CN215916155U - Urethral catheterization device - Google Patents

Abstract

The application provides a urethral catheterization device, mainly including the pipe that has main chamber way to and the location structure of intercommunication main chamber way, the pipe can be worn and locate in the urethra, location structure can be from the axial extension and the radial outside extension of the pipe distal end of pipe, and wherein, location structure elastic deformation is in order to get into the bladder via the urethra under the stress state to can be in order to be located bladder neck under the elastic recovery of unstressed state. Therefore, the positioning effect of the urethral catheterization device in the urethra can be improved, and the operation of putting in and detaching the urethral catheterization device can be conveniently executed.

Description

Urethral catheterization device

Technical Field

The application relates to the field of medical instruments, in particular to a urethral catheterization device.

Background

Indwelling catheterization is a bladder emptying mode which cannot be replaced clinically at present, and is widely applied to urinary retention, dysuria, urine drainage and the like. The total length of the catheter and the bullet-shaped end in front of the catheter balloon is 2-3 cm, which can cause bladder and urinary tract irritation. The urinary tract irritation is a symptom, is mainly common in diseases such as urinary tract infection, urinary tuberculosis, urinary calculus and the like, comprises frequent micturition, urgent micturition, painful urination and incomplete urination, is caused by irritation to the bladder neck and bladder triangle, and is mostly caused by urinary tract infection, non-infectious inflammation and physical and chemical factors.

Furthermore, the radial cross section of the existing catheter is mostly circular, which causes the urethral mucosa secretion not to be discharged, and the urethral mucosa secretion is accumulated around the urinary catheter for a long time to form a biological membrane, and the biological membrane is a microcolonium formed by the aggregation and propagation of microorganisms, organic matters and inorganic matters, which causes the difficulty of conventional bacterial culture and the reduction of the sensitivity to antibacterial drugs, which is an important reason for causing the CAUTI high-frequency and repeatability.

In addition, the urethral stricture patient has a problem that the catheter is difficult to be inserted, and the urethral catheter is not sufficiently rigid and cannot smoothly pass through the urethral stricture.

SUMMERY OF THE UTILITY MODEL

In view of the above, the present application provides a urinary catheterization apparatus to at least partially solve the problems of the prior art described above.

The urethral catheterization device comprises a catheter which can be arranged in a urethra and is provided with a main channel axially penetrating through the catheter; and a positioning structure communicating with the main lumen and extending axially from the catheter distal end of the catheter and expanding radially outward; wherein the positioning structure can be elastically deformed in a stressed state to enter the bladder through the urethra and can be elastically restored in an unstressed state to be positioned at the neck of the bladder.

Optionally, the positioning structure comprises a positioning ring, which is elastically deformable; a connecting portion connecting the positioning ring and the distal end of the catheter, respectively.

Optionally, the connection portion comprises a film; wherein the thin film comprises a monolayer film or a composite film; wherein the film comprises a composite film structure of a spider-type woven mesh or a composite film structure of a grid-type woven mesh.

Optionally, the positioning ring is formed by folding the edge of the connecting part outwards or inwards by using a heat setting process or a plastic dipping process; or the positioning ring is made of metal materials or high polymer materials, and the connecting part is connected with the positioning ring in a heat seal or integrated forming mode.

Optionally, the urethral catheterization device further comprises a traction member connected with the positioning ring and extending to the proximal end of the catheter along the axial direction of the catheter, and a force can be applied to the positioning ring through the traction member so as to enable the positioning ring to have a strip-shaped or oval-shaped elastic deformation tendency.

Optionally, the locating structure is adapted to produce the resilient deformation to be fully received within the main lumen of the catheter, with the distal end of the catheter being radially inwardly constricted.

Optionally, the positioning structure is capable of elastically deforming to be partially received in the distal end of the catheter tube, and an exposed portion of the positioning structure forms a guiding structure, and the radial diameter of the guiding structure is not larger than that of the catheter tube.

Optionally, the urinary catheterization device further comprises a guide member for receiving the positioning structure which generates elastic deformation therein; wherein the guide extends in an axial direction of the catheter; the guide piece further comprises a self-destruction structure, the self-destruction structure can be stressed to destroy the guide piece and expose the positioning structure accommodated in the self-destruction structure, and therefore the positioning structure can be elastically restored.

Optionally, the guide is made of a soft material or a hard material.

