Improved Nutrition Catheter

Abstract

An improved feeding catheter for supplying / recycling chyme to a distal stoma is provided. The improved catheter includes a hollow tube having an end for insertion into the stoma and a second end adapted to be connected to a fluid source. The first end includes a retention mechanism including a plurality of ribs extending outwardly and longitudinally away from the tube and terminating at a nose junction. The web wall extends between at least one pair of adjacent ribs, the ribs further defining a side opening configured for fluid to drain into the gastrointestinal tract. Additionally, the retention mechanism is movable between a relaxed state and an extended state for insertion through the distal opening, the maximum width of the retention mechanism in the extended state being less than the maximum width of the retention mechanism in the relaxed state.

Description

[Technical field]

[0001] The present invention relates to an improved feeding catheter, more particularly, a feeding catheter adapted for use with a stoma device, and more particularly, to an improved feeding catheter for introducing fluid contents into a distal portion of the gastrointestinal tract. [Background technology]

[0002] Colorectal cancer is a cancer that originates in the colon or rectum and is currently the third most prevalent cancer in the world. Patients with colorectal cancer usually need to use a stoma bag after surgery. Ileostomy remains the cornerstone of colorectal cancer treatment, especially rectal cancer. In an ileostomy, the ileum (distal small intestine) is divided and one or both ends are placed against the patient's skin so that the digestive contents can flow into the stoma bag. Traditionally, the digestive contents are collected in the stoma bag, bypassing the colon, which would normally reabsorb fluids, electrolytes, microflora and nutrients.

[0003] A loop ileostomy is a common type of ileostomy intended to temporarily divert digestive contents while the digestive tract distal to the ileum heals after colorectal surgery. Once healed, the intention is to reverse the loop ileostomy by rejoining the divided ends of the intestine. A radiological study is usually performed before reversal surgery to ensure healing is occurring and that there is no intestinal leakage. Patients usually wait at least 1-2 weeks before the digestive tract distal to the ileum is sufficiently healed to perform a radiological leak study and consider reversal surgery.

[0004] After leak testing, some patients may have an ileostomy "early recovery" within 1-2 weeks after surgery. However, it is more common for ileostomy reversal to occur around 6-12 weeks after surgery. Reversal is not considered safe 2-6 weeks after surgery due to the presence of internal adhesions that increase surgical risk. If the patient is undergoing chemotherapy, the ileostomy may need to be maintained for several months until chemotherapy is completed in order to safely perform the surgery.

[0005] As digestive contents are expelled from the patient's body, patients may suffer from loss of fluids, electrolytes, and nutrients because an ileostomy bypasses the colon, which absorbs water, electrolytes, and certain nutrients. As a result, patients may experience dehydration and subsequent kidney damage, and may require readmission for management with intravenous fluids, known as parenteral nutrition. Parenteral nutrition is expensive and carries the risk of pipeline infection and liver complications. In addition, patients may require additional medications (to slow intestinal transit), antibiotics, fecal transplants, or poorly tolerated oral rehydration solutions. All of this requires additional hospital resources.

[0006] Some patients have "high output" ileostomies and are at increased risk of dehydration and renal damage and may require additional management with medications that slow intestinal transit or oral rehydration solutions, which may be poorly tolerated. Stoma patients often use more hospital resources because they require additional management or readmission for stoma-related dehydration.

[0007] Ileostomy patients undergoing chemotherapy may also suffer from excessive stoma output during chemotherapy, leading to dose reductions and suboptimal treatment. Leaving the colon without internal nutrition for extended periods may also increase the risk of "preresection syndrome," a poor bowel function after rectal cancer surgery. Preresection syndrome is associated with poor quality of life in colorectal cancer survivors.

[0008] When the ileostomy is reversed, patients may experience ileus (slow recovery of bowel function). This is in part due to poor gut condition distal to the ileostomy caused by nutritional deficiencies. Additionally, loop ileostomy depletes the bacterial microbiome that normally occupies the colon, which contributes to colonic health, and as a result, patients undergoing reversal surgery may experience Clostridium difficile infection. Clostridium difficile infections can result in longer hospital stays and severe illness, requiring additional treatment including antibiotics, surgery, and fecal transplants.

[0009] Another group of patients who may need a stoma bag are those with enterocutaneous fistulas, which are abnormal connections between the intestine and the skin. Skin-enteric fistulas can develop due to complications from surgery, trauma, or another disease process, such as inflammatory bowel disease. Some newborns can develop enterocutaneous fistulas or stomas due to a disease called necrotizing enterocolitis, in which parts of the intestinal tract die.

[0010] A "stoma" bag is usually placed over the external enteral fistula to collect digestive contents. Patients with fistulas often experience malnutrition and may depend on supplemental nutrition, such as parenteral nutrition given intravenously. Parenteral nutrition is usually an expensive and risky treatment due to the possibility of tract infection and liver damage.

[0011] The nutrient recycling device can be used to collect digestive contents from the proximal opening of the ileum into a stoma bag and recycle / transfer the contents from the stoma bag to the distal opening of the ileum. For example, the applicant's nutrient recycling device disclosed in PCT / IB2018 / 057792 can recycle digestive contents from the proximal opening to the distal opening of the ileum. These devices can reduce or eliminate dehydration and renal dysfunction caused by traditional ileostomy. The nutrient recycling device of the present invention can also reduce the waste content management burden associated with stoma bags.

[0012] Catheters are used to introduce the digestive contents collected in the stoma bag to the distal opening of the ileum. However, conventional catheters are generally not well suited for use in delivering digestive contents from the stoma bag to the distal opening of the ileum. For example, other conventional types of catheters include balloon catheters, Malecot catheters, Pezzer catheters, etc. Balloon catheters retain themselves by inflating the balloon. Balloon catheters have the problem that they can be overinflated, which can cause damage or rupture of the intestinal tract. Another disadvantage of balloon catheters is that they cannot be cut to length, as the inflation passage would also be cut and the balloon would deflate.

[0013] The Malecot and Pezzer catheters have more openings and sharper edges, which can cause granulation that promotes tissue ingrowth into the tube, creating problems that can require surgery to remove.

[0014] What is desired is, and is provided herein, an improved feeding catheter customized to supply contents from a bag, such as a flexible stoma bag, placed over a stoma or fistula to the distal opening of the ileum.

[0015] External sources of information, including patent specifications and other literature, are referenced herein, typically to provide background for discussing features of the invention. Unless otherwise stated, citation to such sources shall not be construed as an admission that such sources are prior art or form part of the common general knowledge in any jurisdiction.

[0016] With respect to this specification, when method steps are described in a sequence, the sequence does not necessarily imply that these steps are arranged in chronological order, unless there is another logical way to interpret the sequence.

[0017] It is an object of the present invention to provide an improved feeding catheter which overcomes or at least partially ameliorates some of the disadvantages discussed above, or at least provides a useful option for the public. Summary of the Invention

[0018] According to a first aspect, the present invention provides a feeding catheter adapted to deliver fluid to an opening of the gastrointestinal tract, comprising: a hollow tube and a retention mechanism adapted to retain at least a portion of the feeding catheter in a distal portion of the gastrointestinal tract; The hollow tube has a first end adapted to be inserted into a distal portion of the gastrointestinal tract through a distal opening; a second end adapted to be connected to a fluid source; a lumen defining a fluid passageway between the first end and the second end of the hollow tube; the retention feature is at or toward the first end of the hollow tube; an insertion end and a tail end at or toward the first end of the hollow tube; a plurality of ribs extending outwardly and longitudinally away from said hollow tube and terminating at a nose junction; a web wall extending completely between at least one pair of adjacent ribs; a side opening disposed between at least one pair of adjacent ribs and configured to allow fluid to exit the gastrointestinal tract; the retention mechanism includes a relaxed state and an extended state for insertion through the distal opening; The nutritional catheter is provided, wherein the maximum width of the retention mechanism in the expanded state is smaller than the maximum width of the retention mechanism in the relaxed state.

