Gastrojejunal tube device and method of use

Abstract

A gastrojejunal (GJ) tube device and a method of using the GJ tube device, the GJ tube device having a plurality of tubes forming lumens within the device, including a guide tube having a closed end that is exposed by cutting a portion of the GJ tube device to allow for the insertion of a guidewire therethrough to assist in the placement of a new GJ tube, for example, when an existing tube becomes clogged or blocked.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefits of U.S. Provisional Patent Application No. 63 / 140,060, filed on January 21, 2021, entitled "GASTROJEJUNAL TUBE APPARATUS AND METHOD OF USE", the entire disclosure of which is hereby incorporated by reference in its entirety.

[0002] The present disclosure generally relates to gastrostomy feeding tube devices, and more particularly to gastrostomy feeding tube devices configured to enable simultaneous delivery of substances above and below the pyloric valve / pylorus of the gastrointestinal tract.

Background Art

[0003] A gastroduodenal (GJ) feeding tube device 20 is a tube that is inserted through an incision in the abdomen 24 into the stomach 22 and the jejunal portion of the small intestine 38. The GJ tube is used in various situations, typically in patients with impaired gastric motility, patients at high risk of respiratory esophageal reflux, patients with pancreatitis, or patients in some other conditions where direct supply to the stomach alone is not preferable or dangerous. The GJ tube device 20 allows for the direct delivery of nutrition, hydrates, other fluids, and medications to a location below the pyloric valve 36 of the jejunum 38 past the duodenum 48.

[0004] A typical GJ tube apparatus 20 includes a first end 26 and a second end 40, as shown in Figure 1. The first end 26 includes a number of access ports 28, 30, 32 that allow access to internal tubes that extend parallel through the body of the apparatus 20. Each tube defines a lumen. The terms “tube” and “lumen” are sometimes used interchangeably herein with respect to a fluid passage (lumen) and the physical structure (tube) that forms the fluid passage. No limitation to structure is intended. Where “tube” is referred to, its element will be understood by a definition that defines at least one lumen. Any tube referred to herein can be an individual tubular element, one of several individual tubular elements mounted together, or one of several integrated inner walls of a single structure, each inner wall defining a fluid passage. Thus, a device having three tubes defines three lumens and may be, for example, one single extruded elongated part or three mounted elongated parts. One access port 28 and associated tube are connected to a balloon portion 34, which can be inflated at least temporarily once the GJ device is positioned to prevent accidental retraction or movement of the device. A second access port 30 and associated tube 44 allow access to an opening 52 positioned in the stomach, through which nutrition, hydrates, other fluids, and / or drugs can be directly introduced into the stomach. A third access port 32 and associated tube 42 allow access to an opening 50 positioned in the jejunum, through which nutrition, hydrates, other fluids, and / or drugs can be directly introduced into the jejunum. The GJ device 20 may also include a disc portion 46 or other external positioning / retaining element that is supported by the skin and can prevent, for example, extreme insertion into the device's opening 47. [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] The procedure for placing a GJ tubing device is typically performed by a clinician in a radiology room, allowing for the use of ultrasound, X-ray, and / or other imaging techniques to assist in the precise placement of the device. While care is usually taken to keep the GJ tubing device clean and functioning properly, it is not uncommon for at least one of the tubes to become clogged. Various different techniques have been developed to attempt to remove clogs when they occur, such as those described in U.S. Patent Application No. 13 / 679,160 to Honig. Such techniques have varying success rates, but a certain percentage of tubes are usually not completely or at least substantially clogged. The clogged tube must be removed, and placing a new one typically requires the same time and resources as the initial placement procedure to accurately guide and position the new GJ tubing device. Devices and procedures are needed to reduce the time and effort required to place the next GJ tubing device in a patient. [Means for solving the problem]

[0006] In one embodiment, a method of treating a patient includes establishing access from an external position to a normally closed retrieval lumen extending parallel to the supply lumen within a gastrojejunal (GJ) tube device, and advancing a guidewire through the retrieval lumen. The method further includes withdrawing the GJ tube device from the patient's body, leaving the guidewire in place. The method further includes advancing a new GJ tube device over the guidewire to a treatment position where the gastric and jejunal supply ports of the new GJ tube device are above and below the pylorus in the patient's gastrointestinal tract, respectively, and then removing the guidewire.

[0007] In another embodiment, the gastrojejunal (GJ) tube device includes a device body having an outer wall, a first proximal end, and a second distal end. The outer wall further includes an inflatable balloon portion and optionally at least one cutting mark. The plurality of tubes run substantially parallel to each other within the device body and include a first tube having an opening at the proximal end of the device body and an opening for the inflatable balloon portion; a second tube having an opening at the proximal end and an opening between the proximal and distal ends forming a gastric supply port; a third tube having an opening at the proximal end and an opening at the distal end forming a jejunal supply port; and a guide tube having a closed-blind end distal to the proximal end and terminating at a position distal to the gastric supply port. Cutting the device body, for example, at at least one cutting mark, creates an opening for the guide tube.

