WO2019007031A1 - 一种适用于女性的导尿管 - Google Patents

一种适用于女性的导尿管 Download PDF

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Publication number
WO2019007031A1
WO2019007031A1 PCT/CN2018/073043 CN2018073043W WO2019007031A1 WO 2019007031 A1 WO2019007031 A1 WO 2019007031A1 CN 2018073043 W CN2018073043 W CN 2018073043W WO 2019007031 A1 WO2019007031 A1 WO 2019007031A1
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Prior art keywords
catheter
guiding
curved
urethra
head
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PCT/CN2018/073043
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English (en)
French (fr)
Inventor
董东生
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威海吉威重症医疗制品有限公司
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Publication of WO2019007031A1 publication Critical patent/WO2019007031A1/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
    • 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
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1078—Urinary tract
    • A61M2210/1085—Bladder
    • 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

Definitions

  • the invention relates to a urinary catheter, in particular to a urinary catheter suitable for women, and belongs 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 operation and placement of the catheter will cause lower urinary tract injury to varying degrees, and the damage of the lower urinary tract is more likely to cause or aggravate the lower urinary tract infection, further affecting the lower urinary tract or even the organ function.
  • the female urethra is shorter and thicker than the male, and the length is only about 4 cm.
  • the structure around the external urethra is complicated. Even if the catheter is not inserted, it is prone to urinary tract infection.
  • the existing clinical catheterization procedure is usually performed in the external urethra. After the surrounding tissue, use two fingers of one hand to press the surrounding tissue of the external urethra to make it relatively fixed, open and expose the external urethra, and the other hand directly or use a forceps, hemostasis, etc. to hold the sterile catheter, and insert it from the outer urethra. When it is necessary to indwell, the diverted urine bag connector is then inserted into the catheter urine outlet to become a closed system.
  • the operator's two fingers are difficult to fix and expose the external urethra, especially in the urethral ectopic ectopic caused by scars such as urinary tract infection, childbirth side incision, elderly women's urethral orifice atrophy or even into the vagina In the case of the wall; fixation of the external urethra and poor exposure not only reduce the success rate of catheter placement but also greatly increase the urethral injury during the implantation process.
  • the microbes on the surface of the female urethra are easily accessible and contaminate the outer surface of the catheter that bends into the urethra, bringing microorganisms into the urethra and bladder; this extraluminal infection is also the lumen of the catheter. Infections caused by external routes are the main cause of early urinary tract infections in patients with indwelling catheters.
  • the present invention provides a catheter suitable for women.
  • a catheter suitable for women comprising a hollow body tube composed of a solid material having an inner surface and an outer surface, the tube being hollow as a lumen of the catheter, including the head entering the bladder when in use, leaving the body outside the body
  • the tail portion and the middle portion connecting the head portion and the tail portion, the head portion is provided with a urine inlet, and the tail portion is provided with a urine outlet; and the guiding protection for at least the catheter tube placed in the bladder and the urethra during the indwelling is also provided
  • the component, the guiding guard component body is a hollow cylinder having a top opening and a tail end opening, the hollow cylinder shape comprising a single independent component that is partially inactive, a hollow part that can be opened and closed, or a hollow cylinder composed of components
  • the length of the inner cylindrical hollow is greater than or equal to the length of the catheter in the bladder and the urethra when indwelling; in use, the tip of the guiding guard member is pressed against the tissue surrounding the external ure
  • the traditional catheterization method when the external urethral opening effect is good, the center point of the open urethral opening is located on the center line of the relatively vertical urethra.
  • the tip of the catheter In the case of the catheter, the tip of the catheter is easy to follow along the vertical urethra center line, the damage to the urethral intima is minimal, and the patient's pain is minimal; as shown in Figure 4, the urethral opening is not effective.
  • the center point of the outer urethra of the urethra may be significantly deviated from the vertical urethra center line.
  • the centerline advances, causing greater or severe damage to the lining of the urethra, causing greater pain in the patient.
  • the catheter is clamped with a tool or a finger, and the catheter is suspended at a distance from the outer urethra to the outer urethra of the urethra.
  • the catheter When encountering the external urethra, it encounters resistance.
  • the catheter As shown in Figure 7, the catheter is flexible and extremely prone to bending. The bending direction is extremely uncertain or up or down or left or right, making the catheter head centerline It does not overlap with the urethral centerline but at an angle ⁇ .
  • the curved urinary catheter head tip cannot advance along the vertical urethra centerline, but is perpendicular or nearly perpendicular to the urethral intima in the urethral orifice. , causing large or serious damage to the endometrium of the urethra, and the endometrium of the urethra after injury is highly susceptible to secondary bacterial infection.
  • the guiding protective member for the female special urinary catheter according to the present invention not only facilitates the fixation and exposure of the external urethral opening, but when used, the outer urethral opening is located in the opening of the top end of the guiding protective member, and the catheter is sleeved in the guiding protection.
  • the starting point of the movement of the apex of the urinary catheter head is the position of the external urethra, and the placement of the urinary catheter becomes a true "near placement", which refers to the outer urethra; further, Since the tubular body of the guiding protective member has a certain length, the catheter is guided by the movement guiding mechanism, so that the catheter is further placed into a "guided approach", so that the catheter does not appear.
  • the curvature causes the center line of the catheter head to overlap with the centerline of the urethra.
  • the tip of the catheter head is easy to follow along the vertical urethral centerline, with minimal damage to the urethral intima and minimal pain.
  • the corresponding drawbacks of the traditional way of "no guide dangling" have been completely eliminated.
  • the guiding protection component may be provided with a finger holding portion protruding from the outer surface thereof, and the finger holding portion may be a boss, a handle and a finger ring connected with the cylindrical body.
  • the length of the guiding catheter can accommodate the length of the catheter to be greater than or equal to the length of the catheter in the bladder and urethra when the catheter is indwelled; the length of the cylindrical body of the guiding guard is matched to the bladder and the urethra.
  • the urinary catheter part ensures that it does not contact the tissue around the external urethra during the catheter placement process, completely eliminating the risk of urinary tract infection caused by tissue contamination of the outer surface of the catheter due to tissue surrounding the urethra;
  • a lubricant such as chitosan or sodium hyaluronate may be applied to the outer surface of the catheter of this length.
  • the top opening portion of the guiding guard member is at an angle to the cylindrical body, and the top end of the guiding member is opened.
  • the portion and the cylindrical body may also be steerable connections including bellows, which refers to an adjustable connection angle.
  • the utility model further comprises a catheter driving component which is sleeved in the tubular body of the guiding protection component.
  • the main body of the catheter driving component has a rod shape and a cylindrical shape, and at least the head of the driving component is sleeved at the bottom end of the guiding shielding component.
  • a cylindrical hollow portion at the opening and slidably conforming with the inner surface of the tubular body of the guiding guard member, the inner surface of the driving member head having at least one force applying portion, and the corresponding position of the urinary tube wall is provided Forced part.
