WO2005016412A2

WO2005016412A2 - In-line automated thoracic drain collection and vent system

Info

Publication number: WO2005016412A2
Application number: PCT/US2004/026289
Authority: WO
Inventors: John J. Giobbi
Original assignee: Margent Development, Llc
Priority date: 2003-08-11
Filing date: 2004-08-11
Publication date: 2005-02-24
Also published as: WO2005016412A3

Abstract

The invention described herein includes an apparatus. The apparatus includes an inflow tube having an inlet and a outlet, wherein the inlet is configured to receive bodily liquids and gases. The apparatus also includes a receptacle having an inlet port positioned to receive the bodily liquids and gases fron the outlet of the inflow tube. The apparatus additionally includes a one-way valve comprising a tubular main body having an inlet that receives bodily liquids and gases fron the outlet of the inflow tube.The tubular main body flattens and expands in response to a pressure differential that moves the liquids and gases through the valve to the receptacle while preventing the flow of the liquids and gases from the receptacle back into the inflow tube. The apparatus also includes a vent attached to the receptacle.

Description

IN-LINE AUTOMATED THORACIC DRAIN COLLECTION AND VENT SYSTEM

Field of the Invention This invention relates generally to a chest drainage device, and in particular, but not by way of limitation, to an apparatus and system for the collection of bodily liquids and gases from a chest drainage device which is attached to a patient. Background Individuals undergoing certain thoracic surgeries, which are surgeries involving the chest, require the use of a thoracic drain for a period of time following their procedure. The puφose of such a drain is to provide a path for any liquids and gases remaining or forming in the chest cavity to drain. The procedure to insert these chest drainage devices, or "chest tubes" as they are often referred to, into a patient's chest is termed a "chest tube thoracostomy". While chest tubes perform a necessary and sometimes life-saving function they carry with them safety, comfort, and convenience-related issues. Materials draining from a chest tube must be collected. This is currently accomplished by attaching a small collection bag to the open exterior end of the chest tube. Standard collection bags collect the draining liquids and gases and, importantly, prevent any of the same from reentering the tube and thereby the chest cavity by utilizing a one-way valve know as a Heimlich valve which is disclosed in US Patent No. 3463159. The Heimlich valve is often called a flutter valve or simply a one-way valve. Since a human's chest cavity maintains an inherently lower pressure state than that of surrounding atmosphere, air will rush into the cavity whenever an opportunity exists. Such opportunity presents itself after many types of thoracic surgeries. As this inflow of air can cause a patient's lungs to partially or fully collapse, the inclusion and proper workings of one-way valves in collection bags is critical. Prior to the invention of the Heimlich valve, patients with chest tubes were confined to beds and their chest tubes were connected to water-seal drainage systems. Such systems incoφorated devices that utilized the pressure of an underwater comiection to restrict backflow in the chest tube. While portable collection bags containing Heimlich valves have since greatly increased the mobility of patients with chest tubes, they have introduced their own set of problems. These problems include the limited use of collection capacity due to ballooning and accidental disconnect of the chest tube from the collection bag. Because chest tubes by their very nature drain liquids and gases, collection bags tend to quickly fill, or "balloon", with gases. This often occurs when only a small percentage of the bag has been filled with fluid. Once ballooned, the bag is no longer able to accept any liquids and must therefore be drained. One means of accomplishing this is to empty the collection bag's entire contents, liquids and gases, into a refuse container. This option in only applicable, however, if a collection bag includes a drain, and when a patient has access to a refuse container. Another option would be to temporarily pinch the chest tube closed, disconnect it from the collection bag, and then empty the bag via its chest tube connection. This would be inherently dangerous in that by disconnecting the chest tube from the bag, the Heimlich valve would be removed from the inflow path introducing the potential for air to enter the chest tube and thereby the chest cavity, and the associated potential for that air to collapse the patient's lungs. Current collection bags generally have no integrated means of ensuring that a tight coupling is maintained to an attached chest tube. This can cause a problem as some patients prefer to allow their bag to hang from their chest tube and the bag's weight may cause inadvertent disconnects and the potential for the associated safety hazards. Users requiring a thoracic drain are likely to be recovering from surgery and already dealing with typical operative recovery issues. Yet, the inherently superficial design of currently available thoracic drain options compound these issues by introducing additional safety concerns and by not addressing issues of convenience and discomfort.

