Non-collapsible catheter

Abstract

Devices according to some embodiments generally include an elongate tubular member having a proximal end and an opposing distal end, and an inflatable balloon surrounding the distal end. The elongate tubular member includes an outer tube, a non-collapsible inner tube located inside the outer tube, and a compressible material located between the outer tube and the inner tube.

Description

[0001] Cross-references to related applications

[0002] 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 which are incorporated herein by reference in their entirety. Background Technology

[0003] Indwelling fecal handling catheters are used to collect and contain liquid or semi-liquid fecal matter from patients in non-mobile hospitals to prevent skin contamination by corrosive effluents, reduce the risk of contamination with potentially infectious materials, and minimize bedding contamination. Fecal handling catheters typically consist of an inflatable balloon / puff that anchors the catheter in the rectum, and a tube that transports fecal matter out of the patient's rectum. Summary of the Invention

[0004] To reduce the force exerted on the sphincter during fecal handling, most indwelling fecal catheters are collapsible, which can create a leakage path of fecal matter around the catheter in the patient's perianal area. Some embodiments of this disclosure relate to a catheter that can apply minimal pressure to the sphincter while allowing efficient removal of fecal matter and reducing or eliminating leakage around the catheter. In some embodiments, the catheter includes a material that compresses to reduce excessive pressure on surrounding tissues and accommodates patient movement. In some embodiments, the catheter includes a flexible but non-collapsible body that is compressible and has reduced pressure applied to the sphincter tissue. This contrasts with other catheter designs that include collapsible catheters (i.e., flexible and collapsible) or fixed-volume air bags, which generate high pressure that can potentially damage the sphincter in contact with the catheter. Conventional fecal catheters employ collapsible catheters as described in US 8,016,816 B2 and EP 2,278,945 B1, while US 8,939,952 and WO2007118621 A1 disclose airbags consisting of two bladders to provide an improved seal against rectal tissue. The latter design, using a closed airbag, has the disadvantage of increased pressure due to the airbag's closed system during bowel movements, patient movement, or when the patient is sitting. Attached Figure Description

[0005] Figure 1 This is a cross-sectional view of an exemplary fecal treatment system with a flexible but non-foldable corrugated pipe.

[0006] Figure 2 This is a cross-sectional view of an exemplary fecal treatment system having a flexible but non-foldable tube with thin and thick sections.

[0007] Figure 3 This is a cross-sectional view of an exemplary fecal treatment system with a flexible but non-foldable helical tube.

[0008] Figure 4 This is a cross-sectional view of an exemplary fecal treatment system with flexible but non-foldable thick-walled tubes.

[0009] Figure 5 A cross-sectional view of an additional chamber containing foldable material.

[0010] Figure 6 A T-shaped connector design is shown, with one connection to an exhaust port and a second connection to a one-way check valve that maintains a preferred pressure difference between the elongated tubular chamber and the atmosphere. Detailed Implementation

[0011] While the concept of this disclosure may have many variations and alternatives, specific embodiments have been shown by way of example in the accompanying drawings and will be described in detail herein. However, it should be understood that the concept of this disclosure is not intended to be limited to the specific forms disclosed, but rather, it is intended to cover all modifications, equivalents, and alternatives consistent with this disclosure and the appended claims.

[0012] The terms "an embodiment," "an embodiment," and "an illustrative embodiment" used in this specification indicate that the described embodiment may include specific features, structures, or characteristics; however, each embodiment may or may not include that specific feature, structure, or characteristic. Furthermore, these phrases do not necessarily refer to the same embodiment. It should be further understood that although the mention of a "preferred" component or feature may indicate that a particular component or feature is desirable for that embodiment, this disclosure does not so limit other embodiments, and such components or features may be omitted in other embodiments. Moreover, when a specific feature, structure, or characteristic is described in connection with an embodiment, it means that implementing such a feature, structure, or characteristic in conjunction with other embodiments is within the knowledge of those skilled in the art, regardless of whether it is explicitly described.

[0013] Furthermore, it should be understood that items included in the list in the form of "at least one of A, B, and C" can represent (A); (B); (C); (A and B); (B and C); (A and C); or (A, B, and C). Similarly, items listed in the form of "at least one of A, B, or C" can refer to (A); (B); (C); (A and B); (B and C); (A and C); or (A, B, and C). Items listed in the form of "A, B, and / or C" can also refer to (A); (B); (C); (A and B); (B and C); (A and C); or (A, B, and C). Furthermore, regarding the claims, the use of words and phrases such as “a,” “at least one,” and / or “at least a portion” should not be construed as limited to a single such element unless specifically stated otherwise, and the use of phrases such as “at least a portion” and / or “a portion” should be construed as encompassing both embodiments that include only a portion of the element and embodiments that include the entire element, unless specifically stated otherwise.

[0014] The term "approximately" may be used in this document to modify certain quantitative measurements. In various forms, the term "approximately" can indicate that the expressed values ​​can differ by as much as 10%, 5%, or 1%. Thus, an indication of a pressure of "approximately 100 kPa" could mean a pressure between 90 and 110 kPa, between 95 and 105 kPa, or between 99 and 101 kPa.

