Heat protection system for a dialysate container

Abstract

A thermal protection system configured for use with a dialysate container or bag in a dialysis system is disclosed. The thermal protection system is configured such that when the dialysate container is subjected to a temperature above a predetermined temperature, for example when the dialysate container is heated within a microwave oven, the thermal protection system is configured to be able to (i) prevent dialysate from flowing from the bag, (ii) indicate that the dialysate container has been subjected to a temperature above the predetermined temperature, or (iii) a combination thereof. In one embodiment, the thermal protection system is a circular hollow ring positioned within an outlet port of the bag, the ring melting to block the flow of dialysate upon reaching the predetermined temperature. Alternatively, and / or in addition, the thermal protection system can be a heat sensitive dye configured to change color upon being subjected to the predetermined temperature.

Description

[0001] Cross-references to related applications

[0002] This document is a non-provisional application filed on December 16, 2020, entitled “Thermal Protection System for a Dialysate Container”, U.S. Patent Application No. 17 / 123,667, and claims priority to the date of its filing, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates generally to dialysis systems, and more particularly to thermal protection for dialysate containers. Background Technology

[0004] Dialysis systems and / or machines are known to be used to treat kidney disease. The two main dialysis methods are hemodialysis (HD) and peritoneal dialysis (PD). During HD, the patient's blood passes through the dialyzer of the HD machine, along with dialysate. A semipermeable membrane in the dialyzer separates the blood from the dialysate within the dialyzer and allows diffusion and osmotic exchange between the dialysate and the blood flow. During PD, the patient's peritoneal cavity is periodically infused with dialysate or dialysis solution. The membranous lining of the patient's peritoneum acts as a natural semipermeable membrane, allowing diffusion and osmotic exchange between the solution and the blood flow. In continuous ambulatory peritoneal dialysis (CAPD), the patient undergoes manual exchange. Automated PD (APD) machines, known as PD circulation machines, are designed to control the entire PD process, allowing it to be performed at home, typically overnight, without the presence of clinical staff.

[0005] A dialysis system includes one or more dialysate containers or sources, such as bags, for containing fluids (e.g., dialysate) for infusion into a patient. During treatment procedures, dialysate, such as fresh and used dialysate, is moved to and removed from the patient. For example, dialysate from one or more dialysate bags is moved into the patient's abdomen.

[0006] During use, cold dialysate can negatively impact a patient's treatment by causing discomfort. If the dialysate is cold enough, the patient may begin to shiver, which could negatively affect their ability to continue treatment. Therefore, the dialysate can be warmed to an appropriate temperature (e.g., approximately 37°C) before treatment. However, if the dialysate is warmed to a temperature significantly higher than the patient's body temperature, severe thermal damage to the peritoneum and surrounding internal organs may occur.

[0007] Because of the potential for serious injury, patients are instructed to place the dialysate bag in a bag warming device, such as a warming cabinet, or wrap with warming blankets. Generally, patients are advised not to immerse the dialysate bag in warm water because of the increased risk of infection, and not to place the dialysate bag in a microwave oven because of the risk of overheating the dialysate. For example, heating a dialysate bag with a microwave can create hot spots within the dialysate. That is, although the dialysate bag can only feel warm to the touch of the patient, there can be small areas within the dialysate that are significantly hotter.

[0008] However, although manufacturers warn against microwaving dialysate bags, published articles advise patients to thoroughly mix the dialysate bag after microwaving. Moreover, although manufacturers warn against microwaving dialysate bags, published articles advise that microwaving a dialysate bag is acceptable. Thus, although manufacturers warn against microwaving dialysate bags, there is evidence that patients and home care providers do microwave dialysate bags in order to save time during the warming process.

[0009] The present improvements can be useful in view of these and other considerations. SUMMARY

[0010] This summary is provided to introduce a selection of concepts that are further described below in the detailed description. This summary is not intended to necessarily identify key or essential features of the claimed subject matter, nor is it meant to limit the scope of the claimed subject matter.

