Non-foldable 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-referencing with the application

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

[0002] Indwelling fecal management catheters are used to capture and contain liquid or semi-liquid feces in immobile hospitalized patients to prevent contamination of the patient's skin with corrosive wastewater, reduce the risk of contamination with potentially infectious materials, and minimize soiling of bedding. Fecal management catheters typically have an inflatable balloon to secure the catheter in the rectum and a tube to keep the feces away from the patient's rectum. [Overview of the project]

[0003] To reduce the force on the sphincter during defecation management, most indwelling defecating catheters have collapsible tubes, which can create a leakage pathway for feces outside the catheter tube around the patient's anus. Specific embodiments of this disclosure relate to catheter tubes that allow for effective stool expulsion while applying minimal pressure to the sphincter and reducing or eliminating leakage around the catheter tube. In some embodiments, the catheter tube has a material that compresses to reduce excessive pressure on surrounding tissue and accommodates patient movement. In some embodiments, the catheter has a soft, non-collapsible tube that is compressible and reduces pressure on sphincter tissue. This is in contrast to collapsible catheter tubes (i.e., soft and collapsible) or other catheter designs that have fixed-volume air pockets that can generate high pressure and damage the catheter tube sphincter. While conventional fecal catheters employ a collapsible catheter tube, as described in U.S. Patent No. 8,016,816B2 and EP No. 2,278,945B1, U.S. Patent No. 8,939,952 and WO2007118621A1 disclose an air pocket consisting of a double balloon to provide an improved seal against rectal tissue. The latter design uses a closed air pocket, but has the disadvantage that pressure increases due to the closed system of the air pocket during defecation, patient movement, or while the patient is sitting. [Brief explanation of the drawing]

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

[0005] [Figure 2] Figure 2 is an exemplary cross-sectional view of a fecal management system having a non-foldable tube with a soft, thin-walled section and a thick-walled section.

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

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

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

[0009] [Figure 6] Figure 6 shows a T-connector design with one connection to a vent and a second connection to a one-way check valve, which maintains a favorable differential pressure between the elongated tubular chamber and the atmosphere. Detailed description of exemplary embodiments

[0010] While the concepts of this disclosure are subject to various modifications and alternative forms, specific embodiments are shown in the drawings as examples and described in detail herein. However, it should be understood that the concepts of this disclosure are not intended to be limited to the specific forms disclosed, but rather are intended to cover all modifications, equivalents, and alternatives that conform to the scope of this disclosure and the appended claims.

[0011] References to “one embodiment,” “one example embodiment,” and “exemplary embodiment” in this specification indicate that the described embodiment may have certain features, structures, or characteristics, but not all embodiments will have those specific features, structures, or characteristics. Furthermore, such expressions do not necessarily refer to the same embodiment. In addition, references to “preferred” components or features may indicate the desirability of certain components or features with respect to a particular embodiment, but it should be understood that this disclosure is not so limited to other embodiments in which such components may be omitted. Furthermore, where certain features, structures, or characteristics are described in relation to an embodiment, whether expressly described or not, it is submitted that implementing such features, structures, or characteristics in relation to other embodiments is within the knowledge of those skilled in the art.

[0012] Furthermore, it should be understood that items included in a list of the form "at least one of A, B, and C" could mean (A);(B);(C);(A and B);(B and C);(A and C); or (A, B, C). Similarly, items listed in the form "at least one of A, B, or C" could 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" could also mean (A), (B), (C), (A and B), (B and C), (A and C), or (A, B, and C). Furthermore, with respect to the claims, the use of phrases such as “one (a),” “one (an),” “at least one,” and / or “at least one portion” should not be interpreted as limiting such elements to only one unless otherwise stated, and the use of phrases such as “at least a portion,” and / or “a portion,” should be interpreted as encompassing both embodiments having only a portion of such elements and embodiments having the entirety of such elements, unless otherwise stated.

[0013] In this specification, the term “approximately” may be used to modify certain quantitative measurements. In various embodiments, the term “approximately” may mean that the expressed value may differ by up to 10%, up to 5%, or up to 1%. Thus, a pressure “approximately 100 kPa” may mean that the pressure is between 90 kPa and 110 kPa, between 95 kPa and 105 kPa, or between 99 kPa and 101 kPa.

