WO2023090810A1

WO2023090810A1 - Autologous urinary suprapubic bladder fistula catheter

Info

Publication number: WO2023090810A1
Application number: PCT/KR2022/017974
Authority: WO
Inventors: 최훈; 김재영
Original assignee: 고려대학교 산학협력단
Priority date: 2021-11-19
Filing date: 2022-11-15
Publication date: 2023-05-25
Also published as: KR20230073558A

Abstract

Disclosed is an autologous urinary suprapubic bladder fistula catheter capable of performing intermittent catheterization without the need for an external urine bag and preventing leakage of urine. The autologous urinary suprapubic bladder fistula catheter according to an embodiment of the present invention can be inserted into the suprapubic bladder fistula through the abdomen and can be placed in the suprapubic bladder fistula for autologous catheterization, the autologous urinary suprapubic bladder fistula catheter comprising: a tubular sleeve that has a urinary drainage passage for draining urine from the suprapubic bladder fistula; a sleeve cover that is formed to surround the sleeve and has a plurality of fixing wings for fixing the autologous urinary suprapubic bladder fistula catheter to the suprapubic bladder fistula; a control cap that moves the sleeve relative to the sleeve cover and operates to expand or fold the plurality of fixing wings so as to protrude from the sleeve; and a drain cover that opens and closes an end of the sleeve to block or open the urinary drainage passage of the sleeve.

Description

Autologous catheterization suprapubic bladder fistula catheter

The present invention relates to a self catheterization suprapubic bladder fistula catheter, and more particularly, to a self catheter suprapubic bladder fistula catheter that enables intermittent catheterization to be performed without requiring an external urine bag.

Representative management methods for patients with inability to urinate who have difficulty urinating include transurethral catheter indwelling, intermittent catheterization, and suprapubic cystostomy. Since transurethral catheter indwelling has a high incidence of urethral damage and urinary tract infection, long-term indwelling is rarely performed at present. Intermittent catheterization has the advantage of preventing bladder stones, upper urinary tract abnormalities, and vesicoureteral reflux compared to suprapubic cystocele. However, many patients have problems such as lack of independence and difficulties in education and management. There is also a risk of complications such as urethral stricture.

The suprapubic bladder fistula is relatively easy to treat, easy to care for and manage, and the treatment effect is excellent, so the satisfaction rate is high. In addition, under the condition that possible complications are effectively prevented through periodic urinary system examination, it is usefully used as a treatment for patients with low activities of daily living, such as elderly patients, quadriplegic patients, patients with severe urethral damage, or patients with chronic diseases. there is. However, after the suprapubic cystostomy procedure, the patient has to carry a urine bag all the time, which is inconvenient for movement, and there may be a problem in that body fluid is discharged through the urine bag connector, so intermittent transurethral catheterization can be applied. Patients tend to prefer intermittent transurethral catheterization.

Nevertheless, intermittent catheterization through the urethra cannot be applied when manual operation is impossible due to quadriplegia, etc., and nursing personnel are often required. In addition, the pain during catheterization is high, the risk of infection is high, and the frequency of implementation is not high due to aversion to catheterization. Conventionally, there is no technology capable of performing intermittent catheterization through a suprapubic bladder fistula while resolving the disadvantages of the suprapubic bladder fistula.

[Prior art literature]

(Patent Document 1) KR 10-1844670 B1 (2018.05.14. Notice)

An object of the present invention is to provide a self-catheter suprapubic bladder fistula catheter capable of performing intermittent catheterization without requiring an external urine bag and preventing leakage of urine.

The self catheter suprapubic bladder fistula catheter according to an embodiment of the present invention is provided to be inserted into the suprapubic bladder fistula by penetrating the abdomen, and can be placed in the suprapubic bladder fistula for self catheterization. A catheter comprising: a tubular sleeve having a urine discharge passage for discharging urine in a suprapubic bladder fistula; a sleeve cover formed to surround the sleeve and having a plurality of fixing wings for fixing the self catheter suprapubic catheter to the suprapubic bladder fistula; a control cap that moves the sleeve relative to the sleeve cover and operates to expand or fold the plurality of stator blades so as to protrude from the sleeve; and a drain cover opening and closing an end of the sleeve to block or open the urine discharge passage of the sleeve.

The self catheter suprapubic bladder fistula catheter according to an embodiment of the present invention includes: a stopper that is made of a flexible material and coupled to surround the periphery of the sleeve cover and adheres to the abdominal wall to fix the self catheter suprapubic bladder fistula catheter so as not to move ; may be further included.