[0008] In yet another embodiment, the method for replacing the GJ tube device described above is achieved by withdrawing a portion of the existing GJ tube device from the patient until, for example, a target region or location which may be indicated by at least one cutting mark is outside the abdominal wall (if the cutting marks are not yet outside the abdominal wall), cutting the existing GJ tube device to create an opening in the guide tube, inserting a guidewire through the opening in the guide tube, withdrawing the existing GJ tube device while leaving the guidewire in place in the patient, positioning the new GJ tube device in the patient by passing the new GJ tube device over the guidewire until the distal end of the new GJ device is past the pyloric valve and in the small intestine, withdrawing the guidewire from the device, and securing the new GJ tube device to the patient.

[0009] In yet another embodiment, the gastrojejunal (GJ) tube device includes a device body having an outer wall, a first proximal end, and a second distal end, and an inflatable balloon portion. The first tube of the device body forms an inflatable fluid lumen extending between the proximal end of the device body and the inflatable balloon portion. The second tube of the device body forms a gastric supply lumen beginning at the proximal end of the device body and ending at a gastric supply port formed between the proximal and distal ends of the device body. The third tube of the device body forms a jejunal supply lumen beginning at the proximal end of the device body and ending at a jejunal supply port formed at the distal end of the device body. The guide tube of the device body forms a retrieval lumen beginning at a closed-blind end and ending at a position distal to the gastric supply port.

[0010] In yet another embodiment, the medical device includes an outer wall and a device body having a first proximal end and a second distal end. The first tube of the device body forms a lumen having a first opening at the proximal end of the device body and a second opening at the distal end of the device body. The second tube of the device body forms a lumen having an open first end at the proximal end of the device body and a closed second end disposed between the proximal end and the distal end of the device body. The third tube of the device body forms a lumen having a closed first end disposed between the proximal end and the distal end of the device body and an open second end at the distal end of the device body. The medical device may further include at least one cutting mark on the device body, which may be positioned so that cutting the device at the cutting mark creates a second open end of the third tube.

[0011] In a further embodiment, the GJ tube replacement kit includes a replacement GJ tube having one or more of the features disclosed above, as well as one or more other devices, such as guide wires and retaining clips, required for the removal and replacement of an existing GJ tube device. [Brief explanation of the drawing]

[0012] [Figure 1] This is an illustrative diagram showing the arrangement of a gastrojejunal (GJ) tube device. [Figure 2]This is a plan view of a GJ tube apparatus according to one embodiment. [Figure 3] Figure 2 is a plan view of a part of the device shown. [Figure 4] This is a plan view of a GJ tube apparatus according to one embodiment. [Figure 5] This is a plan view of a GJ tube apparatus according to one embodiment. [Figure 6] This is a cross-sectional view of the main body of a GJ tube apparatus according to one embodiment. [Figure 7] This is a cross-sectional view of the main body of a GJ tube apparatus according to one embodiment. [Figure 8] This is a cross-sectional view of the main body of a GJ tube apparatus according to one embodiment. [Figure 9] This is a cross-sectional view of the main body of a GJ tube apparatus according to one embodiment. [Figure 10] This is an illustrative diagram showing the replacement of a GJ tube device according to one embodiment. [Figure 11] This is an illustrative diagram showing the replacement of a GJ tube device according to one embodiment. [Figure 12] This is an illustrative diagram showing the replacement of a GJ tube device according to one embodiment. [Figure 13] This is a cross-sectional view of the tip of a GJ tube apparatus according to one embodiment. [Figure 14] This is a plan view of a GJ tube apparatus according to one embodiment. [Figure 15] Figure 14 is a perspective view of the distal end of the GJ tube device. [Figure 16] This is a side view of a fixing clamp according to one embodiment. [Figure 17] Figure 16 is a perspective view of the fixing clamp. [Figure 18] This is an illustrative diagram showing the replacement of a GJ tube device according to one embodiment. [Figure 19] This is an illustrative diagram showing the replacement of a GJ tube device according to one embodiment. [Figure 20] This is a plan view of a GJ tube apparatus according to one embodiment. [Figure 21] It is a cross-sectional view of a GJ tube device according to one embodiment.

Embodiments for Carrying Out the Invention

[0013] Referring to the drawings, medical devices according to some embodiments are shown. This specification is generally understood to refer to all embodiments unless otherwise indicated or apparent from the context. Discussions in this specification of the features or functions of any one embodiment are to be understood, unless otherwise indicated or apparent from the context, as referring, metaphorically speaking, to the features or functions of any other embodiment. References to "first," "second," "third," and similar descriptions are used for convenience only and are not considered to require any particular identification information, order, or arrangement of the elements being described.

