Systems, devices, and methods for automated urination

Abstract

The invention relates to systems, devices and methods for detecting and discharging urine. The catheter (100) uses at least two teardrop-shaped retention balloons (144) and balloon blocking mechanisms (132, 130) to allow for effective and complete discharge of urine from the user after urination. In another embodiment, urine is automatically detected by a sensor and extracted by a pump (201) from the user to a storage position.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to Iranian patent application serial number No. 1401501400030001628 filed on May 5, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates to the field of medical devices. More specifically, the present disclosure relates to systems, devices and methods for automating urination by eliminating the problem of urinary incontinence and the incidence of bacterial infection in catheterized patients. Background Art

[0004] The novel features believed to be characteristic of the present disclosure, including its structure, organization, use and method of operation, as well as further objects and advantages thereof, may be better understood from the following drawings, which will now illustrate the presently preferred embodiments of the present disclosure. However, it should be expressly noted that the drawings are for illustration and description only and are not intended as a definition of the limits of the present disclosure. Embodiments of the present disclosure will now be described by way of example with reference to the accompanying drawings, in which:

[0005] Indwelling or intermittent catheterization of the bladder has historically been considered safe, as sterile methods of use and manufacture have become a common practice. Catheters are used for several different clinical reasons, such as urinary retention, urinary incontinence, and after lower urinary tract surgery. It is well known in the art that the use of external urinary catheters can cause a variety of serious problems for the user. Some of the major problems include the large residual volume left in the bladder, frequent clogging of the catheter, and the occurrence of bacterial infections in catheterized patients, which occur in almost all patients who receive long-term catheterization. A number of complications often occur when the catheter is unable to completely drain the urine.

[0006] In view of these problems, many attempts have been made in the prior art to solve these problems.

[0007] It has been found that current urinary catheter designs may result in a large amount of residual volume remaining in the bladder or elsewhere in the drainage system, such as the drainage tube connecting the urinary catheter to a drainage bag.

[0008] Indwelling balloons used for self-maintaining catheters within the bladder may be one of the main reasons for the large residual volume remaining within the bladder.

[0009] The urinary catheter in the prior art utilizes a single or two balloons that are positioned on the urinary catheter, wherein the balloon completely surrounds the urinary catheter. In a urinary catheter with two balloons, one balloon is placed above the other balloon.

[0010] For example, a single inflatable balloon protruding beyond the tip of the catheter may slip out of the bladder and fail to completely empty the bladder because there is no distal urine inlet at or below the distal end of the single balloon. In addition, since the bladder wall is closed around the single balloon, positioning the hole below the single balloon will not allow continuous drainage. In addition, placing the urine inlet above the single balloon will not allow complete emptying because the balloon completely surrounds the proximal end of the catheter, so the urine is trapped below the single balloon and the residual urine volume will remain in the bladder. In addition to the above-mentioned disadvantages, the indwelling balloon of the prior art has a large surface area, and its surface is prone to biofilm formation, which becomes a breeding ground for microbial reproduction in the bladder, increasing the risk of infection. In the present invention, two indwelling balloons can be configured as spherical members, connected to a bracket with a curved side surface, so that urine flows into the urine drainage tube through the curved space between the balloon bracket and the catheter body. In addition, the indwelling balloon has a smaller surface area, which reduces the risk of infection by providing less breeding ground for the reproduction of microorganisms in the bladder.

[0011] It has also been found that current catheter designs can lead to the risk of urine coagulation in the urine drainage tube, frequent blockage of the catheter, and the subsequent occurrence of bacterial infection. These problems are usually solved by simple procedures such as flushing or manual manipulation. However, in many cases, these procedures fail, necessitating the replacement of the catheter.

[0012] Urine remaining in the urinary drainage catheter may be caused by incomplete drainage, catheter blockage, or closure of the urinary drainage catheter at the proximal end of the catheter, which may result in urine accumulation and direct backflow into the patient. It is also generally accepted that fluid removed from the patient should not be allowed to flow back into the patient for infection control purposes.

[0013] In the present invention, certain provisions have been made to solve the above problems, including closing, cleaning and disinfecting the urine tube. A blocking mechanism configured to occlude and close the urine drainage tube is located just below the distal urine inlet at the distal end of the catheter, thereby forming an empty urine tube for delivering pharmaceutically active agents or washing media.

[0014] Another problem with current urinary catheters is that urine drained from the patient is allowed to flow back into the patient. To address this problem, some urine suction devices have been operated, which typically use a pump to transfer urine from the patient to a tank or reservoir. In the present invention, the control system is programmed to control the complete drainage of the suction pump, so that based on the pressure measured in the bladder, the urine drainage tube is occluded by the control system, and medical or flushing fluid is delivered into the tube.

[0015] Prior art catheters and methods of use do not provide a control device that can simultaneously prevent the occurrence of bacterial infection, allow fully automated urine drainage, prevent urinary catheter blockage, allow medication to flow into the bladder and urinary catheter as needed, and measure urine properties through an automatically controlled catheter device.

[0016] The devices and methods of the present invention described below address these deficiencies and problems and further provide a combined urinary catheter for improved urine volume measurement and urine parameter analysis. The urine drainage catheter itself provides untapped opportunities for collecting and measuring additional patient parameters. Summary of the invention

[0017] The following brief summary is not intended to include all features and aspects of the present application, nor does it mean that the present application must include all features and aspects discussed in this summary.