[0011] According to one exemplary embodiment of the present disclosure, a dialysate container is disclosed. The dialysate container includes a reservoir arranged and configured to store dialysate, an outlet port arranged and configured to be in fluid communication with the reservoir and arranged and configured to be coupleable to tubing such that dialysate can flow from the reservoir to an outlet end of the tubing, and a thermal protection system arranged and configured to be in operative communication with the outlet port, the thermal protection system arranged and configured such that when the dialysate container is subjected to a temperature above a predetermined temperature, the thermal protection system is arranged and configured to either prevent the dialysate from flowing through the outlet port into the tubing, or to indicate that the dialysate container has been subjected to a temperature above the predetermined temperature, or a combination thereof.

[0012] In one embodiment, the thermal protection system is arranged and configured as a circular hollow ring positioned within the outlet port of the dialysate container.

[0013] In one embodiment, the circular ring includes a plastic material.

[0014] In one embodiment, the ring is arranged and configured to melt upon reaching the predetermined temperature, the melted ring blocking dialysate flow through the outlet port into the tubing.

[0015] In one embodiment, the dialysate container further comprises a support ring having a melting temperature higher than the predetermined temperature, such that the support ring can direct the melted ring to block dialysate flow through the outlet port into the tubing.

[0016] In one embodiment, the dialysate container further comprises a metal wrap arranged and configured to heat up faster than the ring to facilitate faster heating of the ring.

[0017] In one embodiment, the thermal protection system comprises a heat sensitive dye arranged and configured to change color upon being subjected to the predetermined temperature to indicate that the dialysate container has been subjected to a temperature higher than the predetermined temperature.

[0018] In one embodiment, the heat sensitive dye is incorporated into a frangible portion of the dialysate container.

[0019] In one embodiment, the thermal protection system comprises a spring loaded plunger comprising a plunger member, a spring, and a retaining member arranged and configured to melt upon reaching the predetermined temperature, and upon melting, the retaining member releases the spring such that the plunger member blocks dialysate flow through the outlet port into the tubing.

[0020] In one embodiment, the plunger member is pivotable from a first position enabling dialysate flow through the outlet port into the tubing to a second position blocking dialysate flow through the outlet port into the tubing.

[0021] In one embodiment, the plunger member is vertically displaceable from a first position enabling dialysate flow through the outlet port into the tubing to a second position blocking dialysate flow through the outlet port into the tubing.

[0022] According to one example embodiment of the present disclosure, a dialysate container is disclosed. The dialysate container includes a reservoir arranged and configured to store dialysate, an outlet port arranged and configured to be in fluid communication with the reservoir and arranged and configured to be coupleable to tubing such that dialysate can flow from the reservoir to an outlet end of the tubing, and a circular hollow ring positioned within the outlet port of the dialysate container, the circular hollow ring arranged and configured such that when the dialysate container is subjected to a temperature above a predetermined temperature, the circular hollow ring melts to prevent the dialysate from flowing through the outlet port into the tubing, or to indicate that the dialysate container has been subjected to a temperature above the predetermined temperature, or a combination thereof.

[0023] In one embodiment, the circular ring includes a plastic material.

[0024] In one embodiment, the circular ring is arranged and configured to melt upon reaching the predetermined temperature, the melted circular ring blocking the dialysate from flowing through the outlet port into the tubing.

[0025] In one embodiment, the dialysate container further includes a support ring having a melting temperature above the predetermined temperature, such that the support ring can direct the melted circular ring to block the dialysate from flowing through the outlet port into the tubing.

[0026] In one embodiment, the dialysate container further includes a metal wrap arranged and configured to heat up faster than the circular ring to facilitate faster heating of the circular ring.

[0027] In one embodiment, the dialysate container further includes a heat sensitive dye arranged and configured to change color upon being subjected to the predetermined temperature to indicate that the dialysate container has been subjected to a temperature above the predetermined temperature.

[0028] In one embodiment, the heat sensitive dye is incorporated into a frangible portion of the dialysate container. BRIEF DESCRIPTION OF DRAWINGS

[0029] Specific embodiments of the disclosed methods and apparatuses will now be described, by way of example, with reference to the drawings, in which:

[0030] Figure 1 An example layout of a continuous ambulatory peritoneal dialysis (CAPD) system is shown;

[0031] Figure 2 A perspective view of a conventional dialysate container or bag that can be used in a CAPD system of Figure 1 is shown.

