Medical tube assembly

Abstract

The present disclosure relates to medical tube assemblies designed to provide fluid communication between an organ in a patient's body and the external environment. Such a medical tube assembly can include a retention catheter assembly having a catheter, an internal retention member configured to move between an expanded configuration and a compacted configuration, and a solid or semi-solid filler material disposed inside a cuff cavity of a cuff of the internal retention member. The medical tube assembly can further include a hub releasably connectable to the catheter such that when connected, the medical tube assembly defines a primary lumen, a solvent introduction lumen and a draining lumen, wherein the solvent introduction lumen and the draining lumen are in fluid communication with the cuff cavity, and wherein the primary lumen is fluidly sealed from the solvent introduction lumen and the draining lumen.

Description

MEDICAL TUBE ASSEMBLYFIELD

[0001] The present disclosure relates to medical tube assemblies that provide fluid communication between a patient's body cavity and an exterior environment, and more precisely, to medical tube assemblies that include an internal retention member configured to anchor the medical tube assembly to the patient's body in an expanded configuration thereof, and to move to a compacted configuration that allows extraction of the medical tube assembly from the patient's body.BACKGROUND

[0002] Gastrostomy tube insertion is a critical medical procedure designed to facilitate longterm feeding, medication delivery, and decompression in patients who are unable to consume food orally. This process involves creating an opening directly into the stomach through the abdominal wall, allowing for the placement of a feeding tube. This procedure is particularly beneficial for patients with conditions that impair their ability to swallow or ingest food through the mouth, ensuring they receive the necessary nutrients and medications for their health and recovery. By bypassing the oral route, gastrostomy tube insertion provides a reliable and effective means of sustaining patients' nutritional and medicinal needs.

[0003] The most prevalent method for gastrostomy tube insertion is percutaneous endoscopic gastrostomy (PEG). PEG involves placement of the feeding tube into the stomach using an endoscope, which is a flexible tube with a camera and light attached to it. This procedure is typically performed under general anesthesia to ensure patient comfort and minimize movement. An external retention member, which can be optionally disc-shaped, is used to secure the tube in place, preventing it from dislodging and ensuring the stability of the feeding channel. PEG is favored for its minimal invasiveness and the reduced recovery time it offers compared to traditional surgical methods.

[0004] The initial setup of the gastrostomy tube includes a relatively stiff or inflexible cup or doughnut- shaped unit, serving as an internal retention member. This component is crucial as it provides the necessary strength to press the stomach wall against the abdominal wall, thereby creating a stable channel for the tube. The channel, usually around 1-5 cm in length, may vary depending on the patient’s body mass index (BMI). Over a period of approximately 10-12 weeks, this channel stabilizes, allowing for the subsequent removal of the initial unit. The initialunit is then replaced with a more flexible and easily replaceable feeding tube, often a Foley- type or other inflatable balloon unit, which can be managed with a simple bedside procedure.

[0005] Despite the effectiveness of PEG, removal and replacement of the initial stiff internal retention member comes with potential complications. Three existing methods for PEG removal include endoscopy, external traction, and the cut and push technique. Each method carries its own risks; endoscopy may lead to upper airway obstruction, esophagitis, retropharyngeal abscess, and complications from sedation. External traction can result in persistent leakage through a gastrocutaneous fistula, bleeding, significant discomfort, and pain. The cut and push method poses risks of intestinal obstruction, ileus, and small bowel perforation. These potential complications underscore the need for careful consideration and skilled execution of the gastrostomy tube insertion and removal process to ensure patient safety and optimal outcomes.SUMMARY

[0006] The present disclosure is directed medical tube assemblies that include an internal retention member filled with a solid or semi solid, optionally particulate and / or porous, filler that can be dissolved and flushed via dedicated fluid introduction and draining lumens, allowing the internal retention member to fold and assume a compacted configuration when removal of the tube assembly is required.

[0007] In some examples, there is provided a medical tube assembly comprising a retention catheter assembly that includes: a catheter, an internal retention member configured to move between an expanded configuration and a compacted configuration, and a solid or semi solid filler material disposed inside the cuff cavity, wherein the solid or semi solid filler material is at least partially soluble in an aqueous medium.

[0008] In some examples, the medical tube assembly further comprises a hub comprising a primary port, a solvent introduction port, and a draining port.

[0009] In some examples, the hub is releasably connectable to the catheter.

[0010] In some examples, when the hub is connected to the catheter, the medical tube assembly defines: a primary lumen extending from the primary port to a distal primary opening at the distal catheter segment, a solvent introduction lumen extending from the solvent introduction port to an introduction lumen opening at the distal catheter segment, and a draining lumen extending from the draining port to a draining lumen opening at the distal catheter segment.

[0011] In some examples, the introduction lumen opening and the draining lumen opening are exposed to the cuff cavity.

[0012] In some examples, the primary lumen is fluidly sealed from the solvent introduction lumen and the draining lumen.

[0013] In some examples, the hub further comprises a secondary port which is in fluid communication with the primary lumen, when the hub is connected to the catheter.

[0014] In some examples, the cuff wall is pre-shaped to assume the expanded configuration of the internal retention member, in a free state of the cuff.

[0015] In some examples, the cuff wall is pre-shaped to a doughnut- shaped configuration.

[0016] In some examples, the internal retention member is configured to assume its compacted configuration when the cuff cavity is emptied from the solid or semi solid filler material.

[0017] In some examples, the cuff wall is flexible enough to be passively folded or compressed, when the internal retention member is passed through a passageway that is narrower than an outer diameter defined by the internal retention member in its expanded configuration.

[0018] In some examples, the solid or semi solid filler material is configured to instill sufficient rigidity in the cuff to allow the internal retention member to maintain its expanded configuration when pressed against a tissue wall.

[0019] In some examples, the solvent introduction lumen is configured to direct solvent into the cuff cavity.

[0020] In some examples, the draining lumen is configured to direct fluid out of the cuff cavity.

[0021] In some examples, the solid or semi solid filler material is particulate, and comprises a plurality of solid or semi solid particles.

[0022] In some examples, the solid filler material comprises at least one salt or sugar.

[0023] In some examples, when the hub is connected to the catheter: the primary lumen is defined by a hub primary channel of the hub being in fluid communication with a tube primary channel of the catheter, the solvent introduction lumen is defined by a hub flushing channel of the hub being in fluid communication with a tube flushing channel of the catheter, and the draining lumen is defined by a hub draining channel of the hub being in fluid communication with a tube draining channel of the catheter.

[0024] In some examples, the hub comprises: an extended primary end portion configured to be inserted into the tube primary channel, an extended flushing end portion configured to be inserted into the tube flushing channel, and an extended draining end portion configured to be inserted into the tube draining channel.

[0025] In some examples, at least one of the extended primary end portion, the extended flushing end portion, and / or the extended draining end portion, is tapered in a distal direction.

[0026] In some examples, the internal retention member is configured to reside inside a stomach, wherein the primary lumen is a feeding lumen configured to introduce enteral nutritional products into the stomach.

[0027] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.BRIEF DESCRIPTION OF THE FIGURES

[0028] Some examples of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some examples may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an example in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.In the Figures:

[0029] Fig. 1 illustrates insertion of a retention catheter assembly into a patient.

[0030] Fig. 2A schematically shows the retention catheter assembly of Fig. 1 extending through a stoma of the patient.

[0031] Fig. 2B shows a connector slide over the catheter of the retention catheter assembly.

[0032] Fig. 2C shows a hub attached to the catheter.

[0033] Fig. 3A shows a perspective side view of an exemplary medical tube assembly, in a pre-assembled configuration thereof.

[0034] Fig. 3B shows a cross-sectional side view of the medical tube assembly of Fig. 3A, in a pre-assembled configuration thereof.

[0035] Fig. 4 shows a cross-sectional side view of the medical tube assembly of Fig. 3B, in an assembled configuration thereof.

[0036] Fig. 5A shows a partial cross-sectional view of a medical tube assembly anchored to the patient's body.

[0037] Fig. 5B illustrates extraction of the medical tube assembly from the patient's body.

[0038] Fig. 6A illustrates a distal portion of an exemplary retention catheter assembly that includes filler material having a mesh structure.

[0039] Fig. 6B illustrates a distal portion of an exemplary retention catheter assembly that includes filler material in the form of a sponge.

[0040] Fig. 6C illustrates a distal portion of an exemplary retention catheter assembly that includes filler material comprising gel.

[0041] Fig. 7 illustrates a distal portion of an exemplary retention catheter assembly that includes a cup-shaped internal retention member.DETAILED DESCRIPTION

[0042] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present, or problems be solved. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possible examples to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosed technology.

