Catheter system with pressure management device

Abstract

The system includes a catheter and a pressure management device. The catheter includes a cuff, a resilient device, a drain passage, and a first fitting. The cuff defines a chamber and has a deflated state and an inflated state. The resilient device is disposed within the chamber and has a compressed state and an expanded state. The resilient device is configured to expand from the compressed state to the expanded state upon transition of the cuff from the deflated state to the inflated state. The drain passage extends from the cuff to an exhaust port. The first fitting is in fluid communication with the chamber. The pressure management device includes a second fitting that engages the first fitting and at least one check valve in fluid communication with the second fitting. In this embodiment, the at least one check valve includes an inlet check valve in fluid communication with the second fitting and an outlet check valve in fluid communication with the second fitting.

Description

Cross-reference to related disclosures

[0001] This disclosure claims the benefit of U.S. Application No. 63 / 173,814, filed April 12, 2021, and U.S. Application No. 63 / 186,528, filed May 10, 2021, the disclosures of which are incorporated herein in their entireties. [Technical field]

[0002] The present disclosure relates generally to catheters and associated systems, and more particularly, but not exclusively, to fecal evacuation catheters and associated systems. [Background technology]

[0003] Indwelling fecal management catheters are often used to manage liquid or semi-liquid feces in non-ambulatory hospitalized patients. Although fecal indwelling catheters are considered the gold standard in most intensive care units (ICUs) for managing non-ambulatory hospitalized patients with fecal incontinence due to liquid or semi-liquid feces, one of the risks for patients when using invasive devices such as fecal indwelling catheters is increased rectal pressure due to the indwelling balloon. To effectively secure the indwelling balloon, the balloon needs to be fully inflated, resulting in increased balloon pressure and therefore increased rectal pressure. Such high rectal pressure over a prolonged period of device use can lead to various adverse events such as pressure ulcers and rectal bleeding. These two factors therefore represent opposing needs in designing the indwelling balloon for essentially all indwelling catheters, including fecal, urinary, and airway.

[0004] To address this unmet patient need, various designs have been developed. For example, European Patent No. 2,278,945 discloses the use of a fill indicator. More specifically, the '945 patent discloses a rectal drainage device including a tubular element having an inflatable balloon at a distal end for securing the rectal drainage device to the rectum. The device may include first and second auxiliary lumens in communication with the inflatable balloon, providing independent inflation and pressure monitoring paths coupled to the balloon. The device may include a pressure status indicator defined by a mechanical element configured to flip between a first and a second state or shape in response to sensed pressure. Pressure status indicators may also be used with bowel drains.

[0005] Another conventional approach is disclosed in U.S. Patent No. 8,939,952, which uses a double balloon containing an air pocket. More specifically, the '952 patent discloses a rectal device having a tubular member defining a passageway for bodily waste and first and second inflatable chamber portions carried on the tubular member to form internal and external seals against the anus. One or both of the inflatable chamber portions have a partially flared shape. The second inflatable portion of the chamber has a low profile and a concave sealing surface. The inflatable chamber portions are at least partially defined by a common flexible membrane restrained near a middle region to define a narrow waist between the two inflatable chamber portions.

[0006] Another conventional approach involving the use of a double balloon containing an air pocket is disclosed in PCT Publication No. WO 2007 / 118621 A1. The '621 publication discloses an occlusion system for managing rectal or anal incontinence, comprising a shaft element having a distal end and a proximal end, the shaft element having a lumen extending from the distal end to the proximal end of the shaft element, and a balloon adhesively sealably attached to the shaft element and capable of being filled with a filling medium via a filling line. The balloon is formed from a tube section and is configured such that when filled with a filling medium, it forms a first balloon shape as an intrarectal balloon and a second balloon shape as an adjacent balloon, separated from each other by a constriction. The distal end of the shaft element is designed with an end cap with a tip, and at least one gas inlet opening is provided at a location remote from the tip that communicates with the lumen of the shaft element. The proximal end of the shaft element is connected to an outlet tube which extends transversely to the longitudinal axis of the shaft element and has an outlet opening at its end which communicates with the lumen.

[0007] Another conventional approach is disclosed in European Patent No. 2,575,703, which generally discloses a catheter comprising a compressible foam. More specifically, the '703 patent discloses a drainage device including a distal portion having an expandable retention cuff for retaining the distal portion in the rectum, intestine or urinary tract. Inflation of the cuff is controlled by a combination of: (a) an elastically deformable device for facilitating inflation of the cuff; (b) a variable sized liquid-containing chamber; and (c) a fluid transfer damper for restricting fluid flow to the chamber as the chamber changes size.