[0032] Figure 3A and Figure 3B one or more features of the present disclosure can be incorporated into a heat protection system for a dialysate container or bag of the type shown in Figure 2 FIG. 1 ;

[0033] Figure 4A one or more features of the present disclosure can be incorporated into a heat protection system for a dialysate container or bag of the type shown in Figure 2 FIG. 2; and / or

[0034] Figure 4B to Figure 4D one or more features of the present disclosure can be incorporated into a heat protection system for a dialysate container or bag of the type shown in Figure 2 FIG. 3. DETAILED DESCRIPTION

[0035] The present embodiments will now be described more fully with reference to the accompanying drawings, in which multiple example embodiments are shown. The subject matter of the present disclosure, however, can be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and fully convey the scope of the subject matter to those skilled in the art. In the drawings, like reference numerals refer to like elements throughout.

[0036] Exemplary embodiments of a heat protection system or device (the terms are used interchangeably herein without intending to limit or distinguish) for a dialysate container (e.g., bag) or for use therewith are disclosed herein. In use, the heat protection system is arranged and configured to indicate and / or prevent (e.g., stop) use of the dialysate container upon determining that the dialysate container has been subjected to an extreme temperature, e.g., when placed within a microwave oven. That is, in use, the heat protection system is arranged and configured to inhibit, prevent, etc. flow of dialysate from the dialysate container upon determining that the dialysate container has been subjected to an extreme temperature, e.g., when placed within a microwave oven. Alternatively, and / or in addition, the heat protection system is arranged and configured to indicate to a user that the dialysate container has been subjected to an extreme temperature, e.g., when placed within a microwave oven.

[0037] Figure 1One example layout of a continuous ambulatory peritoneal dialysis (CAPD) system 100 is shown. In use, as will be described herein, features of the present disclosure are well suited for use with CAPD systems and methods that are typically performed manually. This is in contrast to APD systems and methods, which can be automated. However, it should be understood that while the present invention will be illustrated and described in connection with a CAPD system, the present invention should not be so limited. For example, it is contemplated that the present invention can be used in connection with other dialysis systems, such as in connection with an automated peritoneal dialysis (APD) machine (e.g., a PD cycler). Further, it is contemplated that the present invention can be applicable to other areas and devices that require the delivery of a warm fluid that should not be heated above a given temperature.

[0038] As shown, a patient 105 can have a catheter 120 disposed within a peritoneal cavity 110 of the patient 105. A dialysate container (e.g., bag) 140 can provide dialysate, which can flow from the dialysate container 140 to the catheter 120 via tubing 144. The dialysate can flow through the catheter 120 into the peritoneal cavity 110 of the patient. Thereafter, PD effluent can exit the peritoneal cavity 110 of the patient via the catheter 120 and flow to a drain system 142. Figure 1 That is, in use, the CAPD system 100 is arranged and configured to enable fresh dialysate to flow into the patient and used dialysate to be drained out of the patient. During treatment, a volume of dialysate can enter the patient's abdomen via the catheter 120 and remain for a period of time, e.g., a dwell time. During the dwell time, the dialysate can flow through the peritoneum and absorb contaminants and / or particulates from the patient's blood and exchange substances and fluids (e.g., electrolytes, urea, glucose, albumin, osmotically active particles, and other small molecules). At the end of the dwell time, used dialysate can flow out of the patient's abdomen via the catheter 120 and be removed to a drain system 142, e.g., a drain line, connected to the tubing. This exchange of fresh dialysate and used dialysate can occur for multiple cycles after the dwell time, according to the patient's treatment regimen.

[0039] One or more dialysate containers 140 can be used during a treatment cycle. In some embodiments, as shown, the dialysate container 140 can be a dialysate bag that is hung in the vicinity of the patient. Tubing 144 (e.g., a patient line) can be connected between the dialysate bag 140 and the catheter 120 and can be used to transfer dialysate from the dialysate bag 140 to the peritoneal cavity 110 of the patient. A drain line can be connected to a drain container or drain system 142 and can be used to transfer dialysate from the catheter 120 to the drain system 142 during use.