[0014] In drawings, certain structural or methodological features may be shown in a specific arrangement and / or order. However, it should be understood that such a specific arrangement and / or order is not always necessary. Rather, in some embodiments, such features may be arranged in a different manner and / or order than those shown in the illustrative drawings, unless otherwise indicated. Furthermore, the inclusion of structural or methodological features in a particular drawing does not mean that such features are required in all embodiments, and in some embodiments, they may be omitted or combined with other features.

[0015] In one aspect of this disclosure, a medical device is provided having an elongated tubular element for draining medical waste. The medical device may be part of a fecal management system (FMS), in which case 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 placed within the tubular element that conforms to the tissue when force is applied to the tubular element by a sphincter. An exemplary medical device embodied as an FMS is shown in Figure 1.

[0016] An exemplary FMS 100 includes a catheter 101 having an elongated tubular element 104 with 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 liquid (e.g., saline solution) via a port 124 that connects the inflation lumen to the chambers of the main tube 104 and the balloon 102. In some embodiments, the inflatable balloon 102 can contain a compressible material 106. Within the elongated chamber 110, a lavage passage 128, a balloon inflation / deflation passage 126, and a passage 114 to the elongated tube chamber 110 for pressure management are formed.

[0017] In the illustrated configuration, the device is provided as a catheter 101 of a fecal management system 100. It is also conceivable that the catheter 101 may be provided for other uses, such as a Foley (urethral) catheter or as another form of catheter. Furthermore, the elongated tubular element 104 described herein may potentially be used in other areas of the body, such as forming an airway for a respiratory device.

[0018] In the illustrated configuration, the distal portion of the elongated tubular element 104 is insertable into the subject's rectum and collects waste flowing from the distal portion through a drainage channel 116 within the elongated tubular element 104 to the proximal portion. Once the distal portion is inserted into the rectum, the inflatable balloon 102 engages with internal tissue to hold the distal portion in place and can provide a seal to divert internal waste through the drainage channel 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-foldable, and fluid can pass through the drainage passage 116 without being completely obstructed. For example, the non-foldable elongated tubular element 104 may be reinforced with wires. In some embodiments, the non-foldable tubular element 104 has a spiral insert for making the tube non-foldable. In some embodiments, the elongated tubular element 104 further has a non-foldable tubular element 122. In some embodiments, the non-foldable tubular element 122 has a thick-walled tube that is non-foldable. 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-foldable tubular element 122 has a corrugated tube as shown, for example, in FIG. 1. In some embodiments, the non-foldable tubular element 122 has a profiled extruded tube with alternating thin and thick portions as shown, for example, in FIG. 2. In some embodiments, the non-foldable tubular element 122 has a reinforced spiral or wire as shown, for example, in FIG. 3. In some embodiments, the non-foldable tubular element 122 has a thin-walled tube co-extruded with a reinforcing spiral as shown, for example, in FIG. 3. In some embodiments, the non-foldable tubular element 122 has a thick wall as shown, for example, in FIG. 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 from about 0.5 mm to about 3 mm, or preferably from 0.5 mm to 1 mm. In some embodiments, the non-foldable tubular element 122 has a reinforcing spiral as shown, for example, in FIG. 3. The spiral may be of the same material as the tube or a different material having a higher durometer. In some embodiments, the non-foldable tubular element 122 has a corrugated tube. In some embodiments, the hardness of the non-foldable tubular element 122 is Shore A80 (ASTM D2240) or less, preferably Shore A70 or less, more preferably Shore A60 or less. In some embodiments, the hardness of the elongated tubular element 104 composed of the non-foldable tube 122 and the compressible material 112 is Shore A80 (ASTM D2240) or less, preferably Shore A70 or less, more preferably Shore A60 or less.

