Urinary catheterization device, delivery device, method for inserting and removing a urinary catheterization device

Abstract

The present application provides a urinary catheterization device, a delivery device, a method for inserting and removing the urinary catheterization device, including a catheter body having a urinary catheterization passage and a first positioning structure provided at the distal end of the catheter body. Wherein, the outer diameter of the catheter body is smaller than the inner diameter of the urethra, and the outer diameter of the first positioning structure is larger than the inner diameter of the urethra, so as to position the first positioning structure at the bladder neck opening and position the catheter body in the urethra. Thereby, the present application can not only improve the positioning effect of the urinary catheterization device in the urethra, but also effectively protect the inner wall of the urethra from being scratched during the process of inserting or removing the urinary catheterization device.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a urinary catheterization device, a delivery device, and a method for inserting and removing a urinary catheterization device. Background Art

[0002] Indwelling catheterization is an irreplaceable method of bladder emptying in clinical practice and is widely used in the treatment of diseases such as urinary retention and dysuria.

[0003] In the existing urinary catheter devices, most of them are fixed at the bladder neck by inflating the balloon at the tip of the catheter. However, this positioning method can easily stimulate the bladder wall at the tip of the urinary catheter device, causing discomfort to the patient.

[0004] Furthermore, the existing urinary catheter device is to slide the urinary catheter (or delivery sheath) upward along the urethra into the bladder. However, the operation mode of the urinary catheter abutting against the urethral wall and sliding is very likely to cause damage to the wall surface of the urethra and cause urinary tract infection.

[0005] Specifically, the urinary system is a sterile environment under normal circumstances, and the placement of an indwelling catheter, as an invasive procedure, causes continuous damage to the urethral environment and is directly related to retrograde infection by pathogenic bacteria. The outer surface of the catheter may be contaminated with bacteria when it slides through the male urethral opening, and the bacteria are then carried upward into the sterile area of ​​the urethra and into the bladder, potentially causing urinary tract infection.

[0006] In addition, leaving a urinary catheter in the patient's body for a long time will cause spasm of the patient's urethral sphincter. Therefore, intermittent catheterization is required to restore the patient's autonomic nervous system to control urination as soon as possible.

[0007] In view of this, how to solve the above-mentioned problems existing in the existing urinary catheterization device is the technical issue to be solved in this application. Summary of the invention

[0008] In view of the above problems, the present application provides a urinary catheterization device, a delivery device, and a method for inserting and removing the urinary catheterization device to overcome the above problems or at least partially solve the above problems.

[0009] A first aspect of the present application provides a urinary catheter device, comprising: a urinary catheter body having a urinary catheter passage axially penetrating the urinary catheter body; and a first positioning structure disposed at the distal end of the urinary catheter body; wherein the outer diameter of the urinary catheter body is smaller than the diameter of the urethra and the outer diameter of the first positioning structure is larger than the diameter of the urethra, so that the first positioning structure is positioned at the bladder neck and the urinary catheter body is positioned in the urethra.

[0010] Optionally, the urinary catheter body is an elongated tube made of a thin film.

[0011] Optionally, the film includes multiple interlayers, and the material and / or hardness of each interlayer is different.

[0012] Optionally, the surface of the catheter body is covered with a coating.

[0013] Optionally, the first positioning structure is formed by folding or curling the distal end of the tube body.

[0014] Optionally, the first positioning structure is formed at the distal end of the tube body by using a heat setting process or a dipping molding process.

[0015] Optionally, the first positioning structure is a positioning ring made of a polymer material, and is fixed to the distal end of the tube body by welding, bonding or coating.

[0016] Optionally, the first positioning structure is a positioning balloon disposed at the distal end of the tube body; and wherein the urinary catheter device further comprises a first channel, which extends along the axial direction of the urinary catheter body and is connected to the positioning balloon, and the first channel is used to infuse gas or liquid into the positioning balloon to cause the positioning balloon to expand and deform, or the first channel is used to extract the gas or liquid in the positioning balloon to cause the positioning balloon to contract and deform.

[0017] Optionally, the first positioning structure can be deformed to enter the catheterization passage; and wherein the catheter body can be gradually folded from the distal end of the catheter body toward the proximal end of the catheter body, so that the outer surface of the catheter body facing the urethra is flipped toward the inside of the catheter body to avoid the urethra.

[0018] Optionally, the urinary catheter device further comprises an auxiliary tube body, which further extends from the distal end of the tube body along the axial direction of the urinary catheter tube body.

[0019] Optionally, the auxiliary tube body has a first end connected to the distal end of the tube body and a second end away from the distal end of the tube body; wherein, the auxiliary tube body can be gradually folded from the second end toward the first end, so that the inner surface of the auxiliary tube body is turned toward the outside of the auxiliary tube body to face the urethra, and the folded auxiliary tube body is sleeved on the outside of the catheter body.

[0020] Optionally, the first positioning structure can be deformed so that the outer diameter of the first positioning structure is smaller than the diameter of the urethra: and wherein the auxiliary tube body sleeved on the outside of the catheter body can be gradually folded from the first end toward the second end, so that the inner surface facing the urethra is flipped toward the inside of the auxiliary tube body to away from the urethra.