[0040] ​

[0041] Referring to Figure 2 As will be readily appreciated and understood by one of ordinary skill in the art, the dialysate container 140 can be in the form of a bag. As shown, the dialysate bag 140 includes a reservoir 160 arranged and configured to store fresh dialysate and an outlet port 162 arranged and configured to be coupled to the tubing 144 to enable dialysate to flow from the dialysate bag 140 to the outlet port of the catheter 120. In various embodiments, the dialysate bag 140 can include a frangible component or portion. As will be readily appreciated by one of ordinary skill in the art, the frangible component or portion prevents fluid from flowing from the dialysate bag 140 until the frangible component or portion is broken upon use.

[0042] As previously mentioned, contrary to the manufacturer's warnings, it is known for users to heat the dialysate bag in a microwave oven, rather than the recommended warming box, warming wrap, etc., to save time. However, heating the dialysate bag within a microwave oven can be dangerous. For example, heating the dialysate bag with a microwave can create hot spots within the dialysate. That is, although the patient can only feel warm when touching the dialysate bag, there can be a significantly hotter small area within the dialysate.

[0043] According to one or more features of the present disclosure, a thermal protection system is provided. In use, the thermal protection system is arranged and configured to prevent, inhibit, indicate, etc. when a dialysate container (e.g., bag) 140 has been subjected to a temperature above a predetermined temperature, e.g., when the dialysate bag has been placed within a microwave oven and heated by the microwave oven. In use, upon being subjected to a temperature above the predetermined temperature, the thermal protection system is arranged and configured to indicate and / or prevent (e.g., stop) use of the dialysate container.

[0044] In various embodiments, the thermal protection system is incorporated within the dialysate container (e.g., bag) 140. In one or more embodiments, the thermal protection system can be coupled to, operatively associated with, part of, etc. a frangible component or portion of the dialysate container 140. For example, in one embodiment, the thermal protection system can be integrated into the frangible component such that upon reaching the predetermined temperature, the thermal protection system melts, thereby preventing the frangible component from breaking. Alternatively, in other embodiments, the thermal protection system can be anchored to the frangible component.

[0045] In one embodiment, referring to Figure 3A and Figure 3BThe thermal protection system 200 is arranged and configured to be a circular ring 210 made of, for example, plastic. In use, the plastic ring 210 can be positioned within the outlet port 162 of the dialysate container 140. In one embodiment, the plastic ring 210 includes a central bore 212 arranged and configured to enable the flow of dialysate from the dialysate container 140. Thus, in one embodiment, the plastic ring 210 can be arranged and configured as a hollow stopper, although other configurations can be contemplated.

[0046] During use, when the dialysate container 140 is heated to a temperature above a predetermined temperature (e.g., above 100°F), the plastic ring 210 can melt. Upon melting, the plastic ring 210 blocks subsequent fluid flow, thereby preventing further use of the dialysate container 140 (e.g., the circular ring 210 melts to block the bore 212). In use, it should be understood and / or appreciated that the thermal protection system 200 (e.g., the plastic ring 210) need not be heated throughout the dialysate container 140. Rather, upon reaching the predetermined temperature, the thermal protection system 200 (e.g., the plastic ring 210) can melt, thereby preventing fluid flow (e.g., upon microwave heating of the thermal protection system 200 (e.g., the plastic ring 210) to the predetermined temperature, the thermal protection system 200 (e.g., the plastic ring 210) will activate to prevent fluid flow, regardless of whether the entire dialysate container 140 is heated to the predetermined temperature).

[0047] In one embodiment, the plastic ring 210 can be mounted to a support ring arranged and configured to have an increased microwave absorption (e.g., the support ring has an increased melting point such that the support ring does not melt when subjected to microwave radiation). So arranged, when the dialysate bag 140 is subjected to microwave radiation, the plastic ring 210 melts onto the support ring, which serves as a substrate to hold and direct the melted plastic ring 210 to block fluid flow. Alternatively, in another embodiment, the thermal protection system 200 can be arranged and configured such that, when it melts, the thermal protection system 200 prevents the breakage of a frangible portion. So arranged, existing mechanisms in the dialysate container block fluid flow.

