The present specification generally relates to drainage shunt devices and methods for draining ascites fluid from peritoneal cavities and, more specifically, to peritoneal shunt devices to drain non-malignant ascites fluids and methods for draining non-malignant ascites fluids.
Shunt devices are used to drain fluid from an area within the body. Specifically, peritoneal shunt devices are used to drain ascites fluid from the peritoneal cavity of a subject. Ascites is the accumulation of fluid within the abdomen. In order to drain the fluid from the peritoneal cavity, shunt devices may rely on electronic pumps which provide consistent pressure to pump the fluid from the peritoneal cavity to the central venous system or the bladder of the subject. However, since the pump would always be activated in order to drain the fluid, the battery life of the pump diminishes, and needs recharging. If the pump were to stop functioning, no fluid would be drained from the peritoneal cavity, causing complications to the subject. Even further, blockages may form within the shunt devices as fluid passes through them. In order to clear the blockages within the shunt, varying pressures must be produced within the shunt.
Accordingly, there is a need for peritoneal shunt devices that drain fluid from the peritoneal cavity and clear blockages within the shunt passively.
According to a first aspect, a shunt for draining fluid, including a first catheter, an electronic pump fluidly coupled to the first catheter, a manual pump fluidly coupled to the electronic pump, and a second catheter fluidly coupled to the manual pump. During drainage operation, a fluid is passively pressure-driven through the shunt, and the electronic pump is arranged to prevent blockages within the shunt by flowing a bolus of the fluid through the shunt.
According to a second aspect, a shunt according to the previous aspect, further comprising a control unit that operates the electronic pump at discrete time intervals.
According to a third aspect, a shunt according to any of the previous aspects, wherein the electronic pump moves the bolus of fluid as a pressure wave of the fluid flowing through the shunt at a greater pressure than the fluid being pressure-driven through the shunt.
According to a fourth aspect, a shunt according to any of the previous aspects, further comprising a one-way valve fluidly coupled to the second catheter.
According to a fifth aspect, a shunt according to any of the previous aspects, wherein the first catheter, the electronic pump, the manual pump, the second catheter, and the one-way valve are serially arranged to form the shunt.
According to a sixth aspect, a shunt according to any of the previous aspects, wherein the first catheter is configured to be arranged within a peritoneal space of a subject in order to drain fluid from the peritoneal space.
According to a seventh aspect, a shunt according to any of the previous aspects, wherein the second catheter is configured to be arranged within a bladder of the subject in order to fluidly couple the peritoneal space of the subject with the bladder of the subject.
According to an eighth aspect, a shunt according to any of the previous aspects, wherein the one-way valve inhibits fluid within the bladder from flowing through the shunt.
According to a ninth aspect, wherein the manual pump is arranged and configured to move a bolus of the fluid through the shunt based on a manual activation.
According to a tenth aspect, a shunt for draining a fluid from a peritoneal cavity, including a first catheter, an electronic pump, a manual pump, a second catheter, and a one-way valve. The first catheter is configured to be arranged within the peritoneal cavity of a subject. The electronic pump is fluidly coupled to the first catheter. The manual pump is fluidly coupled to the first catheter. The second catheter is configured to be arranged within a bladder of a subject and is fluidly coupled to the electronic pump and the manual pump. A one-way valve is fluidly coupled to the second catheter and configured to inhibit a back-flow of the fluid from the bladder through the second catheter. The electronic pump is arranged and configured to move a bolus of the fluid in order to inhibit blockages within the shunt. The manual pump is arranged and configured to move a bolus of the fluid in order to inhibit blockages within the shunt when the electronic pump cannot create the bolus of fluid.
According to an eleventh aspect, a shunt according to any of the previous aspects, further comprising a control unit that operates the electronic pump at preselected time intervals.
According to a twelfth aspect, a shunt according to any of the previous aspects, wherein the electronic pump moves the bolus of fluid as a pressure wave of the fluid flowing through the shunt at a greater pressure than the fluid being passively pressure-driven through the shunt.
According to a thirteenth aspect, a shunt according to any of the previous aspects, wherein the electronic pump and the manual pump are arranged and configured to be outside of the peritoneal cavity.
According to a fourteenth aspect, a shunt according to any of the previous aspects, wherein the first catheter, the electronic pump, the manual pump, the second catheter, and the one-way valve are serially arranged to form the shunt.
According to a fifteenth aspect, a shunt according to any of the previous aspects, wherein the electronic pump and the manual pump are fluidly coupled in parallel.
