CN116887791A

CN116887791A - Non-folding catheter

Info

Publication number: CN116887791A
Application number: CN202180092309.6A
Authority: CN
Inventors: M·L·蔡; P·泽连克维奇
Original assignee: Convatec Technologies Inc
Current assignee: Convatec Technologies Inc
Priority date: 2020-12-28
Filing date: 2021-12-28
Publication date: 2023-10-13

Abstract

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

Description

Non-folding catheter

Cross Reference to Related Applications

The present application claims the benefit of U.S. provisional patent application No. 63/186,546 filed 5/10 in 2021 and U.S. provisional patent application No. 63/131,154 filed 12/28 in 2020, both of which are incorporated herein by reference in their entirety.

Background

The indwelling fecal treatment catheter is used to collect and contain liquid or semi-liquid fecal matter from non-mobile hospital patients to prevent contamination of the patient's skin with corrosive exudates, reduce the risk of contamination by potentially infectious substances, and minimize bedding contamination. Fecal management catheters typically include an inflatable balloon/balloon to anchor the catheter within the rectum, and a tube to transport fecal material out of the patient's rectum.

Disclosure of Invention

To reduce the forces exerted on the sphincter during fecal treatment, most indwelling fecal catheter tube sections/bodies are collapsible/contractible (collapsable), which creates a fecal matter leak path around the catheter exterior in the perianal region of the patient. Certain embodiments of the present disclosure relate to a catheter that can exert minimal pressure on the sphincter muscle while allowing for efficient drainage of fecal matter with reduced or no leakage around the catheter. In some embodiments, the catheter comprises a material that compresses to reduce excessive pressure on surrounding tissue and to accommodate patient movement. In some embodiments, the catheter includes a flexible but non-collapsible tube that is compressible and has a reduced pressure applied to sphincter tissue. This is in contrast to other catheter designs including collapsible catheters (i.e., soft and collapsible) or fixed volume airbags, which can create high pressures that can 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, whereas air bags consisting of double balloons are disclosed in US 8,939,952 and WO 2007118621 A1 to provide improved sealing against rectal tissue. The latter design uses a closed air bag, which has the disadvantage that the pressure increases during bowel movements, patient movements or patient sitting due to the closed system of the air bag.

Drawings

Fig. 1 is a cross-sectional view of an exemplary fecal treatment system having flexible but non-collapsible bellows.

Fig. 2 is a cross-sectional view of an exemplary fecal treatment system having a flexible but non-collapsible tube with thin sections and thick sections.

Fig. 3 is a cross-sectional view of an exemplary fecal treatment system having a flexible but non-collapsible helical tube.

Fig. 4 is a cross-sectional view of an exemplary fecal treatment system having a flexible but non-collapsible thick-walled tube.

Fig. 5 is a cross-sectional view of an additional chamber containing a foldable material.

Fig. 6 shows a T-connector design with one connection to the exhaust port and a second connection to a one-way check valve that maintains a preferred pressure differential between the elongate tubular chamber and the atmosphere.

Detailed Description

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

Reference in the specification to "one embodiment," "an illustrative embodiment," etc., means that a particular feature, structure, or characteristic may be included in the described embodiments, but every embodiment may or may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. It should further be understood that although reference to a "preferred" component or feature may indicate that a particular component or feature is desirable for that embodiment, the present disclosure is not so limited to other embodiments, which may omit such component or feature. Furthermore, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to effect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.

Furthermore, it should be understood that items contained in the list in the form of "at least one of A, B and C" may represent (a); (B); (C); (A and B); (B and C); (A and C); or (A, B and C). Similarly, an item listed in the form of "at least one of A, B or C" may 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" may also refer to (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 words and phrases such as "a," "at least one," and/or "at least a portion" should not be construed as limited to only one such element unless specifically stated to the contrary, and the use of phrases such as "at least a portion" and/or "a portion" should be construed as including both embodiments that include only a portion of that element and embodiments that include the entirety of that element unless specifically stated to the contrary.

The term "about" may be used herein to modify certain quantitative measurements. In various forms, the term "about" may mean that the expressed values may differ by up to 10%, up to 5%, or up to 1%. Thus, an indication of a pressure of "about 100 kilopascals" may represent a pressure between 90 kilopascals and 110 kilopascals, between 95 kilopascals and 105 kilopascals, or between 99 kilopascals and 101 kilopascals.

In the drawings, certain structural or methodological features may be shown in a particular arrangement and/or order. However, it should be understood that such a particular 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 figures unless indicated to the contrary. Furthermore, the inclusion of structural or methodological features in a particular figure is not meant to imply that such features are required in all embodiments and may be omitted or combined with other features in some embodiments.

In one aspect of the present disclosure, a medical device is provided that includes an elongate tubular member for medical waste discharge. 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 within the tubular member that conforms to tissue when the sphincter exerts a force on the tubular member. Fig. 1 illustrates an exemplary medical device implemented as a fecal treatment system.

