Non-collapsible catheter tube

Abstract

A device according to certain embodiments generally includes an elongate tubular member having a proximal end and an opposite distal end, an inflatable balloon surrounding the distal end, the elongate tubular member having an outer tube, a non-collapsible inner tube disposed within the outer tube, and a compressible material disposed between the outer tube and the inner tube.

Description

Cross-reference to application

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 186,546, filed May 10, 2021, and U.S. Provisional Patent Application No. 63 / 131,154, filed December 28, 2020, the contents of each of which are incorporated by reference in their entirety. [Background technology]

[0002] Indwelling fecal management catheters are utilized to capture and contain liquid or semi-liquid feces in non-ambulatory hospitalized patients to prevent contamination of the patient's skin with caustic waste fluids, reduce the risk of contamination with potentially infectious materials, and minimize soiling of bedding. Fecal management catheters generally have an inflatable balloon that secures the catheter within the rectum and a tube that directs the feces away from the patient's rectum. Summary of the Invention

[0003] To reduce the force on the sphincter during bowel management, the tubes of most indwelling defecation catheters are collapsible, potentially creating a leakage path for feces outside the catheter tube around the patient's anus. Certain embodiments of the present disclosure relate to catheter tubes that allow for effective evacuation of feces while exerting minimal pressure on the sphincter, reducing or eliminating leakage around the catheter tube. In some embodiments, the catheter tube has a material that compresses to reduce excess pressure on the surrounding tissue and accommodates patient movement. In some embodiments, the catheter has a soft, non-collapsible tube that is compressible and reduces pressure on the sphincter tissue. This is in contrast to other catheter designs that have collapsible catheter tubes (i.e., soft and collapsible) or fixed volume air pockets that can create high pressure and damage the catheter tube sphincter. While typical fecal catheters employ a collapsible catheter tube, as described in U.S. Patent No. 8,016,816 B2 and EP No. 2,278,945 B1, U.S. Patent No. 8,939,952 and WO2007118621A1 disclose an air pocket consisting of a double balloon to provide an improved seal against the rectal tissue. The latter design uses a closed air pocket, but has the disadvantage that the closed system of air pockets allows pressure to build up during defecation, either with patient movement or while the patient is sitting. [Brief description of the drawings]

[0004] [Figure 1] FIG. 1 is a cross-sectional view of an exemplary fecal management system having a soft, non-collapsible, corrugated tube.

[0005] [Diagram 2] FIG. 2 is an exemplary cross-sectional view of a fecal management system having a flexible, non-collapsible tube with thin and thick sections.

[0006] [Diagram 3]FIG. 3 is a cross-sectional view of an exemplary fecal management system having a soft, non-collapsible spiral tube.

[0007] [Figure 4] FIG. 4 is a cross-sectional view of an exemplary fecal management system having a soft, non-collapsible, thick-walled tube.

[0008] [Diagram 5] FIG. 5 is a cross-sectional view of an additional chamber having a compressible material.

[0009] [Figure 6] FIG. 6 shows a T-connector design with one connection to a vent and a second connection to a one-way check valve that maintains a desired pressure differential between the elongated tubular chamber and the atmosphere. DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

[0010] 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 described in detail herein, 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.

[0011] References herein to "one embodiment," "one embodiment," "exemplary embodiment," and the like indicate that the described embodiment may have a particular feature, structure, or characteristic, but not all embodiments will have that particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, references to "preferred" components or features may indicate the desirability of a particular component or feature with respect to an embodiment, but it should be understood that the disclosure is not so limited with respect to other embodiments in which such components 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.

[0012] Additionally, it should be understood that an item 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, C). Similarly, an item stated in the form "at least one of A, B, or C" can mean (A), (B), (C), (A and B), (B and C), (A and C), or (A, B, C). An item stated 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 one," 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 having only a portion of such element and embodiments having the whole of such element, unless specifically stated to the contrary.

[0013] In this specification, the term "about" may be used to modify certain quantitative measurements. In various embodiments, the term "about" may mean that the expressed value may vary by up to 10%, up to 5%, or up to 1%. Thus, an indication that a pressure is "about 100 kPa" may indicate that the pressure is from 90 kPa to 110 kPa, from 95 kPa to 105 kPa, or from 99 kPa to 101 kPa.

[0014] In the figures, some structural or method features may be shown in a particular 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 as shown in the exemplary figures, unless indicated to the contrary. 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, it may be omitted or combined with other features.

[0015] In one aspect of the disclosure, a medical device is provided having an elongated tubular element for drainage of medical waste. The medical device may be part of a fecal management system (FMS), where the tubular element is designed to minimize or eliminate leakage of fecal material around the FMS. In some embodiments, the medical device has a compressible material disposed within the tubular element that conforms to tissue when force is applied to the tubular element by a sphincter muscle. An exemplary medical device embodied as an FMS is shown in FIG.

