Drainage apparatus with removable tubing set
The drainage system with a motor-driven pump and removable tubing set addresses inefficiencies in current drainage methods by enabling automated and sterile fluid removal from pleural or abdominal cavities, enhancing patient convenience and hygiene.
Patent Information
- Application Number
- PCT/US2025/015989
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-02-16
- Filing Date
- 2025-02-14
- Publication Date
- 2025-08-21
AI Technical Summary
Current methods for draining fluids from the pleural or abdominal cavities, such as those used for treating recurrent pleural effusions or ascites, are inefficient, require frequent manual intervention, and pose challenges in maintaining sterility and ease of use.
A drainage system comprising a pump with a motor, rollers, and a removable tubing set that includes a tubing guide, allowing for easy installation and removal of tubing, and a fluid collection container, which facilitates automated and sterile fluid drainage without direct contact between the pump and bodily fluids.
The system provides efficient, automated, and sterile fluid drainage, reducing the need for frequent manual intervention and improving patient convenience and hygiene.
Smart Images

Figure US2025015989_21082025_PF_FP_ABST
Abstract
Description
DRAINAGE APPARATUS WITH REMOVABLE TUBING SETCross Reference to Related Applications
[0001] This application claims priority to U.S. Provisional Application No.63 / 554,285, filed on February 16, 2024, and titled “DRAINAGE APPARATUS WITHREMOVABLE TUBING SET, DISPOSABLE COLLECTION BAG, AND METHODS OFUSE THEREOF.” The disclosure of the priority application is incorporated by reference herein.Field
[0002] The present disclosure relates to a system for draining fluids from a patient. More specifically, a fluid pumping device with removable tubing set, and drainage bag for the drainage of bodily fluids.Overview
[0003] One approach to the treatment of recurrent, symptomatic pleural effusions or ascites involves passing a needle and catheter apparatus into the pleural cavity or abdominal cavity. Once the needle is removed, a catheter is left in the pleural space and / or drainage space or space requiring drainage. The catheter remains in place and, thereby, acts as a drainage tube that allows the excess pleural fluid to be removed from the pleural or abdominal space to a collection reservoir outside of the body. This procedure typically improves symptoms significantly. Unfortunately, fluid build-up can and is likely to recur following drainage and in order to control symptoms, drainage must be repeated frequently. Chronic indwelling catheters may also be placed in the patient permanently or semi -permanently (i.e., for periodic exchange by a physician), allowing a patient to drain fluid to an external reservoir on an intermittent, yet continual, basis. That is, the catheter is placed with one end in the affected space inside the patient's body and the other end of the catheter extends outside of the patient'sbody and remains externally exposed for extended periods of time. In many cases, in order to gain relief from fluid build-up related symptoms, the patient or their caregiver must actively access the external portion of the catheter, connect the catheter to an external reservoir, and drain fluid into a reservoir.
[0004] The current options for pleural or peritoneal drainage typically involve gravity-based drainage and / or rely on an evacuated bottle or container or manual pumping by a user or powered pumps. Maintaining sterility, cleanliness, and improving practicality and efficiency of drainage, especially ease of use for the patient or caregiver are just some of the advantages provided by the aspects described in the current disclosure.Summary
[0005] Some examples of advantages of the system or aspects described herein are further provided in the examples described below.
[0006] In some aspects, the techniques described herein relate to a drainage system for drainage of fluid from a catheter, the drainage system including: a pump with a motor, an interface for controlling operation of the motor, and one more rollers for occluding or partially occluding tubing wherein the motor is operatively connected to one or more rollers; a tubing set for draining the fluid from a catheter with a pumping portion configured to be occluded or partially occluded by the one or more rollers to pump fluid through the tubing from a tubing inlet portion to a tubing outlet portion, the tubing set including tubing guide, wherein the tubing guide is configured to be removably connected to the pump and contain the pumping portion of the tubing set.
[0007] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage system, wherein the pumping portion is in fluid communication with the tubing inlet portion at a first end and with the tubing outlet portion at a second end.
[0008] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage system, wherein the tubing inlet portion is in fluid communication with a catheter interface and the tubing outlet portion is in fluid communication with a fluid collection container.
[0009] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage system, wherein the tubing set includes the catheter interface and the fluid collection container.
[0010] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage system, wherein the tubing guide contains the pumping portion in curved or linear orientation.
[0011] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage system, wherein the tubing guide includes a tubing inlet guide with the tubing inlet portion passed therethrough and a tubing outlet guide with the tubing outlet portion passing therethrough.
[0012] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage system, wherein the tubing inlet guide is a first hole at a first end of the tubing guide and the tubing outlet guide is a second hole at a second end of the tubing guide.
[0013] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage system, wherein the tubing guide further includes an engagement feature, wherein the engagement feature is configured to engage with a captive portion of the pump when the tubing guide is installed into a receiving portion of the pump.
[0014] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage system, wherein the pumping portion isconfigured to be occluded or partially occluded by pinching the pumping portion between an inner surface of the tubing guide and the one or more rollers when the tubing guide portion is installed into the receiving portion of the pump.
[0015] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage pump for drainage of fluid from a catheter, the drainage pump including: a motor; an interface for controlling operation of the motor; and one more rollers for occluding or partially occluding tubing wherein the motor is operatively connected to a one or more rollers; an interface portion configured to receive a tubing guide with a portion of tubing installed therein; and an engagement mechanism, wherein the engagement mechanism is configured to captively engage with one or more engagement features of the tubing guide when the tubing guide is pressed into the interface portion.
[0016] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage pump, wherein the engagement mechanism includes a first captive portion and a second captive portion that are biased away from one another.
[0017] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage pump, wherein the first captive portion and the second captive portion are biased away from one another via a spring.
[0018] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage pump, wherein the first captive portion and the second captive portion include at least one ramp portion configured have a force applied thereto by the engagement features of the tubing guide.
[0019] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage pump, wherein the first captive portion is connected to a first release interfaces and the second captive portion is connected to a secondrelease interface, wherein the release interfaces are configured move the first captive portion and the second captive portion to a release position for releasing the tubing guide from the engagement mechanism when a user presses on the first release interface and the second release interface.
[0020] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage pump, wherein the one or more rollers are connected.
[0021] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage set configured to be connected to a pump for draining a fluid from a catheter when a pumping portion of the pump occludes or partially occludes a pumping portion of a tubing of the drainage set, wherein the drainage set further includes: a tubing guide member configured to captively engage with at least the pumping portion of the tubing, where the tubing guide is configured to be releasably installed into the pump, wherein the tubing set further includes: a catheter interface connector for connecting to a catheter; and a fluid collection container for storing fluid drained via the catheter interface.