[0021] Optionally, the urinary catheter device further comprises a traction member, which extends along the axial direction of the urinary catheter body and is connected to the first positioning structure, and a force can be applied to the first positioning structure via the traction member to cause the first positioning structure to produce the deformation.

[0022] Optionally, the urinary catheter device further comprises a second positioning structure, which is respectively connected to the urinary catheter body and the external urethra opening, so as to position the urinary catheter body relative to the external urethra opening.

[0023] Optionally, the urinary catheter device further comprises an anti-torsion structure, which is arranged on the side wall of the urinary catheter body along the axial direction of the urinary catheter body to prevent the urinary catheter body from twisting and deforming.

[0024] Optionally, the urinary catheter device further comprises a support structure arranged in a ring on the urinary catheter body, for providing support force for a designated part of the urethra.

[0025] Optionally, the support structure comprises at least one support unit, and the strength of the support force of the support structure is adjusted by adjusting the size of the support unit and / or the spacing distance between the support units.

[0026] Optionally, the support unit includes one of a support ring and a support capsule.

[0027] A second aspect of the present application provides a delivery device, which is used to insert the urinary catheter device described in the first aspect into a patient's body so that the first positioning structure of the urinary catheter device is positioned at the bladder neck and the urinary catheter body is positioned in the urethra.

[0028] Optionally, the delivery device comprises a delivery sheath.

[0029] A third aspect of the present application provides a method for removing a urinary catheterization device, which is applied to the urinary catheterization device described in the first aspect above, and the removal method comprises: causing the first positioning structure to be deformed under force so as to enter the urinary catheterization passage of the urinary catheter body; and causing the first positioning structure to continue to move along the urinary catheterization passage toward the proximal end of the urinary catheter body under force, so that the urinary catheter body is gradually folded from the distal end of the urinary catheter body toward the proximal end of the urinary catheter body, so that the outer surface of the urinary catheter body facing the urethra is turned toward the inside of the urinary catheter body and separated from the urethra, thereby removing the urinary catheterization device from the patient's body.

[0030] The fourth aspect of the present application provides a method for inserting and removing a urinary catheter device, which is applied to the urinary catheter device of the first aspect, and the method comprises: when the urinary catheter device needs to be inserted into a patient, the second end of the auxiliary tube body is positioned at the external urethral opening of the patient, and the auxiliary tube body is gradually folded from the second end of the auxiliary tube body toward the first end, so that the inner surface of the auxiliary tube body is turned toward the outside of the auxiliary tube body and faces the urethra, until the first positioning structure is positioned at the bladder neck of the patient, and the urinary catheter body is positioned in the urethra of the patient, and the folded auxiliary tube body is sleeved on the urethra. the outside of the urinary catheter body; when the urinary catheter device needs to be removed from the patient's body, the first positioning structure is deformed by force so that the outer diameter of the first positioning structure is smaller than the diameter of the urethra, so that the first positioning structure enters the urethra from the bladder neck, and the first positioning structure is forced to continue to move along the urethra toward the proximal end of the catheter body, so that the auxiliary tube body sleeved on the outside of the urinary catheter body is gradually folded from the first end to the second end, so that the inner surface of the auxiliary tube body is turned toward the inside of the auxiliary tube body and away from the urethra, thereby removing the urinary catheter device from the patient's body.

[0031] It can be seen from the above technical solutions that the urinary catheter device, the delivery device, and the insertion and removal method of the urinary catheter device provided in the embodiments of the present application, by providing a first positioning structure at the distal end of the catheter body, so that the catheter body is positioned at the bladder neck of the patient by means of the first positioning structure, and the urinary catheter body is positioned in the urethra of the patient, thereby improving the positioning effect of the urinary catheter device and avoiding stimulation to the bladder wall.

[0032] Furthermore, the catheterization device, delivery device, and insertion and removal method of the catheterization device provided in the present application can avoid scratching the inner wall of the catheter due to the sliding of the catheter relative to the urethra, thereby protecting the patient's urethra from damage, by folding the catheter body and / or the auxiliary tube body to insert or remove the catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the embodiments of the present application. For ordinary technicians in this field, other drawings can also be obtained based on these drawings.

[0034] Figure 1 It is a schematic diagram of the main structure of the urinary catheterization device according to the first embodiment of the present application;

[0035] FIG. 2A to FIG. 2B A schematic diagram showing the effect of positioning the urinary catheter device in the patient's body;

[0036] Figure 3 and Figure 4 They are respectively different embodiment diagrams of the first positioning structure of the urinary catheterization device of the present application;

[0037] FIG. 5A to FIG. 5C This is a diagram showing an embodiment of the deformation of the first positioning structure of the urinary catheterization device of the present application;

[0038] FIG. 6A to FIG. 6B Different embodiments of the anti-torsion structure of the urinary catheter device of the present application;

[0039] 7A to 8B Different embodiments of the supporting structure of the urinary catheterization device of the present application;

[0040] 9A to 9D This is a schematic diagram of the main structure of a urinary catheterization device according to a second embodiment of the present application;

[0041] FIG. 10A to FIG. 10B This is a diagram of an embodiment of the conveying device of the present application;

[0042] FIG. 11A to FIG. 11B This is a schematic diagram of an embodiment of the first positioning structure of the present application that is deformed to separate from the bladder neck.