Summary 1. The invention described herein includes an apparatus. The apparatus includes an inflow tube having an inlet and an outlet, wherein the inlet is configured to receive bodily liquids and gases. The apparatus also includes a receptacle having an inlet port positioned to receive the bodily liquids and gases from the outlet of the inflow tube. The apparatus additionally includes a one-way valve comprising a tubular main body having an inlet that receives bodily liquids and gases from the outlet of the inflow tube. The tubular main body flattens and expands in response to a pressure differential that moves the liquids and gases through the valve to the receptacle while preventing the flow of the liquids and gases from the receptacle back into the inflow tube. The apparatus also includes a vent attached to the receptacle. 2. The invention also includes a system. The system includes a chest drainage device having an inlet and an outlet, the inlet configured for insertion into a patient's thoracic cavity. The system also includes an inflow tube having an inlet for receiving bodily liquids and gases from the outlet of the chest drainage device. The system further includes a receptacle having a port for receiving the bodily liquids and gases from the outlet of the inflow tube; and a one-way valve comprising a tubular main body with an inlet and an outlet, the inlet receiving bodily liquids and gases from the outlet of the inflow tube, wherein the tubular main body flattens and expands in response to a pressure differential that moves the liquids and gases through the valve to the receptacle while preventing the flow of the liquids and gases from the receptacle back into the inflow tube. Brief Description of the Drawings hi the drawings, like numerals describe substantially similar components throughout the several views. Like numerals having different letter suffixes represent different instances of substantially similar components. Fig. 1 sets forth a perspective view of the preferred embodiment of the thoracic drain collection and vent apparatus of the present invention. Fig. 2 sets forth a perspective view of the preferred embodiment of the present invention which illustrates liquid and gas flow throughout the apparatus. Fig. 3 sets forth a frontal view of an alternative embodiment of the thoracic drain collection and vent apparatus of the present invention. Fig. 4A sets forth a right-side view of a different alternative embodiment of the thoracic drain collection and vent apparatus of the present invention. Fig. 4B sets forth a frontal view of the alternative embodiment referenced in Fig. 4A. Fig. 5 sets forth a perspective view of the preferred storage arrangement - within a Margent Universal Leg Harness - of the thoracic drain collection and vent apparatus of the present invention. Detailed Description In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be utilized and that structural changes may be made without departing from the scope of the present invention. Therefore, the following detailed description is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims and their equivalents. The present subject matter relates to a compact, in-line, automated bodily liquid and gas collection and venting apparatus and system. One embodiment of apparatus 100 is illustrated in Fig. 1 and includes two tubes, inflow tube 120 and vent tube 130, concentrically arranged linking the vent chamber 140 to the receptacle 150, while a tube securing device 160 ensures solid coupling of the chest drainage device 110 to a tube connector 170. The concentric-flow tubes 120, 130 enable a two-way flow between the vent chamber 140 and receptacle 150. The receptacle 150 can be a collection bag, and is in the preferred embodiment, however, other lightweight containers can also be utilized. As shown in Fig. 2, the inflow tube 120 transports inflowing materials from the chest drainage device 110 through a one-way valve 180 and into the receptacle 150. The vent tube 130 provides a path for collected gases to exhaust from the receptacle 150. This mechanism prevents collected gases from "ballooning" the receptacle which inhibits any further drainage, thus enabling the entire contents of the receptacle 150 to be utilized for the collection of liquids, and limiting the need to empty the receptacle 150 to only those times where it has become filled with liquids and not gases. Referring back to Fig. 1, an outlet port 198 with an associated outlet port cap 199 allows the receptacle 150 to be selectively emptied by the user. A vent chamber 140 separates and vents any gases collected in the receptacle 150 from any collected liquids. In the preferred embodiment, the vent chamber 140 is octagonally shaped, incoφorates a tube connector 170 and a tube securing device 160, is divided internally into an upper vent chamber 180 and a lower vent chamber 190 by a hydrophobic