[0022] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage set, wherein the tubing guide further includes a tubing guide inlet portion with a tubing inlet portion of a tube passing therethrough and a tubing guide outlet portion with a tubing outlet portion of a tube passing therethrough, wherein the pumping portion of the tubing is in fluid communication with the tubing inlet portion and the tubing outlet portion.
[0023] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage set, wherein the tubing inlet portion is in fluid communication with the catheter interface connector and the tubing outlet portion is in fluid communication with the fluid collection container.
[0024] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage set, wherein the tubing guide contains the pumping portion in curved orientation.
[0025] In some aspects usable with any of the above mentioned aspects, the techniques described herein relate to a drainage set, wherein the tubing guide further includes an engagement feature, wherein the engagement feature is configured to engage with a captive portion of the pump when the tubing guide is installed into a receiving portion of the pump.Brief Description of the Drawings
[0026] The novel features believed to be characteristic of aspects of the disclosure are set forth in the description that follows. The drawing figures are not necessarily drawn to scale and certain figures may be shown in exaggerated or generalized form in the interest of clarity and conciseness. The disclosure itself, however, as well as a preferred mode of use, further objects, and advantages thereof, will be best understood by reference to the following detailed description of illustrative aspects of the disclosure when read in conjunction with the accompanying drawings, wherein:
[0027] Figure 1 illustrates an example of a pumping device, tubing guide, and tubing according to aspects of the disclosure;
[0028] Figure 2 illustrates an isometric front view of an example of a pumping device with a tubing set installed therein according to aspects of the disclosure;
[0029] Figure 3 illustrates a front view of the example of the pumping device and a tubing set of Figure 2;
[0030] Figure 4 illustrates a rear-internal view of the pumping device and tubing set of Figures 2-3;
[0031] Figure 5 illustrates various components of a drainage system according to aspects of the disclosure;
[0032] Figure 6 illustrates an example of a tubing set installation and removal procedure according to aspects of the disclosure;
[0033] Figure 7A illustrates a front isometric view of a tubing guide according to aspects of the disclosure;
[0034] Figure 7B illustrates a front isometric view of an example of the tubing guide of Figure 7A interacting with components illustrated by a partial view of a pumping unit according to aspects of the disclosure;
[0035] Figure 8 A illustrates a front view of the features shown in Figure 7B;
[0036] Figure 8B illustrates a cut-away view of Figure 7B;
[0037] Figure 9A illustrates a front isometric view of a tubing guide with tubing installed therein and a partial view of features of a pumping unit according to aspects of the disclosure;
[0038] Figure 9B illustrates a second front cut-away isometric view of the features shown in Figure 9A;
[0039] Figure 10 illustrates a front isometric see-though view of a pumping unit with a tubing set installed therein according to aspects of the disclosure;
[0040] Figure 11 illustrates a front view of the features shown in Figure 10;
[0041] Figure 12 illustrates a front partial view of the features of Figures 10-11;
[0042] Figure 13 A and 13B show isometric and front views of the features ofFigures 10-12;
[0043] Figures 14A and 14B show isometric and front views of a tubing guide and tubing according to aspects of the disclosure;
[0044] Figure 15 A illustrates an example of a communication system and method according to aspects of the disclosure; and
[0045] Figure 15B illustrates a diagram of an example controller according to aspects of the disclosure.Detailed DescriptionI. Terminology
[0046] In the description herein, the following definitions of selected terms employed herein are provided. The definitions include various examples and / or forms of components that fall within the scope of a term and that may be used for implementation. The examples are not intended to be limiting. Further, it will be obvious to one skilled in the art that the present disclosure may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as to not unnecessarily obscure aspects of the present disclosure.
[0047] Throughout the disclosure, the term substantially or approximately may be used as a modifier for a geometric relationship between elements or for the shape of an element or component. While the terms substantially or approximately are not limited to a specific variation and may cover any variation that is understood by one of ordinary skill in the art to be an acceptable variation, some examples are provided as follows. In one example, the terms substantially or approximately may include a variation of less than 10% of the dimension of the object or component. In another example, the terms substantially or approximately may include a variation of less than 5% of the object or component. If the terms substantially or approximately are used to define the angular relationship of one element to another element, one non-limiting example of the terms may include a variation of 5 degrees or less. These examples are not intended to be limiting and may be increased or decreased based on the understanding of acceptable limits to one of ordinary skill in the art.
[0048] For purposes of the disclosure, directional terms are expressed generally with relation to a standard frame of reference when the devices described herein is installed and in an in-use orientation.
[0049] In this disclosure, terms such as a, an, and the are not intended to refer to only a singular entity, but include the general class of which a specific example may be used for illustration. The terms a, an, and the are used interchangeably with the term at least one. The phrases at least one of and comprises at least one of followed by a list refers to any one of the items in the list and any combination of two or more items in the list. All numerical ranges are inclusive of their endpoints and non-integral values between the endpoints unless otherwise stated.
[0050] The terms first, second, third, and fourth are used in this disclosure. It will be understood that, unless otherwise noted, those terms are used in their relative sense only. In particular, in some aspects certain components may be present in interchangeable and / or identical multiples (e.g., pairs). For these components, the designation of first, second, third, and / or fourth may be applied to the components merely as a matter of convenience in the description of one or more of the aspects of the disclosure.
[0051] The terms disposed on, disposed along, disposed with, or disposed toward and variations thereof may define one element can be integral with another element, or that one element can be a separate structure bonded to or placed with or placed near another element.
[0052] The term at, for example when referring to something being located at a specific location, is intended to include any one or more of: proximate, on, near, adjacent to or within the specific location. As used herein, the terms proximal is defined with respect to an object, element, or user. For example, the term proximal may refer to the part or portion closer to the user.II. Detailed Examples
[0053] This disclosure describes a method to collect and / or assist with the collection of fluid from a body cavity, such as the pleural cavity or peritoneal cavity. The system may include one of or a combination of a disposable collection bag and tubing set, as well as some features which may be reusable such as an electro-mechanical pumping unit. The tubing set is such that it fits and engages with the reusable electrical pumping unit in a way that enables the pumping action to occur. In one example, the pump may be a rotary displacement pump used to transport or otherwise provide a driving force to a catheter without the contents being transported coming into contact with the pump components. For example, the aforementioned pumping unit may be a roller or peristaltic-style pump. In one example, the rollers of the peristaltic-style pump may be connected to a center carrier that is configured to rotate about a central axis, thus causing the rollers to compress or occlude a tubing in a round or semi-circular configuration. In another example, rollers of the peristaltic-style pump may be arranged as independent rollers that are configured to independently contact and move linearly or in another configuration while pressing against a tube within the pump. In another example, the one or more rollers may be configured to rotate and recirculating in a loop while compressing and / or occluding a tube within the pump. In another example, the pump can be a reciprocating piston type. In some aspects, features disclosed in the aforementioned patent may be reversed from what is disclosed therein, i.e., features may be used for removal of fluids instead of for infusion. Additional examples are described in further detail below with reference to the example implementations in the Figures.