[0043] Component number

[0044] 1: urinary catheter device; 11: urinary catheter body; 1101: film layer; 1102: braided layer; 11a: outer surface (urinary catheter body); 110: urinary catheter passage; 111: distal end of the tube body; 112: proximal end of the tube body; 12: first positioning structure; 12a: positioning ring; 12b: positioning capsule; 13: first channel; 14: traction member; 15: second positioning structure; 15a: protective sleeve; 15b: elastic ring; 16: auxiliary tube body; 16b: inner surface (auxiliary tube body); 161: first end; 162: second end; 17: anti-torsion structure; 171: lining ribs; 18: supporting structure; 181: supporting unit; 181a: supporting ring; 181b: supporting sac; 182: second channel; 21: urethra; 22: bladder neck; 23: external urethral opening; 24: bladder; 31: hollow catheter; 32: urine bag; 4: foreign body clamp; 5: adjusting part; 6: delivery device; 61: distal end (delivery device). DETAILED DESCRIPTION

[0045] In order to enable those skilled in the art to better understand the technical solutions in the embodiments of the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments in the embodiments of the present application should fall within the scope of protection of the embodiments of the present application.

[0046] The specific implementation of the embodiment of the present application is further explained below in conjunction with the accompanying drawings of the embodiment of the present application.

[0047] First embodiment

[0048] The first embodiment of the present application provides a urinary catheterization device, such as Figure 1 As shown, the urinary catheter device 1 of this embodiment mainly includes a urinary catheter body 11 and a first positioning structure 12 .

[0049] In one embodiment, the urinary catheter body 11 is a slender tube made of a thin film, and has a urinary catheter passage 110 axially penetrating the urinary catheter body 11 for draining urine.

[0050] Optionally, the material of the film is a polymer material, such as a polyurethane material, but is not limited thereto, and other polymer materials may also be applicable to the present application.

[0051] Optionally, the surface of the film can be composed of a positively charged material or a negatively charged material, and the surface of the film has wettability. For example, the film can be made of a material containing a hydrophobic group (such as a polypropylene material), a highly hydrophilic material (such as polyacrylonitrile (PAN), polysulfone (PS), polyvinyl alcohol (PEG), glass material), etc.; the surface of the film can present a morphological feature composed of a series of protrusions and depressions of different heights and spacings (similar to the epidermis features of sharks and crabs).

[0052] Optionally, the surface of the catheter body 11 is also coated with a coating, which can play an antibacterial and lubricating role.

[0053] The thin film catheter body design can reduce the stimulation of the catheter body to the inner wall of the urethra, which is conducive to the discharge of urethral mucosal secretions, thereby effectively preventing the incidence of urinary tract retrograde infection. Furthermore, the thin film catheter body design can provide a larger catheterization path to facilitate the drainage of urine.

[0054] In another embodiment, the film constituting the urinary catheter body 11 includes multiple interlayers, and the material and / or hardness of each interlayer can be designed to be the same or different according to actual needs.

[0055] For example, the urinary catheter body 11 may be formed by stacking a plurality of film layers 1101, or by stacking a film layer 1101 and a woven layer 1102 (see Figure 7B The embodiment shown in the figure is used to strengthen the toughness of the catheter body 11 and adjust the hardness of the catheter body 11 in different sections to prevent the catheter body 11 placed in the urethra 21 from being compressed by external force, which may cause the catheter passage 110 to be bent or even closed.

[0056] The two opposite ends of the catheter body 11 are the distal end 111 and the proximal end 112 . In this embodiment, the distal end 111 is the end of the catheter body 11 that is farther away from the operator than the proximal end 112 .

[0057] The first positioning structure 12 is disposed at the distal end 111 of the catheter body 11, wherein the outer diameter of the catheter body 11 is smaller than the diameter of the urethra 21 and the outer diameter of the first positioning structure 12 is larger than the diameter of the urethra 21, so that the first positioning structure 12 is positioned at the bladder neck 22 and the catheter body 11 is positioned in the urethra 21 (please refer to Figure 2A and Figure 2B ).

[0058] Optionally, the first positioning structure 12 may be formed by folding or curling the distal end 111 of the urinary catheter body 11 .

[0059] Optionally, the first positioning structure 12 may be formed by a heat setting process or an impregnation molding process, but is not limited thereto. The first positioning structure 12 may also be formed by other known processes, and the present application does not impose any limitation thereto.

[0060] Optionally, the first positioning structure 12 may be a positioning ring (polymer ring) made of a polymer material, and may be fixed to the distal end 111 of the tube body by, for example, welding, bonding, or coating.

[0061] Optionally, the material of the first positioning structure 12 and the material of the urinary catheter body 11 may be the same or different.

[0062] Optionally, the outer periphery of the first positioning structure 12 may be covered with a film (not shown), the material of the film may be the same as the material used to constitute the urinary catheter body 11 , so as to reduce the stimulation of the first positioning structure 12 to the bladder neck 22 .

[0063] In one embodiment, the first positioning structure 12 may be a positioning ring 12a formed at the distal end 111 of the tube body. The first positioning structure 12 with a ring design can avoid the pointed design of the end of the catheter body in the prior art from irritating the inner wall of the bladder.