[0018] In one general aspect, the present application describes a medical device having a newly designed indwelling balloon, a specific fluid drainage and drug delivery system, and a method for fluid drainage and drug delivery.

[0019] A medical device according to one embodiment of the present invention may include: a urinary catheter (100) including a distal portion (102), a central portion (104), and a proximal portion (106), one or more openings being defined at the distal portion, a plurality of lumens being disposed along a longitudinal axis of the urinary catheter (100), wherein each of the plurality of lumens may have a distal end in the distal portion of the urinary catheter (100) and a proximal end in the proximal portion;

[0020] In one aspect, the plurality of chambers include a urine drainage chamber (120), a restriction chamber (130), a balloon inflation chamber (140), a drug supply chamber (150), and a pressure sensing chamber (160). The urine drainage chamber (120) can be in fluid communication with at least two distal openings (124) at the distal portion (102), and also in fluid communication with a proximal port (122) at the proximal portion (106) of the urinary catheter (100), wherein urine is drawn out through the urine drainage chamber (120) through the at least two distal openings (124).

[0021] In one aspect, the balloon inflation lumen (140) can be in fluid communication with at least two indwelling balloons (144) at the distal portion (102), and can also be in fluid communication with a proximal balloon port (142) at the proximal portion (106) of the urinary catheter (100), wherein each indwelling balloon (144) can be mounted on an edge of one of the at least two distal openings (124) in the distal portion (102) of the urinary catheter (100). In addition, the at least two indwelling balloons (144) can have a teardrop shape, one end of which has a concavely curved side surface. Furthermore, in order to inflate the indwelling balloons (144) while maintaining the urinary catheter in the bladder, the crescent-shaped cavity (146) can be connected to at least two indwelling balloons (144) at the distal portion (102), and can also be connected to the balloon inflation cavity (140) at the central portion (104) of the urinary catheter to allow sterile liquid or air to be delivered to the at least two indwelling balloons (144) via the inflation cavity (140).

[0022] In one aspect, the drug supply lumen (150) can be in fluid communication with a plurality of infusion outlets (154) at the distal portion (102) of the catheter (100) and a plurality of inner slits (156) on the side wall of the urine drainage lumen (120), wherein the drug supply lumen (150) can be in fluid communication with the urine drainage lumen (120) via the plurality of inner slits (156). In addition, the drug supply lumen (150) can be in fluid communication with a proximal infusion port (152) at the proximal portion (106) of the catheter (100). In addition, a second crescent-shaped lumen (155) having an inner surface and an outer surface can be connected to the distal end of the drug supply lumen (150), wherein the outer surface of the crescent-shaped lumen (155) can be connected to the plurality of infusion outlets (154), and the inner surface of the crescent-shaped lumen (155) can be connected to the plurality of inner slits (156).

[0023] In one aspect, the lumen (130) can be positioned next to the urine drainage lumen (120), wherein the urine drainage lumen (120) and the restriction lumen (130) can be separated by an inner wall (135). In addition, the thickness of the inner wall (135) is thinner in the central portion (104) of the catheter than in the proximal portion (106), wherein the thinner inner wall (135) of the central portion (104) is closer to the distal portion (102) than to the proximal portion (106). In addition, the distal end of the lumen (130) can be closed at the thinner inner wall (135) portion.

[0024] In one aspect, the catheter (100) may further include a blocking balloon (132) positioned within the restricting cavity (130), wherein once the blocking balloon (132) passes through the restricting cavity (130), the blocking balloon (132) enters the urine drainage cavity (120) due to the closed distal end of the cavity (130) at the thinner inner wall (135) portion.

[0025] In one aspect, the pressure sensing balloon (164) can be located at the distal portion (102) of the catheter (100) and can be in fluid communication with the pressure sensing lumen (160). In addition, the pressure sensing lumen (160) can be in fluid communication with the pressure port (162) at the proximal portion (106) of the catheter (100).

[0026] In one aspect, the medical device may further include a control device (200) that may be coupled to the proximal portion (106) of the urinary catheter (100) via a plurality of fluid lines (602, 603, 604, and 605). The control device (200) may include a syringe system (500) for spraying medication and flushing fluid into the urine drainage cavity (120) and / or the bladder, and a balloon inflation system (400) for inflating and deflating the pressure sensing balloon (164) and the blocking balloon (132). In addition, the control device (200) may be configured to control the balloon blocking mechanism (137) to block the urine drainage cavity (120).

[0027] In one aspect, according to an embodiment of the present invention, a method for discharging fluid may include: positioning a urinary catheter (100) in a subject's body, connecting the urinary catheter (100) to communicate with a control device (200), inflating a blocking balloon (132) via a balloon inflation system (400) to pass through an inner wall (135) of a restriction cavity (130) to occlude a urine drainage cavity (120), filling a pressure sensing balloon (164) via the balloon inflation system (400) to measure bladder pressure, and when the pressure difference between the subject's body and the balloon rises above its limit state, deflating the blocking balloon (132) to open the urine drainage cavity (120) to allow fluid to flow along the urine drainage cavity 120, and when the pressure in the pressure sensing balloon (164) is equal to the pressure in the bladder, inflating the blocking balloon (132) to block the urine drainage cavity, and spraying a drug or fluid into the subject's body and the urine drainage cavity (120). BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The novel features believed to be characteristic of the present disclosure, including its structure, organization, use and method of operation, as well as further objects and advantages thereof, may be better understood from the following drawings, which will now illustrate the presently preferred embodiments of the present disclosure. However, it should be expressly noted that the drawings are for illustration and description only and are not intended as a definition of the limits of the present disclosure. Embodiments of the present disclosure will now be described by way of example with reference to the accompanying drawings, in which:

[0029] The invention will now be described with reference to preferred embodiments.