The exemplary fecal treatment system 100 includes a catheter 101, the catheter 101 including an elongate tubular member 104 having a distal end 150 and a proximal end 152, and an inflatable balloon 102 surrounding the distal end 150. The main tube 104 is connected to the inner tube 122 by each of the distal adapter 118 and the proximal adapter 120. In the illustrated embodiment, the inflatable balloon 102 may be inflated with a fluid such as air or a liquid (e.g., saline), for example, by connecting an inflation lumen to the ports 124 of the main tube 104 and the chambers of the balloon 102. In some embodiments, the inflatable bladder 102 may contain a compressible material 106. An irrigation channel 128, a balloon inflation/deflation channel 126, and a channel 114 for pressure management leading to the tubular elongate chamber 110 are formed within the elongate chamber 110.

In the illustrated form, the device is a catheter 101 of a fecal treatment system 100. It is also contemplated that catheter 101 may be used for other purposes, such as a Foley catheter (urinary catheter), or as another form of catheter. Furthermore, it is also contemplated that the elongate tubular member 104 described herein may be used in other areas of the body, such as forming an airway of a respiratory device.

In the illustrated form, the distal portion of the elongate tubular member 104 is insertable into the rectum of a subject to collect bodily waste material flowing from the distal portion to the proximal portion through the discharge channel 116 within the elongate tubular member 104. When the distal portion is inserted into the rectum, the inflatable balloon 102 may engage with the body tissue to hold the distal portion within the rectum and provide a seal to transfer bodily waste material through the discharge channel 116. In certain embodiments, such as those in which 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) to receive waste. In other embodiments, such as those in which the device is intended for use as an airway passage, the proximal end 152 may be connected to a source of air.

In some embodiments, the elongate tubular member 104 is non-collapsible/non-collapsible and fluid may pass through the discharge passage 116 without being completely occluded. For example, the non-collapsible elongated tubular member 104 may be reinforced with wire. In some embodiments, the non-collapsible tubular element 104 comprises a helical insert to render the tube non-collapsible. In some embodiments, the elongate tubular member 104 further comprises a non-collapsible tubular member 122. In some embodiments, the non-collapsible tubular element 122 comprises a non-collapsible 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-collapsible tubular member 122 comprises a bellows, such as shown in fig. 1. In some embodiments, the non-collapsible tubular element 122 comprises a profiled extruded tube composed of alternating thin sections and thick sections, for example as shown in fig. 2. In some embodiments, the non-collapsible tubular member 122 includes a reinforcing spiral or wire, such as shown in fig. 3. In some embodiments, the non-collapsible tubular member 122 comprises a thin-walled tube that is co-extruded with a stiffening screw, for example as shown in fig. 3. In some embodiments, the non-collapsible tubular member 122 includes a thick wall, such as shown in fig. 4.

The material of the elongate tubular member 104 can have a hardness of shore (hardness) a 80 (ASTM D2240) or less, or preferably no more than shore (hardness) a 70, or most preferably no more than shore (hardness) a 60. The elongate tubular member 104 can have a wall thickness of about 0.5 mm to about 3 mm, or preferably between 0.5 mm and 1 mm. In some embodiments, the non-collapsible tubular member 122 includes a reinforcing spiral, such as shown in fig. 3. The screw may be the same material as the tube or may be a different material with a higher hardness. In some embodiments, the non-collapsible tubular element 122 comprises a bellows. In some embodiments, the hardness of the non-collapsible tube 122 is no greater than 80 shore a (ASTM D2240), or preferably less than 70 shore a, or more preferably no greater than 60 shore a. In some embodiments, the elongate tubular member 104 comprising the non-collapsible tube 122 and the compressible material 112 has a durometer of no greater than 80 shore a (ASTM D2240), or preferably less than 70 shore a, or more preferably no greater than 60 shore a.

The elongate tubular member 104 also includes a compressible material 112, the compressible material 112 being conformable to tissue when the sphincter exerts a force on the elongate tubular member 104. In some cases, compressible material 112 includes the same material having the same properties as compressible material 106 within inflatable bladder 102. In some cases, the compressible material 112 of the elongate tubular member 104 includes a different material and/or different properties than the compressible material 106 within the inflatable balloon 102. Non-limiting examples of materials suitable for use as compressible material 112 and/or compressible material 106 include cellular foam and polyurethane.

In some embodiments, the density (ISO 845) of the compressible material 106 and/or the compressible material 112 is about 20 kilograms per cubic meter to about 60 kilograms per cubic meter, or preferably about 20 kilograms per cubic meter to about 30 kilograms per cubic meter. In some embodiments, the compressible material 106 and/or the compressible material 112 has a compression load deflection 40% under a compression load of about 2 kilopascals to about 15 kilopascals, or preferably 2 kilopascals to 5 kilopascals (ISO 3386-1). In some embodiments, the compressible material 106 and/or the compressible material 112 has a dry tensile strength (ISO 1798) of about 50 kilopascals to about 200 kilopascals, or preferably about 100 kilopascals to about 150 kilopascals. In some embodiments, the compressible material has a nominal hardness (durometer, ASTM D2240) of less than 50 shore (hardness) D and/or less than 100 shore (hardness) a, or preferably less than 90 shore (hardness) a. In some embodiments, the compressible material is a quick rebound foam configured to expand to 90% of its original volume within 10 seconds, or preferably within 5 seconds. In some embodiments, compressible material 106 and/or compressible material 112 are memory foam that retain a compressed shape.

In some embodiments, the thickness of the compressible material 112 is less than about 8 millimeters, less than about 5 millimeters, or less than about 2 millimeters when the compressible material 112 is uncompressed. In some embodiments, the thickness of the compressible material 112 is less than about 4 millimeters, less than about 2 millimeters, or less than about 1 millimeter when the compressible material 112 is in at least about 90%/in a state that achieves a degree of full compression of at least about 90%.

