Balloon catheter

The balloon catheter design with a less expandable relief balloon connected via a separate channel addresses improper inflation risks, ensuring correct placement and preventing urethral damage by visually indicating incorrect positioning.

JP2026135666APending Publication Date: 2026-08-25TSUKADA MEDICAL RES CO LTD
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Patent Information

Application Number
JP2025021314
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2025-02-13
Publication Date
2026-08-25

AI Technical Summary

Technical Problem

Conventional balloon catheters risk improper inflation of the indwelling balloon due to user error, potentially causing it to widen the urethral wall during insertion.

Method used

A balloon catheter design featuring a relief balloon less prone to expansion than the indwelling balloon, connected via a separate channel, which inflates instead if the indwelling balloon is mistakenly inflated in an inappropriate position, allowing for visual detection of incorrect placement.

Benefits of technology

Prevents inappropriate inflation of the indwelling balloon and allows for visual confirmation of correct placement, reducing the risk of urethral damage and ensuring secure retention in the bladder.

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Abstract

The present invention aims to provide a balloon catheter that can prevent the indwelling balloon from being inflated in an inappropriate position. [Solution] A balloon catheter 100 having an indwelling balloon 30 for placement inside the body is provided with a relief balloon 40 located at a distance from the indwelling balloon 30 at its proximal end and less prone to expansion than the indwelling balloon 30, and a tube 10 having a first channel 11 for allowing fluid to flow in from the outside and a second channel 12 for fluidically connecting the indwelling balloon 30 and the relief balloon 40.
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Description

Technical Field

[0001] The present invention relates to a balloon catheter having a retention balloon for retention in the body.

Background Art

[0002] Conventionally, a balloon catheter for urination management, which has a retention balloon for retention in the body at its tip, is known (see, for example, Patent Document 1). In this type of balloon catheter, there are many users who cannot sufficiently operate the balloon catheter due to insufficient dexterity, such as cerebrovascular disorder patients and spinal cord injury patients, and a balloon catheter that can be easily and safely operated during insertion and urination of the balloon catheter by themselves has been desired.

[0003] When the balloon catheter is retained in the bladder, first, it is inserted into the urethra with the retention balloon of the balloon catheter in a contracted state. Next, when the tip of the balloon catheter reaches the bladder, the urine accumulated in the bladder is discharged through the balloon catheter. After confirming the urine outflow, the user operates a syringe attached to the rear end of the balloon catheter to discharge the sterilized water stored in the syringe, and the discharged sterilized water is injected into the retention balloon to inflate the retention balloon. As a result, the inflated retention balloon in the bladder is caught in the bladder, so that the balloon catheter is fixed and prevented from coming out of the urethra, and the balloon catheter can be retained in the bladder.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] However, with the conventional balloon catheter technology described above, when inserting the balloon catheter into the bladder, the user may mistakenly believe that the indwelling balloon has reached the bladder even when it has not, and there is a risk that the user will forcibly inflate the indwelling balloon in the narrow urethra, causing the balloon to push against and widen the urethral wall.

[0006] The present invention aims to solve the problems of the above-mentioned conventional technology and to provide a balloon catheter that can prevent the indwelling balloon from being inflated in an inappropriate position. [Means for solving the problem]

[0007] The present invention relates to a balloon catheter having an indwelling balloon for placement in the body, characterized in that it comprises a relief balloon provided at a distance from the indwelling balloon on the proximal end side of the indwelling balloon and less prone to expansion than the indwelling balloon, and a tube having a first channel formed for the flow of fluid flowing in from the outside and a second channel formed for fluidically connecting the indwelling balloon and the relief balloon.

[0008] In this case, the retaining balloon and the relief balloon may be made of members of different thicknesses. The retaining balloon and the relief balloon may be made of members of different materials. The retaining balloon and the relief balloon may have different shapes. The system further has a branching section that branches the first channel and the second channel, and the distance between the relief balloon and the branching section may be smaller than the distance between the relief balloon and the retaining balloon. The relief balloon and the branching section may be adjacent to each other without any gaps. The system further has a branching section that branches the first channel and the second channel, and the relief balloon may be provided at the branching section. The system further has a branching section that branches the first channel and the second channel, and the relief balloon may be provided at the base end of the branching section. The relief balloon may be provided so as to be detachable from the branching section. [Effects of the Invention]

[0009] The present invention provides a balloon catheter that can prevent the indwelling balloon from being inflated in an inappropriate position. [Brief explanation of the drawing]