The self catheterization suprapubic bladder fistula catheter according to an embodiment of the present invention includes: a clamp detachably coupled to the stopper in a state in which the stopper is in close contact with the abdominal wall or detachably coupled between the stopper and the control cap to clamp the stopper device; may further include.

The stopper may include a fixing part that is in close contact with the periphery of the sleeve cover by the clamp device, and a close contact part that extends downward from the fixing part in a dome shape and is in close contact with the abdominal wall.

The self-catheter suprapubic bladder fistula catheter according to an embodiment of the present invention may further include: a check valve inserted into and assembled inside the sleeve to prevent backflow of urine.

The sleeve may be configured to be screwed with the control cap and move along the longitudinal direction of the sleeve cover with respect to the sleeve cover in conjunction with rotation of the control cap.

A ring-shaped locking protrusion protruding toward the inside of the sleeve cover may be formed at a lower end of the sleeve cover, and a locking groove may be formed along an outer circumference of the sleeve so that the locking protrusion is coupled to one side of the sleeve.

The sleeve cover may have a cutout formed between the plurality of fixed blades along the longitudinal direction.

When the control cap is rotated in the first direction, the locking protrusion of the sleeve cover is pushed up by the locking groove of the sleeve, and the plurality of fixed wings made of a flexible material are spread, and the control cap is opposite to the first direction. When rotated in the second direction, the locking protrusion of the sleeve cover is lowered by the locking groove of the sleeve, so that the plurality of stator blades may be folded.

The self catheter suprapubic bladder catheter according to an embodiment of the present invention further includes: a self catheter that is inserted into the urine discharge passage of the sleeve in a state in which the drain cover is open during urination to smoothly discharge urine. can include

According to an embodiment of the present invention, there is provided a self-catheter suprapubic bladder fistula catheter capable of performing intermittent catheterization without requiring an external urine bag and preventing leakage of urine.

1 is a view showing a state of use of a self-catheter suprapubic bladder fistula catheter according to an embodiment of the present invention.

2 is a front view of a self-catheterizing suprapubic bladder fistula catheter according to an embodiment of the present invention.

3 is a cross-sectional view of a self-catheter suprapubic bladder fistula catheter according to an embodiment of the present invention.

FIG. 4 is an enlarged view of part 'A' of FIG. 3 .

5 and 6 are diagrams for explaining a method of operating the self-catheter suprapubic bladder fistula catheter according to an embodiment of the present invention.

7 is a perspective view of a check valve constituting a self-catheter suprapubic bladder fistula catheter according to an embodiment of the present invention.

8 and 9 are cross-sectional views for explaining the operation of the check valve constituting the self-catheter suprapubic cystostomy catheter according to an embodiment of the present invention.

Hereinafter, with reference to the accompanying drawings, embodiments of the present invention will be described in detail so that those skilled in the art can easily carry out the present invention. However, the present invention may be embodied in many different forms and is not limited to the embodiments described herein. In order to clearly describe the present invention in the drawings, parts irrelevant to the description are omitted, and similar reference numerals are attached to similar parts throughout the specification. In this specification, detailed descriptions of well-known functions and configurations that may obscure the subject matter of the present invention will be omitted.

1 is a view showing a state of use of a self-catheter suprapubic bladder fistula catheter according to an embodiment of the present invention. Referring to FIG. 1 , the suprapubic bladder fistula catheter 100 for self catheterization according to an embodiment of the present invention can pass through the user's abdomen and be inserted into the suprapubic bladder fistula 10 for self catheterization.

2 is a front view of a self-catheterizing suprapubic bladder fistula catheter according to an embodiment of the present invention. 3 is a cross-sectional view of a self-catheter suprapubic bladder fistula catheter according to an embodiment of the present invention. FIG. 4 is an enlarged view of part 'A' of FIG. 3 . 5 and 6 are diagrams for explaining a method of operating the self-catheter suprapubic bladder fistula catheter according to an embodiment of the present invention.

1 to 6, the self catheterization suprapubic bladder fistula catheter 100 according to an embodiment of the present invention includes a tubular sleeve 110, a sleeve cover 120, a stopper 130, and a clamp device 140. ), a control cap 150, a drain cover 160 and a check valve 170.

The sleeve 110 may be formed of a sleeve tube 111 made of a substantially cylindrical tube. The sleeve tube 111 may have a urine discharge passage 111a for discharging urine in the suprapubic bladder fistula. The sleeve tube 111 may be provided with a length of approximately 5 cm to 20 cm considering the average distance between the abdominal wall and the suprapubic bladder fistula.