Optionally, the guide comprises a guide body and a guide portion extending from the guide body and converging radially inward.

Optionally, the urinary catheterization device further comprises an auxiliary rod member which can penetrate through the main cavity and the positioning structure and is combined with the positioning ring generating the elastic deformation; and wherein the auxiliary rod member is further axially positionable relative to the catheter to maintain the positioning ring in the elastically deformed state.

Optionally, the auxiliary rod further comprises a deformation maintaining part; the positioning ring which generates the elastic deformation can be combined to the deformation keeping part so as to keep an included angle between the cross section of the positioning ring and the axis of the conduit to be smaller than a preset angle.

Optionally, the shape-changing retaining portion includes a positioning unit for positioning an arbitrary position of the positioning ring so that the positioning ring has a tapered or quasi-tapered cross section.

Optionally, the deformation retaining portion includes two positioning units for positioning two ends of the diameter of the positioning ring, so that the positioning ring forms a spindle-shaped cross section, a tapered cross section, or a similar tapered cross section.

Optionally, the two positioning units are respectively arranged on two opposite side surfaces of the deformation retaining part.

Optionally, the deformation retaining portion further includes an accommodating cavity for accommodating at least a portion of the connecting portion.

Optionally, the hardness of the distal end of the auxiliary rod is less than the hardness of the proximal end of the auxiliary rod; and/or said distal ends of said auxiliary rods are radially inwardly contracted.

Optionally, the catheter is made of silicone, rubber, latex or a polymer material.

Optionally, the outer wall of the catheter tube is formed with a spacer so that a gap is formed between the outer wall of the catheter tube and the inner wall of the urethra.

Optionally, the catheter further comprises an occlusion ring annularly arranged on the catheter, and an outer wall of the occlusion ring is tightly attached to an inner wall of the urethra.

Optionally, the catheter further comprises a through hole penetrating through a wall of the catheter, and the through hole is positioned on one side of the occlusion ring close to the distal end of the catheter.

Optionally, the urinary catheterization apparatus further comprises a sensor, which is arranged at any position of the catheter or the positioning structure, for sensing pressure and/or temperature.

Optionally, the sensor is provided on the occlusion ring of the catheter.

Optionally, the surface of the conduit is coated.

Optionally, the urinary catheterization apparatus further comprises a deformable balloon disposed on the catheter, the deformable balloon having a variable balloon diameter.

Optionally, the catheter further comprises an auxiliary lumen axially penetrating through the catheter, and a channel interface disposed at the proximal end of the catheter and communicating with the auxiliary lumen.

According to the technical scheme, the urethral catheterization device is positioned at the neck opening of the bladder by virtue of the positioning structure formed at the far end of the catheter, so that the stimulation of the fixed end of the traditional urethral catheter to the wall of the bladder can be reduced, and the positioning effect is improved.

Furthermore, the catheterization device of this application forms the interval portion through the outer pipe wall at the pipe to make and form the clearance between pipe and the urethra, can reduce the area of contact of pipe and urethra mucous membrane and then reduce the production of urethra secretion, and borrow by setting up the shutoff ring on the pipe and running through the through-hole of pipe wall, can provide discharge passage for the urethra secretion, in order to reduce the infection probability of taking place.

In addition, by providing a guide member at the distal end of the catheter, it is possible to facilitate the passage of the urinary catheter through the curved and narrowed sections in the urethra, and to increase the strength of the catheter by fitting the auxiliary rod member, so as to facilitate the insertion operation of the urinary catheter.

In addition, the traction piece applies acting force to the positioning structure to enable the positioning structure to generate elastic deformation, so that the detachment operation of the urethral catheterization device can be conveniently completed.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings needed to be used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments described in the embodiments of the present application, and other drawings can be obtained by those skilled in the art according to the drawings.

Fig. 1 is a schematic view showing the overall construction of a urinary catheterization apparatus according to the present application.

Fig. 2A to 2C are schematic radial cross-sectional views of the positioning structure of the present application.

Fig. 3A to 3D are schematic diagrams of different embodiments of the positioning structure of the present application.

Fig. 4 is a partial structural view of the urethral catheterization apparatus of the present application of fig. 1.

FIG. 5 is a schematic view of an embodiment of a positioning structure of a urinary catheterization apparatus of the present application received at the distal end of a catheter.

Fig. 6A to 6B are schematic views showing an example of the spacer of the urethral catheterization apparatus of the present application.