  • the force applying portion may be a partial convex or annular boss or a recess, and the force receiving portion is a convex or annular boss that cooperates with the force applying portion, or may be a recess; when used, when the driving member is toward the urethra When the outer mouth moves, the urinary catheter is driven by it to move synchronously into the urethra; when the driving member moves in the opposite direction to the outer urethra, the urinary catheter can be driven to exit the urethra.
  • the catheter driving member main body has a hollow rod shape or a tubular shape, and may be a semi-arc shaped rod shape or a bent rod shape or a curved shape conforming to a curved guide shielding member.
  • the guiding guard member and the driving member are openable.
  • the closable means that, relative to the urinary catheter constrained therein, after the operation of placing the urinary catheter into the bladder, opening the guiding protective members respectively composed of at least two movable portions and/or The drive member is driven to separate the guide shield member and the drive member from a portion of the catheter that is left in the body.
  • the guiding protection component is openable, the guiding shielding component is composed of two independent parts, one independent guiding shielding component surface is provided with a groove, and the surface of the other independent guiding shielding component is provided with a convex rib, which can slide each other
  • the integrated assembly can also be separated by sliding each other.
  • Guided protective member A releasable design is that the guiding protective member is composed of two parts which are connected in one body but are rotatable in position, and are connected by a line-shaped connecting portion, that is, a connecting line or a hinge, and the two parts are connected. Can be rotated to open and close each other.
  • a scale line is provided on the outer surface of the driving member body.
  • a slightly curved guide groove extends from the distal end opening (712) of the guide guard.
  • a docking catheter has a curved shape, a part of the curved part is integrally connected with the main body, and another part of the arc of the driving part head is rotatably connected to a part of the arc through the connecting line; A portion of the arc of the head of the driving member and another portion of the inner surface of the arc are provided with a plurality of needle-like projections, the length of the needle-like projections being smaller than the thickness of the catheter wall.
  • the bottom end opening of the guiding guard member is provided with two finger rings or curved finger sleeves including the supporting wings protruding from the outer surface thereof, the driving component
  • the tail is provided with at least one finger ring or curved finger cuff including associated support wings.
  • the main body has a hollow cylindrical guide protection member to upgrade the two-point fixed way of relying on two relatively large and soft fingers in the existing operation to a finer and more stable circumferential fixation of the external urethra; outside the urethra
  • the mouth is in the hollow inside the guiding protective part, which is more fixed and exposed.
  • the guiding protective member can prevent the outer surface of the urinary catheter entering the urethral bladder from being contaminated by microorganisms on the surface of the external urethra such as the clitoris and the large and small labia.
  • the driving member that is sleeved with the guiding protective member ensures that the direction of the force is consistent with the direction of movement of the catheter, especially in the case where the urethra is not bent, the direction of the applied force is more easily the same as the center line of the urethra.
  • Figure 1 Schematic diagram of the structure of an existing catheter
  • Figure 2 Schematic diagram of the fixation of the external urethra in the existing catheterization operation
  • Figure 3 shows a good effect of the external fixation of the urethra
  • Figure 4 Schematic diagram showing the poor effect of external fixation of the urethra
  • Figure 5 Schematic diagram of the outer surface of the labial mucosa contaminated catheter
  • Figure 6 is a schematic view showing the force analysis of the catheter head as it travels toward the outer urethra
  • Figure 7 Schematic diagram of force analysis when the head of the catheter is subjected to external urethral resistance
  • Figure 8 Schematic diagram of the closed state of the external urethra
  • Figure 9 Schematic diagram of the open state of the external urethra
  • Figure 10 is a schematic view of the guiding protection member of Embodiment 1 of the present invention.
  • Figure 11 Schematic diagram of the catheter into the bladder urethra
  • Figure 12 is a schematic view showing the guiding and protecting movement of the guiding catheter in the guiding protective member of the first embodiment of the present invention
  • Figure 13 is a schematic view of a curved guiding guard member of the present invention.
  • Figure 14 is a schematic structural view of Embodiment 2 of the present invention.
  • Figure 15 is a plan view showing the schematic view E-E of the second embodiment of the present invention.
  • Figure 16 is a plan view showing the F-F plane of Figure 15 in the second embodiment of the present invention.
  • Figure 17 is a schematic view showing the structure of Embodiment 3 of the present invention.
  • Figure 18 is a schematic view showing the structure of Embodiment 4 of the present invention.
  • Figure 19 is a schematic view showing the structure of Embodiment 5 of the present invention.
  • Figure 20 is a schematic view showing the structure of Embodiment 6 of the present invention.
  • Figure 21 is a perspective view, taken along the line G-G of Figure 20, in a sixth embodiment of the present invention.
  • Figure 22 is a schematic structural view of a driving member according to Embodiment 7 of the present invention.
  • Figure 23 is a schematic view showing the structure of Embodiment 7 of the present invention.
  • Figure 24 is a schematic view showing the structure of Embodiment 8 of the present invention.
  • finger ring connected to the supporting wing 725; 8.
  • Drive unit a needle-like projection on the inner surface of the head; 8118. a bottom end surface of the head of the driving member located inside the guiding shield member; 823. a finger ring of the tail portion of the driving member; 824. a curved finger sleeve of the tail portion of the driving member; 825. Supporting wing; 826. a finger ring connected to the support wing 825; 9. a tick mark.
  • Example 1 A conventional clinically common catheter is shown in Fig. 1.
  • a hollow main body tube composed of a solid material having an inner surface 11 and an outer surface 12 is usually sterilized before use, and the tube is hollow.
  • the urethral lumen 10 includes a head 13 that enters the bladder 0 when in use, a tail portion 14 that is left outside the body, and an intermediate portion 15 that connects the head portion 13 and the tail portion 14.
  • the head portion 13 is provided with a urine inlet 130, and the tail portion 14 is provided with urine.
  • the liquid outlet 140; the bladder fixation balloon 132 for indwelling catheterization is located below the urine inlet 130 of the catheter head 13, and is injected from the one-way valve 2 at the opening 1322 of the bladder-filling capsule filling side branch 142.
  • the amount of gas and/or liquid enters through the passage 1321 in the wall of the catheter and fills the bladder-fixing balloon 132, causing it to remain in the bladder cavity 00 and not easily escape.
  • the placement of the catheter in a female patient is usually performed by two fingers in the clinical operation and the 010 of the external urethra is exposed.
  • the catheter head 13 is clamped with a tool or a finger, and the urethral orifice is 0100.
  • the distance from the urethral orifice 0100 is inserted into the urinary catheter.
  • the arrow in the figure indicates the direction of travel of the catheter head 13; since the female urethra is short and straight, as shown in Fig. 3, when the urethral orifice is fixed, the opening is good.