[0008] Many existing approaches, including those described in the documents referenced above, may have one or more drawbacks or limitations. For example, certain existing approaches can only reduce the risk of balloon overinflation, not the pressure present during standard use. Certain existing approaches are still unable to reduce high balloon pressures, especially when the retention balloon is compressed by the rectal wall during defecation or patient mobility. Certain existing approaches require the use of a fluid transfer damper to restrict the flow of fluid into and out of the retention balloon, but the relatively high balloon pressures are not always reduced immediately due to the slow response of the fluid transfer damper. For these reasons, among others, further improvements are still needed in this technical field. Summary of the Invention

[0009] An example of a system includes a catheter and a pressure management device. The catheter includes a cuff, an elastic device, an exhaust passage, and a first fitting. The cuff defines a chamber and has a deflated state and an inflated state. The elastic device is disposed within the chamber and has a compressed state and an expanded state. The elastic device is configured to transition the cuff from the deflated state to the expanded state by expanding from the compressed state to the expanded state. The exhaust passage extends from the cuff to an exhaust port. The first fitting is in fluid communication with the chamber. The pressure management device includes a second fitting that engages the first fitting and at least one check valve in fluid communication with the second fitting. In certain embodiments, the at least one check valve has an inlet check valve in fluid communication with the second fitting and an outlet check valve in fluid communication with the second fitting. Further embodiments, forms, features, and aspects of the present application will be apparent from the description and drawings provided herein. [Brief description of the drawings]

[0010] [Figure 1] FIG. 1 is a cross-sectional view of a catheter according to a particular embodiment. [Diagram 2] FIG. 2 is a schematic diagram of a system according to certain embodiments, the system including the catheter and pressure management device shown in FIG. [Diagram 3] FIG. 3 is a cross-sectional view of the pressure management device shown in FIG. [Figure 4] FIG. 4 is a schematic flow diagram of a process according to certain embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] While the concepts of the present disclosure are susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are herein described in detail, It is to be understood, however, that there is no intention to limit the concepts of the present disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure and the appended claims.

[0012] References herein to "one embodiment," "one embodiment," "exemplary embodiment," and the like indicate that the described embodiment may include a particular feature, structure, or characteristic, but not all embodiments include that particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. It should be further understood that references to "preferred" components or features may indicate the desirability of a particular component or feature with respect to an embodiment, but the present disclosure is not so limited with respect to other embodiments in which such component or feature may be omitted. Furthermore, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one of ordinary skill in the art to implement such feature, structure, or characteristic in connection with other embodiments, whether or not expressly described.

[0013] Additionally, it is understood that items in a list of "at least one of A, B, C" can mean (A), (B), (C), (A and B), (B and C), (A and C), or (A, B and C). Similarly, items listed in the form "at least one of A, B, C" can mean (A), (B), (C), (A and B), (B and C), (A and C), or (A, B, C). Items listed in the form "A, B, and / or C" can also mean (A), (B), (C), (A and B), (B and C), (A and C), or (A, B, and C). Additionally, with respect to the claims, the use of phrases such as "a," "an," "at least a portion," and / or "at least a portion" should not be construed as limiting such element to only one, unless specifically stated to the contrary, and the use of phrases such as "at least a portion" and / or "a portion" should be construed to encompass both embodiments including only a portion of such an element and embodiments including such an element in its entirety, unless specifically stated to the contrary.

[0014] In the figures, some structural or method features may be shown in a particular arrangement and / or order. However, it should be understood that such a particular arrangement and / or order is not necessarily required. Rather, in some embodiments, such features may be arranged in a different manner and / or order than that shown in the exemplary figures, unless otherwise indicated. Furthermore, the inclusion of a structural or method feature in a particular figure does not imply that such feature is required in all embodiments, and in some embodiments may be omitted or combined with other features.

[0015] As used herein, the term "about" may be utilized to modify quantitative expressions that may allow for acceptable variations from the stated value. In certain embodiments, the term "about" may refer to an acceptable variation of 10%. For example, a pressure described as "about 10 mmHg above atmospheric pressure" may range from 9 to 11 millimeters of mercury (mmHg) above atmospheric pressure. Additionally, the term "atmospheric pressure" refers to standard atmospheric pressure (i.e., about 760 mmHg).

[0016] 1, an indwelling catheter 100 is shown according to a particular embodiment. The catheter 100 generally includes a tubular body portion 110 having a proximal end portion 112 and an opposing distal end portion 114, a cuff 120 disposed at the distal end portion 114 of the body portion 110, a resilient device 130 disposed within a chamber 122 of the cuff 120, an inflation / deflation lumen 140 extending from the cuff 120 to an inflation / deflation port 102, and a first fitting 104 attached to the inflation / deflation port 102. In the illustrated example, the indwelling catheter 100 is provided in the form of a fecal catheter, with the distal end portion 114 configured for insertion into the rectum of a patient. It is also contemplated that the catheter 100 may be provided in other forms, such as a urinary catheter or an airway catheter.