[0054] Figures 1-3 show an example of an electrical or electro-mechanical pumping unit 100 (throughout the disclosure the terms electrical pumping unit, electromechanical pumping unit, and / or pumping unit may be used interchangeably), which may be small enough such that it can be easily held in the hand of the user for portability. The pumpingunit may include an interface 102 (hereinafter interchangeably referred to as “controls”) that allows the user to start / pause the drainage and adjust the pumping rate (and by consequence vacuum pressure) generated by the unit. In one example, the interface may be simple and easy to use.
[0055] In one example, the pumping unit 100 interface 102 may include a pump speed control 102a (Figure 2) and / or a pump advancement control 102b. Further, the interface 102 may include on on / off switch 102d (Figure 1). The pump speed control 102a may for example be a rotary control that increases the pump speed as the rotary control is rotated upwards, and / or may decrease the pump speed as the rotary control is rotated downwards. The pump advancement control 102b may for example be a push button and / or a touch sensitive portion. The pump advancement control 102b may turn off or on rotation of the pump by pressing or touching the pump advancement control 102b once or twice. In another example, the pump speed may be adjusted via one or more buttons (e.g., an upward / higher speed button and a lower / lower speed button). The one or more buttons may replace the rotary control and allow a user to control the speed of the pump.
[0056] As noted above, in some examples, the interface 102 may include an on / off switch 102d. The on / off switch may control power to the device and may prevent accidental advancement of the pumping unit 100.
[0057] The pumping unit 100, and particularly the interface may in the alternative to the features above or in addition to any one or combination of features above also include a screen 104, such as a liquid crystal display (LCD), organic light-emitting diode (OLED), electronic ink (e-ink) and / or other display (e.g., lights, numeric indicators) which can display any one or combination of the flow rate, time, pump status, battery status, and / or other related drainage information. The screen 104 may be touch-sensitive and may substitute for the controls described above and may instead allow for a user to control pump operations via agraphical user interface (GUI). The pumping unit 100 may also contain a computing processor and / or controller(s) (e.g., as shown in Figure 15B and as further described in detail below). The pumping unit 100, and in particular the computing processor and / or controller(s) may include a memory storage for recording drainage information, as well as Bluetooth®, Wi-Fi®, or other wireless communication capabilities for wireless transmission of drainage information to an external computing element, such as a smart device. Additional aspects of the computing processor and wireless communication capabilities are described in further detail below.
[0058] Additionally, the pumping 100 unit may contain one or more sensors for monitoring motor function and / or drainage data, which may include any one of or combination of flow rate, pressures, volume, color, turbidity and / or may integrate or otherwise communicate with a sensor or sensor(s) located in the tubing and / or drainage bag or container to detect a pH of the fluid being drained.
[0059] The pumping unit may contain a replaceable commercial battery to provide power, which can either be recharged or replaced throughout the life of the pumping device. In one example, the pumping unit may have an exchangeable battery 106 (Figure 2) or battery “pack” allowing a user to swap out a depleted battery. In one example, the indicated exchangeable battery 106 shown in Figure 2 may instead be a battery door that is slideably removable from the pumping unit 100 allowing a user to exchange either a commercially available battery or batteries (e.g., AA, AAA, 9-volt or the like) or to remove and replace or exchange a battery pack housed therein. In another example, the pumping unit may contain a rechargeable battery that is not intended to be removed or replace by the user, but is instead recharged by connecting the pump to a charging cable and / or a charging dock.
[0060] In one aspect of the disclosure, the pumping unit 100 may include a peristaltic pump section 108. The peristaltic pump section 108 may for example comprise amotor 114 (Figure 4) for rotating one or more pump rollers, which are described in additional detail below with respect to Figures 6-12. The pump rollers may be configured to interface with or otherwise engage with a removable tubing guide / set 110. The tubing set 110 can be configured so that the pumping unit can displace fluid along the fluid path (i.e., within the lumen of the tubing) without being fluidically coupled to the pumping unit (so that the pumping unit stays "dry" and never comes into contact with the bodily fluid). The aforementioned aspects can be accomplished by compressing the interfacing section of tubing with the rollers so that the tubing is compressed or occluded, which displaces fluid along the inner lumen of the tube.
[0061] The tubing guide / set may include a tubing guide and pump engagement portion 111 (which may hereinafter be interchangeably referred to just as a tubing guide member or tubing guide). The tubing guide member 111 may have a tubing inlet guide Il la, a tubing outlet guide 111b and a center guide portion 111c. In one example, the tubing inlet guide 11 la may be an opening or orifice, or hole configured to have a section of tubing passed therethrough. Likewise, the tubing outlet guide 111b may have an opening or orifice configured to have a section of tubing passed therethrough. The center guide portion 111c may for example be curved or otherwise correspond with the path of one or more pumping rollers of the peristaltic pump section 108. The center guide portion 111c may have installed therein and / or may include a peristaltic pump roller interfacing section of tubing 109c (Figure 14B) with a tubing inlet portion 109a passed through and / or retained within the tubing inlet guide Illa and / or with a tubing outlet portion 109b passed through and / or retained within the tubing outlet guide 111b.
[0062] With reference to Figure 5, the system may further include, either as part of or integrated with the tubing inlet portion 109a, a portion of connector tubing 206 that is connected to, integrated with, or otherwise in fluid communication with a drainage catheterconnector 208. In one example, the connector tubing 206 and tubing inlet portion 109a may be one continuous uninterrupted tube. In another example, the connector tubing 206 may be connected to the tubing inlet portion 109a via an inlet connector 113a. The inlet connector may for example be a barbed or other connection with a passage therethrough for providing a sealed fluid communication between the connector tubing 206 and the tubing inlet portion 109a. In one example, the connector tubing 206 may further include a roller clamp or flow regulation device 212 for gating flow of the fluid through the connector tubing 206 (and ultimately to the drainage container or collection bag 202).
[0063] Further, the system may further include, either as part of or integrated with the tubing outlet portion 109b, a portion of connector tubing 204 that is connected to, integrated with, or otherwise in fluid communication with a drainage container or collection bag 202. In one example, the connector tubing 204 and tubing outlet portion 109b may be one continuous uninterrupted tube. In another example, the connector tubing 204 may be connected to the tubing outlet portion 109b via an outlet connector 113b. The outlet connector 113b may for example be a barbed or other connection with a passage therethrough for providing a sealed fluid communication between the connector tubing 204 and the tubing outlet portion 109b. In another example implementation of the disclosure, the system may include all of the components described above as a single, uninterrupted, permanently connected, fluid passage from the drainage catheter connector 208 to the drainage container or collection bag 202. For example, the connector tubing 206, tubing inlet portion 109a, tubing outlet portion 109b, connector tubing 204 may be a single uninterrupted length of tubing. In one example, any combination of the components described may be provided as single use disposable components. For example, the drainage catheter connector 208, regulation device 212, connector tubing 206, pump engagement portion 111, connector tubing 204 and / or drainage container or collection bag 202 may be provided pre-connected either permanentlyor removably and may be provided as a drainage set or tubing set. One advantage of the aforementioned implementation is that the drainage set, or tubing set may come pre-packaged and disinfected, high level disinfected or sterilized and ready to use, and after drainage is completed, the entire draining set or tubing set may be disposed of or properly handled without the risk of cross contamination or need to disinfect the components connected thereto. The pump described herein may be re-usable or may be used for multiple drainages and / or for a specific patient.