[0010] [Figure 1] A side view of the balloon catheter according to the first embodiment is shown. [Figure 2] This shows an enlarged cross-sectional view of the indwelling balloon. [Figure 3] This shows an enlarged cross-sectional view of the relief balloon. [Figure 4] This diagram shows a balloon catheter correctly positioned in the bladder. [Figure 5] This diagram illustrates a situation where a balloon catheter is not properly positioned in the bladder. [Figure 6] A cross-sectional view of the balloon catheter according to the second embodiment is shown. [Modes for carrying out the invention]

[0011] Preferred embodiments of the present invention will be described below with reference to the drawings. (First Embodiment) Figure 1 shows a side view of the balloon catheter, Figure 2 shows a magnified cross-sectional view of the indwelling balloon, Figure 3 shows a magnified cross-sectional view of the relief balloon, Figure 4 shows a schematic diagram of the balloon catheter correctly positioned in the bladder, and Figure 5 shows a schematic diagram of the balloon catheter not correctly positioned in the bladder.

[0012] The balloon catheter 100 is a catheter intended for use by being placed inside the body, particularly in the bladder, and as shown in Figure 1, it has a tube 10, a tip 20, an indwelling balloon 30, a relief balloon 40, and a branch 50. These components, the tube 10, the tip 20, the indwelling balloon 30, the relief balloon 40, and the branch 50, are joined together by adhesive to form a single unit.

[0013] In this embodiment, the tube 10, tip 20, retaining balloon 30, relief balloon 40, and branch 50 are made of silicone rubber, but they may also be made of latex, natural rubber, isoprene rubber, thermoplastic resin, such as PVC and urethane rubber, fluororubber and fluororesin.

[0014] As shown in Figure 2, the tip of the tube 10 penetrates the retaining balloon 30, and the retaining balloon 30 is attached to the outer circumference near the tip of the tube 10 by adhesive. The tube 10 has a cylindrical tip portion 20 attached to its end face by adhesive.

[0015] Furthermore, as shown in Figure 3, the base end of the tube 10 penetrates the relief balloon 40, and the relief balloon 40 is attached to the outer circumference near the tip of the tube 10 by adhesive. As shown in Figure 1, the branch portion 50 is attached to the base end of the tube 10 by adhesive.

[0016] As shown in Figure 2, the tube 10 has a urination lumen (first channel) 11 formed along the extending direction of the tube 10 for allowing fluids such as urine that flow in from the outside through the tip 20 to flow. The balloon catheter 100 is fluidically connected to the outside and the urination lumen 11 through a tip hole 21 and a side hole 22 formed in the tip 20, so that urine flowing in from the tip hole 21 and the side hole 22 flows through the urination lumen 11 to the branching section 50 at the proximal end.

[0017] The tube 10 is formed with a thickened part that is a portion of an arc, and a balloon lumen 12 for inflating the retention balloon 30 and the relief balloon 40 is formed along the extending direction of the tube 10 in this thickened part. The balloon lumen 12 is fluidly connected to the inside of the retention balloon 30 near the tip of the tube 10 and is fluidly connected to the relief balloon 40 near the base end of the tube 10. That is, the balloon lumen 12 fluidly connects the retention balloon 30 and the relief balloon 40. Thereby, the balloon lumen 12 can inflate the retention balloon 30 and the relief balloon 40 by filling the sterilized water supplied from a syringe (not shown) through the branch portion 50 into the retention balloon 30 and the relief balloon 40.

[0018] The urine drainage lumen 11 is formed to have a substantially circular cross-sectional flow path, and the balloon lumen 12 is formed to have a circular cross-sectional flow path smaller than that of the urine drainage lumen 11.

[0019] The retention balloon 30 has its base-end side end and tip-end side end adhered to the outer peripheral surface of the tube 10, and is formed to be in a cylindrical shape in close contact with the outer peripheral surface of the tube 10 when not inflated. The retention balloon 30 has non-inflated portions at the tip side and the base end side formed in a tapered shape so that the outer diameter smoothly decreases toward the tip and the base end. This retention balloon 30 is fluidly connected to the balloon lumen 12 through a hole 13 formed in the tube 10, and when sterilized water is supplied from the branch portion 50 through the balloon lumen 12, it inflates into a spherical shape centered on the tube 10. Thereby, the balloon catheter 100 is fixed such that the retention balloon 30 catches in the patient's bladder and does not come out.

