are pulled to the proximal end, and the positioning The ring 201 is shrunk in the catheter 100 , and since the positioning ring 201 abuts against the limiting portion 301 in the catheter 100 , the positioning ring 201 is restricted from ejecting from the catheter 100 .
  • the distal end of the delivery member 30 is made of flexible material, and when the positioning ring 201 is shrunk in the catheter 100 , the distal end of the delivery member 30 is exposed outside the catheter 100 .
  • the distal end of delivery member 30 may also be conical-like to facilitate passage through narrow segments.
  • the delivery member 30 is provided with a guiding channel (not shown) axially penetrating through its interior, for use in cooperation with a guiding device (such as a guide wire). For example, for a narrow segment, it can be delivered to the distal end while clearing the channel with a guiding instrument.
  • a guiding channel (not shown) axially penetrating through its interior, for use in cooperation with a guiding device (such as a guide wire).
  • a guiding device such as a guide wire
  • the delivery member 30 also has a receiving portion 302 extending in the axial direction, which is connected to the limiting portion 301.
  • the delivery member 30 delivers the urinary catheter 10
  • the positioning ring 201 Shrunken in the catheter 100
  • the catheter 100 is placed on the receiving portion 302
  • the limiting portion 301 covers the catheter 100 in a circumferential direction
  • the positioning ring 201 is limited in the limiting portion 301 .
  • the distal end of the delivery member 30 has a first limiting portion 301, which includes two arc-shaped first limiting units 3011, and the two arc-shaped first limiting units 3011 form an incoherent
  • the distal end of each first limiting unit 3011 has an oblique extension 3111, which extends radially inward from the distal end of the first limiting unit 3011.
  • the positioning ring 201 eg, the distal end of the positioning ring 201
  • the obliquely extending portion 3111 at the distal end of the first limiting unit 3011 forms a bullet shape.
  • each first limiting unit 3011 is flexibly connected to the receiving portion 302, and the other end forms a ring with a notch with another first limiting unit 3011.
  • the gap becomes larger, and the other end of each first limiting unit 3011 separates away from the axis of the catheter 100 .
  • a second limiting portion 301 between the distal end and the proximal end of the delivery member 30, which includes a second limiting portion 301 that is annular (for example, C-shaped as shown in FIG. 6D ) with a gap.
  • the position unit 3012 and the second position limiting unit 3012 are fixedly connected with the receiving portion 302 .
  • the hardness of the protrusion 3013 is greater than that of the part near the notch.
  • the first limiting unit 3011 and the second limiting unit 3012 may be made of different materials.
  • the urinary catheter assembly 20 further includes: a sheath 203 connected to the distal end of the catheter 100 and communicated with the catheter 100 , the inner diameter of the sheath 203 is greater than or equal to the outer diameter of the catheter 100 , the sheath tube 203 is used to accommodate the retracted positioning ring 201; the pusher 204 can push the positioning ring 201 received in the sheath tube 203 to the distal end along the main lumen 101, so that the positioning ring 201 is separated from the sheath tube 203 and extended , the pushing member 204 can strengthen the rigidity of the tube body of the catheter 100 when it is inserted.
  • the pushing member 204 may be provided with a groove 102 for engaging the positioning ring 201 , so as to control the pushing distance and the unfolding degree of the positioning ring 201 .
  • the distal end of the catheter 100 extends from the bottom along an arc to form a receiving portion 801, and an opening 802 is provided above the receiving portion 801, and the section of the opening 802 can be arc-shaped, L-shaped or any other suitable shape. shape. Opening 802 facilitates complete receipt of positioning structure 200 within catheter 100, release of positioning structure 200, drainage of urine, and introduction of catheter 100 into the urethra.
  • the distal end of the catheter 100 is further provided with a drainage hole 803 , and the distal end D of the drainage hole 803 is farther away from the distal end F of the opening 802 than the proximal end E of the opening 802 .
  • the bottom of the drainage hole 803 can be slightly lower than the horizontal plane 804 where the distal end of the receiving part 801 is located.
  • the drainage hole 803 can drain urine lower than the distal end of the receiving part 801 , allowing for a more thorough drainage of urine.
  • the positioning ring 201 can be pushed out of the catheter 100 through the ejector rod 806, and the positioning ring 201 gradually recovers to a ring shape and drives the connecting part 202 to extend, and is attached to the inner wall of the bladder neck. Together, the drainage hole 803 drains the urine remaining between the connecting portion 202 and the inner wall of the bladder neck.
  • the distal end of the push rod 806 can be concave, flat, etc. When the distal end of the push rod 806 is concave, a part of the positioning ring 201 can be accommodated in the concave surface, so that the push rod 806 can be stably pushed positioning ring 201.
  • the positioning structure 200 can be received by the receiving member 805 into the catheter 100 prior to implantation in the urethra.
  • the receiving part 805 may include a receiving channel 500 and a stabilizing part 501.
  • the receiving channel 500 presses the positioning ring 201 in the circumferential direction, so that it gradually moves axially and shrinks in the receiving channel 500.
  • the stabilizing part 501 further keeps the positioning ring 201 in the circumferential direction. In the compressed state, the positioning structure 200 is then placed in the catheter 100, and the receiving member 805 is withdrawn.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • External Artificial Organs (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

A urethral catheterization device (10), comprising: a catheter (100), which has a main lumen (101) passing through the catheter (100); and a positioning structure (200). The positioning structure comprises: a positioning ring (201), which can be elastically deformed under the action of an external force; and a connecting portion (202), wherein a proximal end thereof is circumferentially connected to a distal end of the catheter (100), extends axially to a distal end thereof, and expands radially outwards, such that the distal end thereof is connected to the positioning ring (201); in a contracted state, the positioning ring (201) is elastically deformed so as to contract with the connecting portion (202); and in an expanded state, the positioning ring (201) recovers from deformation, so as to drive the connecting portion (202) to expand until same expands to have a ring shape. By means of the urethral catheterization device (10), the volume of space occupied by a fixed end of a distal end of a conventional catheter is reduced, such that stimulation to a bladder wall by the fixed end of the conventional catheter is reduced.