Fig. 7A to 7B are schematic views of an embodiment of the plugging ring of the present application.

Fig. 8A-8B are cross-sectional schematic views of the catheter of fig. 7A.

Fig. 9A to 9B are schematic views of an embodiment of a urinary catheterization apparatus having a sensor according to the present application.

Fig. 10 is a schematic view of an embodiment of the inventive urinary catheterization apparatus with a deformable balloon.

Fig. 11 to 15D are views respectively showing different embodiments of the catheterization apparatus of the present application performing the insertion operation.

Element number

10: a urinary catheterization device;

20: a conduit;

202: a main lumen;

204: a catheter distal end;

2042: an end portion;

206: a proximal end of the catheter;

208: a spacer section;

210: a plugging ring;

212: a through hole;

214: auxiliary cavity channels;

216: a channel interface;

218: a capsule access channel;

30: a positioning structure;

302: a positioning ring;

302A, 302B: an end portion;

304: a connecting portion;

306: a film;

308: a guide structure;

40: a traction member;

50: a guide member;

502: a self-destructive structure;

503: a cord;

504: a guide body;

506: a guide section;

60: an auxiliary bar member;

602: a strain holding section;

604, 604A, 604B: a positioning unit;

606: an accommodating cavity;

608: a locking structure;

70: a sensor;

80: a deformable bladder;

90: the urethra;

92: the mucosa of urethra.

Detailed Description

In order to make those skilled in the art better understand the technical solutions in the embodiments of the present application, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, but not all embodiments. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments in the present application shall fall within the scope of the protection of the embodiments in the present application.

The following further describes a specific implementation of the embodiments of the present application with reference to the drawings of the embodiments of the present application.

The present embodiment provides a urinary catheterization apparatus 10, as shown in fig. 1, the urinary catheterization apparatus 10 of the present embodiment mainly includes a catheter 20 and a positioning structure 30.

Wherein the catheter 20 is insertable into the urethra and has a main lumen 202 extending axially through the catheter 20, and the positioning structure 30 communicates with the main lumen 202 and extends axially from and expands radially outwardly of a distal catheter end 204 of the catheter 20.

Alternatively, the catheter 20 may be made of silicone, rubber, latex, or a polymeric material.

Optionally, the surface of the catheter 20 may be coated.

In the present embodiment, the positioning structure 30 can be elastically deformed under a stress condition, such that the radial diameter of the positioning structure 30 is not larger than the diameter of the catheter 20, so that the positioning structure 30 can enter the bladder through the urethra of the patient.

Furthermore, the positioning structure 30 can be elastically restored in an unstressed state, so that the radial diameter of the positioning structure 30 is larger than that of the catheter 20 (i.e. urethra), thereby being positioned at the neck of the bladder of the patient. Therefore, the urethral catheterization device can stimulate the bladder wall and reduce the infection probability of patients.

Alternatively, the positioning structure 30 extending axially and expanding radially outward from the catheter distal end 204 of the catheter 20 may assume a trumpet shape.

Alternatively, the positioning structure 30 may include a retaining ring 302 and a connecting portion 304 connecting the retaining ring 302 to the distal end 204 of the catheter.

Alternatively, the connection portion 304 may be made of a film 306.

Alternatively, the film 306 may be a single layer film (as shown in fig. 2A) or a composite film (as shown in fig. 2B, 2C).

Alternatively, the film 306 may include a composite film structure of a spider-type woven mesh (refer to fig. 2B) or a composite film structure of a grid-type woven mesh (refer to fig. 2C), so that the structural design can effectively enhance the strength of the positioning structure 30 (the connecting portion 304), prevent the connecting portion 304 from being torn during operation, and ensure that the connecting portion 304 can be restored to its original shape after being pressed.

Alternatively, the positioning structure 30 as a whole may be made of the film 306.

For example, the retaining ring 302 may be formed by outwardly crimping (referring to fig. 3A) the edge of the connecting portion 304 or inwardly crimping (referring to fig. 3B) the edge of the connecting portion 304 using a heat setting process or a plastic injection process.

Alternatively, the positioning structure 30 may be made in part from the membrane 306.

For example, the positioning ring 302 of the positioning structure 30 may be a metallic ring made of a metallic material (e.g., nitinol material), or a non-metallic ring made of a polymeric material.