filter 192, contains a vent outlet 194 and an associated vent door 196 in the outer wall of the upper vent chamber 180, and is connected to concentric-flow tubes 120, 130. As shown in both Fig. 1 and Fig. 2, the vent tube 130 is permanently attached to the bottom of the lower vent chamber 190 extending out of the bottom a few inches or more, and is directly molded to the receptacle 150, forming an open channel between the two components. The inflow tube 120, which manages the inflow of bodily liquids and gases from the chest drainage device 110, floats inside the vent tube 130, running vertically upward straight- through the vent chamber 140 where it permanently attaches to the tube connector 170. The other end of the inflow tube 120 terminates in a one-way valve 180 located inside the receptacle 150. The inflow tube 120 thus establishes a path for inflowing bodily liquids and gases from the attached chest drainage device 110 to directly drain through the one-way valve 180 and into the receptacle 150. While the vent tube 130 provides a path for gases exhausted from the receptacle 150 to vent back into the lower vent chamber 190. Once in the lower vent chamber 190, the vented gases pass through the hydrophobic filter 192 and the out the upper vent chamber's 180 vent outlet 194. Liquids inadvertently vented along with the gases are restricted from passing through the hydrophobic filter 192 and due to the angled designed of the lower vent chamber 190, will drip back down the vent tube 130 and into the receptacle 150. The hydrophobic filter 192 can be a plastic scaffold covered with a membrane made of a semi-porous material with the pores being small enough so as to restrict the passage of liquid droplets. This membrane prevents or greatly restricts the passage of liquids while at the same time allowing the easy passage of gases. The exposed area and density of the membrane is designed in such a way as to impose a measured resistance on the liquids and gases rising up the vent tube 130. This resistance minimizes the potential for liquids to leak from the vent outlet 194 due to compression of the receptacle 150. The appropriate level of resistance needed to accomplish this is an important design aspect of the invention. The hydrophobic filter 192 preferably contains an antibacterial coating. There are various means of routing the inflow tube 120 through the center of the vent chamber 140. Some means involve running the inflow tube 120 directly through the center of the hydrophobic filter 192. Importantly, in any configuration where the inflow tube 120 is in direct contact with the hydrophobic filter 192, the area of contact is fully sealed. This seal prevents leaks and preserves the measured resistance imposed by the hydrophobic filter 192. In the embodiment, the vent outlet 194 located on the outer wall of the upper vent chamber 180 is simply a half-moon cutout. This cutout is covered by a round vent door 196 containing a matching half-moon cutout on one side. Therefore, a patient can rotate the vent door 196 to either open or shut the vent outlet 194. When shut, the patient is assured that nothing can escape the vent outlet 194. This capability might be utilized in situations such as when a receptacle 150 is near capacity but the patient cannot immediately empty it, or when a patient must remain in a semi-inverted position for a prolonged period of time. While beneficial, the valve door 196 is optional. Without the valve door 196, the vent outlet 194 simply remains open permanently. In the embodiment shown in Fig. 1 and Fig. 2, the tube comiector 170 and the tube securing device 160 are located on top of the vent chamber 140. The tube connector 170 can have a tapered shape to enable a pressure-fit connection to nearly any size chest drainage device 110. Once a chest drainage device 110 has been attached, it is typical for a nylon tie-down, or equivalent, to be wrapped around the connection and secured to itself. While using such a tie- down is certainly better than relying on the pressure-fit connection alone, it is not foolproof, as the weight of the receptacle 150 may sometimes be enough to cause an inadvertent disconnect from the chest drainage device 110. A feature of the invention designed to address this potentially serious disconnect problem is the inclusion of a flexible, tube securing device 160. Instead of a nylon tie-down being directly secured around the chest drainage device 110 as described above, it is first fed through the tube securing device 160, then around the chest drainage device 110 about midpoint along the portion of the chest drainage device 110 overlapping the tube connector 170 and finally secured to itself. Because this tube securing device 160 is permanently attached to the vent chamber 140, it ensures a secure coupling of the chest drainage device 110 to the vent chamber 140. By providing strain-relief between the