Description

导尿装置及包括该导尿装置的导尿组件Urinary catheterization device and urinary catheterization assembly comprising the same
本申请要求在2021年10月18日提交中国专利局、申请号202111209889.0、发明名称为“导尿装置及包括该导尿装置的导尿组件”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。This application claims the priority of a Chinese patent application filed with the China Patent Office on October 18, 2021, application number 202111209889.0, titled "Urinary Catheter and Urinary Catheter Assembly Including the Urinary Catheter", the entire contents of which are incorporated by reference incorporated in this application.
技术领域technical field
本申请实施例涉及医疗器械技术领域，尤其涉及一种导尿装置以及包括该导尿装置的导尿组件。The embodiments of the present application relate to the technical field of medical devices, and in particular to a catheterization device and a catheterization assembly including the catheterization device.
背景技术Background technique
留置导尿是目前临床不可取代的一种膀胱排空方式，被广泛应用于尿潴留、排尿困难、引流尿液等。导尿管球囊前方的导尿管和子弹头形端头的总长度有2—3cm，会引起膀胱及尿路刺激症。尿路刺激症是一种症状，主要常见于***、尿路结核、泌尿系结石等疾病，包括尿频、尿急、尿痛和尿不尽的感觉，是膀胱颈和***受刺激所致，大部分是由***、非感染性炎症和理化因素引起的。Indwelling catheterization is an irreplaceable bladder emptying method in clinical practice, and is widely used in urinary retention, dysuria, and urine drainage. The total length of the catheter in front of the catheter balloon and the bullet-shaped end is 2-3 cm, which can cause bladder and urinary tract irritation. Urinary tract irritation is a symptom, mainly common in urinary tract infection, urinary tract tuberculosis, urinary stones and other diseases, including frequent urination, urgency, painful urination and endless urination. It is caused by irritation of the bladder neck and bladder triangle. Most of them are caused by urinary tract infection, non-infectious inflammation and physical and chemical factors.
再者，现有的导尿管的径向截面大都为圆形，导致尿道黏膜分泌物无法排出，并长期堆积在尿管周围而形成生物膜，由于生物膜为微生物、有机物以及无机物聚集繁殖形成的微菌落，其将造成常规细菌培养困难，对抗菌药物敏感性降低，此为导致CAUTI高发性和反复性的重要原因。Moreover, most of the radial cross-sections of existing urinary catheters are circular, which leads to the inability to discharge the urethral mucosal secretions and accumulates around the urinary catheter for a long time to form a biofilm. The formed micro-colonies will cause difficulties in conventional bacterial culture and reduce the susceptibility to antibacterial drugs, which is an important reason for the high incidence and recurrence of CAUTI.
传统导尿管的排液口位于导尿管的尖端，即当患者直立或平躺时，排液口的位置高于膀胱尿道开口，即存在一定量的尿液无法从导尿管流出，临床通常称为残余尿，该残余尿容易引起尿管周围结石的形成，以及会引起***风险的增加。The drainage port of the traditional urinary catheter is located at the tip of the catheter, that is, when the patient is standing upright or lying flat, the position of the drainage port is higher than the opening of the bladder urethra, that is, there is a certain amount of urine that cannot flow out of the catheter. Commonly referred to as residual urine, this residual urine predisposes to the formation of periureteral stones and increases the risk of urinary tract infections.
另外，对于尿道狭窄的患者而言，存在着导尿管置入困难的问题，并还存在由于导尿管的硬度不足，而无法顺利通过导尿狭窄段的问题。In addition, for patients with urethral stricture, there is a problem that it is difficult to insert the urinary catheter, and there is also the problem that the urinary catheter cannot pass through the stricture segment smoothly due to insufficient hardness.
发明内容Contents of the invention
鉴于上述问题，本申请提供一种导尿装置以及包括该导尿装置的导尿组件，以克服上述问题或者至少部分地解决上述问题。In view of the above problems, the present application provides a catheterization device and a catheterization assembly including the catheterization device, so as to overcome the above problems or at least partly solve the above problems.
本申请实施例提供一种导尿装置，该导尿装置包括：导管，其可穿设于尿道中，并具有轴向贯穿该导管的主腔道；以及定位结构，其连通该主腔道， 并自导管远端轴向延伸且径向向外扩展，该定位结构包括：定位环，其可产生弹性形变；连接部，其分别连接该定位环与该导管远端，该连接部包括间隔设置的至少一个镂空单元；其中，该定位结构可在受力状态下弹性形变以经由该尿道进入膀胱，并可在未受力状态下弹性恢复以定位于膀胱颈口。An embodiment of the present application provides a urinary catheterization device, which includes: a catheter that can pass through the urethra and has a main lumen that axially passes through the catheter; and a positioning structure that communicates with the main lumen, Extending axially from the distal end of the catheter and expanding radially outward, the positioning structure includes: a positioning ring, which can produce elastic deformation; a connecting part, which respectively connects the positioning ring and the distal end of the catheter, and the connecting part includes spaced At least one hollow unit; wherein, the positioning structure can be elastically deformed to enter the bladder through the urethra under a stressed state, and can be elastically restored to be positioned at the neck of the bladder under a non-stressed state.
可选地，所述定位结构为自该导管远端向外扩张的喇叭形结构。Optionally, the positioning structure is a horn-shaped structure expanding outward from the distal end of the catheter.
可选地，所述至少一个镂空单元沿喇叭形结构的侧壁周向规则排列。Optionally, the at least one hollow unit is regularly arranged along the circumference of the side wall of the horn-shaped structure.
可选地，所述连接部由薄膜、丝状、条状、编织网状材料或上述材料的任意组合形成。Optionally, the connection part is formed of film, wire, strip, woven mesh material or any combination of the above materials.
可选地，所述镂空单元的镂空面积大于输尿管口的口径。Optionally, the hollowed out area of the hollowed out unit is larger than the caliber of the ureteral orifice.
可选地，所述镂空单元大致呈长条形，其自喇叭形结构的远端向近端延伸。Optionally, the hollow unit is roughly elongated and extends from the distal end to the proximal end of the trumpet-shaped structure.
可选地，所述镂空单元大致呈梯形或花瓣形，各镂空单元之间由自喇叭形结构的远端向近端延伸的辐射条分隔开。Optionally, the hollowed-out units are approximately trapezoidal or petal-shaped, and the hollowed-out units are separated by radiating strips extending from the distal end to the proximal end of the trumpet-shaped structure.
可选地，所述导尿装置还包括牵引线，其远端穿过该主腔道与该定位结构连接，近端延伸至该导管的近端；该牵引线的近端设有提示标记，用于提示该牵引线向近端牵拉该定位结构的距离。Optionally, the urinary catheterization device further includes a pull wire, the distal end of which passes through the main lumen and is connected to the positioning structure, and the proximal end extends to the proximal end of the catheter; the proximal end of the pull wire is provided with a reminder mark, It is used to prompt the pulling wire to pull the distance of the positioning structure to the proximal end.
可选地，所述定位环包括至少一个易折部，以及被该易折部分隔开的至少两个连接段，在外力作用下，该易折部可促使该连接段产生弹性形变。Optionally, the positioning ring includes at least one easy-to-break part and at least two connecting sections separated by the easy-to-break part, and the easy-to-break part can prompt the connecting section to produce elastic deformation under the action of external force.
可选地，所述易折部的横截面面积小于连接段的横截面面积。Optionally, the cross-sectional area of the easy-to-break portion is smaller than the cross-sectional area of the connecting section.
可选地，所述易折部为由相邻的连接段形成的大概呈V形的凹槽。Optionally, the easy-to-break portion is a roughly V-shaped groove formed by adjacent connecting segments.
所述易折部为由相邻的连接段的边缘对接形成的对折面。The easy-to-fold portion is a double-fold surface formed by butting edges of adjacent connecting sections.
本申请另一方面还提供一种导尿组件，所述导尿组件包括：如上所述的导尿装置；以及递送件，其具有限位部，用于将该定位环限制于该限位部中，并维持该定位环处于收缩状态。Another aspect of the present application also provides a urinary catheterization assembly, the urinary catheterization assembly includes: the above-mentioned urinary catheterization device; , and maintain the positioning ring in a contracted state.
可选地，所述递送件穿设于该导管的主腔道和该定位结构的内部，当该定位环收缩于该导管中时，该定位环抵靠该限位部。Optionally, the delivery member is passed through the main lumen of the catheter and the inside of the positioning structure, and when the positioning ring is shrunk in the catheter, the positioning ring abuts against the limiting part.
可选地，当该定位环收缩于该导管中时，该定位环的远端或近端抵靠该限位部。Optionally, when the positioning ring is retracted in the catheter, the distal end or the proximal end of the positioning ring abuts against the limiting part.
可选地，所述递送件的远端为柔性材料，当该定位环收缩于该导管中时，该递送件的远端曝露于该导管外。Optionally, the distal end of the delivery element is made of flexible material, and when the positioning ring is shrunk in the catheter, the distal end of the delivery element is exposed outside the catheter.
可选地，所述递送件设有轴向贯穿其内部的引导通道，用于与导引器械配合使用。Optionally, the delivery member is provided with a guide channel axially penetrating through its interior for use with a guide instrument.