  • the urethral opening has a central point 0102 located on the relatively vertical urethral centerline 0101, in which case the catheter tip tip 131 is placed along the vertical urethral centerline 0101, toward the urethral intima 011
  • the injury is minimal and the patient's pain is minimal; when the fixation is not good, as shown in Figure 4, the urethral center point 0102 may deviate significantly from the vertical urethra centerline 0101, in which case the catheter head is placed
  • the tip 131 is pressed vertically or nearly perpendicularly to the urethral intima 011, and cannot smoothly follow the vertical urethral centerline 0101, causing greater or severe damage to the urethral intima 011, causing greater pain in the patient.
  • the arrows in Figures 3 and 4 indicate Catheter head 13 direction of travel.
  • the catheter is clamped with a tool or a finger, and the catheter is suspended from the urethral opening 0100 at a certain distance from the external urethral orifice 0100.
  • the middle arrow indicates the direction in which the catheter head 13 travels; as shown in FIG. 7, when the catheter head tip 131 contacts the outer urethral opening 0100, resistance is encountered. Because the catheter material is flexible, it is prone to bending.
  • the direction of curvature is extremely uncertain, either up or down or left or right, such that the catheter head centerline 1316 does not overlap the urethral centerline 0101 but at an angle a, and the curved catheter head tip point 1315 cannot follow
  • the vertical urethral centerline 0101 is advanced, but the vertical or near-vertical pressure to the urethral intima 011 in the urethral opening 0100, causing greater or severe damage to the urethral intima 011, and the damaged urethra
  • the bacterial infection is highly susceptible to secondary membrane 011, and the arrows in the figure indicate the direction of travel of the catheter head 13.
  • the conventional catheter "without guiding suspended insertion" can easily cause the contaminant 111 on the tissue 013 around the outer urethra to contact the outer surface 12 of the catheter, and bring the contaminant 111 into the bladder. Cavity 00 causes infection.
  • Figure 8 shows the urethral opening 0100 not exposed, and the urethral opening 0100 shown in Figure 9 is exposed by the operator's two fingers, and the position is relatively fixed;
  • Figure 11 shows the catheter into the bladder 0 and the urethra In the case of 01, L is the sum of the lengths of the catheter 1 into the bladder 0 and the urethra 01 when indwelling.
  • Embodiment 1 of the female-dedicated urinary catheter according to the present invention is provided with a guide guard member 7 for accommodating at least the length L of the catheter in use, and guiding the main body of the guard member 7 71 is a hollow cylindrical shape having a distal end opening 711 and a distal end opening 712, and the inner cylindrical hollow 70 can accommodate a catheter of length L.
  • the upper arrow in FIG. 12 indicates the direction in which the catheter head 13 travels, and the lower arrow indicates the finger.
  • the direction of the force application is the same direction; when in use, the side of the top end opening 711 of the guiding guard member 7 is pressed toward the peripheral tissue 013 of the human urethral opening 0100, so that the position of the outer urethral opening 0100 is fixed in the top opening 711 of the guiding guard member 7. .
  • the guiding protection member 7 not only facilitates the fixation and exposure of the external urethral opening 0100.
  • the external urethral opening 0100 of the patient is located in the top opening 711 of the guiding protection member 7, and the catheter head 13 is sleeved on the guiding protective member 7
  • the starting point of the movement of the apex 131 of the urinary catheter head is the urethral opening 0100, and the placement of the urinary catheter becomes a true "near placement", the approaching refers to reaching the outer urethral opening 0100;
  • the guiding body 7 has a length of the tubular body 71, the guiding catheter has a motion guiding effect, so that the placement of the catheter further becomes a "guided approach” method, and thus does not The curvature of the catheter appears, the tip 131 of the catheter head is easy to advance along the vertical urethra centerline 0101, the damage to the urethral intima 011 is minimal, and the patient's pain is minimal, completely eliminating the
  • the length of the guiding catheter 7 can accommodate the catheter to be longer than or equal to the length L of the catheter located in the bladder 0 and the urethra when the catheter is indwelled, the catheter portion entering the bladder and the urethra is placed in the catheter. In the process of entering the process, as shown in Fig. 12, it is ensured that the contact with the contaminant 111 on the tissue 013 around the outer urethra is not completely eliminated, and the urinary tract infection is caused by contamination of the outer surface 12 of the catheter by the tissue 013 around the outer urethra.
  • a lubricant such as chitosan, sodium hyaluronate or the like may be applied to the outer surface 12 of the catheter slightly larger than the length L.
  • the guiding protection member 7 may be provided with a finger holding portion protruding from the outer surface thereof, and the finger holding portion includes a boss 721 connectable with the cylindrical body 71, a handle and a finger ring, and of course, the holding tube can be directly used during use.
  • the main body 71 another consideration, in order to accommodate the urethral stricture, deflection or even urethral curvature of some patients, the tip end opening 711 of the guiding guard member 7 is at an angle to the cylindrical body 71 from the viewpoint of ease of operation and reduction of damage. That is, the cylindrical body 71 bent at the top, as shown in FIG.
  • Embodiment 2 As shown in FIGS. 14, 15, and 16, the finger holding portion of the guiding protective member 7 of the present invention protruding from the outer surface thereof is disposed as two finger rings 723, and the finger is placed in the hollow of the finger ring 723 to operate more stably and reliably. Further, in order to facilitate one-handed operation, a main body that is sleeved with the cylindrical body 71 of the guiding guard member 7 is provided in a rod shape or a cylindrical shape, and the driving member rod-shaped body 81 is provided.
  • One end is a head portion 811 that is sleeved with the cylindrical body 71 of the guiding guard member 7, and the curved head portion 811 of the driving member 8 is completely placed in the tubular hollow 70 of the guiding guard member, and the two are slidably fitted; in order to ensure the catheter 1 is reliably and accurately guided during advancement in the guiding guard member 7, and an annular protruding guiding portion 715 having a length L1 which is slightly larger than the outer diameter of the catheter is formed in the interior of the opening 711 adjacent to the guiding guard member 7.
  • the sliding stroke of the curved tip end surface 8116 of the driving member head portion 811 is blocked when the annular boss 7151 of the guiding member tip guiding portion 715 is blocked, and the curved tip end surface 8116 of the driving member head portion 811 is slid. Stroke greater than or equal catheter in the bladder and urethra when the catheter indwelling in the length L.
  • the inner surface 80 of the head portion 811 of the driving member 8 has at least one concave force applying portion 8115, and the convex portion of the catheter wall is provided with a convex force receiving portion 121;
  • the force applying portion 8115 may also be a partial protrusion or an annular boss, and the force receiving portion 121 is a recess or a protrusion that cooperates with the force applying portion; in use, when the two fingers are normally the index finger and the middle finger, the guiding and shielding member 7 is held.
  • the upper finger 723, the thumb of the same hand pushes the finger ring 823 at the tail of the driving member 8, and when the driving member 8 moves toward the urethral opening 0100, the catheter is driven and synchronously moved via the tip opening 711 of the guiding guard member 7.
  • the guiding portion 715 enters the urethra 01; when the driving member 8 moves in the opposite direction to the urethral opening 0100, the catheter can be driven to exit the urethra 01.