[0014] Figures 2-3 show a gastrojejunal (GJ) tube device 100 according to one embodiment of the present disclosure. In this example, the tube device 100 includes a first proximal end portion 110, i.e., a “hub”, and a second distal end portion 112. The first end portion 110 includes a first access port 104 associated with a first tube 124 that forms an expansion fluid lumen, a second access port 106 associated with a second tube 126 that forms a first supply lumen, and a third access port 108 associated with a third tube 128 that forms a second supply lumen. The access ports 104, 106, and 108 may include closure devices or covers, such as removable caps. The tubes 124, 126, and 128 run substantially parallel to each other through an elongated device body 102. The first access port 104 and tube 124 are operatively connected to the balloon portion 118, allowing for the desired introduction and removal of an inflatable fluid, such as saline solution, contrast agent, water, or air, into the balloon portion 118. The second access port 106 and tube 126 are operatively connected to the opening 116, which allows access to the stomach when the device 100 is placed in the patient. The third access port 108 and tube 128 are operatively connected to the opening 114, which allows access to the jejunum when the device 100 is placed in the patient. The device 100 may further include at least one mark 120 (cutting indicator). The mark 120 may be one or more marks formed in the material of the device 100, such as a line or ridge, a series of lines / ridges, or one or more protrusions. The mark 120 may also include colored or other indelible markings or other visible features, surface texture features, or further marks that provide visual and / or tactile features. In the embodiments shown, the marks are shown both proximal and distal to the balloon portion 118. In some cases, only the mark distal to the balloon portion 118 or only the mark proximal to the balloon portion 118 is used.

[0015] Mark 120 is located in a transitional region 122 of the device body 102, where the fourth tube 130, which forms a normally closed retrieval lumen, begins and runs substantially parallel to tubes 124, 126, and 128 through the device body 102. Mark 120 marks where a new access opening to tube 130 may be established by cutting the device body 102 and removing or partially removing the first end 110 from the device 100, thereby creating a fourth access port or point 132 that allows access to the fourth tube 130 and the associated retrieval lumen. The fourth tube 130 typically ends at a fourth opening that allows access to the small intestine at some point distal to the gastric supply port, past the pyloric valve / pylorus when the device 100 is placed in the patient. The opening of the fourth tube 130 forming the retrieval lumen may include a normally closed opening formed by a valve, a membrane through which a guidewire can be punctured, or other plug or closure that can be removed, enlarged, or opened when the retrieval lumen is used as discussed herein. In one embodiment, the distal opening of the retrieval lumen (the fourth opening of the fourth tube 130) is located at the terminal distal end of the device 100. In other examples, it may be located proximal to the terminal end, proximal to the jejunal inlet, and may be formed in the nature of a side port. In yet another example, the normally closed terminal opening may be located at the distal terminal end of the device 100, as discussed below in reference to Figure 13, and in some cases may even be located distal to the jejunal inlet.

[0016] Embodiments are also conceivable in which the guide tube forming the retrieval lumen is the distal portion of tube 126 forming the gastric supply lumen. As will be apparent to those skilled in the art, a GJ tube can be formed with a lumen extending along the entire longitudinal length of the device, but is blocked or closed at the distal portion to supply nutrients, fluids, etc., to the proximal gastric supply port to the unavailable distal portion. According to this disclosure, the retrieval lumen may be an extension or continuation of the gastric feeding lumen that is accessed or opened to receive a guidewire for replacing the device. Those skilled in the art will also be familiar with the conventional functions of gastric feeding tubes and conventional structures that block or occlude the distal portion of a gastric feeding tube. According to this disclosure, the normally blocked or occluded portion may be removed by cutting and removing the GJ tube device at the cutting marks described herein, but may also be accessed by puncturing the blocked, occluded, or valved portion with a guidewire to establish a retrieval lumen that extends completely to or near the terminal end of the GJ tube device. In such applications, the user may employ a guidewire with a relatively stiff tip to open the retrieval lumen and then replace it with a guidewire having a softer tip, although in other examples the same guidewire may be used. Furthermore, as will be discussed herein, the retrieval lumen and associated tubing may also serve to reinforce the GJ tubing device. Embodiments are conceivable in which the normally closed or occluded portion of the gastrostomy lumen distal to the gastric inlet has the desired rigidity to prevent twisting as discussed herein. The entire gastrostomy lumen, including the proximal portion used for gastrostomy and the normally closed distal portion used as a retrieval lumen, may have greater rigidity than other parts of the GJ tubing device.

