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Title:
PARALLEL AIR LINE SEQUENTIAL PULSATILE PUMP
Document Type and Number:
WIPO Patent Application WO/2021/158332
Kind Code:
A1
Abstract:
Embodiments disclosed herein are directed to a parallel airline sequential pulsatile pump system for moving a fluid through the lumen of a drainage tube to mitigate pooling of fluid therein. Inflating the balloon can result in sequential constriction of the drainage lumen along an axial length thereof to urge a fluid disposed within the drainage lumen toward a container. Embodiments include, for example, the balloon disposed within the drainage lumen, the balloon disposed on an outer surface of the drainage tube, the balloon within a wall of the drainage tube, and combinations thereof. The balloon can include two or more balloons disposed along an axial length and inflated sequentially, The balloon can include compartments fluidly coupled within the balloon, divided by partitions, such that a first compartment will inflate to an expanded configuration prior to a second compartment inflating.

Inventors:
WALTHALL JILL (US)
GLOECKNER D CLAIRE (US)
Application Number:
PCT/US2021/012948
Publication Date:
August 12, 2021
Filing Date:
January 11, 2021
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
BARD INC C R (US)
International Classes:
A61M1/00; F04B43/113; F04B43/12
Foreign References:
GB2235256A1991-02-27
EP1122435A12001-08-08
US4250872A1981-02-17
US202062969875P2020-02-04
Attorney, Agent or Firm:
WIGHT, Todd W. (US)
Download PDF:
Claims:
CLAIMS

What is claimed is:

1. A drainage system, comprising: a first elongate balloon including a first inflation port, and a plurality of individually inflatable compartments designed to inflate sequentially from a first end to a second end, opposite of the first end of the first elongate balloon, wherein each of the inflatable compartments are designed for individual inflation to close a section of a drainage lumen, and individual deflation to open the section of the drainage lumen; and a pulsatile pump in fluid communication with the first inflation port and designed to selectively inflate the first elongate balloon.

2. The drainage system according to claim 1, wherein the plurality of individually inflatable compartments includes a first compartment separated axially from a second compartment by a partition disposed therebetween.

3. The drainage system according to claim 2, wherein the partition includes one of an aperture, a valve, or a thickened portion of a side wall of the first elongate balloon, and provides fluid communication between the first compartment and the second compartment.

4. The drainage system according to any claim of claims 1-3, further comprising a collection container, wherein the sequential inflation of the plurality of inflatable compartments from the first end to the second end moves fluid in the drainage lumen into the collection container.

5. The drainage system according to any claim of claims 1-4, further comprising a drainage tube having the drainage lumen, wherein the first elongate balloon is disposed in the drainage lumen, and wherein each of the inflatable compartments are designed to inflate radially outward to substantially fill the section of the drainage lumen.

6. The drainage system according to any claim of claims 1-5, wherein the first elongate balloon is disposed on an outer surface of a drainage tube having the drainage lumen, and wherein each of the inflatable compartments are designed to inflate radially inward to constrict a section of the drainage lumen.

7. The drainage system according to claim 6, further including an outer jacket disposed on an outer surface of the first elongate balloon and designed to inhibit the first elongate balloon from expanding radially outward.

8. The drainage system according to claim 7, wherein the outer jacket further includes an elongate opening to allow ingress or egress of the drainage tube therefrom.

9. The drainage system according to any claim of claims 1-8, wherein the first elongate balloon is disposed within a wall of a drainage tube having the drainage lumen, and wherein each of the inflatable compartments are designed to inflate radially inward to constrict a section of the drainage lumen.

10. The drainage system according to claim 9, wherein a thickness of the wall of the drainage tube between the first elongate balloon and an outer surface of the drainage tube is greater than a thickness of the wall of the drainage tube between the first elongate balloon and the drainage lumen.

11. The drainage according to claim 9, wherein each of the inflatable compartments extend annularly to surround the drainage lumen.

12. The drainage according to claim 9, wherein each of the inflatable compartments extend about the drainage lumen through an arc of less than 360°.

13. The drainage system according to any claim of claims 1-12, further including a second elongate balloon, including a second inflation port, a distal end of the second elongate balloon disposed adjacent a proximal end of the first elongate balloon.

14. The drainage system according to claim 13, wherein the pulsatile pump is in fluid communication with the second inflation port, and is designed to inflate the first elongate balloon before inflating the second elongate balloon.