The compressible material 112 is located inside the elongate tubular member 104. In some embodiments, the compressible material 112 is located within the interior chamber 132. As a non-limiting example, the chamber 110 may include a tube adjacent the interior of the elongate tubular member 104. As another example, there may be one or more chambers 132 located inside the elongate tubular member including the compressible material 112. As shown in fig. 5, the chamber 110 may be part of the interior of the elongate tubular member 104 or may be a separate structure. In some embodiments, the chamber 110 may be defined by an interior of the outer tube 104 and an exterior of the inner tube 122. In some embodiments, the chamber 110 is comprised of polyurethane. In some embodiments, the chamber 110 is composed of silicone. In some embodiments, the chamber 110 is comprised of a thermoplastic elastomer.

Fecal treatment system 100 further comprises a first pressure control channel 114 connecting chamber 110 to atmosphere via a relief valve 138 and an evacuation valve system 136. The check valve system 136 is intended to allow fluid to quickly flow into the chamber 110 when the force acting on the chamber 110 is suddenly removed. The relief valve 138 is used to relieve pressure when pressure increases due to bowel movement or pushing by patient movement. The first passage 114 may allow pressure equalization between the chamber 110 and the atmosphere through the relief valve 138. When the pressure within the chamber 110 is above atmospheric pressure, the process of achieving equilibrium may involve the flow of fluid (e.g., air, liquid) from the chamber 110 through the first passage 114 to the relief valve 138 to the atmosphere. For fecal treatment systems, the pressure on the sphincter tissue may be determined by the modulus of elasticity and the size of the compressible material 112 within the chamber 110.

If the chamber 110 is overfilled (e.g., the sphincter is compressed with a greater force), the pressure is higher than the modulus of elasticity selected to withstand, and the compressible material 112 is squeezed such that fluid flows under pressure out through the relief valve 138. If the chamber is underfilled (e.g., due to sudden removal of force acting on the chamber 110) and the expansion force of the compressible material 112 is greater than the tissue resistance, fluid will flow into the chamber 110 through the relief 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 the chamber 110 results in a faster release of fluid into the atmosphere than a small overpressure.

In some embodiments, the first channel 114 includes a vent, such as a relief valve 138, that facilitates fluid flow out of the chamber 110 in the event that the tube collapses suddenly during a short period of time, such as a cough, peristaltic movement in the intestine, or pressure from patient movement. In some embodiments, the vent comprises a microporous material. In some embodiments, the vent comprises sintered Polytetrafluoroethylene (PTFE). In one non-limiting example, the exhaust port includes Porex PM0530. In some embodiments, the vent comprises expanded polytetrafluoroethylene (manufactured by Gore) having an average pore size of about 200 microns to about 500 microns. The purpose of the vent is to allow a rapid outflow of air, for example at least 0.5 litres/hour/square cm to 50 litres/hour/square cm at a pressure gradient of 70 mbar, preferably 1 litre/hour/square cm to 5 litres/hour/square cm at a pressure gradient of 70 mbar. Additional exemplary vents, partially permeable plugs, membranes, or other materials include polytetrafluoroethylene, silicone rubber, and dense polyurethane foam. In some embodiments, the vent is a small hole or series of holes to the atmosphere.

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

In some embodiments, the fecal treatment system includes a second channel in fluid communication with the inflatable chamber 110. In some cases, the rate of fluid flow into the inflatable chamber 110 through the second channel is at least about 2, 3, 4, 5, or 10 times the rate of fluid flow out of the inflatable chamber 110 through the second channel. The faster rate of entry into the inflation chamber 110 allows for rapid filling due to bowel movement or patient movement. In some embodiments, the flow out of the plenum chamber 110 is up to about 2 milliliters to about 15 milliliters per minute. In some embodiments, the flow into the plenum 110 may be up to about 20, 30, 40, 50, 60, or 70 milliliters per minute. For the inflatable chamber 110 in a fecal treatment system, the inflatable chamber may 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 inflatable chamber 110 in a fecal treatment system, the inflatable chamber may be deflated in about 1 minute to about 15 minutes or in about 1 minute, about 2 minutes, about 3 minutes, about 4 minutes, about 5 minutes, about 6 minutes, about 7 minutes, about 8 minutes, about 9 minutes, or about 10 minutes.

In some embodiments, fecal treatment system 100 includes a third channel 126 that connects inflatable bladder 102 to inflatable chamber 110 and then to the same valve 134 for inflating/deflating bladder 102 and inflatable chamber 110. Pressure management of the retention balloon 120 through the channel 126 may be combined with pressure management of the inflatable chamber 110 through the channel 114. In some embodiments, as shown in fig. 6, additional connectors may be used to control the pressure at the inflatable chamber 110 or inflatable bladder 102. The check valve 136 is used to expel fluid out of the inflatable chamber 110. Similarly, valve 134 is used to expel fluid from inflatable bladder 102. Once the inflatable chamber 110 and inflatable balloon 102 are deflated, the folded retention balloon may be inserted into the rectum. Once the device is inserted in place, a T-connector 148 (FIG. 6) may be connected to valve system 136 or valve system 134 via connector 144.