chest drainage device 110 and the vent chamber 140, the tube securing device 160 helps ensure that the weight of the receptacle 150, especially as it fills with fluid, will not cause an accidental disconnect. As such a disconnect may cause serious harm to the patient, this strain-relief capability is highly desirable. If desired prior to initial use, a nylon tie-down, or equivalent, may be fed through the tube securing device 160 and minimally secured, ensuring that a tie- down is available and ready for use at the time of installation. As previously described, dual concentrically arranged flow tubes 120, 130 are employed to manage inflowing liquids and gases, as well as the venting of those gases to a surrounding atmosphere. In the preferred embodiment, vinyl, semi-rigid tubing is utilized which resists crimping and eliminates the need for separators to maintain the correct spacing between the concentric-flow tubes 120, 130. The length of the concentric-flow tubes 120, 130 is such that when the receptacle 150 is positioned in a Universal Leg Harness 500, or simply hung from a chest drainage device 110 in the vicinity of the patient's thigh, the vent chamber 140 is above the receptacle 150 and on a substantially vertical plane. This arrangement facilitates gravity's effect in ensuring proper downward flow of materials from the chest drainage device 110. Additionally, the arrangement of the concentric-flow tubes 120, 130 has the added benefit of minimizing blockage problems in the vent tube 130. Having the inner area of the vent tube 130 broken up by the presence of the inflow tube 120, the surface tension of any liquids inadvertently flowing up the vent tube 130 will not typically be great enough to sustain a blockage. In the preferred embodiment shown in Fig. 1 and Fig. 2, the receptacle 150 is molded to the vent tube 130. Then, within the vent tube 130, the inflow tube 120 floats independently, terminating in a one-way valve 180. The oneway valve 180 attached to the inflow tube 120 allows any inflowing materials from the chest drainage device 110 to enter the receptacle 150, but will not allow any reverse flow to occur. This functionally is desirable, as any air allowed to flow into the chest drainage device 110 could potentially collapse a patient's lungs. The location of the one-way valve 180 inside the receptacle 150 protects it from any accidental contact, and enables its use without concern for its resting angle. While the above description represents the invention's preferred embodiment, variations to various components are possible that may present alternative solutions for certain patients in particular situations. Referring to Fig. 3 and Fig. 4, one such modification involves using a single-chamber vent chamber 140. Within the vent chamber 140, a one-way valve 180 resides that is secured to a tube connector 170 linking it to an attached chest drainage device 110. At the top of the vent chamber 140, a hydrophobic filter 192 resides, covering one or more vent outlets 194 in the ceiling of the vent chamber 140. On the opposite side of the one or more vent outlets 194, corresponding vent doors 196 can be located to allow the patient to selectively allow displaced collected air to escape into the surrounding atmosphere. An inflow tube 120 and a vent tube 130 non-concentrically extend from a bottom surface of the vent chamber 140. Each tube 120, 130 enters the vent chamber 140 with the vent tube 130 nearly extending to the ceiling of the vent chamber 140, and the inflow tube 120 terminating near the bottom of the vent chamber 140. With the inflow tube 120 terminating near the bottom of the vent chamber 140, liquids are able to flow down the vent chamber 140 and exit into the receptacle 150. While the vent tube 130, being near the top of the vent chamber 140, enables exhausted gases to escape through the hydrophobic filter 192. The opposite ends of both the inflow tube 120 and the vent tube 130 terminate, without one-way valves 180, inside the receptacle 150. Fig. 3 illustrates one possible shape for the vent chamber 140 in this alternative embodiment, while Figs. 4A and 4B illustrate another possible shape for the vent chamber 140. Fig. 4A shows the front view, as Fig. 4B shows a side view of this alternative vent chamber profile. Material flow through these alternative embodiments is as follows: inflowing materials from the chest drainage device 110 flow through the oneway valve 180, into the vent chamber 140, and down the inflow tube 120 into the receptacle 150. Any collected gases are eventually exhausted up the vent tube 130 and back into the vent chamber 140. The one-way valve 180 prevents any of these exhausted materials from reentering the chest drainage device 110, and the hydrophobic filter 192 prevents any inadvertently exhausted liquids from exiting the one or more vent outlets 194. The "rejected" liquids simply rejoin