In a state in which the self-catheterization suprapubic bladder fistula catheter 100 is implanted in the human body, the inlet 112 of the sleeve tube 111 is positioned within the suprapubic bladder fistula 10 . Accordingly, when the user urinates, urine in the suprapubic bladder fistula 10 flows into the inlet 112 of the sleeve tube 111 and can be discharged to the outside through the urine discharge passage 111a.

The sleeve cover 120 may include a sleeve cover tube 121 formed to surround the sleeve 110 . The sleeve cover 120 may have a plurality of fixing wings 123 for fixing the suprapubic catheter 100 for self catheterization to the suprapubic bladder fistula 10 . Each fixed wing 123 is made of a flexible material and can be unfolded or folded so as to protrude from the sleeve 110 according to the rotational motion of the control cap 150 . The fixed wing 123 serves to support the catheter so that it does not come out of the bladder fistula when the suprapubic bladder fistula catheter 100 is placed.

The control cap 150 may be provided at an outer end region of the sleeve 110 to be located outside the abdominal wall in a state where the self catheterization suprapubic bladder fistula catheter 100 is inserted into the human body. The control cap 150 may move the sleeve 110 relative to the sleeve cover 120 to operate the plurality of fixed wings 123 to extend or fold so as to protrude from the sleeve 110 .

The sleeve 110 is screwed together with the control cap 150 to interlock with the rotation of the control cap 150 relative to the sleeve cover 120 in the longitudinal direction of the sleeve cover 120 (based on the drawings in FIGS. 2 and 3 ). Up and down direction) may be configured to move along. That is, a first threaded portion 115 is provided on the outer circumferential surface of the outer end of the sleeve 110, and a second threaded portion 151 screwed with the first threaded portion 115 of the sleeve 110 on the inner surface of the control cap 150. ) can be provided.

As the sleeve 110 moves up and down with respect to the sleeve cover 120, the plurality of fixed wings 123 of the sleeve cover 120 may be folded or unfolded. In order to allow the fixed wing 123 to be folded or unfolded by the control cap 150, a sleeve cover positioned within the suprapubic bladder unit 10 in a state in which the self catheterization suprapubic bladder catheter 100 is operated on the human body. A ring-shaped locking protrusion 122 protruding toward the inside of the sleeve cover 120 may be formed at the lower end of the 120 .

In addition, in the state where the self catheterization suprapubic bladder fistula catheter 100 is operated on the human body, the protrusion 122 of the sleeve cover 120 is located on the bladder fistula side area of the sleeve tube 111 located in the suprapubic bladder unit 10. ) Along the outer periphery of the sleeve 110 to be coupled, the locking groove 113 may be formed in a shape corresponding to the locking protrusion 122.

The sleeve cover tube 121 has a cutout 124 formed between the plurality of fixed blades 123 along the longitudinal direction of the sleeve cover 120 so that the plurality of fixed blades 123 can be smoothly unfolded or folded. can The cutout 124 may be formed in the shape of a long hole, and may have a structure in which a cutout area in the middle of the long hole, which is an area where the stator blades 123 are folded, is expanded in a convex shape.

Guide grooves (not shown) may be formed on the outer circumferential surface of the sleeve 110 in the vertical direction so that the sleeve 110 can move in the vertical direction when the control cap 150 rotates. A guide protrusion (not shown) formed on the inner diameter of the control cap 150 or the sleeve cover 120 is coupled to the guide groove of the sleeve 110, and thus the sleeve 110 rotates the control cap 150. It can be moved in the longitudinal direction with respect to the sleeve cover 120 at the time.

A flange may be formed at an upper end of the sleeve cover 120 . The control cap 150 may be disposed between the flange of the sleeve cover 120 and the drain cover 160 . Accordingly, the upper position of the sleeve cover 120 is fixed by the drain cover 160 and the control cap 150, and as its lower end is lifted or pushed down by the sleeve 110, the fixed wing 123 moves. unfold or fold

When the control cap 150 is rotated in the first direction (eg, clockwise), the protrusion 122 of the sleeve cover 120 is caused by the step 114, which is the lower surface of the engaging groove 113 of the sleeve 110. ) is pushed up so that the plurality of fixed wings 123 made of a flexible material can protrude from the sleeve 110.

When the control cap 150 is rotated in a second direction opposite to the first direction (eg, counterclockwise), the locking protrusion 122 of the sleeve cover 120 is caused by the locking groove 113 of the sleeve 110. ) is lowered, and accordingly, the plurality of fixed wings 123 protruding can be folded toward the sleeve 110.

The width (width) and protruding height of the fixed wing 123 of the sleeve cover 120 that is unfolded or folded with respect to the sleeve 110 is the shape of the cutout 124 formed in the sleeve cover tube 121 (upper and lower length of the cutout) and can be adjusted according to the width (width).