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

[0022] In some embodiments, the compressible material 106 and / or the compressible material 112 is from about 20 kg / m 3 to about 60 kg / m 3 , preferably from about 20 kg / m 3 to about 30 kg / m 3It has a density (ISO 845). In some embodiments, the compressive load at 40% deflection of compressible material 106 and / or compressible material 112 is about 2 kPa to about 15 kPa, preferably 2 kPa to 5 kPa (ISO 3386-1). In some embodiments, the dry tensile strength of compressible material 106 and / or compressible material 112 is about 50 kPa to about 200 kPa, preferably about 100 kPa to about 150 kPa (ISO 1798). In some embodiments, the nominal hardness (durometer, ASTM D2240) of the compressible material is 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-recovering foam configured to expand to 90% of its initial volume within 10 seconds, preferably within 5 seconds. In some embodiments, the compressible material 106 and / or the compressible material 112 is a shape-memory foam that maintains its 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 not compressed. 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 located inside the elongated tubular element 104. In some embodiments, the compressible material 112 is located inside an internal chamber 132. In a non-limiting example, the chamber 110 may have adjacent tubes inside the elongated tubular element 104. In another example, one or more chambers 132 may be located inside the elongated tubular element having the compressible material 112. The chamber 110 may be part of the interior of the elongated tubular element 104, as shown in Figure 5, or it 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 is made of polyurethane. In some embodiments, the chamber 110 is made of silicone. In some embodiments, the chamber 110 is made of thermoplastic elastomer.

[0025] The FMS 100 further has 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 it increases due to the urge to defecate or patient movement. The first passage 114 can enable pressure equilibrium 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 process to reach equilibrium may include a flow of fluid (e.g., air, liquid) from the chamber 110 through the first passage 114 to the release valve 138 and then to the atmosphere. In the case of the FMS, the pressure on the sphincter tissue is determined by the spring constant and magnitude of the compressible material 112 in the chamber 110.

[0026] When the chamber 110 is overfilled (e.g., when compressed with a strong force by a sphincter), the pressure becomes higher than the spring constant selected to be withstandable, and the compressible material 112 is compressed under the pressure so that the fluid comes out through the release valve 138. When the chamber is underfilled (e.g., as a result of a sudden removal of the force acting on the chamber 110), and when the expansion force of the compressible material 112 is greater than the tissue resistance, the fluid flows into the chamber 110 through the release valve 138 and / or the check valve 136, and the compressible material 112 expands to a predetermined size or until the tissue resistance matches the spring constant. In some embodiments, the flow rate is proportional to the pressure gradient, and when the excess pressure in the chamber 110 is large, the fluid is released towards the atmosphere faster than when the excess pressure is small.

[0027] In some embodiments, the first passage 114 has a vent such as the release valve 138 and can facilitate the flow of fluid from the chamber 110 during short permutations such as coughing, intestinal peristalsis, or pressure from the patient's movement when the tube is suddenly crushed. In some embodiments, the vent has a microporous material. In some embodiments, the vent has sintered polytetrafluoroethylene (PTFE). As a non-limiting example, the vent has Porex PM0530. In some embodiments, the vent has expanded PTFE (manufactured by Gore) with an average pore diameter of about 200 microns to about 500 microns. The purpose of the vent is to quickly let air out. For example, at least, at a pressure gradient of 70 mbar, 0.5 liters / hr / cm 2 (liters / hr / cm 2 ) to 50 liters / hr / cm 2 (liters / hr / cm 2 ), preferably 1 liter / hr / cm 2 (liters / hr / cm 2 ) to 5 liters / hr / cm 2 (liters / hr / cm 2 ). At a pressure gradient of 70 mbar, liters / hr / cm 2Additional exemplary vents, partially permeable plugs, membranes, or other materials include PTFE, silicone rubber, and high-density polyurethane foam. In some embodiments, the vents are small holes or a series of holes to the atmosphere.

[0028] In some embodiments, the first passage 114 is connected to a pressure indicator capable of indicating a pressure in the range of 5 mmHg to 100 mmHg, preferably 10 mmHg to 50 mmHg. The pressure indicator can be a pressure gauge or mechanical means indicating the appropriate pressure in the tubular chamber 110. The pressure indicator can be connected to the passage 114 via a valve 136 located 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 passage that fluidically communicates with an inflatable chamber 110. In some cases, the fluid velocity flowing into the inflatable chamber 110 through the second passage is at least 2, 3, 4, 5, or 10 times the fluid velocity flowing out of the inflated chamber 110 through the second passage. The rapid injection rate into the inflated chamber 110 allows for rapid filling due to defecation or patient movement. In some embodiments, the outflow rate from the inflated chamber 110 is at most about 2 ml to about 15 ml per minute. In some embodiments, the inflow rate into the inflated chamber 110 can be about 20 ml, 30 ml, 40 ml, 50 ml, 60 ml, or 70 ml or less per minute. For the inflatable chamber 110 of the FMS, the inflatable chamber can be filled 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. In the case of the FMS inflatable chamber 110, the inflatable chamber can be deflated in approximately 1 to 15 minutes, or in approximately 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 6 minutes, 7 minutes, 8 minutes, 9 minutes, or 10 minutes.

