WO2018209995A1 - 一种狭窄扩张型导尿管 - Google Patents

一种狭窄扩张型导尿管 Download PDF

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Publication number
WO2018209995A1
WO2018209995A1 PCT/CN2018/073022 CN2018073022W WO2018209995A1 WO 2018209995 A1 WO2018209995 A1 WO 2018209995A1 CN 2018073022 W CN2018073022 W CN 2018073022W WO 2018209995 A1 WO2018209995 A1 WO 2018209995A1
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WIPO (PCT)
Prior art keywords
catheter
lumen
segment
opening
passage
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Application number
PCT/CN2018/073022
Other languages
English (en)
French (fr)
Inventor
董东生
Original Assignee
威海吉威重症医疗制品有限公司
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Publication date
Application filed by 威海吉威重症医疗制品有限公司 filed Critical 威海吉威重症医疗制品有限公司
Priority to US16/339,208 priority Critical patent/US20190232019A1/en
Priority to JP2018567798A priority patent/JP6865341B2/ja
Publication of WO2018209995A1 publication Critical patent/WO2018209995A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10181—Means for forcing inflation fluid into the balloon
    • A61M25/10183—Compressible bulbs
    • 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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0057—Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0496—Urine
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1078—Urinary tract
    • A61M2210/1089—Urethra
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections

Definitions

  • the invention relates to a narrow dilatation type urinary catheter, belonging to the technical field of medical instruments.
  • the urinary catheter is the most common medical device in the clinic. After being placed into the human body, the urine can be drained from the bladder to the outside of the body. It can be taken out after the primary urine is drained, or it can be left for long-term drainage.
  • the female urethra is shorter and thicker than males, the structure around the urethral opening is complicated and prone to urinary tract infection. Therefore, women with catheterization may have urethral stricture due to urinary tract infection before catheterization; Male and female, the existing clinical catheterization usually fixes the external urethra with one hand after disinfecting the external urethra and surrounding tissues, and the other hand directly holds the sterile catheter with tweezers, hemostats, etc., and inserts from the outer urethra; When you encounter urethral stricture or accompanied by bending, you often need to insert forcefully. This situation will lead to more serious urethral injury.
  • the outer surface of the catheter is coated with lubricating oil or lubricating coating.
  • the isolated use is almost ineffective for urethral stricture.
  • the present invention provides a narrow dilatation type catheter.
  • a narrow dilatation catheter is a hollow main body tube composed of a solid material having an inner surface and an outer surface.
  • the tube is hollow as a lumen of the catheter, including a head that enters the bladder when in use, and is left in the tail of the body.
  • the head is provided with a urine inlet, and the tail portion is provided with a urine outlet;
  • the outer surface of the tip end of the catheter head is connected with a nipple-like flexible and hollow thin section, and the hollow inside the thin section is In the inner cavity of the thin section, the inner cavity of the thin section in the non-expanded state may have no air and no volume, the side of the thin section connected to the outer surface of the tip end of the head is the bottom of the thin section, and the other side is the top of the thin section; the bottom of the thin section and the head
  • the outer surface of the top end is connected, which is a connecting portion of the thin section, and the remaining part including the top of the thin section is an expandable portion of the thin section;
  • the inner cavity of the thin section is specifically composed of the inner surface of the thin section and the outer surface of the top end of the head.
  • the portion covered by the expandable portion is formed together; the top of the segment of the catheter is closed to the blind end, and the portion between the farthest point of the segment to the farthest point of the tip of the catheter head has an average outer diameter smaller than that of the catheter head Most of the top Large outer diameter; the inner cavity of the thin segment is connected to the outside through a passage on at least one wall of the urinary catheter, that is, a thin lumen passage, and the inner passage of the thin section has at least one opening connecting the inner cavity of the thin section, which is a passage of the thin lumen The inner opening and the at least one thin-section lumen opening at the tail of the catheter that is connectable to the outer space.
  • the segment is structurally an extension of the tip of the catheter head, and the extension may be in the direction of the central axis of the catheter head, or may be parallel to the central axis, or may be The axial direction is at a certain angle, that is, the deflection extends, and sometimes the extended stretched section is more likely to enter the urethra at the turn; when the urinary catheter encounters a narrow position in the urethra, the outer tip of the larger outer diameter cannot pass, and the outer diameter Smaller segments can enter the narrow urethra.
  • a certain pressure of gas and or liquid is filled into the narrow lumen from the outside by means of a syringe, a pump, an elastic balloon, etc., so that the fine The segment expands and continues for a certain period of time, and the generated thrust acts perpendicularly on the urethral intima of the stenosis, so that the urethra of the stenosis is dilated, and then the gas and or liquid that is drawn into the inner cavity of the thin segment is extracted from the outside, and the expansion of the segment is released, and the conduction is continued.
  • the urinary catheter, the tip of the catheter head is easily passed through the expanded urethral portion.
  • the lateral branch of the catheter is connected to the lumen of the segment lumen.
  • the side branch of the passage, the end of the side branch of the narrow section of the lumen is connected with a hollow elastic capsule, and the inner chamber of the elastic capsule communicates with the outer opening of the passage of the thin section.
  • a hollow elastic capsule is sleeved on the outer portion of the tail portion close to the tail of the catheter or the main branch of the drainage main body, and the inner cavity of the elastic capsule communicates with the outer opening of the passage of the thin section lumen, that is, thin
  • the outer opening of the segment lumen passage is formed on the outer surface of the catheter that is closed by the elastic balloon.
  • the elastic bladder for filling the inner cavity of the thin section is provided with at least one external opening which can be covered by the finger, and the gas and/or liquid in the cavity of the elastic capsule communicate with the outside through the opening.
  • the body of the elastomeric bladder for filling the lumen of the segment can be prefilled with liquid and or gas.
  • the elastic capsule When using, the elastic capsule is covered with a finger to open the elastic capsule at the same time, because the elastic capsule is closed by the finger, and the gas and liquid in the cavity of the elastic capsule are squeezed into the inner cavity through the narrow lumen passage. And it expands and expands the narrow urethra; when the compression is stopped, the elastic capsule recovers, and the gas and or liquid that enters the inner cavity of the thin section are sucked back into the cavity of the elastic capsule, and can also enter the fine section due to the elastic restoring force of the thin section.