可选地，所述递送件还具有沿轴向延伸的承接部，其与该限位部连接， 当该递送件递送该导尿装置时，该定位环收缩于该导管中，该导管置于该承接部上，该限位部周向包覆该导管，且该定位环限制于该限位部中。Optionally, the delivery part also has a receiving part extending in the axial direction, which is connected with the limiting part. When the delivery part delivers the urinary catheter, the positioning ring is shrunk in the catheter, and the catheter is placed On the receiving portion, the limiting portion surrounds the catheter in a circumferential direction, and the positioning ring is limited in the limiting portion.
可选地，所述递送件的远端具有第一限位部，其包括两个弧形的第一限位单元，该两个弧形的第一限位单元形成非连贯的环形；每个第一限位单元的远端具有斜向延伸部，其自该第一限位单元的远端沿径向向内延伸，当该递送件递送该导尿装置时，该定位环限制于该斜向延伸部中。Optionally, the distal end of the delivery member has a first limiting portion, which includes two arc-shaped first limiting units, and the two arc-shaped first limiting units form a non-continuous ring; each The distal end of the first limiting unit has an oblique extension, which extends radially inward from the distal end of the first limiting unit, and when the delivery member delivers the urinary catheter, the positioning ring is limited to the oblique into the extension.
可选地，各第一限位单元的一端与该承接部活动连接，另一端与另外一个第一限位单元形成具有缺口的环形，当向近端撤出该递送件时，该缺口变大，每个第一限位单元的另一端向远离该导管轴线的方向分离。Optionally, one end of each first limiting unit is flexibly connected to the receiving portion, and the other end forms a ring with a gap with another first limiting unit, and the gap becomes larger when the delivery member is withdrawn proximally , the other end of each first limiting unit is separated in a direction away from the axis of the catheter.
可选地，所述递送件的远端与近端之间还具有第二限位部，其包括一个具有缺口的环形的第二限位单元，该第二限位单元与该承接部固定连接。Optionally, there is a second limiting part between the distal end and the proximal end of the delivery member, which includes an annular second limiting unit with a gap, and the second limiting unit is fixedly connected with the receiving part .
可选地，所述第二限位单元与该承接部固定连接处的内侧具有凸起，该导管的外侧设有凹槽，该凸起与该凹槽相配合，以限制该导管沿周向转动。Optionally, the inner side of the fixed connection between the second limiting unit and the receiving part has a protrusion, and the outer side of the conduit is provided with a groove, and the protrusion cooperates with the groove to limit the circumference of the conduit. turn.
可选地，所述凸起的硬度大于靠近该缺口的部分的硬度。Optionally, the hardness of the protrusion is greater than the hardness of the portion close to the notch.
可选地，所述导尿组件还包括：连接该导管的远端且与该导管连通的鞘管，该鞘管的内径大于或等于该导管的外径，该鞘管用于容纳收缩后的定位环；推送件，其可沿该主腔道向远端推送收纳于该鞘管的定位环，使该定位环脱离该鞘管并延展开。Optionally, the urinary catheter assembly further includes: a sheath tube connected to the distal end of the catheter and communicated with the catheter, the inner diameter of the sheath tube is greater than or equal to the outer diameter of the catheter, and the sheath tube is used to accommodate the deflated positioning ring; a pusher, which can push the positioning ring accommodated in the sheath tube to the distal end along the main lumen, so that the positioning ring is separated from the sheath tube and extended.
可选地，所述导管的远端从底部沿弧形向上延伸形成承接部，该承接部的上方设有开口。Optionally, the distal end of the catheter extends upward in an arc from the bottom to form a receiving portion, and an opening is provided above the receiving portion.
可选地，该导管的远端还设有引流孔，该引流孔的远端相对于该开口的近端更加远离该开口的远端。Optionally, a drainage hole is further provided at the distal end of the catheter, and the distal end of the drainage hole is farther away from the distal end of the opening than the proximal end of the opening.
可选地，所述导尿装置还包括顶杆，该顶杆用于穿入该导管中，将该定位环推出该导管。Optionally, the urinary catheterization device further includes a push rod, and the push rod is used to penetrate into the catheter and push the positioning ring out of the catheter.
可选地，所述导尿装置还包括收纳件，该收纳件包括收纳通道和稳定部，该收纳通道用于周向挤压该定位环，使该定位环逐渐轴向移动而收缩于其中，该稳定部用于从周向保持定位环处于压缩状态。Optionally, the catheterization device further includes a receiving part, the receiving part includes a receiving channel and a stabilizing part, and the receiving channel is used to compress the positioning ring in a circumferential direction, so that the positioning ring gradually moves axially and shrinks therein, The stabilizing portion serves to keep the positioning ring in a compressed state from the circumferential direction.
由以上技术方案可见，本申请实施例的定位环在扩展状态下可以定位于膀胱颈口，且与膀胱颈口的内壁较为贴合，减小了传统的导管远端的固定端占用的空间体积，减小了传统的导管固定端对膀胱壁的刺激。It can be seen from the above technical solutions that the positioning ring of the embodiment of the present application can be positioned at the neck of the bladder in the expanded state, and fits closely with the inner wall of the neck of the bladder, reducing the space occupied by the fixed end of the traditional catheter distal end , reducing the irritation of the traditional catheter fixed end to the bladder wall.
而镂空单元的设计，在当膀胱收缩时，一方面，残留在膀胱中(例如膀胱口附近)的尿液可以通过镂空单元进入导管中。另一方面，输尿管口不会被堵塞，而可与镂空单元连通，进而可以避免输尿管中的尿液残留于膀胱颈 口。With the design of the hollow unit, when the bladder contracts, on the one hand, the urine remaining in the bladder (for example near the bladder opening) can enter the catheter through the hollow unit. On the other hand, the ureteral orifice will not be blocked, but can communicate with the hollow unit, thereby preventing the urine in the ureter from remaining at the bladder neck.
在外力作用下，易折部可促使该连接段产生弹性形变，例如当向定位环施加牵引力时，易折部先凹陷，再带动连接段产生形变，使得定位环可以被部分或全部收于导管中，因此定位环更容易收缩于导管中。Under the action of external force, the easy-to-break part can promote the elastic deformation of the connecting section. For example, when a traction force is applied to the positioning ring, the easy-breaking part will first sag, and then drive the connecting section to deform, so that the positioning ring can be partially or completely closed in the catheter , so the positioning ring is easier to shrink into the catheter.
本申请实施例的导尿组件，其包括导尿装置和递送件，递送件具有限位部，用于将该定位环限制于该限位部中，并维持该定位环处于收缩状态。The urinary catheter assembly according to the embodiment of the present application includes a urinary catheter and a delivery member, and the delivery member has a limiting portion for limiting the positioning ring in the limiting portion and maintaining the positioning ring in a contracted state.
附图说明Description of drawings
为了更清楚地说明本申请实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请实施例中记载的一些实施例，对于本领域普通技术人员来讲，还可以根据这些附图获得其他的附图。In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only These are some embodiments described in the embodiments of the present application, and those skilled in the art can also obtain other drawings based on these drawings.
图1A是本申请一种导尿装置的一实施例的立体图；Fig. 1A is a perspective view of an embodiment of a urinary catheterization device of the present application;
图1B是图1A所示的导尿装置的侧视图；Figure 1B is a side view of the catheterization device shown in Figure 1A;
图1C是图1B所示的导尿装置的左视图；Figure 1C is a left side view of the catheterization device shown in Figure 1B;
图2A是本申请一种导尿装置的另一实施例的立体图；Fig. 2A is a perspective view of another embodiment of a urinary catheterization device of the present application;
图2B是图2A所示的导尿装置的侧视图；Figure 2B is a side view of the catheterization device shown in Figure 2A;
图2C是图2B所示的导尿装置的左视图；Figure 2C is a left side view of the catheterization device shown in Figure 2B;
图2D是本申请一种导尿装置的又一实施例的定位环的结构示意图；Fig. 2D is a structural schematic diagram of a positioning ring of another embodiment of a urinary catheterization device of the present application;
图3A和图3B分别是膀胱充盈和收缩状态下导尿装置的示意图；Fig. 3A and Fig. 3B are the schematic diagrams of the catheterization device in the state of bladder filling and contraction respectively;
图3C是膀胱中残余尿液通过导尿装置的镂空单元的示意图；3C is a schematic diagram of the residual urine in the bladder passing through the hollow unit of the catheterization device;
图4A和4B分别是本申请一种导尿装置的又另一实施例的立体图和左视图；4A and 4B are respectively a perspective view and a left side view of yet another embodiment of a catheterization device of the present application;
图4C至4E分别是本申请一种导尿装置的定位环的三个实施例的结构示意图；4C to 4E are structural schematic diagrams of three embodiments of a positioning ring of a catheterization device of the present application;
图5A是本申请一种导尿组件的一实施例的示意图；Fig. 5A is a schematic diagram of an embodiment of a urinary catheter assembly of the present application;
图5B是将图5A所示的导尿组件的定位环的远端卡合至递送件向近端收于导管的状态的剖视图；Fig. 5B is a cross-sectional view of the state where the distal end of the positioning ring of the urinary catheter assembly shown in Fig. 5A is engaged to the state where the delivery member is closed to the proximal end of the catheter;
图5C是将图5A所示的导尿组件的定位环完全收于导管中的状态的剖视图；Fig. 5C is a cross-sectional view of the state where the positioning ring of the urinary catheter assembly shown in Fig. 5A is completely received in the catheter;