[0015] In the accompanying 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 may not be necessary. Rather, in some embodiments, these features may be arranged in a different manner and / or order than shown in the illustrative drawings, unless otherwise indicated. Furthermore, the inclusion of a structural or methodological feature in a particular drawing does not imply that such a feature is necessary in all embodiments, and in some embodiments, it may be omitted or combined with other features.

[0016] In one aspect of this disclosure, a medical device is provided, comprising an elongated tubular element for medical waste disposal. The medical device may be part of a fecal treatment system (FMS), wherein the tubular element is designed to minimize or eliminate leakage of fecal matter around the fecal treatment system. In some embodiments, the medical device includes a compressible material located within the tubular element, which conforms to tissue when a sphincter applies force to the tubular element. Figure 1 An exemplary medical device implemented as a fecal treatment system is shown.

[0017] An exemplary fecal treatment system 100 includes a conduit 101 comprising an elongated tubular element 104 having a distal end 150 and a proximal end 152, and an inflatable bladder 102 surrounding the distal end 150. The main conduit 104 is connected to an inner tube 122 via each of a distal adapter 118 and a proximal adapter 120. In the illustrated embodiment, the inflatable bladder 102 can be inflated with a fluid such as air or a liquid (e.g., saline solution), for example by connecting an inflatable inner lumen to a port 124 of the chamber of the main conduit 104 and the bladder 102. In some embodiments, the inflatable bladder 102 may contain a compressible material 106. A flushing passage 128, a bladder inflation / deflation passage 126, and a pressure management passage 114 leading to the elongated chamber 110 of the conduit are formed within the elongated chamber 110.

[0018] In the illustrated form, the device is a conduit 101 of the fecal treatment system 100. It is also conceivable that the conduit 101 could be used for other purposes, such as as a Foley catheter (urinary catheter), or as another form of conduit. Furthermore, it is conceivable that the elongated tubular element 104 described herein could be used in other areas of the body, such as forming the airway for a breathing apparatus.

[0019] In the illustrated form, the distal portion of an elongated tubular element 104 can be inserted into the rectum of a subject to collect bodily waste flowing from the distal portion to the proximal portion through an exit channel 116 within the elongated tubular element 104. When the distal portion is inserted into the rectum, an inflatable sac 102 can engage with in vivo tissue to retain the distal portion within the rectum and provide a seal for transferring bodily waste through the exit channel 116. In some embodiments, such as those where the device is used as a catheter, the proximal end 152 of the catheter 101 can be connected to a waste collection device (e.g., a bag or other container) to receive waste. In other embodiments, such as those where the device is intended to be used as an airway passage, the proximal end 152 can be connected to an air source.

[0020] In some embodiments, the elongated tubular element 104 is non-foldable / unfoldable, allowing fluid to pass through the discharge channel 116 without complete blockage. For example, the non-foldable elongated tubular element 104 may be reinforced with wire. In some embodiments, the non-foldable tubular element 104 includes a helical insert to prevent the tube from folding. In some embodiments, the elongated tubular element 104 further includes a non-foldable tubular element 122. In some embodiments, the non-foldable tubular element 122 includes a non-foldable thick-walled tube. The wall thickness may be between 0.8 mm and 4 mm, or preferably between 1.0 mm and 2.5 mm. In some embodiments, the non-foldable tubular element 122 includes a bellows, such as... Figure 1As shown. In some embodiments, the non-foldable tubular element 122 comprises a shaped extruded tube consisting of alternating thin and thick segments, such as... Figure 2 As shown. In some embodiments, the non-foldable tubular element 122 includes a reinforcing helix or wire, such as... Figure 3 As shown. In some embodiments, the non-foldable tubular element 122 comprises a thin-walled tube co-extruded with a reinforcing auger, such as... Figure 3 As shown. In some embodiments, the non-foldable tubular element 122 includes thick walls, such as... Figure 4 As shown.

[0021] The material of the elongated tubular element 104 may have a Shore A hardness of 80 (ASTM D2240) or lower, or preferably not exceeding Shore A 70, or most preferably not exceeding Shore A 60. The elongated tubular element 104 may have a wall thickness of approximately 0.5 mm to approximately 3 mm, or preferably between 0.5 mm and 1 mm. In some embodiments, the non-foldable tubular element 122 includes a reinforcing helix, such as... Figure 3 As shown. The spiral component can be the same material as the tube, or it can be a different material with a higher hardness. In some embodiments, the non-foldable tubular element 122 includes a bellows. In some embodiments, the hardness of the non-foldable tube 122 is not greater than 80 Shore A (ASTM D2240), or preferably less than 70 Shore A, or more preferably not greater than 60 Shore A. In some embodiments, the hardness of the elongated tubular element 104, including the non-foldable tube 122 and the compressible material 112, is not greater than 80 Shore A (ASTM D2240), or preferably less than 70 Shore A, or more preferably not greater than 60 Shore A.