  • the gas and/or liquid in the inner cavity is pushed back into the cavity of the elastic capsule, and the closing of the outer opening of the elastic capsule by the finger is released, so that the gas and the liquid in the cavity of the elastic capsule communicate with the outside, and finally the thin section is restored from the expanded state.
  • the gas and liquid of the elastic capsule can flow out from the external opening. This avoids the possible stimulation of the endometrium of the bladder by the expansion of the segment located in the bladder at this time.
  • an outer opening is further provided on the other side of the outer opening of the elastic capsule, that is, the opposite side.
  • These two openings can be simultaneously covered by two fingers that move relative to each other.
  • the elastic capsule is provided with a pressure-free deformation on the elastic capsule or adjacent to the outer wall of the catheter.
  • the switch member is provided with a protrusion that can close another external opening of the elastic capsule body; when the position of the switch member moves, the closed protrusion on the switch body can be released from the body cavity of the elastic capsule
  • the outer opening is closed, and the inner cavity of the elastic capsule communicates with the outside through the hidden passage on the switch member; the hidden passage of the switch member means that the outer surface of the elastic bladder and the outer surface of the switch member cannot be closed.
  • the external connection channel that is, the channel that is not in the easily deformable portion and or that is easy to touch.
  • the rotatable switch member may be selected as the hidden passage of the push-pull switch member end face; the outer surface of the elastic bladder and or the outer surface of the switch member may be provided with a mark indicating the state of the switch member, which may be a printed mark It can also be a concave and convex mark of a partial material.
  • the outer surface of the portion of the head of the catheter that is covered by the thin section of the expandable portion is provided with at least one inward annular recess, and the opening in the passage of the segment is opened in the annular recess.
  • the outer surface of the portion of the urinary catheter head covered by the thin section of the expandable portion is provided with at least two inward annular recesses, and the annular recess is provided with at least one communication groove recessed in the outer surface of the tip end of the head,
  • the opening in the segment lumen passage is defined in the annular recess and or the communication slot.
  • a portion of the tip of the catheter head extends to the lumen of the segment.
  • the apical extension of the urinary catheter head increases the strength of the segment portion, making it easier for the segment to enter the narrow portion of the urethra.
  • the outer surface of the segment of the expandable portion has at least one inward annular recess which can store the lubricant and or the drug, and when the segment is filled and expanded, The stored lubricant and or drug is annularly coated on the inner lining of the urethra.
  • the tip of the catheter head is covered by the thin section of the expandable portion and has at least one inward annular depression, and the thin section of the expandable portion is recessed therein.
  • the ring is also shaped to form a depression. More lubricant and/or drug can be stored in the inner space of this annular conformal recess in the thin section.
  • the thin section can be probed into the stenosis area first. Pressing the elastic capsule can expand the thin section and push the urethral intima of the stenosis vertically to help The catheter passes smoothly through the stenosis and minimizes the horizontal direction of force to promote shear damage to the urethral intima;
  • Lubricating substances and or drugs in the narrow annular depression are precisely applied to the urethral intima at the same time when they are inflated.
  • the precise lubrication of the urethral stricture helps the smooth passage of the catheter, and the targeted application of the drug is also It provides a reliable guarantee for the treatment of urinary tract diseases.
  • Figure 1 Schematic diagram of the existing urinary catheter head into the urethral stricture
  • Figure 2a is a schematic view showing the structure of the present invention in Embodiment 1;
  • Figure 2b is a schematic enlarged view of the structure of the present invention in the first embodiment
  • Figure 2c is a schematic view showing the deflection of the tip of the catheter head in the second embodiment of the present invention.
  • Figure 3 is a schematic view showing the stenosis of the urethra in the thin section of the present invention in Example 1;
  • Figure 4 is a schematic view showing the state in which the thin section of the present invention enters the urethral stricture in Example 1;
  • Figure 5 is a schematic view showing the structure of the elastic capsule which can expand and expand the fine section in the embodiment 3;
  • Figure 6 is a schematic view showing another structure of the elastic capsule which can expand and expand the fine section in the embodiment 4;
  • Figure 7 is a schematic view showing the external opening of the elastic capsule in the fifth embodiment of the present invention.
  • Figure 8a is a schematic view showing a switch member of the elastic bladder of the present invention in Embodiment 6;
  • Figure 8b is a schematic view showing the structure of the closed state of the switch member on the elastic capsule in the sixth embodiment of the present invention.
  • Figure 8c is a schematic view showing the structure of the communication state of the switch member on the elastic capsule in the sixth embodiment of the present invention.
  • Figure 9 is a schematic view showing the annular recessed structure of the urinary catheter head in the seventh embodiment of the present invention.
  • Figure 10a is a schematic view showing the opening structure of the isolated inner segment passage of the urinary catheter head in the seventh embodiment of the present invention.
  • Figure 10b is a schematic cross-sectional view showing the opening of the inner segment of the lumen of the urinary catheter in the seventh embodiment of the present invention.
  • Figure 10c is a schematic cross-sectional view showing the structure of the opening in the inner passage of the narrow section of the urinary catheter head in the embodiment of the present invention.
  • Figure 11 is a schematic view showing the structure of a portion of the tip of the catheter head extending to the lumen of the segment in the embodiment 8;
  • Figure 12a is a schematic view showing the structure in which the outer surface of the thin-section expandable portion is inwardly annularly recessed in the embodiment 9;
  • Figure 12b is a schematic view showing another perspective view of the outer surface of the expanded portion of the expanded portion of the present invention recessed inwardly in the embodiment 9;
  • Figure 13 is a schematic view showing the conformal depression of the tip end of the catheter head and the segment in the embodiment 10;
  • a narrow dilatation catheter is a hollow body tube composed of a solid material having an inner surface 11 and an outer surface 12, and the tube is hollow as a lumen of the catheter 10 Including the head 13 entering the bladder 0 during use, the tail portion 14 left outside the body, and the intermediate portion 15 connecting the head portion 13 and the tail portion 14.
  • the head portion is provided with a urine inlet 130, and the tail portion is provided with a urine outlet 140; the bladder chamber
  • the bladder fixation capsule 132 in the 00, the filling side branch 142 of the bladder fixation capsule 132, the filling side branch 142 has an external opening 1322, and the external opening 1322 of the filling side branch 142 can be resealed by a check valve 2 or after puncture
  • the elastomer is closed, and the difference from the existing clinically used catheter is that the outer surface of the tip 131 of the catheter is connected with a nipple-like flexible and hollow section 16, and the hollow inside the section 16 is a thin section 160.