In this case, the connecting portion 304 may be integrally formed with the retaining ring 302 by heat sealing, such as an outer wrap around retaining ring 302 (shown in FIG. 3C) or an inner wrap around retaining ring 302 (shown in FIG. 3D).

In this embodiment, the connecting portion 304 and the distal end 204 of the catheter can be fixedly connected to each other by heat sealing or integral molding.

Alternatively, the coupling portion 304 may be attached to an outer or inner wall of the catheter distal end 204, or the coupling portion 304 may extend along the wall of the catheter distal end 204 (as shown in fig. 4).

Optionally, the urinary catheterization apparatus 10 further comprises a traction member 40 connected to the positioning ring 302 and extending along the axial direction of the catheter 20 to the proximal end 206 of the catheter 20, and a force can be applied to the positioning ring 302 via the traction member 40 to cause the positioning ring 302 to assume a strip-like or elliptical-like elastic deformation tendency for the positioning ring 302 to disengage from the bladder neck and enter the main channel 202 of the catheter 20 (refer to fig. 5), thereby facilitating the removal of the urinary catheterization apparatus 10 from the patient.

Alternatively, the catheter 20 may be made of a polymeric or rubber-like material, such as polyurethane, silicon-based materials.

The catheter proximal end 206 of the catheter 20 may be circumscribed by a reservoir bag, such as a urine bag (not shown), for receiving liquid (e.g., urine) that flows into the main channel 202 via the positioning structure 30.

Optionally, the outer wall of the catheter 20 may be formed with a spacer 208 to form a gap between the outer wall of the catheter 20 and the inner wall of the urethra 90.

In the present embodiment, the spacer 208 may be a groove formed on the outer wall of the outer tube 20, and may have a regular shape in cross section (as shown in fig. 8A) or an irregular shape in cross section (as shown in fig. 8B).

Referring to fig. 6A and 6B, in the present embodiment, a plurality of spacers 208 are disposed on the outer wall of the catheter 20 to form a gap between the catheter 20 and the urethral mucosa 92, so as to reduce the irritation of the catheter 20 to the urethral mucosa 92 and reduce the formation of the biofilm.

Optionally, the catheter 20 further comprises an occlusion ring 210 annularly arranged on the catheter 20, wherein an outer wall of the occlusion ring 210 may closely fit to an inner wall of the urethra.

Alternatively, the occlusion device 210 may be disposed at the proximal end 206 and/or the distal end 204 of the catheter, but not limited thereto, and may also be disposed at a mid-section position of the catheter 20, which is not limited herein.

In the present embodiment, the catheter 20 further includes a through hole 212 penetrating through the wall of the catheter 20, wherein the through hole 212 may be disposed on a side of the occlusion ring 210 near the distal end 204 of the catheter (refer to fig. 7A and 7B).

By means of the above structure design, the blocking ring 210 can block the secretion between the catheter 20 and the urethral mucosa 92 to prevent the secretion from flowing out from between the catheter 20 and the urethral canal 90, and meanwhile, the through hole 212 designed on the side of the blocking ring 210 close to the catheter distal end 204 can introduce the secretion into the main channel 202 inside the catheter 20 and flow out through the main channel 202, thereby facilitating the drainage of the secretion.

In addition, the occluding ring 210 designed at the distal end 204 of the catheter may also be used to occlude urine flow from between the bladder neck and the positioning structure 30, for example, to prevent urine flow from between the catheter 20 and the urethra 90 when the positioning ring 302 of the positioning structure 30 is not tightly occluded from the bladder neck.

Optionally, the conduit 20 may further include a secondary channel 214 axially extending through the conduit 20, and a channel interface 216 disposed at the proximal end 206 of the conduit and communicating with the secondary channel 214, wherein a water injection device or a water discharge device (not shown) may be provided externally to the conduit 20 via the channel interface 216 to perform a water injection or water discharge operation via the secondary channel 214 (refer to fig. 7A, 8B).

Optionally, the urinary catheterization apparatus 10 further includes a sensor 70, which may be disposed anywhere on the catheter 20 or the positioning structure 30 for sensing pressure and/or temperature.

Preferably, the sensor 70 is disposed on the occlusion ring 210 of the catheter 20 (see fig. 9A and 9B).