[0030] In some embodiments, the FMS 100 has a third passage 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 control of the retaining balloon 120 through passage 126 can be combined with pressure control of the inflatable chamber 110 through passage 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 Figure 6. A check valve 136 is used to drain fluid from the inflatable chamber 110. Similarly, a 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 folded retaining balloon can be inserted into the rectum. Once the device is inserted into place, a T-connector 148 (Figure 6) can be connected to the valve system 136 or valve system 134 via 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 for releasing fluid (e.g., air). In some embodiments, the cracking pressure of the one-way check valve may be selected from 30 mmHg to 35 mmHg, preferably 15 mmHg to 20 mmHg, or most preferably 5 mmHg to 10 mmHg. The cracking pressure determines the pressure level of the inflatable chamber 110 or retaining balloon 102. In other words, when the T connector 148 is connected to the valve system 136 or valve system 134 via the connector 144, the pressure of the inflatable chamber 110 or inflatable balloon 102 cannot exceed the cracking pressure of the one-way check valve 142.

[0032] In an exemplary use, the FMS 100 is prepared for rectal insertion by drawing fluid from the inflatable balloon 102 and the inflatable chamber 110, respectively, through valves 134 and passages 126 and 114, for example, using a syringe. The fluid can be drawn directly from the inflatable chamber 110. The suction of the fluid creates a negative pressure within the inflatable chamber 110 relative to the outside atmosphere, causing the ambient atmospheric pressure to deflate the inflatable chamber 110 and any compressible material 112 present within it. Once the balloon 102 is fully deflated, a portion of the elongated tubular member 104, which has the distal portion of the inflatable balloon 102 and the inflatable chamber 110, is inserted into the rectum, for example, using a finger pocket located between the portion of the inflatable balloon 102 and the elongated tubular element 104. Once inserted, the fluid is reinjected to inflate both the inflatable balloon 102 and the inflatable chamber 110. The inflated balloon 102 provides a means of securing the catheter in place, while the inflated chamber within the elongated tubular element allows for an effective seal toward the sphincter tissue, thus suppressing leakage in the perianal region. 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 inflatable chamber 110 has compressible material 112, the inflatable chamber 110 may remain inflated due to the action of the compressible material 106. When fluid is injected, the atmospheric pressure of the fluid in the inflatable chamber 110 is restored, allowing the compressible material 112 to depressurize. In some cases, reinjecting the same amount of fluid that was removed for insertion may create a slight positive fluid pressure within the inflatable chamber 110. However, this positive pressure may gradually decrease as the excess fluid is slowly discharged and the fluid pressure equilibrium with atmospheric pressure is restored. The temporary positive pressure during defecation or patient movement helps to move the sphincter tissue or feces out of the way and ensure proper sealing. In an exemplary use, a T-connector 148 having a one-way check valve 142 and a release valve 146 can be coupled to a 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 use, the vent is connected via a passage 114 to an inflatable chamber 110, allowing for rapid adjustment of the pressure within the tubular chamber 110 to form an effective seal against the sphincter tissue.