[0043] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0044] All features described herein are independent of one another and, except where structurally impossible, can be used in combination with any other feature described herein.

[0045] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the terms “have” or “includes” means “comprises.” Further, the terms “engaged,” “connected,” “coupled,” and “attached,” as used herein, are interchangeable and generally mean physically and / or mechanically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. As used herein, “and / or” means “and” or “or,” as well as “and” and “or.”

[0046] Directions and other relative references may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as “inner,” “outer,” “upper,” “lower,” “inside,” “outside,” “top,” “bottom,” “interior,” “exterior,” “left,” right,” and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated examples. Such terms are not, however, intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an “upper” part can become a “lower” part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same.

[0047] The term “plurality” or “plural” when used together with an element means two or more of the elements. Directions and other relative references (e.g., inner and outer, upper and lower, above and below, left and right, and proximal and distal) may be used to facilitate discussion of the drawings and principles herein but are not intended to be limiting.

[0048] Throughout the figures of the drawings, different superscripts for the same reference numerals are used to denote different examples of the same elements. Examples of the disclosed devices and assemblies may include any combination of different examples of the same elements. Specifically, any reference to an element without a superscript may refer to any alternative example of the same element denoted with a superscript. In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some components will be introduced via one or more drawings and not explicitly identified in every subsequent drawing that contains that component.

[0049] Various medical tubes may be implanted in a patient body for a limited period of time, after which removal of the tube is required. Such medical tubes can include internal and / or external retention members designed to keep the tube in position after implantation, and can be configured to allow convenient insertion and / or removal of the tube when required, such as bybeing configured to change in shape to a more compacted configuration either during the implantation procedure and / or when removal of the medical tube is required. One type of such a medical tube assembly is a gastrostomy tube, typically used for patients with conditions that impair their ability to swallow or digest food normally. The procedure to place a gastrostomy tube is known as a gastrostomy and can be performed surgically, endoscopically, or radiologically. A gastrostomy tube allows for the direct delivery of nutrients, fluids, and medications, bypassing the mouth and esophagus. It can be a temporary or long-term solution depending on the patient's medical condition.

[0050] Fig. 1 illustrates an exemplary method for insertion of a retention catheter assembly 105 equipped with an internal retention member 130 into a patient 10. The exemplary retention catheter assembly 105 shown in Fig. 1 is part of a medical tube assembly 100 (shown, for example, in Figs. 3A-4), which can be a gastrostomy tube insertable by the percutaneous endoscopic gastrostomy (PEG) technique, during which the end of the retention catheter assembly 105 which is opposite to the internal retention member 130 is entered first, through the patient's mouth, and advanced in a retrograde manner along a patient's esophagus 20, into the stomach 30 and out an incision made in the abdominal wall 12 (indicated in Fig. 2A).

[0051] As shown in Fig. 2A, a multi-lumen catheter 106 of the retention catheter assembly 105 can be then pulled from outside the abdomen until the internal retention member 130 forces the stomach wall 32 against the abdominal wall 12, a process known in the art as “approximation.” An external retention member 138 can be optionally placed on the external portion of the multi-lumen catheter 106 against the outer side of the abdominal wall 12 to hold the stomach wall 32 in contact with the abdominal wall 12. The external portion of the multilumen catheter 106 can be temporarily clamped by a clamp 194 closed thereover to prevent leakage of gastric contents, and sterile scissors (or other cutting tools) can be used to cut the external portion of the multi-lumen catheter 106 to a desired length.

[0052] The medical tube assembly 100 further comprises a multi-port hub 104, which can be then coupled to the external portion of the multi-lumen catheter 106. In some examples, the medical tube assembly 100 can include a connector 190 that can be used to couple the multiport hub 104 to the multi-lumen catheter 106. For example, as shown in Fig. 2B, a connector 190 can be slid over the catheter 106, after which the multi-port hub 104 can be attached to the catheter 106, optionally by insertion of a distal end of the hub 104 into one or more lumens of the multi-lumen catheter 106. The connector 190 can be then slid back towards the connector 190 and utilized to secure the connection between the hub 104 and the catheter 106, as shown in Fig. 2C.

[0053] In some examples, the proximal end of the connector 190 can have inner threads, and the distal portion of the hub 104 can have complementary outer threads 192, such that the connector 190 can be screwed to the hub 104 to lock it in place and create a leak-proof seal. Alternatively, other coupling mechanisms can be implemented between connector 190 and hub 104, such as snap-fit or other modes of engagement. In some examples, no connector is provided, relying on the hub 104 being adapted to form a leak-proof seal when connected to the catheter 106 without the aid of additional or separate elements. Once hub 104 and catheter 106 are properly attached to each other, the clamp 194 can be released to allow for fluid flow through the one or more lumens of the catheter 106.

[0054] The retention catheter assembly 105 can include a distal catheter segment 127, defined as a segment configured to reside inside a patient's body when the medical tube assembly 100 is secured to the patient, and a proximal catheter segment 107, defined as a segment configured to extend outside the patient's body when the retention catheter assembly 105 is secure to the patient. The distal catheter segment 127 can also define a distal portion 128 of the medical tube assembly 100, while a proximal portion 102 of the medical tube assembly 100 can include the proximal catheter segment 107 and the multi-port hub 104 when coupled thereto, the proximal portion 102 similarly defined as a portion of the medical tube assembly 100 configured to extend outside the patient's body when the medical tube assembly 100 is secure to the patient. After the stomach 30 and abdominal wall 12 have been maintained in a fixed position for a certain period of time, such as approximately ten to twelve weeks, a fistulous tract, referred to as a stoma 40, is formed. This stoma 40 extends from the outer surface of the abdominal wall 12.

[0055] The term “proximal,” as used herein, generally refers to a position, direction, or portion of any assembly, device, or a component of a device, which is closer to an end distanced from the patient's skin outside the patient, when the assembly or device is secured to the patient. The term “proximal” when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the proximal end of the device. The term “distal,” as used herein, generally refers to a position, direction, or portion of any assembly, device, or a component of a device, which reside inside the patient's body when the assembly or device is secured to the patient. The term “distal” when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the distal end of the delivery apparatus. The terms “longitudinal” and “axial” are interchangeable, and refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0056] The medical tube assembly 100 shown in Figs. 1-2C can optionally represent a primary gastrostomy tube which is utilized for the initial insertion of a gastric enteral feeding tube into a patient. In contrast, a secondary gastrostomy tube is designed for insertion into an established stoma tract, and can be physically inserted through an open stoma following the removal of the primary gastrostomy tube. The primary gastrostomy tube may require removal for various reasons, including clogging due to the viscous nature of enteral nutritional products, perforation of the mucosal wall, or deterioration over time. Typically, primary gastrostomy tubes have an average functional lifespan ranging from three to twelve months.

[0057] In both primary and secondary gastrostomy tubes, a primary feeding lumen permits the introduction of enteral nutrition products into the stomach. A secondary gastrostomy tube can include a compressible and expandable internal retention member, such as an inflatable balloon disposed around a distal portion thereof. The balloon can be deflated during insertion of the gastrostomy tube through the stoma 40, and inflated once inside the stomach 30 to hold the secondary gastrostomy tube in position. While these balloons exhibit numerous advantageous characteristics, they typically offer a significantly reduced level of retention or resistance required to press the stomach against the abdominal wall during stoma formation.

[0058] While an exemplary gastrostomy tube is illustrated in Figs. 1-2C, it is to be understood that any medical tube assembly 100 with adaptable anchoring functionality configured to allow removal of the assembly 100 from the patient's body is not limited to gastrostomy tubes. A medical tube assembly 100 disclosed herein can take the form of virtually any medical tube or catheter which is mounted to a patient for a limited period of time to provide fluid communication between an external source and a body cavity, and allowing relatively convenient removal thereof from the patient's body without the need for a subsequent surgical or otherwise interventional procedure.

[0059] Figs. 3A and 3B are perspective and cross-sectional side views of an exemplary medical tube assembly 100 in a pre-assembled configuration thereof, showing the retention catheter assembly 105 and the multi-port hub 104 separated from each other. Fig. 4 is a cross-sectional side view of the medical tube assembly 100 of Fig. 3B in an assembled configuration thereof, showing the retention catheter assembly 105 and the multi-port hub 104 separated from each other coupled to each other. As mentioned above, medical tube assembly 100 defines a distal portion 128 that can be also referred to as an indwelling portion, configured to extend into the patient's body and terminate within a body cavity, such as within the stomach 30 in the case of a gastrostomy tube, when secured to patient 10, and a proximal portion 102 that can be also referred to as an external portion, configured to extend proximally from the patient's body.