[0022] The elongated tubular element 104 also includes a compressible material 112 that conforms to the tissue when the sphincter muscle applies force to the elongated tubular element 104. In some cases, the compressible material 112 comprises the same material having the same properties as the compressible material 106 within the inflatable sac 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 within the inflatable sac 102. Non-limiting examples of materials suitable for use as compressible material 112 and / or compressible material 106 include porous foam and polyurethane.

[0023] In some embodiments, the density (ISO 845) of compressible material 106 and / or compressible material 112 is from about 20 kg / m³ to about 60 kg / m³, or preferably from about 20 kg / m³ to about 30 kg / m³. In some embodiments, compressible material 106 and / or compressible material 112 has a compressive load deflection of 40% (ISO 3386-1) under a compressive load of about 2 kPa to about 15 kPa, or preferably 2 kPa to 5 kPa. In some embodiments, the dry tensile strength (ISO 1798) of compressible material 106 and / or compressible material 112 is from about 50 kPa to about 200 kPa, or preferably from about 100 kPa to about 150 kPa. In some embodiments, the nominal hardness (hardness tester, 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-rebound foam configured to expand to 90% of its initial volume within 10 seconds, or preferably within 5 seconds. In some embodiments, compressible material 106 and / or compressible material 112 is a memory foam that retains its compressed shape.

[0024] In some embodiments, when the compressible material 112 is not compressed, the thickness of the compressible material 112 is less than about 8 mm, less than about 5 mm, or less than about 2 mm. In some embodiments, when the compressible material 112 is at least about 90% fully compressed, the thickness of the compressible material 112 is less than about 4 mm, less than about 2 mm, or less than about 1 mm.

[0025] Compressible material 112 is located inside the elongated tubular element 104. In some embodiments, compressible material 112 is located within an internal chamber 132. As a non-limiting example, chamber 110 may include a tube adjacent to the interior of the elongated tubular element 104. As another example, one or more chambers 132 may be located inside the elongated tubular element including the compressible material 112. Figure 5 As shown, chamber 110 may be part of the interior of elongated tubular element 104, or it may be a separate structure. In some embodiments, chamber 110 may be defined by the interior of outer tube 104 and the exterior of inner tube 122. In some embodiments, chamber 110 is composed of polyurethane. In some embodiments, chamber 110 is composed of silicone resin. In some embodiments, chamber 110 is composed of thermoplastic elastomer.

[0026] The fecal treatment system 100 also includes a first pressure control channel 114, which connects chamber 110 to the atmosphere via a check valve 138 and a drain valve system 136. The check valve system 136 is designed to allow rapid fluid inflow into chamber 110 when the force acting on chamber 110 is suddenly removed. The check valve 138 is used to release pressure when pressure increases due to bowel movements or patient movement. The first channel 114 can achieve pressure balance between chamber 110 and the atmosphere via the check valve 138. When the pressure within chamber 110 is higher than atmospheric pressure, the process of achieving balance can involve the flow of fluid (e.g., air, liquid) from chamber 110 through the first channel 114 to the check valve 138 and then to the atmosphere. For the fecal treatment system, the pressure on the sphincter tissue can be determined by the elastic modulus and dimensions of the compressible material 112 within chamber 110.

[0027] If chamber 110 is overfilled (e.g., a sphincter is compressed with a large force), the pressure exceeds the selected elastic modulus, and the compressible material 112 is squeezed, causing fluid to flow out under pressure through release valve 138. If chamber 110 is underfilled (e.g., due to the sudden removal of the force acting on chamber 110), and the expansion force of the compressible material 112 is greater than the tissue resistance, fluid will flow into chamber 110 through release valve 138 and / or check valve 136, and the compressible material 112 will expand to a specified size or until the tissue resistance matches the elastic modulus. In some embodiments, the flow rate is proportional to the pressure gradient, such that a large overpressure in chamber 110 causes fluid to be released into the atmosphere faster than a small overpressure.

[0028] In some embodiments, the first channel 114 includes an vent, such as a release valve 138, which facilitates fluid outflow from chamber 110 in the event of a sudden folding of the tube due to pressure generated by coughing, intestinal peristalsis, or patient movement. In some embodiments, the vent comprises a microporous material. In some embodiments, the vent comprises sintered polytetrafluoroethylene (PTFE). In a non-limiting example, the vent comprises Porex PM0530. In some embodiments, the vent comprises expanded polytetrafluoroethylene (manufactured by Gore) having an average pore size of approximately 200 micrometers to approximately 500 micrometers. The purpose of the vent is to allow air to flow out rapidly, for example, at least 0.5 L / h / cm² to 50 L / h / cm² at a pressure gradient of 70 mbar, preferably 1 L / h / cm² to 5 L / h / cm² at a pressure gradient of 70 mbar. Additional exemplary vents, partially permeable plugs, films, or other materials include polytetrafluoroethylene, silicone rubber, and dense polyurethane foam. In some embodiments, the vent is a small hole or a series of holes leading to the atmosphere.

[0029] In some embodiments, the first channel 114 is connected to a pressure indicator capable of indicating a pressure in the range of 5 mmHg to 100 mmHg, or preferably in the range of 10 mmHg to 50 mmHg. The pressure indicator may be a pressure gauge or a mechanical device to indicate the appropriate pressure in the tubular chamber 110. The pressure indicator may be connected to channel 114 via a valve 136 at the proximal end of the device. In some embodiments, valve 136 is provided as a check valve.