[0020] As shown in FIG. 3, the relief balloon 40 has its proximal end and distal end adhesively attached to the outer peripheral surface of the tube 10 in the same manner as the indwelling balloon 30, and is formed to be in a cylindrical shape while closely adhering to the outer peripheral surface of the tube 10 when not inflated. This relief balloon 40 is made of a member thicker than the indwelling balloon 30, making it more difficult to inflate than the indwelling balloon 30. That is, the relief balloon 40 is configured to inflate when it receives an internal pressure higher than the internal pressure at which the indwelling balloon 30 begins to inflate.

[0021] The non-inflated portions on the distal end side and proximal end side of the relief balloon 40 are formed in a tapered shape, such that the outer diameter smoothly decreases toward the distal end and proximal end. This relief balloon 40 is fluidly connected to the balloon lumen 12 through the hole 14 formed in the tube 10, and when sterile water is supplied from the branch portion 50 through the balloon lumen 12, it is configured to inflate into a spherical shape centered on the tube 10.

[0022] As shown in FIG. 1, the relief balloon 40 is provided on the proximal end side of the indwelling balloon 30 with a gap therebetween. The distance between the relief balloon 40 and the branch portion 50 is smaller than the distance between the relief balloon 40 and the indwelling balloon 30, and in the relief balloon 40 according to the present embodiment, the relief balloon 40 and the branch portion 50 are positioned adjacent to each other without a gap.

[0023] The branch portion 50 has its distal end side connected to the tube 10 by adhesion, while its proximal end side branches and has a urine discharge port 15 and a balloon injection port 16, and the urine discharge lumen 11 fluidly connected to the urine discharge port 15 and the balloon lumen 12 fluidly connected to the balloon injection port 16 branch off.

[0024] The urine discharge port 15 is connectable to a bag or the like for collecting and storing the discharged urine.

[0025] The balloon inlet 16 can be connected to a syringe or the like (not shown) for injecting sterile water into the balloon lumen 12.

[0026] When the balloon catheter 100 is correctly placed in the bladder 60, as shown in Figure 4, only the indwelling balloon 30 inflates, and even if the balloon catheter 100 is pulled towards the proximal end, the indwelling balloon 30 gets caught in the bladder 60 and cannot be pulled out. At this time, when the indwelling balloon 30 in the bladder 60 is inflated to the appropriate pressure, the relief balloon 40 is in an uninflated state. In this state, if the user injects more sterile water and the internal pressure of the indwelling balloon 30 in the bladder 60 becomes too high, the relief balloon 40 will also inflate after the indwelling balloon 30 has inflated, allowing the user to visually determine that the pressure of the indwelling balloon 30 is too high.

[0027] On the other hand, as shown in Figure 5, if the balloon catheter 100 has not reached the bladder 60 and the indwelling balloon 30 is located inside the urethra 61, that is, if the balloon catheter 100 is not properly placed inside the bladder 60, only the relief balloon 40 will inflate. Specifically, even if the user injects sterile water to inflate the indwelling balloon 30, the indwelling balloon 30 is pushed back by the urethral wall of the urethra 61 and cannot inflate, so the pressure escapes into the relief balloon 40 and only the relief balloon 40 inflates. This allows the user to visually determine that the indwelling balloon 30 has not reached the bladder 60.

[0028] The balloon catheter 100 according to this embodiment has a relief balloon 40 which is provided at a distance from the indwelling balloon 30 at the proximal end and is less likely to inflate than the indwelling balloon 30, and a tube 10 which has a urination lumen 11 for allowing fluid to flow in from the outside and a balloon lumen 12 which fluidly connects the indwelling balloon 30 and the relief balloon 40. As a result, if the user attempts to inflate the indwelling balloon 30 before it has reached the bladder 60, the relief balloon 40 will inflate instead of the indwelling balloon 30, thus preventing the indwelling balloon from being inflated in an inappropriate position.

[0029] Furthermore, because the relief balloon 40 of the balloon catheter 100 is less likely to inflate than the indwelling balloon 30, if the internal pressure of the indwelling balloon 30, which is properly positioned in the bladder 60 and inflating smoothly, becomes too high, the relief balloon 40 will begin to inflate instead. This allows the user to visually determine that the internal pressure of the indwelling balloon 30 has become too high, thereby preventing the indwelling balloon 30 from rupturing.

[0030] (Second Embodiment) Figure 6 shows a cross-sectional view of a balloon catheter according to the second embodiment.

[0031] In the following description, the same reference numerals will be used for substantially the same components as in the first embodiment. The balloon catheter 200 according to the second embodiment differs from the balloon catheter 100 according to the first embodiment in that, as shown in Figure 6, the relief balloon 140 is provided at the branching portion 150.