[0019] According to another aspect, the retention feature forms a partially open bulbous shape in the relaxed state.

[0020] According to another aspect, a pair of adjacent ribs forming said side outlet are absent said web walls.

[0021] According to another aspect, the side outlet defines a substantially circular opening.

[0022] According to another aspect, the retention mechanism includes a single sided exit. According to another aspect, the single sided outlet is disposed between a single pair of adjacent ribs. According to another aspect, adjacent ribs defining the side outlets are spaced apart a greater distance than adjacent ribs joined by the web wall. According to another aspect, the ribs forming the side outlets have an angular orientation of less than 180°.

[0023] According to another aspect, the ribs forming the side outlets have an angular orientation of about 140°.

[0024] According to another aspect, the side opening provides for the opening of most or all of the fluid from the feeding catheter outlet into the gastrointestinal tract. According to another aspect, the web wall is a flexible membrane.

[0025] According to another aspect, the web wall has a thickness less than a thickness of the plurality of ribs.

[0026] According to another embodiment, the web wall thickness is less than 20% of the rib thickness.

[0027] According to another embodiment, the thickness of the web wall is about 10% to 20% of the thickness of the rib.

[0028] According to another aspect, the web walls are configured to collapse generally inwardly in a stretched state.

[0029] According to another aspect, the web wall is configured to collapse between the ribs in a tensioned state.

[0030] According to another aspect, the web wall includes score lines that assist the web wall in collapsing when moved to the extended state.

[0031] According to another aspect, the scorelines are longitudinal indentations along the web walls.

[0032] According to another aspect, the lumen of the tube is adapted to receive an introducer.

[0033] According to another aspect, the introducer is configured to engage an inner surface of the nose joint to force the retention member to move from a relaxed state to an extended state.

[0034] According to another aspect, the retention mechanism further includes a pocket on an inner surface of the nose joint for receiving the tip of the introducer.

[0035] According to another aspect, the nose joint is radially opposed to the first end of the hollow tube.

[0036] According to another aspect, the nose joint is radially opposed to the first end of the hollow tube.

[0037] According to another embodiment, the retention mechanism includes 3 to 5 ribs.

[0038] According to another aspect, the retention feature includes three ribs.

[0039] According to another aspect, the hollow tube comprises: a neck portion disposed toward the first end; an expanded diameter portion disposed toward the second end, The enlarged diameter portion has a larger pipe diameter than the neck portion.

[0040] According to another aspect, the enlarged section comprises a length that is at least 40% of the length of the nutritional catheter and is adapted to be cut to a desired length.

[0041] According to another aspect, the enlarged section comprises a length that is at least 25% of the length of the feeding catheter and is adapted to be cut to a desired length.

[0042] According to another embodiment, the enlarged diameter portion has an outer diameter of about 10 mm to 20 mm.

[0043] According to another embodiment, the enlarged diameter portion has an outer diameter of about 10 mm to 15 mm.

[0044] According to another embodiment, the neck portion has an outer diameter of about 4 mm to 12 mm.

[0045] According to another embodiment, the neck portion has an outer diameter of about 8 mm to 10 mm.

[0046] According to another aspect, the feeding catheter is formed from an elastic material.

[0047] According to another aspect, the elastic material is medical grade silicone.

[0048] According to another aspect, the feeding catheter is a one-piece piece.

[0049] According to another embodiment, the first end of the hollow tube is suitable for insertion into the ileum.

[0050] According to another aspect, the fluid source is provided by a pump adapted to pump fluid into the hollow tube.

[0051] According to another aspect, the feeding catheter is adapted for use with a device for recycling fluid digestive contents from a proximal opening of the gastrointestinal tract to a distal opening of the gastrointestinal tract.

[0052] According to another embodiment, the opening(s) in the gastrointestinal tract is a stoma or fistula.

[0053] In accordance with another aspect, the invention generally includes an elbow guide, the elbow guide comprising: and an at least semi-rigid elbow guide for receiving and guiding the nutrition catheter within the flexible bag, the at least semi-rigid elbow guide comprising: a guide body including a first end and a second end, and a guide passage extending between the first end and the second end for passing the nutrition catheter, the guide passage having a bent portion for holding the catheter in a bent position, the guide body having a first passage opening and a second passage opening; a flange disposed at a first end of the guide body and adapted to engage an exterior surface of a patient's body to maintain a position of the nutritional catheter; the first passage opening is disposed toward an edge of the flange such that there is a substantial engagement surface area disposed away from the edge for engaging an exterior surface of the patient's body; The at least semi-rigid elbow guide is positioned over the nutritional catheter to hold the catheter in a bent position.

[0054] In accordance with another aspect, the invention generally includes an assembly including a feeding catheter as described in any of the preceding paragraphs and an elbow guide as described in the preceding paragraphs.

[0055] According to another aspect, the at least semi-rigid elbow guide is slidable relative to the nutrition catheter to adjust a bent position of the catheter.

[0056] According to another aspect, the at least semi-rigid elbow guide includes an elbow bend adapted to guide the nutritional catheter downwardly so that the second end is positioned toward a bottom region of the flexible bag.

[0057] According to another aspect, the at least semi-rigid elbow guide is positioned to set the depth to which the nutrition catheter is inserted into the patient's body.

[0058] According to another aspect, the flange provides a substantially flat surface adapted to engage an inner surface of the flexible bag.

[0059] According to another aspect, the elbow guide assembly further includes a second flange spaced apart from the flange, the second flange including a larger diameter or width than the flange.

[0060] According to another aspect, the guide body generally surrounds the guide passage and includes a plurality of cantilever fingers configured to resiliently grip the nutrition catheter.

[0061] According to another embodiment, the at least three cantilever fingers are arranged in a staggered pattern.

[0062] According to another embodiment, the flange has a diameter or width that is two to three times the diameter of the guide passage.

[0063] According to another embodiment, the guide passage has a diameter or width of about 6 mm to 12 mm.

[0064] According to another aspect, the first passage opening is located towards the top of the flange.

[0065] According to another aspect, the first access opening is disposed toward an edge of the flange closest to a proximal opening of the patient's gastrointestinal tract.

[0066] According to another aspect, the first passage opening is off-center relative to the flange.

[0067] According to another aspect, at least the semi-rigid elbow guide is formed from medical grade silicone.

[0068] According to another embodiment, the flexible bag is a stoma bag.

[0069] According to another aspect, the present invention generally comprises a nutrient recycling device for transferring fluid digestive contents from a proximal opening to a distal opening of the gastrointestinal tract, the nutrient recycling device comprising a nutrient catheter as described in any of the above paragraphs.

[0070] According to another aspect, the present invention generally comprises a nutritional recycling device for transferring fluid digestive contents from a proximal opening to a distal opening of the gastrointestinal tract, the nutritional recycling device comprising a nutritional catheter and elbow guide assembly as described in any of the above paragraphs.

[0071] In accordance with another aspect, the present invention generally relates to a method for transferring fluid contents from a flexible bag to a distal opening of the gastrointestinal tract using a feeding catheter, the method comprising: Providing a feeding catheter according to any of the above clauses; extending the retention mechanism to an extended state for inserting the feeding catheter through a distal opening of the gastrointestinal tract; inserting a first end of the feeding catheter through a distal opening of the gastrointestinal tract into a distal portion of the gastrointestinal tract; Releasing the retention mechanism to allow the device to return to a relaxed state in the gastrointestinal tract; and positioning the flexible bag over a distal opening of the gastrointestinal tract.