图5D是将导尿组件的定位环的近端卡合至递送件向近端收于导管的状态的剖视图；Fig. 5D is a cross-sectional view of the state where the proximal end of the positioning ring of the urinary catheter assembly is engaged to the state where the delivery member is retracted to the proximal end of the catheter;
图6A是本申请一种导尿组件的另一实施例的示意图；Fig. 6A is a schematic diagram of another embodiment of a urinary catheter assembly of the present application;
图6B是图6A所示的导尿组件的递送件与导尿装置组合状态示意图；Fig. 6B is a schematic diagram of the combination state of the delivery part and the urinary catheterization device of the urinary catheterization assembly shown in Fig. 6A;
图6C是图6A所示的导尿组件的第一限位单元的截面视图；Fig. 6C is a cross-sectional view of the first limiting unit of the urinary catheter assembly shown in Fig. 6A;
图6D是图6A所示的导尿组件的第二限位单元的截面视图；Fig. 6D is a cross-sectional view of the second limiting unit of the urinary catheter assembly shown in Fig. 6A;
图6E是图6A所示的导尿组件的第一限位单元与导管组合状态的截面视图；Fig. 6E is a cross-sectional view of the combined state of the first limiting unit and the catheter of the urinary catheter assembly shown in Fig. 6A;
图6F是图6A所示的导尿组件的第二限位单元与导管组合状态的截面视图；Fig. 6F is a cross-sectional view of the combined state of the second limiting unit and the catheter of the urinary catheter assembly shown in Fig. 6A;
图7是本申请一种导尿组件的又一实施例的示意图；Fig. 7 is a schematic diagram of another embodiment of a urinary catheter assembly of the present application;
图8A-8C分别是本申请导管远端的一实施例的俯视图、剖视图和侧视图；8A-8C are respectively a top view, a cross-sectional view and a side view of an embodiment of the catheter distal end of the present application;
图8D是本申请定位结构从导管中释放的状态示意图；Fig. 8D is a schematic diagram of the release state of the positioning structure of the present application from the catheter;
图8E是本申请的导尿装置经由尿道进入膀胱后定位结构释放的状态示意图；Fig. 8E is a schematic diagram of the release state of the positioning structure after the catheterization device of the present application enters the bladder through the urethra;
图8F是本申请的定位结构在膀胱中逐渐收缩于导管中的状态示意图；Fig. 8F is a schematic diagram of the positioning structure of the present application being gradually shrunk into the catheter in the bladder;
图9A是本申请的收纳件辅助收纳定位结构于导管中的状态示意图；Fig. 9A is a schematic diagram of the state of the auxiliary storage and positioning structure of the storage device in the catheter of the present application;
图9B-9C分别是收纳件的两个实施例的立体图。9B-9C are perspective views of two embodiments of the receiving element, respectively.
元件标号Component number
导尿装置10；导管100；主腔道101；定位结构200；定位环201；连接部202；薄膜2021；镂空单元2022；牵引线300；拉环301；易折部2011；连接段2012；导尿组件20；递送件30；限位部301；承接部302；第一限位单元3011；斜向延伸部3111；第二限位单元3012；凸起3013；凹槽102；鞘管203；推送件204；承接部801；弧形开口802；引流孔803；收纳件805；806：顶杆；收纳通道500；稳定部501。 Catheter device 10; catheter 100; main cavity 101; positioning structure 200; positioning ring 201; connecting part 202; film 2021; hollow unit 2022; Urine assembly 20; delivery member 30; limiting part 301; receiving part 302; first limiting unit 3011; obliquely extending part 3111; second limiting unit 3012; protrusion 3013; groove 102; Part 204; receiving part 801; arc-shaped opening 802; drainage hole 803; receiving part 805; 806: push rod; receiving channel 500;
具体实施例specific embodiment
为了使本领域的人员更好地理解本申请实施例中的技术方案，下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅是本申请实施例一部分实施例，而不是全部的实施例。基于本申请实施例中的实施例，本领域普通技术人员所获得的所有其他实施例，都应当属于本申请实施例保护的范围。In order to enable those skilled in the art to better understand the technical solutions in the embodiments of the present application, the following will clearly and completely describe the technical solutions in the embodiments of the present application in conjunction with the drawings in the embodiments of the present application. Obviously, the described The embodiments are only some of the embodiments of the present application, but not all of them. All other embodiments obtained by persons of ordinary skill in the art based on the embodiments in the embodiments of the present application shall fall within the protection scope of the embodiments of the present application.
所述的“近端”是指操作者在操作导尿装置或导尿组件时，导尿装置或导尿组件靠近该操作者的一端。所述的“远端”是指操作者在操作导尿装置 或导尿组件时，导尿装置或导尿组件远离该操作者的一端。The "near end" refers to the end of the catheterization device or catheterization assembly that is close to the operator when the operator operates the catheterization device or catheterization assembly. Described " far-end " refers to operator when operating catheterization device or urinary catheterization assembly, urinary catheterization device or urinary catheterization assembly is away from the end of this operator.
所述的“底部”、“上方”是指以图示所在的当前纸面为基准，相关部件的相对位置。The "bottom" and "above" refer to the relative positions of the relevant components based on the current page where the illustration is located.
所述的定位环收缩于主腔道中，包括定位环部分或全部收缩于主腔道中。The positioning ring shrinks in the main lumen, including the positioning ring partially or completely shrinks in the main lumen.
下面结合本申请实施例附图进一步说明本申请实施例具体实现。The specific implementation of the embodiment of the present application will be further described below in conjunction with the accompanying drawings of the embodiment of the present application.
参见图1A至图7，在本申请一具体实现中，提供一种导尿装置10，包括：导管100，可穿设于尿道中，导管100具有贯穿导管100的主腔道101；定位结构200，其连通主腔道101，并自导管100远端轴向延伸且径向向外扩展，定位结构200包括：定位环201，在外力作用下可产生弹性形变；连接部202，其近端与导管100的远端周向连接，例如包覆导管100的外周，并沿轴向向远端延伸，且径向向外扩展，以使其远端与定位环201连接。在一实施例中，定位环201和连接部202形成类似于喇叭状的结构，定位环201的截面可以为选自圆环形、花瓣形、四边形、三角形、不规则形状或其他任何适合的形状。在一实施例中，定位环201形成自导管100远端向外扩张的喇叭形结构的喇叭口。定位结构200可在受力状态下弹性形变以经由尿道进入膀胱，并可在未受力状态下弹性恢复以定位于膀胱颈口，在收缩状态下，定位环201发生弹性形变，以与连接部202部分或全部收缩于主腔道101内；在扩展状态下，定位环201恢复弹性形变，脱离主腔道101，带动连接部202延展开，直至扩展至最大幅度。定位环201在扩展状态下可以定位于膀胱颈口，且与膀胱颈口的内壁较为贴合，减小了传统的导管100远端的固定端占用的空间体积，减小了传统的导管100固定端对膀胱壁的刺激。Referring to FIG. 1A to FIG. 7 , in a specific implementation of the present application, a urinary catheterization device 10 is provided, including: a catheter 100 that can be inserted into the urethra, and the catheter 100 has a main lumen 101 that runs through the catheter 100 ; a positioning structure 200 , which communicates with the main lumen 101, and extends axially from the distal end of the catheter 100 and expands radially outward. The positioning structure 200 includes: a positioning ring 201, which can be elastically deformed under the action of an external force; a connecting part 202, whose proximal end and The distal end of the catheter 100 is circumferentially connected, for example, covers the outer circumference of the catheter 100 , extends axially to the distal end, and expands radially outward, so that the distal end thereof is connected to the positioning ring 201 . In one embodiment, the positioning ring 201 and the connecting portion 202 form a trumpet-like structure, and the cross section of the positioning ring 201 can be selected from circular, petal-shaped, quadrangular, triangular, irregular shapes or any other suitable shape . In one embodiment, the positioning ring 201 forms a trumpet mouth of a trumpet-shaped structure that expands outward from the distal end of the catheter 100 . The positioning structure 200 can be elastically deformed to enter the bladder via the urethra under a stressed state, and elastically recover to be positioned at the neck of the bladder under a non-stressed state. 202 partially or completely shrinks in the main lumen 101; in the expanded state, the positioning ring 201 resumes elastic deformation, breaks away from the main lumen 101, and drives the connecting part 202 to expand until it expands to the maximum extent. The positioning ring 201 can be positioned at the neck of the bladder in the expanded state, and fits closely to the inner wall of the neck of the bladder, which reduces the space volume occupied by the fixed end of the traditional catheter 100 distal end, and reduces the traditional catheter 100. irritation of the bladder wall.
在一实施例中，镂空单元2022可以为一个或多个，可以沿喇叭形结构的侧壁周向规则排列。连接部202可以由薄膜2021(如图1A)、丝状(如图4A-4D)、条状(如图2A-2C)、编织网状(如图1C)材料或上述材料的任意组合形式形成。In one embodiment, there may be one or more hollow units 2022, which may be regularly arranged along the circumference of the side wall of the trumpet-shaped structure. The connecting part 202 can be formed by a film 2021 (as shown in FIG. 1A ), a filament (as shown in FIGS. 4A-4D ), a strip (as shown in FIGS. 2A-2C ), a braided mesh (as shown in FIG. 1C ) or any combination of the above materials. .