  • the inner cavity of the thin section may have no air and no volume, but the inner cavity 160 may be enlarged after being filled with the fluid, and the side of the thin section 16 connected to the outer surface of the top end 131 of the head is a thin section bottom 161, and the other side Is the top portion 162 of the segment; a portion of the bottom portion 161 of the segment is opposite to the outer surface of the tip 131 of the head
  • the connection is a thin section of the connecting portion, and the remaining portion including the thin section top 162 is a thin section of the expandable portion 1612; the thin section inner cavity 160 is specifically composed of the inner surface of the thin section expandable portion 1612 and the outer surface of the head top end 131
  • the portion 1315 covered by the thin segment expandable portion 1612 is formed together; the top portion 162 of the catheter segment is closed to the blind end; the average of the portion from the farthest point 162p of the top of the segment to the farthest point 131p of the tip of the catheter head is averaged
  • the outer diameter is
  • the head of the existing catheter can not pass smoothly when entering the urethral stricture, and the urethral intima of the injury stenosis will be sheared by force; the invention shown in Fig. 3, when the catheter is in the urethra
  • the head tip 131 having a larger outer diameter when the middle travel encounters a narrow point cannot pass, and the thin section 16 having a smaller outer diameter, especially the top portion 162 of the thin section, can enter the urethral cavity 010a of the narrow portion, and does not
  • the degree of injury or injury to the urethra is the lowest.
  • the catheter is stopped, as shown in Figure 4.
  • the passage 1312 is filled into the narrow lumen 160, so that the segment 16 is filled and expanded for a certain period of time, and the thrust generated by the expansion and expansion of the segment 16 acts perpendicularly on the urethral intima of the stenosis, and the urethra at the stenosis is expanded, and then extracted from the body. Entering the gas and or liquid of the inner cavity 160, the segment 16 is expanded and released, and the catheter is further advanced.
  • the tip 131 of the catheter is easily passed through the urethral cavity 010b of the expanded urethral portion without damaging the urethra. Under the premise of the catheter 0 cystatin advancing direction; Zaiyu move as narrow filling procedure is repeated the thin section 16, until a successful catheter placement.
  • the urinary catheter tip 131 is biased to one side; the segment 16 is structurally a functional extension of the urinary catheter tip 131, which may be oriented along the catheter.
  • the direction of the central axis of the head 13 may be parallel to the direction of the central axis, or may extend at a certain angle from the direction of the central axis, that is, the extension 16 may be more likely to enter the urethra at the bend; this embodiment and
  • the difference of Embodiment 1 is that the tip end 131 of the catheter head is biased to one side, and the thin section 16 connected thereto is also biased in the same direction.
  • the present invention can derive the power of the fine segment filling and expansion from an elastic balloon body 17, which is located on the fine-filled side branch 143 of the catheter tail portion 14, and the thin segment lumen opening is open.
  • 1313 is opened in the inner body cavity 170 of the elastic capsule, and the inner cavity 170 of the elastic capsule communicates with the inner passage 1312 of the thin section, and the gas therein can be filled into the inner cavity 160 due to the external pressure of the elastic capsule 17, and the thin section 16
  • the air filled into the inner cavity 160 of the thin section is returned to the inner body cavity 170 of the elastic capsule by the elastic restoring force of the wall of the elastic capsule 17, and the thin section 16 is restored to the original state;
  • the inner cavity 170 of the elastic capsule can also be prefilled without Liquid substances such as bacteria water and glycerin.
  • the fixed intracapsular lumen 1320 passes through the fixed balloon on the wall of the catheter.
  • the body passage 1321 is connected to the fixed capsule filling side branch 142 of the catheter tail portion 14.
  • the fixed capsule passage side branch external opening 1322 can be sealed to the outside by a pierced elastic body or a check valve 2 which can be resealed.
  • the filling side branch 143 and the fixed balloon filling side branch 142 are combined into one, that is, the two passages are commonly connected to the side branch of the catheter tail 14 via the side branch, and the elastic capsule 17 is located on the side branch, the drawing is omitted.
  • the elastic capsule 17 which can expand and expand the segment is located in the middle portion 15 of the tail portion 14 of the catheter, and is sleeved on the outer surface 12 of the catheter. Nested on the outer surface 12 of the drainage main branch 141, the two natural openings of the elastic capsule 17 are sealingly connected by the outer surface 12 of the catheter, and the inner chamber 170 of the elastic capsule communicates with the outer opening 1313 of the narrow lumen passage. The outer lumen opening 1313 is opened on the outer surface 12 of the catheter which is closed by the elastic capsule 17. This design is located in the middle portion of the catheter due to the elastic capsule 17 to be pressed during use. Or draining the main branch 141, it is more convenient to operate.
  • the difference between the embodiment and the embodiment 3 and the embodiment 4 is that the elastic capsule 17 for filling the inner cavity 160 is provided with at least one elastic capsule covering the outer opening 171 which can be covered by the finger.
  • the gas in the inner cavity 170 of the elastic capsule communicates with the outside through the opening.
  • the elastic capsule is covered with a finger to the outer opening 171 and simultaneously squeezes the elastic capsule 17.
  • the elastic capsule is closed by the finger to the outer opening 171, and the elastic capsule is closed.
  • the gas of 170 is squeezed into the narrow lumen 160 through the narrow lumen passage 1312 and is filled and expanded to expand the narrow urethra; when the compression is stopped, the elastic capsule 17 is restored, and the gas entering the narrow lumen 160 is sucked.
  • the elastic inner body cavity 170 can also be used to push the gas entering the narrow inner cavity 160 back into the elastic inner cavity 170 due to the elastic restoring force of the thin section 16, and the finger can be released from the outer opening 171 of the elastic capsule.
  • the gas in the body cavity 170 of the elastic capsule communicates with the outside, and finally the thin segment 16 is restored from the expanded state; and during the indwelling of the catheter, due to the presence of the outer opening 171 of the elastic balloon, when the lower limb does not consciously move or the medical operation is partially operated, etc.