[0017] When the device 100 becomes clogged due to material adhering to one or both of the gastric and jejunal feeding lumens and requires replacement, a guidewire may be inserted over the length of the tube 130, the clogged GJ tube device may be removed, and the new GJ device may be positioned by following the length of the guidewire, which maintains a proper placement route. The guidewire may then be removed, and the new GJ tube device may be secured as desired. The fourth tube 130 provides clear access over any blockages in the pyloric valve / pyloric and jejunal feeding lumens and assists in the placement of the new GJ tube device by passing over the guidewire as needed. By surrounding the opening 132 (closed blind end of tube 130) to the tube 130, it is ensured that the tube remains unintentionally used, unclogging, and sterile, and does not provide a route of infection for the patient or exhibit other problems. In conventional GJ tubes, only one of the tubes (the tube that accesses the jejunum) typically provides access to a point past the pyloric valve / pylorus, and that tube is often likely to be blocked, and therefore cannot be used to insert a guidewire past the blockage when used to provide nutrition to the jejunum.

[0018] Figure 4 shows a gastrojejunal (GJ) tube device 140 according to another embodiment. In this example, the GJ tube device includes a first end 142 and a second end (not shown). The first end 142 has a first access port 144 associated with a first tube, a second access port 146 associated with a second tube, and a third access port 148 associated with a third tube. The GJ tube device 140 further includes a fourth access port 152 associated with a fourth tube 150 that forms a recovery lumen and is positioned along the GJ tube body 156 between the first end 142 and the second end. The fourth access port 152 includes a sealing portion 154 to prevent material from entering the tube 150. The sealing portion 154 may be a removable / replaceable device such as a cap, lid, or plug, or it may be a sealed closure that must be cut to allow access to the opening 152 and the tube 150. Optionally, one or more marks 158 may be included on the tube body 156 to indicate where the GJ tubing device 140 may be cut to allow access to the tube 150.

[0019] Figure 5 shows a gastrojejunal (GJ) tube device 160 according to another embodiment. In this example, the GJ tube device 160 includes a first end 162 and a second end (not shown). The first end 162 has a first access port 164 associated with a first tube, a second access port 166 associated with a second tube, and a third access port 168 associated with a third tube. The GJ tube device 160 further includes a fourth access port 170 associated with a fourth tube 172 located at the first end 162 and forming a recovery lumen. The fourth access port 170 may include a sealing portion 174 to prevent material from entering the tube 172. The sealing portion 174 may be a removable / replaceable device such as a cap, lid, or plug, or it may be a sealed closure that must be cut to allow access to the access port 170 and the tube 172. Optionally, one or more marks 176 may be included on the tube body to indicate where the GJ tubing device 160 may be cut to allow access to the tube 172.

[0020] Referring here to Figure 13, a GJ tube device 300 having a distal tip 310 is shown. The device 300 may be any of the embodiments considered herein, or may be combined with any of the embodiments considered herein, and includes a retrieval lumen 322 formed by a guide tube 320. A jejunal nutrition lumen 328 penetrates the device 300. A radiopaque marker 330 is attached to the tip 310 in the shown embodiment. A guidewire is shown 326 so as to be visible immediately adjacent to a diaphragm 324 or another preferred closure such as a valve at the distal opening of the retrieval lumen 322. Various different closure techniques can be used for the distal opening of the retrieval lumen so that the retrieval lumen is typically closed until the time it is opened for use. It will be understood that the retrieval lumen 322 may typically be closed at both its proximal and distal ends. The guide tube 320 may be associated with or attached to a reinforcing element such as an embedded coil, which may be formed from a reinforcing material as described herein, or the guide tube may be otherwise connected to a reinforcing element such as an embedded coil. 320 The guide tube 320 may be configured to give the portion of the device 300 through which it penetrates the desired reinforced rigidity. The guide tube 320 may extend along the entire length of the device 300 and is normally closed and can be opened by cutting or removing a closure at the proximal end, but may also extend only along a portion of the device 300, as will be discussed in relation to some embodiments herein. The device 300 has one or more weights embedded in the material at the tip 310 332 The weight 332 also helps to advance the tip 310 and the device 300 through the patient's body, for example, past the pylorus. 332 It may be made of metal, for example.

[0021] Figures 6–9 show cross-sectional views of gastrojejunal (GJ) tube apparatus bodies according to several embodiments. These examples are provided for illustrative purposes only, and the exact size, shape, and configuration of the tubes in different embodiments may vary. Typically, the tubes used to provide access to the stomach and jejunum will be larger than the tubes providing access to the balloon portion and the guidewire placement route or retrieval lumen. The exact size, shape, and configuration of individual tubes may vary according to the requirements and design of a particular GJ tube apparatus. The GJ tube walls are made of elastomer polyurethane, polyacrylate, polyolefin, polyamide including nylon, polyester, fluoropolymer, silicone, polyphosphazene, perfluoroelastomer, Fluoroelastomer ( flu о roelastomer ) They may be made from various materials such as polymers and copolymers, and derivatives, mixtures, and alloys of such polymers may be used. Furthermore, reinforcing materials such as metals and / or composite materials may be included in all or part of the GJ tube wall as desired. The fourth tube forming the recovery lumen may include, for example, polyimide.