[0060] The multi-lumen catheter 106 defines at least three lumens or channels separated from each other and extending axially, optionally in parallel to each other, the channels including a tube primary channel 109, a tube flushing channel 113, and a tube draining channel 119. The multi-port hub 104 similarly includes at least three ports defining corresponding channels, such that when the hub 104 is coupled to the catheter 106, the channels of the hub 104 are in fluid communication with the corresponding channel of the catheter 106. The at least three ports include a primary port 110, a solvent introduction port 116, and a draining port 122. The at least three channels of the hub include a hub primary channel 160 extending from the primary port 110 to an extended primary end portion 170 of the hub 104, a hub flushing channel 164 extending from the solvent introduction port 116 to an extended flushing end portion 172 of the hub 104, and a hub draining extending from the draining port 122 to an extended draining end portion 174 of the hub 104.

[0061] The primary channel 109 extends from the proximal catheter segment 107 to a distal primary opening 126 at the distal catheter segment 127. When the hub 104 is connected to the catheter 106, the hub primary channel 160 and the tube primary channel 109 together define a continuous primary lumen 108. When the assembled medical tube assembly 100 is secured to the patient 10, the primary lumen 108 is exposed, via distal primary opening 126, to a body cavity, such as that of the stomach 30 in the case of a gastrostomy tube. For example, a primary port 110 of a tube assembly 100 implemented as a gastrostomy tube, can serve the role of a feeding port 110 configured to permit introduction of enteral nutritional product, through the primary lumen 108, which can serve in such a case as a feeding lumen 108, into the stomach 30. The feeding port 110 can be connected to a supply source of a nutrition product directly of via one or more adapters (not shown).

[0062] The terms “catheter” and “tube,” as used herein, refer to a flexible tube or cannula that can be extruded from medical grade materials, including an outer wall which is flexible at least in a portion if not over most if not all of its length, and one or more channels or lumens extending from one end to another end of the catheter or tube, such as between a proximal and a distal segment thereof. The term “indwelling portion” refers to a portion of a catheter or tube intended for insertion into a patient's body, such that the distal catheter segment 127 resides within a body cavity. In contrast, the term “external portion” refers to a portion of the catheter or tube, such as the proximal catheter segment 107, intended to reside out of the patient's body.

[0063] The terms “medical tube assembly 100,” “tube assembly 100” and “assembly 100,” as used throughout the specification, are interchangeable. The terms “multi-lumen catheter 106”and “catheter 106,” as used throughout the specification, are interchangeable. The terms “multiport hub 104” and “hub 104,” as used throughout the specification, are interchangeable.

[0064] The term “organ,” as used herein, refers to an internal organ in a patient's body into which or from which materials may be transferred, via catheter and / or tube lumens for example, from / to an external location. Exemplary organs may include, but are not limited to: the stomach, jejunum, bladder, kidney, heart, intestines, uterus, lungs, urinary tract, and the like. The term “body cavity,” as used herein, refers to an inner cavity in a patient's body, which can be a cavity of an organ, or another cavity such as the peritoneal cavity, the abdominal cavity, and the like.

[0065] In some examples, attachment of the hub 104 to catheter 106 can include insertion of the extended end portions 170, 172 and 174 into the corresponding channels 109, 113 and 119. In some examples, as shown in Figs. 3A-3B, any of the extended feeding end portion 170, the extended flushing end portion 172, and / or the extended draining end portion 174 can taper in the distal direction to allow for easier insertion to the corresponding channels of catheter 106. The extended end portions 170, 172 and 174 can be dimensioned to allow insertion into the corresponding channels 109, 113 and 119, such that when pushed into the channels, optionally as far as they can go, a snug fit may be ensured therebetween.

[0066] As shown in Fig. 4, when the assembly 100 is in its assembled configuration: (1) the hub primary channel 160 is in fluid communication with the tube primary channel 109, together defining a continuous primary lumen 108; (2) the hub flushing channel 164 is in fluid communication with the tube flushing channel 113, together defining a continuous solvent introduction lumen 114; and (3) and the hub draining channel 166 is in fluid communication with the tube draining channel 119, together defining a continuous draining lumen 120.

[0067] While a connector 190 is not illustrated in Figs. 3A-4, it is to be understood that in some examples, a connector 190 can be further included in any example of assembly 100 disclosed herein, to facilitate locking of the hub 104 to the catheter 106 in a sealed manner.

[0068] As mentioned above, the distal primary opening 126 is exposed to the surrounding environment, such as inside the stomach 30 in the case of a gastrostomy tube, and is in fluid communication via the primary lumen 108 with the primary port 110 in the assembled configuration of assembly 100, thus providing fluid communication between the body cavity (such as that of stomach 30) and primary port 110. In some examples, the multi-port hub 104 can further include a secondary port 112 defining a hub secondary channel 162, which is also in fluid communication with the hub primary channel 160, such that when the hub 104 is coupled to the catheter 106, the secondary port 112 is in fluid communication, via hubsecondary channel 162, with the primary lumen 108. The secondary port 112 may be optionally used to administer medication therethrough, such as in the form of crushed pills or liquid, or when gastric suction is required, for example. In some examples, the diameter of the primary port 110 can be greater than that of the secondary port 112. In some examples, the diameter of the hub primary channel 160 can be greater than that of the hub secondary channel 162.

[0069] It is to be understood that a secondary port 112 with hub secondary channel 162 is shown in Figs. 3A-4 by way of illustration and not limitation, and that any exemplary multiport hub 104 disclosed herein can be provided with a secondary port 112, as illustrated in the examples of Figs. 3A-4, or without a secondary port, as illustrated for example in Figs. 2B-2C.

[0070] As used herein, the term “fluid communication” with respect to two or more regions or components of the assembly 100, means that such regions or components are interconnected by a lumen, channel, passage, etc. that allows and / or facilitates the passage of fluid therethrough from one region or component to the other region or component.

[0071] The retention catheter assembly 105 of medical tube assembly 100 further includes an internal retention member 130 comprising a cuff 132 attached to the catheter 106 at the distal portion 128 of the assembly 100. The cuff 132 surrounds the catheter 106 and has a cuff wall 134 affixed to the catheter, such as by being RF-welded, glued, over-molded, or otherwise affixed thereto. The cuff 132 defines an enclosed cuff cavity 136 between the cuff wall 134 and the catheter 106. The cuff 132 can be optionally filled with a solid or semi solid filler material 150 disposed within its cavity 136. In some examples, the cuff wall 134 can be a relatively thin and flexible wall. In some examples, the cuff wall 134 can be pre-shaped to assume a fully expanded outer configuration, such as a generally spheroid configuration and / or doughnut- shaped configuration, in a free state thereof.

[0072] The term “free state,” as used herein with respect to a cuff 132, refers to a state of the cuff 132 when no external forces are applied thereto. In contrast, a cuff 132 can deform from its free state to a folded or bent configuration, for example when passed through passageways which are narrower than a diameter assumed thereby in the free state.

[0073] The internal retention member 130 is configured to move between an expanded configuration and a compacted configuration. The amount of solid or semi solid filler material 150 filled in the cuff cavity 136 is configured to force the cuff 132 to assume the expanded configuration, extending radially outwards from the catheter 106. In this sense, it is to be understood that “amount” can relate to the volume occupied by the solid or semi solid filler material 150, rather than to its mass.

[0074] Various exemplary implementations for medical tube assemblies, multi-port hubs, retention catheter assemblies, and / or components thereof, can be referred to, throughout the specification, with superscripts, for ease of explanation of features that refer to such exemplary implementations. It is to be understood, however, that any reference to structural or functional features of any device, assembly or component, without a superscript, refers to these features being commonly shared by all specific exemplary implementations that can be also indicated by superscripts. In contrast, features emphasized with respect to an exemplary implementation of any device, assembly or component, referred to with a superscript, may be optionally shared by some but not necessarily all other exemplary implementations.

[0075] For example, an exemplary retention catheter assembly 105aof medical tube assembly 100ashown in Figs. 3A-4 can be structurally and functionally similar to any retention catheter assembly 105 described herein, except that the solid or semi solid filler material 150aof exemplary retention catheter assembly 105ais particulate or granular, which are forms that are characterized by voids between the solid or semi solid particles and thus assuming larger volume than, e.g., powders. In some examples, the solid or semi solid filler material 150ainclude hardened hydrogel beads. In some examples, particles or granules of the filler material 150acan be porous (example not illustrated).