  • the elastomeric bladder 17 pressure, the elastic balloon lumen 170 and a gas or liquid from the external elastomeric bladder outflow opening 171, so as to avoid this time is located within the bladder expansion segment thin lining of bladder irritation potential.
  • an outer opening 172 may be provided, which can be simultaneously covered by two fingers of relative movement when in use.
  • the gas and liquid of the elastic capsule body 170 are present due to the presence of the two outer elastic capsules 171, 172.
  • the reliability of the outflow from the two outer openings 171, 172 can be greatly improved compared to one opening.
  • a switch member which is not easily deformed by pressure and which can move relative to the outer surface 12 of the catheter and the elastic capsule 17 is provided on or adjacent to the elastic capsule 17 of the present invention.
  • the switch member 3 is provided with a protrusion 31 for closing the outer opening 173 of the elastic body cavity 170, as shown in Fig. 8b. When the position of the switch member 3 is moved, the closing protrusion 31 thereon can be released.
  • the closure of another outer opening 173 of the elastomeric balloon lumen 170, as in Figure 8c, and such that the elastomeric balloon lumen 170 communicates with the exterior through the hidden channel 30 on the switch member 3; the switch component hidden channel 30 is The outer connecting passage that presses the outer surface of the elastic bladder 17 and or the outer surface of the switch member cannot be closed, that is, the passage that is not in the easily deformable portion or the easy-to-touch portion.
  • a hidden channel 30 is provided on the end face of the rotatable switch member, and a hidden channel at the end face of the pushable switch member can also be applied; on the outer surface of the elastic capsule 17 and or the switch member 3
  • the outer surface may be provided with indicia 32 indicating the state of the switch member and an indication arrow 33, which may be a printed mark or a mark formed by the unevenness of the partial material.
  • the outer surface of the portion 1315 of the catheter head tip 131 covered by the thin section expandable portion 1612 is provided with at least one inward annular recess 1310 in which the narrow lumen passage opening 1311 is opened. Inside the annular recess 1310.
  • Figs. 10a, 10b, and 10c when the opening 1311 in the inner passage passage of the tip end 131 of the urinary catheter head of the present invention is of an isolated design, the fine section 16 is filled during the filling process, and the area of the thin section of the inner opening 1311 is too small. It is difficult to overcome the vertical pressure of the urethral wall at the urethral stricture.
  • the pressure direction is as shown by the arrow in Fig. 10c, and the opening 1311 in the narrow lumen passage is opened in the annular recess 1310, and the fluid in the filling can be contacted with a larger area.