[0016] The exemplary FMS 100 includes a catheter 101 having an elongated tubular element 104 having a distal end 150 and a proximal end 152, and an inflatable balloon 102 surrounding the distal end 150. The main tube 104 is connected to an inner tube 122 via a distal adapter 118 and a proximal adapter 120, respectively. In the illustrated embodiment, the inflatable balloon 102 can be inflated with a fluid, such as air or a liquid (e.g., saline), for example, via a port 124 connecting an inflation lumen to the main tube 104 and the chamber of the balloon 102. In some embodiments, the inflatable balloon 102 can contain a compressible material 106. Formed within the elongated chamber 110 are a flushing passageway 128, a balloon inflation / deflation passageway 126, and a passageway 114 to the elongated tube chamber 110 for pressure management.

[0017] In the illustrated form, the device is provided as a catheter 101 of a fecal management system 100. It is also envisioned that the catheter 101 may be provided for other uses, such as for use as a Foley (urinary) catheter or as another form of catheter. It is further contemplated that the elongate tubular element 104 described herein may be used in other areas of the body, such as to form an airway for a breathing device.

[0018] In the illustrated form, the distal portion of the elongated tubular element 104 is insertable into the rectum of a subject to collect waste that flows from the distal portion through a drainage passage 116 in the elongated tubular element 104 to a proximal portion. When the distal portion is inserted into the rectum, the inflatable balloon 102 may engage body tissue to retain the distal portion within the rectum and provide a seal to divert body waste through the drainage passage 116. In certain embodiments, such as when the device is used as a catheter, the proximal end 152 of the catheter 101 may be connected to a waste collection device (e.g., a bag or other container) for receiving waste. In other embodiments, such as when the device is intended to be used as an airway passage, the proximal end 152 may be connected to an air source.

[0019] In some embodiments, the elongated tubular element 104 is non-collapsible, allowing fluid to pass through the drainage passage 116 completely unimpeded. For example, the non-collapsible elongated tubular element 104 may be reinforced with wire. In some embodiments, the non-collapsible tubular element 104 has a spiral insert to make the tube non-collapsible. In some embodiments, the elongated tubular element 104 further has a non-collapsible tubular element 122. In some embodiments, the non-collapsible tubular element 122 has a thick-walled tube that is non-collapsible. The wall thickness may be from 0.8 mm to 4 mm, preferably from 1.0 mm to 2.5 mm. In some embodiments, the non-collapsible tubular element 122 has a corrugated tube, for example as shown in FIG. 1. In some embodiments, the non-collapsible tubular element 122 has a profiled extruded tube with alternating thin and thick sections, for example as shown in FIG. 2. In some embodiments, the non-collapsible tubular element 122 has a reinforced spiral or wire, for example as shown in FIG. 3. In some embodiments, the non-collapsible tubular element 122 comprises a thin-walled tube co-extruded with a reinforcing spiral, for example as shown in Figure 3. In some embodiments, the non-collapsible tubular element 122 has a thicker wall, for example as shown in Figure 4.

[0020] The material of the elongated tubular element 104 may have a durometer of Shore A80 (ASTM D2240) or less, preferably Shore A70 or less, and most preferably Shore A60 or less. The elongated tubular element 104 may have a thickness of about 0.5 mm to about 3 mm, or preferably 0.5 mm to 1 mm. In some embodiments, the non-collapsible tubular element 122 has a reinforcing spiral, for example as shown in FIG. 3. The spiral may be the same material as the tube or a different material with a higher durometer. In some embodiments, the non-collapsible tubular element 122 has a corrugated tube. In some embodiments, the hardness of the non-collapsible tube 122 is Shore A80 (ASTM D2240) or less, preferably Shore A70 or less, and more preferably Shore A60 or less. In some embodiments, the hardness of the non-collapsible tube 122 and the elongated tubular element 104 of compressible material 112 is Shore A80 (ASTM D2240) or less, preferably Shore A70 or less, and more preferably Shore A60 or less.

[0021] The elongated tubular element 104 further comprises a compressible material 112 that may conform to tissue when the sphincter applies a force to the elongated tubular element 104. In some cases, the compressible material 112 comprises the same material with the same properties as the compressible material 106 in the inflatable balloon 102. In some cases, the compressible material 112 of the elongated tubular element 104 comprises a different material and / or different properties than the compressible material 106 in the inflatable balloon 102. Non-limiting examples of materials suitable for use as the compressible material 112 and / or compressible material 106 include open cell foam and polyurethane.

[0022] In some embodiments, the compressible material 106 and / or the compressible material 112 have a compressible strength of about 20 kg / m 3 ~about 60kg / m 3 , preferably about 20 kg / m 3 ~about 30kg / m 3(ISO 845). In some embodiments, the compressible material 106 and / or the compressible material 112 have a compressive load at 40% deflection of about 2 kPa to about 15 kPa, preferably 2 kPa to 5 kPa (ISO 3386-1). In some embodiments, the compressible material 106 and / or the compressible material 112 have a dry tensile strength of about 50 kPa to about 200 kPa, preferably about 100 kPa to about 150 kPa (ISO 1798). In some embodiments, the compressible material has a nominal hardness (durometer, ASTM D2240) of less than 50 Shore D and / or less than 100 Shore A, or preferably less than 90 Shore A. In some embodiments, the compressible material is a fast recovery foam configured to expand to 90% of its initial volume within 10 seconds, preferably within 5 seconds. In some embodiments, compressible material 106 and / or compressible material 112 are memory foams that maintain their compressed shape.