[0072] According to another aspect, the retention mechanism is stretched using the introducer.

[0073] According to another aspect, the method of using the nutritional catheter further includes the step of connecting a pump to the second end of the hollow tube prior to positioning the flexible bag.

[0074] According to another aspect, the method of using the nutritional catheter described in any of the above paragraphs further includes a step of cutting a portion of the enlarged portion of the hollow tube before positioning the flexible bag.

[0075] According to another aspect, the method of using the nutritional catheter described in any of the above paragraphs further includes a step of positioning at least a semi-rigid elbow guide described in any of the above paragraphs on the nutritional catheter to provide a catheter bend.

[0076] According to another aspect, the at least semi-rigid elbow guide is positioned such that the at least semi-rigid elbow guide and feeding catheter have a low profile within the flexible bag.

[0077] According to another aspect, the at least semi-rigid elbow guide is positioned to guide the nutritional catheter downwardly so that the second end is positioned toward a bottom region of the flexible bag.

[0078] According to another aspect, the method of using a nutritional catheter described in any of the above paragraphs further includes a step of sliding the at least semi-rigid elbow guide to position the catheter bend along the length of the catheter.

[0079] According to another embodiment, the flexible bag is a stoma bag.

[0080] According to another aspect, the feeding catheter is adapted for use in a stoma device for transferring fluid digestive contents from a proximal opening to a distal opening of the gastrointestinal tract.

[0081] According to another embodiment, the opening(s) is a stoma or fistula.

[0082] Other aspects of the invention will become apparent from the following description, given by way of example only and with reference to the accompanying drawings, in which:

[0083] The term "fluid" as used herein means liquids and / or pulps, mixtures and / or suspensions of liquids and solids. In particular, the term "fluid" includes natural edible chyme (semi-liquid partially digested food) and / or artificially provided liquids or pastes, etc.

[0084] As used herein, the term "stoma" is used specifically to describe an opening in the abdomen connected to the intestine for accessing the intestine. Typically, the stoma is created by a surgical procedure, but the term is broad and includes naturally occurring openings such as fistulas.

[0085] As used herein, the term "and / or" means "and" or "or," or both.

[0086] As used herein, "(s)" following a noun refers to the plural and / or singular form of the noun.

[0087] The term "comprises" as used in this specification and in the claims means "comprises at least partially." In interpreting the specifications and claims containing the term, the features preceding the term in each specification must be present, but other features may also be present. Related terms such as "includes" and "comprises" should be interpreted in the same manner.

[0088] The invention will now be described, by way of example only, with reference to the accompanying drawings in which: [Brief description of the drawings]

[0089] [Figure 1] FIG. 2 shows a perspective view of a nutritional catheter. [Diagram 2] 1 shows a cross-sectional side view of a nutritional catheter. [Diagram 3] FIG. 13 shows an enlarged view of the open side of the retention mechanism of the nutrition catheter. [Figure 4A] 1 shows an enlarged view of the rear of the retention mechanism. [Figure 4B] FIG. 1 shows an end view of a feeding catheter. [Diagram 5] FIG. 2 shows a schematic diagram of the open side of the retention mechanism in an extended state. [Figure 6] 13 shows a schematic view of the back side of the retention mechanism in an extended state. [Figure 7] FIG. 1 shows a side view of the feeding catheter and introducer. [Figure 8] FIG. 1 is a schematic diagram of a feeding catheter in an expanded state partially inserted into a distal portion of the gastrointestinal tract. [Figure 9] FIG. 1 shows a schematic diagram of a feeding catheter in a relaxed state inserted into a distal portion of the gastrointestinal tract. [Figure 10] FIG. 1 shows a schematic diagram of a nutrient recycling device for inserting a feeding catheter into the distal portion of the gastrointestinal tract. [Figure 11] FIG. 1 shows a schematic diagram of a nutrient recycling device with rigid / semi-rigid elbow guides that fit snugly against the patient's abdomen. [Figure 12] FIG. 12 shows a schematic diagram of a nutrient recycling device with rigid / semi-rigid elbow guides in different positions than in FIG. 11. [Figure 13] FIG. [Figure 14] FIG. 14 is a front view of the elbow guide of FIG. 13. [Figure 15] FIG. 13 shows a perspective view of another elbow guide. [Figure 16] 16 shows another perspective view of the elbow guide of FIG. 15. [Figure 17] 16 shows another perspective view of the elbow guide of FIG. 15. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0090] A feeding catheter 100 and methods of using the feeding catheter in a stoma device as will now be described are provided according to various configurations shown in Figures 1-17. It should be understood that these figures are illustrative of the structure and general principles of construction, and the invention is not limited to the exact configurations shown.

[0091] A general description of the various configurations of the present invention as shown in FIG. 1 will now be provided, followed by a description of the method of using the feeding catheter 100.

[0092] 1, in a most preferred configuration, the feeding catheter 100 comprises a hollow tube 110. Preferably, the stoma device is a nutrient recycling device 1, particularly adapted to be worn externally by the patient.

[0093] The hollow tube 110 is an elongated elastic structure that conforms to its insertion structure (e.g., the gastrointestinal tract, particularly the ileum) or contact structure. Preferably, the elastic tube 110 is soft enough to bend and fit. Preferably, the elastic tube 110 is rigid and elastically returns to a generally elongated shape rather than maintaining a bent shape by itself. In a preferred configuration, the feeding catheter 100 is formed of an elastic material such as medical grade silicone. Other catheter materials known to those skilled in the art, such as polyurethane, PVC, latex rubber, or other biocompatible plastic elastomers, may also be used.

[0094] The feeding catheter 100 is adapted to be partially inserted into a patient's body and retained in place for a desired period of time. The feeding catheter 100 preferably includes a retention mechanism 150 (best shown in Figures 3-6) for retaining the feeding catheter in the distal portion 6 of the gastrointestinal tract once inserted into the patient's body.

[0095] The feeding catheter 100 is adapted for use in / as part of a stoma device. Preferably, the stoma device is a nutrient recycling device 1, as shown in FIG.

[0096] A feeding catheter 100 delivers digestive contents 7 from the flexible bag 10 of the nutrient recycling device 1 to the distal opening 4 of the gastrointestinal tract 6 .

[0097] Fluids and nutrients from the digestive contents 7 are preferably recycled / transferred from the proximal opening 4 to the distal portion 6 of the gastrointestinal tract. Recycling the digestive contents 7 reduces the loss of fluids, electrolytes, and nutrients that typically occurs as a result of an ileostomy bypass. As a result, patients are less likely to experience dehydration and subsequent kidney damage from the ileostomy bypass.

[0098] The feeding catheter 100 is adapted to reside within the gastrointestinal tract (preferably the ileum) for days, weeks, or months, rather than the relatively short operative period of many standard catheters.

[0099] In a preferred configuration, the feeding catheter 100 facilitates ease of insertion into a patient's body while also providing the time necessary to effectively and safely maintain the feeding catheter within the patient's body.

[0100] The nutritional catheter 100 of the present invention is adapted to be inserted into larger cavities (e.g., fistulas or fistula openings) as compared to standard catheters and has a relatively large lumen diameter that allows chyme (including both liquid and semi-solid digestive contents) to pass back to the patient.

[0101] A nutrient recycling device 1 for recycling digestive contents (chyme) 7 from a proximal opening of the gastrointestinal tract 3 to a distal opening of the gastrointestinal tract 4, where the digestive contents 7 are recycled from the proximal opening of the gastrointestinal tract 3 to the distal opening of the gastrointestinal tract 4. A preferred flow path for the digestive contents 7 is shown by the arrows in Figure 10.