[0064] For example, the distal end 111 of the catheter body 11 may be crimped (see Figure 3) is processed to form a positioning ring 12a with an outer diameter slightly larger than the diameter of the urethra 21 at the distal end 111 of the tube body. The positioning ring 12a formed in this way has a certain elasticity, so that it is positioned at the patient's bladder neck 22. Furthermore, the positioning ring 12a can be deformed by an external force, so that the outer diameter of the positioning ring 12a is smaller than the diameter of the urethra 21, so that the urethra 21 can be removed from the patient's body (please describe in detail later).

[0065] In another embodiment, the first positioning structure 12 may also be a positioning capsule 12 b formed at the distal end 111 of the tube.

[0066] Optionally, the positioning capsule 12b may be in the form of an annular cavity.

[0067] Optionally, the positioning balloon 12 b may be formed by folding the distal end 111 of the urinary catheter body 11 .

[0068] Optionally, the positioning balloon 12 b can be attached (eg, adhered) to the distal end 111 of the urinary catheter body 11 by using a heat setting process.

[0069] Optionally, the material of the positioning balloon 12 b and the material of the urinary catheter body 11 may be the same or different.

[0070] Optionally, the urinary catheter device 1 further comprises a first channel 13 (such as Figure 4 As shown), it extends along the axial direction of the catheter body 11 and is connected to the positioning balloon 12b, wherein the first channel 13 can be used to infuse gas or liquid into the positioning balloon 12b to cause the positioning balloon 12b to expand and deform, or the first channel 13 can be used to extract the gas or liquid in the positioning balloon 12b to cause the positioning balloon 12b to contract and deform.

[0071] For example, a hollow catheter 31 can be inserted into the first channel 13 to infuse gas / liquid into the positioning balloon 12b through the hollow catheter 31 to expand the positioning balloon 12b, or the gas / liquid in the positioning balloon 12b can be extracted through the hollow catheter 31 to shrink the positioning balloon 12b, so that medical staff can adjust the volume of the positioning balloon 12b of the catheter body 11 in vitro according to the patient's condition.

[0072] In this embodiment, when the positioning balloon 12b is in an expanded state, the outer diameter of the positioning balloon 12b is larger than the diameter of the urethra 21, so that the positioning balloon 12b can be clamped in the patient's bladder neck 22, and the catheter body 11 can be positioned in the urethra 21; when the positioning balloon 12b is in a contracted state, the outer diameter of the positioning balloon 12b is smaller than the diameter of the urethra 21, so that the catheter device 1 can be removed from the patient's body.

[0073] Preferably, the first positioning structure 12 can be deformed to enter the catheter passage 110, and the catheter body 11 can be gradually folded from the distal end 111 to the proximal end 112, so that the outer surface of the catheter body 11 facing the urethra 21 is turned toward the inside of the catheter body 11 and away from the urethra 21.

[0074] Specifically, the first positioning structure 12 can be deformed by external force and can be moved from the outside of the urinary catheter passage 110 (refer to Figure 5A The state) enters the interior of the urinary catheterization passage 110 (reference Figure 5B In this state, the first positioning structure 12 can be further moved along the catheter passage 1100 toward the proximal end 112 of the tube body by external force, so that the catheter body 11 is gradually folded from the distal end 111 of the tube body toward the proximal end 112 of the tube body, and the outer surface 11a of the catheter body 11 facing the urethra 21 is turned inside the catheter body 11 and gradually separated from the urethra 21, thereby providing the catheter device 1 for removal from the patient's body.

[0075] Thus, the urinary catheter device provided in this embodiment can be removed from the patient's body by folding the urinary catheter body, thereby preventing the urinary catheter body from sliding relative to the urethra and scratching the inner wall of the urethra.

[0076] Optionally, when the urinary catheter device 1 needs to be removed from the patient's body, the foreign body clamp 4 can be inserted into the urinary catheter passage 110 of the urinary catheter body 11 and extended from the distal end 111 of the catheter body to hook the first positioning structure 12 clamped on the bladder neck 22, and a force is applied to the first positioning structure 12 to deform it. As the foreign body clamp 4 enters the urinary catheter passage 110, the foreign body clamp 4 is further dragged to make the first positioning structure 12 continue to move along the urinary catheter passage 110 toward the proximal end 112 of the catheter body (refer to Figure 5A and Figure 5B ), thereby driving the catheter body 11 to gradually fold from the distal end 111 to the proximal end 112 of the catheter body.

[0077] Optionally, the urinary catheter device 1 may further include a traction member 14 extending along the axial direction of the urinary catheter body 11 and connected to the first positioning structure 12 , and a force may be applied to the first positioning structure 12 via the traction member 14 to deform the first positioning structure 12 .

[0078] like Figure 5CAs shown, in this embodiment, the traction member 14 can be designed as a string, which is inserted into the urinary catheter passage 110 of the urinary catheter body 11, wherein one end of the traction member 14 extends from the distal end 111 of the tube body and is connected to the first positioning structure 12, and the other end of the traction member 14 extends from the proximal end 112 of the tube body. When the urinary catheter device 1 needs to be removed from the patient's body, a force can be applied to the traction member 14 along the F1 direction, so that the first positioning structure 12 is deformed under the action of the traction member 14 and enters the urinary catheter passage 110, and continues to move along the urinary catheter passage 1100 toward the proximal end 112 of the tube body with the traction member 14, so as to drive the urinary catheter body 11 to gradually fold from the distal end 111 of the tube body to the proximal end 112 of the tube body. Furthermore, this embodiment has the advantages of good structural flexibility and small structural volume, simple structural design, and low manufacturing cost, etc. by using the traction member 14 designed as a string.