[0030] Figure 1Ashows a general perspective view of a urinary catheter including a plurality of individual ports according to an exemplary and non-limiting implementation;

[0031] Figure 1B shows a general perspective view of a urinary catheter having different portions (distal, central, and proximal) consistent with one or more exemplary embodiments of the present disclosure;

[0032] Figure 1C shows a general perspective view of a urinary catheter consistent with one or more exemplary embodiments of the present disclosure, the urinary catheter including an inflatable indwelling balloon, a distal infusion outlet, a pressure sensing balloon, and a distal opening;

[0033] Figure 2 One or more exemplary embodiments of the present disclosure are consistent with the following Figure 1C A cross-sectional top view taken along line FF shown in FIG.

[0034] Figure 3A shows a perspective view of a deflated indwelling balloon mounted on a distal opening at a distal portion of a urinary catheter consistent with one or more exemplary embodiments of the present disclosure;

[0035] Figure 3B One or more exemplary embodiments of the present disclosure are shown along Figure 3A A longitudinal sectional side view of the deflated indwelling balloon, the inner slit and the distal infusion outlet of the urinary catheter taken along line EE shown in FIG.

[0036] Figure 3C One or more exemplary embodiments of the present disclosure are shown along Figure 5A A longitudinal sectional side view taken along line EE shown in FIG.

[0037] Figure 4A The distal end portion of the urinary catheter according to one or more exemplary embodiments of the present disclosure is illustrated along Figure 1C A cross-sectional view taken along line BB shown in FIG.

[0038] Figure 4B The distal end portion of a urinary catheter consistent with one or more exemplary embodiments of the present disclosure is illustrated along Figure 1C A cross-sectional view taken along line BB shown in , showing fluid communication between the balloon inflation lumen and the indwelling balloon;

[0039] Figure 5A illustrates a perspective view of a distal end and a central portion of a urinary catheter consistent with one or more exemplary embodiments of the present disclosure;

[0040] Figure 5BOne or more exemplary embodiments of the present disclosure are consistent with the following Figure 5A A cross-sectional view taken along line GG shown in FIG.

[0041] FIG. 5C illustrates a diagram of a method of performing a multi-step process along a path consistent with one or more exemplary embodiments of the present disclosure. Figure 5A A cross-sectional view taken along line GG shown in FIG.

[0042] Fig. 6A illustrates a perspective view of a urinary catheter having a balloon occlusion mechanism consistent with one or more exemplary embodiments of the present disclosure;

[0043] Figure 6B A longitudinal cross-sectional view illustrating an open state of a balloon occluding mechanism consistent with one or more exemplary embodiments of the present disclosure;

[0044] Figure 6C A longitudinal cross-sectional view illustrating a closed condition of a balloon occluding mechanism consistent with one or more exemplary embodiments of the present disclosure;

[0045] Fig. 7A shows a cross-sectional side view of a pressure sensing balloon coupled to a pressure sensing chamber consistent with one or more exemplary embodiments;

[0046] Figure 7B shows a cross-sectional side view of an inflated pressure sensing balloon coupled to a pressure sensing chamber consistent with one or more exemplary embodiments;

[0047] Figure 8 shows a perspective view of a control device coupled to a proximal portion of a urinary catheter, consistent with one or more exemplary embodiments;

[0048] Fig. 9 shows an exploded perspective view of a syringe system consistent with one or more exemplary embodiments;

[0049] Fig.10 shows a perspective view of a control device consistent with one or more exemplary embodiments;

[0050] Fig.11 shows an exploded perspective view of a balloon inflation system consistent with one or more exemplary embodiments; DETAILED DESCRIPTION

[0051] The novel features which are believed to be characteristic of the disclosure, both as to its structure, organization, use and method of operation, together with further objects and advantages thereof, will be better understood from the following discussion.

[0052] In the figures of the accompanying drawings, aspects of the present invention are described by way of example and not limitation, and the reference numerals in the drawings represent similar elements. It should be noted that references to "one" and "an" embodiment in this disclosure do not necessarily refer to the same embodiment, and these references mean at least one. In the following description, many specific details are set forth to provide a comprehensive description of the present invention. However, it will be appreciated by those skilled in the art that the present invention can be practiced without these specific details. In other cases, in order not to obscure the present invention, well-known features are not described in detail.

[0053] Figure 1A An embodiment of a urinary catheter 100 and several of its features are illustrated, which can be understood to have various portions including, but not limited to, a distal or bladder-residing portion 102, hereinafter referred to as the "distal portion", a central or urethra-residing portion 104, hereinafter referred to as the "central portion", and a proximal portion 106 that remains external to the subject.