  • a slightly curved guide groove 7121 extends from the end opening 712 of the guiding guard member 7.
  • the catheter driving member 8 drives the catheter to guide the inside of the protective member 7, the catheter is slightly The curved guide groove 7121 is slid to avoid extraordination of the urinary catheter due to gravity.
  • the catheter driving member main body 81 may also be a hollow rod-shaped or cylindrical shape that accommodates the catheter 1, or may be a semi-arc-shaped rod or a curved rod that is adapted to the curved guiding member. Shape, curved shape, etc.
  • the tip opening 711 of the guiding guard member 7 does not have to be in close contact with the external urethral opening 0100, but has a certain distance from it to facilitate observation and adjustment of the direction in which the catheter 1 is placed.
  • Embodiment 3 As shown in FIG. 17, different from Embodiment 2, the driving member 8 has two consecutive rings 823 at the tail. This design obviously lengthens the distance of finger manipulation, and when the patient's urethra is long, it is inserted into one. When the stroke of the thumb in the finger ring 823 is not completed, the catheter 1 is not completed, and the other finger ring 823 can be switched in time to continue the advancement.
  • Embodiment 4 As shown in FIG. 18, different from Embodiment 2, the driving member 8 has two consecutive curved finger sleeves 824 at the tail portion, and two curved finger sleeves 724 are disposed on the guiding protection member 7, and the curved finger sleeves are provided.
  • the opening on the 724 side is more convenient for fingers to enter and disengage, and the distance between the two consecutive curved finger sleeves 824 can also be extended to further extend the stroke of the finger manipulation.
  • the finger sleeve and the finger ring can also be applied simultaneously.
  • Embodiment 5 As shown in Fig. 19, a closable design is that the guide guard member 7 is composed of two independent portions 7a, 7b, and the outer surface of the independent guide guard member 7a is provided with a recess 7a1, and the other is independent.
  • the side of the guiding protection member 7b is provided with a rib 7b1, which can be slidably fitted to each other or can be slid to each other until separated.
  • the opposite double arrows in the figure indicate the assembly and separation directions, and when the assembly is in place, the two are avoided.
  • the two sides of the independent guiding protection member 7a are respectively provided with a snap connection member 7a2, and the two sides of the independent guide protection member 7b are also respectively provided with a snap connection member 7b2, and the snap connection members 7a2, 7b2 are weakly formed.
  • the snap-fit interference fit, the two independent guiding guard members 7a, 7b are force-fitted, and the projections 7b20 on the snap-connecting member 7b2 are interference-engaged in the corresponding positions of the other snap-connecting members 7a2,
  • the guiding guard members 7a, 7b are integrally connected to each other. After the end of use, the two independent guiding guard members 7a, 7b can be separated by a small force.
  • Embodiment 6 As shown in Figs. 20 and 21, the guide guard member 7 is composed of two parts 71a, 71b which are integrally connected but are rotatable in position, and are connected by a line-like connecting portion, that is, a connecting line 71c.
  • the portions 71a, 71b are rotated and opened, and the catheter 1 and the driving member head 811 are placed and then closed, and the rotation is prevented by the snap connection; when the catheter 1 is successfully placed into the bladder 0, the buckle connection is opened to
  • the connecting line 71c is a rotating shaft that is rotated to open the two portions 71a, 71b of the guiding guard member 7 from the opening of the curved driving member head portion 811 with a slight force to disengage the catheter 1 therefrom; for precise understanding of the operation
  • the advancement distance of the catheter 1 and the length of the urethra are determined after successful placement, and a scale line 9 is provided on the outer surface of the driving member main body 81 for accurate measurement.
  • Embodiment 7 As shown in Figs. 22 and 23, the difference from Embodiments 5 and 6 is that a portion 811a of the arcuate portion of the driving member head portion 811 is integrally connected with the main body 81, and the other portion 811b of the driving member head portion 811 is curved.
  • the connecting line 811c is rotatably connected to the 811a; the curved portion 811a of the driving member head 811 and the inner surface of the curved other portion 811b are provided with a plurality of sharp needle-like protrusions 8117, a curved portion 811a, curved
  • the other portion 811b is formed into a circular shape for accommodating the catheter 1, and a sharp needle-like projection 8117 of the inner surface 80 thereof penetrates into the wall of the catheter to move the catheter, and the position of the needle-like projection 8117 And the depth of penetration does not touch the passage of the bladder fixation balloon or other passages in the wall, and the length of the needle protrusion 8117 must not exceed the wall thickness of the catheter 1.
  • the inner surface of the opening end 712 of the guiding shielding member 7 is provided with an annular or partially dispersed boss 7152.
  • the boss 7152 abuts against the bottom end surface 8118 of the driving member head portion 811 to prevent it from coming out.
  • Embodiment 8 As shown in FIG. 24, in order to avoid interference with the operation of the catheter 1 located outside the guiding shield member 7 during use, the interference is mainly the finger ring of the catheter 1 being operated as the ring in the above embodiment. 723, 823 or curved finger cuffs 724, 824 are too close so that the fingers located therein are easy to touch the urinary catheter 1 to generate resistance, interfering operation; on the side away from the urinary catheter 1, guiding the shielding member 7 and the driving member 8
  • the above positions are respectively provided with two supporting wings 725 and one supporting wing 825, and the finger rings 726, 826 or the arcuate finger sleeves are connected thereto, and the two finger rings 726 of the guiding protection component 7 and one finger ring 826 of the driving component 8 can be located at one position. In the plane.