[0017] The catheter body portion 110 extends from the proximal end portion 112 to the distal end portion 114 and defines an exhaust passageway 116 having an inlet 115 formed at the distal end portion 114 and an exhaust or outlet 113 formed at the proximal end portion 112. The passageway 116 is configured to allow fluid (e.g., air, liquid, or semi-liquid) to flow from the inlet 115 to the outlet 113. For example, in the illustrated example, effluent flows from the inlet 115 to the outlet 113 and is exhausted from the outlet 113. In certain embodiments, such as when the catheter 100 is utilized as an airway catheter, the passageway 116 can further facilitate the flow of fluid (e.g., air) from the outlet 113 to the inlet 115, for example during inhalation by the patient.

[0018] The cuff 120 is disposed at the distal end portion 114 of the body portion 110 and defines a chamber 122 in which the elastic device 130 is housed. Although other configurations are contemplated, the illustrated cuff 120 is provided in the form of a substantially toroidal balloon surrounding the entrance 115 to the exhaust passageway 116. As described herein, the cuff 120 has a contracted state corresponding to a collapsed state of the elastic device 130 and an inflated state corresponding to an expanded state of the elastic device 130. During deflation of the cuff 120, the cuff 120 compresses or collapses the elastic device such that the elastic device stores mechanical energy that can be released to inflate the cuff 120.

[0019] The resilient device 130 is located within the chamber 122 and has a collapsed state and an expanded state. In the illustrated example, the resilient device 130 is provided in the form of an open cell foam 132, such as an open cell polyurethane foam. It is contemplated that the resilient device 130 may be provided in other forms, such as including one or more springs. As described herein, the resilient device 130 is configured to collapse upon contracting the cuff 120 for insertion into a cavity (e.g., the rectal cavity) of a patient, and then expand to cause inflation of the cuff 120 to secure the cuff 120 within the cavity.

[0020] The inflation / deflation lumen 140 has a distal end 142 that is open to the chamber 122, a proximal end 144 that is connected to the inflation / deflation port 102, and optionally an elongated portion 146 that extends between and connects the distal end 142 and the proximal end 144 such that the chamber 122 is in fluid communication with the inflation / deflation port 102. As a result, the cuff 120 is operable to be inflated and deflated via the first fitting 104, as described herein. The first fitting 104 may be provided in the form of a normally closed check valve configured to transition to an open state upon engagement with a mating syringe 220 or pressure management device 210, for example, as described herein.

[0021] 2 , a system 200 according to certain embodiments is shown. The system 200 includes the catheter 100 and a pressure management device 210 according to certain embodiments, and may further include a negative pressure generator, such as a syringe 220. In certain embodiments, the pressure management device 210 may be tethered to a proximal end portion of the catheter 100 to prevent loss of the pressure management device 210. For example, the pressure management device 210 may include a strap that secures the pressure management device 210 to a portion of the catheter 100 near the fitting 104 of the inflation / deflation port 102.

[0022] 3, the pressure management device 210 generally includes a body 212 defining a fluid passageway 213, a second fitting 214 connected to a first branch 215 of the fluid passageway 213, an inlet check valve 216 connected to a second branch 217 of the fluid passageway 213, and an outlet check valve 218 connected to a third branch 219 of the fluid passageway 213. In the illustrated example, the fluid passageway 213 is generally T-shaped with the third branch 219 being substantially perpendicular to the first branch 215 and the second branch 217. It is contemplated that the fluid passageway 213 may take other forms. For example, the fluid passageway 213 may be provided in a generally Y-shaped configuration with the branches 215, 217, 219 extending at oblique angles to one another, or a V-shaped configuration in which the first branch 215 is omitted. The second fitting 214 is configured to mate with the first fitting 104 such that the fluid passageway 213 is in communication with the inflation / deflation lumen 140 when the fittings 104, 214 are engaged with one another.

[0023] The inlet check valve 216 is normally closed, has a first cracking pressure, and is configured to permit fluid flow from a first pressure source to the fluid passageway 213 when the pressure of the first pressure source exceeds the pressure in the fluid passageway 213 by at least the first cracking pressure. When the pressure management device fitting 214 is secured to the catheter fitting 104, the pressure in the fluid passageway 213 corresponds to the pressure in the cuff chamber 122. In the illustrated embodiment, the first pressure source is ambient air, although other pressure sources are contemplated. The illustrated inlet check valve 216 is provided in the form of a duckbill valve, although it is contemplated that the inlet check valve 216 may be provided in other forms, such as an umbrella valve, a disc valve, a diaphragm valve, or an open vent.