[0054] According to one implementation of the present disclosure, the disclosed urinary catheter system 100 may be configured to be connected to a control device 200 (eg, Figure 8 ) to measure urine excretion flow, control automatic urine drainage, and deliver pharmaceutically active agents to the bladder and / or urine drainage cavity 120.

[0055] The main elements of the disclosed urinary catheter 100 are explained in more detail in further figures herein. The disclosed details are not intended to be limited to the implementations shown, but should be accorded the widest possible scope consistent with the principles and features disclosed herein.

[0056] Return to reference Figure 1A The urinary catheter 100 may include one or more openings near the distal portion 102 of the urinary catheter 100 and a plurality of separate ports near the proximal portion 106 of the urinary catheter 100, wherein some or all of the ports may be integrated into a single port, or as shown in FIG. Figure 8 As shown, it can be integrated into the urine drainage line leading to the control device 200.

[0057] As a main embodiment consistent with one or more exemplary embodiments of the present disclosure, the urinary catheter 100 may have multiple lumens, such as Figures 1A to 1C As shown, these lumens are described herein as extending along the longitudinal axis of the catheter and can be connected to Figure 8100 ; a urine drainage lumen 120 adapted to transfer urine to a collection container (not shown) in the control device 200; a restriction lumen 130 adapted to block the urine drainage lumen 120 via the control device 200; a balloon inflation lumen 140 adapted to deliver a pressurized fluid for inflating at least two inflatable indwelling balloons 144 to maintain the urinary catheter in the bladder; a drug supply lumen 150 adapted to infuse a pharmaceutically active agent or flushing fluid into the bladder through a plurality of infusion outlets 154 near the distal portion 102 of the catheter 100; and a pressure sensing lumen 160 adapted to measure bladder pressure to control automatic drainage of urine.

[0058] Figure 2 Explained in more detail Figures 1A to 1C , and shows a cross-sectional top view of a proximal portion 106 of a urinary catheter 100 according to one or more exemplary embodiments of the present disclosure, the top view being taken along Figure 1C The imaginary line FF shown in FIG. Figure 2 An embodiment of the present disclosure is illustrated in which a urinary catheter 100 surrounds a urine drainage lumen 120 , a restriction lumen 130 , a drug supply lumen 150 , and a pressure sensing lumen 160 , and at least two indwelling balloons 144 and a balloon port 142 are located beside the urinary catheter 100 .

[0059] According to some exemplary embodiments of the present disclosure, Figure 1A As shown, the urine drainage lumen 120 disposed along the longitudinal axis of the catheter may have at least two distal openings 124 present in the bladder-residing portion 102 of the catheter. Figure 1A As shown, the urine drainage lumen 120 may also have a proximal port 122 at the proximal portion 106 of the urinary catheter. In this exemplary embodiment, the urine drainage lumen 120 may be in fluid communication with at least two distal openings 124 and the proximal port 122. In this embodiment, urine may be drawn from the at least two distal openings 124 and directed out of the urinary catheter 100 through the proximal port 122.

[0060] In an exemplary embodiment, to maintain the catheter in the bladder, as Figure 1B As shown, at least two inflatable indwelling balloons 144 can be installed on one edge of at least two distal openings 124 in the distal portion 102 of the catheter, wherein the at least two indwelling balloons 144 can be fluidically connected to a balloon inflation cavity 140, which is fluidically connected to a balloon port 142 at or near the proximal portion 106 of the catheter.

[0061] According to various embodiments of the present disclosure, installing at least two indwelling balloons 144 on the catheter 100 may increase the diameter of the catheter. In order to reduce the diameter of the catheter 100, the at least two distal openings 124 need to have enough space to accommodate at least two indwelling balloons 144 when the balloons are deflated.

[0062] Figure 3A The position of a deflated indwelling balloon 144 within a distal opening 124 is illustrated in accordance with an exemplary embodiment of the present disclosure. FIG. 3B to FIG. 3C is a longitudinal cross-sectional view of the distal end portion 102 of the urinary catheter 100 according to one or more exemplary embodiments of the present disclosure, the view being taken along Figure 3A The imaginary line EE shown is intercepted. Figure 3B and Figure 3C The positions of the deflated and inflated indwelling balloon 144 relative to the at least two distal openings 124 are illustrated, respectively.

[0063] The at least two indwelling balloons 144 of the urinary catheter may remain indwelling inside the bladder and continuously contact the mucosal lining of the inner wall of the bladder, which results in a residual urine volume remaining below the at least two distal openings 124 and around the at least two indwelling balloons 144. This residual urine volume may cause serious problems for the patient, including the accumulation and proliferation of pathogenic microorganisms in the bladder, which may make the patient susceptible to subsequent infection or damage to the bladder and kidney tissue.

[0064] In order to avoid residual urine volume remaining below the at least two distal openings 124 and around the at least two indwelling balloons 144, in accordance with one or more exemplary embodiments of the present disclosure, Figure 1B The embodiment shown (some details of which are in Figure 3A In the exemplary embodiment, at least two distal openings 124 may accommodate at least two indwelling balloons 144, while the other at least two distal openings 124 may not have an indwelling balloon 144 placed thereon. In this exemplary embodiment, each of the at least two indwelling balloons 144 may have a teardrop shape with one end having a concavely curved side surface. This may help urine flow into the at least two distal openings 124 through the curved space present between the at least two indwelling balloons 144 and the at least two distal openings 124. In addition to this configuration, the location of the at least two indwelling balloons 144 synergistically increases the urine flow rate and allows urine drainage without leaving a residual urine volume inside the bladder.