其中，薄膜的材料可以是硅胶类、高分子及其复合材料等。薄膜2021上还可以设有内衬，用于保持或加强薄膜的形态，内衬类似于骨架的支撑作用，包括丝状、条状、编织网状材料等，内衬的材料硬度可以大于薄膜的硬度。内衬的材料可以选自高分子材料，例如聚氨酯、尼龙、peek、ppsu、镍钛合金丝等合金丝。连接部202也可以仅由丝状、条状、编织网状材料或其组合形成，而不包含薄膜。Wherein, the material of the film can be silica gel, polymer and its composite material, etc. The film 2021 can also be provided with a liner to maintain or strengthen the shape of the film. The liner is similar to the supporting role of the skeleton, including filamentous, strip-shaped, woven mesh materials, etc. The hardness of the material of the liner can be greater than that of the film. hardness. The material of the lining can be selected from polymer materials, such as polyurethane, nylon, peek, ppsu, nickel-titanium alloy wire and other alloy wires. The connecting portion 202 may also be formed only of filament, strip, woven mesh material or a combination thereof without including a film.
通常导管100的排液口位于导管100的尖端，即当患者直立或平躺时， 排液口的位置高于膀胱尿道开口，即存在一定量的尿液无法从导管100流出，临床通常称为残余尿，残余尿容易引起尿管周围结石的形成，以及会引起***风险的增加。而镂空单元2022的设计，如图3A至3C，在当膀胱收缩时，一方面，残留在膀胱中(例如膀胱口附近)的尿液可以通过镂空单元2022进入导管100中。另一方面，输尿管口不会被堵塞，而可与镂空单元2022连通，进而可以避免输尿管中的尿液残留于膀胱颈口。Usually, the drainage port of the catheter 100 is located at the tip of the catheter 100, that is, when the patient is standing upright or lying flat, the position of the drainage port is higher than the opening of the bladder urethra, that is, there is a certain amount of urine that cannot flow out of the catheter 100, which is commonly referred to as Residual urine, residual urine can easily lead to the formation of periureteral stones and increase the risk of urinary tract infection. As for the design of the hollow unit 2022 , as shown in FIGS. 3A to 3C , when the bladder contracts, on the one hand, the urine remaining in the bladder (for example near the bladder opening) can enter the catheter 100 through the hollow unit 2022 . On the other hand, the ureteral opening will not be blocked, but can communicate with the hollow unit 2022, thereby preventing the urine in the ureter from remaining at the bladder neck opening.
在一可选实施例中，镂空单元2022的镂空面积大于输尿管口的口径，以尽量因镂空面积较小导致薄膜2021部分堵塞。In an optional embodiment, the hollowed out area of the hollowed out unit 2022 is larger than the caliber of the ureteral orifice, so as to partially block the membrane 2021 due to the small hollowed out area.
镂空单元2022的形状可以有多种，如图1A至1C，在一可选实施例中，镂空单元2022大致呈长条形，其自喇叭形结构200的远端向近端延伸。在另一可选实施例中，镂空单元2022大致呈梯形(如图2A至2C)或花瓣形(4A-4B)，各镂空单元2022之间由自喇叭形结构200的远端向近端延伸的辐射条分隔开，各镂空单元2022由远端的定位环201、连接部202的辐射条和连接部202的近端部分形成。The hollow unit 2022 can have various shapes, as shown in FIGS. 1A to 1C . In an optional embodiment, the hollow unit 2022 is roughly elongated, extending from the distal end to the proximal end of the trumpet-shaped structure 200 . In another optional embodiment, the hollowed-out units 2022 are approximately trapezoidal (as shown in Figures 2A to 2C) or petal-shaped (4A-4B), and each hollowed-out unit 2022 extends from the distal end to the proximal end of the trumpet-shaped structure 200. The radiating strips are separated, and each hollow unit 2022 is formed by the positioning ring 201 at the distal end, the radiating strips of the connecting part 202 and the proximal part of the connecting part 202 .
如图1B所示，在一实施例中，导尿装置10还包括牵引线300，其远端穿过主腔道101与定位环201或连接部202连接，近端延伸至导管100的近端；牵引线300的近端设有提示标记，用于提示牵引线300向近端牵拉定位结构200的距离，例如当需要移除导管100时，先保持导管100不动，向近端拉动牵引线300至露出提示标记时，提示定位环201已部分或全部收缩于导管100中，此时可保持牵引线300和导管100同步向近端移出。牵引线300的近端可以设有拉环301，通过拉环301拉动牵引线300。As shown in FIG. 1B , in one embodiment, the catheterization device 10 further includes a pull wire 300 , the distal end of which passes through the main lumen 101 and is connected to the positioning ring 201 or the connecting portion 202 , and the proximal end extends to the proximal end of the catheter 100 The proximal end of the traction wire 300 is provided with a reminder mark, which is used to prompt the distance that the traction wire 300 pulls the positioning structure 200 to the proximal end. When the wire 300 exposes the prompting mark, the prompting positioning ring 201 has been partially or completely shrunk in the catheter 100, and at this time, the pulling wire 300 and the catheter 100 can be kept moving toward the proximal end synchronously. A pull ring 301 may be provided at the proximal end of the pull wire 300 , and the pull ring 300 is pulled through the pull ring 301 .
如图4A至4E，定位环201可包括至少一个易折部2011，以及被易折部2011分隔开的至少两个连接段2012，在外力作用下，易折部2011可促使连接段2012产生弹性形变，例如当向定位环201施加牵引力时，易折部2011先凹陷，再带动连接段2012产生形变，使得定位环201可以被部分或全部收于导管100中，易折部2011的设置，减小了定位环201的应力集中，定位环201在收缩时长宽比更大，因此定位环201更容易收缩于导管100中。在一实施例中，如图4A至4C、4E所示，易折部2011为由相邻的弧形的连接段2012形成，易折部2011的横截面面积小于定位环201的其他部分，例如连接段的横截面面积，有利于变形。作为其中一可选实施例，易折部2011大概呈V形的凹槽。在另一实施例中，如图4D所示，易折部2011为由相邻的线性连接段2012的边缘对接形成的对折面。As shown in Figures 4A to 4E, the positioning ring 201 may include at least one frangible part 2011, and at least two connecting sections 2012 separated by the frangible part 2011. Elastic deformation, for example, when a traction force is applied to the positioning ring 201, the frangible part 2011 is first dented, and then the connecting section 2012 is driven to deform, so that the positioning ring 201 can be partially or completely received in the catheter 100, the setting of the frangible part 2011, The stress concentration of the positioning ring 201 is reduced, and the aspect ratio of the positioning ring 201 is larger when shrinking, so the positioning ring 201 is easier to shrink into the catheter 100 . In one embodiment, as shown in FIGS. 4A to 4C and 4E, the easy-to-break portion 2011 is formed by adjacent arc-shaped connecting segments 2012, and the cross-sectional area of the easy-to-break portion 2011 is smaller than other parts of the positioning ring 201, for example The cross-sectional area of the connecting segment is conducive to deformation. As an optional embodiment, the easy-to-break portion 2011 is approximately a V-shaped groove. In another embodiment, as shown in FIG. 4D , the easy-to-fold portion 2011 is a double-fold surface formed by butting edges of adjacent linear connecting segments 2012 .
如图5A至图7所示，本申请另一方面还提供一种导尿组件20，其包括 导尿装置10和递送件30，递送件30具有限位部301，用于将定位环201(例如定位环201的远端)限制于限位部301中，并维持定位环201处于收缩状态。As shown in FIGS. 5A to 7 , another aspect of the present application also provides a urinary catheter assembly 20, which includes a urinary catheter device 10 and a delivery member 30. The delivery member 30 has a limiting portion 301 for positioning the positioning ring 201 ( For example, the distal end of the positioning ring 201) is limited in the limiting portion 301, and maintains the positioning ring 201 in a contracted state.
如图5A至5D所示，递送件30穿设于导管100的主腔道101和定位结构200的内部，当定位环201收缩于导管100中时，定位环201的远端(如图5C所示)或近端(如图5D所示)抵靠限位部301。在实施例中，限位部301为凹槽，在将定位环201收缩于导管100中时，将定位环201的一部分嵌入凹槽中，向近端拉动递送件30和牵引线300，则定位环201收缩于导管100中，由于在导管100中定位环201抵靠限位部301，因此会限制定位环201弹出导管100。As shown in FIGS. 5A to 5D , the delivery member 30 is installed inside the main lumen 101 and the positioning structure 200 of the catheter 100. When the positioning ring 201 is shrunk in the catheter 100, the distal end of the positioning ring 201 (as shown in FIG. 5C ) or the proximal end (as shown in FIG. 5D ) abuts against the limiting portion 301. In the embodiment, the limiting portion 301 is a groove. When the positioning ring 201 is shrunk into the catheter 100, a part of the positioning ring 201 is embedded in the groove, and the delivery member 30 and the pulling wire 300 are pulled to the proximal end, and the positioning The ring 201 is shrunk in the catheter 100 , and since the positioning ring 201 abuts against the limiting portion 301 in the catheter 100 , the positioning ring 201 is restricted from ejecting from the catheter 100 .
在一可选实施例中，递送件30的远端为柔性材料，当定位环201收缩于导管100中时，递送件30的远端曝露于导管100外。递送件30的远端还可以为类圆锥形，以便于穿过狭窄段。In an optional embodiment, the distal end of the delivery member 30 is made of flexible material, and when the positioning ring 201 is shrunk in the catheter 100 , the distal end of the delivery member 30 is exposed outside the catheter 100 . The distal end of delivery member 30 may also be conical-like to facilitate passage through narrow segments.
在一可选实施例中，递送件30设有轴向贯穿其内部的引导通道(图中未示出)，用于与导引器械(例如导丝)配合使用。例如对于狭窄段而言，可以一边用导引器械疏通通道，一边向远端递送。In an optional embodiment, the delivery member 30 is provided with a guiding channel (not shown) axially penetrating through its interior, for use in cooperation with a guiding device (such as a guide wire). For example, for a narrow segment, it can be delivered to the distal end while clearing the channel with a guiding instrument.