The check valve 136 may be provided as a one-way valve that allows air to flow in one direction quickly but prevents 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 may be selected to be 30 to 35 millimeters of mercury, or preferably 15 to 20 millimeters of mercury, or most preferably 5 to 10 millimeters of mercury. The cracking pressure will determine the pressure level of the inflatable chamber 110 or the retention bladder 102. In other words, once the T-connector 148 is connected to the valve system 136 or the valve system 134 via the connector 144, the pressure at the inflatable chamber 110 or the inflatable bladder 102 cannot exceed the opening pressure of the one-way check valve 142.

In an exemplary method of use, fecal treatment system 100 is prepared for insertion into the rectum by withdrawing fluid from inflatable bladder 102 and inflatable chamber 110 via valve 134 and channel 126 and channel 114, respectively, using, for example, a syringe. Fluid may be withdrawn directly from the inflatable chamber 110. The withdrawal of fluid creates a negative pressure in the inflatable chamber 110 relative to the external atmosphere, and the surrounding atmospheric pressure collapses the inflatable chamber 110 and any compressible material 112 that may be present in the inflatable chamber 110. Once the balloon 102 is fully deflated, the distal portion of the inflatable balloon 102 and a portion of the elongate tubular member 104 including the inflatable chamber 110 are inserted into the rectum, for example using a finger pocket located between a portion of the inflatable balloon 102 and the elongate tubular element 104. Once inserted, the fluid is re-injected to allow the inflatable bladder 102 and inflatable chamber 110 to expand. While the inflated balloon 102 provides an anchoring means for the catheter to remain in place, the inflation lumen in the elongate tubular member allows for effective sealing of the sphincter tissue, thereby preventing leakage from the perianal area. The fluid may be air or a liquid. The fluid flow to the inflatable bladder 102 and inflatable chamber 110 may be the same or different. In an exemplary embodiment, the fluid is air.

If the expandable chamber 110 contains the compressible material 112, the expandable chamber 110 may remain expanded under the influence of the compressible material 106. The injected fluid allows the atmospheric fluid pressure in the expandable chamber 110 to be restored so that the compressible material 112 can be depressurized. In some cases, re-injecting the same amount of fluid as was removed for insertion may create a slight positive fluid pressure within the inflatable chamber 110. However, as excess fluid slowly escapes to restore atmospheric fluid pressure balance, this positive pressure may gradually decrease. Temporary positive pressure during bowel movement or patient movement helps to dislodge sphincter tissue or stool to achieve a proper seal. In an exemplary method of use, a T-connector 148 including a one-way check valve 142 and a relief valve 146 may be coupled to the valve system 136 or the valve system 134 to maintain a system pressure set by the opening pressure of the one-way check valve 142 or the relief valve 146. In another exemplary method of use, a vent is connected to the inflatable chamber 110 through a passageway 114 to allow for rapid adjustment of the pressure in the tubular chamber 110 to create an effective seal against sphincter tissue.

Once the inflatable balloon 102 and a portion of the elongate tubular member 104 (including the inflatable chamber 110) are inserted into the rectum, the non-collapsible nature of the elongate tubular member 104 (including the inflatable chamber 110 and the compressible material 112) may be used to expel fecal matter while reducing or preventing leakage around the elongate tubular member 104. This may be achieved by obtaining a pressure balance between the chamber 110 and the atmosphere via the first channel 114. The inflatable chamber 110 and compressible material 112 inside the elongate tubular member 104 are intended to balance the compressive forces of the sphincter. For example, when the sphincter pressure is higher than the pressure of the inflatable chamber 110, the positive pressure compresses the inflatable chamber 110 containing the compressible material 112, which will then trigger the release of pressure through the release valve 138. The fluid continues to escape until the fluid pressure in the inflatable chamber 110 reaches atmospheric pressure. As the compression pressure of the sphincter drops or as the patient moves, the inflatable chamber 110 expands due to the restoration of the compressible material 112, creating a negative gauge pressure. When the negative gauge pressure exceeds the opening pressure of the check valve 136, the check valve 136 opens, allowing fluid to flow into the chamber 110. The relief valve 138 and check valve 136 are self-regulating and maintain pressure balance between the inflatable chamber 110 and the surrounding sphincter. The pressure on the sphincter tissue surrounding the elongate tubular member 104 including the compressible material 112 may be determined by the modulus of elasticity and/or the size of the compressible material 112 within the chamber 110. In some embodiments, the first channel 114 in the fecal treatment system 100 includes an exhaust port, and the process of achieving equilibrium involves the flow of fluid through the exhaust port. In some embodiments, the first channel 114 is connected to a channel 126, the channel 126 being designed to manage pressure control by way of the inflatable bladder 102. In some embodiments, the first channel 114 is connected to the channel 126, the channel 126 being designed to manage pressure control by the inflatable bladder 102, the inflatable bladder 102 further comprising the compressible material 106.

For fecal treatment systems having a compressible material 112 within the expandable chamber 110 of the elongate tubular member 104, the pressure on the sphincter tissue is determined by the modulus of elasticity and/or the size of the compressible material 112 within the expandable chamber 110. If the inflatable chamber 110 is over inflated, the pressure exerted between the inflatable chamber 110 and the tissue is higher than the modulus of elasticity that the compressible material 112 is designed to withstand. In this case, the inflatable chamber 110 is squeezed and the fluid within the inflatable chamber 110 is under pressure. As a result, fluid from the inflatable chamber 110 flows outwardly through the second channel to relieve pressure. When the second channel and/or the first channel include a vent, the vent restricts fluid flow such that pressure slowly drops due to sphincter tissue and muscle. The fluid continues to escape until the fluid pressure in the inflatable chamber 110 reaches atmospheric pressure.