[0065] Return to reference Figures 1A to 1C, there is a drug supply lumen 150 that passes through the interior of the catheter body and along the longitudinal axis of the catheter 100, and is in communication with a plurality of infusion outlets 154 at the end of the distal portion 102 of the catheter 100, and is in communication with a proximal infusion port 152 at the proximal portion 106 of the catheter 100. In this exemplary embodiment according to the present disclosure, the drug supply lumen 150 and the plurality of infusion outlets 154 placed into the bladder can be used as an infusion conduit for infusible medicaments, pharmaceutically active agents, or any flushing fluids.

[0066] In this exemplary embodiment, the proximal infusion port 152 may be configured to allow a syringe to be coupled thereto and deliver medication into the bladder through the drug supply lumen 150 .

[0067] In such Figure 1B In the exemplary embodiment shown, in order to inflate at least two indwelling balloons 144 while maintaining the catheter in the bladder, the balloon inflation lumen 140 in the distal portion 102 of the catheter can be connected to at least two smaller lumens 147. Figure 4A It is more clear in that according to one or more exemplary embodiments of the present disclosure, the cross-sectional top view of the distal end portion 102 of the catheter is along Figure 1C The line BB shown in FIG. Figure 4A As shown, the two smaller lumens 147 can be interconnected with the balloon inflation lumen 140 so that at least two indwelling balloons 144 can be inflated by flowing sterile liquid or air through the smaller lumen 147 via the inflation lumen 140. The at least two indwelling balloons 144 are generally attached to the smaller lumen 147, which means that the balloons can be directly connected and fixed to the smaller lumen 147, or can be connected via various types of connection ports and means.

[0068] Figure 4B Another exemplary embodiment of the present disclosure is illustrated. As shown in this figure, there is a crescent-shaped cavity 146 at the distal end portion 102 of the catheter, which is hereinafter referred to as the "first crescent-shaped cavity" to distinguish it from other crescent-shaped cavities explained in the following section and is connected to the end section of the balloon inflation cavity 140, and the crescent-shaped cavity surrounds a semicircular area smaller than the cross-sectional area of ​​the distal end portion 102 of the catheter 100. Figure 4B As shown, this embodiment may have two holes on opposite arcs at its inner boundary as fluid outlets 148. In this exemplary embodiment, the fluid outlet 148 may be coupled to at least two indwelling balloons 144. The first crescent-shaped cavity 146 allows fluid communication between the balloon port 142 and the at least two indwelling balloons 144.

[0069] Fluid drainage catheters are often faced with frequent blockages, which may cause bacterial infections in intubated patients (especially those with long-term intubation). In order to solve the problem of urine drainage cavity 120 being blocked by debris carried by the fluid, thereby eliminating bacterial infections, the urine drainage cavity 120 of the present disclosure can be unblocked and disinfected via a drug or flushing fluid. In some implementations, the flushing fluid may include, for example, antibacterial drugs, antiviral drugs, antibacterial agents, or detergents. For this purpose, Figure 8 As shown, a control device 200 including a syringe system 500 may be used, which is configured to inject medication and flushing fluid into the urine drainage chamber 120. According to this embodiment, the fluid flow from the syringe system 500 passes through the drug supply chamber 150, which can be in fluid communication with a plurality of infusion outlets 154 at the distal portion 102 of the catheter 100 and a plurality of internal slits 156 on the side wall of the urine drainage chamber 120, so that the drug supply chamber 150 can be in fluid communication with the urine drainage chamber 120 via the plurality of internal slits 156. In an exemplary embodiment, as shown in FIG. Figure 5A As shown, the urinary catheter may include a smaller lumen 151 that may be in fluid communication with the drug supply lumen 150 and may be configured to couple with a plurality of internal slits 156 , wherein medication and flushing fluid flow from the syringe system 500 through the smaller lumen 151 and ejected into the urine drainage lumen 120 .

[0070] In order to deliver medication and flushing fluid simultaneously to the bladder and urine drainage lumen, e.g. Figure 5B As shown, another embodiment of the present disclosure may have a crescent-shaped cavity 155, which is hereinafter named as a second crescent-shaped cavity in order to distinguish it from the other crescent-shaped cavity explained in the previous section. Figure 5B Illustrated along the Figure 1C The second crescent-shaped cavity 155 may have an inner surface (a) and an outer surface (b), and may be coupled to the distal end of the drug supply cavity 150 at the distal end portion 102 of the catheter, the crescent-shaped cavity enclosing a substantially circular area equal to or less than the cross-sectional area of ​​the distal end portion 102 of the catheter. Figure 5B As shown, the outer surface (b) of the second crescent-shaped cavity 155 can be connected to a plurality of infusion outlets 154 for injecting medicine or flushing fluid into the bladder, and the inner surface (a) of the second crescent-shaped cavity 155 can be connected to the inner slit 156 on the side wall of the urine drainage cavity 120 for injecting medicine or flushing fluid into the urine drainage cavity 120. This embodiment can avoid the use of a plurality of smaller cavities, thereby reducing the diameter of the urinary catheter.