[0034] When a portion of the elongated tubular member 104 having an inflatable balloon 102 and an inflatable chamber 110 is inserted into the rectum, the non-folding feature of the elongated tubular element 104 having the inflatable chamber 110 and compressible material 112 allows for the expulsion of feces while reducing or preventing leakage from the periphery of the elongated tubular member 104. This can be achieved by achieving pressure equilibrium between the chamber 110 and the atmosphere via the first passage 114. The inflatable chamber 110 and compressible material 112 within the elongated tubular element 104 are intended to balance the compressive force of the sphincter. For example, if the pressure of the sphincter is higher than the pressure of the inflatable chamber 110, the positive pressure compresses the inflated chamber 110 with the compressible material 112, triggering the release of that pressure through the release valve 138. The fluid continues to escape until the fluid pressure within the inflatable chamber 110 reaches atmospheric pressure. When the sphincter compression pressure weakens or the patient moves, the recovery of the compressible material 112 causes the inflatable chamber 110 to expand, generating 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 flows into the chamber 110. The release valve 138 and check valve 136 are self-regulating and maintain a pressure balance between the inflatable chamber 110 and the surrounding sphincter. The pressure on the sphincter tissue surrounding the compressible material 104 having elongated tubular elements 112 may be determined by the spring constant and / or size of the compressible material 112 within the chamber 110. In some embodiments, the first passage 114 in the FMS 100 has a vent, and the process of reaching equilibrium involves 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 an inflatable balloon 102. In some embodiments, the first passage 114 is connected to a passage 126 designed to manage pressure control by an inflatable balloon 102 further having a compressible material 106.

[0035] In a FMS having a compressible material 112 within an inflatable chamber 110 of an elongated tubular element 104, the pressure on the sphincter tissue is determined by the spring constant and / or size of the compressible material 112 within the inflatable chamber 110. If the inflatable chamber 110 is overinflated, the pressure between the inflatable chamber 110 and the tissue becomes higher than the spring constant for which the compressible material 112 is designed to withstand. In such a case, the inflatable chamber 110 is compressed, and pressure is exerted on the fluid within the inflatable chamber 110. As a result, the fluid from the inflatable chamber 110 flows outward through a second passage, releasing the pressure. If the second passage and / or the first passage has a vent, the vent restricts the fluid flow, so the pressure slowly decreases by the sphincter tissue and muscle. The fluid continues to escape until the fluid pressure within the inflatable chamber 110 reaches atmospheric pressure.

[0036] If the inflatable chamber 110 is not sufficiently inflated and the expansion pressure generated by the compressible material 112 is greater than the resistance of the sphincter tissue, the fluid will be drawn in through the first and / or second passages. As a result, the compressible material 112 tends to inflate the inflatable chamber 110 to its expanded shape, or until the resistance of the tissue matches the elastic modulus of the compressible material 112. If vents are present, the fluid inflow velocity may also be limited.

[0037] An exemplary system 100 may further include a pressure control device, which includes a valve assembly in fluid communication with the chamber 110, and this pressure control device generally includes maintaining the pressure in the chamber within a selected pressure range having a minimum pressure and a maximum pressure. In a particular embodiment, the minimum pressure is from atmospheric pressure to a pressure about 15 mmHg below atmospheric pressure. In a particular embodiment, the minimum pressure is from a pressure 8 mmHg below atmospheric pressure to a pressure 12 mmHg below atmospheric pressure. In a particular embodiment, the minimum pressure is from atmospheric pressure to a pressure about 10 mmHg below atmospheric pressure. In a particular embodiment, the maximum pressure is about 30 mmHg above or below atmospheric pressure. In a particular embodiment, the maximum pressure is about 20 mmHg above or below atmospheric pressure. In a particular embodiment, the maximum pressure is about 10 mmHg above or below atmospheric pressure. In a particular embodiment, the maximum pressure is 4–6 mmHg above atmospheric pressure. In certain embodiments, the pressure control means may include maintaining the pressure inside the chamber 110 within a range from 10 mmHg below atmospheric pressure to 20 mmHg above atmospheric pressure. In certain embodiments, the pressure control means may include maintaining the pressure inside the chamber 110 within a range from 10 mmHg below atmospheric pressure to 10 mmHg above atmospheric pressure. In certain embodiments, the pressure control means may include maintaining the pressure inside the chamber 110 within a range from 10 mmHg below atmospheric pressure to 5 mmHg above atmospheric pressure. The external pressure is the sum of the chamber internal pressure described above and the expansion force exerted on the chamber 110 by the elastic foam 112, and may be about 10 mmHg or less, based on the type of foam selected according to Table 1. Accordingly, at least some embodiments of the present disclosure enable the maximum cuff pressure in contact with the anal sphincter to be at least 30 mmHg above atmospheric pressure, preferably at least 20 mmHg above atmospheric pressure, and more preferably at least 10 mmHg above atmospheric pressure.