[0076] Fig. 6A illustrates a distal portion of an exemplary retention catheter assembly 105b, which can be structurally and functionally similar to any retention catheter assembly 105 described herein, except that the solid filler material 150bcomprises a mesh structure or a plurality of solid filaments that can be intermingled or otherwise arranged within the cuff 134 in a manner that forms spacings between the filaments to allow for flexibility of the retention member 130b. The dimensions and distribution of the filaments (e.g., average diameters and lengths of the filaments, average spacing between filaments) can be designed so as to impart a desired conformability to internal retention member 130b.

[0077] In some examples, the filler material 150 may be a porous (e.g., a solid foam, sponge, sintered solid and the like), which is also characterized by voids between the solid portions that assume large volume. Fig. 6B illustrates a distal portion of an exemplary retention catheter assembly 105c, which can be structurally and functionally similar to any retention catheter assembly 105 described herein, except that the solid filler material 150cis implemented as a sponge or sponge-like material defining a plurality of pores or voids therein. The pores can have varying sizes, and can be dimensioned and distributed in a manner that imparts a desired conformability to internal retention member 130c. It is to be understood to the person having ordinary skill in the art that while the pores and / or voids occupy empty space and / or a gas, thesponge or sponge-like material 150cis still considered to be a solid material. It is further to be understood that open-cell sponges, while theoretically can be described as including a single interconnected void, are considered as comprising a plurality of pores or voids, according to the present terminology, as referred above.

[0078] Fig. 6C illustrates a distal portion of an exemplary retention catheter assembly 105d, which can be structurally and functionally similar to any retention catheter assembly 105 described herein, except that the semi-solid filler material 150dis implemented as a gel filler that allows for a desired flexibility of the retention member 130d. It is to be understood that gel fillers may define a continuous or semi-continuous matrix, or they can be discrete. Examples, or discrete gels include hardened hydrogel beads, in some examples, as detailed with respect to the solid or semi- solid filler material 150a.

[0079] In the expanded configuration of the internal retention member 130, such as when the cuff 132 is filled with the solid or semi solid filler material 150, and is in a free state thereof, the internal retention member 130 assumes an outer diameter that is greater than that of the remainder of the catheter 106. For example, in the case of a tube assembly 100 implemented as a gastrostomy tube, an outer diameter of the catheter 106 can be in a range between about 3 mm and 9 mm, depending on patient characteristics and stoma size. An outer diameter of the internal retention member 130 in its expanded configuration can be in a range between about 15 mm and about 30 mm. In some examples, the outer diameter of the internal retention member 130, in its expanded configuration, is at least two times greater than the outer diameter of catheter 106. In some examples, the outer diameter of the internal retention member 130, in its expanded configuration, is at least three times greater than the outer diameter of catheter 106.

[0080] The internal retention member 130 is configured to retain the assembly distal portion 128 within a body cavity, such as within the stomach 30. The wider profile of the internal retention member 130, in its expanded configuration, can press against the inner surface of an organ wall, such as the gastric surface of the stomach wall 32, preventing it from slipping out of the stomach 30.

[0081] Various materials may be utilized to form the internal retention member 130 with a predetermined cavity volume. Suitable materials include, but are not limited to, polyurethane (PU), low-density polyethylene (LDPE), polyvinyl chloride (PVC), polyamide (PA), and polyethylene terephthalate (PETP), and / or combinations thereof.

[0082] In some examples, the internal retention member 130 can terminate distally to the distal catheter segment 107 or its distal primary opening 126. For example, the cuff wall 134 can beattached, at a proximal end thereof, to the catheter 106, at a first attachment region which is proximal to the openings 118 and 124, extend radially away from the catheter 106, bend distally to a position which is axially distal to the distal catheter segment 107 or its distal primary opening 126, extend therefrom radially inwards towards the radial position of the catheter 106, and then extend proximally to connect with the catheter 106 at a second attachment region which is distal to the openings 118 and 124. In some examples, the catheter 106 can define a step at its distal end, into which the cuff wall 134 can extend at the second attachment region. In some examples, the cuff wall 134 can be connected to an inner surface of the catheter 106 at the second attachment region. In some examples, the portion of the cuff 132 extending distally from the distal primary opening 126 of catheter 106 can define a generally tapering configuration.

[0083] As mentioned, when the medical tube assembly 100 is in its assembled configuration, the solvent introduction lumen 114 extends from a solvent introduction port 116 at the proximal portion 102 of the assembly 100, to an introduction lumen opening 118 at the distal portion 128 exposed to the cuff cavity 136. The draining lumen 120 extends from a draining port 122 at the proximal portion 102 of the assembly 100, to a draining lumen opening 124 exposed to the cuff cavity 136. The primary lumen 108 is fluidly sealed from the solvent introduction lumen 114 and the draining lumen 120, while the cuff cavity 136 is in fluid communication with both the solvent introduction lumen 114 and the draining lumen 120 via respective introduction lumen opening 118 and draining lumen opening 124.

[0084] The term “solid,” as used herein, relates to a hardened material that retains its shape under moderate stress or pressure or mere gravity. It is to be understood that solid filler material 150 is referred herein to be in a solid state when it is not dissolved in any solvent, e.g., when provided neat. Several of the present examples may relate to the same material upon dissolution in a solvent. In such examples, the solid filler material 150 will lose its solidity, as can be understood to the person having ordinary skill in the art. The term “solvent” is intended to mean a compound that is liquid at room temperature and is capable of dissolving at least one solid or semi solid.

[0085] The solid filler material 150 may be provided in a low-density non-condense form. It is to be understood that in this context, a low-density form of material does not require that the material from which the low-density form is constructed, is itself a low density solid material. Low-density form may include “fluffy” solid forms that have a large portion of voids therein, such that the volume assumed thereby is greater that the volume assumed by a condense form of the same solid material.

[0086] The term “semi-solid,” as used herein, refers to a material state intermediate between a solid and a liquid. A semi-solid may maintain its own shape to some degree and resist flow under mild gravitational forces, yet deform, flow, or conform under applied pressure. Semisolids are typically characterized by a partially structured three-dimensional matrix that provides structural integrity while allowing reversible deformation or displacement. In the context of the present invention, semi-solids may include, but not limited to, porous, particulate, or gel-based materials, such as hydrogels (e.g., hardened hydrogels), that occupy a defined space, conform to surrounding structures, and can be subsequently dissolved, degraded, or flushed to allow removal or detachment of the surrounding elements.

[0087] In some examples, the low-density solid or semi solid filler material 150 has a density of no more than 3gr / cm3, no more than 2gr / cm3, no more than 1.5gr / cm3, no more than lgr / cm3, no more than 0.75gr / cm3, no more than 0.5gr / cm3or no more than 0.25gr / cm3. Each possibility represents a separate example.

[0088] In some examples, the solid or semi solid filler material 150 is a porous material. In some examples, the solid or semi solid filler material 150 has a porosity in the range of at least 10%, 25%, at least 50% or at least 75%. Each possibility represents a separate example.

[0089] The term “porous,” as used herein means an object that includes void(s) within a solid matrix. The term is not limited to whether the voids are continuous (e.g., non-cellular foam) or isolated (e.g., cellular foam). The term is also not limited to the shape of the void(s), and includes both rounded voids, such as the bubbles inside a sponge, and channels, such as the voids between the fibers of cotton candy. Typically, porous objects have porosity of at least 10%. Both solids and semi-solids may be porous, for example, Song et al. (Song, X.; Zhu, C.; Fan, D.; Mi, Y.; Li, X.; Fu, R.Z.; Duan, Z.; Wang, Y.; Feng, R.R. A Novel Human-Like Collagen Hydrogel Scaffold with Porous Structure and Sponge-Like Properties. Polymer 2017, 9, 638) discloses hydrogel scaffold with porous structure and sponge-like properties, and the hydrogels porosities as measured gravimetrically via ethanol uptake and weight differences, and Tang et al. (Tang, Z.; Yu, M.; Mondal, A.K.; Lin, X. Porous Scaffolds Based on Polydopamine / Chondroitin Sulfate / Polyvinyl Alcohol Composite Hydrogels. Polymers 2023, 75, 271) discloses porous scaffolds based on hydrogels, and the hydrogel porosities as evaluated from image analysis of SEM micrographs.

[0090] The term “porosity,” as used herein means the proportion of voids per unit volume of a solid or semi solid object.

[0091] In some examples, the porous material is selected from the group consisting of: a sintered solid, a fibrous solid, a foam and a sponge. Each possibility represents a separate example.