[0030] In some embodiments, the fecal treatment system includes a second channel in fluid communication with the expandable chamber 110. In some cases, the rate at which fluid flows into the expandable chamber 110 through the second channel is at least about 2, 3, 4, 5, or 10 times the rate at which fluid flows out of the expandable chamber 110 through the second channel. The faster rate of entry into the inflatable chamber 110 allows for rapid filling due to intestinal motility or patient movement. In some embodiments, the flow rate out of the inflatable chamber 110 is up to about 2 ml to about 15 ml per minute. In some embodiments, the flow rate into the inflatable 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 in the fecal treatment system, the expandable 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. For the expandable chamber 110 in the fecal treatment system, the expandable chamber can be degassed 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 5 minutes, about 6 minutes, about 7 minutes, about 8 minutes, about 9 minutes, or about 10 minutes.

[0031] In some embodiments, the fecal treatment system 100 includes a third channel 126 that connects the expandable bladder 102 to the expandable chamber 110 and then to the same valve 134 for inflating / deflating the bladder 102 and the expandable chamber 110. Pressure management of the bladder 120 via channel 126 can be combined with pressure management of the expandable chamber 110 via channel 114. In some embodiments, such as Figure 6 As shown, additional connectors can be used to control the pressure at the expandable chamber 110 or the expandable bladder 102. Check valve 136 is used to drain fluid from the expandable chamber 110. Similarly, valve 134 is used to drain fluid from the expandable bladder 102. Once the expandable chamber 110 and the expandable bladder 102 are deflated, the folded retaining bladder can be inserted into the rectum. Once the device is in place, T-connector 148 ( Figure 6 It can be connected to valve system 136 or valve system 134 via connector 144.

[0032] The check valve 136 can be configured as a one-way valve, allowing air to flow in rapidly in one direction but preventing air from flowing out in the opposite direction. The release valve 138 is an exhaust port that allows fluid (e.g., air) to be released. In some embodiments, the opening pressure of the one-way check valve can be selected to be 30 mmHg to 35 mmHg, or preferably 15 mmHg to 20 mmHg, or most preferably 5 mmHg to 10 mmHg. The opening pressure will determine the pressure level of the expandable chamber 110 or the holding bladder 102. In other words, once the T-connector 148 is connected to valve system 136 or valve system 134 via connector 144, the pressure at the expandable chamber 110 or the expandable bladder 102 cannot exceed the opening pressure of the one-way check valve 142.

[0033] In an exemplary method of use, the fecal treatment system 100 is prepared for insertion into the rectum by drawing fluid from the expandable sac 102 and the expandable chamber 110 via, for example, a syringe through valve 134 and channels 126 and 114, respectively. Fluid can be drawn directly from the expandable chamber 110. The extraction of fluid creates a negative pressure in the expandable chamber 110 relative to the external atmosphere, and the ambient atmospheric pressure causes the expandable chamber 110, as well as any compressible material 112 that may be present within it, to collapse. Once the sac 102 is fully deflated, the distal portion of the expandable sac 102 and a portion of the elongated tubular member 104 including the expandable chamber 110 are inserted into the rectum, for example using a finger pouch located between the portion of the expandable sac 102 and the elongated tubular member 104. Once inserted, fluid is re-injected to allow the expandable sac 102 and the expandable chamber 110 to expand. While the inflatable sac 102 provides an anchoring device for holding the catheter in place, the inflatable chamber in the elongated tubular element allows for an effective seal against the sphincter tissue, thereby preventing leakage in the perianal area. The fluid can be air or liquid. The fluid flowing to the inflatable sac 102 and the inflatable chamber 110 can be the same or different. In an exemplary embodiment, the fluid is air.

[0034] If the expandable chamber 110 contains compressible material 112, the expandable chamber 110 can remain expanded under the action of compressible material 106. Injected fluid allows the atmospheric fluid pressure in the expandable chamber 110 to be restored, enabling the compressible material 112 to depressurize. In some cases, re-injection of the same amount of fluid as removed for insertion may create a slight positive fluid pressure within the expandable chamber 110. However, this positive pressure may gradually decrease as excess fluid slowly escapes to restore atmospheric fluid pressure balance. Temporary positive pressure during bowel movement or patient movement helps to remove sphincter tissue or feces to achieve a proper seal. In an exemplary method of use, a T-connector 148 including a one-way check valve 142 and a release valve 146 can be coupled to valve system 136 or valve system 134 to maintain the system pressure set by the opening pressure of the one-way check valve 142 or the release valve 146. In another exemplary method of use, the vent is connected to the expandable chamber 110 via a channel 114 to allow for rapid adjustment of the pressure in the tubular chamber 110, thereby creating an effective seal relative to the sphincter tissue.