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Abstract

一种适用于女性的导尿管（1），包括具有内表面（11）、外表面（12）的实体材料构成的中空的主体管路，还包括使用时至少可将留置时位于膀胱（0）及尿道（01）内的导尿管（1）套设于其内的主体呈筒状的导向防护部件（7），还包括与导向防护部件（7）的筒状主体套接的主体为杆状的导尿管驱动部件（8），以"有导向抵近置入"的安全模式消除了传统的"无导向悬空置入"的弊端、彻底避免尿道外口（0100）周围组织（013）对导尿管（1）的污染，还最大程度避免置入过程中因尿道（01）狭窄而导致的尿道内膜（011）损伤。

Description

一种适用于女性的导尿管 技术领域
本发明涉及导尿管，特别涉及一种适用于女性的导尿管，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，导尿管置入的操作以及留置会不同程度的导致下尿路损伤，而下尿路的损伤更易于引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。
女性尿道较男性短而粗，长度仅4厘米左右，尿道外口周围结构复杂，即使不插入导尿管也易于发生尿路感染；现有临床的女性导尿步骤，通常在消毒尿道外口及周边组织后用一手的两指按压尿道外口周边组织使其相对固定，撑开并暴露尿道外口，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；当需要留置时，随即将引流尿袋接头插入导尿管尿液出口，成为一封闭系统。
现有女性患者的导尿存在以下问题：
1.操作者两个手指难以固定并暴露尿道外口，尤其是在因诸如尿路感染、分娩侧切口的瘢痕牵拉导致的尿道外口异位、老年女性的尿道外口萎缩甚至陷入阴道前壁的情况下；尿道外口固定及暴露不良不仅降低导尿管置入成功率还会大大增加置入过程的尿道损伤。
2.女性尿道外口附近如大、小阴唇表面的微生物极易接触并污染曲折进入尿道的导尿管外表面，将微生物带入尿道及膀胱内；此种腔外感染也即导尿管内腔外的途径导致的感染是留置导尿患者早期尿路感染的主要原因。
3.使用手指或镊子、止血钳把持导尿管悬空施力的方式因导尿管为柔性，曲折行进，施加的力方向难以与尿道中心线相同，行进方向与施力的方向呈一定角度，平行于尿道中心线的作用力仅是施加的力的一个分力，故较大的力才能将导尿管置入，因而尿道损伤较大。
发明内容
本发明为了解决上述三方面的不足，提供了一种适用于女性的导尿管。
本发明的目的是这样实现的：
一种适用于女性的导尿管，包括具有内表面、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；还包括至少可将留置时位于膀胱及尿道内的导尿管套设于其内的导向防护部件，导向防护部件主体为具有顶端开口及尾端开口的中空的筒状，所述中空筒状，包括局部不能活动的一体式的独立部件、可开合的两个部分或部件组成的中空筒状，内部筒状中空的长度大于等于留置时位于膀胱及尿道内的导尿管的长度；使用时，导向防护部件顶端压向人体尿道外口周边组织，使尿道外口的位置处于导向防护部件顶端开口内。
由于女性尿道短且直，如图3、图6所示，传统的导尿方式，尿道外口固定效果好时，张开的尿道外口其中心点位于相对竖直的尿道中心线上，此情形下置入的导尿管头部顶端易于沿着竖直的尿道中心线前行，对尿道内膜的损伤最小，患者的疼痛感也最小；如图4所示，尿道外口固定效果不佳时尿道外口中心点可能显著偏离竖直的尿道中心线，此情形下置入的导尿管头部顶端垂直或近乎垂直的压向尿道内膜，而无法顺利的沿着竖直的尿道中心线前行，对尿道内膜产生较大或严重的损伤，使患者产生更大的疼痛感。
按传统方式即使固定效果好，如图6所示，使用工具或手指将导尿管夹持，距离尿道外口一定距离将导尿管悬空的向尿道外口插入，当导尿管头部顶端接触到尿道外口时遇到阻力，如图7所示，因导尿管材质为柔性极易发生弯曲，弯曲方向极不确定或上或下或左或右，使得导尿管头部中心线与尿道中心线无法重叠而是成一角度α，弯曲后的导尿管头部顶端点无法沿着竖直的尿道中心线前行，而是垂直或近乎垂直的压向尿道外口内的尿道内膜，对尿道内膜产生较大或严重的损伤，而损伤后的尿道内膜处极易继发细菌感染。
应用本发明所述的女性专用导尿管的导向防护部件，不仅便于尿道外口的固定及暴露，使用时，尿道外口位于导向防护部件顶端开口内，而导尿管又套设在导向防护部件内，导尿管头部顶端运动的起点即是尿道外口位置，导尿管的置入成为真正的“抵近置入”，所述抵近是指抵近尿道外口；进一步的，因导向防护部件筒状的主体具有一定长度，对其内的导尿管起到运动导向作用，使导尿管的置入进一步成为“有导向抵近置入”，因而不会出现导尿管的弯曲，使得导尿管头部中心线与尿道中心线重叠，导尿管头部顶端易于沿着竖直的尿道中心线前行，对尿道内膜的损伤最小，患者的疼痛感也最小，彻底消除了“无导向悬空置入”的传统方式的相应弊端。
为方便操作，导向防护部件上可设有突出其外表面的手指把持部分，手指把持部分可为与筒状主体连接的凸台、手柄、指环。
导向防护部件内部可容纳导尿管的长度大于等于导尿管留置时位于膀胱及尿道内的导尿管长度；这种导向防护部件的筒状主体的长度匹配设计，使得进入膀胱及尿道内的导尿管部 分在导尿管置入过程中确保不与尿道外口周围的组织接触，彻底消除了因尿道外口周围的组织污染导尿管外表面而导致尿路感染的风险；当应用现有的导尿管外表面润滑涂层的技术时，润滑物如壳聚糖、透明质酸钠等涂布于此长度的导尿管外表面即可。
另一种考虑，为了适应部分患者尿道外口狭窄、偏斜甚至尿道弯曲，从便于操作及降低损伤角度考虑，导向防护部件的顶端开口部分与筒状主体呈一定角度，导向防护部件的顶端开口部分与筒状主体也可以是包括波纹管在内的可转向连接，所述可转向连接是指连接角度可调节的连接。
进一步的，还包括套接于导向防护部件的筒状主体内的导尿管驱动部件，导尿管驱动部件主体为杆状、筒状，至少驱动部件的头部套接在导向防护部件底端开口处的筒状中空内，并与导向防护部件的筒状主体内表面可滑动的适形配合，驱动部件头部内表面上至少有一个施力部分，相应位置的导尿管壁上设有受力部分。
施力部分可以是部分凸起或环形凸台，也可以是凹陷，受力部分则是与施力部分相配合的凸起或环形凸台，也可以是凹陷；使用时，当驱动部件向尿道外口方向运动时，导尿管被其驱动也做同步运动而带入尿道内；当驱动部件向尿道外口相反方向运动时，导尿管可被其驱动而退出尿道。
具体实施时，导尿管驱动部件主体为中空杆状、筒状，也可以是半弧形杆状或与弯曲的导向防护部件适型的弯杆状、弯筒状等。
为了便于导尿管置入后能将导向防护部件及驱动部件与导尿管分离，导向防护部件和或驱动部件为可开合的。