[0038] Those skilled in the art will readily understand that the pressure range maintained within the chamber 110 depends at least in part on the cracking pressure selected for the check valve 136, and will readily be able to select a check valve having an appropriate cracking pressure to maintain a desired pressure range within the chamber 110. For example, in an embodiment where the minimum selected pressure within the chamber 110 is about 10 mmHg lower than atmospheric pressure, the inlet check valve 136 may be selected with a cracking pressure of about 10 mmHg (e.g., 10 mmHg ± 2 mmHg). Similarly, in an embodiment where the maximum selected pressure within the chamber 110 is about 20 mmHg higher than atmospheric pressure, the outlet check valve 138 may be selected with a cracking pressure of about 20 mmHg (e.g., 20 mmHg ± 4 mmHg) or less. Certain embodiments may utilize an open vent to allow for rapid equilibrium to atmospheric pressure.

[0039] A particular embodiment of the present application relates 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, wherein the elongated tubular member comprises an outer tube, a non-foldable 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-foldable inner tube is corrugated along at least a portion of its length.

[0041] In certain embodiments, the non-foldable inner tube has alternating thick-walled and thin-walled sections.

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

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

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

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

[0046] In certain embodiments, the non-foldable 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 has at least one of open-cell foam or polyurethane.

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

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

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

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

[0052] In certain embodiments, when the compressible material is not compressed, its thickness is less than approximately 4 mm, less than approximately 3 mm, or less than approximately 2 mm.

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

[0054] In certain embodiments, the device further comprises a second compressible material placed inside 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 to return from the compressed state to an expanded state in response to the removal of pressure, thereby causing the balloon to expand.

[0056] In certain embodiments, the apparatus further includes a valve assembly that is in fluid communication with the chamber, the valve assembly having at least one pressure-regulating check valve.

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

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

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

[0060] A particular embodiment of this application relates to a fecal catheter having the device.

[0061] A particular embodiment of the present application relates to a device comprising an elongated tubular member having a proximal end and a distal end opposite to the proximal end; an inflatable balloon surrounding the distal end; a first chamber formed in either the elongated tubular member or the balloon; a first compressible material housed in the first chamber; and a valve assembly fluidly communicating with the first chamber, wherein the valve assembly has at least one pressure-regulating check valve.

[0062] In a particular embodiment, at least one pressure regulating check valve comprises a first check valve and a second check valve, the first check valve being 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 being 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, the first chamber is formed within an elongated tubular member.

[0064] In a particular embodiment, the elongated tubular member has an outer tube and an inner tube located inside the outer tube, and a first chamber is defined between the inner tube and the outer tube.

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

[0066] In certain embodiments, when the first compressible material is not compressed, its thickness is less than approximately 4 mm, less than approximately 3 mm, or less than approximately 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 apparatus further includes a second chamber formed in the other end of an elongated tubular member or balloon, and a second compressible material housed 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 to return from the compressed state to an expanded state in response to the release of pressure, thereby causing the first chamber to expand.

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

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

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

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

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

[0076] In certain embodiments, the first compressible material has a fast-recovering 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] A particular embodiment of this application relates to a fecal management system having the device.

[0079] A particular embodiment of this application relates to a method for inserting an elongated tubular member into a body cavity having soft tissue. The elongated tubular member comprises an outer tube, a non-foldable inner tube positioned within the outer tube, and a first compressible material positioned between the inner tube and the non-foldable inner tube.

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

[0081] In certain embodiments, inflating the balloon involves inflating a second compressible material located within the balloon's cavity.

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

[0083] In certain embodiments, expanding the first compressible material involves introducing a fluid into a chamber containing the first compressible material.

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

[0085] In certain embodiments, the method further comprises selectively flowing fluid to the first compressible material through a check valve connected to the first compressible material and the fluid during the expansion of the first compressible material, thereby facilitating the 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 through a check valve fluid-communicated with the first compressible material, thereby facilitating the compression of the first compressible material.

[0087] In a particular embodiment, the check valve is further in fluid communication with a fluid source, and selectively flowing fluid to a first compressible material means that the fluid is flowed to the first compressible material only when the differential pressure between the first compressible material and the fluid source exceeds the cracking pressure of the check valve.

[0088] In certain embodiments, the fluid source is the atmosphere.

[0089] In certain embodiments, the cracking pressure is in the range of 10 mmHg to 25 mmHg.