[0092] The term “sintered,” as used herein is not to be construed to be limited to a product made using any specific sintering process, but to any product in which the resulting material presents a number of particles bonded together and forming a body having pores.

[0093] The solid or semi solid filler material 150 may include a plurality of particles, which are rigid in form such that they occupy a portion of the cuff cavity 136 and force the internal retention member 130 to assume its expanded profile to retain the tube assembly 100 secured to the patient 10.

[0094] In some examples, the solid or semi solid filler material 150 is at least partially soluble in an aqueous medium. In some examples, the solid or semi solid filler material 150 is soluble in an aqueous medium.

[0095] The term “partially soluble” relates to a material, which has a solubility of at least lOgr / L in a specific solvent medium at 25°C. The term “soluble” relates to a material, which has a solubility of at least lOOgr / L in a specific solvent medium at 25°C.

[0096] The phrases “soluble in an aqueous medium” and “partially soluble in an aqueous medium” relate to the solubility of material in any type of aqueous composition, which comprises at least 50% water. Unless specified otherwise, the term “aqueous medium” is not limited to pH. For example, calcium carbonate, which is highly soluble in acidic conditions (>100gr / L at water pH<2) is considered to be soluble in an (acidic) aqueous medium, despite being sparingly soluble in basic conditions. Other optional filler materials may be soluble in both basic and acidic aqueous media, for example sodium chloride has a solubility of around 360gr / L at a broad pH and temperature range, and sucrose has a temperature dependent solubility (about 260gr / L at 50°C and about 420gr / L at 90°C), but which is not significantly affected by pH. It is to be understood that the aqueous medium is a liquid aqueous medium.

[0097] In some examples, the solid or semi solid filler material has a solubility of at least lOgr / L, at least 25gr / L, at least 50gr / L, at least 75gr / L or at least lOOgr / L in the aqueous medium. Each possibility represents a separate example.

[0098] As known in the art, solubility is affected by temperature and pH. In general, the solubility is increased with temperature elevation. Acidic compounds are more soluble in basic aqueous media, whereas basic compounds (e.g., carbonates) compounds are more soluble in acidic aqueous media. Preferably, in some examples, the filler material, the aqueous medium, or both are adjusted such that the filler material has a solubility as defined herein in the aqueousmedium. For example, the medical tube assembly 100 may include a solvent container, which contains a solvent, which comprises the aqueous medium, as specified herein. The properties of the aqueous medium, e.g., pH and / or temperature, may be adjusted, so that the filler material is at least partially soluble (or soluble) therein, which may allow convenient and quick flushing of a solution form upon the dissolution of the filler material in the aqueous medium, in some examples. Also, in some examples, the solvent may be selected based on regulatory and / or safety requirement, and the solid or semi solid material may be selected so that it is soluble within the chosen solvent.

[0099] In some examples, the aqueous medium in which the solid or semi solid filler material 150 is at least partially soluble has pH in the range of 2 to 8.

[0100] In some examples, the solid or semi solid filler material 150 is a solid filler material. In some examples, the solid or semi solid filler material 150 is a semi solid filler material.

[0101] In some examples, the solid filler material 150 comprises at least one salt, at least one solid sugar or a combination thereof. Advantageously, the solid filler material 150 can have a long expiration date, e.g., of over 1 year, for extending the storage period of the present tube assembly 100. In some examples, the solid filler material 150 comprises a gel. In some examples, the solid filler material 150 comprises a hydrogel. In some examples, the solid filler material 150 comprises a hardened hydrogel. Advantageously, the solid or semi solid filler material 150 can also be a material that is safe to use, for example it can be approved for use in medical devices by the regulatory authorities, such as the Food and Drug Administration.

[0102] In some examples, the solid filler material 150 comprises at least one salt, at least one sugar, or both.

[0103] In some examples, solid filler material 150 comprises at least one sugar. In some examples, the sugar comprises sucrose.

[0104] In some examples, the solid filler material 150 comprises at least one salt. In some examples, the salt is selected from the group consisting of: sodium salt, potassium salt and calcium salt. In some examples, the salt is selected from the group consisting of: halide salt, phosphate salt, sulfate salt, carbonate salt and bicarbonate salt. In some examples, the halide is chloride. In some examples, the solid filler material 150 is selected from the group consisting of: sodium chloride, potassium chloride, calcium chloride, calcium carbonate, sodium carbonate, potassium carbonate, calcium bicarbonate, sodium bicarbonate, potassium bicarbonate and a combination thereof.

[0105] According to some embodiments, the solid or semi-solid filler material 150 further include a radiocontrasting agent.

[0106] The term “radiocontrasting agent,” as used herein, refers to a compound or composition administered or applied to improve the visibility of internal features or materials in radiographic imaging techniques, such as X-ray or computed tomography (CT). Radiocontrasting agents typically function by selectively absorbing or scattering radiation and may include iodine-based, barium-based, or particulate agents.

[0107] Specifically, as detailed herein, the gastrostomy tube implantation procedure to place a gastrostomy tube is known as a gastrostomy and can be performed radiologically. For improved visualization of the filling and distribution of the solid or semi solid filler material 150 within the internal retention member 130, a radiocontrasting agent may be added to the filler material 150 composition, and observed during the procedure using a radiograph.

[0108] In some examples, the solid or semi solid filler material 150 is particulate. In some examples, the solid or semi solid filler material 150 comprises a plurality of solid or semi solid particles. In some examples, the solid or semi solid particles have a mean particle size in the range of 0.5 mm to 4 mm, 0.5 mm to 3 mm or 0.5 mm to 2 mm, including each value and subrange within the specified range. Each possibility represents a separate example.

[0109] In some examples, the particles have a shape which is not completely spherical, e.g., oblate spheroid or ellipsoid, having a more than a single diameter, and wherein the largest diameter is equal to or greater than 0.5 mm.

[0110] The particle size of the solid or semi solid filler material 150 can be dictated by two considerations: (a) smaller particle size can facilitate dissolution of the solid or semi solid filler material 150 in the aqueous medium; and (b) larger particle size can prevent exiting of the solid or semi solid filler material 150 from the cuff cavity 136 (e.g., through the introduction lumen opening 118 and / or the draining lumen 120). The particle size / diameter in the range of 0.5 mm to 4 mm was found to satisfy both requirements.

[0111] In addition to the absolute size / diameter requirements of the solid or semi solid filler material 150 particles, a diameter relative to the introduction lumen opening 118 and / or draining lumen opening 124 may be required so that the particles will be prevented from penetrating the tube flushing channel 113 and tube draining channel 119. Thus, in some examples, the solid or semi solid filler material 150 comprises particles having diameters larger than a diameter of the draining lumen opening 124 (not shown). In some examples, at least 90%, at least 95%, at least 99% or each one of the particles has a diameter larger than the diameter of the draining lumen opening 124. In some examples, the particles have diameters at least 5%, at least 10%, at least 20% or at least 30% larger than the diameter of the draining lumen opening 124. In some examples, the solid or semi solid filler material 150 comprisesparticles having diameters larger than a diameter of the introduction lumen opening 118 (not shown). In some examples, at least 90%, at least 95%, at least 99% or each one of the particles has a diameter larger than the diameter of the introduction lumen opening 118. In some examples, the particles have diameters at least 5%, at least 10%, at least 20% or at least 30% larger than the diameter of the introduction lumen opening 118. Specifically, without wishing to be bound by any theory of mechanism of action, as the particles may vary is size and shape, and may include semi-solids, which can condense under pressure and penetrate smaller orifices, the particles and / or openings may be selected such that the openings are significantly smaller than the particles.

[0112] In some examples, particles of the solid or semi solid filler material 150 are small-sized and movable relative to each other inside the cuff cavity 136, such that when the tube assembly 100 is inserted into a patient body, while the internal retention member 130 is already filled with the solid or semi solid filler material 150, passage through narrower pathways, such as through the esophagus 20, exerts bending forces on the internal retention member 130, causing particles of the solid or semi solid filler material 150 to slide over each other such that the internal retention member 130 can deform and assume a smaller profile, allowing it to pass through the esophagus 20 (or other narrow passageway), and reverting to the free-state outer diameter of the internal retention member 130 upon reaching the stomach 30, for example.

[0113] When the solid filler material comprises a flexible sponge-like material and / or a mesh structure, the sponge or mesh structure is configured to passively bend to assume a smallenough profile when passed through a narrow passageway such as the esophagus 20, and can be further configured to resiliently return to a naturally full-expanded configuration thereof when released into a larger volume, such as that of the stomach 30.