所述可开合的，是指相对被约束其内的导尿管而言，当完成导尿管置入膀胱的操作后，打开分别是由至少两个可活动部分构成的导向防护部件和或驱动部件，从而使导向防护部件及驱动部件与留置在体外的部分导尿管分离。
导向防护部件为可开合的，导向防护部件由独立的两部分构成，一个独立的导向防护部件表面设有凹槽，另一个独立的导向防护部件的表面设有凸筋，二者可相互滑动配合装配一体也可通过相互滑动而分离。
导向防护部件一种可开合的设计是，导向防护部件由连为一体但位置可旋转的两部分组成，二者之间通过线条状的连接部分也即连接线条相连或合页相连，两部分可相互旋转开启及关闭。
为了精确了解导尿管推进的长度及判断留置时位于膀胱及尿道内的导尿管长度，在驱动部件主体外表面设有刻度线。
为了顺利推进导尿管，导向防护部件尾端开口(712)处延伸出一个略加弯曲的导向槽。
一种对接导尿管的方案是，驱动部件头部为弧形，弧形的一部分与主体一体式相连，驱动部件头部弧形的另一部分通过连接线条与弧形的一部分可旋转的相连；驱动部件头部的弧形的一部分、弧形的另一部分内表面设有多个针状突起，针状突起的长度小于导尿管管壁厚度。
为了避免操作中因距离太近而产生的导尿管对手指的可能干涉，导向防护部件底端开口处设有突出其外表面的包括连带支撑翼的两个指环或弧形指套，驱动部件尾部设有包括连带支撑翼的至少1个指环或弧形指套。
本发明的有益效果是：
1.主体呈中空筒状的导向防护部件可将现有操作中依赖人的两个相对粗大且柔软手指的两点式固定方式升级为尿道外口精细的更为稳定的环周固定；尿道外口处于导向防护部件内部中空内，固定及暴露更为充分。
2.导向防护部件可避免进入尿道膀胱内的导尿管外表面遭受尿道外口附近组织如阴蒂及大、小阴唇表面微生物的污染。
3.与导向防护部件套接的驱动部件可确保施力方向与导尿管运动方向一致，尤其是尿道没有弯曲的情况下，施加的力的方向更易于与尿道中心线相同。
附图说明：
图1：现有导尿管结构示意图；
图2：现有导尿操作中对尿道外口的固定方式示意图；
图3：示意尿道外口固定效果好的情形；
图4：示意尿道外口固定效果不佳的情形；
图5：阴唇粘膜污染导尿管外表面示意图；
图6：导尿管头部向尿道外口行进时的受力分析示意图；
图7：导尿管头部受到尿道外口阻力时的受力分析示意图；
图8：尿道外口闭合状态示意图；
图9：尿道外口开启状态示意图；
图10：本发明实施例1的导向防护部件示意图；
图11：导尿管进入膀胱尿道示意图；
图12：本发明实施例1的导向防护部件对其内的导尿管运动导向及防护示意图；
图13：本发明弯曲的导向防护部件示意图；
图14：本发明实施例2的结构示意图；
图15：本发明实施例2的示意图E-E立体剖切后的平面视图；
图16：本发明实施例2中图15的F-F平面剖切后的平面视图；
图17：本发明实施例3的结构示意图；
图18：本发明实施例4的结构示意图；
图19：本发明实施例5的结构示意图；
图20：本发明实施例6的结构示意图；
图21：本发明实施例6中图20的G-G立体剖切后的立体视图；
图22：本发明实施例7的驱动部件结构示意图；
图23：本发明实施例7的结构示意图；
图24：本发明实施例8的结构示意图。
图中：0.膀胱；00.膀胱腔；01.尿道；010.尿道内腔；0100.尿道外口；0101.尿道中心线；0102.尿道外口中心点；011.尿道内膜；013.尿道外口周边组织；0131.阴唇；1.导尿管；10.导尿管内腔；11.导尿管内表面；111.尿道外口周边组织上的污染物；12.导尿管外表面；121.导尿管壁上受力部分；13.导尿管头部；130.尿液入口；131.导尿管头部顶端；1315.导尿管头部顶端点；1316.导尿管头部中心线；132.膀胱固定囊体；1321.膀胱固定囊体通路；1322.膀胱固定囊体充盈侧支对外开口；14.导尿管尾部；140.尿液出口；142.膀胱固定囊体充盈侧支；15.导尿管中间部；2.单向阀；4.弯盘；7.导向防护部件；7a、7b.独立的导向防护部件；7a1.导向防护部件外表面凹槽；7b1.导向防护部件侧面凸筋；7a2、7b2.卡扣连接部件；7b20.连接部件7b2上的凸起；70.导向防护部件筒状中空；71.导向防护部件筒状主体；71a、71b.导向防护部件两部分筒状主体；71c.导向防护部件的连接线条；711.导向防护部件的顶端开口；712.导向防护部件的尾端开口；7121.导向防护部件的导向槽；713.导向防护部件内表面；715.导向防护部件顶端内部环形突出的导向部分；L1.715的长度；L.留置时位于膀胱及尿道内的导尿管长度；7151.导向防护部件顶端导向部分上的环形凸台；7152.导向防护部件尾端开口712处的内表面上的凸台；721.可用作把持的凸台；723.导向防护部件上的指环；724.导向防护部件上的弧形指套；725.导向防护部件上的支撑翼；726.与支撑翼725相连的指环；8.驱动部件；80.驱动部件头部内表面；81.驱动部件杆状主体；811.驱动部件头部；811a、811b.驱动部件头部两个相连的弧形部分；811c.驱动部件头部两个可活动相连的弧形部分的连接线；8116.驱动部件头部的顶端面；8117.驱动部件头部内表面上的针状突起；8118.位于导向防护部件内部的驱动部件头部的底端面；823.驱动部件尾部的指环；824.驱动部件尾部的弧 形指套；825.驱动部件上的支撑翼；826.与支撑翼825相连的指环；9.刻度线。
具体实施方式
实施例1：现有临床常见的导尿管如图1所示，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，使用前通常灭菌处理，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13设有尿液入口130，尾部14设有尿液出口140；用于留置导尿的膀胱固定囊体132位于导尿管头部13的尿液入口130之下，从膀胱固定囊体充盈侧支142开口1322处的单向阀2内注入一定量的气体和或液体，经由导尿管壁内的通路1321进入并充盈膀胱固定囊体132，使其滞留在膀胱腔00内不易脱出。
如图2所示，女性患者导尿管的置入通常临床操作上常用两个手指固定及暴露尿道外口0100，使用工具或手指将导尿管头部13夹持，距离尿道外口0100一定距离将导尿管悬空的向尿道外口0100插入，图中箭头指示导尿管头部13行进方向；由于女性尿道短且直，如图3所示，尿道外口固定效果好时张开的尿道外口其中心点0102位于相对竖直的尿道中心线0101上，此情形下置入的导尿管头部顶端131易于沿着竖直的尿道中心线0101前行，对尿道内膜011的损伤最小，患者的疼痛感也最小；固定效果不佳时，如图4所示，尿道外口中心点0102可能显著偏离竖直的尿道中心线0101，此情形下置入的导尿管头部顶端131垂直或近乎垂直的压向尿道内膜011，而无法顺利的沿着竖直的尿道中心线0101前行，对尿道内膜011产生较大或严重的损伤，使患者产生更大的疼痛感，图3、4中箭头指示导尿管头部13行进方向。