[0035] Once the inflatable sac 102 and a portion of the elongated tubular member 104 (including the inflatable chamber 110) are inserted into the rectum, the non-foldable nature of the elongated tubular member 104 (including the inflatable chamber 110 and the compressible material 112) allows for the expulsion of fecal matter while reducing or preventing leakage around the elongated tubular member 104. This is achieved by achieving pressure balance between the chamber 110 and the atmosphere via the first channel 114. The inflatable chamber 110 and the compressible material 112 within the elongated tubular member 104 are designed to balance the sphincter's compressive forces. For example, when the sphincter pressure is higher than the pressure in the inflatable chamber 110, positive pressure compresses the inflatable chamber 110 containing the compressible material 112, which then triggers pressure release through the release valve 138. Fluid continues to escape until the fluid pressure in the inflatable chamber 110 reaches atmospheric pressure. As the sphincter's compressive pressure decreases or when the patient moves, the inflatable chamber 110 expands due to the recovery of the compressible material 112, creating negative gauge pressure. When the negative gauge pressure exceeds the opening pressure of check valve 136, check valve 136 opens, allowing fluid to flow into chamber 110. Relief valve 138 and check valve 136 are self-regulating and maintain pressure balance between the expandable chamber 110 and the surrounding sphincter tissue. The pressure on the sphincter tissue surrounding the elongated tubular element 104, which includes compressible material 112, can be determined by the elastic modulus and / or size of the compressible material 112 within chamber 110. In some embodiments, a first channel 114 in the fecal treatment system 100 includes a vent, and the process of achieving balance involves fluid flow through the vent. In some embodiments, the first channel 114 is connected to a channel 126, which is designed to manage pressure control via an expandable bladder 102. In some embodiments, the first channel 114 is connected to a channel 126, which is designed to manage pressure control via an expandable bladder 102, which also includes compressible material 106.

[0036] For a fecal treatment system having a compressible material 112 within an expandable chamber 110 of an elongated tubular element 104, the pressure on the sphincter tissue is determined by the elastic modulus and / or dimensions of the compressible material 112 within the expandable chamber 110. If the expandable chamber 110 over-expands, the pressure applied between the expandable chamber 110 and the tissue exceeds the elastic modulus that the compressible material 112 is designed to withstand. In this case, the expandable chamber 110 is compressed, and the fluid within the expandable chamber 110 is under pressure. As a result, the fluid from the expandable chamber 110 flows outward through a second channel to release the pressure. When the second channel and / or the first channel includes an vent, the vent restricts fluid flow, causing the pressure to decrease slowly due to the sphincter tissue and muscle. Fluid continues to escape until the fluid pressure in the expandable chamber 110 reaches atmospheric pressure.

[0037] If the expandable chamber 110 is underinflated and the expansion pressure generated by the compressible material 112 exceeds the resistance of the sphincter tissue, fluid will be drawn out through the first and / or second channels. As a result, the compressible material 112 will tend to expand the expandable chamber 110 to an expanded state, or until the tissue resistance matches the modulus of the compressible material 112. If present, an vent can also limit the rate of fluid inflow.

[0038] Example system 100 may also include a pressure management device comprising a valve assembly in fluid communication with chamber 110, typically involved in maintaining pressure within the chamber within a selected pressure range having a minimum pressure and a maximum pressure. In some embodiments, the minimum pressure is between atmospheric pressure and about 15 mmHg below atmospheric pressure. In some embodiments, the minimum pressure is between 8 mmHg and 12 mmHg below atmospheric pressure. In some embodiments, the minimum pressure is between atmospheric pressure and about 10 mmHg below atmospheric pressure. In some embodiments, the maximum pressure is about 30 mmHg or less above atmospheric pressure. In some embodiments, the maximum pressure is about 20 mmHg or less above atmospheric pressure. In some embodiments, the maximum pressure is about 10 mmHg or less above atmospheric pressure. In some embodiments, the maximum pressure is 4-6 mmHg or more above atmospheric pressure. In some embodiments, the pressure management device may involve maintaining pressure within chamber 110 within a range from 10 mmHg below atmospheric pressure to 20 mmHg above atmospheric pressure. In some embodiments, the pressure management device may involve maintaining the pressure within chamber 110 in the range of 10 mmHg below atmospheric pressure to 10 mmHg above atmospheric pressure. In some embodiments, the pressure management device may involve maintaining the pressure within chamber 110 in the range of 10 mmHg below atmospheric pressure to 5 mmHg above atmospheric pressure. The external pressure is the sum of the aforementioned internal chamber pressure and the expansion force exerted on chamber 110 by the elastic foam 112, and based on the foam type selected according to Table 1, the external pressure may be approximately 10 mmHg or less. Therefore, at least some embodiments of this disclosure allow a maximum airbag pressure in contact with the anal sphincter to be a maximum pressure of approximately 30 mmHg above atmospheric pressure or less, or preferably, a maximum pressure of approximately 20 mmHg above atmospheric pressure or less, or more preferably, a maximum pressure of approximately 10 mmHg above atmospheric pressure or less.