[0023] In some embodiments, the thickness of the compressible material 112 is less than about 8 mm, less than about 5 mm, or less than about 2 mm when the compressible material 112 is uncompressed. In some embodiments, the thickness of the compressible material 112 is less than about 4 mm, less than about 2 mm, or less than about 1 mm when the compressible material 112 is at least about 90% of its fully compressed state.

[0024] The compressible material 112 is disposed within the interior of the elongated tubular element 104. In some embodiments, the compressible material 112 is disposed within an interior chamber 132. As a non-limiting example, the chamber 110 may comprise a tube adjacent to the interior of the elongated tubular element 104. As another example, one or more chambers 132 may be disposed within the interior of the elongated tubular element having the compressible material 112. The chamber 110 may be a portion of the interior of the elongated tubular element 104 as shown in FIG. 5 or may be a separate structure. In some embodiments, the chamber 110 may be defined by the interior of the outer tube 104 and the exterior of the inner tube 122. In some embodiments, the chamber 110 comprises polyurethane. In some embodiments, the chamber 110 comprises silicone. In some embodiments, the chamber 110 comprises a thermoplastic elastomer.

[0025] The FMS 100 further includes a first pressure control passage 114 that connects the chamber 110 to the atmosphere via a release valve 138 and a valve system 136. The check valve system 136 is intended to allow a rapid inflow of fluid into the chamber 110 when the force acting on the chamber 110 is suddenly removed. The release valve 138 is for releasing pressure when pressure builds up due to bowel movements or patient movement. The first passage 114 can allow pressure equilibration between the chamber 110 and the atmosphere via the release valve 138. If the pressure in the chamber 110 is higher than atmospheric pressure, the equilibration process can include the flow of fluid (e.g., air, liquid) from the chamber 110 through the first passage 114 to the release valve 138 and to the atmosphere. In the case of the FMS, the pressure on the sphincter tissue is determined by the spring constant and size of the compressible material 112 in the chamber 110.

[0026] If the chamber 110 is overfilled (e.g., compressed too forcefully by the sphincter muscles), the pressure will be higher than the spring constant selected to withstand, and the compressible material 112 will be compressed such that fluid under pressure will exit through the release valve 138. If the chamber is underfilled (e.g., as a result of the force acting on the chamber 110 being suddenly removed), and the expansion force of the compressible material 112 is greater than the tissue resistance, fluid will flow through the release valve 138 and / or check valve 136 into the chamber 110, and the compressible material 112 will expand to a predetermined amount or until the tissue resistance matches the spring constant. In some embodiments, the flow rate is proportional to the pressure gradient, and a large excess pressure in the chamber 110 will release fluid to the atmosphere faster than a smaller excess pressure.

[0027] In some embodiments, the first passageway 114 includes a vent, such as a release valve 138, to facilitate fluid flow out of the chamber 110 in the event of sudden collapse of the tube during brief permutations, such as pressure from coughing, intestinal peristalsis, or patient movement. In some embodiments, the vent includes a microporous material. In some embodiments, the vent includes sintered polytetrafluoroethylene (PTFE). In a non-limiting example, the vent includes Porex PM0530. In some embodiments, the vent includes expanded PTFE (Gore) with an average pore size of about 200 microns to about 500 microns. The purpose of the vent is to allow air to escape quickly, e.g., at least 0.5 liters / hour / cm at a pressure gradient of 70 mbar. 2 (liters / hr / cm 2 ) ~50 litres / hour / cm 2 (liters / hr / cm 2 ), preferably 1 litre / hour / cm 2 (liters / hr / cm 2 ) ~5 liters / hour / cm 2 (liters / hr / cm 2 ) at a pressure gradient of 70 mbar. 2Additional exemplary vents, partially permeable plugs, membranes, or other materials include PTFE, silicone rubber, and high density polyurethane foam. In some embodiments, the vent is a small hole or series of holes to the atmosphere.

[0028] In some embodiments, the first passageway 114 is connected to a pressure indicator capable of indicating a pressure ranging from 5 mmHg to 100 mmHg, preferably from 10 mmHg to 50 mmHg. The pressure indicator can be a pressure gauge or a mechanical means for indicating the appropriate pressure in the tubular chamber 110. The pressure indicator can be connected to the passageway 114 via a valve 136 at the proximal end of the device. In some embodiments, the valve 136 is provided as a check valve.