如图6A至6F所示，在一实施例中，递送件30还具有沿轴向延伸的承接部302，其与限位部301连接，当递送件30递送导尿装置10时，定位环201收缩于导管100中，导管100置于承接部302上，限位部301周向包覆导管100，且定位环201限制于限位部301中。As shown in FIGS. 6A to 6F , in one embodiment, the delivery member 30 also has a receiving portion 302 extending in the axial direction, which is connected to the limiting portion 301. When the delivery member 30 delivers the urinary catheter 10, the positioning ring 201 Shrunken in the catheter 100 , the catheter 100 is placed on the receiving portion 302 , the limiting portion 301 covers the catheter 100 in a circumferential direction, and the positioning ring 201 is limited in the limiting portion 301 .
在一可选实施例中，递送件30的远端具有第一限位部301，其包括两个弧形的第一限位单元3011，两个弧形的第一限位单元3011形成非连贯的环形；每个第一限位单元3011的远端具有斜向延伸部3111，其自第一限位单元3011的远端沿径向向内延伸，当递送件30递送导尿装置10时，定位环201(例如定位环201的远端)限制于斜向延伸部3111中。在一可选实施例中，第一限位单元3011远端的斜向延伸部3111形成子弹头形状。In an optional embodiment, the distal end of the delivery member 30 has a first limiting portion 301, which includes two arc-shaped first limiting units 3011, and the two arc-shaped first limiting units 3011 form an incoherent The distal end of each first limiting unit 3011 has an oblique extension 3111, which extends radially inward from the distal end of the first limiting unit 3011. When the delivery member 30 delivers the urinary catheter 10, The positioning ring 201 (eg, the distal end of the positioning ring 201 ) is constrained in the diagonal extension 3111 . In an optional embodiment, the obliquely extending portion 3111 at the distal end of the first limiting unit 3011 forms a bullet shape.
在一可选实施例中，各第一限位单元3011的一端与承接部302活动连接，另一端与另外一个第一限位单元3011形成具有缺口的环形，当向近端撤出递送件30时，缺口变大，每个第一限位单元3011的另一端向远离导管100轴线的方向分离。In an optional embodiment, one end of each first limiting unit 3011 is flexibly connected to the receiving portion 302, and the other end forms a ring with a notch with another first limiting unit 3011. When the delivery member 30 is withdrawn proximally, , the gap becomes larger, and the other end of each first limiting unit 3011 separates away from the axis of the catheter 100 .
在一可选实施例中，递送件30的远端与近端之间还具有第二限位部301，其包括一个具有缺口的环形(例如如图6D所示的C形)的第二限位单元3012，第二限位单元3012与承接部302固定连接。In an optional embodiment, there is a second limiting portion 301 between the distal end and the proximal end of the delivery member 30, which includes a second limiting portion 301 that is annular (for example, C-shaped as shown in FIG. 6D ) with a gap. The position unit 3012 and the second position limiting unit 3012 are fixedly connected with the receiving portion 302 .
如图6C至6G所示，第二限位单元3012与承接部302固定连接处的内侧具有凸起3013，导管100的外侧设有凹槽102，凸起3013与凹槽102相配合，以限制导管100沿周向转动。As shown in Figures 6C to 6G, there is a protrusion 3013 on the inner side of the fixed connection between the second limiting unit 3012 and the receiving part 302, and a groove 102 is provided on the outer side of the catheter 100, and the protrusion 3013 cooperates with the groove 102 to limit The catheter 100 rotates in a circumferential direction.
在一可选实施例中，所述凸起3013的硬度大于靠近缺口的部分的硬度。如图6D所示，第一限位单元3011和第二限位单元3012可以由不同的材料制成。In an optional embodiment, the hardness of the protrusion 3013 is greater than that of the part near the notch. As shown in FIG. 6D , the first limiting unit 3011 and the second limiting unit 3012 may be made of different materials.
如图7所示，在一可选实施例中，导尿组件20还包括：连接导管100的远端且与导管100连通的鞘管203，鞘管203的内径大于或等于导管100的外径，鞘管203用于容纳收缩后的定位环201；推送件204，其可沿主腔道101向远端推送收纳于鞘管203的定位环201，使定位环201脱离鞘管203并延展开，推送件204可加强置入时导管100管身的硬度。推送件204上可以设有凹槽102，用于卡合定位环201，从而可以控制定位环201被推出的距离和展开的程度。As shown in FIG. 7 , in an optional embodiment, the urinary catheter assembly 20 further includes: a sheath 203 connected to the distal end of the catheter 100 and communicated with the catheter 100 , the inner diameter of the sheath 203 is greater than or equal to the outer diameter of the catheter 100 , the sheath tube 203 is used to accommodate the retracted positioning ring 201; the pusher 204 can push the positioning ring 201 received in the sheath tube 203 to the distal end along the main lumen 101, so that the positioning ring 201 is separated from the sheath tube 203 and extended , the pushing member 204 can strengthen the rigidity of the tube body of the catheter 100 when it is inserted. The pushing member 204 may be provided with a groove 102 for engaging the positioning ring 201 , so as to control the pushing distance and the unfolding degree of the positioning ring 201 .
如图8A-8F所示，导管100的远端从底部沿弧形向上延伸形成承接部801，承接部801的上方设有开口802，开口802的剖面可以为弧形、L形或其他任意适合的形状。开口802便于将定位结构200完全收纳于导管100中，也便于定位结构200的释放、尿液的引流以及便于将导管100引入尿道中。在一实施例中，导管100的远端还设有引流孔803，引流孔803的远端D相对于开口802的近端E更加远离开口802的远端F。引流孔803的底部可以略低于承接部801的远端所处的水平面804，当导管100将定位结构200经尿道引入膀胱后，引流孔803可以引流低于承接部801的远端的尿液，从而可以更彻底地引流尿液。As shown in Figures 8A-8F, the distal end of the catheter 100 extends from the bottom along an arc to form a receiving portion 801, and an opening 802 is provided above the receiving portion 801, and the section of the opening 802 can be arc-shaped, L-shaped or any other suitable shape. shape. Opening 802 facilitates complete receipt of positioning structure 200 within catheter 100, release of positioning structure 200, drainage of urine, and introduction of catheter 100 into the urethra. In one embodiment, the distal end of the catheter 100 is further provided with a drainage hole 803 , and the distal end D of the drainage hole 803 is farther away from the distal end F of the opening 802 than the proximal end E of the opening 802 . The bottom of the drainage hole 803 can be slightly lower than the horizontal plane 804 where the distal end of the receiving part 801 is located. When the catheter 100 introduces the positioning structure 200 into the bladder through the urethra, the drainage hole 803 can drain urine lower than the distal end of the receiving part 801 , allowing for a more thorough drainage of urine.
当导管100将定位结构200经尿道引入膀胱后，可以通过顶杆806将定位环201推出导管100，定位环201逐渐弹性恢复为环形并带动连接部202延展开，与膀胱颈口的内壁部分贴合，引流孔803引流残留于连接部202与膀胱颈口内壁之间的尿液。如图8B所示，顶杆806的远端可为凹面、平面等，当顶杆806的远端为凹面时，定位环201的一部分可以容置于凹面中，以使顶杆806稳定地推动定位环201。After the catheter 100 introduces the positioning structure 200 into the bladder through the urethra, the positioning ring 201 can be pushed out of the catheter 100 through the ejector rod 806, and the positioning ring 201 gradually recovers to a ring shape and drives the connecting part 202 to extend, and is attached to the inner wall of the bladder neck. Together, the drainage hole 803 drains the urine remaining between the connecting portion 202 and the inner wall of the bladder neck. As shown in Figure 8B, the distal end of the push rod 806 can be concave, flat, etc. When the distal end of the push rod 806 is concave, a part of the positioning ring 201 can be accommodated in the concave surface, so that the push rod 806 can be stably pushed positioning ring 201.
如图9B-9C所示，在植入尿道之前，定位结构200可以通过收纳件805收纳进导管100中。收纳件805可包括收纳通道500和稳定部501，收纳通道500周向挤压定位环201，使其逐渐轴向移动而收缩于收纳通道500中，稳定部501从周向进一步保持定位环201处于压缩状态，之后将定位结构200置入导管100中，撤走收纳件805。As shown in FIGS. 9B-9C , the positioning structure 200 can be received by the receiving member 805 into the catheter 100 prior to implantation in the urethra. The receiving part 805 may include a receiving channel 500 and a stabilizing part 501. The receiving channel 500 presses the positioning ring 201 in the circumferential direction, so that it gradually moves axially and shrinks in the receiving channel 500. The stabilizing part 501 further keeps the positioning ring 201 in the circumferential direction. In the compressed state, the positioning structure 200 is then placed in the catheter 100, and the receiving member 805 is withdrawn.
最后应说明的是：以上实施例仅用以说明本申请实施例的技术方案，而非对其限制；尽管参照前述实施例对本申请进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本申请各实施例技术方案的精神和范围。Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the embodiments of the present application, and are not intended to limit them; although the application has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: It is still possible to modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements for some of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and spirit of the technical solutions of the various embodiments of the present application. scope.