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

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

[0092] In certain embodiments, the method further comprises guiding waste from the cavity to a waste collection device connected to the proximal end of an elongated tubular member via a non-foldable inner tube.

[0093] A particular embodiment relating to the present application relates to a device comprising an elongated tubular member having a proximal end and a distal end opposite to it, a chamber formed in the elongated tubular member, a compressible material housed in the chamber, and a valve assembly fluidly communicating with the chamber, the valve assembly having at least one pressure-regulating check valve.

[0094] In certain embodiments, at least one pressure regulating check valve comprises a first check valve and a second check valve, the first check valve configured to allow fluid to flow out of the chamber when the chamber and compressible material are compressed, and the second check valve configured to allow fluid to flow into the chamber when the chamber and compressible material are expanded.

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

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

[0097] In certain embodiments, when the compressible material is not compressed, its thickness is less than approximately 4 mm, less than approximately 3 mm, or less than approximately 2 mm.

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

[0099] In certain embodiments, a compressible material is configured to move from an expanded state to a compressed state in response to a compressive pressure, and to return from the compressed state to an expanded state in response to the removal of the pressure, thereby causing expansion.

[0100] In certain embodiments, the check valve is configured such that fluid flows from the fluid source into the chamber when the differential pressure between the chamber and the liquid source exceeds the cracking pressure of the check valve.

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

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

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

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

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

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

[0107] A particular embodiment of this application relates to a fecal catheter having 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 only as examples. Those skilled in the art will see that numerous modifications, alterations, and substitutions are possible without departing from the present invention. It should be understood that various alternatives to the embodiments of the present invention described herein may be used in carrying out the present invention. The following claims define the scope of the present invention, and methods and structures within the scope of these claims and their equivalents are intended to be covered thereby.

Claims

1. A long, slender tubular member having a proximal end and a distal end that can be inserted into the patient's rectum on the opposite side, It has an inflatable balloon surrounding the distal end, The aforementioned elongated tubular member comprises an outer tube and a non-foldable inner tube disposed within the outer tube. It has a compressible material disposed between the outer tube and the inner tube, The non-foldable inner tube comprises at least one of alternating thick-walled and thin-walled sections, a helical element, or the non-foldable inner tube is corrugated along at least a portion of its length. A fecal management system equipped with a device having the following features.

2. The non-foldable 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 according to claim 1.

3. The helical element has a wire, or the helical element is integrally formed with the non-foldable inner tube. The fecal management system according to claim 1.

4. The non-foldable inner tube has a durometer of Shore A 80 or less, Shore A 70 or less, or Shore A 60 or less. The fecal management system according to claim 1.

5. The compressible material has at least one of open-cell foam or polyurethane. The fecal management system according to claim 1.

6. (a) The compressive load at 40% deflection of the compressible material is approximately 2 kPa to approximately 15 kPa, or approximately 2 kPa to approximately 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 according to claim 1.

7. (a) The compressible material has a fast-recovering 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 of about 50 kPa to about 200 kPa, or preferably about 100 kPa to 150 kPa, in a dry state. The fecal management system according to claim 1.

8. (a) The compressible material, when not compressed, has a thickness of less than approximately 4 mm, less than approximately 3 mm, or less than approximately 2 mm, 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, (c) The compressible material is located in a chamber defined between the outer tube and the inner tube. The fecal management system according to claim 1.

9. The balloon further comprises a second compressible material placed inside the balloon, The second compressible material is configured to move from an expanded state to a compressed state in response to the pressure applied to compress the balloon. The second compressible material is configured to return from a compressed state to an expanded state in response to the release of pressure, thereby causing the balloon to expand. The fecal management system according to claim 1.

10. It further comprises a valve assembly that is in fluid communication with the chamber, The valve assembly has at least one pressure regulating check valve. The fecal management system according to claim 1.

11. The check valve has at least one of the following: a duckbill valve, an umbrella valve, a disc valve, a diaphragm valve, or an open vent. Fecal management system according to claim 10.

12. The valve assembly includes a first check valve that can be operated to allow fluid to flow out of the chamber when the chamber and the compressible material are compressed, and a second check valve that can be operated to allow fluid to flow into the chamber when the chamber and the compressible material are expanded. Fecal management system according to claim 10.

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