[0029] In some embodiments, the FMS has a second passageway in fluid communication with the expandable chamber 110. In some cases, the flow rate of fluid entering the expandable chamber 110 through the second passageway is at least about 2, 3, 4, 5, or 10 times the flow rate of fluid exiting the expanded chamber 110 through the second passageway. The high rate of filling the expanded chamber 110 allows for rapid filling due to bowel movements or patient movement. In some embodiments, the flow rate of the expanded chamber 110 is up to about 2 ml to about 15 ml per minute. In some embodiments, the flow rate of the expanded chamber 110 can be up to about 20 ml, 30 ml, 40 ml, 50 ml, 60 ml, or 70 ml per minute. For the expandable chamber 110 of the FMS, the expandable chamber can fill in less than about 2 minutes, less than about 90 seconds, less than about 80 seconds, less than about 70 seconds, less than about 60 seconds, less than about 50 seconds, less than about 40 seconds, or less than about 30 seconds. For the FMS expandable chamber 110, the expandable chamber can be deflated in about 1 minute to about 15 minutes, or in about 1 minute, about 2 minutes, about 3 minutes, about 4 minutes, about 5 minutes, about 6 minutes, about 7 minutes, about 8 minutes, about 9 minutes, or about 10 minutes.

[0030] In some embodiments, the FMS 100 has a third passageway 126 that connects the inflatable balloon 102 to the inflatable chamber 110 and then to the same valve 134 for inflating / deflating both the balloon 102 and the inflatable chamber 110. Pressure management of the retention balloon 120 through the passageway 126 can be combined with pressure management of the inflatable chamber 110 through the passageway 114. In some embodiments, additional connectors can be used to control the pressure of the inflatable chamber 110 or the inflatable balloon 102, as shown in FIG. 6. The check valve 136 is used to drain liquid from the inflatable chamber 110. Similarly, the valve 134 is used to drain fluid from the inflatable balloon 102. Once the inflatable chamber 110 and the inflatable balloon 102 are deflated, the collapsed retention balloon can be inserted into the rectum. Once the device is inserted in place, a T-connector 148 (FIG. 6) can be connected to the valve system 136 or the valve system 134 via the connector 144.

[0031] The check valve 136 may be provided as a one-way valve that allows air to flow in quickly in one direction but prevents air from flowing out in the opposite direction. The release valve 138 is a vent to release fluid (e.g., air). In some embodiments, the cracking pressure of the one-way check valve may be selected between 30 mmHg and 35 mmHg, or preferably between 15 mmHg and 20 mmHg, or most preferably between 5 mmHg and 10 mmHg. The cracking pressure determines the pressure level of the inflatable chamber 110 or the retention balloon 102. In other words, when the T-connector 148 is connected to the valve system 136 or the valve system 134 via the connector 144, the pressure of the inflatable chamber 110 or the inflatable balloon 102 cannot exceed the cracking pressure of the one-way check valve 142.

[0032] In an exemplary method of use, the FMS 100 is prepared for insertion into the rectum by withdrawing fluid from the inflatable balloon 102 and the inflatable chamber 110, for example with a syringe, via the valve 134 and the passages 126 and 114, respectively. Liquid may be withdrawn directly from the inflatable chamber 110. The withdrawal of fluid creates a negative pressure in the inflatable chamber 110 relative to the outside atmosphere, and the surrounding atmospheric pressure collapses the inflatable chamber 110 and any compressible material 112 that may be present within the inflatable chamber 110. Once the balloon 102 is fully deflated, the distal portion of the inflatable balloon 102 and the portion of the elongated tubular member 104 carrying the inflatable chamber 110 are inserted into the rectum, for example with a finger pocket located between the portion of the inflatable balloon 102 and the elongated tubular member 104. Once inserted, fluid is reinjected to expand both the inflatable balloon 102 and the inflatable chamber 110. The inflated balloon 102 provides an anchoring means for the catheter to remain in place, while the inflated chamber within the elongated tubular element allows for an effective seal against the sphincter tissue, thus inhibiting leakage in the perianal area. The fluid may be air or a liquid. The fluid to the inflatable balloon 102 and the fluid to the inflatable chamber 110 may be the same or different. In an exemplary embodiment, the fluid is air.

[0033] If the expandable chamber 110 has a compressible material 112, the expandable chamber 110 may remain expanded by the action of the compressible material 106. Injecting fluid restores atmospheric pressure to the fluid in the expandable chamber 110, allowing the compressible material 112 to depressurize. In some cases, reinjecting the same amount of liquid as was removed for insertion may create a slight positive fluid pressure in the expandable chamber 110. However, this positive pressure may gradually decrease as excess fluid is slowly drained and atmospheric fluid pressure equilibrium is restored. The momentary positive pressure during bowel movements or patient movement helps move sphincter tissue or feces out of the way to allow for proper sealing. In an exemplary method of use, a T-connector 148 having a one-way check valve 142 and a release valve 146 may be coupled to the valve system 136 or 134 to maintain the system pressure set by the cracking pressure of the one-way check valve 142 or 146. In another exemplary method of use, a vent is connected to the inflatable chamber 110 via a passageway 114, allowing the pressure within the tubular chamber 110 to be rapidly adjusted to form an effective seal against the sphincter tissue.