[0024] The outlet check valve 218 is normally closed, has a second cracking pressure, and is configured to permit fluid flow from the fluid passageway 213 to the second pressure source when the pressure in the fluid passageway 213 exceeds the pressure of the second pressure source by at least the second cracking pressure. As described above, when the pressure management device fitting 214 is secured to the catheter fitting 104, the pressure in the fluid passageway 213 corresponds to the pressure in the cuff 122. In the illustrated embodiment, the second pressure source is ambient air, although other pressure sources are contemplated. Although the illustrated outlet check valve 218 is provided in the form of a duckbill valve, it is contemplated that the outlet check valve 218 may be provided in other forms, such as an umbrella valve, a disc valve, or a diaphragm valve.

[0025] In certain embodiments, the inlet check valve 216 and the outlet check valve 218 can be selected to be the same type of check valve (e.g., duckbill, umbrella, disk, diaphragm, or open vent). In certain embodiments, the inlet check valve 216 and the outlet check valve 218 can be selected to be different types of check valves.

[0026] As described herein, the pressure management device 210 is configured to maintain the pressure in the cuff chamber 122 within a predetermined pressure range having a minimum pressure corresponding to a cracking pressure of the inlet check valve 216 and a maximum pressure corresponding to a cracking pressure of the outlet check valve 218. In certain embodiments, the cracking pressure of the inlet check valve 216 may be greater than or equal to 5 mmHg and less than or equal to 15 mmHg. In certain embodiments, the cracking pressure of the inlet check valve 216 may be approximately 10 mmHg (e.g., between 9 mmHg and 11 mmHg). In certain embodiments, the cracking pressure of the outlet check valve 218 may be approximately 30 mmHg (e.g., between 27 mmHg and 33 mmHg). In certain embodiments, the cracking pressure of the outlet check valve 218 may be approximately 20 mmHg (e.g., between 18 mmHg and 22 mmHg). In certain embodiments, the cracking pressure of the outlet check valve 218 may be about 10 mmHg (e.g., 9 mmHg to 11 mmHg). In certain embodiments, the cracking pressure of the outlet check valve 218 may be 4 to 6 mmHg or about 5 mmHg (e.g., 4.5 mmHg to 5.5 mmHg).

[0027] The syringe 220 generally includes a body portion 212 partially defining a fluid chamber 223, a third fitting 224, and a plunger 226 slidably mounted to the body portion 222. The third fitting 224 is configured to mate with the first fitting 104 such that the fluid chamber 223 is in communication with the inflation / deflation lumen 140 when the fittings 104, 224 are engaged with one another. When so engaged, retraction of the plunger 226 inflates the fluid chamber 223, thereby generating a negative pressure in the cuff chamber 122. The negative pressure in the cuff chamber 122 can also be generated in other ways, such as by use of a pump.

[0028] As discussed above, each of the pressure management device fittings 214 and the syringe 224 are configured to mate with the catheter fitting 104. One of ordinary skill in the art would be able to readily select an appropriate fitting for use as the fittings 104, 214, 224. In certain embodiments, the catheter fitting 104 may be provided in the form of one of a female luer fitting or a male luer fitting, and each of the pressure management device fittings 214 and the syringe fittings 224 may be provided in the form of the other of a female luer fitting or a male luer fitting. For example, the catheter fitting 104 may be provided in the form of a female luer fitting, and each of the pressure management device fittings 214 and the syringe fittings 224 may be provided in the form of a mating male luer fitting. It should be understood that other configurations of fittings are contemplated and can be utilized to form the appropriate connections.

[0029] With further reference to FIG. 4, an exemplary process 300 that may be performed using system 200 is shown. It is understood that the illustrated blocks of the processes of the present application are merely exemplary, and that the blocks may be combined, divided, added, deleted, or reordered in whole or in part, unless expressly stated to the contrary. Furthermore, while the blocks are illustrated relatively serially, it is understood that two or more blocks may be performed simultaneously or in parallel with one another. Furthermore, while process 300 is described herein with specific reference to the systems shown in FIGS. 1 and 2, it is understood that process 300 may be performed in systems having additional or alternative features.

[0030] The process 300 may begin at block 310, which generally involves generating a negative gauge pressure in a chamber having a resilient device disposed therein, thereby compressing the resilient device. In certain embodiments, the chamber is formed in the cuff, and an exhaust passageway extends from the cuff to an exhaust port. In the illustrated example, block 310 involves generating a negative pressure in the chamber 122 of the cuff 120 using a negative pressure generating device, such as a syringe 220. More specifically, block 310 involves connecting a syringe fitting 224 to the catheter fitting 104, which is typically a one-way normally closed check valve, causing a plunger 226 to retract, thereby creating a negative gauge pressure in the chamber 122. It is also contemplated that block 310 may include activating another form of negative pressure generating device to generate a negative pressure in the chamber 122. For example, block 310 may include operating a pump to generate a negative pressure in the chamber 122.