[0022] In some embodiments, other components or the whole of the GJ device, other than the fourth tube forming the recovery lumen, may be formed from a first material, and the fourth tube may be formed from a second material different from the first material. Some tubes of the GJ tube device according to this disclosure may be co-extruded. In some embodiments, the fourth tube can be inserted into a lumen formed in the body of the GJ tube device and embedded therein, for example, by adhesive, melting, friction retention, or attachment by any other preferred method. In yet another embodiment, the fourth (rescue) lumen may be formed open at both ends, and then one end, which will be the proximal end, is closed / sealed before the lumen is placed in the GJ tube device.

[0023] In the first example shown in Figure 6, the GJ tube apparatus 180 includes an outer wall 182 that surrounds and defines the outer circumference of a plurality of tubes. The tubes include a first tube 188, a second tube 190, a third tube 186, and a fourth tube 192. The first tube 188 and the second tube 192 are separated by a partition wall 184. In this example, the third tube 186 and the fourth tube 192 are separated from the first tube 188 and the second tube 190 by thickened portions 194 and 196 of the outer wall 182, respectively.

[0024] In the example shown in Figure 7, the GJ tube apparatus 200 includes an outer wall 202 that surrounds and defines the outer circumference of a plurality of tubes. The tubes include a first tube 210, a second tube 212, a third tube 206, and a fourth tube 208. The first tube 210 and the second tube 212 are separated by a partition wall 204. In this example, the third tube 206 and the fourth tube 208 are separated from the first tube 210 and the second tube 212 by a thickened portion 214 of the outer wall 202.

[0025] In the third example shown in Figure 8, the GJ tube apparatus 220 includes a defining outer wall 222 surrounding the outer periphery of a plurality of tubes. The tubes include a first tube 224, a second tube 226, a third tube 230, and a fourth tube 232. The first tube 224 and the second tube 226 are separated by a partition wall 228. In this example, the third tube 230 and the fourth tube 232 are separated from the first tube 224 and the second tube 226 by thickened portions 234, 236 of the outer wall 222. In this particular example, the third tube 230 and the fourth tube 232 are shown to have an elliptical cross-section. Furthermore, the third tube 230 is defined by a wall 238 containing one or more reinforcing materials as discussed earlier. The wall 238 of the third tube 230 in this example is generally more rigid than the wall 222 of tube 220, which acts to resist torsion of the apparatus during and after placement, particularly when it moves past the pyloric valve / pylorus during placement, and prevents pinching and potential collapse of one or more of the other tubes of the apparatus. The material from which the wall 238 is made, such as polyimide, may have anti-torsional stiffness compared to the stiffness of the walls of the other tubes. In this example, the wall 238 and the third tube 230 form a retrieval lumen with a closed blind end outside the plane of the page in Figure 8. Tube 230 is cut to form a new opening in the tube 230 that supplies the guidewire through the apparatus 220, as described herein.

[0026] In the fourth example shown in Figure 9, the GJ tube apparatus 250 includes a defining outer wall 252 surrounding the outer periphery of a plurality of tubes. The tubes include a first tube 256, a second tube 254, a third tube 260, and a fourth tube 262. The first tube 256 and the second tube 254 are separated by a partition wall 258. In this particular example, the first tube 256 is larger than the second tube 254. In this example, the third tube 260 and the fourth tube 262 are separated from the first tube 256 by a thickened portion 264 of the outer wall 252. In this particular example, the third tube 260 and the fourth tube 262 are shown to have an elliptical cross-section. Furthermore, portions of the outer wall 252 include one or more reinforcing materials 266 as discussed previously. In this example, the wall 252 portion may include an integrated reinforcement that acts to prevent twisting of the apparatus during and after placement, and to prevent pinching and potential collapse of one or more of the apparatus's tubes. In other examples, all or selected portions of the outer wall may include reinforcing material to prevent twisting along the entire length of the GJ tube apparatus or in selected portions of the apparatus.

[0027] Various applications of the anti-torsion reinforcement properties of the integrated reinforcement component can be observed in the field. The reinforced reinforcement can help maintain the tube shape and prevent twisting after the GJ tube device is placed and secured in the precise position of the patient and the guidewire is removed. During the normal physiological process of gastrointestinal peristalsis, the movement of the patient's gastrointestinal tract can sometimes cause or lead to obstruction and dysfunction. The additional rigidity of the GJ tube at selected positions according to this disclosure, including the distal portion in the jejunum, can help maintain the desired position and potentially extend the usable time of the device. Another cause of premature GJ tube failure may be backward displacement of the portion of the GJ tube intended for positioning in the jejunum into the patient's stomach due to retraction and sometimes retraction. For example, changes in the patient's body can be associated with different orientations of the GJ tube, and changes in the GJ tube incidence angle at the time of insertion may occur based on, to name a few, the choice of the physician performing the procedure, unavoidable changes between procedures, access to the stomach related to the position of the pylorus, and the overall shape of the stomach. Physiological forces such as peristalsis and duodenogastric reflux (related to GI motility problems, nausea, and vomiting) may contribute to this phenomenon. Further rigidity as described herein, including a relatively greater variety of rigid materials or inserted or embedded molded metal coil components in key areas associated with important anatomical locations, can help suppress anatomical variations, positional variability, and physiological processes that may cause undesirable migration during the intended service life of the GJ tubing device.