[0079] Optionally, the urinary catheter device 1 further comprises a second positioning structure 15 , which can respectively connect the urinary catheter body 11 and the external urethral opening 23 , so as to position the urinary catheter body 11 relative to the external urethral opening 23 .

[0080] Specifically, after the catheter body 11 is inserted into the patient's urethra 21, the first positioning structure 12 that is clamped on the patient's bladder neck 22 and the second positioning structure 15 that provides positioning for the catheter body 11 relative to the urethral external opening 23 can effectively prevent the middle section of the catheter body 11 located between the first positioning structure 12 and the second positioning structure 15 from being displaced relative to the urethra 21. This design not only provides a good positioning effect, but also prevents bacteria from invading the patient's bladder 24 through the urethral external opening 23.

[0081] For example, the second positioning structure 15 may be a protective cover 15a (such as Figure 2A As shown), after the catheter body 11 is inserted into the urethra 21, a force can be applied to the protective cover 15a so that the protective cover 15a is positioned at the patient's urethral opening 23 by electrostatic adsorption / adhesion, thereby providing positioning of the catheter body 11 relative to the urethral opening 23.

[0082] For another example, the second positioning structure 15 may also be an elastic ring 15b (such as Figure 2B As shown), the elastic ring 15b is made of a flexible material and can be positioned at the external urethral opening 23.

[0083] Furthermore, the proximal end 112 of the urinary catheter body 11 can extend from the external urethral opening 23 and be connected to the urine bag 32 .

[0084] In another embodiment, the urinary catheter device 1 further includes an anti-torsion structure 17 (see Figure 1), which is arranged on the side wall of the catheter body 11 along the axial direction of the catheter body 11 to prevent the catheter body 11 from twisting and deforming, thereby causing the internal catheter passage 110 to be narrowed or blocked.

[0085] like Fig. 6A As shown, in one embodiment, when the catheter body 11 of this embodiment is made of a film, the anti-torsion structure 17 can be the overlapping joint edge (i.e. the overlapping joint of two layers of film) formed when the film is rolled from a flat state to a tube state.

[0086] In another embodiment, the anti-torsion structure 17 may further include an inner lining rib 171 disposed at the overlapping edge, thereby increasing the anti-torsion effect of the catheter body 11. The inner lining rib 171 may be sandwiched between two layers of film (i.e. Figure 6B State shown) or arranged on the outside of the overlapping joint edge.

[0087] Please continue to refer to 7A to 7C In another embodiment, the urinary catheter device 1 further comprises a support structure 18 disposed around the urinary catheter body 11, wherein when the urinary catheter body 11 is positioned in the urethra 21, the support structure 18 can be used to provide support force for a designated portion of the urethra 21, for example, by opening the prostate urethral sphincter of the patient (refer to Figure 7C ) so that urine can flow out naturally. By means of the design of the above-mentioned support structure 18, the present embodiment can adjust the support force provided by the catheter body 11 for the prostate according to the actual needs of the patient (e.g., voluntary urination control, passive urination). In addition, the support structure 18 can also be used to compress the prostate to stop bleeding in patients after prostatectomy.

[0088] In this embodiment, the support structure 18 includes at least one support unit 181 , and the strength of the support force provided by the support structure 18 can be adjusted by adjusting the size of the support unit 181 and / or the spacing between the support units 181 .

[0089] In this embodiment, each supporting unit 181 includes one of a supporting ring 181 a and a supporting capsule 181 b .

[0090] For example, the support structure 18 may be composed of at least one support capsule 181b (see Figure 7B ), by adjusting the expansion size of each supporting capsule 181b, the strength of the supporting force provided by the supporting structure 18 can be adjusted, wherein, when the expansion size of each supporting capsule 181b is larger, the strength of the supporting force provided by the supporting structure 18 is larger, and conversely, when the expansion size of each supporting capsule 181b is smaller, the strength of the supporting force provided by the supporting structure 18 is smaller.

[0091] In addition, corresponding to the design of the above-mentioned support sac 181b, the urinary catheter device 1 of this embodiment also includes a second channel 182, which extends along the axial direction of the catheter body 11 and is connected to the support sac 181b. The second channel 182 is used to infuse gas or liquid into the support sac 181b to cause the support sac 181b to expand and deform, or the second channel 182 is used to extract gas or liquid in the support sac 181b to cause the support sac 181b to contract and deform.

[0092] Optionally, the first channel 13 communicating with the positioning capsule 12b and the second channel 182 communicating with the supporting capsule 181b may be disposed on opposite sides of the urinary catheter body 11 (eg, Fig.7D As shown), but not limited to this, the first channel 13 and the second channel 182 can also be arranged on the same side of the catheter body 11 (refer to Figure 7B ), this application does not limit this.