[0034] When the expandable balloon 102 and a portion of the elongated tubular member 104 having the expandable chamber 110 are inserted into the rectum, the non-collapsible feature of the elongated tubular element 104 having the expandable chamber 110 and the compressible material 112 allows for the expulsion of feces while reducing or preventing leakage around the periphery of the elongated tubular member 104. This may be accomplished by achieving pressure equilibrium between the chamber 110 and the atmosphere via the first passageway 114. The expandable chamber 110 and the compressible material 112 within the elongated tubular element 104 are intended to balance the compressive force of the sphincter. For example, if the sphincter pressure is higher than the pressure of the expandable chamber 110, the positive pressure will compress the expanded chamber 110 having the compressible material 112, triggering the pressure to be released through the release valve 138. Fluid will continue to escape until the fluid pressure within the expandable chamber 110 reaches atmospheric pressure. When the sphincter compression pressure subsides or the patient moves, the recovery of the compressible material 112 expands the expandable chamber 110, creating a negative gauge pressure. When the negative gauge pressure exceeds the cracking pressure of the check valve 136, the check valve 136 opens and fluid enters the chamber 110. The release valve 138 and the check valve 136 are self-regulating and maintain a pressure balance between the expandable chamber 110 and the surrounding sphincter. The pressure exerted on the sphincter tissue surrounding the compressible material 104 with the elongated tubular element 112 may be determined by the spring constant and / or size of the compressible material 112 in the chamber 110. In some embodiments, the first passage 114 in the FMS 100 has a vent and the process of reaching equilibrium includes the flow of fluid through the vent. In some embodiments, the first passage 114 is connected to a passage 126 designed to manage pressure control by the inflatable balloon 102. In some embodiments, the first passageway 114 is connected to a passageway 126 designed to manage pressure control by an inflatable balloon 102 further comprising a compressible material 106 .

[0035] For FMSs having compressible material 112 in the expandable chamber 110 of the elongated tubular element 104, the pressure on the sphincter tissue is determined by the spring constant and / or size of the compressible material 112 in the expandable chamber 110. If the expandable chamber 110 is over-expanded, the pressure between the expandable chamber 110 and the tissue will be higher than the spring constant that the compressible material 112 is designed to withstand. In such a case, the expandable chamber 110 will be compressed, putting pressure on the fluid in the expandable chamber 110. As a result, fluid from the expandable chamber 110 will flow outward through the second passageway, relieving the pressure. If the second passageway and / or the first passageway have vents, the vents restrict the flow of fluid, so the pressure is slowly lowered by the sphincter tissue and muscle. The fluid will continue to escape until the fluid pressure in the expandable chamber 110 reaches atmospheric pressure.

[0036] If the expandable chamber 110 is insufficiently expanded and the expansion pressure generated by the compressible material 112 is greater than the resistance of the sphincter tissue, fluid will be drawn through the first and / or second passageways. As a result, the compressible material 112 will tend to expand the expandable chamber 110 to an expanded shape or until the resistance of the tissue matches the elastic modulus of the compressible material 112. If a vent is present, the rate of fluid inflow may also be limited.

[0037] The exemplary system 100 may further include a pressure management device including a valve assembly in fluid communication with the chamber 110, which generally includes maintaining the pressure in the chamber at a selected pressure range having a minimum pressure and a maximum pressure. In certain embodiments, the minimum pressure is from atmospheric pressure to about 15 mmHg below atmospheric pressure. In certain embodiments, the minimum pressure is from 8 mmHg below atmospheric pressure to about 12 mmHg below atmospheric pressure. In certain embodiments, the minimum pressure is from atmospheric pressure to about 10 mmHg below atmospheric pressure. In certain embodiments, the maximum pressure is about 30 mmHg above or below atmospheric pressure. In certain embodiments, the maximum pressure is about 20 mmHg above or below atmospheric pressure. In certain embodiments, the maximum pressure is about 10 mmHg above or below atmospheric pressure. In certain embodiments, the maximum pressure is 4-6 mmHg above atmospheric pressure. In certain embodiments, the pressure management means can include maintaining the pressure in the chamber 110 in a range from 10 mmHg below atmospheric pressure to 20 mmHg above atmospheric pressure. In certain embodiments, the pressure management means can include maintaining the pressure in the chamber 110 in a range from 10 mmHg below atmospheric pressure to 10 mmHg above atmospheric pressure. In certain embodiments, the pressure management means can include maintaining the pressure in the chamber 110 in a range from 10 mmHg below atmospheric pressure to 5 mmHg above atmospheric pressure. The external pressure is the sum of the internal chamber pressure described above and the expansion force exerted on the chamber 110 by the resilient foam 112, and can be about 10 mmHg or less based on the type of foam selected according to Table 1. Thus, at least some embodiments of the present disclosure allow for a maximum cuff pressure that contacts the anal sphincter muscle that is at least about 30 mmHg above atmospheric pressure, preferably at least about 20 mmHg above atmospheric pressure, and more preferably at least about 10 mmHg above atmospheric pressure.