Claims (28)

  1. 一种导尿装置，其特征在于，该导尿装置包括：A urinary catheter, characterized in that the urinary catheter comprises:
    导管，其可穿设于尿道中，并具有轴向贯穿该导管的主腔道；以及a catheter that can be threaded in the urethra and has a main lumen extending axially through the catheter; and
    定位结构，其连通该主腔道，并自导管远端轴向延伸且径向向外扩展，该定位结构包括：A positioning structure, which communicates with the main lumen, extends axially from the distal end of the catheter and expands radially outward, and the positioning structure includes:
    定位环，其可产生弹性形变；positioning ring, which can produce elastic deformation;
    连接部，其分别连接该定位环与该导管远端，该连接部包括间隔设置的至少一个镂空单元；a connecting part, which respectively connects the positioning ring and the distal end of the catheter, and the connecting part includes at least one hollow unit arranged at intervals;
    其中，该定位结构可在受力状态下弹性形变以经由该尿道进入膀胱，并可在未受力状态下弹性恢复以定位于膀胱颈口。Wherein, the positioning structure can be elastically deformed to enter the bladder through the urethra under a stressed state, and elastically recover to be positioned at the neck of the bladder under a non-stressed state.
  2. 根据权利要求1所述的导尿装置，其特征在于，所述定位结构为自该导管远端向外扩张的喇叭形结构。The urinary catheter device according to claim 1, wherein the positioning structure is a horn-shaped structure expanding outward from the distal end of the catheter.
  3. 根据权利要求2所述的导尿装置，其特征在于，所述至少一个镂空单元沿喇叭形结构的侧壁周向规则排列。The urinary catheter according to claim 2, wherein the at least one hollow unit is regularly arranged along the circumference of the side wall of the trumpet-shaped structure.
  4. 根据权利要求1所述的导尿装置，其特征在于，所述连接部由薄膜、丝状、条状、编织网状材料或上述材料的任意组合形成。The catheterization device according to claim 1, characterized in that, the connecting part is formed of film, wire, strip, woven mesh material or any combination of the above materials.
  5. 根据权利要求1所述的导尿装置，其特征在于，所述镂空单元的镂空面积大于输尿管口的口径。The catheterization device according to claim 1, wherein the hollow area of the hollow unit is larger than the diameter of the ureteral orifice.
  6. 根据权利要求3或5所述的导尿装置，其特征在于，所述镂空单元大致呈长条形，其自喇叭形结构的远端向近端延伸。The catheterization device according to claim 3 or 5, characterized in that, the hollow unit is substantially elongated and extends from the distal end to the proximal end of the trumpet-shaped structure.
  7. 根据权利要求3或5所述的导尿装置，其特征在于，所述镂空单元大致呈梯形或花瓣形，各镂空单元之间由自喇叭形结构的远端向近端延伸的辐射条分隔开。The catheterization device according to claim 3 or 5, wherein the hollowed-out units are roughly trapezoidal or petal-shaped, and the hollowed-out units are separated by radial strips extending from the distal end to the proximal end of the trumpet-shaped structure open.
  8. 根据权利要求1所述的导尿装置，其特征在于，所述导尿装置还包括牵引线，其远端穿过该主腔道与该定位结构连接，近端延伸至该导管的近端；该牵引线的近端设有提示标记，用于提示该牵引线向近端牵拉该定位结构的距离。The catheterization device according to claim 1, wherein the catheterization device further comprises a pull wire, the distal end of which passes through the main lumen and is connected to the positioning structure, and the proximal end extends to the proximal end of the catheter; A reminder mark is provided at the proximal end of the pulling wire, which is used to remind the distance that the pulling wire pulls the positioning structure to the proximal end.
  9. 根据权利要求1所述的导尿装置，其特征在于，所述定位环包括至少一个易折部，以及被该易折部分隔开的至少两个连接段，在外力作用下，该易折部可促使该连接段产生弹性形变。The urinary catheter according to claim 1, wherein the positioning ring comprises at least one easy-to-break part and at least two connecting sections separated by the easy-to-break part, and the easy-to-break part Elastic deformation of the connecting section can be induced.
  10. 根据权利要求9所述的导尿装置，其特征在于，所述易折部的横截面面积小于连接段的横截面面积。The urinary catheter device according to claim 9, wherein the cross-sectional area of the easy-to-break part is smaller than that of the connecting section.
  11. 根据权利要求10所述的导尿装置，其特征在于，所述易折部为由相邻的连接段形成的大概呈V形的凹槽。The urinary catheter according to claim 10, wherein the easy-to-break portion is a roughly V-shaped groove formed by adjacent connecting segments.
  12. 根据权利要求9所述的导尿装置，其特征在于，所述易折部为由相邻的连接段的边缘对接形成的对折面。The urinary catheter according to claim 9, wherein the easy-to-fold portion is a double-fold surface formed by butting edges of adjacent connecting sections.
  13. 根据权利要求1所述的导尿装置，其特征在于，所述导管的远端从底部沿弧形向上延伸形成承接部，该承接部的上方设有开口。The catheterization device according to claim 1, wherein the distal end of the catheter extends upwards in an arc from the bottom to form a receiving portion, and an opening is provided above the receiving portion.
  14. 根据权利要求13所述的导尿装置，其特征在于，该导管的远端还设有引流孔，该引流孔的远端相对于该开口的近端更加远离该开口的远端。The catheterization device according to claim 13, characterized in that, the distal end of the catheter is further provided with a drainage hole, and the distal end of the drainage hole is farther away from the distal end of the opening than the proximal end of the opening.
  15. 根据权利要求13或14所述的导尿装置，其特征在于，所述导尿装置还包括顶杆，该顶杆用于穿入该导管中，将该定位环推出该导管。The urinary catheterization device according to claim 13 or 14, characterized in that, the urinary catheterization device further comprises a push rod, and the push rod is used to penetrate into the catheter and push the positioning ring out of the catheter.
  16. 根据权利要求13所述的导尿装置，其特征在于，所述导尿装置还包括收纳件，该收纳件包括收纳通道和稳定部，该收纳通道用于周向挤压该定位环，使该定位环逐渐轴向移动而收缩于其中，该稳定部用于从周向保持定位环处于压缩状态。The catheterization device according to claim 13, characterized in that, the urinary catheterization device further comprises a receiving part, the receiving part includes a receiving channel and a stabilizing part, and the receiving channel is used to squeeze the positioning ring circumferentially, so that the positioning ring The positioning ring gradually moves axially and shrinks therein, and the stabilizing part is used to keep the positioning ring in a compressed state from the circumferential direction.
  17. 一种导尿组件，其特征在于，所述导尿组件包括：A catheter assembly, characterized in that the catheter assembly includes:
    权利要求1至12之任意一项所述的导尿装置；以及A urinary catheter as claimed in any one of claims 1 to 12; and
    递送件，其具有限位部，用于将该定位环限制于该限位部中，并维持该定位环处于收缩状态。The delivery part has a limiting part, which is used to limit the positioning ring in the limiting part and maintain the positioning ring in a contracted state.
  18. 根据权利要求17所述的导尿组件，其特征在于，所述递送件穿设于该导管的主腔道和该定位结构的内部，当该定位环收缩于该导管中时，该定位环抵靠该限位部。The urinary catheter assembly according to claim 17, wherein the delivery member is passed through the main lumen of the catheter and the inside of the positioning structure, and when the positioning ring shrinks in the catheter, the positioning ring abuts against Rely on the limiting part.
  19. 根据权利要求18所述的导尿组件，其特征在于，当该定位环收缩 于该导管中时，该定位环的远端或近端抵靠该限位部。The urinary catheter assembly according to claim 18, wherein when the positioning ring is shrunk in the catheter, the distal end or the proximal end of the positioning ring abuts against the limiting part.
  20. 根据权利要求18所述的导尿组件，其特征在于，所述递送件的远端为柔性材料，当该定位环收缩于该导管中时，该递送件的远端曝露于该导管外。The urinary catheter assembly according to claim 18, wherein the distal end of the delivery member is made of flexible material, and when the positioning ring is shrunk in the catheter, the distal end of the delivery member is exposed outside the catheter.
  21. 根据权利要求18所述的导尿组件，其特征在于，所述递送件设有轴向贯穿其内部的导引通道，用于与导引器械配合使用。The urinary catheter assembly according to claim 18, characterized in that, the delivery member is provided with a guiding channel axially penetrating through its interior, for use in cooperation with a guiding device.
  22. 根据权利要求17所述的导尿组件，其特征在于，所述递送件还具有沿轴向延伸的承接部，其与该限位部连接，当该递送件递送该导尿装置时，该定位环收缩于该导管中，该导管置于该承接部上，该限位部周向包覆该导管，且该定位环限制于该限位部中。The urinary catheter assembly according to claim 17, wherein the delivery member further has a receiving portion extending in the axial direction, which is connected with the limiting portion, and when the delivery member delivers the urinary catheter device, the positioning The ring shrinks in the catheter, the catheter is placed on the receiving part, the limiting part wraps around the catheter, and the positioning ring is limited in the limiting part.
  23. 根据权利要求21所述的导尿组件，其特征在于，所述递送件的远端具有第一限位部，其包括两个弧形的第一限位单元，该两个弧形的第一限位单元形成非连贯的环形；每个第一限位单元的远端具有斜向延伸部，其自该第一限位单元的远端沿径向向内延伸，当该递送件递送该导尿装置时，该定位环限制于该斜向延伸部中。The urinary catheter assembly according to claim 21, wherein the distal end of the delivery member has a first limiting portion, which includes two arc-shaped first limiting units, and the two arc-shaped first limiting units The limiting unit forms a non-continuous ring; the distal end of each first limiting unit has an oblique extension, which extends radially inward from the distal end of the first limiting unit, when the delivery member delivers the guide When the urine set is used, the positioning ring is limited in the oblique extension.
  24. 根据权利要求22所述的导尿组件，其特征在于，各第一限位单元的一端与该承接部活动连接，另一端与另外一个第一限位单元形成具有缺口的环形，当向近端撤出该递送件时，该缺口变大，每个第一限位单元的另一端向远离该导管轴线的方向分离。The urinary catheter assembly according to claim 22, wherein one end of each first limiting unit is flexibly connected to the receiving portion, and the other end forms a ring with a gap with the other first limiting unit, and when moving toward the proximal end When the delivery member is withdrawn, the gap becomes larger, and the other end of each first limiting unit separates away from the axis of the catheter.
  25. 根据权利要求21所述的导尿组件，其特征在于，所述递送件的远端与近端之间还具有第二限位部，其包括一个具有缺口的环形的第二限位单元，该第二限位单元与该承接部固定连接。The urinary catheter assembly according to claim 21, characterized in that, there is a second limiting portion between the distal end and the proximal end of the delivery member, which includes an annular second limiting unit with a gap, the The second limiting unit is fixedly connected with the receiving portion.
  26. 根据权利要求24所述的导尿组件，其特征在于，所述第二限位单元与该承接部固定连接处的内侧具有凸起，该导管的外侧设有凹槽，该凸起与该凹槽相配合，以限制该导管沿周向转动。The urinary catheter assembly according to claim 24, wherein the inner side of the fixed connection between the second limiting unit and the receiving part has a protrusion, and the outer side of the catheter is provided with a groove, and the protrusion and the concave The slot cooperates to limit the circumferential rotation of the catheter.
  27. 根据权利要求25所述的导尿组件，其特征在于，所述凸起的硬度大于靠近该缺口的部分的硬度。The urinary catheter assembly according to claim 25, wherein the hardness of the protrusion is greater than that of the portion close to the notch.
  28. 根据权利要求17所述的导尿组件，其特征在于，所述导尿组件还包括：The urinary catheter assembly according to claim 17, wherein the urinary catheter assembly further comprises:
    连接该导管的远端且与该导管连通的鞘管，该鞘管的内径大于或等于该导管的外径，该鞘管用于容纳收缩后的定位环；A sheath connected to the distal end of the catheter and communicated with the catheter, the inner diameter of the sheath is greater than or equal to the outer diameter of the catheter, and the sheath is used to accommodate the retracted positioning ring;
    推送件，其可沿该主腔道向远端推送收纳于该鞘管的定位环，使该定位环脱离该鞘管并延展开。The pusher can push the positioning ring accommodated in the sheath tube to the distal end along the main lumen, so that the positioning ring is separated from the sheath tube and extended.
PCT/CN2022/123868 2021-10-18 2022-10-08 Urethral catheterization device, and urethral catheterization assembly comprising same WO2023066033A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202111209889.0A CN115990084A (en) 2021-10-18 2021-10-18 Urethral catheterization device and urethral catheterization assembly comprising same
CN202111209889.0 2021-10-18