[0093] For another example, the support structure 18 may also be composed of a plurality of support rings 181a, wherein when the spacing between the support rings 181a is zero, the support structure 18 forms a support tube; when the spacing between the support rings 181a is greater than zero, the support structure 18 forms a bellows, similar to the structure of a straw or a woven net (see Fig. 8A and Figure 8B ), and the strength of the supporting force provided by the supporting structure 18 can be adjusted by adjusting the spacing between two adjacent supporting rings.

[0094] Preferably, an adjusting member 5 connected to the support structure 18 can be further provided, and the spacing distance between two adjacent support rings 181a can be adjusted by moving the adjusting member 5 axially relative to the catheter body 11. The larger the spacing distance between two adjacent support rings 181a, the smaller the strength of the support force provided by the support structure 18 (refer to Fig. 8A ), when the distance between two adjacent support rings 181a is smaller, the strength of the support force provided by the support structure 18 is greater (refer to Figure 8B ).

[0095] The design of the support structure 18 can help patients train their autonomous urination function. Specifically, when the support structure 18 supports the patient's prostate urethra, the patient urinates passively. When the patient needs to train his autonomous urination function, the liquid or gas in the support bladder 181b can be evacuated so that when urine is discharged from the urethra through the bladder, the prostate is stimulated to generate a nerve reflex, thereby establishing an autonomous urination reflex to accelerate the patient's recovery.

[0096] Second embodiment

[0097] The second embodiment of the present application provides a urinary catheterization device 1 . The main structure of the urinary catheterization device 1 of this embodiment is basically the same as that of the urinary catheterization device 1 of the first embodiment. The difference is that the urinary catheterization device 1 of this embodiment further includes an auxiliary tube 16 .

[0098] like 9A to 9D As shown, the auxiliary tube 16 further extends from the distal end 111 of the tube along the axial direction of the urinary catheter body 11 and communicates with the urinary catheter passage 110 .

[0099] In this embodiment, the auxiliary tube body 16 has a first end 161 connected to the tube body distal end 111 and a second end 162 away from the tube body distal end 111. The auxiliary tube body 16 can be gradually folded from the second end 162 to the first end 161, so that the inner surface 16b of the auxiliary tube body 16 is turned toward the outside of the auxiliary tube body 16 and faces the inner wall of the urethra 21.

[0100] Specifically, when the urinary catheter device 1 is to be placed in a patient's body, the second end 162 of the auxiliary tube 16 can be positioned at the patient's urethral opening 23 (see Fig. 9C ), and then the auxiliary tube body 16 is gradually folded from the second end 162 to the first end 161 to enter the patient's urethra 21, and extends along the urethra 21 toward the bladder 24. At the same time, the inner surface 16b of the auxiliary tube body 16 is turned toward the outside of the auxiliary tube body 16 and faces the inner wall of the urethra 21 (refer to Fig.9D ), thereby providing the first positioning structure 12 of the catheterization device 1 to be positioned at the bladder neck 22 of the patient and the catheter body 11 to be positioned in the urethra 21 of the patient.

[0101] Thus, the urinary catheter device of the second embodiment of the present application can be inserted into the patient's body by folding the auxiliary tube body 16 to prevent the urinary catheter body 11 from sliding relative to the urethra 21 and scratching the inner wall of the urethra 21. At the same time, since the sterile inner surface of the auxiliary tube body is in actual contact with the patient's urethra, the risk of infection can be further reduced.

[0102] Third embodiment

[0103] The third embodiment of the present application provides a delivery device 6, which is used to insert the catheter device 1 of the first embodiment or the second embodiment into the patient's body, so that the first positioning structure 12 of the catheter device 1 is positioned at the bladder neck and the catheter body 11 is positioned in the urethra.

[0104] In this embodiment, the delivery device 6 is a delivery sheath tube 6 , and the outer diameter of the delivery sheath tube 6 is smaller than the diameter of the urethra.

[0105] In one embodiment, when the delivery device 6 is used to insert the catheter device 1 described in the first embodiment into the patient's body, the catheter device 1 can be inserted into the delivery sheath 6 as a whole, and the first positioning structure 12 of the catheter device 1 can be delivered to the patient's bladder 24 through the patient's urethra by the delivery sheath 6. Then, the proximal end 112 of the catheter body 11 is pressed against and the delivery sheath 6 is withdrawn, so that the first positioning structure 12 located at the distal end 111 of the catheter body extends from the distal end 61 of the delivery sheath 6 under the support of the anti-torsion structure 17 and is exposed in the bladder 24, and the delivery sheath 6 is continued to be withdrawn so that the delivery sheath 6 is completely withdrawn from the patient's body, and the proximal end 112 of the catheter body 11 is pulled so that the first positioning structure 12 is stuck in the patient's bladder neck 22, thereby providing the catheter body 11 with a positioning in the patient's urethra 21 (refer to Fig. 10A , Fig. 10B , Figure 2A , Figure 2B ).

[0106] Furthermore, for patients with urethral stenosis, when the catheter body 11 is inserted into the patient's body, a guide wire or imaging device can be set inside the catheter body 11 (for example, the catheterization passage 110) to assist in guiding the delivery sheath 6 into the patient's urethra, and the delivery sheath 6 can be used to expand the narrow part of the urethra, thereby solving the problem of difficulty in catheterization caused by urethral stenosis and other reasons.