Optionally, the urinary catheterization apparatus 10 may further include a deformable balloon 80 (refer to fig. 10) disposed on the catheter 20, wherein a balloon access channel 218 communicating with an internal cavity of the deformable balloon 80 is further formed on the catheter 20, and an injection operation may be performed on the deformable balloon 80 through the balloon access channel 218 to expand the deformable balloon 80, and gas or liquid in the deformable balloon 80 is discharged through the balloon access channel 218 to contract the deformable balloon 80, so as to adjust a balloon diameter of the deformable balloon 80, thereby providing a compression hemostasis effect for the prostatic urethra.

The catheterization apparatus 10 of the present application can be implemented by deforming the positioning structure 30 to perform the insertion operation of the catheterization apparatus 10, which can be implemented by various embodiments, and it should be noted that the following examples are only used for illustration and are not intended to limit the present application.

First embodiment

Referring to fig. 11, in the present embodiment, the positioning structure 30 can be elastically deformed to be completely accommodated in the main channel 202 of the conduit 20.

For example, the auxiliary rod 60 may be disposed and inserted into the main lumen 202 of the catheter 20, so that the auxiliary rod 60 may be placed into the urethra of the patient along with the catheter 20, thereby increasing the stiffness of the catheter 20 and facilitating the placement of the urinary catheterization apparatus 10.

Preferably, the end 2042 of the distal end 204 of the catheter is radially inwardly contractible to reduce resistance during the threading procedure and to facilitate smooth passage of the catheter 20 through bends and/or strictures in the urethra and into the bladder.

After the distal end 204 of the catheter successfully reaches the bladder of the patient, the positioning structure 30 received in the main channel 202 can be pushed to the outside of the catheter 20 by the auxiliary rod 60, and the exposed positioning structure 30 (positioning ring 302) can automatically and elastically recover to make its radial section (diameter) larger than the diameter of the urethra, so as to be positioned at the bladder neck connecting the bladder and the urethra.

It should be noted that the auxiliary rod 60 may also be inserted into the main channel 202 of the catheter 20 after the distal end 204 of the catheter successfully reaches the bladder of the patient, for pushing the positioning structure 30 received in the main channel 202 to the outside of the catheter 20 to perform the positioning operation.

Second embodiment

Referring to fig. 12, in the present embodiment, the positioning structure 30 can be elastically deformed to be partially received in the distal end 204 of the catheter 20, and an exposed portion of the positioning structure 30 forms a guiding structure 308.

In this embodiment, the radial diameter of the guiding structure 308 is not larger than the radial diameter of the catheter 20, and the guiding structure 308 can have a tapered shape, which is more flexible than the catheter 20 due to the elastic material property of the positioning structure 30 (positioning ring 302), thereby providing a good guiding effect to facilitate the passage of the catheter 20 through the stenosis or physiologic curve of the urethra.

After the urinary catheterization apparatus 10 is positioned at the predetermined position (for example, after reaching the bladder), the present embodiment may also be used with the auxiliary rod 60 to achieve the elastic recovery and the positioning operation of the positioning structure 30.

Third embodiment

Referring to fig. 13A and 13B, in the present embodiment, the urinary catheterization device 10 further includes a guiding member 50 for receiving the positioning structure 30 that generates elastic deformation therein.

In this embodiment, the guiding element 50 can extend along the axial direction of the catheter 20, and preferably, the radial diameter of the guiding element 50 is not larger than the radial diameter of the catheter 20, so as to facilitate the smooth passage of the catheter 20 through the curve and/or stenosis in the urethra into the bladder.

Alternatively, the guide 50 may be made of a soft material or a hard material.

For example, the guide 50 may be made of a thin film material (refer to fig. 13A and 13B), and for example, the guide 50 may be a sheath made of a polymer or rubber-like material (refer to fig. 13C and 13D), which is not limited in this application.

Further, the deformed positioning structure 30 can be completely received in the guide 50 (see fig. 13A and 13D), or a part of the deformed positioning structure 30 can be received in the main channel 202 of the guide tube 20 and another part of the deformed positioning structure can be received in the guide 50 (see fig. 13C).

In this embodiment, the guiding element 50 further includes a self-destruction structure 502, and the self-destruction structure 502 can be damaged by being forced to expose the positioning structure 30 accommodated therein, so that the positioning structure 30 generates elastic recovery.

Specifically, the positioning structure 30 received in the guide member 50 may be exposed by providing a cord 503 connected to the self-destructive structure 502, and extending the cord 503 in the axial direction of the catheter 20 to the proximal end 206 of the catheter and exposing the cord 503, wherein after the distal end 204 of the catheter reaches the bladder of the patient, the self-destructive structure 502 is destroyed (e.g., torn) by pulling the cord 503.