If inflatable chamber 110 is not fully inflated and the inflation pressure created by compressible material 112 is greater than the sphincter tissue resistance, fluid will be drawn through the first channel and/or the second channel. As a result, the compressible material 112 will tend to expand the expandable chamber 110 to an expanded form, or until the tissue resistance matches the modulus of the compressible material 112. The exhaust port may also limit the rate of fluid inflow, if present.

The example system 100 may further include a pressure management apparatus including a valve assembly in fluid communication with the chamber 110, which generally involves maintaining the pressure within the chamber within a selected pressure range having a minimum pressure and a maximum pressure. In certain embodiments, the minimum pressure is between atmospheric and about 15 mmhg below atmospheric pressure. In certain embodiments, the minimum pressure is between 8 mmhg below atmospheric pressure and 12 mmhg below atmospheric pressure. In certain embodiments, the minimum pressure is between atmospheric pressure and about 10 mmhg below atmospheric pressure. In certain embodiments, the maximum pressure is about 30 mmhg or less above atmospheric pressure. In certain embodiments, the maximum pressure is about 20 mmhg or less above atmospheric pressure. In certain embodiments, the maximum pressure is about 10 mmhg or less above atmospheric pressure. In certain embodiments, the maximum pressure is 4-6 mmHg above atmospheric pressure. In some embodiments, the pressure management device may involve maintaining the pressure within the chamber 110 in a range of 10 millimeters of mercury below atmospheric pressure to 20 millimeters of mercury above atmospheric pressure. In some embodiments, the pressure management device may involve maintaining the pressure within the chamber 110 in a range of 10 millimeters of mercury below atmospheric pressure to 10 millimeters of mercury above atmospheric pressure. In some embodiments, the pressure management device may involve maintaining the pressure within the chamber 110 in a range of 10 millimeters of mercury below atmospheric pressure to 5 millimeters of mercury above atmospheric pressure. The external pressure is the sum of the internal chamber pressure described above and the expansion force exerted by the resilient foam 112 on the chamber 110, and may be about 10 mmhg or less based on the type of foam selected according to table 1. Thus, at least some embodiments of the present disclosure allow the maximum balloon pressure in contact with the anal sphincter to be a maximum pressure of about 30 millimeters of mercury or less above atmospheric pressure, or preferably a maximum pressure of about 20 millimeters of mercury or less above atmospheric pressure, or more preferably a maximum pressure of about 10 millimeters of mercury or less above atmospheric pressure.

Those skilled in the art will readily appreciate that the range of pressure maintained within chamber 110 depends at least in part on the cracking pressure of check valve 136, and that a check valve having an appropriate cracking pressure will be readily selected to maintain the desired pressure range within chamber 110. For example, in embodiments where the minimum pressure within chamber 110 is selected to be about 10 millimeters of mercury below atmospheric pressure, inlet check valve 136 may be selected to have a cracking pressure of about 10 millimeters of mercury (e.g., 10 millimeters of mercury +/-2 millimeters of mercury). Similarly, in embodiments where the maximum value selected for the pressure within chamber 110 is about 20 mmhg above atmospheric pressure, release check valve 138 may be selected to have a cracking pressure of about 20 mmhg (e.g., 20 mmhg +/-4 mmhg) or less. Certain embodiments may utilize an open exhaust port to allow for rapid equalization of atmospheric pressure.

Certain embodiments of the application relate to an apparatus comprising: an elongate tubular member having a proximal end and an opposite distal end; and an inflatable balloon surrounding the distal end; wherein the elongate tubular member comprises: an outer tube; a non-collapsible inner tube disposed inside the outer tube; and a compressible material located between the outer tube and the inner tube.

In some embodiments, the non-collapsible inner tube is corrugated along at least a portion of the length of the non-collapsible inner tube.

In some embodiments, the non-collapsible inner tube includes alternating thick-walled portions and thin-walled portions.

In certain embodiments, the non-collapsible inner tube has a wall thickness between 0.8 mm and 4 mm, or between 1.0 mm and 2.5 mm.

In certain embodiments, the non-collapsible inner tube comprises a helical element.

In certain embodiments, the helical element comprises a wire.

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

In certain embodiments, the hardness of the non-collapsible inner tube does not exceed shore (hardness) a 80, does not exceed shore (hardness) a 70, or does not exceed shore (hardness) a 60.

In certain embodiments, the compressible material includes at least one of a cellular foam or polyurethane.

In certain embodiments, the compressible material has a compression load deflection of 40% under a compression load of about 2 kilopascals to about 15 kilopascals, or about 2 kilopascals to about 5 kilopascals.

In certain embodiments, the compressible material has a hardness of less than 50 shore D and/or less than 100 shore a.

In certain embodiments, the compressible material comprises a quick rebound foam configured to expand to 90% of its original volume within 10 seconds, or preferably within 5 seconds.