[0064] It is noted that while a collection bag 202 is shown in Figure 5, the collection container in addition may be any one or combination of a rigid container, semi-rigid container that is permanent or removably connected to the connector tubing 204.
[0065] As noted above, any one or combination of the features above may be provided in a kit or system, which may include additional relevant components not pictured and may be packaged or otherwise provided in a sterilized, disinfected, or high-level disinfected package. As shown Figure 5, the catheter or tubing may have a connector at the end thereof that is configured to be connected to or otherwise placed in fluid communication with an indwelling catheter (e.g., in the plural or abdominal space of a patient) to allow for drainage or suction of fluid via the indwelling catheter. In one example, the pump 100 may be reusable (i.e., can be used for multiple drainages) and the connector 208, tubing 206, 204, and guide 111, connectors 109a and / or 109b, and collection container 202 may be disposable (i.e., only used for a single drainage and then disposed of or recycled / refurbished afterwards).
[0066] To set up the peristaltic pump 100, for drainage of fluid, the tubing (flow path) may be routed into the pump roller mechanism fitted with at least two rollers so that the rollers squeeze or occlude the tubing against the inside surface of the round pump body creating pinch points that are advanced from the tubing entrance towards the exit as the rollers turn, thus driving the defined volume of fluid out of the pump. The tubing guide member 111allows for alignment or placement of the tubing between the pump rollers and an inner surface of the tubing guide member 111 for correct functionality of the pump for ease and convenience in removing / replacing tubing or a tubing set, which was cumbersome in the past. As noted above, the pump body does not necessarily need to be round. For example, the at least two rollers could be arranged in a linear configuration (or any other configuration) with two or more rollers occluding or pinching the tubing and moving along the length of the tubing to advance fluid within the tubing lumen.
[0067] In an example usable with any one of or all of the features described herein, the tubing set and / or pump provides a solution for patient self-use at home, caregiver use, and / or in a medical or hospital setting. The tubing guide 111 is a rigid or semi-rigid component that accompanies the tubing and / or may have tubing pre-installed, and the center guide portion 111c may provide a hard backing surface against which the tubing is squeezed, compressed, or occluded when the tubing guide 111 is installed into the pump and the pump is operational. The tubing guide 111 may be easily removeable from / exchangeable from the pump 100, to simplify the removal and replacement of tubing from the pump. One example of an installation and removal procedure is shown in Figure 6.
[0068] As shown in Figure 6, when a user wishes to perform a drainage operation, a first tubing guide member 11 Id associated with a first tubing set 110 may be installed in step 603. As noted in the description above, the first tubing set may include any one or combination of the features described above with respect to Figure 6. The installation of the first tubing guide 111 into the pump may be guided via one or more guiding features and / or may further be guided by tactile engagement between the tubing inlet guide 111 the pump. For example, the first tubing guide member 111 may be guided into a receiving portion of the pump via a channel or other features and the first tubing guide member 111 may click-into or otherwise engage with corresponding engaging features of the pump once the first tubing guide member111 is correctly installed into the pump so that the first tubing set 110 is in proper alignment for engagement with one or more of the pump rollers 120a, 120b, and / or 120c. Additional examples of the engagement features and / or the channel or other alignment features are described in further detail below.
[0069] Once the first tubing guide member 11 Id and the first tubing set 110a are connected to the pump, the user may proceed with a drainage operation. During the drainage operation, one or more of the pump rollers 120a, pump rollers 120b and / or pump rollers 120c press against or occlude the first tubing set 110a by pressing the first tubing set 110a against the inner surface of the first tubing guide member 11 Id as they rotate in the directions indicated by the arrows in the pictographic representation of step 602.
[0070] Once a drainage operation is complete in step 603, a user may disengage the first tubing guide member 11 Id and the first tubing set 110a and dispose of the tubing set. The steps above may be repeated during subsequent drainage operations with another tubing set 110a and / or tubing guide member 11 Id. The aforementioned configuration may provide an easily removable / exchangeable pre-configured tubing set that allows for increased efficiency in removal of collection tubing after a draining operation is complete (e.g., for disposal of the collection tubing and container) and installation of a new collection tubing at the next draining operation. As noted above, the tubing and / or the tubing guide may be disposed of after a draining operation is complete and replaced with new tubing and / or a new tubing guide at the next draining operation.
[0071] Figures 7A-8B show one example of a tubing guide member 311. The tubing guide member 311 may be share features with or may be analogous with the tubing guide member tubing guide member 111 described above or below. As noted above, any one of the tubing guide members 111 and / or the tubing guide member 311 may include one or more pump engagement feature(s). For example, the tubing guide member 311 may includefirst engagement feature or features 345a and / or a second engagement feature or features 345b. The engagement features 345a and / or 345b may have one or more protrusions that are configured to click-into or otherwise engage with a corresponding convex portion or groove of the pumping unit (e.g., pumping unit 100) to allow for removable replacement of a tubing set while ensuring proper engagement with the pump rollers (e.g., pump rollers 320a-320c). to allow the tubing and / or tubing guide to be easily removed and installed onto the pump. Figures 7A-8B show non-limiting examples of a tubing guide 311 with a tubing guide inlet portion 311a that may be analogous with or may share features with the tubing inlet guide Illa described above and below. The tubing guide member 311 may further include a tubing outlet guide 311b that may share features with or may be analogous with the tubing outlet guide 111b described above and in further detail below. The tubing guide member 311 may further include an inner wall or inner engagement surface 373 that is configured to have a portion of tubing 109c, which may be analogous with or share features with the tubing described above, compressed thereagainst (thus causing occlusion or partial occlusion of the tubing) by one or more pump rollers 320a-320c. The pump rollers 320a-320c may be analogous with or may share features with pump rollers 120a- 120c described above and in additional detail below. In one example, two or more of the pump rollers (e.g., 320b and / or 320c) may press against to compress, occlude, or partially occlude the portion of tubing 109c at locations 409 when the pump rollers 320b and / or 320c roll against the tubing thus pressing any fluids within the tubing from the tubing inlet portion 109a to the tubing outlet portion 109b.