15. A method of moving fluid through a drainage lumen, comprising: inflating a plurality of inflatable compartments of an elongate balloon in a sequential manner from a distal end to a proximal end, the elongate balloon extending parallel to an axis of the drainage lumen; closing a plurality of sections of the drainage lumen in a sequential manner from a distal end to a proximal end; and urging fluid disposed within the drainage lumen in a proximal direction.

16. The method according to claim 15, wherein the plurality of individually inflatable compartments includes a first compartment separated axially from a second compartment by a partition disposed therebetween.

17. The method according to claim 16, wherein the partition includes one of an aperture, a valve, or a thickened portion of a side wall of the elongate balloon, and provides fluid communication between the first compartment and the second compartment.

18. The method according to any claim of claims 15-17, further comprising a drainage tube having the drainage lumen, wherein the first elongate balloon is disposed in the drainage lumen, and wherein each of the inflatable compartments are designed to inflate radially outward to substantially fill the section of the drainage lumen.

19. The method according to any claim of claims 15-18, wherein the first elongate balloon is disposed on an outer surface of a drainage tube having the drainage lumen, and wherein each of the inflatable compartments are designed to inflate radially inward to constrict the section of the drainage lumen.

20. The method according to any claim of claims 15-19, wherein the first elongate balloon is disposed within a wall of a drainage tube having the drainage lumen, and wherein each of the inflatable compartments are designed to inflate radially inward to constrict the section of the drainage lumen.

Description:
PARALLEL AIR LINE SEQUENTIAL PULSATILE PUMP

PRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Application

No. 62/969,875, filed February 4, 2020, which is incorporated by reference in its entirety into this application.

SUMMARY

[0002] Briefly summarized, systems and methods disclosed herein are directed to a parallel airline sequential pulsatile pump for moving a fluid through a drainage tube lumen to mitigate the pooling of fluid therein. Dependent loops are formed within drainage tubes when slack portions of tube create a positive incline. These dependent loops trap fluid and can create a retrograde flow, leading to various complications. For example, urine pooling within a drainage tube can become a source of catheter associated urinary tract infection (“CAUTI”) causing agents such as bacteria, microbes, and the like. Hospital Acquired Infections (“HAT’), such as CAUTI, are detrimental to the patient, and also incur extra costs in treating these additional complications.

[0003] Disclosed herein is a drainage system including, a first elongate balloon including a first inflation port, and a plurality of individually inflatable compartments designed to inflate sequentially from a first end to a second end, opposite of the first end of the first elongate balloon, wherein each of the inflatable compartments are designed for individual inflation to close a section of a drainage lumen, and individual deflation to open the section of the drainage lumen, and a pulsatile pump in fluid communication with the first inflation port and designed to selectively inflate the first elongate balloon.

[0004] In some embodiments, the plurality of individually inflatable compartments includes a first compartment separated axially from a second compartment by a partition disposed therebetween. The partition includes one of an aperture, a valve, or a thickened portion of a side wall of the first elongate balloon, and provides fluid communication between the first compartment and the second compartment. In some embodiments, the drainage system further includes a collection container, wherein the sequential inflation of the plurality of inflatable compartments from the first end to the second end moves fluid in the drainage lumen into the collection container. [0005] In some embodiments, the drainage system further includes a drainage tube having the drainage lumen, wherein the first elongate balloon is disposed in the drainage lumen, and wherein each of the inflatable compartments are designed to inflate radially outward to substantially fill the section of the drainage lumen. The first elongate balloon is disposed on an outer surface of a drainage tube having the drainage lumen, and wherein each of the inflatable compartments are designed to inflate radially inward to constrict a section of the drainage lumen. In some embodiments, the drainage system further includes an outer jacket disposed on an outer surface of the first elongate balloon and designed to inhibit the first elongate balloon from expanding radially outward.

[0006] In some embodiments, the outer jacket further includes an elongate opening to allow ingress or egress of the drainage tube therefrom. The first elongate balloon is disposed within a wall of a drainage tube having the drainage lumen, and wherein each of the inflatable compartments are designed to inflate radially inward to constrict a section of the drainage lumen. In some embodiments, a thickness of the wall of the drainage tube between the first elongate balloon and an outer surface of the drainage tube is greater than a thickness of the wall of the drainage tube between the first elongate balloon and the drainage lumen.