Publications (1)

Publication Number Publication Date
WO2023066033A1 true WO2023066033A1 (en) 2023-04-27

Family

ID=85992699

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2022/123868 WO2023066033A1 (en) 2021-10-18 2022-10-08 Urethral catheterization device, and urethral catheterization assembly comprising same

Country Status (2)

Country Link
CN (1) CN115990084A (en)
WO (1) WO2023066033A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117244124A (en) * 2023-11-17 2023-12-19 北京大学第一医院 Abdominal cavity postoperative peritoneal infection prevents stifled drainage device

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3954110A (en) * 1974-01-24 1976-05-04 Hutchison Ernest L Retention catheter with bilobate balloon
CN211325907U (en) * 2019-12-04 2020-08-25 江苏诺瑞思医疗器械有限公司 Urinary tract stent placed on neck of bladder
CN112316274A (en) * 2020-11-04 2021-02-05 蔺淑娟 Indwelling catheter
CN113384796A (en) * 2021-06-24 2021-09-14 温州医科大学附属第一医院 Balloon-free indwelling catheter
CN216876765U (en) * 2021-10-18 2022-07-05 上海康路联医疗科技有限公司 Catheterization device and catheterization assembly comprising same

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3954110A (en) * 1974-01-24 1976-05-04 Hutchison Ernest L Retention catheter with bilobate balloon
CN211325907U (en) * 2019-12-04 2020-08-25 江苏诺瑞思医疗器械有限公司 Urinary tract stent placed on neck of bladder
CN112316274A (en) * 2020-11-04 2021-02-05 蔺淑娟 Indwelling catheter
CN113384796A (en) * 2021-06-24 2021-09-14 温州医科大学附属第一医院 Balloon-free indwelling catheter
CN216876765U (en) * 2021-10-18 2022-07-05 上海康路联医疗科技有限公司 Catheterization device and catheterization assembly comprising same

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117244124A (en) * 2023-11-17 2023-12-19 北京大学第一医院 Abdominal cavity postoperative peritoneal infection prevents stifled drainage device
CN117244124B (en) * 2023-11-17 2024-03-22 北京大学第一医院 Abdominal cavity postoperative peritoneal infection prevents stifled drainage device

Also Published As

Publication number Publication date
CN115990084A (en) 2023-04-21

Similar Documents

Publication Publication Date Title
US5209741A (en) Surgical access device having variable post-insertion cross-sectional geometry
US6673058B2 (en) Temporary dilating tip for gastro-intestinal tubes
US20060173525A1 (en) Methods and systems for deploying luminal prostheses
US8496645B2 (en) Suture winding for a drainage catheter
US6733536B1 (en) Male urethral stent device
US20230355414A1 (en) Scaffold loading and delivery systems
US7670331B2 (en) Device for opening a human bladder
US20180043135A1 (en) Dynamic Catheterization Devices Configured to Facilitate Drainage
EP0558642A1 (en) Tension guide and dilator.
JP2003531696A (en) Catheter O. with a flippable sleeve T. Introducing device for L
WO2023066033A1 (en) Urethral catheterization device, and urethral catheterization assembly comprising same
US20230063969A1 (en) Flow control valve
CN216876765U (en) Catheterization device and catheterization assembly comprising same
AU2007200977B2 (en) Medical tube set
CN215916155U (en) Urethral catheterization device
US20100010478A1 (en) Intraurethral catheter
US20240009422A1 (en) Urinary catheter assembly and introducer device for use in such an assembly
CN117065185A (en) Separable balloon catheter
CN115430015A (en) Urethral catheterization device
CN112043945A (en) Anti-backflow drainage tube for interventional therapy of ultrasonic endoscope
CN117157037A (en) Catheter tube

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: 22882643

Country of ref document: EP

Kind code of ref document: A1