[0072] As shown in Figures 7A-8D, and with reference to Figures 1-4 above, the engagement features 345a and / or 354b may hook into or engage with or otherwise interact with a release mechanism of the pump. The release mechanism of the pump 100 may for example include one or more release interfaces 140. The release interfaces may for exampleinclude a user-pressable button or buttons, or some other like user interface that releases the tubing guide member 111, 311 when a user applies a pressing force to the release interface(s)140.
[0073] Figures 9A and 9B show examples of a release mechanism according to aspects of the disclosure. The tubing guide member 311 and / or release mechanism described below may share features with or may be analogous with any of the release mechanisms described herein and / or may share features with or may be analogous with the release mechanisms shown in Figures 1-8B above and / or Figure 10-14B below. The release mechanism may include one or more one or more release interfaces 340a and / or 340b. The release interface(s) may for example have surfaces that protrude from the pump housing as buttons or other tactile features that allow a user to press inward on the release interfaces 340a and / or 240b (e.g., in the directions indicated by the arrows shown in Figures 9A and 9B. Each of the one or more release interfaces 340a and / or 340b may have a captive portion 346a and / or 346b that may be configured to captively engage with the one or more engagement features 345a and / or 345b when a user installs the tubing guide member 311 into the pump and presses downward in direction DD. The captive portion 346a and / or 346b may each have a hookshaped catch portion with ramps to allow ramps of the engagement features 345a and / or 345b of the tubing guide 311 to provide a force in an inward direction (i.e., a direction indicated by the arrows shown in Figures 9A and 9B) to the captive portion 346a and / or 346b. As a user continues to press downward, the engagement features 345a and / or engagement features 345b continue to press inward on the captive portion 346a and / or 346b until the ramped surface of the engagement features 345a and / or 345b pass an edge of the ramped portions of the captive portion 346a and / or 346b, causing the hook portion of the captive portion 346a and / or 346b to engage with and otherwise captively lock the tubing guide member 311 with respect to the captive portion 346a and / or 346b. The aforementioned engagement then ensure that a user isprovided with a tactile and / or visual indication that the tubing guide member 311 is correctly installed into the pump 100.
[0074] The release mechanism may include a biasing member 361, which may be a coil spring that provides a force to the one or more one or more release interfaces 340a and / or one or more one or more release interfaces 340b in an outward direction (i.e., a direction opposite the arrows shown in Figure 9A and 9B. The biasing member 361 further ensures that once the engagement features 345a and / or 345b are pressed into and progress down the ramps of the hook shaped catch portions 346a and / or 246b, the hook-shaped catch portions retain the pump engagement features 345a and / or 345b.
[0075] To remove the tubing guide 311 and / or tubing (e.g., after a draining operation is complete), a user can press inward on the one or more one or more release interfaces 340a and / or 240b of the release mechanism as indicated by the arrows in Figure 9A or 9B to release the tubing guide 311 (and thus the tubing set) from the pump.
[0076] Figures 10-14B show partial views of a peristaltic portion and engagement / release features of a pump according to aspects of the disclosure and a tubing guide and / or tubing according to aspects of the disclosure. The portions of the pump not shown may share features with or may be analogous with the pump 100 described above. Further, the features described with respect to Figures 10-13B may share features with or may be analogous with the examples described above. As noted above, the pump 100 may include a pump body with outer surface(s) 112. The pumping unit 100 may be configured to have installed therein a tubing guide member 111. The tubing guide member 111 may be share features with or may be analogous with the tubing guide member 111 and / or 311 described above.
[0077] The pumping unit 100 may include a motor (e.g., motor 114 in Figure 4). The pump motor may have a shaft that is mechanically connected to the center RR (Figure11) of a roller cage 180. The roller cage 180 may have one or more pump rollers 120a, 120b, and / or 120c that are rotatably mounted to the roller cage 180. Thus, then the motor rotates, the roller cage 180 rotates causing the pump rollers 120a, 120b, and / or 120c to rotate when the surfaces of each respective roller are in frictional contact with a tube that is installed into the tubing guide member 111, for example.
[0078] As in the examples above, a tube or other conduit that is installed into the tubing guide member 111 may be in fluid communication with a fluid collection bag and / or a catheter interface (e.g., as described above with respect to Figure 5).
[0079] The tubing guide member 111 may include one or more pump engagement feature(s) that may share features with or may be analogous with the pump engagement features described above. For example, the tubing guide member 111 may include first engagement feature or features 145a and / or a second engagement feature or features 145b. The engagement features 145a and / or 145b may have one or more protrusions that are configured to click-into or otherwise engage with a corresponding convex portion or groove of the pumping unit 100 to allow for removable replacement of a tubing set while ensuring proper engagement with the pump rollers (e.g., pump rollers 320a-320c). to allow the tubing and / or tubing guide to be easily removed and installed onto the pump. As noted above, the tubing guide 311 may include a tubing guide inlet portion Il la that may be analogous with or may share features with the tubing inlet guide(s) described above. The tubing guide member 111 may further include a tubing outlet guide 111b that may share features with or may be analogous with the tubing outlet guide(s) described above. The tubing guide member 111 may further include an inner wall or inner engagement surface 173 (Figure 14b) that is configured to have a portion of tubing 109c, which may be analogous with or share features with the tubing described above, pressed thereagainst by one or more pump rollers 120a-120c. As shown, the inner engagement surface 173 may form an extended curved surface that may havea radius or diameter that corresponds with the path of the pump rollers 120a- 120c. The pump rollers 120a-120c may be analogous with or may share features with pump rollers 320a-320c described above. In one example, two or more of the pump rollers (e.g., 120b and / or 120c) may press against, occlude and / or partially occlude the portion of tubing 109c and roll against the tubing thus pressing any fluids within the tubing from the tubing inlet portion 109a to the tubing outlet portion 109b when the tubing guide is installed, and the pump engagement features(s) are engaged with the pump.