[0007] In some embodiments, each of the inflatable compartments extend annularly to surround the drainage lumen. Each of the inflatable compartments extend about the drainage lumen through an arc of less than 360°. In some embodiments, the drainage system further includes a second elongate balloon, including a second inflation port, a distal end of the second elongate balloon disposed adjacent a proximal end of the first elongate balloon. The pulsatile pump is in fluid communication with the second inflation port, and is designed to inflate the first elongate balloon before inflating the second elongate balloon.

[0008] Also disclosed is a method of moving fluid through a drainage lumen including, inflating a plurality of inflatable compartments of an elongate balloon in a sequential manner from a distal end to a proximal end, the elongate balloon extending parallel to an axis of the drainage lumen, closing a plurality of sections of the drainage lumen in a sequential manner from a distal end to a proximal end, and urging fluid disposed within the drainage lumen in a proximal direction.

[0009] In some embodiments, the plurality of individually inflatable compartments includes a first compartment separated axially from a second compartment by a partition disposed therebetween. The partition includes one of an aperture, a valve, or a thickened portion of a side wall of the elongate balloon, and provides fluid communication between the first compartment and the second compartment. In some embodiments, the method further includes a drainage tube having the drainage lumen, wherein the first elongate balloon is disposed in the drainage lumen, and wherein each of the inflatable compartments are designed to inflate radially outward to substantially fill the section of the drainage lumen. The first elongate balloon is disposed on an outer surface of a drainage tube having the drainage lumen, and wherein each of the inflatable compartments are designed to inflate radially inward to constrict the section of the drainage lumen. The first elongate balloon is disposed within a wall of a drainage tube having the drainage lumen, and wherein each of the inflatable compartments are designed to inflate radially inward to constrict the section of the drainage lumen.

DRAWINGS

[0010] A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0011] FIG. 1 shows an exemplary catheter and fluid collection system, in accordance with embodiments disclosed herein.

[0012] FIG. 2A shows a fluid collection system including a sequential pulsatile pump system, in accordance with embodiments disclosed herein.

[0013] FIG. 2B shows a fluid collection system including a sequential pulsatile pump system, in accordance with embodiments disclosed herein.

[0014] FIGS. 3A-3F show close up details of a sequential pulsatile pump system, in accordance with embodiments disclosed herein.

[0015] FIG. 4A shows a fluid collection system including a sequential pulsatile pump system, in accordance with embodiments disclosed herein. [0016] FIG. 4B shows a cross-sectional view of the system of FIG. 4A, in accordance with embodiments disclosed herein.

[0017] FIGS. 5A-5D show close up details of a sequential pulsatile pump system, in accordance with embodiments disclosed herein.

[0018] FIGS. 6A-6D show close up details of a sequential pulsatile pump system, in accordance with embodiments disclosed herein.

[0019] FIGS. 7A-7B show cross-sectional views of a sequential pulsatile pump system, in accordance with embodiments disclosed herein.

[0020] FIG. 7C shows close up details of a sequential pulsatile pump system, in accordance with embodiments disclosed herein.

DESCRIPTION

[0021] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

[0022] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. [0023] With respect to “proximal,” a “proximal portion” or a “proximal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Likewise, a “proximal length” of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient. A “proximal end” of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter.

[0024] With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, a “distal length” of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient. A “distal end” of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient. The distal portion, the distal end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter.

[0025] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

[0026] FIG. 1 shows an exemplary fluid collection system 100, which generally includes a catheter 110, a drainage tube (“tube”) 120, and a collection container (“container”) 130. Exemplary catheters 110 include indwelling catheters, Foley catheters, balloon catheters, peritoneal drainage catheters, or the like, and are configured to be inserted into an orifice within the body of a patient to drain a fluid therefrom. In an embodiment, the catheter 110 can be inserted through the urethra and into a bladder of a patient. The catheter 110 includes an eyelet 112 that provides fluid communication with a lumen of the catheter 110, and is configured to drain a fluid, e.g. urine. [0027] The tube 120 extends from a distal end 128 to a proximal end 126 to define an axial length, and defines a lumen. The distal end 128 of the tube 120 is configured to engage a proximal 116 end of the catheter 110. The tube 120 provides fluid communication between the lumen of the catheter 110 and the collection container 130. The tube 120 can be formed of rubber, plastic, polymer, silicone, or similar suitably compliant material. The collection container 130 can include a rigid container, a flexible collection bag, or similar suitable container for receiving a fluid, e.g. urine, drained from the catheter 110. In an embodiment, the container 130 includes graduated markings 102 for measuring a fluid disposed therein. As shown in FIG. 1, dependent loops 122 can form when slack portions of the tube 120 create a positive incline relative to the direction of fluid flow. This can lead to fluid pooling within the tube and can be detrimental to the patient.