[0032] The relief balloon 140 according to this embodiment is not provided on the tube 10, but is provided integrally with the branch section 150 at the base end of the branch section 150. Specifically, it is provided on a flow path that is fluidly connected to the balloon lumen 12 and the balloon inlet 16 in the branch section 150. This relief balloon 140 is fluidly connected to the balloon lumen 12 at a hole 151 formed in the branch section 150, and expands into a spherical shape centered on the tube 10 when sterile water is supplied from the branch section 50. The relief balloon 140 is less likely to expand than the indwelling balloon 30, similar to the relief balloon 40 according to the first embodiment.

[0033] In this embodiment of the balloon catheter 200, if the indwelling balloon 30 has not reached the bladder 60 but is located in the urinary tract 61 and the user attempts to inflate the indwelling balloon 30, the relief balloon 140 provided at the branch 150 will inflate instead of the indwelling balloon 30, thus preventing the indwelling balloon from being inflated in an inappropriate position.

[0034] Furthermore, because the relief balloon 140 of the balloon catheter 200 is less likely to inflate than the indwelling balloon 30, if the internal pressure of the indwelling balloon 30, which is properly positioned in the bladder 60 and inflating smoothly, becomes too high, the relief balloon 140 will begin to inflate. This allows the user to visually determine that the internal pressure of the indwelling balloon 30 has become too high, thereby preventing the indwelling balloon 30 from rupturing.

[0035] The present invention has been described above based on embodiments, but the present invention is not limited thereto. For example, in the above embodiments, the retaining balloon 30 and the relief balloons 40 and 140 are formed from members of different thicknesses, but the present invention is not limited thereto. The retaining balloon and the relief balloon may be formed from members of different materials or have different shapes, as long as the relief balloon is less likely to inflate than the retaining balloon.

[0036] Furthermore, in the second embodiment described above, the relief balloon 140 is provided integrally with the branching portion 150, but the present invention is not limited thereto. If the relief balloon is less likely to inflate than the retained balloon, the relief balloon may be provided separately from the branching portion, detachably connected to the balloon inlet of the branching portion.

[0037] Furthermore, in the above embodiment, the relief balloons 40 and 140 are provided on the balloon catheters 100 and 200 in an exposed state, but the present invention is not limited thereto. If the inflation of the relief balloons can be visually observed, they may be placed in a transparent container or the like to protect them from external impacts. [Explanation of Symbols]

[0038] 10... Tube 11…Lumen for urination 12... Lumens for balloons 13...hole 14...hole 15... Urinary opening 16...Balloon inlet 20...Tip 21...Tip hole 22...Side hole 30…Indwelling balloon 40…Relief balloon 50... Branching point 60…Bladder 61...urethra 100... Balloon catheter 140…Relief balloon 150... Branching point 151...hole 200... Balloon catheter

Claims

1. In a balloon catheter having an indwelling balloon for placement inside the body, A relief balloon is provided at a distance from the aforementioned retaining balloon, closer to the base end, and less prone to expansion than the aforementioned retaining balloon. A balloon catheter characterized by having a tube having a first channel formed for the flow of fluid that flows in from the outside, and a second channel formed for the fluidic connection between the indwelling balloon and the relief balloon.

2. In the balloon catheter according to claim 1, A balloon catheter characterized in that the indwelling balloon and the relief balloon are formed from materials of different thicknesses.

3. In the balloon catheter according to claim 1, A balloon catheter characterized in that the indwelling balloon and the relief balloon are formed from components of different materials.

4. In the balloon catheter according to claim 1, A balloon catheter characterized in that the indwelling balloon and the relief balloon have different shapes.

5. In the balloon catheter according to claim 1, A balloon catheter further having a branching section that separates the first channel and the second channel, characterized in that the distance between the relief balloon and the branching section is smaller than the distance between the relief balloon and the indwelling balloon.

6. In the balloon catheter according to claim 5, A balloon catheter characterized in that the relief balloon and the branching portion are adjacent to each other without any gaps.

7. In the balloon catheter according to claim 1, A balloon catheter further having a branching section that separates the first channel and the second channel, wherein the relief balloon is provided at the branching section.

8. In the balloon catheter according to claim 1, A balloon catheter further having a branching section that separates the first channel and the second channel, wherein the relief balloon is provided on the proximal end side of the branching section.

9. In the balloon catheter according to claim 8, A balloon catheter characterized in that the relief balloon is detachably provided from the branching portion.

Citation Information

Patent Citations

  • Intermittent urethra-indwelling catheter set

    WO2005018714A1