[0107] In another embodiment, when the delivery device 6 is used to place the urinary catheter device 1 described in the second embodiment into the patient's body, the urinary catheter device 1 can be inserted into the delivery sheath 6 and the second end 162 of the auxiliary tube 16 is exposed, and the exposed second end 162 is positioned at the patient's urethral opening 23 (refer to Fig. 9C ), and then push the delivery sheath 6 into the patient's urethra 21, so that the second end 162 of the auxiliary tube body 16 is folded under the pushing action of the delivery sheath 6 and enters the patient's urethra 21, and continuously extends along the urethra 21 toward the bladder 24. In this state, the inner surface 16b of the auxiliary tube body 16 is gradually folded outward from the second end 162 toward the first end 161 and faces the inner wall of the urethra 21 (refer to Fig.9D ) until the first positioning structure 12 of the catheter device 1 is delivered to the patient's bladder 24, then the delivery sheath 6 is withdrawn to allow the first positioning structure 12 to extend from the distal end 61 of the delivery sheath 6, and the delivery sheath 6 is continued to be withdrawn so that the delivery sheath 6 is completely withdrawn from the patient's body, and the first positioning structure 12 is clamped on the patient's bladder neck 22 by pulling the proximal end 112 of the catheter body 11, thereby providing the catheter body 11 with positioning in the patient's urethra 21.

[0108] In this embodiment, when the urinary catheter device 1 is positioned in the patient's body, the folded auxiliary tube 16 is sleeved on the outside of the urinary catheter body 11 to form a double-layer film structure, and the first positioning structure 12 is sandwiched between the auxiliary tube 16 and the urinary catheter body 11 .

[0109] Furthermore, when the urinary catheterization device 1 needs to be removed from the patient's body, the first positioning structure 12 can be subjected to force and deformed, so that the outer diameter of the first positioning structure 12 is smaller than the diameter of the urethra 21, so as to release the state in which the first positioning structure 12 is stuck in the bladder neck 22 and enter the patient's urethra 21. By allowing the first positioning structure 12 to continue to move along the patient's urethra 21 toward the urethral external opening 23, the auxiliary tube body 16 is folded again from the first end 161 toward the second end 162, so that the inner surface 16b of the auxiliary tube body 16 is flipped to the inside of the auxiliary tube body 16 and away from the inner wall of the urethra 21, so that the urinary catheterization device 1 can be removed from the patient's body as a whole.

[0110] Fourth embodiment

[0111] The fourth embodiment of the present application provides a method for removing a urinary catheter device, which is used for the urinary catheter device described in the first embodiment. FIG. 5A to FIG. 5B The method of this embodiment mainly includes the following steps:

[0112] The first positioning structure 12 is deformed by an external force to enter the urinary catheter passage 110 of the urinary catheter body 11;

[0113] The first positioning structure 12 is forced to continue to move along the catheter passage 110 toward the proximal end 112 of the catheter body 11, so that the catheter body 11 is gradually folded from the distal end 111 to the proximal end 112, so that the outer surface 11a of the catheter body 11 is turned toward the inside of the catheter body 11 and separated from the inner wall of the urethra, thereby removing the catheter device 1 from the patient's body.

[0114] The fifth embodiment of the present application provides a method for inserting and removing a urinary catheterization device, which is applied to the urinary catheterization device described in the second embodiment. The method of this embodiment mainly includes the following steps:

[0115] Please refer to Fig. 9C and Fig.9D When the urinary catheter device 1 is to be placed in the patient's body, the second end 162 of the auxiliary tube body 16 is positioned at the patient's urethral external opening 23, and the auxiliary tube body 16 is gradually folded from the second end 161 toward the first end 162, so that the inner surface 16b of the auxiliary tube body 16 is turned toward the outside of the auxiliary tube body 16 and faces the patient's urethra 21, until the first positioning structure 12 is positioned at the patient's bladder neck 22, and the urinary catheter body 11 is positioned in the patient's urethra 21 (refer to Figure 2A and Figure 2B status shown).

[0116] When the urinary catheter device needs to be removed from the patient's body, the first positioning structure 12 is deformed by force so that the outer diameter of the first positioning structure 12 is smaller than the diameter of the urethra 21, so that the first positioning structure 12 is separated from the bladder neck 22 and enters the urethra 21 (refer to Fig.11A and Fig. 11B The auxiliary tube 16 is gradually folded from the first end 161 to the second end 162, so that the inner surface 16b of the auxiliary tube 16 is turned toward the inside of the auxiliary tube 16 and separated from the inner wall of the urethra 21, thereby removing the urinary catheter device 1 from the patient's body.

[0117] In summary, the catheterization device, delivery device, and insertion and removal method of the catheterization device provided in the embodiments of the present application, by setting a first positioning structure to be positioned at the patient's bladder neck, can not only ensure the positioning effect of the catheterization device in the patient's body, but also reduce the stimulation to the patient's bladder wall.

[0118] Furthermore, the present application inserts the urinary catheter device into the patient's body or removes the urinary catheter device from the patient's body by folding, which can avoid the problem of the urinary catheter device sliding relative to the urethra and causing scratches on the inner wall mucosa of the urethra.