[0102] Preferably, the feeding catheter 100 is introduced into the ileum (small intestine) portion of the gastrointestinal tract, which is the region of the gastrointestinal tract that is addressed by the ileostomy.

[0103] Preferably, the proximal and distal openings 3, 4 of the gastrointestinal tract are stomas (or fistulas) in the patient's abdominal surface providing access to the proximal and distal portions 5, 6 of the ileum, respectively.

[0104] The nutrient recycling device 1 is adapted to be worn externally by the patient.

[0105] The intended nutritional catheter 100 and related methods of using the nutritional catheter may be used in conjunction with other devices for introducing contents (such as chyme, medications, and other contents) into a patient (e.g., via the distal opening 4).

[0106] The flexible bag 10 for the nutrient recycling device 1 may be a typical stoma bag 10. The flexible bag 10 is usually made of plastic (e.g., polyethylene) and is elastic so that it can lie flat against the wearer's body while retaining the shape of the contents, and expands as needed, for example when digestive contents 7 enter the bag.

[0107] The hollow tube 110 of the feeding catheter 100 has a first end 111 adapted for insertion into a distal portion 6 of the gastrointestinal tract, preferably the ileum, via the distal opening 4 (see FIG. 10). Digestive contents 7 move from the flexible bag 10 and leave the feeding catheter 100 into the distal portion 7 of the ileum, recycling fluid and nutrients from the proximal portion 5 of the ileum.

[0108] The hollow tube 110 of the nutritional catheter 100 has a second end 112. Preferably, the nutritional catheter 100 is soft and flexible so that the second end 112 is located toward the bottom 11 of the flexible bag 10 while maintaining comfort. Preferably, the nutritional catheter 100 is kink resistant so as to maintain the passage of the contents 7. Alternatively, the catheter may be a "lay flat" tube that expands when the pump (described below) is activated.

[0109] The digestive contents 7 from the flexible bag 10 enter the feeding catheter 100 via the second end 112.

[0110] In a preferred configuration, the second end 112 is adapted to connect to a fluid source, preferably a pump 9, as shown in FIG.

[0111] In a most preferred configuration, the pump 9 is located within or integrated into the flexible bag 10 (e.g., integrated into the interior of the flexible bag 10 or into the wall of the bag, etc.). The digestive contents 7 are collected by gravity towards the bottom of the flexible bag 10. The pump 9 connected to the second end 111 is adapted to drive the digestive contents 7 against gravity and upward along the feeding catheter 100. Alternatively, the fluid source may be provided by gravity, a syringe, or other suitable method known to those skilled in the art.

[0112] The nutritional catheter 100 has a lumen 113 between the first end 111 and the second end 112 of the hollow tube 110. The lumen 113 is a passageway within the hollow tube 110 that allows the digestive contents 7 to be in fluid communication from the second end 112 to the first end 111 of the hollow tube. The feeding catheter 100 is adapted to be retained within a patient's body and therefore includes a retention mechanism 150, as best shown in FIGS.

[0113] The retention mechanism 150 has an insertion end 151 and a tail end 152. The tail end 152 is preferably located at or toward the first end 111 of the hollow tube.

[0114] As previously discussed, the retention mechanism 150 can aid in insertion into the patient's body and can effectively and safely retain the feeding catheter within the patient's body for a desired period of time (typically longer than conventional catheters). In a preferred configuration, the retention mechanism 150 can be safely removed (without getting stuck) without causing any or limited irritation while remaining within the patient's body.

[0115] In a preferred configuration, the retention mechanism 150 has a relaxed state and an extended state. The retention mechanism 150 can be forced to transition from the relaxed state to the extended state. In the extended state, the retention mechanism 150 has a narrower profile than in the relaxed state, such that it is configured to be inserted into the distal opening 4.

[0116] Preferably, the maximum width of the retention mechanism 150 in the extended state (width W shown in FIGS. 5 and 6) is 2 ) is the maximum width of the retention mechanism in the relaxed state (width W 1 ) is smaller than In the expanded state, the retention feature 150 is preferably stretched longitudinally such that the width of the retention feature decreases and the length of the retention feature increases.

[0117] In a preferred configuration, the maximum width of the retention mechanism 150 in a relaxed state (width W 1 ) is 15mm~40mm.

[0118] In a preferred configuration, the maximum width of the retention mechanism 150 in the extended state (width W 2 ) is 6mm~20mm.

[0119] It is anticipated that the size of the feeding catheter 100 will be adapted to a particular patient or application / situation. The primary function of the retention mechanism 150 is to secure the feeding catheter 100 in a desired location (once inserted) in the distal portion 6 of the gastrointestinal tract for a desired period of time (days, weeks, or longer) without causing undue discomfort or irritation due to patient movement. The retention feature 150 is widest in a relaxed state when the retention feature 150 is at rest (e.g., prior to insertion) or after the force stretching the retention feature is no longer applied. The ribs 153 are preferably biased toward the relaxed state. The ribs 153 may, for example, be formed of a resilient material such that they resiliently return to the expanded state.

[0120] Preferably, after the feeding catheter 100 is inserted into the distal portion of the ileum 6, the ribs 153 are allowed to naturally expand to a relaxed state to secure the feeding catheter 100 to the distal portion of the gastrointestinal tract (FIG. 9).

[0121] The retention mechanism 150 facilitates holding the feeding catheter 100 in place and prevents unintentional movement and / or removal of the feeding catheter 100. The retention mechanism 150 is adapted to secure the feeding tube 100 within the gastrointestinal tract (preferably the ileum) for days, weeks, or months. The feeding catheter 100 may remain in the ileum for several months (e.g., about 9 months).

[0122] On the other hand, some standard catheters are used temporarily for surgical or other medical procedures and are not designed to be inserted into a patient's body and left in place for extended periods of time (some inside the patient and some outside the patient).

[0123] The retention mechanism 150 preferably keeps the feeding catheter 100 in the proper position (once inserted) as the patient moves about during daily activities. It may be undesirable for the feeding catheter 100 to move further into the patient's body (potentially damaging the ileum) or out of the ileum.

[0124] In a most preferred configuration, the retention mechanism forms a partially open sphere in the relaxed state, as shown in Figures 3, 4A, and 4B. The resulting shape preferably resembles a catcher's mitt or has an approximately hemispherical "cup."

[0125] The retention feature 150 preferably includes a plurality of ribs 153 that extend longitudinally outward (generally radially) away from the hollow tube 110 and terminate at a nose joint 180. Preferably, the nose joint 180 is radially opposed to the first end 111 of the hollow tube 110.

[0126] Preferably, the nose portion 180 retaining features aid in inserting the feeding catheter 100 into the distal opening 4 and distal portion 6 of the gastrointestinal tract.

[0127] The plurality of ribs 153 provide structural integrity to the retention mechanism 150. The contour and physical properties of the ribs 153 allow the retention mechanism 150 to have sufficient physical integrity (strength / rigidity) to retain its shape (at rest and for retention within the patient). In a preferred configuration, the wall thickness of the ribs 153 is 1.0-4.0 mm, with the ribs 153 being slightly thicker near the nose junction 180 to customize the bending characteristics along the length of the ribs 153.

[0128] Preferably, the ribs 153 are formed of a material having suitable elasticity to allow for flexible extension and insertion into the patient's body, and to expand after insertion to remain within the patient's body, thereby effective in holding the nutritional catheter 100 in the proper position.

[0129] The ribs 153 are preferably stiff enough to maintain the shape of the retention feature, yet resilient enough to stretch for insertion.

[0130] In a preferred configuration, the retention mechanism 150 includes 3-5 ribs.

[0131] In some preferred configurations, the retention mechanism 150 includes three ribs.