[0028] FIGS. 2A-3F show embodiments of a fluid collection system including a sequential pulsatile pump system (“system”) 200. The pump system 200 includes a drainage tube 220, an elongate peristalsis balloon (“balloon”) 240 disposed within the tube lumen 224, and a pump device 204 coupled with the balloon 240. The system 200 can be coupled with a catheter 110 disposed at a distal end, and coupled with a collection container 130 disposed at a proximal end, to provide fluid communication therebetween. In an embodiment, the system 200 can be provided as part of a kit including a catheter 110 and/or collection container 130.

[0029] In an embodiment, the system 200 can further include a one-way valve 218, disposed between the proximal end 116 of the catheter 110 and the distal end 228 of the tube 220. The valve 218 is designed to prevent retrograde flow of fluid from the drainage tube lumen 224 into the lumen of the catheter 110. In an embodiment, one or more of the catheter 110, valve 218, the drainage tube 220, or collection container 130, or combinations thereof, are connected using a luer lock, spin nut, or similar suitable fluid connection.

[0030] The balloon 240 can extend axially through at least a portion of the tube lumen

224. In an embodiment, the balloon 240 extends through the entire length of the tube lumen 224, from the distal end 228 to the proximal end 226. The balloon 240 is in fluid communication with an inflation port 238 that extends through a side wall of the tube 220. The inflation port 238 can be sealed with the side wall of the tube 220 to prevent any fluids escaping from the tube lumen 224, between the outside of the inflation port 238 and the side wall of the tube 220. The inflation port 238 can be sealed in place using adhesive, bonding, ultrasonic welding, or similar suitable methods. Although only a single inflation port 238 is shown, it will be appreciated that the balloon can include two or more inflation ports disposed along the length of the balloon 240, for example a first inflation port disposed at a distal end and a second inflation portion disposed at a proximal end. Further it will be appreciated that the inflation port(s) 238 can also be used for deflation of the balloon.

[0031] In an embodiment, the inflation port 238 can be coupled with a pump device

(“pump”) 204, or similar device, configured to selectively inflate and/or deflate the balloon 240. The balloon 240 can be inflated using an inflation fluid. In an embodiment, the inflation fluid includes a gas, such as air, carbon dioxide, nitrogen, or the like. In an embodiment, the inflation fluid includes a liquid, such as water, saline, oil, or the like. In an embodiment, the pump 204 can be a mechanical pump, syringe, squeeze bulb, or similar device for providing a pressurized fluid. In an embodiment, the pump 204 can be a source of compressed gas, such as a compressed gas bottle, medical compressed air line, or the like. In an embodiment, the pump 204 can both selectively provide a pressurized fluid for inflating the balloon 240, and provide a vacuum for selectively deflating the balloon 240. In an embodiment, the port 238 can be coupled with a first pump device for inflating the balloon 240 and a second pump device for selectively deflating the balloon 240. In an embodiment, the pump 204 can be triggered automatically using sensors, by a time-based trigger, an action-based trigger, or combinations thereof, to start/stop the inflation/deflation sequence.

[0032] FIGS. 3A-3F show close up detail of the system 200, including the elongate balloon 240 disposed within a tube lumen 224. As shown in FIG. 3A, the balloon 240 is disposed within the drainage tube lumen 224 in an uninflated, or relaxed, state. In an embodiment, the balloon 240 comprises one or more compartments 242. The compartments 242 extend axially along a length of the balloon 240, and are connected by partitions 244. In an embodiment, a partition 244 includes an aperture, e.g. aperture 246, in an end wall of the compartment 242 that provides fluid communication between a first compartment 242A and a second compartment 242B. In an embodiment, a partition 244 includes a valve (not shown) that controls a fluid flow between a first compartment 242A and a second compartment 242B. For example, the valve can inhibit fluid flow between the first compartment 242 A and the second compartment 242B until the first compartment 242A is fully inflated. Once fully inflated, a fluid can flow through the first compartment 242A and into the second compartment 242B to inflate the second compartment 242B. In an embodiment, a connecting tube (not shown) can provide fluid communication between a first compartment 242B and a second compartment 242B.