[0114] In some examples, particles of the solid or semi solid filler material 150 can be spheroid in shape or otherwise rounded so as to define an atraumatic shape that will eliminate risk of scratching or otherwise damaging the cuff wall 134 when contacted thereby.

[0115] In addition, without wishing to be bound by any theory of mechanism of action, spherical or round-shaped particles have a kinetic advantage of being dissolved quickly, in general, compared to other shapes of particles.

[0116] When removal of the medical tube assembly 100 is desired, an appropriate solvent can be administered via flushing port 116 and through the solvent introduction lumen 114 into the cuff cavity 136. For example, a syringe or a pump (not shown) can be connected to the solvent introduction port 116, so as to introduce solvent, via lumen 114 and introduction lumen opening 118, to fill the cuff cavity 136 containing the solid or semi solid filler material 150. The solventserves to dissolve the solid or semi solid filler material 150, creating a mixture (e.g., a solution) that can be drained from the cuff cavity 136, via opening 124 and draining lumen 120, towards draining port 122. For example, an external suction means (not shown), such as an external pump or syringe, can be connected to the draining port 122.

[0117] The term “suction,” as used herein, means the flow of fluid (e.g., a liquid) towards a partial vacuum or region of lower pressure. The pressure gradient between this region at the draining port 122, and the ambient pressure within cuff cavity 136, will propel matter toward the low-pressure area. The terms “suction means” and “source of suction,” as used herein, encompass any device capable of drawing a fluid through a lumen, such as the draining lumen 120. Such devices may include, but are not limited to, vacuum pumps, suction pumps, syringes, vacuum blowers, suction systems / plenums commonly found in surgical suites, etc.

[0118] In some examples, the present medical tube assembly 100 is provided as a kit that further comprises a dedicated container for containing the solvent.

[0119] In some examples, the solvent comprises an aqueous medium. The aqueous medium can be as described herein with respect to the solubility of the solid or semi solid filler material 150. In some examples, the aqueous medium has pH in the range of 2 to 8.

[0120] In some examples, the various ports 110, 112, 116 and / or 122 can be branched from a common multi-port hub 104 at the proximal portion 102 of the tube assembly 100. In some examples, the medical tube assembly 100 can further comprise an external retention member 138 (shown in Fig. 3 but removed from view in Fig. 4 for illustrative purpose) disposed over the catheter 106 at the proximal portion 102 of the assembly 100. In some examples, the external retention member 138 can be slidably movable over the catheter 106. The internal retention member 130 is configured to press against the stomach wall 32, and the external retention member 138 is configured to be placed adjacent the epidermis of abdominal wall 12. Cooperation between both retention members 130 and 138 is configured to apply proper tension on the catheter 106 to prevent undesirable movement of the catheter 106 through the stoma 40.

[0121] Fluid introduction via lumen 114, and suction via lumen 120, can be optionally synchronized with each other to provide the same flow such that the volume of fluid introduced into the cuff cavity 136 through port 116 and lumen 114 is also evacuated through lumen 120 and port 122. In some examples, solvent can be introduced via lumen 114 into the cavity 136 and allowed to fill the cuff cavity 136 for a short duration of time prior to initiation of suction via draining port 122, so as to allow the solvent to at least partially dissolve the solid or semi solid filler material 150 over this limited time duration. The term “at least partially dissolve”can refer to either substantially full dissolution or partial dissolution to the extent that the remaining undissolved material is flushable (e.g., it includes few enough and small enough undissolved material) with the solvent in the route described herein.

[0122] In some examples, fluid can be fed into solvent introduction port 116 continuously. In some examples, solvent can be fed into solvent introduction port 116 intermittently. In some examples, fluid suction through draining port 122 is continuous. In some examples, fluid suction through draining port 122 is intermittent. In some examples, fluid supply into solvent introduction port 116 and suction via draining port 122 are performed in a synchronous manner. In some examples, fluid supply into solvent introduction port 116 and suction via draining port 122 can be performed asynchronously.

[0123] In some examples, a one-way valve can be further attached to, or positioned in, any of the ports 110, 112, 116 and / or 122. For example, the solvent introduction port 116, can include an inlet one-way valve 180 (see Figs. 3A-4) configured to allow fluid flow in a distal direction towards the cuff cavity 136 and prohibit backflow out of the port 116. In some examples, an outlet one-way valve 182 (see Figs. 3A-4) can be attached to, or positioned in, the draining port 122, configured to allow proximally directed fluid flow out of the port 122 and restrict distally- oriented flow back into the cuff cavity 136.

[0124] It is to be understood that one-way valves 180 and 182 are shown in Figs. 3A-4 in ports 116 and 112, respectively, by way of illustration and not limitation, and that any of the ports can be provided with or without one-way valves. For example, any of the primary port 110 and / or secondary port 112 can be provided with an optional inlet one-way valve 180 configured to allow fluid flow in a distal direction into the primary lumen, and prohibit backflow out of the corresponding port.

[0125] In some examples, a cap 176 can be further provided to seal any of the ports 110, 112, 116 and / or 122. A cap 176 can be optionally connected to the corresponding port by a flexible arm 178 or any other type of connector. It is to be understood that caps 176 and optional connector arms 178 thereof are shown in Fig. 3A-4 in connection with the primary port 110 and secondary port 112 by way of illustration and not limitation, and that any of the ports can be provided with or without caps 176. For example, during the time period in which the medical tube assembly 100 is secured to patient 10 prior to initiation of removal thereof, both the solvent introduction port 116 and the draining port 122 can be capped to prevent release of material from these ports during this time period. The caps can be removed, in such cases, prior to connecting the solvent introduction port 116 to a pump or other fluid source, and connecting the draining port 122 to an appropriate suction means.

[0126] It is to be understood that any of the ports can optionally include a cap 176, a one-way valve, or both. In some examples, at least some of the ports include indicia or markings configured to designate their type or role. For example, when caps 176 are provided, differently colored or otherwise marked caps can be used to distinguish between the different ports, such as to distinguish between the solvent introduction port 116 and the draining port 122. In some examples, markings can be provided over the ports themselves, such as on an outer surface of the ports, to similarly distinguish between the type or role of different ports.

[0127] Fig. 5A is a partial cross sectional view of the medical tube assembly 100 anchored to the patient's body, such as by extending across stoma 40 through the abdominal wall 12 and stomach wall 32, wherein the internal retention member 130 sits against the stomach wall 32 in its expanded configuration, thereby anchoring the medical tube assembly 100 to the patient. Enteral fluid can be periodically introduced in this state, via primary lumen 108 and out of the distal primary opening 126, into the stomach 30, without interacting with any of the cuff cavity 136 and the lumens 114, 120 exposed thereto. The solid or semi solid filler material 150 disposed inside the cuff 132 is configured to instill sufficient rigidity in the cuff to allow the internal retention member 130 to maintain its expanded annular configuration when pressed against the stomach wall 32.

[0128] When removal of the medical tube assembly 100 is desired, solvent can be introduced via lumen 114 and out of the opening 118 into the cuff cavity 136 to substantially dissolve the solid or semi solid filler material 150, and the formed solution can be then evacuated via opening 124 and lumen 120, as described above, until the cuff cavity 136 is emptied. Advantageously, utilization of two separate lumens 114, 120 and respective ports thereof 116, 122, allows for simultaneous and optionally continuous solvent introduction and suctioning of the resulting solution, as the process of dissolving the solid or semi solid filler material 150 can be gradual, and require ongoing flow from the introduction lumen 114, through the cavity 136, and out of the cavity 136 through the draining lumen 120. In some examples, aqueous medium introduced into the cuff cavity 136 through port 116 and lumen 114 can at least partially dissolve particles of the solid or semi solid filler material 150 so as to reduce their diameter to a size small enough that allows them to be flushed through the opening 124, via lumen 120 and out of the port 122.

[0129] In some examples, the solid or semi solid filler material 150 can be colored such that when dissolved in the solvent, a colored solution can be visually detected by the naked eye as it evacuated out of the draining port 122, while the solvent itself can be transparent (or can have a different color). In this manner, a user can visually track the color of the evacuated fluidsuch that when no longer colored by the color of the solid or semi solid filler material 150, the original transparent or differently colored solvent ejected from the draining port 122 may be indicative of the fact that the solid or semi solid filler material 150 has been sufficiently dissolved and introduction of the solvent into the assembly may be ceased. Thus, in some examples, the solid or semi solid filler material 150 may further include a colorant. The colorant, in some examples, is safe to use, for example it can be approved for use in medical devices by the regulatory authorities, such as the Food and Drug Administration.