[0132] Web walls 154 preferably extend between at least one pair of adjacent ribs 153, as shown in Figure 3, and preferably as shown in Figure 4B. Web walls 154, in a preferred configuration, form a substantially bulbous (or substantially hemispherical) shape that retains retention feature 150.

[0133] Preferably, the retention mechanism 150 further comprises an opening 155 that allows the digestive contents / chyme to exit the catheter generally laterally (i.e., generally laterally to the lumen of the catheter, precisely at ±45 degrees laterally) and is located between at least one pair of adjacent ribs and configured to expel the contents from the hollow tube 110 into the gastrointestinal tract. The opening 155 is preferably defined and formed by a pair of adjacent ribs without a web wall.

[0134] The digestive contents 7 (flowing out of the exit of the tube 110) exit through the side opening 155, as shown by the arrow in Figure 10. Preferably, most (or all) of the digestive contents 7 from the feeding catheter enters the lower distal portion of the gastrointestinal tract through the side opening 155.

[0135] Preferably, adjacent ribs that define side openings 155 are spaced apart greater than adjacent ribs that are joined by web walls 153 .

[0136] Preferably, the side opening 155 provides a sufficient exit area to allow digestive contents to exit the feeding catheter 100 and into the patient's body. The size of the side opening 155 should be limited while the ribs 153 can maintain the structural integrity of the retention mechanism 150.

[0137] Preferably, the ribs 153 that define the side openings 155 have an angular orientation (as viewed from the end of the catheter, as shown in FIG. 4B) of less than 180°.

[0138] In one preferred configuration, the ribs 153 forming the side openings 155 have an angular orientation of about 140°. That is, the ribs 153 are not equally spaced at an angle, but are configured to form large side outlets 155 so as not to restrict the flow of digestive contents. In some preferred configurations (where the retention mechanism 150 includes three ribs), the "closed" ribs are preferably spaced at angular intervals of about 110°, while the side outlets 155 have angular intervals of about 140°.

[0139] Preferably, the side opening 155 forms a generally circular / circular opening.

[0140] Preferably, the retention feature 150 comprises a generally hemispherical feature.

[0141] Preferably, the shape of the ribs and side openings 155 are smooth and rounded with no sharp edges to reduce pressure points that can lead to irritation and / or tissue ingrowth. Tissue ingrowth into the catheter can be problematic because it can cause the feeding catheter 100 to become clogged, requiring surgery to remove.

[0142] In a most preferred configuration, the retention mechanism 150 includes a single-sided opening 155. Preferably, the single-sided opening 155 is located between a pair of adjacent ribs 153. Limited exit, for example by the single-sided opening 155, reduces the possibility of tissue ingrowth. The specific side opening 155 cooperates with the rib and web structure to provide an effective feeding catheter 100 for effective and safe insertion and retention within the gastrointestinal tract (preferably the small intestine or large intestine). In a preferred configuration, the retention mechanism 150 can be safely removed (without getting stuck) without causing irritation or limited irritation while remaining within the patient's body.

[0143] The feeding catheter 100 is designed to reside within the gastrointestinal tract, a unique environment created by involuntary contraction and relaxation of smooth muscle tissue, making it difficult for the catheter to remain in place.

[0144] Additionally, the feeding catheter 100 is configured to remain in the patient's body for a desired period of time (usually longer than conventional catheters), expanding the range of suitable applications for existing catheters that are not suitable for insertion and retention in the gastrointestinal tract and delivery of contents (chyme) to the patient.

[0145] Tissue ingrowth is possible and standard catheters are not designed to remain within a patient for extended periods of time (days, weeks, or months).

[0146] Standard catheters without an appropriate retention mechanism are not suitable for insertion into the gastrointestinal tract as the catheter will not stay in place (it may be "swallowed" by the peristaltic movement of the intestine).

[0147] Additionally, catheters designed for insertion into and accessing the gastrointestinal tract with multiple openings can facilitate ingrowth by allowing adhesions to grow through the openings if irritated. If adhesions grow in and around the catheter and reattach to the intestine, the catheter can become stuck and tear, or require surgery to remove.

[0148] Optionally, as shown in Figure 4A, the feeding catheter 100 has a hole 116 on the hollow tube 110 towards the first end 111 of the tube. The hole 116 is preferably for interrupting suction / reducing pressure to prevent the tube from being sucked into the intestinal wall when the pump stops suction and the chyme falls back into the bag.

[0149] Preferably, opening 116 is positioned far enough away from side opening 155 so that if any adhesions develop due to irritation, they are unlikely to grow through the tube and emerge from the other side, hooking the tube in place.

[0150] Ribs 153 are preferably stiffer than web walls 154. Web walls 154 are best seen in FIG.

[0151] The web walls 154 are preferably flexible relative to the ribs 153. The web walls 154 are preferably formed from a flexible membrane or film. The thin web walls 154 between the ribs 153 form a barrier that guides the chyme to the side openings 155 and prevents growth into the areas between the ribs.

[0152] In a preferred configuration, when the retention feature 150 is reduced in width / diameter and inserted into the patient's gastrointestinal tract (ie, the ribs are deformed into an extended state), the web walls 154 collapse.

[0153] In a preferred configuration, the web walls 154 are configured to normally collapse inwardly in an extended state. The web walls 154 collapse generally inwardly in a direction toward the central longitudinal axis of the feeding catheter 100.

[0154] The highly flexible thin web walls 154 (which are relatively thinner and more flexible than the ribs) allow for low folding between adjacent ribs 153 .

[0155] Preferably, the thin-walled web wall 154 is folded in tension between and generally flush with the ribs 153. In such a configuration, it is preferred that the web wall 154 does not collapse into the lumen space of the catheter and impede or unduly restrict flow.

[0156] In some configurations, the web wall 154 includes score lines 156 such that the web wall is configured to fold in tension (see FIGS. 4A and 6). The web wall 154 folds inward along the score lines and the plurality of ribs 153 move together such that the retention feature 150 assumes a narrower, extended configuration for insertion.

[0157] In some configurations, the scoreline 156 is a longitudinal depression or crease along the web wall 157 .

[0158] The thickness of the web wall 154 is preferably less than the thickness of the plurality of ribs 153 .

[0159] In a preferred construction, the thickness of the web walls 154 is less than 50% of the thickness of the ribs 153 .

[0160] More preferably, the thickness of the web walls 154 is less than 30% of the thickness of the ribs 153 .

[0161] More preferably, the thickness of the web walls 154 is less than 20% of the thickness of the ribs 153 .

[0162] In a most preferred configuration, the thickness of the web walls 154 is greater than or equal to 10% and less than or equal to 20% of the thickness of the ribs 153 .

[0163] In a preferred configuration, the thickness of the web wall 154 is greater than or equal to 0.2 mm and less than or equal to 0.8 mm.

[0164] In a preferred configuration, the thickness of the rib 153 is not less than 1.0 mm and not more than 4.0 mm.

[0165] In a preferred configuration, as shown in FIGS. 7 and 8, an introducer 300 can be used to move the nutritional catheter 100 from a relaxed state to an extended state.

[0166] Preferably, lumen 113 is configured to receive an introducer 300. The introducer is preferably an introducer rod or similar device known to those of skill in the art.

[0167] In these configurations, preferably introducer 300 is configured to engage the inner surface of nose joint 180 to force the retention member from a relaxed state to an extended state. The tip of introducer 300 presses inwardly against the inner surface of nose joint 180 in the insertion direction while tube 100 is held in place or pulled in the opposite direction. When retention member 150 is forced into an extended state, preferably the width / diameter of the member decreases and the length of the member increases for insertion.

[0168] In some configurations, the retention mechanism 150 further includes a pocket 181 on the inner surface of the nose joint to receive the tip of the introducer. The pocket is an indentation on the inner surface of the nose that is shaped and configured to receive the tip and hold it in place during extension.