[0033] In an embodiment, the partition 244 includes thickened portion of a wall 248 of the balloon 240 that inhibits expansion of the wall 248 at the partition, e.g. partition 244A, until an upstream compartment, e.g. compartment 244A, is fully inflated. Once fully inflated, a fluid can flow through the first compartment 242A and into the second compartment 242B to inflate the second compartment 242B.

[0034] As shown in FIGS. 2A, 3A-3F, in an exemplary method of use, a peristalsis balloon 240 is inflated, using an inflation fluid, by way of inflation port 238 disposed towards a distal end of the balloon 240. As shown in FIG. 3B, the inflation fluid causes a first compartment 242A, disposed distally, to inflate and dilate to an expanded configuration, e.g. expand until an outer wall 248 of the balloon 240 contacts an inner surface. A first partition 244A, restricts expansion of subsequent compartments 242 of the balloon 240, until the first compartment 242A is fully dilated.

[0035] As shown in FIGS. 3A-3B, inflating the first compartment 242A causes the balloon to substantially fill the section of the drainage lumen. As such, any fluid 222 disposed within the tube lumen 224, between the outer surface of the balloon 240 and the inner surface of the tube lumen 224, is urged proximally. Once the first compartment 242A is fully inflated, the inflation fluid passes through the first compartment 242A and into the second compartment 242B, causing the second compartment 242B to inflate. A second partition 244B inhibits further expansion of the balloon until the second compartment 242B is fully inflated.

[0036] As shown in FIGS. 3B-3C, the second compartment 242B expands and substantially fills a second portion of the tube lumen 224 urging the fluid 222 yet further. As shown in FIGS. 3C-3D, the process repeats sequentially with subsequent compartments, e.g. compartments 242C, 242D, and moves the fluid 222 through the lumen 224 to the container 130. Advantageously, the fluid 222 can be moved through the lumen 224 irrespective of any positive incline, displacing any pooled fluid into the container 130.

[0037] In an embodiment, as shown in FIG. 3E, the compartments 242 are inflated and deflated sequentially along an axial length of the tube 220 to move the fluid 222 through the tube lumen 224, while still allowing additional fluid 223 to enter the tube lumen 224 from a distal end. Advantageously, this peristaltic, or “wave-like” action of inflation/deflation of the balloon compartments 242, moves fluid through the tube lumen in a wave-like manner and provides an uninterrupted flow of fluids therethrough.

[0038] As shown in FIG. 3F, in an embodiment, distal compartments, e.g. first compartment 242A, remain inflated until the entire balloon 240 is fully inflated and the balloon. The compartments 242 then deflate simultaneously. Advantageously, this ensures the tube lumen 224 is fully purged of any fluid 222 before deflating the balloon 240. In an embodiment, the compartments 242 inflate sequentially from a distal end to a proximal end until the balloon 240 is fully inflated before allowing the compartments 242 to deflate sequentially from a distal end to a proximal end.

[0039] In an embodiment, the balloon 240 comprises a single compartment that expands from a distal end to a proximal end. Once fully inflated the fluid is released, allowing the balloon 240 to contract to a relaxed state. In an embodiment, the balloon 240 contracts evenly along a longitudinal length of the balloon 240. In an embodiment, the balloon 240 contracts from a proximal end to a distal end.

[0040] As shown in FIG. 2B, in an embodiment, the system 200 can include two or more elongate balloons 240 disposed axially along a length the tube lumen 224. For example, a proximal end of a first balloon 240A is adjacent a distal end of a second balloon 240B. Each balloon 240 can include an inflation/deflation port 238 that is fluidly coupled with a pump device 204. It will be appreciated that each inflation port 238 can be connected with a single pump device configured to selectively inflate/deflate each balloon independently, or each balloon 240 can be connected with a separate pump device, or combinations thereof, and still fall within the scope of the present invention. In an embodiment, each of the balloons 240A- 240C can be inflated and deflated, either sequentially, or in waves, similar to the inflation/deflation of the compartments 242, as described herein. As such, the coordinated inflation/deflation of the balloons 240A-240C can move a fluid 222 through the tube lumen to a container 130.