[0071] In some embodiments of the present disclosure, certain provisions have been made to address the problem of urinary incontinence. There is a risk of infection associated with the conventional continuously open urine drainage cavity, which provides bacteria or other microorganisms with a direct access to the bladder. In order to solve this problem in the present disclosure, such as FIG. 6A to FIG. 6C As shown, a balloon blocking mechanism 137 can be configured to control the occlusion of the urine drainage lumen 120 in the urinary catheter 100. When the blocking balloon 132 is engaged, the balloon blocking mechanism 137 generally blocks the drainage lumen to prevent urine from being discharged through the drainage lumen of the urinary catheter. The balloon blocking mechanism 137 is located directly below the at least two distal openings 124 in the central portion 104 of the urinary catheter 100 and can include the urine drainage lumen 120, the restriction lumen 130 and the blocking balloon 132, and the balloon blocking mechanism 137 can be connected to the control device 200. As shown in FIG. FIG. 6A to FIG. 6C As shown, the urine drainage cavity 120 and the restriction cavity 130 are separated by an inner wall 135, wherein the thickness of the inner wall 135 is thinner in the central portion 104 than in the proximal portion 106 of the urinary catheter 100. Fig. 6A As shown, the distal end of the cavity 130 may be closed at a thinner inner wall 135 portion.

[0072] Figure 6B and Figure 6C The opening and closing conditions respectively occurring in the drainage cavity 120 described in the previous paragraph are specifically described. The blocking balloon 132 according to the same exemplary embodiment can be placed in the limiting cavity 130 and then pass through the limiting cavity 130 to block the urine drainage cavity 120. Due to the closed distal end of the cavity 130 at the thinner inner wall 135 portion, once the blocking balloon 132 passes through the limiting cavity 130, the blocking balloon 132 enters the urine drainage cavity 120.

[0073] Since the balloon blocking mechanism 137 is located directly below at least two distal openings 124 in the central portion 104 of the catheter 100, a very small amount of urine remains in the urine drainage cavity 120 during the closed state of the balloon blocking mechanism 137, thereby reducing the risk of urine solidifying in the urine drainage cavity 120 and the incidence of bacterial infection will also be controlled.

[0074] Various embodiments of the urinary catheter system of the present disclosure may include the ability to measure intra-bladder pressure via connection of one or more pressure balloons to the urinary catheter 100 or via insertion of one or more pressure balloons or pressure sensors within an associated lumen of the urinary catheter 100. Figure 1B and Figure 1C An exemplary embodiment of the present invention is shown, and Fig. 7AIn further detail in FIG. 1 , an inflatable pressure sensing balloon 164 may be placed at or near the distal end portion of the urinary catheter 102 in order to measure intra-bladder pressure to control automatic drainage of urine.

[0075] like Fig. 7A The pressure sensing balloon 164 shown can be coupled to a pressure sensing lumen 160 that is coupled to a pressure port 162 ( Figure 1B ) is connected. In an exemplary embodiment, Figure 7B As shown, the pressure sensing balloon 164 is formed of or includes a flexible membrane, wherein the surface area of ​​the membrane expands or contracts according to inflation of the balloon.

[0076] In an exemplary embodiment, in order to measure urine excretion flow, control automatic urine drainage, and deliver pharmaceutically active agents, the distal end or bladder-residing portion 102 of the catheter 100 can be inserted into the patient's bladder through the urethra, and the proximal portion 106 of the catheter can be connected to the control device 200 via a connection assembly 600 including a connection ring 601, wherein the lumens (120, 150, and 160) of the catheter can be connected to the fluid lines (602, 603, 604, and 605) of the control device 200, as shown. Figure 8 In an exemplary embodiment, the control device 200 may further include a pump-syringe system 500 and a balloon inflation system 400 .

[0077] In order to deliver the pharmaceutically active agent to the bladder through the drug delivery lumen 150, Fig. 9 In the illustrated exemplary embodiment of the present disclosure, the proximal infusion port 152 may be connected to the pump-syringe system 500 via a line 602. In this embodiment, the pump-syringe system 500 may include a drug storage unit 808, a syringe holder 807, a syringe heater 204 for heating the fluid in the syringe, a stepper motor 202, a temperature sensor 203, a guide rod 809, a threaded rod 810, a syringe arm portion 811, and a micro switch 501.

[0078] In an exemplary embodiment, the urine drainage chamber 120 can be connected to a pipeline drainage portion 603 that is in fluid communication with a urine drainage tube 804, which is configured to transport urine to a collection container (not shown). In this exemplary embodiment, the urine drainage tube 804 can be integrated with a flow meter sensor 801, or can operate without being integrated with the flow meter sensor 801. The flow meter sensor 801 in this exemplary embodiment is configured to measure the flow properties of urine while detecting bubbles, water or other obstructions that may form in the urine drainage chamber 120. The flow properties measured by the flow meter sensor 801 can be at least one or more of the following indicators: the volume, mass or velocity of urine passing through or approaching the flow meter.