[0031] When negative pressure is created within chamber 122, cuff 120 moves from an inflated state to a deflated state, causing the walls of cuff 120 to compress resilient device 130. As a result, resilient device 130 transitions to a compressed state during deflation of cuff 120. In the compressed state, resilient device 130 stores mechanical energy that, when released, causes resilient device 130 to expand to its expanded state, thereby inflating cuff 120 as described herein.

[0032] In certain embodiments, process 300 generally includes block 320, which includes inserting the cuff into a cavity of the patient. In the illustrated example, catheter 100 is a fecal catheter, and block 320 includes inserting cuff 120 into the patient's rectum. It is contemplated that block 320 may also include inserting cuff 120 into another cavity of the patient, for example, if catheter 100 is configured for use as a urinary catheter or airway catheter.

[0033] Process 300 further includes block 330, which generally includes connecting a first fitting in fluid communication with the chamber to a second fitting of a pressure management device. In certain embodiments, the pressure management device includes an inlet check valve in fluid communication with the second fitting and an outlet check valve in fluid communication with the second fitting. In the illustrated example, block 330 includes connecting the inlet / outlet fitting 104 of catheter 100 to fitting 214 of pressure management device 210, which includes inlet check valve 216 and outlet check valve 218. As described above, each of check valves 216, 218 is in fluid communication with pressure management device fitting 214 via fluid passageway 213. In certain embodiments, such as those including block 320, block 330 may be performed with cuff 120 positioned within the patient's cavity.

[0034] Process 300 further includes block 340, which generally involves expanding a resilient device from a compressed state to an expanded state, thereby inflating the cuff and allowing fluid to enter the chamber through the inlet check valve. In the illustrated example, block 340 includes allowing resilient foam 332 to expand from a compressed state to an expanded state, thereby inflating cuff 120. Cuff 120 remains deflated at blocks 310 and 320 despite the negative gauge pressure due to the one-way check valve nature of first fitting 104. As described in block 330, connecting pressure management device 210 to first fitting 104 communicates the negative pressure within cuff 120 to pressure management device 210 through inflation / deflation lumen 140. When the pressure differential across the inlet check valve 216 of the pressure management device 210 exceeds the cracking pressure of the inlet check valve 216 (normally closed), the inlet check valve 216 opens, thereby allowing atmospheric air to flow into the chamber 122 to inflate the cuff 120. Between blocks 330 and 340, the cuff 120 is still under negative pressure, so the outlet check valve 218 remains closed. The flow of fluid into the cuff 120 continues until the pressure in the cuff reaches the cracking pressure of the inlet check valve 216, beyond which flow is automatically shut off. The use of the one-way inlet check valve 216 allows the internal cuff pressure to remain at negative pressure, or at its limit of atmospheric pressure, depending on the cracking pressure selected.

[0035] Process 300 may further include block 350, which generally involves at least partially compressing the resilient device in response to an externally applied force on the cuff, thereby at least partially collapsing the cuff so that fluid flows out of the chamber through the outlet check valve. The externally applied force may be the result of a patient's movement, such as coughing, sneezing, or contraction of the rectum to induce defecation. In the illustrated example, block 350 involves at least partially compressing the resilient device 130 in response to an externally applied force on the cuff 120, thereby at least partially collapsing the cuff 120 so that fluid flows out of the chamber 122 through the outlet check valve 218. One skilled in the art will readily appreciate that when the external force is removed, the resilient device 130 will again expand to re-inflate the cuff 120 in a manner similar to that described with reference to block 340. The flow of fluid out of the cuff 120 reduces the pressure in the cuff. Because the cuff 120 is at positive pressure during block 350, the inlet check valve 216 remains closed. Fluid flow out of the cuff 120 continues until the pressure in the cuff reaches the cracking pressure of the outlet check valve 216, at which point flow automatically stops. By using a one-way outlet check valve, the pressure inside the cuff remains either positive or at the limit of atmospheric pressure, depending on the cracking pressure selected.