[0028] In another example shown in Figure 14, the GJ tube apparatus 360 includes a first proximal end portion 364 and a second distal end portion 382. The proximal end portion 364 includes a number of access ports 366, 368, 370, each associated with a separate lumen (not shown) that allows for the introduction of fluids such as nutrition, medicine, hydration, or balloon inflation. Other examples provide more or fewer access ports. The access ports 366, 368, 370 may include closure devices or covers, such as removable caps. The lumens run substantially parallel to each other through the elongated apparatus body 372. One of the access ports and its associated lumen is operationally connected to the balloon portion 376, allowing for the desired introduction and removal of inflation fluids, such as saline solution, contrast agent, water, or air, into and out of the balloon portion 376. The disc portion 374 is positioned on the device body 372 between the proximal end 364 and the balloon portion 376 so that when the device is placed in the patient and the balloon is inflated, the device is secured in place in the abdominal wall between the balloon and the disc portion 374. In this particular example, one of the remaining access ports is associated with a lumen that allows access to the stomach, and another access port and associated lumen are operatively connected to an opening that allows access to the jejunum when the device 360 ​​is placed in the patient.

[0029] The GJ tubing device 360 ​​further includes a fixed portion 380 disposed around the device body 372 at a point between the distal end 382 and the proximal end 364. The fixed portion 380 may be made of the same or different material as the device body 372. The fixed portion 380 may be formed as part of the manufacturing process of the device body 372, or it may be formed separately and then later attached and fixed to the device body 372 (for example, using a bonding agent, sonic welding, or other suitable melting method). Optionally, the fixed portion 380 may be colored to make it easier to distinguish from the device body 372. The fixed portion 380 may be rough to make identification by gripping and / or touch easier, and may include markings indicating cutting lines or zones, or the cutting markings may be placed near the fixed portion 380, for example, proximal, to guide the clinician to the appropriate position to make new access to the recovery lumen, as will be further discussed herein.

[0030] A fourth lumen, comprising a recovery or rescue lumen 384, begins at a point between the proximal end 364 and the distal end 382 of the GJ tube device 360 ​​and runs substantially parallel to the other lumens before ending at the distal end 382 or a distal end 386 near the distal end 382 of the GJ tube device 360. In this particular example, the rescue lumen 384 begins at the proximal end 378, which has a sealed or blind end 362 positioned between the fixed portion 380 and the proximal end 364 of the GJ tube device 360. In other examples, the rescue lumen may begin at sealed end portions positioned at several points surrounded by the fixed portion. The precise positioning of the proximal end of the rescue lumen and its length relative to the overall length of the GJ tube device body according to the disclosed invention may vary depending on the specific application. In one example, the rescue lumen is at least 50% to 66% of the overall length of the GJ tube device body. In another example, in so-called "low-profile" GJ tube devices, such as those used in birth situations, the rescue lumen may comprise up to 80% of the total length of the GJ tube device body.

[0031] The rescue lumen typically ends with an opening that allows access to the small intestine at some point distal to the gastric supply port, past the pyloric valve / pylorus when the device 360 ​​is positioned in the patient. The rescue lumen opening may include a normally closed opening formed by a valve, a membrane that can be perforated through a guidewire, or other plugs or closures that can be removed, enlarged, or opened when the retrieval lumen is used as discussed herein. In one embodiment, the distal opening of the retrieval lumen is located at the terminal distal tip of the GJ tube device. In other examples, it may be located proximal to the terminal tip, proximal to the jejunal supply port, and may be formed with the properties of a side port. In yet another example, the normally closed terminal opening may be located at the distal terminal tip of the GJ tube device, as discussed previously in relation to Figure 13, and in some cases may even be located distal to the jejunal supply port.

[0032] One example of the distal end of a rescue lumen is shown in detail in Figure 15. In this particular example, the distal end 382 of the GJ tube device 360 ​​includes a lumen tip 388 having a first opening 390 and a second opening 392 separated by a partition 394. The partition 394 is positioned and configured to prevent material passing through the lumen of the device body 372 from being collected and accumulating in the lumen tip 388. Such accumulation can create an obstruction that prevents the GJ tube device 360 ​​and / or valve assembly 396 of the rescue lumen 384 from functioning properly. Optionally, the lumen tip 388 is made of an X-ray opaque material to increase visibility during the placement of the GJ tube device 360. The distal end 386 of the rescue lumen 384 is disposed within the lumen tip and is provided with a concave valve assembly 396. The valve assembly 396 acts as a check valve to prevent substances (such as food or medicine) passing through other lumens of the GJ tube device 360 ​​from entering the rescue lumen 384 and potentially clogging it. However, a guidewire that travels through the rescue lumen 384 from the proximal end 378 to the distal end 386 opens the valve assembly 396, allowing for proper wire positioning during the GJ tube device replacement procedure.