[0039] Those skilled in the art will readily understand that the pressure range maintained within chamber 110 depends at least in part on the opening pressure of check valve 136, and that a check valve with an appropriate opening pressure can be readily selected to maintain the desired pressure range within chamber 110. For example, in an embodiment where the minimum pressure within chamber 110 is selected to be approximately 10 mmHg below atmospheric pressure, inlet check valve 136 can be selected to have an opening pressure of approximately 10 mmHg (e.g., 10 mmHg ± 2 mmHg). Similarly, in an embodiment where the maximum pressure within chamber 110 is selected to be approximately 20 mmHg above atmospheric pressure, release check valve 138 can be selected to have an opening pressure of approximately 20 mmHg (e.g., 20 mmHg ± 4 mmHg) or less. Some embodiments may utilize an open vent to allow for rapid equalization of atmospheric pressure.

[0040] Some embodiments of this application relate to an apparatus comprising: an elongated tubular member having a proximal end and a relatively distal end; and an inflatable bladder surrounding the distal end; wherein the elongated tubular member comprises: an outer tube; a non-foldable inner tube disposed inside the outer tube; and a compressible material located between the outer tube and the inner tube.

[0041] In some embodiments, the non-foldable inner tube is corrugated along at least a portion of its length.

[0042] In some embodiments, the non-foldable inner tube includes alternating thick-walled and thin-walled portions.

[0043] In some embodiments, the wall thickness of the non-foldable inner tube is between 0.8 mm and 4 mm, or between 1.0 mm and 2.5 mm.

[0044] In some embodiments, the non-foldable inner tube includes a helical element.

[0045] In some embodiments, the helical element comprises a metal wire.

[0046] In some embodiments, the spiral element is integrally formed with the non-foldable inner tube.

[0047] In some embodiments, the hardness of the non-foldable inner tube does not exceed Shore A 80, Shore A 70, or Shore A 60.

[0048] In some embodiments, the compressible material includes at least one of porous foam or polyurethane.

[0049] In some embodiments, the compressible material has a compressive load deflection of 40% under a compressive load of about 2 kPa to about 15 kPa or about 2 kPa to about 5 kPa.

[0050] In some embodiments, the compressible material has a hardness of less than 50 Shore D and / or less than 100 Shore A.

[0051] In some embodiments, the compressible material comprises fast-rebound foam configured to expand to 90% of its initial volume within 10 seconds, or preferably within 5 seconds.

[0052] In some embodiments, the dry tensile strength of the compressible material is about 50 kPa to 200 kPa, or preferably about 100 kPa to 150 kPa.

[0053] In some embodiments, when the compressible material is not compressed, the thickness of the compressible material is less than about 4 mm, less than about 3 mm, or less than about 2 mm.

[0054] In some embodiments, when the compressible material is in a state of being fully compressed to at least about 90%, the thickness of the compressible material is less than about 2 mm, less than about 1.5 mm, or less than about 1 mm.

[0055] In some embodiments, the device further includes a second compressible material located within the capsule.

[0056] In some embodiments, the second compressible material is configured to move from an inflated state to a compressed state in response to pressure compressing the capsule; and wherein the second compressible material is configured to return from a compressed state to an inflated state in response to removal of pressure, thereby causing the capsule to inflate.

[0057] In some embodiments, the device further includes a valve assembly in fluid communication with the chamber, the valve assembly including at least one pressure-regulating check valve.

[0058] In some embodiments, the check valve includes at least one of a duckbill valve, an umbrella valve, a disc / plate valve, a diaphragm valve, or an open vent.

[0059] In some embodiments, the compressible material is disposed within a cavity defined between the outer tube and the inner tube.

[0060] In some embodiments, the device further includes a valve assembly in fluid communication with the chamber, the valve assembly including: 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.

[0061] Some embodiments of this application relate to a fecal conduit including the device.

[0062] Some embodiments of this application relate to an apparatus comprising: an elongated tubular member having a proximal end and a relatively distal end; an inflatable bladder surrounding the distal end; a first chamber formed in one of the elongated tubular member or the bladder; a first compressible material contained in the first chamber; and a valve assembly in fluid communication with the first chamber, the valve assembly including at least one pressure-regulating check valve.

[0063] In some embodiments, at least one pressure regulating check valve includes a first check valve and a second check valve; wherein the first check valve is configured to allow fluid to flow out of the first chamber during compression of the first chamber and the first compressible material; and wherein the second check valve is configured to allow fluid to flow into the first chamber during expansion of the first chamber and the first compressible material.

[0064] In some embodiments, the first chamber is formed within the elongated tubular member.

[0065] In some embodiments, the elongated tubular member includes an outer tube and an inner tube located inside the outer tube; and wherein the first chamber is defined between the inner tube and the outer tube.

[0066] In some embodiments, the inner tube is not foldable.

[0067] In some embodiments, when the first compressible material is not compressed, the thickness of the first compressible material is less than about 4 mm, less than about 3 mm, or less than about 2 mm.

[0068] In some embodiments, when the first compressible material is in a state of being fully compressed to at least about 90%, 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.

[0069] In some embodiments, the device further includes: a second chamber formed in one of the elongated tubular members or the capsule; and a second compressible material contained in the second chamber.

[0070] In some embodiments, the first chamber and the second chamber are in fluid communication with each other.

[0071] In some 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 wherein the first compressible material is configured to return from a compressed state to an expanded state in response to removal of pressure, thereby causing the first chamber to expand.