[0038] Those skilled in the art will readily appreciate that the pressure range maintained within chamber 110 will depend at least in part on the cracking pressure selected for check valve 136, and will be able to readily select a check valve having an appropriate cracking pressure to maintain the desired pressure range within chamber 110. For example, in an embodiment in which the minimum selected for pressure within chamber 110 is approximately 10 mmHg below atmospheric pressure, inlet check valve 136 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 110 is approximately 20 mmHg above atmospheric pressure, discharge check valve 138 may be selected with a cracking pressure of approximately 20 mmHg (e.g., 20 mmHg ± 4 mmHg) or less. Certain embodiments may utilize an open vent to allow for rapid equalization to atmospheric pressure.

[0039] Certain embodiments of the present application relate to a device having an elongated tubular member having a proximal end and an opposite distal end, and an inflatable balloon surrounding the distal end, the elongated tubular member having an outer tube, a non-collapsible inner tube disposed within the outer tube, and a compressible material disposed between the outer tube and the inner tube.

[0040] In certain embodiments, the non-collapsible inner tube is corrugated along at least a portion of the length of the non-collapsible inner tube.

[0041] In certain embodiments, the non-collapsible inner tube has alternating thicker and thinner sections.

[0042] In certain embodiments, the non-collapsible inner tube has a wall thickness of from 0.8 mm to 4 mm, or from 1.0 mm to 2.5 mm.

[0043] In certain embodiments, the non-collapsible inner tube has a helical element.

[0044] In certain embodiments, the helical element comprises a wire.

[0045] In certain embodiments, the helical element is integrally formed with the non-collapsible inner tube.

[0046] In certain embodiments, the non-collapsible inner tube has a durometer of Shore A80 or less, Shore A70 or less, or Shore A60 or less.

[0047] In certain embodiments, the compressible material comprises at least one of an open cell foam or a polyurethane.

[0048] In certain embodiments, the compressive load at 40% deflection of the compressible material is from about 2 kPa to about 15 kPa, or from about 2 kPa to about 5 kPa.

[0049] In certain embodiments, the compressible material has a durometer of less than 50 Shore D and / or less than 100 Shore A.

[0050] In certain embodiments, the compressible material comprises a fast recovery foam configured to expand to 90% of its initial volume within 10 seconds, preferably within 5 seconds.

[0051] In certain embodiments, the compressible material has a dry tensile strength of about 50 kPa to about 200 kPa, preferably about 100 kPa to 150 kPa.

[0052] In certain embodiments, the compressible material, when uncompressed, has a thickness of less than about 4 mm, less than about 3 mm, or less than about 2 mm.

[0053] In certain embodiments, the thickness of the compressible material is less than about 2 mm, less than about 1.5 mm, or less than about 1 mm when the compressible material is at least about 90% of its fully compressed state.

[0054] In certain embodiments, the device further comprises a second compressible material disposed within the balloon.

[0055] In certain embodiments, the second compressible material is configured to move from an expanded state to a compressed state in response to pressure compressing the balloon, and the second compressible material is configured to return from the compressed state to the expanded state upon removal of the pressure, thereby causing expansion of the balloon.

[0056] In certain embodiments, the apparatus further comprises a valve assembly in fluid communication with the chamber, the valve assembly comprising at least one pressure regulating check valve.

[0057] In certain embodiments, the check valve comprises at least one of a duckbill valve, an umbrella valve, a disk valve, a diaphragm valve, or an open vent.

[0058] In certain embodiments, the compressible material is disposed within a chamber defined between the outer tube and the inner tube.

[0059] In certain embodiments, the apparatus further includes a fluidly connected valve assembly having a chamber, the valve assembly having a first check valve operable to allow fluid to flow out of the chamber during compression of the chamber and the compressible material, and a second check valve operable to allow fluid to flow into the chamber during expansion of the chamber and the compressible material.

[0060] Certain embodiments of the present application relate to fecal catheters comprising the device.

[0061] Certain embodiments of the present application relate to a device including an elongate tubular member having a proximal end and an opposite distal end, an inflatable balloon surrounding the distal end, a first chamber formed in either the elongate tubular member or the balloon, a first compressible material contained in the first chamber, and a valve assembly in fluid communication with the first chamber, the valve assembly having at least one pressure regulating check valve.

[0062] In certain embodiments, the at least one pressure regulating check valve has a first check valve and a second check valve, the first check valve configured to allow fluid to flow out of the first chamber during compression of the first chamber and the first compressible material, and the second check valve configured to allow fluid to flow into the first chamber during expansion of the first chamber and the first compressible material.