按传统方式操作即使尿道外口固定效果好，如图6所示，使用工具或手指将导尿管夹持，距离尿道外口0100一定距离将导尿管悬空的向尿道外口0100插入，图中箭头指示导尿管头部13行进方向；如图7所示，当导尿管头部顶端131接触到尿道外口0100时遇到阻力，因导尿管材质为柔性，极易发生弯曲，弯曲方向极不确定，或上或下或左或右，使得导尿管头部中心线1316与尿道中心线0101无法重叠而是成一角度α，弯曲后的导尿管头部顶端点1315无法沿着竖直的尿道中心线0101前行，而是垂直或近乎垂直的压向尿道外口0100内的尿道内膜011，对尿道内膜011产生较大或严重的损伤，而损伤后的尿道内膜011处极易继发细菌感染，图中箭头指示导尿管头部13行进方向。
如图5所示传统的导尿管“无导向悬空置入”的方式极易引发尿道外口周围的组织013上的污染物111接触导尿管外表面12，而将污染物111带入膀胱腔00导致感染。
图8所示未被撑开暴露的尿道外口0100，图9所示尿道外口0100被操作者两个手指撑 开暴露，位置相对固定；图11所示为导尿管进入膀胱0及尿道01的情形，L为留置时导尿管1进入膀胱0及尿道01内的长度之和。
本发明所述的女性专用导尿管的实施例1如图10、12所示，设置一使用时至少可将上述长度L的导尿管容纳其内的导向防护部件7，导向防护部件7主体71为具有顶端开口711及尾端开口712的中空的筒状，内部筒状中空70可容纳长度L的导尿管，图12中上方箭头指示导尿管头部13行进方向，下方箭头指示手指施力方向，二者同向；使用时，导向防护部件7顶端开口711一侧，压向人体尿道外口0100周边组织013，使尿道外口0100的位置固定于导向防护部件7顶端开口711内。
导向防护部件7，不仅便于尿道外口0100的固定及暴露，使用时，患者的尿道外口0100位于导向防护部件7顶端开口711内，而导尿管头部13又套设在导向防护部件7内，导尿管头部顶端131运动的起点即是尿道外口0100，导尿管的置入成为真正的“抵近置入”，所述抵近是指抵近尿道外口0100；进一步的，因导向防护部件7筒状的主体71具有一定长度，对其内的导尿管起到运动导向作用，使导尿管的置入进一步成为“有导向抵近置入”方式，因而不会出现导尿管的弯曲，导尿管头部顶端131易于沿着竖直的尿道中心线0101前行，对尿道内膜011的损伤最小，患者的疼痛感也最小，彻底消除了“无导向悬空置入”的传统方式的相应弊端。
由于导向防护部件7内部可容纳导尿管的长度大于等于导尿管留置时位于膀胱0及尿道内的导尿管的长度L，使得进入膀胱及尿道内的导尿管部分在导尿管置入过程中如图12所示可确保不与尿道外口周围的组织013上的污染物111接触，彻底消除了因尿道外口周围的组织013污染导尿管外表面12而导致尿路感染的风险；当应用现有的导尿管外表面12润滑涂层的技术时，润滑物如壳聚糖、透明质酸钠等涂布于略大于此长度L的导尿管外表面12即可。
为方便操作，导向防护部件7上可设有突出其外表面的手指把持部分，手指把持部分包括可与筒状主体71连接的凸台721以及手柄、指环，当然也可在使用时直接把持筒状主体71；另一种考虑，为了适应部分患者尿道外口狭窄、偏斜甚至尿道弯曲，从便于操作及降低损伤角度考虑，导向防护部件7的顶端开口711部分与筒状主体71呈一定角度，即顶端弯曲的筒状主体71，如图13所示。
实施例2：如图14、15、16所示，本发明的导向防护部件7上突出其外表面的手指把持部分设置成两个指环723，手指置于指环723的中空内操作更为稳定可靠；进一步的，尤其是为了方便单手操作，还设置有与导向防护部件7的筒状主体71套接的主体为杆状也可是筒状的导尿管驱动部件8，驱动部件杆状主体81一端为与导向防护部件7的筒状主体71套接的头部811，驱动部件8弧形的头部811完全置于导向防护部件筒状中空70内，二者滑动配 合；为了确保导尿管1在导向防护部件7内前进过程中得到可靠精准的导向，在邻近导向防护部件7顶端开口711处的内部设有一段内径略大于导尿管外径的长度为L1的环形突出的导向部分715；驱动部件头部811的弧形的顶端面8116的滑动行程至导向防护部件顶端导向部分715的环形凸台7151时受阻停止，驱动部件头部811的弧形的顶端面8116的滑动行程大于等于导尿管留置时位于膀胱及尿道内的导尿管长度L。
为了与导尿管1同步运动，驱动部件8头部811的内表面80上至少有一个凹陷的施力部分8115，相应位置的导尿管壁上设有凸出的受力部分121；当然，施力部分8115也可以是部分凸起或环形凸台，受力部分121则是与施力部分相配合的凹陷或凸起；使用时，当两个手指通常为食指及中指把持导向防护部件7上的指环723，同一个手的拇指推动驱动部件8尾部的指环823，驱动部件8向尿道外口0100方向运动时，导尿管被其驱动也做同步运动经由导向防护部件7顶端开口711处的导向部分715而进入尿道01内；当驱动部件8向尿道外口0100相反方向运动时，导尿管可被其驱动而退出尿道01。
本实施例中，导向防护部件7尾端开口712处延伸出一个略加弯曲的导向槽7121，当导尿管驱动部件8驱动导尿管向导向防护部件7内行进时，导尿管在略加弯曲的导向槽7121内滑动，避免因重力导致的导尿管严重下坠弯曲而产生额外的推进阻力。
作为本实施例的变通，导尿管驱动部件主体81也可为容纳导尿管1的中空杆状、筒状，也可以是半弧形杆状或与弯曲的导向防护部件适型的弯杆状、弯筒状等。
作为具体操作时的灵活变通，有些情况导向防护部件7顶端开口711不必贴紧尿道外口0100，而是与其有一定距离便于观察及调整导尿管1置入方向。
实施例3：如图17所示，与实施例2不同的是，驱动部件8尾部有连续2个指环823，这种设计显然延长了手指操控的距离，当患者尿道较长时，套入一个指环823中的拇指行程结束时尚未完成导尿管1置入，可及时切换到另一个指环823继续推进。
实施例4：如图18所示，与实施例2不同的是，驱动部件8尾部有连续2个弧形指套824，导向防护部件7上设置两个弧形指套724，弧形指套724一侧的开口更方便手指进入及脱离，两个连续的弧形指套824之间也可有一定的距离，进一步延长手指操控的行程。
当然，指套和指环也可同时应用。
实施例5：如图19所示，一种可开合的设计是，导向防护部件7由独立的两部分7a、7b构成，独立的导向防护部件7a外表面设有凹槽7a1，另一个独立的导向防护部件7b的侧面设有凸筋7b1，二者可相互滑动配合装配一体也可通过相互滑动直至分离，图中相反的双箭头指示装配及分离方向，当装配到位时避免使用中二者分离，独立的导向防护部件7a两侧分别设有卡扣连接部件7a2，独立的导向防护部件7b的两侧也分别设有卡扣连接部件7b2，卡扣 连接部件7a2、7b2之间形成较弱的卡扣过盈配合，两个独立的导向防护部件7a、7b用力对合，卡扣连接部件7b2上的凸起7b20过盈嵌入另一个卡扣连接部件7a2上的相应位置的凹槽内，使用时将导向防护部件7a、7b对合连接为一体，使用结束后人手分别把持两个独立的导向防护部件7a、7b稍加用力即可将二者分离。