[0079] In some exemplary embodiments, the control device 200 ( Figures 8 to 11 ) may include a keyboard 802 for setting the operating mode and a screen 803 for displaying various indicators, such as the amount of urine emptied from the bladder and / or the amount of medication delivered.

[0080] In another exemplary embodiment of the present disclosure, Fig.11 As shown, the pressure port 162 can be connected to a line 604, which is in fluid communication with a port 805 connected to the balloon inflation system 400. In this exemplary embodiment, the balloon inflation system 400 may include a pressure gauge sensor 401 for measuring bladder pressure, a pressure gauge sensor 402 for controlling the pressure of the blocking balloon 132, an air pump 404 for inflating the balloon, a plurality of connecting tubes 405, and at least two electric valves 403 for controlling air flow.

[0081] In an exemplary embodiment, occluder balloon port 132 and pressure port 162 may be connected to balloon inflation system 400 via lines 604 and 605, respectively.

[0082] In addition to measuring urine excretion flow and delivering pharmaceutically active agents via the control device 200, embodiments of the systems and methods disclosed in the present disclosure may also include an automated urine drainage system. FIG. 6A to FIG. 6C As shown, when the catheter is inserted into the bladder, the deflated blocking balloon 132 is configured to be filled with air and can pass through the restriction cavity 130 to close the urine drainage cavity 120. When the inflation fluid is applied to the deflated blocking balloon 132, the balloon is inflated to a fully expanded condition and passes through the thin inner wall 135 of the cavity 130 to block the urine drainage cavity 120. The fluid can then enter the pressure sensing cavity 160, which can result in filling the pressure sensing balloon 164 including the pressure sensing interface to measure the bladder pressure. The amount of air volume that should enter the pressure sensing balloon 164 is measured by the pressure gauge sensor 402. Therefore, the tuning system (not shown) can detect the optimal target pressure and volume for inflating the pressure sensing balloon 164, and add or remove air or fluid volume as needed until the pressure in the balloon 164 is equal to the pressure in the bladder.

[0083] According to the illustrated exemplary embodiment, once the pressure in the bladder is measured, the valve 806 can be opened and maintained in an open state until the occluding balloon 132 is deflated. When the occluding balloon 132 is deflated within the restriction cavity 130, fluid (urine, drug media and agents according to the present disclosure) is allowed to flow along the urine drainage cavity 120 between the at least two distal openings 124 and the proximal port 122, and can flow out to the pipeline drainage portion 603. Therefore, when urine enters the urine drainage tube 804, the urine pump 201 can be activated to pump the urine to the collection container.

[0084] In this exemplary embodiment, the flow meter can measure the actual volume of urine passing through the flow meter, and when the detected volume reaches a substantially full state, the blocking balloon 132 can be inflated and block the urine drainage chamber 120. In one aspect, in order to avoid sudden discharge of urine and / or bladder bleeding, the emptying step can be performed intermittently every 15 minutes, or as needed. Therefore, automatic urine drainage can be controlled by measuring the amount of urine.

[0085] Alternatively, measuring the pressure difference between the bladder and the pressure sensing balloon 164 is another way to control automatic urine drainage. In an exemplary embodiment, as the volume of urine in the bladder increases, the pressure on the pressure sensing balloon 164 will also increase, and when the detected pressure reaches its limit state, the urine drainage process can be allowed to flow in the urine drainage chamber 120. Once the pressure in the balloon 164 is equal to the pressure in the bladder, it can be understood that there is no urine in the bladder, and the urine drainage process can eventually be stopped. Therefore, when the bladder is emptied of urine; the drug pump can be activated to spray the drug or fluid that has been brought to the desired temperature by the heater 204 into the bladder and the urine drainage chamber 120, and then the bladder can be emptied again.

Claims

1. A medical device, comprising: a urinary catheter 100 comprising a distal portion 102, a central portion 104 and a proximal portion 106, wherein one or more openings are defined at the distal portion, a plurality of lumens are disposed along a longitudinal axis of the urinary catheter 100, wherein each of the plurality of lumens has a distal end in the distal portion and a proximal end in the proximal portion of the urinary catheter 100; Wherein, the plurality of cavities include: a urine drainage lumen 120 in fluid communication with at least two distal openings 124 at the distal portion 102 , wherein urine is drawn out through the urine drainage lumen 120 through the distal openings 124 ; a balloon inflation lumen 140 in fluid communication with at least two indwelling balloons 144, wherein each indwelling balloon 144 is mounted on an edge of one of the distal openings 124 in the distal portion 102 of the urinary catheter 100; and a drug supply lumen 150 , which is in fluid communication with a plurality of infusion outlets 154 at the distal end portion 102 of the catheter 110 and a plurality of inner slits 156 on the side wall of the urine drainage lumen 120 , wherein the drug supply lumen 150 is in fluid communication with the urine drainage lumen 120 via the plurality of inner slits 156 .

2. The medical device according to claim 1, wherein: Each of the indwelling balloons 144 has a teardrop shape with a concavely curved side surface at one end.

3. The medical device according to claim 1, wherein: The urine drainage lumen 120 is in fluid communication with a proximal drainage port 122 at the proximal portion 106 .

4. The medical device according to claim 1, wherein: The balloon inflation lumen 140 is in fluid communication with a proximal balloon port 142 at the proximal portion 106 of the urinary catheter 100 .