In certain embodiments, the compressible material has a dry tensile strength of about 50 kilopascals to about 200 kilopascals, or preferably about 100 kilopascals to about 150 kilopascals.

In certain embodiments, the compressible material has a thickness of less than about 4 millimeters, less than about 3 millimeters, or less than about 2 millimeters when the compressible material is uncompressed.

In certain embodiments, the compressible material has a thickness of less than about 2 millimeters, less than about 1.5 millimeters, or less than about 1 millimeter when the compressible material is in a state that achieves a degree of complete compression of at least about 90%.

In certain embodiments, the device further comprises a second compressible material positioned within the balloon.

In certain embodiments, the second compressible material is configured to move from the expanded state to the compressed state in response to a pressure compressing the bladder; and wherein the second compressible material is configured to return from the compressed state to the expanded state in response to the removal of the pressure, thereby causing the bladder to expand.

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

In certain embodiments, the check valve comprises at least one of a duckbill valve, umbrella valve, disc valve/flap valve, diaphragm valve, or open exhaust port.

In certain embodiments, the compressible material is disposed within a cavity defined between the outer tube and the inner tube.

In certain embodiments, the apparatus further comprises a valve assembly in fluid communication with the chamber, the valve assembly comprising: 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.

Certain embodiments of the application relate to a fecal catheter comprising the device.

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

In certain embodiments, the at least one pressure regulating check valve comprises 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.

In certain embodiments, the first chamber is formed in the elongate tubular member.

In certain embodiments, the elongate tubular member comprises an outer tube and an inner tube positioned inside the outer tube; and wherein the first chamber is defined between the inner tube and the outer tube.

In some embodiments, the inner tube is non-collapsible.

In certain embodiments, the first compressible material has a thickness of less than about 4 millimeters, less than about 3 millimeters, or less than about 2 millimeters when the first compressible material is uncompressed.

In certain embodiments, the first compressible material has a thickness of less than about 2 millimeters, less than about 1.5 millimeters, or less than about 1 millimeter when the first compressible material is in a state that achieves a degree of complete compression of at least about 90%.

In certain embodiments, the apparatus further comprises: a second chamber formed in the other of the elongate tubular member or the balloon; and a second compressible material contained in the second chamber.

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

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

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

In some embodiments, the cracking pressure is between 10 and 25 millimeters of mercury.

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

In certain embodiments, the first compressible material has a compression load deflection of 40% under a compression load of about 2 kilopascals to about 15 kilopascals, or about 2 kilopascals to about 5 kilopascals.

In certain embodiments, the first compressible material has a hardness of less than 50 shore (hardness) D and/or less than 100 shore (hardness) a.

In certain embodiments, the first compressible material comprises a quick rebound foam configured to expand to 90% of its original volume within 10 seconds, or preferably within 5 seconds.

In certain embodiments, the first compressible material has a dry tensile strength of about 50 kilopascals to about 200 kilopascals, or preferably about 100 kilopascals to about 150 kilopascals.

Certain embodiments of the application relate to a fecal treatment system comprising the device.

Certain embodiments of the present application relate to a method comprising: inserting an elongate tubular member into a body cavity comprising soft tissue, wherein the elongate tubular member comprises an outer tube, an inner non-collapsible tube disposed inside the outer tube, and a first compressible material between the inner tube and the inner non-collapsible tube.

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

In some embodiments, inflating the balloon includes expanding a second compressible material located within the balloon cavity.

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

In certain embodiments, expanding the first compressible material includes introducing a fluid into a chamber containing the first compressible material.

In certain embodiments, the body cavity is a rectal cavity.

In certain embodiments, the method further comprises: during expansion of the first compressible material, fluid is selectively caused to flow into the first compressible material through a check valve in fluid communication with the first compressible material, thereby facilitating expansion of the first compressible material.

In certain embodiments, the method further comprises: during compression of the first compressible material, fluid is forced out of the first compressible material through a check valve in fluid communication with the first compressible material, thereby facilitating compression of the first compressible material.

In certain embodiments, the check valve is further in fluid communication with a fluid source; and wherein selectively flowing the fluid into the first compressible material includes flowing the fluid into the first compressible material only when a pressure differential between the first compressible material and the fluid source exceeds a cracking pressure of the check valve.

In certain embodiments, the fluid source is the atmosphere.

In certain embodiments, the cracking pressure is in the range of 10 millimeters of mercury to 25 millimeters of mercury.

In some embodiments, the cracking pressure is no greater than 25 mmhg.

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

In certain embodiments, the method further comprises introducing waste from the cavity into a waste collection device connected to the proximal end of the elongate tubular member by a non-collapsible inner tube.

Certain embodiments of the application relate to an apparatus comprising: an elongate tubular member having a proximal end and an opposite distal end; a chamber formed in the elongate tubular member; a compressible material contained in the chamber; and a valve assembly in fluid communication with the chamber, the valve assembly including at least one pressure regulating check valve.

In certain embodiments, the at least one pressure regulating check valve comprises 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.

In certain embodiments, the elongate tubular member comprises an outer tube and an inner tube positioned inside the outer tube; and wherein the chamber is defined between the inner tube and the outer tube.

In some embodiments, the inner tube is non-collapsible.

In certain embodiments, the compressible material has a thickness of less than about 2 millimeters, less than about 1.5 millimeters, or less than about 1 millimeter when in a state that achieves a degree of complete compression of at least about 90%.