[0033] Figures 16-17 show an example of a fixing clip 400 used with a GJ tube assembly, such as the one shown in Figure 14. In this particular example, the fixing clip 400 includes a first part 414 or jaw having a first fixing feature 402 and a clamping portion 408, and a second part 414 or jaw having a second fixing feature 404 and a clamping portion 410. The first part 416 and the second part 414 are operatively connected by a flexible hinge 406. A block 411 may be located within the hinge 406 to prevent accidental placement of the tube near the hinge 406. The first part 416 and the second part 414 may further include associated gripping portions 412 to allow for easier gripping and use. The hinge 406 is configured such that when the first portion 416 and the second portion 414 are biased toward each other, the first fixing feature portion 402 and the second fixing feature portion 404 interact to hook, snap, lock, or otherwise secure the clip 400 in the closed position. The first fixing feature portion 402 and the second fixing feature portion 404 are optionally configured so that once secured in the closed / latched position, they cannot be released. The first clamping portion 408 and the second clamping portion 410 are configured such that when the fixing clip 400 is in the closed / locked position, the clamping portions 408 and 410 form an opening that is slightly smaller in diameter than, but optionally equal in diameter to, the device body 372 of the GJ tube device 360 ​​as shown in Figure 14. That is, when the device body 372 is positioned within the clamping portions 408, 410 of the closing / fixing clip 400, the clamping portions 408, 410 apply pressure to the device body 372 that is sufficient to prevent the clip 400 from moving relative to the device body 372, but insufficient to crush or close the lumen inside the device body 372. In another example, the first clamping portion 408 and the second clamping portion 410 are sized and configured such that when the fixing clip 400 is in the closed / fixed position, the clamping portions 408, 410 form an opening with a diameter slightly smaller than the fixing portion 380 of the GJ tube device 360 ​​as shown in Figure 14.In other words, when the device body 372 is positioned within the clamping portions 408 and 410 of the closing / fixing clip 400, the clamping portions 408 and 410 form a passage having a diameter smaller than the diameter of the fixing portion 380, such that the fixing clip cannot slide on or past the fixing portion 380, thereby preventing the GJ tube from returning to the opening in the abdominal wall.

[0034] Optionally, the clamping portions 408, 410 may include a surface texture or material (such as an adhesive or abrasive) to enhance the grip between the clamping portions 408, 410 and the fixing portion 380. The use of the fixing clip 400 as described in this example in the replacement procedure of the GJ tube apparatus 360 as shown in Figure 14 will be described in further detail below with respect to Figures 18-19. The GJ tube assemblies as described herein are intended to be packaged in a suitable sterile package together with the associated fixing clips (one or more), guide wires (one or more), and other articles used during the replacement procedure. Such a package ensures that all necessary or desired materials are present and that such materials are precisely sized and constructed for use together.

[0035] Referring here to Figure 20, a GJ tube device 660 is shown, which has similarities to other embodiments discussed herein but with certain differences. The GJ tube device 660 is configured as a multi-lumen catheter, comprising a hub at a proximal end 664 and a distal end 686 including a distal tip 687. Although not specifically shown, a jejunal feeding lumen extends entirely through the GJ tube device 660. A balloon inflation lumen extends to a balloon (not shown). It will be understood that such a balloon may be positioned distal to a disk 674, substantially equivalent to a similar structure discussed elsewhere herein. A gastric feeding lumen 670 extends to any preferred number of gastric feeding ports 661, which constitute side ports of the GJ tube device 660. A plug or backfill material 678 is located in the gastric feeding lumen 670 distal to the feeding ports 661. However, further distal, no backfill is used, thus creating an open, usable guiding tube or retrieval lumen 685.

[0036] Therefore, it will be understood that during construction, a lumen extending throughout the entire length of the GJ tubing device 660, but selectively inserted distal to the gastric supply location, can be formed, for example, by extrusion. A one-way valve, membrane, or similar as discussed herein may be located within the most distal portion of the retrieval lumen 685. As also discussed herein, a one-way valve or other obstruction may be recessed within the distal tip 687, as in the case of Figure 15.

[0037] The enlarged fixing portion 680, for example, a sleeve or simply an enlarged part of the GJ tubing device 680, is positioned distal to the gastric supply port 661 and distal to at least a portion of the backfill material 678. In this configuration, the user can cut the fixing portion 680 to create a new opening at the proximal end, where the original retrieval lumen 685 is a blind end. The use of the GJ tubing device 660 is similar to other embodiments discussed herein in that, if used, the user can partially withdraw the GJ tubing device from the patient to expose the fixing portion 680, then cut the GJ tubing device 660, apply a clip, and then replace the GJ tubing device 660 for replacement.