Alternatively, the guide member 50 may be wrapped around the positioning structure 30 only (see fig. 13A and 13B), or both the positioning structure 30 and the distal end 204 of the catheter (see fig. 13C and 13D), which is not limited in this respect.

Optionally, the guide 50 may include a guide body 504 and a guide portion 506 (see fig. 13A) extending from the guide body 504 and converging radially inward to facilitate passage of the urinary catheter 10 through a stricture or bend of the urethra.

Fourth embodiment

Referring to fig. 14A to 15D, in the present embodiment, the urinary catheterization apparatus 10 further includes an auxiliary rod 60 which can penetrate through the main lumen 202 of the catheter 20 and the positioning structure 30 for fixing the elastically deformable positioning ring 302 thereon (refer to fig. 14A), and the auxiliary rod 60 can be axially positioned with respect to the catheter 20 to maintain the positioning ring 302 in an elastically deformed state, so as to assist in pushing the positioning structure 30 to the bladder and positioning it at the neck opening of the bladder.

Optionally, the auxiliary rod 60 may have a hollow lumen for passage of a guide wire or a scope.

Optionally, the assistant rod member 60 further comprises a deformation maintaining portion 602, and the positioning ring 302 generating elastic deformation can be coupled to the deformation maintaining portion 602, and by positioning the assistant rod member 60 relative to the conduit 20, the included angle between the cross section of the positioning ring 302 and the axis of the conduit 20 can be maintained to be smaller than a preset angle.

In this embodiment, the smaller the angle between the cross-section of the positioning ring 302 and the axis of the catheter 20, the better, for example, the cross-section of the positioning ring 302 is kept substantially parallel to the axis of the catheter 20, so as to facilitate the insertion of the urinary catheterization apparatus 10.

Referring to fig. 14A to 14D, the shape-changing retaining portion 602 may optionally include a positioning unit 604 for positioning any position of the positioning ring 302, so as to make the positioning ring 302 have a tapered or cone-like cross section.

Specifically, in an unstressed state in which the cross section of the positioning ring 302 is substantially perpendicular to the axis of the catheter 20 (see fig. 14B), the auxiliary rod member 60 can be made to penetrate the main channel 202 and the positioning structure 30 and expose the deformation-retaining portion 602, and in this state, the end portion 302A of the positioning ring 302 can be positioned in the positioning unit 604 (e.g., a positioning groove), and the portion 304 of the positioning ring 302 located on the upper side of the deformation-retaining portion 602 (i.e., the portion between the end portion 302A of the positioning ring 302 and the distal end 204 of the catheter) is elastically deformed by further pushing the auxiliary rod member 60 forward along the main channel 202 (i.e., axially moving in the direction of F1 of fig. 14C), thereby bringing the other end portion 302B of the positioning ring 302 gradually closer to the deformation-retaining portion 602 until the positioning ring 302 forms a tapered or quasi-tapered cross section parallel to the axis of the catheter 20 (see fig. 14C), and by axially positioning the auxiliary rod member 60 with respect to the catheter 20 (e.g., the positioning ring 302 is maintained in the current elastically deformed state by the locking structure 608 provided on the shaft member 60 and the catheter 20 (refer to fig. 14D), thereby performing the insertion operation of the urinary catheterization apparatus 10.

Furthermore, after the positioning structure 30 reaches the bladder, the positioning ring 302 can be gradually restored to its original shape by withdrawing the subsidiary rod 60 in the direction F2 shown in FIG. 14C until the end 302A of the positioning ring 302 is separated from the positioning unit 604 of the subsidiary rod 60, so that the positioning ring 302, which is completely restored to its original shape, is positioned at the neck of the bladder.

Referring to fig. 15A to 15D, alternatively, the deformed retaining portion 602 may include two positioning units 604A,604B for positioning both ends, e.g., the ends 302A,302B, of the diameter of the positioning ring 302 to form the positioning ring 302 with a spindle-shaped cross section, a tapered cross section, or a tapered-like cross section.

Alternatively, two positioning units 604A,604B may be disposed on opposite side surfaces of the deformation retaining portion 602.