5. The medical device according to claim 1, wherein: The drug supply lumen 150 is in fluid communication with a proximal infusion port 152 at the proximal portion 106 of the urinary catheter 100 .

6. The medical device according to claim 1, wherein: The urinary catheter 100 further includes a first crescent-shaped cavity 146 connected to the indwelling balloon 144 .

7. The medical device according to claim 1, wherein: The urinary catheter 100 further includes a second crescent-shaped lumen 155 coupled to the distal end of the drug supply lumen 150 and having an inner surface and an outer surface.

8. The medical device according to claim 7, wherein: An outer surface of the second crescent-shaped cavity 155 is coupled to the plurality of infusion outlets 154 .

9. The medical device according to claim 6, wherein: The inner surface of the second crescent-shaped cavity 155 is coupled to the plurality of inner slits 156 .

10. The medical device according to claim 1, wherein: The urinary catheter 100 further includes a restriction cavity 130 located beside the urine drainage cavity 120 .

11. The medical device according to claim 10, wherein: The urine drainage cavity 120 and the restriction cavity 130 are separated by an inner wall 135 .

12. The medical device according to claim 12, wherein: The thickness of the inner wall 135 is thinner in the central portion 104 than in the proximal portion 106 of the catheter.

13. The medical device according to claim 10, wherein: The distal end of the cavity 130 is closed at a thinner inner wall 135 portion.

14. The medical device according to claim 12, wherein: The thinner inner wall 135 of the central portion 104 is closer to the distal portion 102 than to the proximal portion 106 .

15. The medical device according to claim 10, wherein: The urinary catheter 100 further includes a blocking balloon 132 located within the restriction cavity 130 .

16. The medical device according to claim 15, wherein: The blocking balloon 132 is mounted on the thinner inner wall 135 of the central portion 104 .

17. The medical device according to claim 1, wherein: The urinary catheter 100 further includes a pressure sensing balloon 164 located at the distal end portion 102 of the urinary catheter 100 and in fluid communication with the pressure sensing lumen 160 .

18. The medical device according to claim 1, wherein: The pressure sensing lumen 160 is in fluid communication with a pressure port 162 at the proximal portion 106 of the urinary catheter 100 .

19. A medical device system, comprising: - a urinary catheter, comprising: - at least one opening near or at the distal end of the catheter; a plurality of lumens disposed along the longitudinal axis of the body of the catheter; wherein each lumen has a distal end and a proximal end; a urine drainage lumen 120 in fluid communication with at least two distal openings 124 present in the distal portion 102; a restriction lumen 130 located beside the urine drainage lumen 120; wherein the urine drainage lumen 120 and the restriction lumen 130 are separated by an inner wall 135; a blocking balloon 132 located within the restriction lumen 130; a pressure sensing balloon 164 located at the distal end of the catheter and in fluid communication with the pressure sensing lumen 160; and - control device 200; The control device 200 is connected to the proximal portion 106 of the urinary catheter 100 .

20. The medical device system of claim 19, wherein: The control device 200 is coupled to the proximal portion 106 via a plurality of fluid lines ( 602 , 603 , 604 , and 605 ).

21. The medical device system of claim 20, wherein: The plurality of fluid pipelines are assembled together via a connecting ring 601 .

22. The medical device system of claim 19, wherein: The control device 200 drains urine from the urine drainage cavity 120 to the collection container.

23. The medical device system of claim 19, wherein: The drainage flow rate of the urine is measured via the control device 200 .

24. The medical device system of claim 19, wherein: Bladder pressure is measured via the control device 200 .

25. The medical device system of claim 19, wherein: The control device 200 controls the opening of the urine drainage cavity 120 .

26. A method for discharging a fluid, the method comprising: - positioning a urinary catheter into the subject; The urinary catheter comprises: at least one opening at the distal portion of the urinary catheter; a plurality of cavities disposed along the longitudinal axis of the body of the urinary catheter; wherein each cavity has a distal end and a proximal end; a urine drainage cavity 120 configured to be in fluid communication with at least two distal openings 124; a restriction cavity 130 located beside the urine drainage cavity 120; wherein the urine drainage cavity 120 and the restriction cavity 130 are separated by an inner wall 135; a blocking balloon 132 located in the restriction cavity 130; a pressure sensing balloon 164 located at the distal end of the urinary catheter and in fluid communication with the pressure sensing cavity 160; - connecting the control device 200 to communicate with the urinary catheter 100, wherein the control device 200 includes a balloon inflation system 400, a pump-syringe system 500 and a connection assembly 600; - inflating the blocking balloon 132 via the balloon inflation system 400 to pass through the inner wall 135 of the restriction cavity 130, thereby occluding the urine drainage cavity 120; filling the pressure sensing balloon 164 via the balloon inflation system 400 to measure bladder pressure; - when the pressure difference between the body subject and the balloon increases to a level higher than a limit state of the pressure difference, the blocking balloon 132 is deflated to open the urine drainage lumen 120 so that the fluid is allowed to flow along the urine drainage lumen 120; - when the pressure in the pressure sensing balloon 164 equals the pressure in the bladder, inflating the blocking balloon 132 to block the urine drainage cavity; and - Injecting medicine or fluid into the subject's body and into the urine drainage lumen 120 .

Images