the incoming flow and loop back down the inflow tube 120. Exhausted gases, however, pass through the hydrophobic filter 192 and out one or more of the vent outlets 194. The alternative embodiments essentially possess a "closed-loop", where separate paths exist for incoming materials and vented gases. This closed-loop mechanism physically exists below the one-way valve 180. Thus, the vent chamber 140 is a self-contained draining and venting unit, with a one-way valve 180 -protected tube connector 170. The receptacle 150 plays no other role besides that of a receptacle in these configurations. The alternative embodiments may be preferable in situations where unusually large quantities of liquids and gases are to be collected, as having independent inflow 120 and vent 130 tubes arranged in a closed-loop configuration below the one-way valve 180, allows for very efficient and complete management of incoming materials. These embodiments employ two, externally- visible, tubes between the vent chamber 140 and the receptacle 150, and due to the one-way valve's 180 location within the vent chamber 140, a larger vent chamber 140 housing than in the preferred embodiment shown in Fig. 1 and Fig. 2. Another alternative embodiment not yet mentioned involves adding secondary vent tubes 130, terminating with manually controlled valves, onto receptacles 150 incoφorating internal one-way valves 180 on their inflow tubes 120. Controls may take the form of simple plugs, or may involve the use of spring-loaded valves, either of which patients can temporarily open to vent accumulated gases. Yet another alternative embodiment not yet mentioned involves the same basic configuration as the preferred embodiment illustrated in Fig. 1 and Fig. 2, with the exception that the inflow tube 120 and the vent tube 130 are arranged independently as opposed to concentrically. In this configuration, the one-way valve 180 is still located within the receptacle 150 and molded to the outlet end of the inflow tube 120. Fig. 5 illustrates how one embodiment of apparatus 100 can be slipped into a Universal Leg Harness 500 where the receptacle 150 and vent chamber 140 are secured in an optimal and comfortable arrangement. The Universal Leg Harness 500 is disclosed in Provisional Application Serial No. 60/471,590 filed May 19, 2003, entitled "Urologic Catheter Integrated Mounting and Stabilization System." Other embodiments are described as follows: The present invention provides an apparatus and system for the collection of bodily liquids and gases associated with a chest drainage device. The apparatus automates the process of separating incoming thoracic drain materials into liquids and gases, venting gases and capturing liquids, and in so doing, utilizes a one-way valve to prevent the reverse flow of drain materials back into the chest drainage device. Further, the present invention provides improved connection mechanisms to ensure inadvertent discomiects do not occur. In one embodiment, liquids and gases flowing from the chest drainage device are transported directly to an attached receptacle, which can be a collection bag, where they exit via a one-way valve. In another embodiment, liquids and gases flowing from the chest drainage device are first transported to a vent chamber where they exit via a one-way valve, the liquids and some gases are then transported to a receptacle by way of an inflow tube, hi various embodiments, as the receptacle fills, increasing pressure forces gases, and occasionally liquids, to vent up a vent tube where they exhaust into a vent chamber. In one embodiment, the inflow tube and the vent tube are concentric. In another embodiment, the flow tubes are non-concentrically arranged. In one embodiment, a hydrophobic filter is located in such a way as to horizontally divide the vent chamber into an upper vent chamber and a lower vent chamber and is used to separate liquids and gases. In another embodiment, the hydrophobic filter is located at the top of the vent chamber. In various embodiments, the hydrophobic filter allows gases to pass through and out one or more vent outlets, but rejects liquids causing them to ultimately drain back into the receptacle. In various embodiments, one or more vent doors can be engaged to temporarily close the one or more vent outlets as needed. hi various embodiments, a tube connector is located on or near the vent chamber to accept all standard size chest drainage devices. In one embodiment, a tube securing device aids the tube connector to eliminate the possibility of inadvertent disconnect. Once the chest drainage device is attached to the tube connector, a nylon tie-down can be fed through the tube securing device, around the chest drainage device and secured to itself. It is understood that the above description is intended to be illustrative, and not restrictive. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