[0072] In some embodiments, the check valve is configured to allow fluid to flow from the fluid source into the first chamber in response to a pressure difference between the first chamber and the fluid source exceeding the check valve's opening pressure.

[0073] In some embodiments, the opening pressure is between 10 mmHg and 25 mmHg.

[0074] In some embodiments, the fluid source is at atmospheric pressure.

[0075] In some embodiments, the first compressible material has a compressive load deflection of 40% under a compressive load of about 2 kPa to about 15 kPa or about 2 kPa to about 5 kPa.

[0076] In some embodiments, the hardness of the first compressible material is less than 50 Shore (hardness) D and / or less than 100 Shore (hardness) A.

[0077] In some embodiments, the first compressible material comprises fast-rebound foam configured to expand to 90% of its initial volume within 10 seconds, or preferably within 5 seconds.

[0078] In some embodiments, the first compressible material has a dry tensile strength of about 50 kPa to about 200 kPa, or preferably about 100 kPa to about 150 kPa.

[0079] Some embodiments of this application relate to a fecal treatment system including the device.

[0080] Some embodiments of this application relate to a method comprising: inserting an elongated tubular member into a body cavity comprising soft tissue, wherein the elongated tubular member comprises an outer tube, a non-foldable inner tube disposed inside the outer tube, and a first compressible material located between the inner tube and the non-foldable inner tube.

[0081] In some embodiments, the method further includes inflating a bladder attached to the insertion end of the elongated tubular member to form a seal with the soft tissue.

[0082] In some embodiments, inflating the capsule includes expanding a second compressible material located within the capsule cavity.

[0083] In some embodiments, the method further includes expanding a first compressible material from a compressed state to an expanded state, thereby forming a seal between the outer tube and the soft tissue.

[0084] In some embodiments, expanding the first compressible material includes introducing fluid into a chamber containing the first compressible material.

[0085] In some embodiments, the body cavity is the rectal cavity.

[0086] In some embodiments, the method further includes: during the expansion of the first compressible material, selectively allowing fluid to flow into the first compressible material through a check valve in fluid communication with the first compressible material, thereby promoting the expansion of the first compressible material.

[0087] In some embodiments, the method further includes: during the compression of the first compressible material, allowing fluid to flow out of the first compressible material through a check valve in fluid communication with the first compressible material, thereby promoting the compression of the first compressible material.

[0088] In some embodiments, the check valve is further in fluid communication with a fluid source; and wherein selectively allowing fluid to flow into the first compressible material includes allowing fluid to flow into the first compressible material only when the pressure difference between the first compressible material and the fluid source exceeds the opening pressure of the check valve.

[0089] In some embodiments, the fluid source is the atmosphere.

[0090] In some embodiments, the opening pressure is in the range of 10 mmHg to 25 mmHg.

[0091] In some embodiments, the opening pressure is no greater than 25 mmHg.

[0092] In some embodiments, a first compressible material surrounds the non-foldable inner tube and is surrounded by the outer tube.

[0093] In some embodiments, the method further includes introducing waste from the cavity into a waste collection device connected to the proximal end of the elongated tubular member via a non-foldable inner tube.

[0094] Some embodiments of this application relate to an apparatus comprising: an elongated tubular member having a proximal end and a relatively distal end; a chamber formed in the elongated tubular member; a compressible material contained in the chamber; and a valve assembly in fluid communication with the chamber, the valve assembly including at least one pressure-regulating check valve.

[0095] In some embodiments, at least one pressure regulating check valve includes a first check valve and a second check valve; wherein the first check valve is configured to allow fluid to flow out of the chamber during compression of the chamber and the compressible material; and wherein the second check valve is configured to allow fluid to flow into the chamber during expansion of the chamber and the compressible material.

[0096] In some embodiments, the elongated tubular member includes an outer tube and an inner tube located inside the outer tube; and wherein the chamber is defined between the inner tube and the outer tube.

[0097] In some embodiments, the inner tube is not foldable.

[0098] In some embodiments, when the compressible material is not compressed, the thickness of the compressible material is less than about 4 mm, less than about 3 mm, or less than about 2 mm.

[0099] In some embodiments, when the compressible material is in a state of being fully compressed to at least about 90%, the thickness of the compressible material is less than about 2 mm, less than about 1.5 mm, or less than about 1 mm.

[0100] In some embodiments, the compressible material is configured to move from an expanded state to a compressed state in response to pressure compressing the chamber; and wherein the compressible material is configured to return from a compressed state to an expanded state in response to removal of pressure, thereby causing the chamber to expand.

[0101] In some embodiments, the check valve is configured to allow fluid to flow from the fluid source into the chamber in response to a pressure difference between the chamber and the fluid source exceeding the check valve's opening pressure.

[0102] In some embodiments, the opening pressure is between 10 mmHg and 25 mmHg.

[0103] In some embodiments, the fluid source is at atmospheric pressure.

[0104] In some embodiments, the compressible material has a compressive load deflection of 40% under a compressive load of about 2 kPa to about 15 kPa or about 2 kPa to about 5 kPa.