[0048] In use, while the circular ring 210 has been described as being manufactured from a plastic material, the circular ring 210 can be manufactured from any suitable material arranged and configured to be manufactured from any suitable material having a suitable melting point. Similarly, the support ring can be manufactured from any suitable material arranged and configured to be manufactured from any suitable material having a suitable melting point, including, for example, plastic. Alternatively, the support ring can be made from a suitable material arranged and configured to be able to expand to close or block the outlet port to block fluid flow when a predetermined temperature is reached. Subsequently, in one embodiment, the support ring can contract to again enable fluid flow when cooled below the predetermined temperature. Alternatively, the member can remain in the expanded configuration, thus the dialysate container needs to be discarded.

[0049] In one embodiment, a wrap can also be provided. For example, a metal or foil wrap can be provided. In use, the metal wrap is arranged and configured to be able to quickly receive microwave absorption. Upon receiving microwave absorption, the metal wrap quickly heats the circular or plastic ring 210 to ensure that the circular or plastic ring 210 melts to prevent fluid flow. That is, so arranged that the thermal protection system can include a thin metal layer specifically intended to quickly heat the circular or plastic ring 210 in order to ensure that even a brief or short microwave attempt on the dialysate container will render the dialysate container unusable.

[0050] In one embodiment, the thermal protection system 200 can be in the form of or include a filter-like matrix containing a plurality of openings or holes (e.g., a filter having a grid pattern of openings or holes). In use, the openings or holes can be large enough to allow dialysate to flow freely under normal use. However, in use, the filter can include a matrix of meltable material. Upon reaching a predetermined temperature, the matrix of meltable material melts to seal the openings or holes formed in the filter, thereby preventing fluid flow.

[0051] Alternatively and / or in addition, in another embodiment, the thermal protection system 200 can be in the form of or include a heat sensitive dye. In use, upon being subjected to a higher temperature, instead of or in addition to melting, the thermal protection system 200 can be arranged and configured to change color. So arranged, the thermal protection system 200 is arranged and configured to provide an indication that the dialysate container 140 should not be used. For example, in one embodiment, the circular or plastic ring 210 can be arranged and configured to change color upon reaching a predetermined temperature instead of or in addition to melting. Alternatively, in one embodiment, the dialysate container 140 can include, for example, a plastic frangible component or portion that can be arranged and configured to change color upon being subjected to a predetermined temperature. Further, by appropriately adjusting the thermal protection system 200, the thermal protection system 200 can be used to determine whether the dialysate container 140 has been stored properly such that, for example, if the dialysate container has been subjected to a temperature that exceeds an acceptable storage safety limit, the thermal protection system 200 can change color, thereby indicating that the dialysate container 140 should not be used again. In one embodiment, a dye can be incorporated into a portion of the plastic or plastic container, preferably not visible during normal use, but which melts upon reaching a predetermined temperature such that the dye appears and / or is released. Alternatively, in another embodiment, the dye itself can be arranged and configured to be heat sensitive such that it has little or no color, but once heated to a predetermined temperature, undergoes a chemical reaction that produces a color change.