[0080] Figures 10-14B further show examples of a release mechanism according to aspects of the disclosure. The tubing guide member 111 and / or release mechanism described below may share features with or may be analogous with any of the release mechanisms described herein and / or may share features with or may be analogous with the release mechanisms shown in Figures 1-9B above. The release mechanism may include one or more one or more release interfaces 140a and / or 140b. The release interface(s) may for example have surfaces that protrude from the pump housing as buttons or other tactile features that allow a user to press inward on the release interfaces 140a and / or 140b (e.g., in the directions indicated by the arrows shown in Figures 9A and 9B. Each of the one or more one or more release interfaces 140a and / or 140b may have a captive portion 146a and / or 146b that may be configured to captively engage with the one or more engagement features 145a and / or 145b when a user installs the tubing guide member 111 into the pump and presses downward in direction DD (Figure 9A). The captive portion 146a and / or 146b may each have a hookshaped catch portions that include ramps to allow ramps of the engagement features 145a and / or 145b of the tubing guide 111 to provide a force in an inward direction (i.e., a direction indicated by the arrows shown in Figure 11) to the captive portion 146a and / or 146b. As a user continues to press downward, the engagement features 145a and / or engagement features 145b continue to press inward on the captive portion 146a and / or 146b until the ramped surface ofthe engagement features engagement features 145a and / or 145b pass an edge of the ramped portions of the captive portion 146a and / or 146b, causing the hook portion of the captive portion 146a and / or 146b to engage with and otherwise captively lock the tubing guide member 111 with respect to the captive portion 146a and / or 146b. The aforementioned engagement then ensures that a user is provided an indication that the tubing guide member 111 is correctly installed into the pump 100. be pressed into a corresponding opening of the pump. The release mechanism may include a biasing member (not shown in Figures 10-12, but similar to or identical to biasing member 361 in Figures 9A and 9B), which may be a coil spring that provides a force to the one or more one or more release interfaces 140a and / or one or more one or more release interfaces 140b in an outward direction (i.e., a direction opposite the arrows shown in Figure 11. The biasing member further ensures that once be spring-loaded or otherwise biased engagement features 145a and / or 145b are pressed into and progress down the ramps of the hook shaped catch portions 146a and / or 146b, the hook-shaped catch portions retain the pump engagement features 145a and / or 145b.
[0081] As shown in Figures 10, 11, 13A and 13B, the pumping unit 100 may further include a receiving portion as an opening or receiving slot 112a (Figure 13 A) that is a discontinuity or opening in the housing surface 112. The slot 112a may be configured to receive the tubing guide member 111 and the outer surface 190 of the tubing guide member 111 and the pumping unit housing surface 112 may be configured to match-up or otherwise provide a relatively continuous or uninterrupted surface when the tubing guide member Ill is properly installed into the pumping unit 100 and the tubing guide member 111 is properly engaged with the pumping unit 100 as described above.
[0082] As noted above, the Figures / examples above are provided merely as examples, other engagement features, tubing guide configurations, and / or pumps could be implemented without departing from the scope of the disclosure. Further, any of the featuresabove may be combined partially or fully into an example implementation without departing from the scope of this disclosure.
[0083] In one example method of use, the reusable pumping unit may be provided to the patient after the implantation of an indwelling drainage catheter in the body. The disposable drainage container / tubing set (e.g., the drainage container or collection bag 202, connector tubing 204, tubing guide member 111, connector tubing 206, drainage catheter connector 208 and / or the regulation device 212 described above with respect to Figure 5) would be shipped to the patient in bulk or as individual “kits” which may be packaged in sterilized or high-level disinfected packaging. In the aforementioned example, a new tube, container, and tubing set (with pre-installed tubing) could be used for each periodic drainage (as fluid accumulates in the body cavity). The aforementioned aspects may improve on the economic and / or environmental impact when compared to current systems on the market while minimizing risks of contamination and / or generally promoting a clean and sterile method of draining.
[0084] Additionally, a separate disposable tubing set and bag may be developed which will allow for infusion of therapy (such as chemotherapy agents for treatment of metastatic cancer, or talc for pl eurodesis through an Indwelling Pleural Catheter) into the body cavity as well. This tubing set may also include similar features to those described above, but the pumping unit would now actuate the pumping mechanism to reverse the flow of fluid for infusion into the body. Similarly, in such a configuration the interface 120 of the pumping unit would allow for such reversal and the motor (and thus pumping rollers) would be controlled accordingly.
[0085] Additionally, the pumping unit may be configured to collect or otherwise detect drainage data through integrated sensors, which may include automatic detection of the volume drained, time, and fluid properties. The data can then be processed in the device and / orwirelessly transmitted to an external smart device (such as smart phone) for storage and reporting to clinicians. In a preferred aspect, the tubing and / or collection bag may be fluidly sealed and connect to a handheld portable drive subassembly and may contain sensors for detection of actual flow rate instead and / or pump rotation(s) and may use the sensor output to calculate or otherwise determine the volume of fluid drained.
[0086] The fluid removal rate could be set using the interface of the handheld interface or a smartphone application which interfaces with the handheld pumping unit wirelessly - additional aspects of the computing system for the handheld interface as well as the wireless communication aspects are described in further detail below.
[0087] In one aspect of the disclosure, the pumping unit may recognize which tubing set is connected (infusion versus drainage) and / or that a tubing set is connected in general through electronic means, for example RFID tags or switches which are recognized or triggered when the different tubing sets are connected, which would then set the direction which the pumping mechanism actuates. In some aspects, the tubing set may be detected via an RFID tag or other non-contact or contact-based identification method. As another example, the tubing set may be color-coded or otherwise include a visual or optically detectable indication that is detectable by the pumping unit. The tubing sets could also be configured with one-way valves to prevent backflow of fluid when draining or infusing. The disposable tubing could be configured such that the system is vented to the external environment using a one-way valve that allows air to escape but not enter.
[0088] Further, while in the examples, above, the pumping system is located between the indwelling catheter and collection bag such that the fluid passes through the system, the pumping unit could instead be located after the collection bag or container thus providing a negative pressure to the system and drawing fluid from the catheter into the collection container or bag.
[0089] The pump unit and / or collection bag and tubing could also be configured with or configured to fit-within or be stored-within a backpack, holster, and / or a fanny-pack like attachment to the body for wearable drainage.
[0090] The system, e.g., the pumping unit may include a user input portion allowing a user to control or otherwise manipulate the flow rate of the system (i.e., the rate of drainage) or that may allow a user to control other features of the device. The pumping unit may provide feedback to the user on flow rate settings for future drainages and create custom drainage rate protocols for individual patients.
[0091] The system may further include one or more pressure sensor(s) to measure pressure in the system before, during, and / or after drainage. In one example, the output of the pressure sensor(s) may be used to control the operation of the pumping device. For example, if the pressure exceeds a predetermined threshold or range, the pump speed may be decreased or stopped until the pressure again falls below the threshold or within a desired range.
[0092] The system may additionally include pH sensors, oxygen sensors, glucose sensors, optical transmitters / receivers for monitoring the properties of the fluid being drained. In one example, the system may detect inflammatory biomarkers. The output of the sensor(s) may be used to either help determine condition of the patient and / or for data gathering for determining or otherwise monitoring health trends associated with such outputs.