[0130] When the internal retention member 130 is emptied, the medical tube assembly 100 can be extracted from within the body cavity (e.g., cavity of stomach 30) and through the stoma 40, such as be being outwardly pulled in the direction of arrow 80, as illustrated in Fig. 5B. Due to the pliability of the cuff wall 134, in the absence of rigid solid or semi solid filler material 150 residing in cuff cavity 136 (or a small enough residual amount of the solid or semi solid filler material 150 that may remain in the cavity 136), a health attendant can extract the internal retention member 130 through the stoma 40. In so doing, the inner walls of stoma 40 urge the internal retention member 130 to a compacted state thereof, by compressing and / or bending the cuff wall 134. As described above, the internal retention member 130 can optionally extend past the distal end of catheter 106 or its distal primary opening 126, such that it can assume a relatively narrow profile when forced to compress when pulled through stoma 40, optionally tapering to a smaller size in the distal direction.

[0131] It is to be understood that a circular disc-shaped external retention member 138 is shown in Fig. 2A-2C by way of illustration and not limitation, and that an external retention member 138 can have any of a variety of shapes, such as circular, triangular, star-shaped, and the like.

[0132] While a doughnut or disc-shaped internal retention member 130ais illustrated in Figs. 3A-4, it is to be understood that other shapes can be used. Fig. 7 illustrates a distal portion of an exemplary retention catheter assembly 105e, which can be structurally and functionally similar to any retention catheter assembly 105 described herein, except that the internal retention member 130eis shown to be cup-shaped. A cup-shaped configuration can be of advantage for easier extraction of the retention catheter assembly 105 from a patient’s body. For example, while a doughnut- shaped or disc-shaped internal retention member 130 is illustrated in Figs. 5A-5B, it is to be understood that any other type or shape is contemplated.

[0133] When a cup-shaped internal retention member 130eis used, it can collapse faster and in an easier manner to a smaller profile, optionally requiring a smaller pull force for extraction out of the corresponding body cavity. Other cuff shapes can be used, as long as the internalretention member 130 is designed, in its expanded state, to define a contact area with the anatomic wall (e.g., stomach wall 32) to retain the internal retention member 130 inside the body cavity 30.

[0134] As mentioned above, releasable tube anchoring is not limited to gastrostomy tubes, and while examples of medical tube assembly 100 are described throughout the current disclosure with reference to gastrostomy tubes, it is to be understood that a medical tube assembly 100 disclosed herein can be implemented as any other type of tube or catheter assembly mounted to a patient to provide fluid communication between a body cavity and the external environment. The target body cavity, which can be, in some cases, a cavity of a target organ against which an internal retention member 130 is anchored, is thus also selected according to the type of the medical tube assembly 100 is implemented as.

[0135] In some examples, the medical tube assembly 100 is implemented as a gastrostomy tube configured to provide nutrition into the stomach 30. In some examples, the medical tube assembly 100 is implemented as a nasojejunal or jejunostomy feeding tube configured to provide nutrition into the jejunum or the duodenum. In some examples, the medical tube assembly 100 is implemented as a nephrostomy catheter configured to drain urine from the kidney. In some examples, medical tube assembly 100 is implemented as a urine catheter configured to drain urine from the bladder. In some examples, medical tube assembly 100 is utilized to administer medicine into the patient body. In some examples, medical tube assembly 100 is utilized to supply oxygen to a patient in need thereof. In some examples, the medical tube assembly 100 is implemented as a peritoneal dialysis catheter configured to direct fluid (e.g., cleansing liquid) into and out of the peritoneal cavity.Some Examples of the Disclosed Implementations

[0136] Some examples of above-described implementations are enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more examples below are examples also falling within the disclosure of this application.

[0137] Example 1: A medical tube assembly comprising: a hub comprising a primary port, a solvent introduction port, and a draining port; a retention catheter assembly comprising: a catheter; an internal retention member configured to move between an expanded configuration and a compacted configuration, the internal retention member comprising a cuff attached to the catheter and surrounding the catheter at a distal segment of the catheter, wherein the cuff comprises a cuff wall defining an enclosed cuff cavity between the catheter and the cuff wall; and a solid or semi solid filler material disposed inside the cuff cavity, wherein the solid orsemi solid filler material is at least partially soluble in an aqueous medium; wherein the hub is releasably connectable to the catheter such that when the hub is connected to the catheter, the medical tube assembly defines: a primary lumen extending from the primary port to a distal primary opening at the distal catheter segment; a solvent introduction lumen extending from the solvent introduction port to an introduction lumen opening at the distal catheter segment; and a draining lumen extending from the draining port to a draining lumen opening at the distal catheter segment; wherein the introduction lumen opening and the draining lumen opening are exposed to the cuff cavity; and wherein the primary lumen is fluidly sealed from the solvent introduction lumen and the draining lumen.

[0138] Example 2: The medical tube assembly of any one of the examples herein, particularly example 1, wherein the hub further comprises a secondary port which is in fluid communication with the primary lumen, when the hub is connected to the catheter.

[0139] Example 3: The medical tube assembly of any one of the examples herein, particularly any one of examples 1-2, wherein the distal catheter segment is configured to reside inside a patient's body and a proximal catheter segment of the catheter is configured to extend out of the patient's body, when the medical tube assembly is secured to the patient's body.

[0140] Example 4 : The medical tube assembly of any one of the examples herein, particularly any one of examples 1-3, wherein the cuff wall is pre-shaped to assume the expanded configuration of the internal retention member, in a free state of the cuff.

[0141] Example 5 : The medical tube assembly of any one of the examples herein, particularly example 4, wherein the cuff wall is pre-shaped to a spheroid configuration.

[0142] Example 6: The medical tube assembly of any one of the examples herein, particularly example 4, wherein the cuff wall is pre-shaped to a doughnut- shaped configuration.

[0143] Example 7: The medical tube assembly of any one of the examples herein, particularly any one of examples 1-6, wherein an outer diameter defined by the internal retention member in its expanded configuration, is at least three times greater than an outer diameter defined by the catheter.

[0144] Example 8: The medical tube assembly of any one of the examples herein, particularly any one of examples 1-7, wherein the internal retention member is configured to assume its compacted configuration when the cuff cavity is emptied from the solid or semi solid filler material.

[0145] Example 9: The medical tube assembly of any one of the examples herein, particularly any one of examples 1-8, wherein the cuff wall is flexible enough to be passively folded or compressed, when the internal retention member is passed through a passageway that isnarrower than an outer diameter defined by the internal retention member in its expanded configuration.

[0146] Example 10: The medical tube assembly of any one of the examples herein, particularly any one of examples 1-9, wherein the solid or semi solid filler material is configured to instill sufficient rigidity in the cuff to allow the internal retention member to maintain its expanded configuration when pressed against a tissue wall.

[0147] Example 11: The medical tube assembly of any one of the examples herein, particularly any one of examples 1-10, wherein the solvent introduction lumen is configured to direct solvent into the cuff cavity.

[0148] Example 12: The medical tube assembly of any one of the examples herein, particularly any one of examples 1-11, wherein the draining lumen is configured to direct fluid out of the cuff cavity.

[0149] Example 13: The medical tube assembly of any one of the examples herein, particularly any one of examples 1-12, wherein the solid or semi solid filler material is particulate, and comprises a plurality of solid or semi solid particles.

[0150] Example 14: The medical tube assembly of any one of the examples herein, particularly example 13, wherein the solid or semi solid particles have an average particle size in the range of 0.5 mm to 4 mm.

[0151] Example 15: The medical tube assembly of any one of the examples herein, particularly any one of examples 13-14, wherein the solid or semi solid particles are spheroidal.

[0152] Example 16: The medical tube assembly of any one of the examples herein, particularly any one of examples 1-12, wherein the solid or semi solid filler material is porous.

[0153] Example 17: The medical tube assembly of any one of the examples herein, particularly example 16, wherein the porous solid or semi solid filler material has a porosity of at least 25%.

[0154] Example 18: The medical tube assembly of any one of the examples herein, particularly any one of examples 1-17, wherein the solid filler material comprises at least one salt or sugar.

[0155] Example 19: The medical tube assembly of any one of the examples herein, particularly example 18, wherein the solid filler material comprises sucrose.

[0156] Example 20: The medical tube assembly of any one of the examples herein, particularly example 18, wherein the solid filler material comprises a sodium salt, a potassium salt, a calcium salt or a combination thereof.

[0157] Example 21: The medical tube assembly of any one of the examples herein, particularly example 18 or 20, wherein the solid filler material comprises a halide, a bicarbonate or a combination thereof.