What is claimed is: 1. An apparatus comprising: an inflow tube having an inlet and an outlet, wherein the inlet is configured to receive bodily liquids and gases; a receptacle having an inlet port positioned to receive the bodily liquids and gases from the outlet of the inflow tube; a one-way valve comprising a tubular main body having an inlet that receives bodily liquids and gases from the outlet of the inflow tube, wherein the tubular main body flattens and expands in response to a pressure differential that moves the liquids and gases through the valve to the receptacle while preventing the flow of the liquids and gases from the receptacle back into the inflow tube; and a vent attached to the receptacle.

2. The apparatus of claim 1, wherein the vent includes a vent tube having an inlet and an outlet, the inlet attached to the receptacle.

3. The apparatus of claim 2, wherein the vent further includes a hydrophobic filter proximal to the outlet of the vent tube.

4. The apparatus of claim 3, wherein the vent further comprises a vent door proximal to the hydrophobic filter.

5. The apparatus of claim 1, wherein the receptacle further includes an outlet port and an outlet port cap positioned to selectively discharge the collected bodily liquids and gases contents accumulated within the receptacle.

6. The apparatus of claim 1, wherein the receptacle comprises a collection bag.

7. The apparatus of claim 1, further comprising a tube connector positioned on or near the vent chamber to accept all standard size chest drainage devices.

8. The apparatus of claim 1, wherein the inflow tube and the vent tube are concentric.

9. The apparatus of claim 1, wherein the inflow tube and vent tube are non- concentrically arranged.

10. An system comprising: a chest drainage device having an inlet and an outlet, the inlet configured for insertion into a patient's thoracic cavity; an inflow tube having an inlet for receiving bodily liquids and gases from the outlet of the chest drainage device; a receptacle having a port for receiving the bodily liquids and gases from the outlet of the inflow tube; and a one-way valve comprising a tubular main body with an inlet and an outlet, the inlet receiving bodily liquids and gases from the outlet of the inflow tube, wherein the tubular main body flattens and expands in response to a pressure differential that moves the liquids and gases through the valve to the receptacle while preventing the flow of the liquids and gases from the receptacle back into the inflow tube.

11. The system of claim 10, further comprising a tube connector positioned on or near the vent chamber to accept all standard size chest drainage devices.

12. The system of claim 10, further comprising a vent that allows bodily gases to flow out of the receptacle when displaced by the bodily liquids.

13. A package for use in a thoracic drainage system comprising: a one-way valve structured to allow thoracic fluid to drain in one direction but not allowing such fluid to flow in an opposite direction; and a tube having a first end and a second end, the first end coupled to the one-way valve and a second end sized to receive thoracic fluid.

14. A package for use in a thoracic drainage system comprising: an inner tube configured to receive thoracic fluid and sized to attach to a one-way valve; and an outer tube, the outer tube possesses an unattached inner diameter larger in size than an outer diameter of the inner tube to allow a path for fluid flow. wherein the inner tube possesses a longer axially extending body than the outer tube.

15. The package of claim 14, further comprising a receptacle coupled near an end of the outer tube and encapsulating the second end of the inner tube.

16. A package for use in a thoracic drainage system comprising a receptacle having at least two inlet ports, at least one inlet port sized to receive thoracic fluid and at least one inlet port sized to dispatch thoracic fluids, the receptacle having outer dimensions to allow encasement within a Universal Leg Harness.

17. A method for performing thoracic draining comprising: Inserting a chest tube comprising the apparatus of claim 1.