[0063] In certain embodiments, a first chamber is formed within the elongate tubular member.

[0064] In certain embodiments, the elongate tubular member has an outer tube and an inner tube positioned within the outer tube, the first chamber being defined between the inner tube and the outer tube.

[0065] In certain embodiments, the inner tube is non-collapsible.

[0066] In certain embodiments, the first compressible material, when uncompressed, has a thickness of less than about 4 mm, less than about 3 mm, or less than about 2 mm.

[0067] In certain embodiments, when the first compressible material is at least about 90% of its fully compressed state, the thickness of the first compressible material is less than about 2 mm, less than about 1.5 mm, or less than about 1 mm.

[0068] In certain embodiments, the device further comprises a second chamber formed in the other of the elongate tubular member or the balloon, and a second compressible material contained within the second chamber.

[0069] In certain embodiments, the first chamber and the second chamber are in fluid communication with each other.

[0070] In certain embodiments, the first compressible material is configured to move from an expanded state to a compressed state in response to pressure compressing the first chamber, and the first compressible material is configured to return from the compressed state to the expanded state in response to removal of the pressure, thereby causing expansion of the first chamber.

[0071] In certain embodiments, the check valve is configured to allow fluid to flow from the fluid source into the first chamber when a pressure differential between the first chamber and the fluid source exceeds a cracking pressure of the check valve.

[0072] In certain embodiments, the cracking pressure is from 10 mmHg to 25 mmHg.

[0073] In certain embodiments, the fluid source is at atmospheric pressure.

[0074] In certain embodiments, the compressive load at 40% deflection of the first compressible material is from about 2 kPa to about 15 kPa, or from about 2 kPa to about 5 kPa.

[0075] In certain embodiments, the first compressible material has a durometer of less than 50 Shore D and / or less than 100 Shore A.

[0076] In certain embodiments, the first compressible material comprises a fast recovery foam configured to expand to 90% of its initial volume within 10 seconds, preferably within 5 seconds.

[0077] In certain embodiments, the first compressible material has a dry tensile strength of about 50 kPa to about 200 kPa, preferably about 100 kPa to about 150 kPa.

[0078] Certain embodiments of the present application relate to a fecal management system comprising the device.

[0079] Certain embodiments of the present application relate to a method that includes inserting an elongated tubular member into a body cavity having soft tissue, the elongated tubular member having an outer tube, a non-collapsible inner tube disposed within the outer tube, and a first compressible material disposed between the inner tube and the non-collapsible inner tube.

[0080] In certain embodiments, the method further comprises inflating a balloon coupled to the insertion end of the elongate tubular member, thereby forming a seal with the soft tissue.

[0081] In certain embodiments, expanding the balloon includes expanding a second compressible material disposed within a cavity of the balloon.

[0082] In certain embodiments, the method further includes expanding the first compressible material from a compressed state to a deployed state, thereby forming a seal between the outer tube and the soft tissue.

[0083] In certain embodiments, expanding the first compressible material comprises introducing a fluid into a chamber in which the first compressible material is contained.

[0084] In certain embodiments, the body cavity is the rectal cavity.

[0085] In certain embodiments, the method further includes selectively flowing fluid through a check valve fluidly connected to the first compressible material during expansion of the first compressible material, thereby facilitating expansion of the first compressible material.

[0086] In certain embodiments, the method further includes, during compression of the first compressible material, flowing fluid from the first compressible material via a check valve in fluid communication with the first compressible material, thereby facilitating compression of the first compressible material.

[0087] In certain embodiments, the check valve is further in fluid communication with the fluid source, and selectively flowing fluid through the first compressible material includes flowing fluid through the first compressible material only if a pressure differential between the first compressible material and the fluid source exceeds a cracking pressure of the check valve.

[0088] In a particular embodiment, the fluid source is the atmosphere.

[0089] In certain embodiments, the cracking pressure ranges from 10 mmHg to 25 mmHg.

[0090] In certain embodiments, the cracking pressure is less than or equal to 25 mmHg.

[0091] In certain embodiments, a first compressible material surrounds the non-collapsible inner tube and is surrounded by the outer tube.

[0092] In certain embodiments, the method further includes directing waste from the cavity through a non-collapsible inner tube to a waste collection device connected to the proximal end of the elongated tubular member.

[0093] Certain embodiments related to the present application relate to an apparatus having an elongate tubular member having a proximal end and an opposite distal end, a chamber formed in the elongate tubular member, a compressible material contained in the chamber, and a valve assembly in fluid communication with the chamber, the valve assembly having at least one pressure regulating check valve.

[0094] In certain embodiments, the at least one pressure regulating check valve has a first check valve and a second check valve, the first check valve configured to allow fluid to flow out of the chamber upon compression of the chamber and the compressible material, and the second check valve configured to allow fluid to flow into the chamber upon expansion of the chamber and the compressible material.

[0095] In certain embodiments, the elongate tubular member has an outer tube and an inner tube disposed within the outer tube, defining a chamber between the inner tube and the outer tube.