[0158] Example 22: The medical tube assembly of any one of the examples herein, particularly any one of examples 1-21, further comprising an external retention member configured to be disposed over the catheter at a catheter proximal segment thereof.

[0159] Example 23: The medical tube assembly of any one of the examples herein, particularly example 22, wherein the external retention member is slidably movable relative to the catheter.

[0160] Example 24: The medical tube assembly of any one of the examples herein, particularly any one of examples 1-23, wherein, when the hub is connected to the catheter: the primary lumen is defined by a hub primary channel of the hub being in fluid communication with a tube primary channel of the catheter; the solvent introduction lumen is defined by a hub flushing channel of the hub being in fluid communication with a tube flushing channel of the catheter; and the draining lumen is defined by a hub draining channel of the hub being in fluid communication with a tube draining channel of the catheter.

[0161] Example 25: The medical tube assembly of any one of the examples herein, particularly example 24, wherein hub comprises: an extended primary end portion configured to be inserted into the tube primary channel; an extended flushing end portion configured to be inserted into the tube flushing channel; and an extended draining end portion configured to be inserted into the tube draining channel.

[0162] Example 26: The medical tube assembly of any one of the examples herein, particularly example 25, wherein at least one of the extended primary end portion, the extended flushing end portion, and / or the extended draining end portion, is tapered in a distal direction.

[0163] Example 27: The medical tube assembly of any one of the examples herein, particularly any one of examples 1-26, wherein the internal retention member is configured to reside inside a stomach, and wherein the primary lumen is a feeding lumen configured to introduce enteral nutritional products into the stomach.

[0164] Example 28: The medical tube assembly of any one of the examples herein, particularly any one of examples 1-27, further comprising a solvent container, which comprises the solvent, wherein the solvent comprises the aqueous medium in which the solid or semi solid filler material is at least partially soluble therein.

[0165] Example 29: The medical tube assembly of any one of the examples herein, particularly example 28, wherein the solid or semi solid filler material has a solubility of at least lOOgr / L in the aqueous medium.

[0166] Example 30: The medical tube assembly of any one of the examples herein, particularly any one of examples 28-39, wherein the aqueous medium is selected from the group consisting of: an acidic aqueous solution, a basic aqueous solution and a pH neutral aqueous solution.

[0167] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate examples, may also be provided in combination in a single example. Conversely, various features of the invention, which are, for brevity, described in the context of a single example, may also be provided separately or in any suitable sub-combination or as suitable in any other described example of the invention. No feature described in the context of an example is to be considered an essential feature of that example, unless explicitly specified as such.

[0168] In view of the many possible examples to which the principles of the disclosure may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope. Rather, the scope is defined by the following claims. We therefore claim all that comes within the scope and spirit of these claims.

Claims

CLAIMS1. A medical tube assembly comprising: a hub comprising a primary port, a solvent introduction port, and a draining port; a retention catheter assembly comprising: a catheter; an internal retention member configured to move between an expanded configuration and a compacted configuration, the internal retention member comprising a cuff attached to the catheter and surrounding the catheter at a distal catheter segment of the catheter, wherein the cuff comprises a cuff wall defining an enclosed cuff cavity between the catheter and the cuff wall; and a solid or semi solid filler material disposed inside the cuff cavity, wherein the solid or semi solid filler material is at least partially soluble in an aqueous medium; wherein the hub is releasably connectable to the catheter such that when the hub is connected to the catheter, the medical tube assembly defines: a primary lumen extending from the primary port to a distal primary opening at the distal catheter segment; a solvent introduction lumen extending from the solvent introduction port to an introduction lumen opening at the distal catheter segment; and a draining lumen extending from the draining port to a draining lumen opening at the distal catheter segment; wherein the introduction lumen opening and the draining lumen opening are exposed to the cuff cavity; and wherein the primary lumen is fluidly sealed from the solvent introduction lumen and the draining lumen.

2. The medical tube assembly of claim 1, wherein the hub further comprises a secondary port which is in fluid communication with the primary lumen, when the hub is connected to the catheter.

3. The medical tube assembly of any one of claims 1-2, wherein the distal catheter segment is configured to reside inside a patient's body and a proximal cathetersegment of the catheter is configured to extend out of the patient's body, when the medical tube assembly is secured to the patient's body.

4. The medical tube assembly of any one of claims 1-3, wherein the cuff wall is pre- shaped to assume the expanded configuration of the internal retention member, in a free state of the cuff.

5. The medical tube assembly of claim 4, wherein the cuff wall is pre-shaped to a spheroid configuration.

6. The medical tube assembly of claim 4, wherein the cuff wall is pre-shaped to a doughnut- shaped configuration.

7. The medical tube assembly of any one of claims 1-6, wherein an outer diameter defined by the internal retention member in its expanded configuration, is at least three times greater than an outer diameter defined by the catheter.

8. The medical tube assembly of any one of claims 1-7, wherein the internal retention member is configured to assume its compacted configuration when the cuff cavity is emptied from the solid or semi solid filler material.

9. The medical tube assembly of any one of claims 1-8, wherein the cuff wall is flexible enough to be passively folded or compressed, when the internal retention member is passed through a passageway that is narrower than an outer diameter defined by the internal retention member in its expanded configuration.

10. The medical tube assembly of any one of claims 1-9, wherein the solid or semi solid filler material is configured to instill sufficient rigidity in the cuff to allow the internal retention member to maintain its expanded configuration when pressed against a tissue wall.

11. The medical tube assembly of any one of claims 1-10, wherein the solvent introduction lumen is configured to direct solvent into the cuff cavity.

12. The medical tube assembly of any one of claims 1-11, wherein the draining lumen is configured to direct fluid out of the cuff cavity.

13. The medical tube assembly of any one of claims 1-12, wherein the solid or semi solid filler material is particulate, and comprises a plurality of solid or semi solid particles.

14. The medical tube assembly of claim 13, wherein the solid or semi solid particles have an average particle size in the range of 0.5 mm to 4 mm.

15. The medical tube assembly of any one of claims 13-14, wherein the solid or semi solid particles are spheroidal.

16. The medical tube assembly of any one of claims 1-12, wherein the solid or semi solid filler material is porous.

17. The medical tube assembly of claim 16, wherein the porous solid or semi solid filler material has a porosity of at least 25%.

18. The medical tube assembly of any one of claims 1-17, wherein the solid filler material comprises at least one salt or sugar.

19. The medical tube assembly of claim 18, wherein the solid filler material comprises sucrose.

20. The medical tube assembly of claim 18, wherein the solid filler material comprises a sodium salt, a potassium salt, a calcium salt or a combination thereof.

21. The medical tube assembly of claim 18 or 20, wherein the solid filler material comprises a halide, a bicarbonate or a combination thereof.

22. The medical tube assembly of any one of claims 1-21, further comprising an external retention member configured to be disposed over a proximal catheter segment of the catheter.

23. The medical tube assembly of claim 22, wherein the external retention member is slidably movable relative to the catheter.

24. The medical tube assembly of any one of claims 1-23, wherein, when the hub is connected to the catheter: the primary lumen is defined by a hub primary channel of the hub being in fluid communication with a tube primary channel of the catheter; the solvent introduction lumen is defined by a hub flushing channel of the hub being in fluid communication with a tube flushing channel of the catheter; and the draining lumen is defined by a hub draining channel of the hub being in fluid communication with a tube draining channel of the catheter.

25. The medical tube assembly of claim 24, wherein the hub comprises: an extended primary end portion configured to be inserted into the tube primary channel; an extended flushing end portion configured to be inserted into the tube flushing channel; andan extended draining end portion configured to be inserted into the tube draining channel.

26. The medical tube assembly of claim 25, wherein at least one of the extended primary end portion, the extended flushing end portion, and / or the extended draining end portion, is tapered in a distal direction.

27. The medical tube assembly of any one of claims 1-26, wherein the internal retention member is configured to reside inside a stomach, and wherein the primary lumen is a feeding lumen configured to introduce enteral nutritional products into the stomach.

28. The medical tube assembly of any one of claims 1-27, further comprising a solvent container, which comprises the solvent, wherein the solvent comprises the aqueous medium in which the solid or semi solid filler material is at least partially soluble therein.

29. The medical tube assembly of claim 28, wherein the solid or semi solid filler material has a solubility of at least lOOgr / L in the aqueous medium.

30. The medical tube assembly of any one of claims 28-29, wherein the aqueous medium is selected from the group consisting of: an acidic aqueous solution, a basic aqueous solution and a pH neutral aqueous solution.

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