The stopper 130 may be made of a flexible material and coupled to surround the periphery of the sleeve cover 120 . The stopper 130 is disposed below the control cap 150 and adheres to the abdominal wall, thereby serving to fix the self catheterization suprapubic cystostomy catheter 100 so as not to move.

The clamp device 140 is detachably coupled to the stopper 130 while the stopper 130 is in close contact with the abdominal wall, or detachably coupled between the stopper 130 and the control cap 150 to clamp the stopper 130 can In the illustrated example, the clamp device 140 is formed in the form of an elastic ring and is configured to clamp the upper region of the stopper 130 . Friction protrusions may be formed on the inner surface of the ring of the clamp device 140 to increase frictional force with the stopper 130 .

The stopper 130 is a fixing part 132 that is in close contact with the periphery of the sleeve cover 120 by the clamp device 140, and a close contact part 131 that extends downward from the fixing part 132 in a dome shape and is in close contact with the abdominal wall , It may include a circular protruding ring portion 133 formed on the top of the fixing portion 132 to prevent the separation of the clamp device 140.

The drain cover 160 is formed in the form of a stopper and can open or close the end of the sleeve 110 to block or open the urine discharge passage 111a of the sleeve 110 . The drain cover 160 is connected to the support part 163 coupled to the outside of the sleeve cover 120 to open or shield the end of the sleeve 110 from the blocking part 161 and the lower surface of the blocking part 161. It is formed to be narrowed downward and may include a coupling portion 162 coupled to the sleeve 110 .

After the stopper 130 is brought into close contact with the abdominal wall, the fixing part 132 of the stopper 130 is fixed to the sleeve cover 120 with the clamp device 140, so that the suprapubic bladder fistula catheter 100 can It can be held motionless by the fixed wing 123 and the stopper 130. After indwelling the suprapubic bladder fistula catheter 100, leakage of urine can be prevented by covering the drain cover 160.

7 is a perspective view of a check valve constituting a self-catheter suprapubic bladder fistula catheter according to an embodiment of the present invention. 8 and 9 are cross-sectional views for explaining the operation of the check valve constituting the self-catheter suprapubic cystostomy catheter according to an embodiment of the present invention. FIG. 8 shows a state in which the check valve is closed by fluid pressure, and FIG. 9 illustrates a state in which the check valve is opened by inserting a self catheter into the check valve.

The check valve 170 may be inserted and assembled inside the sleeve 110 to prevent backflow of urine. The check valve 170 has a slit groove, and may be made of an elastic material such as silicon so that a catheter can be inserted through the slit groove. The check valve 170 may prevent the fluid from being discharged to the outside by closing the slit groove by being pressurized by the flow of the fluid indicated by the arrow in FIG. 8 .

A stopper member 180 in the shape of a disk ring made of rubber may be provided in the sleeve 110 . The stopper member 180 may prevent the check valve 170 from leaving. In this way, by assembling the check valve 170 inside the sleeve 110 and assembling the drain cover 160, it is possible to prevent backflow of urine and prevent secondary leakage.

The self-catheter suprapubic bladder fistula catheter 100 according to an embodiment of the present invention is installed in the urine discharge passage 111a of the sleeve 110 with the drain cover 160 open during urination to smoothly discharge urine. It may further include an inserted self catheter (not shown). The stopper member 180 may have a hole through which an autologous catheter can be inserted.

Hereinafter, the operation method and use method of the self catheterization suprapubic bladder fistula catheter 100 according to an embodiment of the present invention as described above will be described. First, the suprapubic cystostomy is used to insert the self-catheter suprapubic cystostomy catheter 100 with the fixed wings 123 folded into the suprapubic cystostomy 10 through the abdomen.

When the placement of the self catheterization suprapubic bladder fistula catheter 100 is completed, the control cap 150 is manipulated to spread the fixed wing 123 so that the self catheterization suprapubic bladder fistula catheter 100 is inserted into the suprapubic bladder fistula 10. After the stopper 130 is brought into close contact with the abdominal wall, the fixing part 132 of the stopper 130 is fixed to the sleeve cover 120 with the clamp device 140 so that the suprapubic bladder fistula catheter 100 is stable. to be attracted to

While the bladder is filled with urine, when the need to urinate is felt through the suprapubic bladder fistula check valve or sufficient urine is filled in the bladder to cause catheterization, open the drain cover (160) and insert the self-catheter. It is inserted to drain urine from the bladder to the outside.