[0105] In some embodiments, the compressible material has a hardness of less than 50 Shore D and / or less than 100 Shore A.

[0106] In some embodiments, the compressible material comprises fast-rebound foam configured to expand to 90% of its initial volume within 10 seconds, or preferably within 5 seconds.

[0107] In some embodiments, the compressible material has a dry tensile strength of about 50 kPa to about 200 kPa, or preferably about 100 kPa to about 150 kPa.

[0108] Some embodiments of this application relate to a fecal conduit including the device.

[0109] While preferred embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that these embodiments are provided by way of example only. Many variations, modifications, and substitutions will occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in carrying out the invention. The following claims are intended to define the scope of the invention and thereby cover the methods and structures within the scope of these claims and their equivalents.

Claims

1. A fecal treatment system, the fecal treatment system comprising an apparatus, the apparatus comprising: An elongated tubular member having a proximal end and an opposing distal end, wherein the distal end is insertable into the patient's rectum; and An inflatable sac surrounding the distal end; The elongated tubular member includes: outer tube; A non-foldable inner tube housed inside the outer tube; and A compressible material placed between the outer and inner tubes.

2. The feces treatment system according to claim 1, wherein The non-foldable inner tube is corrugated along at least a portion of its length.

3. The feces treatment system according to claim 1, wherein The non-foldable inner tube comprises alternating thick-walled and thin-walled sections.

4. The feces treatment system according to claim 1, wherein The wall thickness of the non-foldable inner tube is between 0.8 mm and 4 mm.

5. The feces treatment system according to claim 1, wherein The wall thickness of the non-foldable inner tube is between 1.0 mm and 2.5 mm.

6. The feces treatment system according to claim 1, wherein The non-foldable inner tube includes a helical element, wherein the helical element comprises a metal wire or the helical element is integral with the non-foldable inner tube.

7. The feces treatment system according to claim 1, wherein The hardness of the non-foldable inner tube does not exceed 80 Shore A.

8. The feces treatment system according to claim 1, wherein, The hardness of the non-foldable inner tube does not exceed 70 Shore A hardness.

9. The feces treatment system according to claim 1, wherein, The hardness of the non-foldable inner tube does not exceed 60 Shore A hardness.

10. The feces treatment system according to claim 1, wherein, The compressible material includes at least one of porous foam or polyurethane.

11. The feces treatment system according to claim 1, wherein (a) The compressible material has a compressive load deflection of 40% under a compressive load of 2 kPa to 15 kPa; or (b) The hardness of the compressible material is less than 50 Shore D.

12. The fecal treatment system according to claim 1, wherein, The compressible material exhibits a compressive load deflection of 40% under a compressive load of 2 kPa to 5 kPa; or (b) The hardness of the compressible material is less than 100 Shore A.

13. The fecal treatment system according to claim 1, wherein, (a) The compressible material includes fast-rebound foam configured to expand to 90% of its initial volume within 10 seconds; or (b) The compressible material has a dry tensile strength of 50 kPa to 200 kPa.

14. The fecal treatment system according to claim 1, wherein, (a) The compressible material includes fast-rebound foam configured to expand to 90% of its initial volume within 5 seconds; or (b) The compressible material has a dry tensile strength of 100 kPa to 150 kPa.

15. The fecal treatment system according to claim 1, wherein, (a) When the compressible material is not compressed, the compressible material has a thickness of less than 4 mm; or (b) When the compressible material is in a state of at least 90% full compression, the compressible material has a thickness of less than 2 mm; or (c) The compressible material is disposed in a cavity defined between the outer tube and the inner tube.

16. The fecal treatment system according to claim 1, wherein, (a) When the compressible material is not compressed, the compressible material has a thickness of less than 3 mm; or (b) When the compressible material is in a state of at least 90% full compression, the compressible material has a thickness of less than 1.5 mm; or (c) The compressible material is disposed in a cavity defined between the outer tube and the inner tube.

17. The fecal treatment system according to claim 1, wherein, (a) When the compressible material is not compressed, the compressible material has a thickness of less than 2 mm; or (b) When the compressible material is in a state of at least 90% full compression, the compressible material has a thickness of less than 1 mm; or (c) The compressible material is disposed in a cavity defined between the outer tube and the inner tube.

18. The fecal treatment system according to claim 1, further comprising a second compressible material located within the capsule, in, The second compressible material is configured to move from an inflated state to a compressed state in response to the pressure that compresses the capsule; and The second compressible material is configured to return from a compressed state to an expanded state in response to the removal of pressure, thereby causing the capsule to expand.

19. The fecal treatment system of claim 1 further comprises a valve assembly in fluid communication with the chamber, the valve assembly including at least one pressure regulating check valve.

20. The fecal treatment system according to claim 19, wherein, The check valve includes at least one of a duckbill valve, an umbrella valve, a disc valve, a diaphragm valve, or an open vent.

21. The fecal treatment system according to claim 19, wherein, The valve assembly includes: A first check valve, operable to allow fluid to exit the chamber during compression of the compressible material; and A second check valve is operable to allow fluid to flow into the chamber during the expansion of the chamber and the compressible material.

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