[0119] In addition, by providing a support structure on the catheter body, effective support can be provided for the patient's prostate to enable the patient to complete passive urination. At the same time, the support force provided by the support structure of the present application can be adjusted as needed to help the patient train the autonomous urination function.

[0120] In addition, the catheter body made of thin film material has the advantages of being softer and having a larger diameter of the catheter passage with the same outer diameter. It can not only reduce the stimulation of the catheter body to the inner wall of the urethra, but also facilitate the discharge of urethral mucosal secretions, and effectively prevent the incidence of retrograde urinary tract infection.

[0121] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of the present application, rather than to limit them. Although the present application has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. A urinary catheterization device, characterized in that, it comprises: a urinary catheter body having a urinary catheterization passage axially penetrating the urinary catheter body; and a first positioning structure provided at the distal end of the catheter body; wherein, the outer diameter of the urinary catheter body is smaller than the inner diameter of the urethra and the outer diameter of the first positioning structure is larger than the inner diameter of the urethra, so that the first positioning structure is positioned at the bladder neck opening and the urinary catheter body is positioned in the urethra; the first positioning structure can be deformed so that the outer diameter of the first positioning structure is smaller than the inner diameter of the urethra: and wherein, the urinary catheterization device further comprises an auxiliary tube body which further extends axially along the urinary catheter body from the distal end of the urinary catheter body, and the auxiliary tube body has a first end connecting the distal end of the urinary catheter body and a second end away from the distal end of the urinary catheter body; wherein, the auxiliary tube body can be gradually folded from the second end towards the first end, so that the inner surface of the auxiliary tube body is turned towards the outside of the auxiliary tube body and faces the urethra, and the folded auxiliary tube body is sleeved outside the urinary catheter body; the auxiliary tube body sleeved outside the urinary catheter body can be gradually folded from the first end towards the second end, so that the inner surface facing the urethra is turned towards the inside of the auxiliary tube body to deviate from the urethra.

2. The urinary catheterization device according to claim 1, characterized in that, the urinary catheter body is an elongated tube body made of a thin film.

3. The urinary catheterization device according to claim 2, characterized in that, the thin film comprises multiple layers of interlayers, and the materials and / or hardness of each interlayer are different.

4. The urinary catheterization device according to claim 2, characterized in that, the first positioning structure is formed by folding or curling the distal end of the urinary catheter body.

5. The urinary catheterization device according to claim 1, characterized in that, the surface of the urinary catheter body is coated.

6. The urinary catheterization device according to claim 1, characterized in that, the first positioning structure is formed at the distal end of the urinary catheter body by using a heat setting process or an impregnation molding process.

7. The urinary catheterization device according to claim 1, characterized in that, the first positioning structure is a positioning ring made of a polymer material and is fixed to the distal end of the urinary catheter body by welding, bonding, or covering.

8. The urinary catheterization device according to claim 1, characterized in that, the first positioning structure is a positioning bladder provided at the distal end of the urinary catheter body; and wherein, the urinary catheterization device further comprises a first channel which extends axially along the urinary catheter body and communicates with the positioning bladder, and the first channel is used for perfusing gas or liquid into the positioning bladder to cause the positioning bladder to generate an expansion deformation, or the first channel is used for pumping out the gas or liquid in the positioning bladder to cause the positioning bladder to generate a contraction deformation.

9. The urinary catheterization device according to claim 1, characterized in that, the first positioning structure can be deformed to enter the urinary catheterization passage; and wherein, the urinary catheter body can be gradually folded from the distal end of the urinary catheter body towards the proximal end of the catheter body, so that the outer surface of the urinary catheter body facing the urethra is turned towards the inside of the urinary catheter body to deviate from the urethra.

10. The urinary catheterization device according to claim 1 or 9, characterized in that, the urinary catheterization device further includes a traction member, which extends along the axial direction of the catheter body and is connected to the first positioning structure, and a force can be applied to the first positioning structure via the traction member to cause the first positioning structure to generate the deformation.

11. The urinary catheterization device according to claim 1, characterized in that, the urinary catheterization device further includes a second positioning structure, which is respectively connected to the catheter body and the external urethral orifice to position the catheter body relative to the external urethral orifice.

12. The urinary catheterization device according to claim 1, characterized in that, the urinary catheterization device further includes an anti-torsion structure, which is arranged on the side wall of the catheter body along the axial direction of the catheter body to prevent the catheter body from being torsionally deformed.

13. The urinary catheterization device according to claim 1, characterized in that, the urinary catheterization device further includes a support structure looped around the catheter body for providing a supporting force to a designated part of the urethra.

14. The urinary catheterization device according to claim 13, characterized in that, the support structure includes at least one support unit, and the strength of the supporting force of the support structure is adjusted by adjusting the size of the support unit and / or the interval distance between the support units.

15. The urinary catheterization device according to claim 14, characterized in that, the support unit includes one of a support ring and a support bladder.

16. A delivery device, characterized in that, the delivery device is used to place the urinary catheterization device according to any one of claims 1 to 15 into a patient's body, so that the first positioning structure of the urinary catheterization device is positioned at the bladder neck, and the catheter body is positioned in the urethra.

17. The delivery device according to claim 16, characterized in that, the delivery device includes a delivery sheath.

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