According to a sixteenth aspect, a method of draining a peritoneal cavity of a fluid includes arranging a first catheter within the peritoneal cavity of a subject and arranging a second catheter within a bladder of the subject. The first catheter and the second catheter are fluidly coupled. The fluid from the peritoneal cavity is passively moved to the bladder through the first catheter and the second catheter due to a pressure differential between the peritoneal cavity and the bladder. A first bolus of fluid is moved via an electronic pump fluidly coupled to first catheter and the second catheter. A second bolus of fluid is moved via a manual pump fluidly coupled to the first catheter and the second catheter when the electronic pump cannot create the first bolus of fluid. The first bolus of fluid or the second bolus of fluid is flowed through the second catheter in order to reduce a blockage within the second. catheter
According to a seventeenth aspect, a method of draining a peritoneal cavity of a fluid according to any of the previous aspects, wherein the first bolus of fluid and the second bolus of fluid are moved at preselected time intervals.
According to an eighteenth aspect, a method of draining a peritoneal cavity of a fluid according to any of the previous aspects, wherein the first bolus of fluid and the second bolus of fluid are pressure waves of the fluid flowing through the second catheter at a greater pressure than the fluid flowing from the peritoneal cavity to the bladder through the second catheter due to the pressure differential between the peritoneal cavity and the bladder.
According to a nineteenth aspect, a method of draining a peritoneal cavity of a fluid according to any of the previous aspects, wherein a one-way valve is fluidly coupled to the second catheter in order to inhibit a back-flow of the fluid from the bladder through the second catheter.
According to a twentieth aspect, a method of draining a peritoneal cavity of a fluid according to any of the previous aspects, wherein the electronic pump and the manual pump are only used to move the first bolus of the fluid or the second bolus of the fluid.
These and additional features provided by the embodiments described herein will be more fully understood in view of the following detailed description, in conjunction with the drawings.
The embodiments set forth in the drawings are illustrative and exemplary in nature and not intended to limit the subject matter defined by the claims. The following detailed description of the illustrative embodiments can be understood when read in conjunction with the following drawings, where like structure is indicated with like reference numerals and in which:
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The electronic pump 102 is fluidly coupled to the first catheter 108 to draw fluid to flow from the first catheter 108 through the electronic pump 102. The first catheter 108 includes a tip portion 130, which is arranged to be placed within the peritoneal cavity of a subject. In embodiments, the first catheter 108 is long enough to arrange the tip portion 130 within the peritoneal cavity of a subject, while allowing the electronic pump 102 to be arranged outside of the peritoneal cavity, but within a subject's body. The first catheter 108 may be any type of flexible tubing suitable to be inserted within a subject's body. Additionally, in embodiments, the first catheter 108 may be shaped in various forms in order to secure the first catheter 108 within a peritoneal cavity. For example, the tip portion 130 may be bent in a curve or spiral shape in order to secure the tip portion 130 within a peritoneal cavity.
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Arranged on the opposite side of the one-way valve 106 from the manual pump 110 is the second catheter 110. The second catheter 110 includes a tip portion 136 which is inserted into the bladder of a subject. The second catheter 110 may be any type of flexible tubing suitable to be inserted within a subject's body. Additionally, in embodiments, the second catheter 110 may be shaped in various forms in order to secure the second catheter 110 within a peritoneal cavity. For example, the tip portion 136 may be bent in a curve or spiral shape in order to secure the tip portion 136 within a peritoneal cavity.
Referring now to
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Due to the arrangement of the shunt device 100 within the body 16 of the subject 10, with the first catheter 108 arranged within the peritoneal cavity 12 and the second catheter 110 arranged within the bladder 14, a passive pressure-driven flow of fluid 18 can be formed between the peritoneal cavity 12 and the bladder 14 through the shunt device 100. Since the peritoneal cavity 12 and the bladder 14 are fluidly coupled, any pressure gradient between the peritoneal cavity 12 and the bladder 14 will create a pressure-driven flow of fluid 18. For example, as pressure increases within the peritoneal cavity 12, the fluid 18 stored within the peritoneal cavity 12 will be forced through the first catheter 108 as a pressure release for the peritoneal cavity 12. The pressure within the peritoneal cavity 12 may be increased by having the subject exert their diaphragm into their abdominal cavity, or by breathing normally. Since the action of breathing or exerting a diaphragm does not increase the pressure within the bladder 14, a pressure gradient is formed between the peritoneal cavity 12 and the bladder 14, with the high pressure being present in the peritoneal cavity 12, and the low pressure being present in the bladder 14. This difference in pressures passively flows the fluid 18 from the peritoneal cavity 12 to the bladder 14, without the need of additional pumping mechanisms. Due to the arrangement of the electronic pump 102 and the manual pump 104 being in fluid communication, the passive pressure driven flow may still flow through the shunt device 100 even when the pumps are not activated.