实施例6：如图20、21所示，导向防护部件7由连为一体但位置可旋转的两部分71a、71b组成，二者之间通过线条状的连接部分也即连接线条71c相连，两部分71a、71b旋转开启，置入导尿管1及驱动部件头部811后再对合关闭，通过卡扣连接避免旋转开启；当导尿管1成功置入膀胱0后开启卡扣连接，以连接线条71c为旋转轴，旋转打开导向防护部件7的两部分71a、71b，从弧形的驱动部件头部811的开口处向下略用力使导尿管1从其上脱离；为精确了解操作时导尿管1的推进距离及留置成功后确定尿道的长度，在驱动部件主体81外表面设有刻度线9以供精确测量。
实施例7：如图22、23所示，与实施例5、6显著不同的是驱动部件头部811弧形的一部分811a与主体81一体式相连，驱动部件头部811弧形的另一部分811b通过连接线条811c与811a可旋转的相连；驱动部件头部811的弧形的一部分811a、弧形的另一部分811b内表面设有多个锐利的针状突起8117，弧形的一部分811a、弧形的另一部分811b对合成可容纳导尿管1的圆形，其内表面80的锐利的针状突起8117刺入导尿管壁内从而可带动导尿管随之运动，针状突起8117的位置及刺入的深度不得触及膀胱固定囊体通路或其他管壁内的通路，针状突起8117的长度更不得超越导尿管1的壁厚。
进一步的，为了避免导尿管操作未结束时驱动部件头部811可能从导向防护部件7内脱出，导向防护部件7尾端开口712处的内表面上设有环形或局部分散的凸台7152，当套设在导向防护部件7内的驱动部件头部811向外部滑动时，凸台7152与驱动部件头部811的底端面8118相抵，阻止其脱出。
实施例8：如图24所示，为避免使用时位于导向防护部件7外的导尿管1对操作的干扰，这种干扰主要为导尿管1距离操作的指环如上述实施例中的指环723、823或弧形指套724、824太近使得位于其中的手指易于触及导尿管1而产生阻力，干涉操作；在远离导尿管1的一侧，导向防护部件7及驱动部件8的上述位置均分别设有两个支撑翼725及一个支撑翼825，指环726、826或弧形指套与之相连，导向防护部件7的两个指环726及驱动部件8的一个指环826可位于一个平面内。

Claims (10)

  1. 一种适用于女性的导尿管，包括具有内表面(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，还包括至少可将留置时位于膀胱(0)及尿道(01)内的导尿管套设于其内的导向防护部件(7)，导向防护部件(7)主体(71)为具有顶端开口(711)及尾端开口(712)的中空的筒状，所述中空筒状，包括局部不能活动的一体式独立部件、可开合的两个部分或部件组成，内部筒状中空(70)的长度大于等于留置时位于膀胱(0)及尿道(01)内的导尿管的长度(L)；使用时，导向防护部件(7)顶端压向人体尿道外口(0100)周边组织(013)，使尿道外口(0100)的位置处于导向防护部件(7)顶端开口(711)内。
  2. 根据权利要求1所述的一种适用于女性的导尿管，其特征在于，还包括套接于导向防护部件(7)的筒状主体(71)内的导尿管驱动部件(8)，导尿管驱动部件(8)主体为杆状、筒状，至少驱动部件(8)的头部(811)套接在导向防护部件(7)底端开口(712)处的筒状中空(70)内，并与导向防护部件(7)的筒状主体(71)内表面(713)可滑动的适形配合，驱动部件(8)头部(811)内表面(80)上至少有一个施力部分(8115)，套设其内的导尿管相应位置的管壁上设有受力部分(121)。
  3. 根据权利要求1、2所述的一种适用于女性的导尿管，其特征在于，导向防护部件(7)底端开口(712)处设有突出其外表面的两个指环(723)或弧形指套(724)作为手指把持部分，在邻近导向防护部件(7)顶端开口(711)处的内部设有一段内径略大于导尿管外径的环形突出的导向部分(715)；驱动部件(8)弧形的头部(811)完全置于导向防护部件筒状中空(70)内，二者滑动配合；导尿管嵌入驱动部件(8)弧形的头部(811)内；驱动部件头部(811)的弧形的顶端面(8116)的滑动行程至导向防护部件顶端导向部分(715)的环形凸台(7151)时受阻停止，驱动部件头部(811)的弧形的顶端面(8116)的滑动行程大于等于导尿管留置时位于膀胱(0)及尿道(01)内的导尿管长度(L)；驱动部件(8)尾部设有至少一个指环(823)或弧形指套(824)。
  4. 根据权利要求1、2所述的一种适用于女性的导尿管，其特征在于，导向防护部件(7)底端开口(712)处设有突出其外表面的两个指环(723)或弧形指套(724)作为手指把持部分，驱动部件(8)尾部有至少连续2个指环(823)或弧形指套(824)。
  5. 根据权利要求1所述的一种适用于女性的导尿管，其特征在于，导向防护部件(7)为可开合的，导向防护部件(7)由独立的两部分(7a)、(7b)构成，一个独立的导向防护部件(7a)表面设有凹槽(7a1)，另一个独立的导向防护部件(7b)的表面设有凸筋(7b1)，二者可相互滑动配合装配一体也可通过相互滑动而分离。
  6. 根据权利要求1所述的一种适用于女性的导尿管，其特征在于，导向防护部件(7)为可开合的，导向防护部件(7)由连为一体但位置可旋转的两部分(71a)、(71b)组成，二者之间通过线条状的连接部分也即连接线条(71c)相连或合页相连，两部分(71a)、(71b)可相互旋转开启及关闭。
  7. 根据权利要求1、2、5、6所述的一种适用于女性的导尿管，其特征在于，在驱动部件(8)主体(81)外表面设有刻度线(9)。
  8. 根据权利要求1、2、5、6所述的一种适用于女性的导尿管，其特征在于，导向防护部件尾端开口(712)处延伸出一个略加弯曲的导向槽(7121)。
  9. 根据权利要求1、2、5、6所述的一种适用于女性的导尿管，其特征在于，驱动部件头部(811)为弧形，弧形的一部分(811a)与主体(81)一体式相连，驱动部件头部(811)弧形的另一部分(811b)通过连接线条(811c)与弧形的一部分(811a)可旋转的相连；驱动部件头部(811)的弧形的一部分(811a)、弧形的另一部分(811b)内表面(80)设有多个针状突起(8117)，针状突起(8117)的长度小于导尿管管壁厚度。
  10. 根据权利要求1、2、5、6所述的一种适用于女性的导尿管，其特征在于，导向防护部件(7)底端开口(712)处设有突出其外表面的包括连带支撑翼(725)的两个指环(726)或弧形指套，驱动部件(8)尾部设有包括连带支撑翼(825)的至少1个指环(826)或弧形指套。
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