[0036] The process 300 may further include block 360, which generally includes maintaining the pressure in the chamber at a selected pressure range having a minimum pressure and a maximum pressure. Block 360 may be performed, for example, by the pressure management device 210. In certain embodiments, the minimum pressure is greater than atmospheric pressure and less than about 15 mmHg below atmospheric pressure. In certain embodiments, the minimum pressure is greater than atmospheric pressure and less than about 8 mmHg below atmospheric pressure and less than about 12 mmHg below atmospheric pressure. In certain embodiments, the minimum pressure is greater than atmospheric pressure and less than about 10 mmHg below atmospheric pressure. In certain embodiments, the maximum pressure is less than about 30 mmHg above atmospheric pressure. In certain embodiments, the maximum pressure is less than about 20 mmHg above atmospheric pressure. In certain embodiments, the maximum pressure is less than about 10 mmHg below atmospheric pressure. In certain embodiments, the maximum pressure is between 4 and 6 mmHg above atmospheric pressure. In certain embodiments, block 360 may include maintaining the pressure in chamber 122 in a range of 10 mmHg below atmospheric pressure to 20 mmHg above atmospheric pressure. In certain embodiments, block 360 may include maintaining the pressure in chamber 122 in a range of 10 mmHg below atmospheric pressure to 10 mmHg above atmospheric pressure. In certain embodiments, block 360 may include maintaining the pressure in chamber 122 in a range of 10 mmHg below atmospheric pressure to 5 mmHg above atmospheric pressure. The ability to maintain a negative pressure (i.e., below atmospheric pressure) while the cuff is fully inflated is one difference between existing approaches and certain embodiments of the disclosed subject matter. The external cuff pressure is the sum of the internal cuff pressure described above and the expansion force exerted by the resilient foam 130 on the cuff 120, and may be approximately 10 mmHg or less based on the type of foam selected according to Table 1. Thus, at least some embodiments of the present disclosure enable the maximum pressure of the cuff in contact with the mucosal tissue of the body cavity to be no greater than about 30 mmHg above atmospheric pressure, preferably no greater than about 20 mmHg above atmospheric pressure, and more preferably no greater than about 10 mmHg above atmospheric pressure.

[0037] Those skilled in the art will readily appreciate that the pressure range maintained within chamber 122 will depend at least in part on the cracking pressure selected for check valves 216, 218, and that check valves having appropriate cracking pressures can be selected to maintain the desired pressure range within chamber 122. For example, in an embodiment in which the minimum selected for pressure within chamber 122 is approximately 10 mmHg below atmospheric pressure, inlet check valve 216 may be selected with a cracking pressure of approximately 10 mmHg (e.g., 10 mmHg ± 2 mmHg). Similarly, in an embodiment in which the maximum selected for pressure within chamber 122 is approximately 20 mmHg above atmospheric pressure, outlet check valve 218 may be selected with a cracking pressure of approximately 20 mmHg (e.g., 20 mmHg ± 4 mmHg). Certain embodiments may utilize an open vent to allow for rapid equilibration with atmospheric pressure.

[0038] As can be seen, the system 200, including the catheter 100 and pressure management device 210, can accommodate patient movement while mitigating certain difficulties associated with conventional approaches, such as patient discomfort and the risk of bedsores. For example, as the patient moves, the increased pressure in the chamber 122 acts on the outlet check valve 218 to open, allowing the pressure to drop rapidly. The use of one-way check valves 216, 218 can additionally or alternatively provide the advantages of rapid pressure regulation and conformance to the rectal wall, which may correlate with improved sealing properties.

[0039] In certain embodiments, the system 200 can provide a response time that is superior to conventional approaches. For example, certain prior approaches required the use of a fluid transfer damper that may be omitted in the presently described system 200. In certain prior approaches requiring the use of a fluid transfer damper, the response time generally ranged from 10 to 20 minutes. In other words, in such prior systems including a fluid transfer damper, it takes 10 to 20 minutes for the cuff 120 and the resilient device 130 to expand and / or contract. Such response times may be improved by certain embodiments of the system 200. For example, the system 200 may be configured to allow the cuff 120 to transition from an inflated state to a compressed state in less than 2 minutes, less than 1 minute, or less than 30 seconds. Such response times depend on a number of factors, including the compressibility or resilience of the resilient device 130 and / or the cracking pressure of the outlet check valve 218. After reading this disclosure, one of ordinary skill in the art would be readily able to select these factors to provide the above-mentioned response times. Exemplary parameters that may facilitate a shorter response time and / or improved patient comfort are provided herein as Table 1. TIFF2024517086000002.tif34170

[0040] Certain embodiments of interest herein relate to a system 200 having a catheter 100 and a pressure management device 210. The catheter 100 includes a cuff 120 defining a chamber 122, the cuff 120 having a deflated state and an inflated state, a resilient device 130 disposed within the chamber 122 and having a compressed state corresponding to the deflated state and an expanded state corresponding to the inflated state, the resilient device 130 configured to expand from the compressed state to the expanded state upon transition of the cuff 120 from the deflated state to the inflated state, a vent passage 116 extending from the cuff 120 to the vent 113, and a first fitting 104 in fluid communication with the chamber 122. The pressure management device 210 includes a second fitting 214 in releasable engagement with the first fitting 104 and at least one check valve 214 / 216 in fluid communication with the second fitting 214.

[0041] In certain embodiments, the at least one check valve includes an inlet check valve 216 in fluid communication with the second fitting 214 and an outlet check valve 218 in fluid communication with the second fitting 214 .