After the catheter is completely drained, the self-catheter is removed and the drain cover 160 is covered to prevent leakage of urine double by the check valve 170 and the drain cover 160. According to an embodiment of the present invention, complications can be reduced and pain can be minimized by a method of catheterization by inserting an autologous catheter.

In addition, the self-catheter suprapubic bladder fistula catheter 100 according to an embodiment of the present invention can minimize the inconvenience of attaching a catheter and urine bag necessary for catheterization outside the body and carrying around without wearing a urine bag. Because of this, more free activities are possible while not urinating.

The self catheter suprapubic bladder fistula catheter 100 according to an embodiment of the present invention is used in all cases in which catheterization through the urethra is impossible, for example, in cases where continuous urination is not possible due to neurogenic bladder, ureterovesical reflux disease, or chronic prostatic hyperplasia. Applicable for urination of patients when direct urine discharge from the bladder is required due to infection of the urethra and prostate, when the catheterization method needs to be changed due to problems such as pain or complications, or when a change to a catheterization method that is easy to live with and has fewer side effects is desired. do.

Although the embodiments of the present invention have been described in detail above, the scope of the present invention is not limited thereto, and various modifications and improvements of those skilled in the art using the basic concept of the present invention defined in the following claims are also provided. belong to the scope of the invention.

[Description of code]

10: suprapubic bladder fistula

100: self-catheter suprapubic bladder fistula catheter

110: sleeve

111: sleeve tube

111a: urine discharge passage

112: inlet

115: first screw part

120: sleeve cover

121: sleeve cover tube

122: stumbling block

123: fixed wing

124: incision

130: stopper

131: close contact

132: fixing part

133: circular protruding ring

140: clamp device

150: control cap

151: second screw part

160: drain cover

161: blocking unit

162: coupling part

163: support

170: check valve

180: stopper member

Claims

A self-catheterization suprapubic bladder fistula catheter provided to be insertable into the suprapubic bladder fistula through the abdomen and capable of being placed in the suprapubic bladder fistula for self catheterization, comprising:

a tubular sleeve having a urine discharge passage for discharging urine in the suprapubic bladder fistula;

a sleeve cover formed to surround the sleeve and having a plurality of fixing wings for fixing the self catheter suprapubic catheter to the suprapubic bladder fistula;

a control cap that moves the sleeve relative to the sleeve cover and operates to expand or fold the plurality of stator blades so as to protrude from the sleeve; and

A self catheter suprapubic bladder fistula catheter comprising a drain cover opening and closing an end of the sleeve to block or open the urine discharge passage of the sleeve.
The method of claim 1,

and a stopper made of a flexible material and coupled to surround the periphery of the sleeve cover and fixed to the abdominal wall so as not to move the self-catheterization suprapubic cystostomy catheter.
The method of claim 2,

The self catheter suprapubic bladder catheter further comprising a clamp device detachably coupled to the stopper or detachably coupled between the stopper and the control cap to clamp the stopper while the stopper is in close contact with the abdominal wall.
The method of claim 3,

The self catheter suprapubic bladder fistula catheter according to claim 1 , wherein the stopper includes a fixing part adhered to the periphery of the sleeve cover by the clamp device and a contact part extending downward from the fixing part in a dome shape to adhere to the abdominal wall.
The method of claim 1,

The self catheter suprapubic bladder fistula catheter further comprising a check valve inserted into and assembled inside the sleeve to prevent backflow of urine.
The method of claim 1,

wherein the sleeve is screwed with the control cap and is configured to move relative to the sleeve cover along the longitudinal direction of the sleeve cover in conjunction with rotation of the control cap.
The method of claim 6,

A ring-shaped locking protrusion protruding toward the inside of the sleeve cover is formed at the lower end of the sleeve cover,

The catheter according to claim 1 , wherein a locking groove is formed along an outer periphery of the sleeve so that the locking protrusion is coupled to one side of the sleeve.
The method of claim 7,

The sleeve cover is a self catheter suprapubic bladder fistula catheter in which an incision is formed between the plurality of fixed wings along the longitudinal direction.
The method of claim 8,

When the control cap is rotated in a first direction, the locking protrusion of the sleeve cover is pushed up by the locking groove of the sleeve, and the plurality of stator blades made of a flexible material are spread.

When the control cap is rotated in a second direction opposite to the first direction, the locking protrusion of the sleeve cover is lowered by the locking groove of the sleeve and the plurality of fixed wings are folded.
The method of claim 1,

The self-catheter suprapubic bladder catheter further comprising a self-catheter inserted into the urine discharge passage of the sleeve in a state in which the drain cover is opened during urination to smoothly discharge urine.