[0169] In a preferred configuration, the hollow tube 110 has a neck portion 114 located toward the first end 111 of the tube. Preferably, the hollow tube 110 further has an enlarged diameter portion 115 toward the second end 112. The enlarged diameter portion 115 has a larger tube diameter than the neck portion 114.

[0170] The enlarged diameter section 115 is adapted to be positioned within the flexible bag 10 and connected to the pump 9, and therefore has a larger diameter than the neck section 114. The smaller diameter of the neck section 114 allows it to be inserted into the gastrointestinal tract 2 with minimal discomfort.

[0171] Preferably, the upset 115 is the main portion of the hollow tube 110, and the hollow tube 100 may be cut at different locations along the upset 115 such that the second end 112 of the hollow tube 100 is located at an appropriate length towards the bottom of the flexible bag 10. Since the digestive contents 7 will be collected by gravity towards the bottom of the flexible bag 10, the second end 112 of the tube (and therefore the pump 9) should be positioned towards the bottom.

[0172] As previously mentioned, in a preferred configuration, a pump 9 is connected to the second end 112 of the tube 110 so as to drive the digestive contents 7 upwardly along the feeding catheter 100 against gravity and into the distal portion of the ileum 6.

[0173] Preferably, the length of the feeding catheter 100 is also customized for the patient to minimize discomfort, and the catheter does not protrude outward relative to the flexible bag 10 due to excessive tubing length.

[0174] Preferably, the enlarged portion 115 configures the hollow tube 110 sufficiently to allow cutting of the hollow tube 100 to customize the length of the feeding catheter 100 to fit various patient anatomies and flexible bags 10. It should be appreciated that due to patient anatomical changes, it is advantageous if the feeding catheter 100 can be cut to customize the length accordingly while leaving a portion of the enlarged portion 115 connected to the pump 9.

[0175] Some conventional catheters do not have an enlarged section and are not suitable for connection to a pump 9. Other conventional catheters have sections with an enlarged section, but these sections are generally very short and do not provide sufficient length to be cut and customized for the patient / stoma bag as described above.

[0176] It may also be useful to cut and customize the length of the hollow tube 110 so that the feeding catheter 100 has a flat profile within the flexible bag 10. If the feeding catheter 100 is too long, it will protrude outward relative to the flexible bag 10. It should be understood that typically, a patient will desire a low-profile stoma bag 10 with a flat profile.

[0177] Additionally, a customized catheter length may be advantageous because it may increase comfort and / or reduce the likelihood of damage to the gastrointestinal tract (e.g., pressure necrosis) due to external pressure exerted by movement of the feeding catheter and transmitted to the gastrointestinal tract.

[0178] Preferably, the expanded diameter portion 115 has an outer diameter of about 10 mm to 20 mm.

[0179] Most preferably, the expanded diameter portion 115 has an outer diameter of about 10 mm to 15 mm.

[0180] In one configuration, the diameter of the upset 115 is about 12.5 mm.

[0181] Neck portion 114 preferably has an outer diameter of about 4 mm to 12 mm.

[0182] Most preferably, neck portion 114 has an outer diameter of about 8 mm to 10 mm.

[0183] In one configuration, the diameter of the neck 114 is approximately 9.3 mm.

[0184] Preferably, the expanded diameter portion 115 comprises at least 25% of the length of the nutritional catheter 100.

[0185] Most preferably, the expanded diameter portion 115 comprises a length that is at least 40% of the length of the nutritional catheter 100.

[0186] In some configurations, the upset 115 is at least 100 mm long for a feeding catheter having a length of approximately 300 mm.

[0187] Preferably, the feeding catheter 100 comprises a resilient material so that it conforms securely (and with limited discomfort to the patient) to the structures it inserts into or contacts.

[0188] In a preferred construction, the feeding catheter 100 is made of silicone (medical grade). Other catheter materials known to those skilled in the art may also be used, such as polyurethane, PVC, latex rubber, or other biocompatible plastic elastomers.

[0189] Preferably, the feeding catheter 100 is a one-piece component. The hollow tube 110 and the retention mechanism 150 are formed as one piece.

[0190] The feeding catheter 100 may be molded in one piece or formed using other techniques known to those of skill in the art.

[0191] In some independent configurations, as shown in Figure 10, at least a semi-rigid elbow guide 200 is adapted to receive and guide the feeding catheter 100 within the flexible bag 10. The rigid / semi-rigid elbow guide 200 is most preferably used with the feeding catheter 100 described above. However, in some independent configurations, it is anticipated that the rigid / semi-rigid elbow guide 200 will be used in conjunction with other catheters.

[0192] Preferably, as described above, the rigid / semi-rigid elbow guide 200 is part of a nutrient recycling device 1 for recycling digestive contents from a proximal opening 5 of the gastrointestinal tract to a distal opening 6 of the gastrointestinal tract.

[0193] The rigid / semi-rigid elbow guide 200 has an elbow adapted to guide the feeding catheter 100, the catheter is formed in a suitable position, and holds the catheter elbow 120. As shown in FIG. 10, preferably, the feeding catheter 100 is held in a bent shape (at least via the semi-rigid elbow guide 200) so that the holding mechanism 150 and the neck portion 114 are located in the distal portion 6 of the gastrointestinal tract, while the enlarged portion 115 is substantially vertical (with respect to the enlarged portion 114) and faces downward, so that the second end 112 (of the hollow tube 110) is located toward the bottom region 11 of the flexible bag 10.

[0194] The rigid / semi-rigid elbow guide 200 is formed of at least a semi-rigid material that can maintain the desired shape of the nutritional catheter 100 (provide bending).

[0195] Even without the rigid / semi-rigid elbow guide 200, the nutritional catheter 100 can be pressed against the flexible bag 10 when it naturally protrudes from the distal opening 4 or when it protrudes laterally. This can be undesirable because the nutritional catheter 100 bulges against the flexible bag 10 and becomes less noticeable.

[0196] In a most preferred configuration, the rigid / semi-rigid elbow guide 200 is slidable relative to the feeding catheter 100 to adjust the position of the catheter bend 120 (as shown in Figures 13 and 14). The position of the catheter bend 120 can be adjusted to customize the catheter contour for different patients / stoma bags, or may be adjusted for the comfort of the same patient at different times.

[0197] Preferably, the profile of the rigid / semi-rigid elbow guide 200 reduces the likelihood of kinking (the tubular mass folding back on itself in a manner that blocks the passage / flow of the contents) of the feeding catheter 100. Preferably, the bend radius of the rigid / semi-rigid elbow guide 200 is large enough to prevent kinking.

[0198] In a preferred configuration, the rigid / semi-rigid elbow catheter 200 is slidable relative to the feeding catheter 100 by expanding the length of the catheter and decreasing the diameter of the catheter. In this case, the rigid / semi-rigid elbow guide 200 has a larger diameter guide groove 203 than the catheter 100 so that it may slide along the length of the catheter.

[0199] 15-17, elbow guide 200 with optional gripping mechanism is shown and will be described in more detail. It will be appreciated that many features are shared with guide 200 shown in Figures 13 and 14 and therefore the same reference numbers are used.

[0200] The guide body 210 in this configuration includes a number of cantilever fingers 301 (separated from the remainder of the body 210 by notches 302) to provide additional resilience to the semi-rigid body. As shown, the cantilever fingers 301 typically surround the nutritional catheter interior passageway (203 - not shown) and serve to resiliently pinch the nutritional catheter therein. In such a configuration, the material of the body 210 may be relatively stiff (more so than previous configurations), and the cantilever fingers provide the desired semi-rigid structure to interact with the catheter.