  • the segment expandable portion 1612 is easier to fill.
  • the present invention has a flexible design and must have the ability to first enter the urethral stricture.
  • the portion 1316 of the urinary catheter tip 131 of the present embodiment extends to the narrow lumen without increasing or not
  • the external strength of the segment 16 is increased under the premise of significantly increasing the outer diameter of the segment 16 to facilitate its smooth entry into the urethral stricture.
  • the outer surface of the thin section expandable portion 1612 is provided with an inwardly directed annular recess 164.
  • the lubricant or the lining of the urinary tract can be uniformly applied to the urethral lining of the urinary tract in the narrow area.
  • Lubrication, auxiliary expansion effect is more conducive to the smooth passage of the catheter.
  • the targeted application of anti-infective, mucosal growth-promoting drugs, etc., even if it is not used for the expansion of the narrow urethra, has a correspondingly high clinical value.
  • the catheter head tip 131 of the present embodiment is synchronized with the segment 16 in conformity with the recess 1314.
  • the storage or addition in the ring as described in the embodiment 9 is avoided.
  • the lubricant and/or drug 163 in the recess 164 may be lost due to the easy deformation of the segment 16 during the travel of the catheter 1; while the urinary catheter tip 131 and the segment 16 are simultaneously compliant with the recess 1314

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Abstract

临床上尿道本身的生理、病理狭窄及弯曲均会加大导尿管置入的难度，一种狭窄扩张型导尿管，导尿管头部顶端(131)外表面连有一奶嘴状柔性且中空的细段(16)，细段底部(161)与导尿管头部顶端(131)外表面相连接，是细段的连接部分，包括细段顶部(162)的其余部分为细段的可膨胀部分(1612)；细段内腔(160)通过至少一个导尿管壁上的通路即细段内腔通路(1312)与外界相连，细段内腔通路(1312)至少有一个连通细段内腔(160)的开口，为细段内腔通路内开口(1311)和至少一个位于导尿管中间部(15)或尾部(14)的可连通外部空间的细段内腔通路外开口(1313)。导尿管置入过程中，可以针对性充盈头部细段可膨胀部分(1612)，配合润滑物质(163)的均匀涂布，在提高置入成功率的同时将损伤和感染风险降到最低。

Description

一种狭窄扩张型导尿管 技术领域
本发明涉及一种狭窄扩张型导尿管，属医疗器械技术领域。
背景技术
导尿管为临床最为常见的医疗器械，从尿道置入人体后可将尿液从膀胱引流至体外；可一次尿液引流后取出，也可长期留置用于多次引流。
然而，导尿管置入的操作本身是对尿道及膀胱的严重刺激，加之人体尿道本身的生理、病理狭窄及弯曲均会加大导尿管置入的难度，并加重置入过程中的下尿路损伤，而下尿路的损伤会诱发或加重下尿路感染，进一步影响下尿路甚或全身脏器功能。
女性尿道虽较男性而言短而粗，但尿道外开口周围结构复杂，易于发生尿路感染；因而女性导尿患者在导尿前极可能因尿路感染等原因已导致尿道狭窄的存在；无论男女，现有临床的导尿通常在消毒尿道外口及周边组织后用一手将尿道外口固定，另一手直接或用镊子、止血钳等把持无菌导尿管，从尿道外口徐徐插入；当遭遇尿道狭窄或伴有弯曲时常需用力插入，此情形会导致更为严重的尿道损伤；而阻力过大无法通过时，常需加涂润滑油和或使用更为粗大坚硬的尿道探子用力扩张尿道，扩张后再将导尿管置入，给患者带来极大痛苦及下尿路结构的破坏，润滑油在导尿管行进过程中会被尿道内膜大部截留，行至狭窄处时已所剩无几；即便使用超滑涂层的导尿管，遭遇尿道狭窄时单纯润滑效果依旧不佳。
现有临床的导尿在置入过程中存在以下问题：
1.当导尿管头部顶端行进至尿道狭窄处时通常需加大外力推进，头部顶端与狭窄处尿道会发生剪切作用，即便通过狭窄尿道，尿道内膜也遭受严重挫伤且为微生物感染创造条件。
2.导尿管外表面涂抹润滑油或润滑涂层，孤立使用对尿道狭窄近乎无效。
发明内容
本发明为了解决上述问题，提供了一种狭窄扩张型导尿管。
本发明的目的是这样实现的：
一种狭窄扩张型导尿管，为具有内表面、外表面的实体材料构成的中空的主体管路，管 路中空为导尿管内腔，包括使用时进入膀胱的头部，留置于体外的尾部及连接头部与尾部的中间部，头部设有尿液入口，尾部设有尿液出口；导尿管头部顶端外表面连有一奶嘴状柔性且中空的细段，细段内部的中空为细段内腔，非扩张状态下细段内腔可以没有空气没有体积，细段与头部顶端外表面相连的一侧为细段底部，另一侧为细段顶部；细段底部与头部顶端外表面相连接，是细段的连接部分，包括细段顶部的其余部分为细段的可膨胀部分；细段内腔具体由细段可膨胀部分的内表面及头部顶端外表面被细段可膨胀部分覆盖的部分共同形成；导尿管细段顶部为盲端对外封闭，细段顶部最远点至导尿管头部顶端最远点之间的部分其平均外径小于导尿管头部顶端的最大外径；细段内腔通过至少一个导尿管壁上的通路即细段内腔通路与外界相连，细段内腔通路至少有一个连通细段内腔的开口，为细段内腔通路内开口和至少一个位于导尿管尾部的可连通外部空间的细段内腔通路外开口。