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

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 differential between the chamber and the fluid source exceeding a cracking pressure of the check valve.

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

While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Many variations, modifications and substitutions will now occur to those skilled in the art without departing from the application. It should be understood that various alternatives to the embodiments of the application described herein may be employed in practicing the application. The following claims are intended to define the scope of the application and their equivalents are therefore covered by this method and structure within the scope of these claims and their equivalents.

Claims

1. An apparatus, comprising:

an elongate tubular member having a proximal end and an opposite distal end; and

an inflatable balloon surrounding the distal end;

wherein the elongate tubular member comprises:

an outer tube;

a non-collapsible inner tube disposed inside the outer tube; and

a compressible material disposed between the outer tube and the inner tube.

2. The device of claim 1, wherein the non-collapsible inner tube is corrugated along at least a portion of a length of the non-collapsible inner tube.

3. The device of claim 1, wherein the non-collapsible inner tube comprises alternating thick-walled segments and thin-walled segments.

4. The device of claim 1, wherein the non-collapsible inner tube has a wall thickness of between 0.8 and 4 millimeters, or between 1.0 and 2.5 millimeters.

5. The device of claim 1, wherein the non-collapsible inner tube comprises a helical element.

6. The device of claim 5, wherein the spiral element comprises a wire.

7. The device of claim 5, wherein the spiral element is integral with the non-collapsible inner tube.

8. The device of claim 1, wherein the non-collapsible inner tube has a hardness of no more than 80 shore a, no more than 70 shore a, or no more than 60 shore a.

9. The device of claim 1, wherein the compressible material comprises at least one of a porous foam or polyurethane.

10. The device of claim 1, wherein the compressible material has a compression load deflection of 40% at a compression load of about 2 kilopascals to about 15 kilopascals, or about 2 kilopascals to about 5 kilopascals.

11. The device of claim 1, wherein the compressible material has a hardness of less than 50 shore (hardness) D and/or less than 100 shore (hardness) a.

12. The device of claim 1, wherein the compressible material comprises a quick-rebound foam configured to expand to 90% of its original volume within 10 seconds or preferably within 5 seconds.

13. The device of claim 1, wherein the compressible material has a dry tensile strength of about 50 kilopascals to about 200 kilopascals, or preferably about 100 kilopascals to 150 kilopascals.

14. The device of claim 1, wherein the compressible material has a thickness of about less than 4 millimeters, about less than 3 millimeters, or about less than 2 millimeters when the compressible material is uncompressed.

15. The device of claim 1, wherein the compressible material has a thickness of about less than 2 millimeters, about less than 1.5 millimeters, or about less than 1 millimeter when the compressible material is in a state that achieves a degree of complete compression of at least about 90%.

16. The device of claim 1, further comprising a second compressible material positioned within the balloon.

17. The device of claim 16, wherein the second compressible material is configured to move from an expanded state to a compressed state in response to a pressure compressing the balloon; and

wherein the second compressible material is configured to return from the compressed state to the expanded state in response to removal of pressure, thereby causing the bladder to expand.

18. The apparatus of claim 1, further comprising a valve assembly in fluid communication with the chamber, the valve assembly comprising at least one pressure regulating check valve.

19. The device of claim 18, wherein the check valve comprises at least one of a duckbill valve, an umbrella valve, a disc valve, a diaphragm valve, or an open exhaust.

20. The device of claim 1, wherein the compressible material is disposed within a chamber defined between the outer tube and the inner tube.

21. The apparatus of claim 18, further comprising a valve assembly in fluid communication with the chamber, the valve assembly comprising:

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.

22. A fecal treatment system comprising the device of claim 1.

23. An apparatus, comprising:

an elongate tubular member having a proximal end and an opposite distal end;

an inflatable balloon surrounding the distal end;

a first chamber formed in one of the elongate tubular member or the balloon;

a first compressible material contained in the first chamber; and

a valve assembly in fluid communication with the first chamber, the valve assembly including at least one pressure regulating check valve.

24. The apparatus of claim 23, wherein the at least one pressure regulating check valve comprises 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.

25. The device of claim 23, wherein the first chamber is formed in the elongate tubular member.

26. The device of claim 23, wherein the elongate tubular member comprises an outer tube and an inner tube disposed inside the outer tube; and

wherein a first chamber is defined between the inner tube and the outer tube.

27. The device of claim 26, wherein the inner tube is non-collapsible.

28. The device of claim 23, wherein the first compressible material has a thickness of less than about 4 millimeters, less than about 3 millimeters, or less than about 2 millimeters when the first compressible material is uncompressed.

29. The device of claim 23, wherein the first compressible material has a thickness of less than about 2 millimeters, less than about 1.5 millimeters, or less than about 1 millimeter when the first compressible material is in a state that achieves a degree of complete compression of at least about 90%.

30. The apparatus of claim 23, further comprising:

a second chamber formed in the other of the elongate tubular member or balloon; and

a second compressible material contained in the second chamber.

31. The device of claim 30, wherein the first chamber and the second chamber are in fluid communication with each other.

32. The apparatus of claim 23, wherein the first compressible material is configured to move from an expanded state to a compressed state in response to a 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 expansion of the first chamber.

33. The device of claim 23, wherein the check valve is configured to allow fluid to flow from the fluid source into the first chamber in response to a pressure differential between the first chamber and the fluid source exceeding a cracking pressure of the check valve.