[0093] In one example, the system may include a monitoring system. In another example, as shown in the example implementation of Figure 15 A, the system 100 may wirelessly communicate with or otherwise communicate the status of the device and / or output data related to one or more sensor(s) to an external device (e.g., a smartphone and / or a smart tablet and / or a hub 900, or directly to the cloud 901) using a known system or via the aspects described below. The smartphone, and / or smart tablet, and / or hub may implement an application or other software for allowing the aforementioned devices to monitor any one ora combination of conditions in the pump, pressure within the pump, volume of fluid drained, frequency of drainage, and may include monitoring of user inputs such as perceive pain or other observations. The application and / or software may further communicate with or may be integrated into a patient monitoring system for review and / or monitoring by a physician or healthcare provider and may be communicated from the pump 100 to a smartphone or other personal device 900 and to the cloud for access by a physician or healthcare provider 901. In another example, the pump 100 may communicate directly with the cloud and / or a user’s personal device 900 and / or a physician or healthcare provider terminal 901.
[0094] The aforementioned monitoring system and / or one or more monitoring sensor(s) could be integrated into or otherwise associated with the device or otherwise output and be integrated with an application or other software implemented method to measure the amount, flowrate, and / or pressure of fluid that is collected. Any of the aforementioned aspects may be monitored with respect to time and / or may be monitored with respect to a patient’s perceived pain or other patient observation(s). The reusable pumping unit’s wireless connectivity may be used for transmission of acquired drainage data (such as flow rate, volume drained) from the pumping unit to an external smart device. The smart device may have a custom-developed app to receive the data and store it in a drainage log. In addition, the app could provide feedback to the user on flow rate settings for future drainages and create custom drainage rate protocols for individual patients.
[0095] In one example, and as described in the example above, the system (e.g., the pumping unit 100) may include readout screen for displaying any of the monitoring aspects described above. In one aspect the readout screen may also be an input device (i.e., a touchscreen).
[0096] In some examples, the output of the sensor(s) may be configured to provide information to and / or may otherwise be communicatively coupled with one or moremicrocontrollers. Various components of such a controller 1100 are shown in representative block diagram form in Figure 16. In Figure 6, the controller 1100 includes a CPU 1102, clock 1104, RAM 1108, ROM 1110, a timer 1112, a BUS controller 1114, an interface 1116, and an analog-to-digital converter (ADC) 1118 interconnected via a BUS 1106.
[0097] The CPU 1102 may be implemented as one or more single core or multicore processors, and receive signals from an interrupt controller 1120 and a clock 1104. The clock 1104 may set the operating frequency of the entire microcontroller 1100 and may include one or more crystal oscillators having predetermined frequencies. Alternatively, the clock 1104 may receive an external clock signal. The interrupt controller 1120 may also send interrupt signals to the CPU, to suspend CPU operations. The interrupt controller 1120 may transmit an interrupt signal to the CPU when an event requires immediate CPU attention.
[0098] The RAM 1108 may include one or more Static Random Access Memory (SRAM), Dynamic Random Access Memory (DRAM), Synchronous Dynamic Random Access Memory (SDRAM), Double Data-Rate Random Access Memory (DDR SDRAM), or other suitable volatile memory. The Read-only Memory (ROM) 1110 may include one or more Programmable Read-only Memory (PROM), Erasable Programmable Read-only Memory (EPROM), Electronically Erasable Programmable Read-only memory (EEPROM), flash memory, or other types of non-volatile memory.
[0099] The timer 1112 may keep time and / or calculate the amount of time between events occurring within the controller 1100, count the number of events, and / or generate baud rate for communication transfer. The BUS controller 1114 may prioritize BUS usage within the controller 1100. The ADC 1118 may allow the controller 1100 to send out pulses to signal other devices.
[0100] The interface 1116 may comprise an input / output device that allows the controller 1100 to exchange information with other devices. In some implementations, theinterface 1116 may include one or more of a parallel port, a serial port, or other computer interfaces.
[0101] In addition, the monitoring or analysis of the fluid through the device and / or system may be implemented using hardware, software, or a combination thereof and may be implemented in one or more computer systems or other processing systems. In an aspect of the present disclosures, features are directed toward one or more computer systems capable of carrying out the functionality described herein.
[0102] The computer system may include one or more processors that may be connected to a communication infrastructure (e.g., a communications bus, cross-over bar, or network or wireless network). Various software aspects are described in terms of this example computer system.
[0103] The computer system may include a display interface that forwards graphics, text, and other data from the communication infrastructure (or from a frame buffer) for display on a display unit. Computer system also includes a main memory, preferably random-access memory, and may also include a secondary memory. The secondary memory may include, for example, a hard disk drive, and / or a removable storage drive. The removable storage drive reads from and / or writes to a removable storage unit in a well-known manner. As will be appreciated, the removable storage unit includes a computer usable storage medium having stored therein computer software and / or data.
[0104] Alternative aspects of the present disclosure may include secondary memory and may include other similar devices for allowing computer programs or other instructions to be loaded into computer system. Such devices may include, for example, a second removable storage unit and an interface. Examples of such may include a program memory chip (such as an erasable programmable read only memory (EPROM), or programmable read only memory (PROM)) and associated socket, and other removablestorage units and interfaces, which allow software and data to be transferred from the removable storage unit to computer system.
[0105] Computer system may also include a communications interface. Communications interface allows software and data to be transferred between computer system and external devices. Examples of communications interface may include a known modem or wireless interface, a network interface, a communications port, a Personal Computer Memory Card International Association (PCMCIA) element, etc. Software and data transferred via communications interface are in the form of signals, which may be electronic, electromagnetic, optical, or other signals capable of being received by communications interface. These signals are provided to communications interface via a communications path (e.g., a channel). This path carries signals and may be implemented using wire or cable, fiber optics, a wireless, Wi-Fi, Bluetooth, and / or cellular link, an RF link and / or other communications channels. In this document, the terms “computer program medium” and “computer usable medium” are used to refer generally to media such as a removable storage drive, a hard disk installed in hard disk drive, and signals. These computer program products provide software to the computer system. Aspects of the present disclosures are directed to such computer program products.
[0106] Computer programs (also referred to as computer control logic) are stored in main memory and / or secondary memory. Computer programs may also be received via communications interface. Such computer programs, when executed, enable the computer system to perform the features in accordance with aspects of the present disclosures, as discussed herein. In particular, the computer programs, when executed, enable the processor to perform the features in accordance with aspects of the present disclosures. Accordingly, such computer programs represent controllers of the computer system.
[0107] In an aspect of the present disclosures where the output of the sensor or sensors is monitored or otherwise analyzed via the implementation of software, the software may be stored in a computer program product and loaded into computer system using removable storage drive, hard drive, or the communications interface. The control logic (software), when executed by the processor, causes the processor to perform the functions described herein. In another aspect of the present disclosures, the system is implemented primarily in hardware using, for example, hardware components, such as application specific integrated circuits (ASICs). Implementation of the hardware state machine so as to perform the functions described herein will be apparent to persons skilled in the relevant art(s).