Specifically, in an unstressed state in which the cross section of the positioning ring 302 is substantially perpendicular to the axis of the catheter 20 (see fig. 15B), the auxiliary rod 60 can be made to penetrate the main channel 202 and the positioning structure 30 and expose the deformed retaining portion 602. in this state, the connecting portion 304 of the positioning ring 302 on the upper side of the deformed retaining portion 602 can be elastically deformed (e.g., the portion between the end 302A of the positioning ring 302 and the distal end 204 of the catheter) to position the end 302A of the positioning ring 302 in the positioning unit 604A (e.g., positioning groove) and the end 302B of the positioning ring 302 in the positioning unit 604B (e.g., positioning groove).

Optionally, the deformed retaining portion 602 may further include a receiving cavity 606 (see fig. 15A) that may be used to receive at least a portion of the coupling portion 304 (e.g., the portion between the end 302B of the retaining ring 302 to the catheter distal end 204).

In this state, the positioning ring 302 may form a spindle-shaped cross section, a tapered cross section or a similar tapered cross section parallel to the axis of the catheter 20 (see fig. 15C), and the positioning ring 302 may be maintained in the current elastically deformed state (see fig. 15D) by axially positioning the assistant rod member 60 with respect to the catheter 20 (e.g., by the locking structure 608 respectively disposed on the assistant rod member 60 and the catheter 20) for performing the insertion operation of the urinary catheterization apparatus 10.

Further, after the positioning structure 30 reaches the bladder, the positioning ring 302 can be gradually restored to its original shape by first withdrawing the auxiliary rod 60 in the direction F2 shown in FIG. 15C so that the end 302B of the positioning ring 302 is withdrawn from the positioning unit 604B until the end 302A of the positioning ring 302 is withdrawn from the positioning unit 604A so that the positioning ring 302, which is completely restored to its original shape, is positioned at the neck opening of the bladder.

Alternatively, the hardness of the distal end of the auxiliary rod 60 may be less than that of the proximal end of the auxiliary rod 60, and the distal end of the auxiliary rod 60 may be radially inwardly contracted to assume a tapered shape, whereby the resistance to pushing can be reduced, facilitating passage through the curved and narrow segments in the urethra.

In summary, the urethral catheterization device provided by the application is positioned at the neck of the bladder by the positioning ring, so that the irritation of the urethral catheterization device to the bladder wall can be reduced.

Furthermore, the spacer part is designed on the catheter, so that the contact area between the catheter and the urethral mucosa can be reduced, and the generation of secretion is reduced.

In addition, a blocking ring and a through hole are arranged on the catheter to provide a drainage channel for secretion, so that the secretion can be discharged through a main channel of the catheter.

In addition, the guide structure is formed at the front end of the catheter by utilizing components such as the distal end of the catheter, the positioning structure, the guide piece, the auxiliary rod piece and the like, so that the urinary catheterization device can conveniently pass through a bending section or a narrow section of a urethra, and in addition, the auxiliary rod piece penetrating through the main cavity can further enhance the hardness of the catheter, so that the catheter is not easy to bend and deform in the process of placing the catheter into the body.

Finally, it should be noted that: the above embodiments are only used for illustrating the technical solutions of the embodiments of the present application, and are not limited thereto; although the present application has been described in detail with reference to the foregoing embodiments, it should be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions in the embodiments of the present application.

Claims (26)

1. A urinary catheterization device, comprising:

a catheter insertable into a urethra and having a main lumen extending axially therethrough; and

a positioning structure communicating with the main lumen and extending axially and radially outwardly from the catheter distal end of the catheter;

wherein the positioning structure can be elastically deformed in a stressed state to enter the bladder through the urethra and can be elastically restored in an unstressed state to be positioned at the neck of the bladder.

2. The urinary catheterization apparatus of claim 1, wherein the positioning structure comprises:

a positioning ring which is elastically deformable;

a connecting portion connecting the positioning ring and the distal end of the catheter, respectively.

3. The urinary catheterization device of claim 2, wherein the connection portion comprises a membrane;

wherein the thin film comprises a monolayer film or a composite film;

wherein the film comprises a composite film structure of a spider-type woven mesh or a composite film structure of a grid-type woven mesh.

4. The urinary catheterization device of claim 3,

the positioning ring is formed by outwardly crimping or inwardly crimping the edge of the connecting part by utilizing a heat setting process or a plastic dipping process; or

The positioning ring is made of metal materials or high polymer materials, and the connecting part is connected with the positioning ring in a heat sealing or integrated forming mode.