细段结构上是对导尿管头部顶端的延伸，所述的延伸其方向可以是顺沿着导尿管头部的中轴线方向，也可以是与中轴线方向平行，也可以是与中轴线方向成一定角度即偏向延伸，有时偏向延伸的细段更容易进入拐弯处的尿道；当导尿管在尿道中行进遇到狭窄处时外径较大的头部顶端无法通过，而外径较小的细段则可进入狭窄的尿道部分，此时用注射器、泵、弹性球囊等工具从体外将一定压力的气和或液经由细段内腔通路充入细段内腔，使得细段膨胀并持续一定时间，产生的推力垂直作用于狭窄处的尿道内膜，使狭窄处的尿道扩张，随即从体外抽出进入细段内腔的气体和或液体，细段膨胀解除，继续推进导尿管，导尿管头部顶端则易于通过被扩张后的尿道部分。
为了方便细段充盈膨胀起到扩张尿道狭窄的目的，在导尿管尾部除设有与导尿管内腔连通的引流主支外还包括与细段内腔通路相连的侧支即细段内腔通路侧支，细段内腔通路侧支末端连有一中空的弹性囊体，该弹性囊体内腔与细段内腔通路外开口相连通。
为了进一步方便操作，在接近导尿管尾部的中间部或引流主支的外表面上套设有中空的弹性囊体，该弹性囊体内腔与细段内腔通路外开口相连通，也即细段内腔通路外开口开设于被该弹性囊体封闭覆盖的导尿管外表面上。
用于充盈细段内腔的弹性囊体上设有至少一个可被手指覆盖的对外开口，弹性囊体内腔内的气体和或液体通过此开口与外部连通。用于充盈细段内腔的弹性囊体内腔内可预先充有液体和或气体。
使用时用手指覆盖弹性囊体对外开口同时挤压弹性囊体，因弹性囊体对外开口被手指封闭，弹性囊体内腔的气体和或液体通过细段内腔通路被挤压至细段内腔并使其膨胀，扩张狭窄的尿道；停止挤压则弹性囊体复原，进入细段内腔的气体和或液体被吸回弹性囊体内腔， 也可因细段的弹性复原力使进入细段内腔的气体和或液体被推回弹性囊体内腔，也可解除手指对弹性囊体对外开口的封闭而使弹性囊体内腔的气体和或液体与外部连通，最终使得细段从膨胀状态恢复；而在留置尿管期间由于弹性囊体对外开口的存在，当下肢不自觉运动或医护局部操作等原因导致的弹性囊体受压，弹性囊体内腔的气体和或液体可从此对外开口流出，从而避免了此时位于膀胱内的细段膨胀对膀胱内膜可能的刺激。
进一步地，在一个弹性囊体对外开口的另一侧也即对侧再设置一个对外开口。这两个开口使用时可被相对运动的两个手指同时覆盖。留置尿管期间当下肢不自觉运动或医护局部操作等原因导致的弹性囊体受压时，因相对的两个弹性囊体对外开口存在，弹性囊体内腔的气体和或液体可从此两个对外开口流出的可靠性较一个开口大为提高。
更进一步地，为了确保留置尿管期间体外的弹性囊体不会因意外受压而充盈体内的细段，弹性囊体上或邻近区域设有一个不易受压变形的且可与导尿管外壁发生相对运动的开关部件，此开关部件上设有可将弹性囊体内腔另一种外开口封闭的凸起；当开关部件位置发生移动，其上的封闭凸起可解除对弹性囊体内腔另一种外开口的封闭，并使得弹性囊体内腔通过开关部件上的潜藏式通道与外部连通；所述的开关部件潜藏式通道是指压迫弹性囊体外表面和或开关部件外表面不能被封闭的对外连接通道，也即不处于易于变形部分和或易于触碰部分的通道。
可以选择可旋转的开关部件也可以是可推拉的开关部件端面的潜藏式通道；在弹性囊体的外表面和或开关部件的外表面可设有指示开关部件状态的标记，可以是印刷的标记也可以是局部材料的凹凸标记。
为了确保细段易于充盈膨胀，导尿管头部顶端被细段可膨胀部分覆盖的部分上的外表面设有至少一个向内的环形凹陷，细段内腔通路内开口开设在此环形凹陷内。
导尿管头部顶端被细段可膨胀部分覆盖的部分上的外表面设有至少两个向内的环形凹陷，环形凹陷间设有至少一个凹陷于头部顶端外表面内的连通槽，细段内腔通路内开口开设在此环形凹陷和或连通槽内。
为了增加细段行进中的对外强度，导尿管头部顶端一部分延伸至细段内腔。此导尿管头部顶端延伸部分增加了细段部分的强度，使细段更易于进入尿道的狭窄部分。
为了润滑物和或药物的定向精准均匀涂抹，细段可膨胀部分的外表面上有至少一个向内的环形凹陷，此环形凹陷内部空间可存储润滑物和或药物，当细段充盈膨胀时可将存储的润滑物和或药物环形涂布在尿道内膜。
为了避免润滑物和或药物在未到达涂抹部位前的损失，导尿管头部顶端被细段可膨胀部 分覆盖的部分上有至少一个向内的环形凹陷，细段可膨胀部分在此环形凹陷处也环形适形凹陷。在细段的此环形适形凹陷的内部空间可存储更多的润滑物和或药物。
本发明的有益效果是：
1.当导尿管头部顶端行进至尿道狭窄处时，细段则可先行探入狭窄区域，按压弹性囊体可使细段膨胀，垂直方向推开狭窄处的尿道内膜，有助于导尿管顺利通过狭窄处且最大程度避免了水平方向用力推进对尿道内膜的剪切损伤；
2.细段环形凹陷内的润滑物质和或药物在其膨胀时同步精准涂抹在狭窄处的尿道内膜，尿道狭窄处的精准润滑更有助于导尿管的顺利通过，药物的定向施加也为尿道疾病的治疗提供了可靠的保障。
附图说明
图1：现有导尿管头部进入尿道狭窄处示意图；
图2a：本发明在实施例1中结构示意图；
图2b：本发明在实施例1中细段放大结构示意图；
图2c：本发明在实施例2中导尿管头部顶端偏向情形示意图；
图3：本发明在实施例1中细段进入尿道狭窄处示意图；
图4：本发明在实施例1中细段进入尿道狭窄处膨胀状态示意图；
图5：本发明在实施例3中可使细段充盈膨胀的弹性囊体的一种结构示意图；
图6：本发明在实施例4中可使细段充盈膨胀的弹性囊体的另一种结构示意图；
图7：本发明在实施例5中弹性囊体上的对外开口示意图；
图8a：本发明在实施例6中弹性囊体上的开关部件示意图；
图8b：本发明在实施例6中弹性囊体上的开关部件封闭状态结构示意图；
图8c：本发明在实施例6中弹性囊体上的开关部件连通状态结构示意图；
图9：本发明在实施例7中导尿管头部顶端环形凹陷结构示意图；
图10a：本发明在实施例7中导尿管头部顶端孤立的细段内腔通路内开口结构示意图；
图10b：本发明在实施例7中导尿管头部顶端孤立的细段内腔通路内开口剖面结构示意图；
图10c：本发明在实施例7中导尿管头部顶端孤立的细段内腔通路内开口受压剖面结构示意图；
图11：本发明在实施8中导尿管头部顶端一部分延伸至细段内腔的结构示意图；
图12a：本发明在实施9中细段可膨胀部分外表面向内环形凹陷的结构示意图；
图12b：本发明在实施例9中细段可膨胀部分外表面向内环形凹陷的另一个视角结构示意图；
图13：本发明在实施例10中导尿管头部顶端与细段同步适形凹陷的示意图；