[0041] FIGS. 4A-5D show an embodiment of a sequential pulsatile pump system

(“system”) 300, including one or more peristalsis balloons 340 and a pump device 204. The balloon, e.g. balloons 340A-340E, can be arranged annularly about an outer surface of a drainage tube 320. In an embodiment, the balloons 340 include one or more inflation/deflation ports that fluidly couple the balloons 340 with one or more pump devices 204. The pump device 204 is designed to sequentially inflate/deflate the balloons 340 using an inflation fluid, as described herein. In an embodiment, the balloons 340 can be formed as a single balloon and include one or more compartments separated by partitions, as described herein.

[0042] In an embodiment, the balloon(s) 340 are formed as a separate structure from the tube 320 and can include a supporting structure such as a resilient outer jacket (“jacket”) 306. In an embodiment, the jacket 306 resists outward expansion of the balloons 340 as they are inflated. As such, the balloons 340 expand inwards and can compress a tube 320 disposed therein. As shown in FIG. 4B, in an embodiment, the jacket 306 and balloon(s) 340 include an elongate opening 308 extending axially, and allows ingress and egress of the tube 320 into and out of the supporting structure 306. In an embodiment, the jacket 306 further includes a fastener, such as a zip or clasp, to secure the elongate opening in a closed position. The jacket 306 can be formed of various resilient materials such as plastic, polymer, woven or non-woven material, organic or synthetic material, combinations thereof, or the like. Advantageously, the system 300 can be used with various types of collection systems, e.g. catheters, drainage tubes, containers, etc., or with collection systems that are already in use.

[0043] In an embodiment, the drainage tube 320 can be provided as part of the system

300, i.e. preloaded within the jacket 306 and balloons 340. The drainage tube 320 can then be coupled with a catheter 110 and a container 130 to provide fluid communication therebetween. In an embodiment, the system 300 can be provided as part of a kit including a catheter 110, a one way valve 218, a drainage tube 320, a container 130, or combinations thereof.

[0044] FIGS. 5A-5D show a close up view of a portion of system 300, including a tube

320 defining a tube lumen 324, one or more balloons 340, and jacket 306. As shown in FIG. 5B, as a first balloon 340A is inflated, the jacket 306 resists any outward expansion, causing the balloon 340A to compress a first portion of the tube 320 disposed therein and constrict a cross-sectional area of the tube lumen of the first portion. Any fluid 222 disposed within the lumen of the tube is then urged proximally. As shown in FIG. 5C, a second balloon 340B, disposed proximally of the first balloon 340A, can then be inflated which compresses a second portion of the tube 320. This constricts a cross-sectional area of the tube lumen of the second portion, which is proximal of the first portion, and urges the fluid 222 proximally.

[0045] As shown in FIG. 5D, a third balloon 340C proximal of the second balloon

340B, can then be inflated which compresses a third portion of the tube 320, which is proximal of the second portion of the tube, and urges the fluid 222 proximally, as described herein. As such the process repeats through sequential balloons 340A-340E until the fluid 222 is moved into the container 130. Advantageously, the fluid can be moved through the lumen 324 irrespective of any positive incline, displacing any pooled fluid into the container 130.

[0046] In an embodiment, each of the balloons 340A-340E can be inflated sequentially, and remain inflated before deflating the balloons 340A-340E simultaneously. Advantageously, this ensures the tube lumen 324 us fully purged of any fluid 222. In an embodiment, as shown in FIG. 5D, the balloons 340A-340E can inflate sequentially, and then deflate sequentially, to move fluid through the lumen 324 in a peristaltic or “wave-like” manner. Advantageously, this moves fluid through the lumen in a wave-like manner to maintain a consistent flow through the tube 320.

[0047] In an embodiment, the balloons 340 can be actively inflated by the pump 204 and then actively deflated by applying a vacuum to remove the inflation fluid therefrom. In an embodiment, the balloons 340 can be inflated and deflated from the same port, or from separate ports. In an embodiment, the balloons can be actively inflated and then allowed to passively deflate by allowing the inflation fluid to escape when inflation is ceased. For example, the tube 320, and/or balloon(s) 340 are biased towards a resting, underformed state, e.g. as shown in FIG. 5A. As such, the tube 320 and/or balloon 340 can expel the inflation fluid from the balloon 340.

[0048] As shown in FIGS. 6A-7C, in an embodiment, a sequential pulsatile pump system (“system”) 400, includes a drainage tube 420 that defines a central drainage lumen 424, and further includes one or more balloons 440 formed within a wall 418 of the tube 420 and coupled with a pump device 204. In an embodiment, as shown in FIG. 6A, the balloon 440 extends continuously along an axial length of the tube 420, and, as shown in FIG. 7A, extends annularly about the drainage lumen 424. In an embodiment, as shown in FIGS. 6A-6D, the balloon 440 can be partitioned into one or more compartments 442 that are in fluid communication with each other, as described herein. In an embodiment, the partition 444 between the compartments 442 can include an aperture, a valve, or a thickened portion of wall 418, as described herein.