[0108] The monitoring sensor(s), system or apparatus may implement various example communication system components usable in accordance with an aspect of the present disclosure. The communication system my include one or more accessors (which may for example comprise any of the aforementioned systems and features) and one or more terminals. In one aspect, data for use in accordance with aspects of the present disclosure is, for example, input and / or accessed by accessors via the terminals such as personal computers (PCs), minicomputers, mainframe computers, microcomputers, telephonic devices, smartphone(s), tablets, or wireless devices, such as personal digital assistants (“PDAs”) or a hand-held wireless devices coupled to a server, such as a PC, minicomputer, mainframe computer, microcomputer, or other device having a processor and a repository for data and / or connection to a repository for data, via, for example, a network, such as the Internet or an intranet.
[0109] Aspects of the disclosure further include method for draining fluid from a patient using the device and systems described herein. The method may include the following steps:a. Connect disposable tubing to catheter end (e.g., install the drainage catheter connector 208 of Figure 5 into the catheter) and insert the tubing guide and tubing (e.g., install the tubing guide member 111) into the pumping mechanism. b. To begin draining, press power button on pumping mechanism (e.g., pumping unit 100) or on phone application (e.g., phone application 900 shown in Figure 15 A). c. To control drainage flow rate, adjust via buttons or other interface (e.g., interface 102) on pumping device or phone application (e.g., phone application 900 shown in Figure 15 A). d. To pause the drainage temporarily, press play / pause button or interface (e.g., interface 102) on pumping device or (e.g., phone application 900 shown in Figure 15A). To resume drainage, press the play / pause button again. e. When finished draining, turn off the pump module (e.g., via switch 102d in Figure 1, via the interface, and / or via the phone application). Disconnect access tip from catheter and / or remove tubing set (e.g., by pressing one or more release interfaces 140 and / or 340 shown in Figures 1-4, 10-13B) from pumping mechanism, seal disposable bag full of drainage fluid and dispose of the drainage bag and tubing set (e.g., the tubing set shown in Figure 5).
[0110] In one example, any one or combination of the features described herein could be labeled clearly with numbers and / or color coded and / or may include any combination of written and / or pictographic instructions thereon so that the user can comprehend the steps for installation and / or use of the device or features thereof.
[0111] In some examples, the aforementioned and / or a related procedure and / or method for using the system may be described in instructions provided with the device and any additional components included therewith (e.g., a catheter, drainage bag, the pumping unit, and / or any other components provide to assist with installation, use-of and / ormaintenance of the devices or components). The instructions may be provided as a pamphlet or as written instructions on the packaging of the kit or system. The aforementioned instructions may also be provided as digital content (provided by accessing information on a network, such as a webpage on the Internet). In one example, any one of the component systems, the packaging of the system components and / or any components provided therewith may include an address and / or a quick response “QR” code for accessing instructions and / or digital content related to methods of installation and / or use thereof. In addition, the instructions may also be provided by salesperson via marketing materials to name another non-limiting example.
[0112] While a number of example aspects and aspects have been discussed above, those of skill in the art will recognize that still further modifications, permutations, additions, and sub-combinations thereof of the features of the disclosed aspects are still possible and thus this disclosure should be interpreted to include all such modifications, permutations, additions, and sub-combinations as are within its true spirit and scope.
Claims
CLAIMSWhat is claimed is:
1. A drainage system for drainage of fluid from a catheter, the drainage system comprising: a pump with a motor, an interface for controlling operation of the motor, and one more roller for occluding or partially occluding tubing wherein the motor is operatively connected to a one or more rollers; a tubing set for draining the fluid from a catheter with a pumping portion configured to be occluded or partially occluded by the one or more rollers to pump fluid through the tubing from a tubing inlet portion to a tubing outlet portion, the tubing set comprising tubing guide, wherein the tubing guide is configured to be removably connected to the pump and contain the pumping portion of the tubing set.
2. The drainage system of claim 1, wherein the pumping portion is in fluid communication with the tubing inlet portion at a first end and with the tubing outlet portion at a second end.
3. The drainage system of claim 1 or 2, wherein the tubing inlet portion is in fluid communication with a catheter interface and the tubing outlet portion is in fluid communication with a fluid collection container.
4. The drainage system of any one of claims 1-3, wherein the tubing set comprises the catheter interface and the fluid collection container.
5. The drainage system of any one of claims 1-4, wherein the tubing guide contains the pumping portion in curved or linear orientation.
6. The drainage system of any one of claims 1-5, wherein the tubing guide comprises a tubing inlet guide with the tubing inlet portion passed therethrough and a tubing outlet guide with the tubing outlet portion passing therethrough.
7. The drainage system of any one of claims 1-6, wherein the tubing inlet guide is a first hole at a first end of the tubing guide and the tubing outlet guide is a second hole at a second end of the tubing guide.
8. The drainage system of any one of claims 1-7, wherein the tubing guide further comprises an engagement feature, wherein the engagement feature is configured to engage with a captive portion of the pump when the tubing guide is installed into a receiving portion of the pump.
9. The drainage system of any one of claims 1-8, wherein the pumping portion is configured to be occluded or partially occluded by pinching the pumping portion between an inner surface of the tubing guide and the one or more rollers when the tubing guide portion is installed into the receiving portion of the pump.
10. A drainage pump for drainage of fluid from a catheter, the drainage pump comprising: a motor; an interface for controlling operation of the motor; and one more roller for occluding or partially occluding tubing wherein the motor is operatively connected to a one or more rollers; an interface portion configured to receive a tubing guide with a portion of tubing installed therein; andan engagement mechanism, wherein the engagement mechanism is configured to captively engage with one or more engagement features of the tubing guide when the tubing guide is pressed into the interface portion.
11. The drainage pump of claim 10, wherein the engagement mechanism comprises a first captive portion and a second captive portion that are biased away from one another.
12. The drainage pump of any one of claims 10 or 11, wherein the first captive portion and the second captive portion are biased away from one another via a spring.
13. The drainage pump of any one of claims claim 10-12, wherein the first captive portion and the second captive portion comprise at least one ramp portion configured have a force applied thereto by the engagement features of the tubing guide.
14. The drainage pump of any one of claims 10-13, wherein the first captive portion is connected to a first release interfaces and the second captive portion is connected to a second release interface, wherein the release interfaces are configured move the first captive portion and the second captive portion to a release position for releasing the tubing guide from the engagement mechanism when a user presses on the first release interface and the second release interface.
15. A drainage set configured to be connected the pump of claim 10 for draining a fluid from a catheter when a pumping portion of the pump occludes or partially occludes a pumping portion of a tubing of the drainage set, wherein the drainage set further comprises:a tubing guide member configured to captively engage with at least the pumping portion of the tubing, where the tubing guide is configured to be releasably installed into the pump, wherein the tubing set further comprises: a catheter interface connector for connecting to a catheter; and a fluid collection container for storing fluid drained via the catheter interface.
Citation Information
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