As the fluid 18 flows from the peritoneal cavity 12 to the bladder 14 through the shunt device 100, biological material may be present within the fluid and can form potential blockages within the shunt device 100 as the biological material collects on the inner surfaces of the fluid channels forming the shunt device 100. In order to prevent blockages, or to clear blockages, a bolus of fluid may be created and flowed through the components of the shunt device 100 in order to remove the biological matter to the bladder 14. A bolus of fluid is a pressure wave of the fluid 18 flowing through the shunt device 100 at a greater pressure than the fluid 18 being passively pressure-driven through the shunt device 100. The bolus of fluid may be formed by either the electronic pump 102 and/or the manual pump 104. In embodiments, the electronic pump 102 is programed to activate and create a bolus of fluid at discrete time intervals throughout the day. The purpose of having discrete time intervals to create a blockage clearing bolus is to prevent blockages from forming initially. Since the electronic pump 102 only activates for short periods of time, and only a few times per day, the battery life of the electronic pump 102 may be extended when compared to shunt devices which routinely require a pump to drain the fluid 18 from the peritoneal cavity 12 at a constant rate.
In the event that the electronic pump 102 cannot create a bolus of fluid to prevent or clear blockages within the shunt device 100, the manual pump 104 may be used to create the bolus of fluid. Situations where the electronic pump 102 may fail include a malfunction with the electrical components, the mechanical components, or a depleted battery. In these situations, without the presence of the manual pump 104, the subject 10 would be required to undergo immediate surgery to replace the electronic pump 102, otherwise excessive fluid 18 may build up within the peritoneal cavity 12 of the subject, which may cause other related health problems. The manual pump 104 may be used to create a bolus of fluid, of the same or greater pressure than that of the electronic pump 102, in order to prevent or clear blockages within the shunt device 100. If the manual pump 104 is required to be used, the subject 10 should pump the manual pump 104 at discrete time intervals throughout the day of a set number of pumps. For example, the subject should pump the manual pump 104 every twelve hours for at least twenty individual pumps. This would create a sufficient bolus of fluid 18 to clear any biological material within the shunt device 100.
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At step 404, a second catheter is arranged within a bladder of the subject. Referring to
At step 406, fluid is flowed form the peritoneal cavity to the bladder. Referring to
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At step 412, the first bolus of fluid or the second bolus of fluid are flowed through the second catheter. Referring to the example described in the preceding paragraphs, a bolus of fluid 18 is propagated through the tubing of the shunt device 100 in order to remove any biological material which may form a blockage within the shunt device 100. Depending on the bolus creating state of the electronic pump 102, the bolus of fluid 18 may be create using the manual pump 104. If the electronic pump 102 is capable of creating a bolus of fluid 18, then the manual pump 104 would not be required to create a bolus of fluid 18.
It should now be understood that embodiments described herein are directed to a shunt device for draining non-malignant ascites fluid. The shunt device includes an electronic pump, a manual pump, a one-way valve, a first catheter, and a second catheter. The shunt device may be used in order to drain ascites fluid from the peritoneal cavity of a subject to the bladder of a subject, in order to remove the ascites fluid from the subject's body. For example, the first catheter may be arranged within the peritoneal cavity, and the second catheter may be arranged within the bladder, fluidly coupling the peritoneal cavity to the bladder. Accordingly, ascites fluid from the peritoneal cavity will flow to the bladder due to a pressure gradient between the peritoneal cavity and the bladder. Furthermore, the electronic pump and manual pump may be arranged to create a bolus of fluid at varying time intervals in order to clear any blockages that may have formed within the shunt device. The manual pump may only be required to create a bolus of fluid when the electronic pump is unable to create a bolus of fluid due to a malfunction or loss of power. The electronic pump activates automatically based on a pre-programmed time interval to allow a subject to not have to manually pump the shunt device in order to clear any biological material form the shunt device.
It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments described herein without departing from the spirit and scope of the claimed subject matter. Thus it is intended that the specification cover the modifications and variations of the various embodiments described herein provided such modification and variations come within the scope of the appended claims and their equivalents.
This application claims priority to U.S. Provisional Patent Application No. 63/014,204, filed on Apr. 23, 2020, the entire disclosure of which is hereby incorporated by reference.
Filing Document | Filing Date | Country | Kind |
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PCT/US2021/028097 | 4/20/2021 | WO |
Number | Date | Country | |
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63014204 | Apr 2020 | US |