图中：0.膀胱；00膀胱腔；01.尿道壁；010.尿道内腔；010a.扩张前狭窄处的尿道内腔；010b.扩张后的尿道内腔；1.导尿管；10.导尿管内腔；11.导尿管内表面；12.导尿管外表面；13.导尿管头部；130.尿液入口；131.导尿管头部顶端；131p.导尿管头部顶端最远点；1310.导尿管头部顶端环形凹陷；1311.细段内腔通路内开口；1312.细段内腔通路；1313.细段内腔通路外开口；1314.导尿管头部顶端环形适形凹陷；1315.导尿管头部顶端被细段可膨胀部分覆盖的部分；1316.导尿管顶端向细段内腔延伸的部分132.膀胱固定囊体；1320.膀胱固定囊体内腔；1321.膀胱固定囊体通路；1322.膀胱固定囊体通路侧支对外开口；14导尿管尾部；140.尿液出口；141.引流主支；142.固定囊体充盈侧支；143.细段充盈侧支；15.导尿管中间部；16.细段；160.细段内腔；161.细段底部；1612.细段可膨胀部分；162.细段顶部；162p.细段顶部最远点；163.润滑物和或药物；164.细段环形凹陷；17.中空的弹性囊体；170.弹性囊体内腔；171、172.弹性囊体对外开口；173.弹性囊体另一种对外开口；2.单向阀；3.开关部件；30.潜藏式通道；31.封闭凸起；32.指示开关部件状态的标记；33.指示箭头。
具体实施方式
实施例1：
如图2a、2b、3、4所示，一种狭窄扩张型导尿管，为具有内表面11、外表面12的实体材料构成的中空的主体管路，管路中空为导尿管内腔10，包括使用时进入膀胱0的头部13，留置于体外的尾部14及连接头部13与尾部14的中间部15，头部设有尿液入口130，尾部设有尿液出口140；膀胱腔00内的膀胱固定囊体132，膀胱固定囊体132的充盈侧支142，充盈侧支142有一对外开口1322，充盈侧支142的对外开口1322可被一单向阀2或穿刺后可再密封的弹性体封闭，与现有临床使用的导尿管区别是，导尿管头部顶端131外表面连有一奶嘴状柔性且中空的细段16，细段16内部的中空为细段内腔160，细段内腔可以是没有空气没有体积的，但充入流体后细段内腔160可以增大，细段16与头部顶端131外表面相连的一侧为细段底部161，另一侧为细段顶部162；细段底部161的一部分与头部顶端131外表面相 连接，是细段的连接部分，包括细段顶部162的其余部分为细段的可膨胀部分1612；细段内腔160具体由细段可膨胀部分1612的内表面及头部顶端131外表面被细段可膨胀部分1612覆盖的部分1315共同形成；导尿管细段顶部162为盲端对外封闭；细段顶部最远点162p至导尿管头部顶端最远点131p之间的部分其平均外径小于导尿管头部顶端131的最大外径；细段内腔160通过至少一个导尿管壁上的通路即细段内腔通路1312与外界相连，细段内腔通路1312至少有一个连通细段内腔160的开口，为细段内腔通路内开口1311和至少一个位于导尿管尾部14的可连通外部空间的细段内腔通路外开口1313；本实施例中细段内腔通路外开口1313位于导尿管尾部14的细段充盈侧支143上。
如图1所示现有导尿管头部进入尿道狭窄处时无法顺利通过，用力前行会剪切损伤狭窄处的尿道内膜；如图3所示的本发明，当导尿管在尿道中行进遇到狭窄处时外径较大的头部顶端131无法通过，而外径较小的细段16尤其是细段顶部162，则可进入狭窄部分的尿道内腔010a，且不会对尿道产生损伤或损伤程度相比最低，此时停止推进导尿管，如图4所示，而用注射器、泵、弹性球囊等工具从体外将一定压力的气和或液经由细段内腔通路1312充入细段内腔160，使得细段16充盈膨胀并持续一定时间，细段16充盈膨胀产生的推力垂直作用于狭窄处的尿道内膜，使狭窄处的尿道扩张，随即从体外抽出进入细段内腔160的气和或液，细段16膨胀解除，继续推进导尿管，导尿管头部顶端131则易于通过被扩张后的尿道部分的尿道内腔010b，在不损伤尿道的前提下将导尿管顺利向膀胱0方向推进；继续前行如再遇狭窄则重复上述细段16充盈过程，直至导尿管1成功置入。
实施例2：
如图2c所示，导尿管头部顶端131偏向一侧；细段16结构上是对导尿管头部顶端131的功能性延伸，所述的延伸其方向可以是顺沿着导尿管头部13的中轴线方向，也可以是与中轴线方向平行，也可以是与中轴线方向成一定角度即偏向延伸，有时偏向延伸的细段16更容易进入拐弯处的尿道；本实施例与实施例1的区别在于，导尿管头部顶端131偏向一侧，与其相连的细段16亦同步偏向。
实施例3：
如图5所示，本发明可使细段充盈膨胀的动力来源于一弹性囊体17，弹性囊体17位于导尿管尾部14的细段充盈侧支143上，细段内腔通路外开口1313开设于弹性囊体内腔170内，弹性囊体内腔170只与细段内腔通路1312连通，其内的气体可因弹性囊体17外部受压而充盈至细段内腔160，细段16膨胀，解除压力后充盈至细段内腔160的空气因弹性囊体17壁的弹性复原力回流到弹性囊体内腔170内，细段16恢复原状；弹性囊体内腔170内也可预 先充盈无菌水、甘油等液体物质。
当导尿管设有可充盈膨胀并使导尿管不易从膀胱内脱出的固定囊体132时，如图2a、2b、5、6，固定囊体内腔1320通过导尿管壁上的固定囊体通路1321与导尿管尾部14的固定囊体充盈侧支142相连，固定囊体通路侧支对外开口1322可用一被刺穿后能够再密封的弹性体或单向阀2对外密封，细段充盈侧支143与固定囊体充盈侧支142合二为一，即两种通路在导尿管尾部14共同经由一个侧支，弹性囊体17位于此侧支上，附图略。
实施例4：
如图6所示，与实施例3不同的是，可使细段充盈膨胀的弹性囊体17位于接近导尿管尾部14的中间部15，套设在导尿管外表面12上，也可套设在引流主支141的外表面12上，该弹性囊体17的两个自然开口被导尿管外表面12密封连接，该弹性囊体内腔170与细段内腔通路外开口1313相连通，也即细段内腔通路外开口1313开设于被该弹性囊体17封闭覆盖的导尿管外表面12上，此种设计由于使用时需按压的弹性囊体17位于导尿管中间部15或引流主支141上，操作时更为便利。
实施例5：
如图7所示，本实施例与实施例3、实施例4的区别在于，用于充盈细段内腔160的弹性囊体17上设有至少一个可被手指覆盖的弹性囊体对外开口171，弹性囊体内腔170内的气体通过此开口与外部连通，使用时用手指覆盖弹性囊体对外开口171同时挤压弹性囊体17，因弹性囊体对外开口171被手指封闭，弹性囊体内腔170的气体通过细段内腔通路1312被挤压至细段内腔160并使其充盈膨胀，扩张狭窄的尿道；停止挤压则弹性囊体17复原，进入细段内腔160的气体被吸回弹性囊体内腔170，也可因细段16的弹性复原力使进入细段内腔160的气体被推回弹性囊体内腔170，也可解除手指对弹性囊体对外开口171的封闭而使弹性囊体内腔170的气体与外部连通，最终使得细段16从膨胀状态恢复；而在留置尿管期间由于弹性囊体对外开口171的存在，当下肢不自觉运动或医护局部操作等原因导致的弹性囊体17受压，弹性囊体内腔170的气体和或液体可从此弹性囊体对外开口171流出，从而避免了此时位于膀胱内的细段膨胀对膀胱内膜可能的刺激。
也可在一个弹性囊体对外开口171的另一侧，也即对侧，再设置一个对外开口172，这两个开口使用时可被相对运动的两个手指同时覆盖。留置尿管期间当下肢不自觉运动或医护局部操作等原因导致的弹性囊体17受压时，因相对的两个弹性囊体对外开口171、172存在，弹性囊体内腔170的气体和或液体可从此两个对外开口171、172流出的可靠性较一个开口大为提高。