[0049] In an embodiment, as shown in FIG. 7C, the tube 420 can include one or more separate balloons 440, e.g. balloon 440A, 440B, disposed annularly about drainage lumen 424. In an embodiment, as shown in FIG. 7B, the tube 420 can include one or more balloons 440 that extend parallel to the drainage lumen 424, and extend through an arc that partially surrounds the drainage lumen 424. In an embodiment, a balloon 440 extends through an arc that is less the 360°. In an embodiment, a balloon 440 extends through an arc of substantially 90°. In an embodiment, a balloon, e.g. balloon 440A expands to constrict the entire cross- sectional area of the tube lumen 424. In an embodiment, the balloons 440A-440D each expand to constrict a portion of the cross-sectional area of the tube lumen 424.

[0050] In an embodiment, a thickness of the tube wall 418 between the balloon 440 and the drainage lumen 424 is less than a thickness of the tube wall 418 between the balloon 440 and an outer surface of the tube 420. As such, and as shown in FIGS. 6B-6C, the balloons 440 expand inwards, constricting the drainage lumen therebetween and urging any fluid 222 disposed therein in a proximal direction. As described herein, the balloon 440 can include partitions 444 can cause distally disposed compartments, e.g. compartment 424A to expand prior to proximally disposed compartments, e.g. compartment 424B, as described herein.

[0051] In an embodiment, separate balloons 440 can be inflated/deflated using separate inflation ports that optionally can be coupled with separate pump sources 204. As such, the balloons 440 can be inflated and deflated in a sequential manner to urge the fluid 222 proximally through the drainage lumen 424, as described herein. In an embodiment, the balloon 440, or compartments 424 thereof, can be inflated sequentially and then deflated simultaneously when the entire length of the drainage tube is purged. As shown in FIG. 6D, in an embodiment, balloons 440, or compartments 424, can be inflated sequentially and then deflated sequentially, in a wave-like formation to urge fluid 222 through the tube lumen 424 while allowing more fluid 223 to enter the lumen from distal end.

[0052] In an embodiment, various combinations of the pump systems 200, 300, 400 are also contemplated. These can include one or more of the drainage tube(s) 220, 320, 420, balloon(s) 240, 340, 440, as described herein, arranged and operated in various combinations. For example, a system can include a drainage tube 220 including balloon(s) 240 disposed within the drainage lumen 242 (i.e. the intra-luminal system 200) and include either a balloon system 300 with the balloons disposed on an outer surface (i.e. an extra-luminal system 300), and/or a system 400, where the balloons are disposed within a tube wall. The systems 200, 300, 400 can be inflated in a coordinated manner such as simultaneously, sequentially, alternately, or combinations thereof. [0053] The systems 200, 300, 400 can fill or compress the drainage lumen simultaneously, sequentially, or alternately to move fluid through the lumen. For example, in an embodiment, the extra-luminal system 300 can inflate radially inward to counteract any radially outward distortion of the drainage tube from the intra-luminal system 200. In an embodiment, the system 400 can inflate to provide increased turgor to the drainage tube and resist any distortion from the intra-luminal systems 200. In an embodiment, one or more of the systems 200, 300, 400 can be appended sequentially along a portion of the drainage tube. For example a mid-portion of the drainage tube can include an intra-luminal system 200, followed by a proximal portion including an extra-luminal system 300. These and other combinations of embodiments, disclosed herein, are also contemplated to fall within the scope of the present invention.

[0054] In an embodiment, the drainage tube(s) 220, 320, 420, or balloon(s) 240, 340,

440, or combinations thereof can be formed of a material such as rubber, silicone, plastic, polymer or similarly suitable material. In an embodiment, the material includes elastic properties that allow the tube or balloon to expand when inflated. In an embodiment, the material includes inelastic properties to provide a turgid structure when inflated. In an embodiment, the drainage tube (s) 220, 320, 420, balloon(s) 240, 340, 440, jacket 306, or combinations thereof can be formed of a translucent, or semi-translucent material to allow observation of a fluid 222 disposed within the drainage tube.

[0055] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.