[0096] In certain embodiments, the inner tube is non-collapsible.

[0097] In certain embodiments, the compressible material, when uncompressed, has a thickness of less than about 4 mm, less than about 3 mm, or less than about 2 mm.

[0098] In certain embodiments, the compressible material, when at least about 90% of its fully compressed state, has a thickness of less than about 2 mm, less than about 1.5 mm, or less than about 1 mm.

[0099] In certain embodiments, the compressible material is configured to move from the expanded state to the compressed state in response to a compressing pressure, and the compressible material is configured to revert from the compressed state back to the expanded state in response to removing the pressure, thereby causing expansion.

[0100] In certain embodiments, the check valve is configured to allow fluid to flow from the fluid source into the chamber in response to a pressure differential between the chamber and the liquid source exceeding a cracking pressure of the check valve.

[0101] In certain embodiments, the cracking pressure is from 10 mmHg to 25 mmHg.

[0102] In certain embodiments, the fluid source is at atmospheric pressure.

[0103] In certain embodiments, the compressive load at 40% deflection of the compressible material is from about 2 kPa to about 15 kPa, or from about 2 kPa to about 5 kPa.

[0104] In certain embodiments, the compressible material has a durometer of less than 50 Shore D and / or less than 100 Shore A.

[0105] In certain embodiments, the compressible material comprises a fast recovery foam configured to expand to 90% of its initial volume within 10 seconds, preferably within 5 seconds.

[0106] In certain embodiments, the compressible material has a dry tensile strength of about 50 kPa to about 200 kPa, preferably about 100 kPa to about 150 kPa.

[0107] Certain embodiments of the present application relate to fecal catheters comprising the device.

[0108] While preferred embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions are possible for those skilled in the art without departing from the invention. It is understood that various alternatives to the embodiments of the invention described herein may be used in carrying out the invention. The following claims define the scope of the invention, and it is intended that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

1. an elongated tubular member having a proximal end and a distal end insertable into a patient's rectum; an inflatable balloon surrounding the distal end; The elongated annular member includes an outer tube, a non-collapsible inner tube disposed within the outer tube, and a compressible material disposed between the outer tube and the inner tube; A feces management system comprising a device having the above structure.

2. The non-collapsible inner tube is corrugated along at least a portion of the length of the non-collapsible inner tube. The fecal management system of claim 1 .

3. The non-collapsible inner tube has alternating thick and thin walled sections. The fecal management system of claim 1 .

4. The non-collapsible inner tube has a wall thickness of 0.8 mm to 4 mm, or 1.0 mm to 2.5 mm. The fecal management system of claim 1 .

5. the non-collapsible inner tube having a helical element; The helical element comprises a wire or the helical element is integrally formed with the non-collapsible inner tube. The fecal management system of claim 1 .

6. The non-collapsible inner tube has a durometer of Shore A80 or less, Shore A70 or less, or Shore A60 or less. The fecal management system of claim 1 .

7. The compressible material comprises at least one of an open cell foam or a polyurethane. The fecal management system of claim 1 .

8. (a) the compressible material has a compressive load at 40% deflection of about 2 kPa to about 15 kPa, or about 2 kPa to about 5 kPa; or (b) the durometer of the compressible material is less than 50 Shore D and / or less than 100 Shore A; The fecal management system of claim 1 .

9. (a) the compressible material has a fast recovery foam configured to expand to 90% of its initial volume within 10 seconds, preferably within 5 seconds; or (b) the compressible material has a tensile strength in a dry state of about 50 kPa to about 200 kPa, or preferably about 100 kPa to 150 kPa. The fecal management system of claim 1 . (a) the compressible material has a thickness of less than about 4 mm, less than about 3 mm, or less than about 2 mm when the compressible material is uncompressed; or (b) the compressible material has a thickness of less than about 2 mm, less than about 1.5 mm, or less than about 1 mm when the compressible material is at least about 90% of its fully compressed state; or (c) the compressible material is disposed within a chamber defined between the outer tube and the inner tube; The fecal management system of claim 1 .

11. a second compressible material disposed within the balloon; the second compressible material is configured to move from an expanded state to a compressed state in response to a pressure compressing the balloon; The second compressible material is configured to return from a compressed state to an expanded state upon removal of pressure, thereby causing expansion of the balloon. The fecal management system of claim 1 .

12. The method of claim 1, further comprising: a valve assembly in fluid communication with the chamber; The valve assembly includes at least one pressure regulating check valve. The fecal management system of claim 1 .

13. The check valve comprises at least one of a duckbill valve, an umbrella valve, a disk valve, a diaphragm valve, or an open vent. The fecal management system of claim 12.

14. The valve assembly having a first check valve operable to allow fluid to flow out of the chamber upon compression of the chamber and the compressible material, and a second check valve operable to allow fluid to flow into the chamber upon expansion of the chamber and the compressible material. The fecal management system of claim 12.

Images