实施例6：
如图8a、8b、8c所示，上述本发明弹性囊体上17上或邻近区域设有一个不易受压变形的且可与导尿管外表面12及弹性囊体17发生相对运动的开关部件3，此开关部件3上设有可将弹性囊体内腔170另一种对外开口173封闭的凸起31，如图8b；当开关部件3位置发生移动，其上的封闭凸起31可解除对弹性囊体内腔170的另一种外开口173的封闭，如图8c，并使得弹性囊体内腔170通过开关部件3上的潜藏式通道30与外部连通；所述的开关部件潜藏式通道30是指压迫弹性囊体17外表面和或开关部件外表面不能被封闭的对外连接通道，也即不处于易于变形部分和或易于触碰部分的通道。
本实施例中描述了一种位于可旋转的开关部件端面的潜藏式通道30，也可应用位于可推拉的开关部件端面的潜藏式通道；在弹性囊体17的外表面和或开关部件3的外表面可设有指示开关部件状态的标记32及指示箭头33，可以是印刷的标记也可以是局部材料的凹凸形成的标记。
实施例7：
如图9所示，导尿管头部顶端131被细段可膨胀部分1612覆盖的部分1315上的外表面设有至少一个向内的环形凹陷1310，细段内腔通路内开口1311开设在此环形凹陷1310内。
如图10a、10b、10c所示，当本发明导尿管头部顶端131细段内腔通路内开口1311为孤立的设计时，细段16充盈过程，内开口1311接触的细段面积过小，难以克服尿道狭窄处尿道壁的垂直压力，压力方向如图10c箭头所示，而将细段内腔通路内开口1311开设在环形凹陷1310内，充盈时的流体则可接触面积更大的细段可膨胀部分1612，更易于充盈。
实施例8：
如图11，本发明由于细段16为柔性设计，又必须具有率先进入尿道狭窄处的能力，本实施例的导尿管头部顶端131一部分1316延伸至细段内腔，在不增加或不显著增加细段16外径的前提下增加了细段16的对外强度，有助于其顺利进入尿道狭窄处。
实施例9：
如图12a、12b所示，细段可膨胀部分1612外表面设有向内的环形凹陷164。当细段16充盈膨胀时可将存储或添加此处的润滑物如甘油、石蜡油等和或药物163环形均匀涂布在狭窄处的尿道内膜，由于润滑物质在狭窄处尿道内膜的精准润滑，辅助扩张效果更有助于导尿管的顺利通过。而抗感染、促粘膜生长等药物的定向施加，即使不用于狭窄尿道的扩张，也有相应的极高的临床价值。
实施例10：
如图13所示，本实施例导尿管头部顶端131与细段16同步适形凹陷1314，为了避免因细段16较柔软，其内的如实施例9中描述的存储或添加在环形凹陷164内的润滑物和或药物163可能会在导尿管1行进过程中因细段16易于形变而损失；同时导尿管头部顶端131与细段16同步适形凹陷1314也可相对增大细段环形凹陷164的容积，其内可储存、添加更多的润滑物和或药物163。

Claims (10)

  1. 一种狭窄扩张型导尿管，为具有内表面(11)、外表面(12)的实体材料构成的中空的主体管路，管路中空为导尿管内腔(10)，包括使用时进入膀胱(0)的头部(13)，留置于体外的尾部(14)及连接头部(13)与尾部(14)的中间部(15)，头部设有尿液入口(130)，尾部设有尿液出口(140)；其特征在于，导尿管头部顶端(131)外表面连有一奶嘴状柔性且中空的细段(16)，细段(16)内部的中空为细段内腔(160)，细段(16)与头部顶端(131)外表面相连的一侧为细段底部(161)，另一侧为细段顶部(162)；细段底部(161)与头部顶端(131)外表面相连接，是细段的连接部分，包括细段顶部(162)的其余部分为细段的可膨胀部分(1612)；细段内腔(160)具体由细段可膨胀部分(1612)的内表面及头部顶端(131)外表面被细段可膨胀部分(1612)覆盖的部分(1315)共同形成；导尿管细段顶部(162)为盲端对外封闭，细段顶部最远点(162p)至导尿管头部顶端最远点(131p)之间的部分其平均外径小于导尿管头部顶端(131)的最大外径；细段内腔(160)通过至少一个导尿管壁上的通路即细段内腔通路(1312)与外界相连，细段内腔通路(1312)至少有一个连通细段内腔(160)的开口，为细段内腔通路内开口(1311)和至少一个位于导尿管中间部(15)或尾部(14)的可连通外部空间的细段内腔通路外开口(1313)。
  2. 根据权利要求1所述的一种狭窄扩张型导尿管，其特征在于，在导尿管尾部(14)除设有与导尿管内腔(10)连通的引流主支(141)外，还包括与细段内腔通路(1312)相连的分支即细段内腔通路分支(143)，细段内腔通路分支(143)末端连有一中空的弹性囊体(17)，该弹性囊体内腔(170)与细段内腔通路外开口(1313)相连通。
  3. 根据权利要求1所述的一种狭窄扩张型导尿管，其特征在于，在接近导尿管尾部(14)的中间部(15)或引流主支(141)的外表面(12)上套设有中空的弹性囊体(17)，该弹性囊体内腔(170)与细段内腔通路外开口(1313)相连通，也即细段内腔通路外开口(1313)开设于被该弹性囊体(17)封闭覆盖的导尿管外表面(12)上。
  4. 根据权利要求2、3所述的一种狭窄扩张型导尿管，其特征在于，用于充盈细段内腔(160)的弹性囊体(17)上设有至少一个可被手指覆盖的对外开口(171)，弹性囊体内腔(170)通过此开口与外部联通。
  5. 根据权利要求4所述的一种狭窄扩张型导尿管，其特征在于，在一个弹性囊体对外开口(171)的另一侧也即对侧再设置一个对外开口(172)。
  6. 根据权利要求2、3所述的一种狭窄扩张型导尿管，其特征在于，在弹性囊体(17)上或邻近区域设有一个不易受压变形的且可与导尿管外壁发生相对运动的开关部件(3)，此开关部件(3)上设有可将弹性囊体内腔(170)另一种外开口(173)封闭的凸起(31)；当开关部件(3)位置发生移动，其上的封闭凸起(31)可解除对弹性囊体内腔(170)另一种外 开口(173)的封闭，并使得弹性囊体内腔(170)通过开关部件(3)上的潜藏式通道(30)与外部连通。
  7. 根据权利要求1所述的一种狭窄扩张型导尿管，其特征在于，导尿管头部顶端(131)被细段可膨胀部分(1612)覆盖的部分(1315)上的外表面设有至少一个向内的环形凹陷(1310)，细段内腔通路内开口(1311)开设在此环形凹陷(1310)内。
  8. 根据权利要求1所述的一种狭窄扩张型导尿管，其特征在于，导尿管头部顶端(131)一部分(1316)延伸至细段内腔(160)。
  9. 根据权利要求1所述的一种狭窄扩张型导尿管，其特征在于，细段可膨胀部分(1612)的外表面上有至少一个向内的环形凹陷(164)。
  10. 根据权利要求1所述的一种狭窄扩张型导尿管，其特征在于，导尿管头部顶端(131)被细段可膨胀部分(1612)覆盖的部分(1315)上有至少一个向内的环形适形凹陷(1314)，细段可膨胀部分(1612)在此环形适形凹陷(1314)处也同步环形凹陷(164)。
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