[0042] In certain embodiments, the inlet check valve 216 has a first cracking pressure and is configured to allow fluid flow from the first pressure source to the chamber 122 when the pressure of the first pressure source exceeds the pressure in the chamber 122 by at least the first cracking pressure, and the outlet check valve 218 has a second cracking pressure and is configured to allow fluid flow from the chamber 122 to the second pressure source when the pressure in the chamber 122 exceeds the pressure of the second pressure source by at least the second cracking pressure.

[0043] In certain embodiments, each of the first pressure source and the second pressure source is atmospheric air.

[0044] In certain embodiments, pressure management device 210 does not have a fluid transfer damper.

[0045] In a particular embodiment, the resilient device 130 comprises a compressible foam 132 .

[0046] In certain embodiments, the inlet check valve 216 and the outlet check valve 218 each comprise at least one of a duckbill valve, an umbrella valve, a disk valve, and a diaphragm valve.

[0047] In certain embodiments, the outlet check valve 218 is configured to allow the cuff 120 to move from an inflated state to a deflated state in less than two minutes.

[0048] In certain embodiments, the outlet check valve 218 is configured to allow the cuff 120 to move from an inflated state to a deflated state in less than one minute.

[0049] In certain embodiments, the pressure management device 210 is configured to maintain the pressure in the chamber 122 between a minimum pressure and a maximum pressure, the minimum pressure being equal to or greater than atmospheric pressure and equal to or less than 12 mmHg below atmospheric pressure, and the maximum pressure being equal to or less than 30 mmHg above atmospheric pressure.

[0050] In certain embodiments, the maximum pressure is up to 20 mmHg above atmospheric pressure.

[0051] In a particular embodiment, the maximum pressure is up to 4-6 mmHg above atmospheric pressure.

[0052] Certain embodiments of the present application relate to a method of creating 310 a negative gauge pressure in a chamber 122 having a resilient device 130, thereby compressing the resilient device 130 to a compressed state, the chamber 122 being formed in a cuff 120, a vent passageway 116 extending from the cuff 120 to a vent 113, connecting 330 a first fitting 104 in fluid communication with the chamber 122 to a second fitting 214 of a pressure management device 210, the pressure management device 210 having an inlet check valve in fluid communication with the second fitting 214. the inlet check valve 216 and an outlet check valve 218 fluidly connected to the second fitting 214, expanding 340 the resilient device 130 from a compressed state to an expanded state, thereby inflating the cuff 120 and allowing fluid to flow into the chamber 122 through the inlet check valve 216, and at least partially compressing 350 the resilient device 130 in response to an externally applied force on the cuff 120, thereby at least partially collapsing the cuff 120 so that fluid can flow out of the chamber 122 through the outlet check valve 218.

[0053] In certain embodiments, the inlet check valve 216 allows the resilient device 130 to transition from a compressed state to an expanded state in less than two minutes.

[0054] In certain embodiments, the inlet check valve 216 allows the resilient device 130 to transition from a compressed state to an expanded state in less than one minute.

[0055] In certain embodiments, the outlet check valve 218 allows the resilient device 130 to transition from the expanded state to the compressed state in less than two minutes.

[0056] In certain embodiments, the outlet check valve 218 allows the resilient device 130 to transition from an expanded state to a compressed state in less than one minute.

[0057] In certain embodiments, the pressure management device 210 maintains the pressure in the chamber 122 between a minimum pressure and a maximum pressure, where the minimum pressure is equal to or greater than atmospheric pressure and equal to or less than 12 mmHg below atmospheric pressure, and the maximum pressure is equal to or less than 20 mmHg above atmospheric pressure.

[0058] In certain embodiments, the maximum pressure is less than or equal to 10 mmHg above atmospheric pressure.

[0059] In a particular embodiment, the maximum pressure is 4-6 mmHg above atmospheric pressure.

[0060] In a particular embodiment, the fluid is air.

[0061] Certain embodiments of the present application relate to a pressure management device 210 configured for use with a catheter 110 having a catheter fitting 104 in fluid communication with a chamber 122 defined by a cuff 120, the pressure management device 210 comprising a fluid passageway 213, a fitting 214 in fluid communication with the fluid passageway 213 and configured for mating engagement with the catheter fitting 104 such that when the fitting 214 is in mating engagement with the catheter fitting 104, the fluid passageway 213 is in fluid communication with the chamber 122, and an inlet check valve 216 disposed between the fluid passageway 213 and the ambient air, The fluid passage 213 includes an inlet check valve 216 having a first cracking pressure and configured to allow ambient air to flow into the fluid passage 213 when the ambient pressure exceeds the pressure in the fluid passage 213 by more than the first cracking pressure, and an outlet check valve 218 disposed between the fluid passage 213 and the ambient air, the outlet check valve 213 having a second cracking pressure and configured to allow ambient air to flow out of the fluid passage 213 when the pressure in the fluid passage 213 exceeds the ambient pressure by more than the second cracking pressure.