[0201] In the configuration shown, there are at least three cantilever fingers 301, staggered relative to one another, although it is envisaged that more than two cantilever fingers 301 may be provided.

[0202] In the configuration of Figure 15, a single flange 250 is provided on the body 210. The flange 250 preferably tapers towards the lower end of the body 210 (near the hole 205) so that the periphery of the elbow presents a tapered shape that facilitates insertion into a stoma bag. 15, there is also a transition 260 between the hole 204 adjacent the stoma (in use) that tapers towards the flange 250. This transition 260 provides a cone for engaging the stoma, which can further help hold the assembly in place (when in use).

[0203] Preferably, the diameter of the guide passage 203 has the same or similar diameter as the feeding catheter 100 in an unextended state to hold the rigid / semi-rigid elbow guide 200 in a desired position on the catheter.

[0204] Preferably, the rigid / semi-rigid elbow guide 200 is thin. The rigid / semi-rigid elbow guide 200 positions the catheter bend 120 so that the feeding catheter 100 does not protrude too much outward relative to the flexible bag 10. Preferably, wearing the stoma bag 10 with the feeding catheter 100 is significantly less cumbersome than wearing a conventional stoma bag without an internal part.

[0205] The rigid / semi-rigid elbow guide 200 preferably positions the catheter bend 120 so that the elbow guide guides the nutritional catheter 100 downwardly and the second end 202 is positioned toward the bottom region 11 of the flexible bag 10.

[0206] In some configurations, the rigid / semi-rigid elbow guide 200 is formed from silicone. It is anticipated that other materials having similar rigid / semi-rigid properties may be used to form the rigid / semi-rigid elbow guide 200.

[0207] The semi-rigid elbow guide 200 in a preferred configuration is molded in a bent configuration (to form the catheter bend 120) so that when the feeding catheter 100 is inserted into the guide, the guide bends it.

[0208] In a preferred configuration, the material of the semi-rigid elbow catheter 200 has the same (or very similar) physical properties as the feeding catheter 100. However, due to the different cross-sectional area on the bending axis, it has a greater resistance to bending (compared to the feeding catheter).

[0209] In other configurations, the semi-rigid elbow guide 200 is made from a material having different properties than the delivery catheter 100, resulting in a stiffer guide for forming the bend in the catheter.

[0210] In a preferred configuration, as shown in FIG. 13, the rigid / semi-rigid elbow guide 200 has a guide body 210 having a first end 201 and a second end 202 .

[0211] Preferably, the rigid / semi-rigid elbow guide 200 extends between a first end 201 and a second end 202 and has a guide passageway 203 for guiding the catheter 100 through the catheter bend 120. The guide passageway 203 has a first passageway opening 204 and a second passageway opening 205.

[0212] Preferably, the rigid / semi-rigid elbow guide 200 has a flange 206 at the first end 201 of the guide body 210. The flange 206 provides a substantially flat surface adapted to engage an inner surface of the flexible bag 10. The flange 206 positions the rigid / semi-rigid elbow guide within the flexible bag 10 and can aid in the flexible bag 10 positioning the feeding catheter 100.

[0213] Intestinal peristalsis can grab objects such as the retention mechanism 150 and pull them downstream, which is undesirable. In a preferred configuration, the flange 206 is adapted to engage with an external surface of the patient's body to maintain the position of the nutritional catheter. When the second end 112 of the nutritional catheter 100 is free (e.g., not connected to the pump 9), the flange 206 preferably prevents the nutritional catheter 100 from being drawn into the stoma (distal opening) 4 or from being drawn into the stoma or "swallowed."

[0214] Preferably, the first passage opening 204 is located toward the edge of the flange such that there is a substantial engagement surface area away from the edge for engaging the exterior surface of the patient's body, thereby maintaining the position of the nutritional catheter.

[0215] The first access opening 204 located towards the flange edge allows the digestive contents / chyme 7 to exit the proximal opening 3 (i.e., the first access opening 204 does not cover the proximal opening but has support for the flexible bag 10 and the patient's body). Typically, the proximal and distal air holes 3, 4 are located close to the exterior surface of the patient's body. If the first access opening 204 of the flange 206 is located towards the centre of the flange, it is undesirable for the flange to cover or partially cover the proximal opening 3.

[0216] Preferably, the first access opening 204 is located towards the edge of the flange closest to the proximal opening of the patient's gastrointestinal tract.

[0217] In a preferred configuration, the flange 206 is off-center relative to the first passage opening 204 of the rigid / semi-rigid elbow guide 200, as shown in FIG. In some preferred configurations, the first passage opening 204 is off-center relative to the flange 206 .

[0218] Preferably, the first passage opening 204 is located towards the top of the flange 204 .

[0219] Preferably, the diameter (if the flange is circular) or the length (if the flange is not circular) of the flange 206 is 2 to 3 times the diameter of the guide passage 203 .

[0220] The guide passage 203 preferably has a diameter of about 6 mm to 12 mm.

[0221] Most preferably, the guide passage 203 has a diameter of about 8 mm to 10 mm.

[0222] In some configurations, the flange 206 has a circular cross-section, as shown, although it is envisioned that the flange 206 may take other shapes, such as rectangular.

[0223] In some configurations, the rigid / semi-rigid elbow guide 200 includes a secondary flange 207 (not present in the configurations of Figures 15-17).

[0224] Preferably, the secondary flange 207 is spaced from the primary flange 206 .

[0225] Preferably, the second flange 207 has a larger diameter / width than the flange 206 .

[0226] Preferably, the secondary flange 207 acts as a "back-up" flange in the event that the primary flange 206 does not stop the elbow guide 200 from moving into the stoma. The primary flange 206 is sized so that it does not occlude the proximal stoma, allowing chyme to exit. Ideally, the front primary flange 206 is large to prevent the feeding catheter from moving into the stoma. However, if the smaller flange 206 is not properly aspirated into the intestine, the larger secondary flange 207 preferably engages the exterior of the patient's body to maintain the position of the feeding catheter.

[0227] Following the above description of the structure of the present invention, a general description of the method of use of the feeding catheter 100 will be provided. The feeding catheter 100 is used to supply recycled digestive nutrients 7 from a flexible bag 10 to a distal opening 4 of the gastrointestinal tract 6. The flexible bag 10 may be a typical stoma bag, and is preferably made of plastic (e.g., polyethylene). The flexible bag 10 is easily deformable so that it can be laid flat on the patient's abdomen, and can expand as needed when digestive contents enter it.

[0228] The digestive contents preferably flow from the proximal portion 5 of the gastrointestinal tract through the proximal gastrointestinal tract opening 3 towards the bottom region 11 of the flexible bag 10 (of the nutrient recycling device 1) where they are collected by gravity. Preferably, the gastrointestinal tract is the ileum (small intestine) and the gastrointestinal tract opening is a stoma (formed by an ileostomy) or fistula in the patient's abdominal surface.

[0229] First, the above-mentioned feeding catheter 100 is provided. The first catheter end 101 (insertion end) of the feeding catheter 100 is preferably inserted into the proximal portion 6 of the gastrointestinal tract 2 through the distal opening 4 of the gastrointestinal tract 2.

[0230] Preferably, the retention mechanism 150 is extended to its extended state for insertion of the feeding catheter 100 through the distal opening 4 of the gastrointestinal tract. Preferably, the retention mechanism 150 is extended using the introducer 300 .

[0231] Once in the expanded state, the first catheter end is preferably inserted into the distal portion of the gastrointestinal tract through the distal opening 4 of the gastrointestinal tract.

[0232] Once the feeding catheter 100 is at least partially inserted, the retention mechanism 150 is released to return to its relaxed state within the gastrointestinal tract, and the ribs 153 and web walls 154 of the retention mechanism 150 elastically expand back to the relaxed state. Thus, the feeding catheter 100 is fixed in position within the distal portion 6 of the gastrointestinal tract by the retention mechanism 150.