[0052] Alternatively, with reference to Figure 4A and Figure 4B , in one embodiment, the thermal protection system 200 can be arranged and configured as a spring loaded plunger. In use, the spring loaded plunger 220 can include a plunger member or valve member 222, a spring 224, and a retaining member 226. Upon being subjected to a predetermined temperature, the retaining member 226 melts, which releases the spring 224 such that the plunger member or valve 222 blocks the outlet port 162. For example, with reference to Figure 4A , the plunger member 222 can be arranged and configured to pivot to block the outlet port 162. That is, the plunger member 222 can pivot from a first position that allows fresh dialysate to flow through the outlet port 162 into the tubing to a second position that blocks fresh dialysate from flowing through the outlet port 162 into the tubing. Alternatively, with reference to Figure 4B and Figure 4C , the plunger member 222 can be arranged and configured to vertically displace to block the outlet port 162. In use, the vertically displacing spring loaded plunger can be any system now known or later developed whereby fluid flow is allowed in a first position and prevented in a second position. For example, as illustrated in FIG. 6, the spring 224 can be arranged and configured to be a coil spring that is arranged and configured to be compressed in a first position and expanded in a second position.Figure 4C As shown, the spring-loaded plunger 220 can be arranged and configured as a spring-loaded ball check valve including a spring 224 and a ball 226, where in a first position, the spring 224 is held in a compressed configuration by, for example, a retaining member (e.g., a plastic member that holds the spring 224 in its compressed state but melts upon reaching a predetermined temperature, thereby releasing the spring 224). However, upon reaching the predetermined temperature, the retaining member releases the spring 224, thereby moving the ball 226 into abutting contact with an inner wall 228 of the spring-loaded plunger 220, thereby preventing fluid flow. Alternatively, referring to Figure 4D , the spring-loaded plunger 220 can be arranged and configured as a spring-loaded plate including a spring 230 and a plate 232, where in a first position, the spring 230 is held in a compressed configuration by, for example, a retaining member. However, upon reaching the predetermined temperature, the retaining member releases the spring 230, thereby moving the plate 230 into abutting contact with an inner wall or shoulder 234 of the spring-loaded plunger 220, thereby preventing fluid flow. In either embodiment, the spring-loaded plunger 220 can be displaced vertically from a first position enabling fresh dialysate to flow through the outlet port into the tubing to a second position blocking fresh dialysate flow through the outlet port into the tubing. Alternatively, in other embodiments, a non-spring loaded system can be used. For example, in one embodiment, a plug can be used, where in a first configuration, the plug is sized and configured to enable fluid flow. However, upon reaching the predetermined temperature, the plug can be sized and configured to permanently expand to block the outlet port, thereby preventing fluid flow.

[0053] As used herein, an element or operation recited in the singular and proceeded with the conjunctive "a" or "an" or "the" should be understood as not excluding plural elements or operations, unless such exclusion is explicitly recited. Furthermore, references to "one embodiment" of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate those features.

[0054] The foregoing discussion is presented for the purpose of illustration and description and is not intended to limit the disclosure to the forms disclosed herein. For example, for purposes of simplicity of the present disclosure, various features of the present disclosure are grouped together in one or more aspects, embodiments, or configurations. However, the features disclosed with respect to a particular aspect, embodiment, or configuration are

[0055] The present disclosure is not limited to the specific embodiments described herein. In fact, it will be apparent to those of ordinary skill in the art that various implementations of the present disclosure beyond those described herein and modifications to those implementations are possible and contemplated. Therefore, such other implementations and modifications are intended to fall within the scope of the present disclosure. Moreover, although the present disclosure has been described herein in the context of particular implementations for particular purposes, those of ordinary skill in the art will appreciate that its usefulness is not limited thereto and that it can be beneficially implemented in any number of environments for any number of purposes. Accordingly, the claims set forth below should be construed in view of the full scope and spirit of the present disclosure as described herein.

Claims

1. A dialysate container comprising: a reservoir arranged and configured to store dialysate; an outlet port arranged and configured to be in fluid communication with the reservoir and arranged and configured to be coupled to tubing such that dialysate can flow from the reservoir to the tubing; and a circular hollow ring positioned within the outlet port of the dialysate container, the circular hollow ring arranged and configured such that when the dialysate container is subjected to a temperature above a predetermined temperature, the circular hollow ring melts upon reaching the predetermined temperature to block the bore of the circular hollow ring, thereby preventing the dialysate from flowing through the outlet port into the tubing. The circular hollow ring comprises a plastic material.

2. The dialysate container of claim 1, wherein, The dialysate container further comprises a support ring having a melting temperature above the predetermined temperature such that the support ring can direct the melted circular hollow ring to block the dialysate from flowing through the outlet port into the tubing.

3. The dialysate container of claim 1 or 2, wherein, The dialysate container further comprises a metal wrap arranged and configured to be heated faster than the circular hollow ring to facilitate faster heating of the circular hollow ring.

4. The dialysate container of claim 1 or 2, wherein, The dialysate container further comprises a heat sensitive dye arranged and configured to change color upon being subjected to the predetermined temperature to indicate that the dialysate container has been subjected to a temperature above the predetermined temperature.

5. The dialysate container of claim 1 or 2, wherein, The heat sensitive dye is incorporated into a frangible portion of the dialysate container.

6. The dialysate container of claim 5, wherein, ​

Images