5. The urinary catheterization apparatus according to claim 4, further comprising a traction member connected to the positioning ring and extending in the axial direction of the catheter tube to the proximal end of the catheter tube, wherein a force is applied to the positioning ring via the traction member to cause the positioning ring to assume a strip-like or elliptical elastic deformation tendency.

6. The urinary catheterization apparatus of claim 2, wherein the positioning structure is elastically deformable to be fully received within the main lumen of the catheter, and the distal end of the catheter is radially inwardly constricted.

7. The urinary catheterization apparatus of claim 2, wherein the positioning structure is elastically deformable to be partially received in the distal end of the catheter tube and to form an exposed portion of the positioning structure into a guide structure having a radial diameter no greater than a radial diameter of the catheter tube.

8. The urinary catheterization apparatus defined in claim 2, further comprising a guide member for receiving the resiliently deformable positioning structure therein;

wherein the guide extends in an axial direction of the catheter;

the guide piece further comprises a self-destruction structure, the self-destruction structure can be stressed to destroy the guide piece and expose the positioning structure accommodated in the self-destruction structure, and therefore the positioning structure can be elastically restored.

9. The urinary catheterization apparatus of claim 8, wherein the guide member is made of a soft material or a hard material.

10. The urinary catheterization apparatus of claim 8, wherein the guide member includes a guide member body and a guide portion extending from the guide member body and converging radially inward.

11. The urinary catheterization apparatus of claim 2, further comprising an auxiliary rod member which extends through the main channel and the positioning structure and incorporates the elastically deformable positioning ring thereon;

and wherein the auxiliary rod member is further axially positionable relative to the catheter to maintain the positioning ring in the elastically deformed state.

12. The urinary catheterization apparatus of claim 11, wherein the auxiliary rod further comprises a shape-change retention portion; wherein the content of the first and second substances,

the positioning ring which generates the elastic deformation can be combined to the deformation keeping part so as to keep the included angle between the cross section of the positioning ring and the axial line of the conduit to be smaller than a preset angle.

13. The urinary catheterization apparatus of claim 12, wherein the shape-change retention portion includes a positioning unit for positioning any position of the positioning ring such that the positioning ring has a tapered or cone-like cross-section.

14. The urinary catheterization apparatus of claim 12, wherein the shape-change retention portion comprises two positioning units for positioning the two diametrical ends of the positioning ring so that the positioning ring forms a spindle-shaped cross-section, a tapered cross-section or a cone-like cross-section.

15. The urinary catheterization apparatus of claim 14, wherein the two positioning units are respectively arranged on two opposite side surfaces of the shape-change retention portion.

16. The urinary catheterization apparatus of claim 14, wherein the shape-change retention portion further comprises a receiving cavity for receiving at least a portion of the connecting portion.

17. The urinary catheterization apparatus of claim 11,

the hardness of the far end of the auxiliary rod piece is less than that of the near end of the auxiliary rod piece; and/or

The distal end of the auxiliary rod is contracted radially inward.

18. The urinary catheterization device of claim 1, wherein the catheter is made of silicone, rubber, latex or a polymeric material.

19. The urinary catheterization apparatus of claim 1, wherein the outer wall of the catheter is formed with a spacer to form a gap between the outer wall of the catheter and the inner wall of the urethra.

20. The urinary catheterization apparatus of claim 19, wherein the catheter further comprises an occlusion ring disposed around the catheter, the outer wall of the occlusion ring being in close proximity to the inner wall of the urethra.

21. The urinary catheterization apparatus of claim 20, wherein the catheter further comprises a through-hole extending through the wall of the catheter, the through-hole being located on a side of the occlusion ring proximate the distal end of the catheter.

22. The urinary catheterization apparatus of claim 20, further comprising a sensor disposed at any location of the catheter or the positioning structure for sensing pressure and/or temperature.

23. The urinary catheterization apparatus of claim 22, wherein the sensor is disposed on the occlusion ring of the catheter.

24. The urinary catheterization device of claim 1, wherein the surface of the catheter is coated.

25. The urinary catheterization apparatus of claim 1, further comprising a deformable balloon disposed on the catheter, the deformable balloon having a variable bladder diameter.

26. The urinary catheterization apparatus of claim 1, wherein the catheter further comprises a secondary lumen extending axially through the catheter, and a channel port disposed at the proximal end of the catheter and communicating with the secondary lumen.

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