[0233] In a preferred configuration, a flexible bag 10 is placed over the proximal and distal openings 3, 4 of the gastrointestinal tract 2 after the feeding catheter has been inserted.

[0234] In some configurations, a portion of the upset 115 of the hollow tube 110 is cut prior to positioning the flexible bag to customize the tube length depending on the patient / stoma bag location.

[0235] In a preferred configuration, the pump 9 is connected to the second end 112 of the hollow tube 110 prior to positioning the flexible bag 10 .

[0236] Preferably, the nutritional catheter 100 has a low profile within the flexible bag 10. Preferably, the nutritional catheter 100 is disposed with the second end 112 of the hollow tube 110 toward the bottom region 11 of the flexible bag 10.

[0237] In some preferred configurations, a rigid / semi-rigid elbow guide 200 is provided and positioned above the nutritional catheter 100 to provide the catheter bend 120.

[0238] Preferably, the rigid / semi-rigid elbow guide 200 is slidable relative to the feeding catheter to position the catheter bend 120 in the appropriate position.

[0239] Preferably, the rigid / semi-rigid elbow guide 200 is positioned such that the rigid / semi-rigid elbow guide and feeding catheter 100 have a low profile within the flexible bag 10 (i.e., the feeding catheter does not protrude too far outward relative to the bag).

[0240] Preferably, the rigid / semi-rigid elbow guide 200 is positioned to guide the feeding catheter 100 downwardly so that the second end 112 is positioned towards the bottom region 11 of the flexible bag 10.

[0241] In some configurations, the rigid / semi-rigid elbow guide 200 is positioned to set the depth to which the feeding catheter is inserted into the patient.

[0242] It should be appreciated that the above provides an improved feeding catheter that is resilient (cannot over-expand, can withstand degradation within a patient's body for one month, and is resistant to kinking), yet flexible enough to conform to the structures it is inserted into or comes into contact with.

[0243] Similarly, the improved feeding catheter is also soft enough to be cut, so that the second end of the feeding catheter can be positioned toward the bottom of the flexible bag to customize it to fit the patient's anatomy / stoma bag type, minimizing discomfort and preventing the feeding catheter from protruding outward relative to the flexible bag and being pushed downward into the flexible bag, causing pressure necrosis / gastrointestinal damage.

[0244] Additionally, the improved feeding catheter is smooth and free of sharp edges to reduce discomfort, prevent ulcers from penetrating the intestinal tract, and reduce pressure causing irritation, adhesions and / or granulations that can cause tissue ingrowth requiring surgical removal.

[0245] The above provides at least a semi-rigid elbow guide (slidable and torsion resistant) to position the nutritional catheter in a bent shape and guide the second end of the nutritional catheter downwardly toward the bottom region of the flexible bag to prevent outward protrusion relative to the flexible bag.

[0246] Additionally, the flange of the at least semi-rigid elbow guide is adapted to support the flexible bag against the patient's abdomen (and optionally position the at least semi-rigid elbow guide against an inner surface of the flexible bag) and prevent the feeding catheter from being pulled into the distal portion of the gastrointestinal tract.

[0247] Numerous modifications in the structure of the present invention, as well as widely differing embodiments and applications, will become apparent to those skilled in the art to which the present invention pertains without departing from the scope of the invention as defined by the appended claims.

[0248] The present invention may also include the parts, elements and features referred to or indicated herein, individually or collectively, and any or all combinations of any two or more of such parts, elements or features, and where specific integers referred to herein have known equivalents in the art to which the present invention pertains, these known equivalents are deemed to be incorporated herein as if set forth separately.

Claims

1. 1. A feeding catheter adapted to deliver fluids to an opening in the gastrointestinal tract, comprising: a hollow tube and a retention mechanism adapted to retain at least a portion of the feeding catheter in a distal portion of the gastrointestinal tract; The hollow tube has a first end adapted to be inserted into a distal portion of the gastrointestinal tract through a distal opening; a second end adapted to be connected to a fluid source; a lumen defining a fluid passageway between the first end and the second end of the hollow tube; the retention feature is at or toward the first end of the hollow tube; an insertion end and a tail end at or toward the first end of the hollow tube; a plurality of ribs extending outwardly and longitudinally away from said hollow tube and terminating at a nose junction; a flexible membrane web wall extending completely between all but one pair of adjacent ribs and defining a single side opening disposed between said pair of adjacent ribs and configured for fluid to exit into the gastrointestinal tract; the retention mechanism includes a relaxed state and an extended state for insertion through the distal opening; a maximum width of the retention feature in the stretched state is smaller than a maximum width of the retention feature in the relaxed state; A feeding catheter, wherein the retention mechanism forms a partially open bulbous shape in the relaxed state.

2. The feeding catheter of claim 1 , wherein the pair of adjacent ribs forming the side opening are free of the web wall therebetween.

3. The feeding catheter of claim 1 , wherein adjacent ribs forming the side openings are spaced apart a greater distance than adjacent ribs joined by the web wall.

4. The nutritional catheter of claim 1 , wherein the ribs forming the side openings have an angular orientation of less than 180°.

5. The feeding catheter of claim 4, wherein the ribs forming the side openings have an angular orientation of approximately 140°.

6. The feeding catheter of claim 1 , wherein the wall thickness of the web is less than the wall thickness of the plurality of ribs.

7. The feeding catheter of claim 1 , wherein the web walls are configured to collapse generally inward between the ribs in an extended state.

8. the web wall includes score lines that assist the web wall in collapsing when moving to the extended state; The feeding catheter of claim 7 , wherein the score lines are longitudinal indentations along the web wall.

9. the lumen is adapted to receive an introducer; The feeding catheter of claim 1 , wherein the introducer is configured to engage an inner surface of the nose joint to forcibly move the retention member from a relaxed state to an extended state.

10. The feeding catheter of claim 9, wherein the retention mechanism further comprises a pocket on an inner surface of the nose joint for receiving the tip of the introducer.

11. The feeding catheter of claim 9 , wherein the nose joint is radially opposed to the first end of the hollow tube.

12. 10. The feeding catheter of claim 1, further comprising a hole in the hollow tube toward the first end of the tube to provide a suction interruption.

13. The nutritional catheter of claim 1 , wherein the retention mechanism includes 3 to 5 ribs.

14. The nutritional catheter according to any one of claims 1 to 13, further comprising: an at least semi-rigid elbow guide for receiving and guiding a nutritional catheter within the flexible bag, the at least semi-rigid elbow guide comprising: a guide body including a first end and a second end, and a guide passage extending between the first end and the second end for passing the nutrition catheter, the guide passage having a bent portion for holding the catheter in a bent position, and a first passage opening and a second passage opening; a flange disposed at a first end of the guide body and adapted to engage an exterior surface of a patient's body to maintain a position of the nutritional catheter; the first passage opening is disposed toward an edge of the flange such that there is a substantial engagement surface area disposed away from the edge for engaging an exterior surface of the patient's body; A feeding catheter, wherein the at least semi-rigid elbow guide is positioned above the feeding catheter to hold the catheter in a bent position.

15. The nutritional catheter of claim 14, wherein the at least semi-rigid elbow guide is slidable relative to the nutritional catheter to adjust a bent position of the catheter.

16. The feeding catheter of claim 14, wherein the flange presents a substantially flat surface adapted to engage an inner surface of the flexible bag.

17. the guide body generally surrounding the guide passage and including a plurality of cantilever fingers configured to resiliently grip the nutrition catheter; The feeding catheter of claim 14, wherein at least three of the cantilever fingers are arranged in a staggered pattern.

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