34. The device of claim 33, wherein the cracking pressure is between 10 and 25 millimeters of mercury.

35. The apparatus of claim 33, wherein the fluid source is at atmospheric pressure.

36. The apparatus of claim 23, wherein the first compressible material has a compression load deflection of 40% at a compression load of about 2 kilopascals to about 15 kilopascals, or about 2 kilopascals to about 5 kilopascals.

37. The device of claim 23, wherein the first compressible material has a hardness of less than 50 shore (hardness) D and/or less than 100 shore (hardness) a.

38. The device of claim 23, wherein the first compressible material comprises a quick-rebound foam configured to expand to 90% of its original volume within 10 seconds, or preferably within 5 seconds.

39. The device of claim 23, wherein the first compressible material has a dry tensile strength of about 50 kilopascals to about 200 kilopascals, or preferably about 100 kilopascals to about 150 kilopascals.

40. A fecal catheter comprising the device of claim 23.

41. A method, comprising:

inserting an elongate tubular member into a body cavity comprising soft tissue, wherein the elongate tubular member comprises an outer tube, an inner non-collapsible tube disposed inside the outer tube, and a first compressible material disposed between the inner tube and the inner non-collapsible tube.

42. The method of claim 41, further comprising: a balloon coupled to the insertion end of the elongate tubular member is inflated to form a seal with soft tissue.

43. The method of claim 42, wherein inflating the balloon comprises expanding a second compressible material disposed within the balloon cavity.

44. The method of claim 41, further comprising: the first compressible material is expanded from a compressed state to an expanded state to form a seal between the outer tube and the soft tissue.

45. The method of claim 44, wherein expanding the first compressible material comprises introducing a fluid into a chamber containing the first compressible material.

46. The method of claim 41, wherein the body cavity is a rectal cavity.

47. The method of claim 41, further comprising:

during expansion of the first compressible material, fluid is selectively caused to flow into the first compressible material via a check valve in fluid communication with the first compressible material, thereby facilitating expansion of the first compressible material.

48. The method of claim 47, further comprising:

during compression of the first compressible material, fluid is caused to flow out of the first compressible material via a check valve in fluid communication with the first compressible material, thereby facilitating compression of the first compressible material.

49. The method of claim 47, wherein the check valve is further in fluid communication with a fluid source; and

wherein selectively flowing fluid into the first compressible material comprises: fluid is caused to flow into the first compressible material only when the pressure differential between the first compressible material and the fluid source exceeds the cracking pressure of the check valve.

50. The method of claim 49, wherein the fluid source is atmosphere.

51. The method of claim 49, wherein the cracking pressure is in the range of 10 to 25 millimeters of mercury.

52. The method of claim 49, wherein the cracking pressure is no greater than 25 mmHg.

53. The method of claim 41, wherein the first compressible material surrounds the non-collapsible inner tube and is surrounded by the outer tube.

54. The method of claim 41, further comprising: waste is directed from the cavity to a waste collection device connected to the proximal end of the elongate tubular member by the non-collapsible inner tube.

55. An apparatus, comprising:

an elongate tubular member having a proximal end and an opposite distal end;

a chamber formed in the elongate tubular member;

a compressible material contained in the chamber; and

a valve assembly in fluid communication with the chamber, the valve assembly including at least one pressure regulating check valve.

56. The apparatus of claim 55, wherein the at least one pressure regulating check valve comprises 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.

57. The device of claim 55, wherein the elongate tubular member comprises an outer tube and an inner tube disposed inside the outer tube; and

wherein the chamber is defined between the inner tube and the outer tube.

58. The device of claim 57, wherein the inner tube is non-collapsible.

59. The device of claim 55, wherein the compressible material has a thickness of less than about 4 millimeters, less than about 3 millimeters, or less than about 2 millimeters when the compressible material is uncompressed.

60. The device of claim 55, wherein the compressible material has a thickness of less than about 2 millimeters, less than about 1.5 millimeters, or less than about 1 millimeter when the compressible material is in a state that achieves a degree of complete compression of at least about 90%.

61. The device of claim 55 wherein the compressible material is configured to move from an expanded state to a compressed state in response to a 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.

62. The device of claim 55, wherein the check valve is configured to allow fluid to flow from the fluid source into the chamber in response to a pressure differential between the chamber and the fluid source exceeding a cracking pressure of the check valve.

63. The apparatus of claim 62, wherein the cracking pressure is between 10 and 25 millimeters of mercury.

64. The apparatus of claim 62, wherein the fluid source is at atmospheric pressure.

65. The device of claim 55, wherein the compressible material has a compression load deflection of 40% at a compression load of about 2 kilopascals to about 15 kilopascals, or about 2 kilopascals to about 5 kilopascals.

66. The device of claim 55, wherein the compressible material has a hardness of less than 50 shore (hardness) D and/or less than 100 shore (hardness) a.

67. The device of claim 55, wherein the compressible material comprises a quick-rebound foam configured to expand to 90% of its original volume within 10 seconds, or preferably within 5 seconds.

68. The device of claim 55, wherein the compressible material has a dry tensile strength of about 50 kilopascals to about 200 kilopascals, or preferably about 100 kilopascals to about 150 kilopascals.

69. A fecal catheter comprising the device of claim 55.