[0062] In certain embodiments, pressure management device 210 further includes a housing defining a fluid passageway 213, with fitting 214, inlet check valve 216, and outlet check valve 218 each mounted to the housing.

[0063] In certain embodiments, each of the inlet check valve 216 and the outlet check valve 218 comprises one of a duckbill valve, an umbrella valve, a disk valve, a diaphragm valve, or an open vent.

[0064] In certain embodiments, the first cracking pressure is greater than or equal to 0 mmHg and less than or equal to 15 mmHg.

[0065] In certain embodiments, the first cracking pressure is less than or equal to about 10 mmHg.

[0066] In certain embodiments, the second cracking pressure is less than or equal to about 30 mmHg.

[0067] In certain embodiments, the second cracking pressure is less than or equal to about 20 mmHg.

[0068] In certain embodiments, the second cracking pressure is less than or equal to about 10 mmHg.

[0069] In certain embodiments, the second cracking pressure is greater than or equal to 4 mmHg and less than or equal to 6 mmHg.

[0070] In certain embodiments, catheter fitting 104 comprises one of a male or female Luer fitting, and fitting 214 comprises the other of a male or female Luer fitting.

[0071] Certain embodiments of the present application relate to a method of using a pressure management device, comprising: with a cuff 120 in a deflated state, matingly engaging a catheter fitting 104 with the fitting 104, thereby fluidly connecting a fluid passageway 213 to a chamber 122; and a compressed resilient device 130 disposed within the cuff 120 to permit ambient air to flow into the chamber 122 via an inlet check valve 216 in response to ambient pressure exceeding the pressure in the fluid passageway 213 by a first cracking pressure or more, and to permit ambient air to flow out of the chamber 122 via an outlet check valve 218 in response to the pressure in the fluid passageway 213 exceeding the ambient pressure by a second cracking pressure or more.

[0072] While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiments have been shown and described, and that all changes and modifications which come within the spirit of the invention are desired to be protected.

[0073] It should be understood that the use of words such as preferred, preferably, preferred, or more preferred as utilized in the above description indicates that the feature so described may be more preferred, but that it may not be necessary, and embodiments lacking the same may be contemplated as being within the scope of the present invention, the scope of which is defined by the claims that follow. In reading the claims, when words such as "a," "an," "at least one," or "at least a portion" are used, it is intended that no attempt is made to limit the scope of the claim to only one item, unless specifically stated to the contrary in the claim. When the words "at least a portion" and / or "a portion" are used, the item may include some and / or all items, unless specifically stated to the contrary.

Claims

1. a cuff defining a chamber, the cuff having a deflated state and an inflated state; a resilient device disposed within the chamber, the resilient device having a compressed state corresponding to the contracted state and an expanded state corresponding to the inflated state, the resilient device configured to expand from the compressed state to the expanded state such that the cuff moves from the contracted state to the inflated state; a vent passageway extending from the cuff to a vent; and a first fitting in fluid communication with the chamber; a catheter having a second fitting removably engaged with the first fitting; and at least one check valve in fluid communication with the second fitting; A pressure management device having the at least one check valve includes an inlet check valve in fluid communication with the second fitting and an outlet check valve in fluid communication with the second fitting; the inlet check valve has a first cracking pressure and is configured to permit fluid flow from the first pressure source to the chamber when the pressure of the first pressure source exceeds the pressure in the chamber by at least the first cracking pressure; the outlet check valve has a second cracking pressure and is configured to permit fluid flow from the second pressure source to the chamber when the pressure of the second pressure source exceeds the pressure in the chamber by at least the second cracking pressure; the first pressure source and the second pressure source are each ambient air; system.

2. The inlet check valve and the outlet check valve are each configured as at least one of a duckbill valve, an umbrella valve, a disk valve, or a diaphragm valve. The system of claim 1 .

3. the outlet check valve is configured to allow the cuff to transition from the inflated state to the deflated state in less than two minutes. The system of claim 1 .

4. the outlet check valve is configured to allow the cuff to transition from the inflated state to the deflated state in less than one minute. The system of claim 3.

5. The resilient device comprises a compressible foam. The system of claim 1 .

6. the pressure management device is configured to maintain a pressure in the chamber between a minimum pressure and a maximum pressure; The minimum pressure is equal to or greater than 12 mmHg lower than atmospheric pressure and equal to or less than atmospheric pressure, The maximum pressure is equal to or less than 20 mmHg higher than atmospheric pressure. The system of claim 1 .

7. The maximum pressure is equal to or less than 10 mmHg higher than atmospheric pressure. The system of claim 6.

8. The pressure in the chamber is a negative pressure equal to or greater than 12 mmHg lower than atmospheric pressure and equal to or less than atmospheric pressure. The system of claim 6.

Images