[0038] Now, let's refer to Figure 21. ,difference Furthermore, a GJ tube apparatus 760 according to another embodiment This is shown The GJ tubing device 760 has similarities to other embodiments discussed herein, but also has certain differences. The GJ tubing device 760 can be implemented similarly to the GJ tubing device 660 of Figure 20 and includes a gastric feeding lumen 770 with one or more gastric supply ports 761, and a backfill 778 in a single tubular passage forming a retrieval lumen 785 with a blind end formed by the backfill 778. An anti-cut structure 795 is embedded in the GJ tubing 760 and works to prevent the GJ tubing device from being cut when it is cut to form an opening to the retrieval lumen 785, similar to other embodiments discussed herein. In one embodiment, the anti-cut structure 795 includes a metal wire or coil. In another example, the anti-cut structure 795 includes a relatively hard non-metallic material within a relatively soft non-metallic material forming a suitable GJ tubing device 760. Thus, the user can cut the relatively soft non-metallic material, but the cut tends to be stopped by contact with the anti-cut structure 795. Since the GJ tubing device 760 is not cut into two parts, the risk of the distal portion returning to the patient is reduced or eliminated, and therefore the use of clips or similar structures or other techniques may be unnecessary.

[0039] While some of the aforementioned embodiments employ a single continuous passage that is partially backfilled to separate the gastric feeding lumen from the retrieval lumen, it should be understood that the disclosure is not limited thereto. The dedicated gastric feeding lumen may extend only as far as necessary to reach the gastric supply port, for example, running in parallel or continuously to a retrieval lumen that is blocked at its proximal end. Those skilled in the art will conceive of yet other alternative strategies that allow the user to access a normally closed retrieval lumen.

[0040] Industrial applicability As described above, healthcare professionals have long struggled with clogged GJ tubes, which often require a complete replacement when the blockage cannot be cleared. Figures 10–12 illustrate a suitable procedure for removing and replacing a GJ tube device according to one embodiment of the disclosed invention. In this particular example, a GJ tube device 270 according to one or more of the previously described embodiments, having one or more clogged tubes / nutrition lumens, is replaced. In this example, the GJ tube device 270 is first placed in the patient by creating a small opening 278 through the abdominal wall 272 and stomach 274 so that a cutting mark 280 on the tube is positioned inside the patient. In other examples, the cutting mark is outside the abdominal wall when the GJ tube device is precisely placed. If necessary, the inflated balloon portion 276 of the device is deflated to prevent the tube 270 from being unintentionally pulled out, and the GJ tube device 270 is pulled out until the cutting mark 280 is visible (Figure 11).

[0041] As shown in Figure 10, the balloon portion 276 may include radiopaque stripes 290. The stripes or "stripes" 290 can stretch and potentially curve in accordance with the inflation of the balloon portion 290, providing a visual indication to the user, with the help of radiography, regarding the inflated versus uninflated state of the balloon portion 276. When the balloon portion 276 is not inflated, for example, the stripes 290 may be parallel to each other. Such features can eliminate the need to use contrast agents to determine the balloon state.

[0042] The exact distance at which the GJ tube device is withdrawn from the patient's body to expose the cutting mark may vary, but in some cases it can be between 5 cm and 20 cm. The distance at which the GJ tube device is withdrawn from the abdominal wall to the patient will usually be less than the distance at which the distal end of the GJ tube device is withdrawn past the pyloric valve / pylorus. The total length of the GJ tube device as conceivable herein may be approximately 60 cm to 75 cm, while the length between the balloon portion 118 and the distal end may be approximately 45 cm.

[0043] Once the cutting mark is exposed, the GJ tube device may be cut along the mark, for example with scissors or a surgical knife or scalpel, to expose the inside of the device 282, including the opening 284 of the guide tube 286 that forms the rescue lumen (Figure 12). The guidewire 288 is then inserted through the opening 284 along the length of the guide tube 286, thereby positioning the guidewire 288 through the pyloric valve / pylorus into the small intestine. The blocked GJ tube device may then be withdrawn from the patient through the small opening 278 over the guidewire 288. The new GJ tube device is then inserted into the patient by passing it over the guidewire and advanced to the therapeutic position, with the gastrointestinal and jejunal supply ports of the new GJ tube positioned above and below the pylorus in the patient's digestive tract, respectively. The guidewire is then withdrawn, and the replacement GJ tube is secured using a typical procedure.

[0044] Figures 18-19 illustrate a procedure suitable for the removal and replacement of a GJ tubing device according to another embodiment of the disclosed invention. In this particular example, a GJ tubing device 420 according to one or more of the previously described embodiments, having one or more clogged tubes / nutrient lumens, is replaced. The GJ tubing device 420 includes a rescue tube 428 disposed therein, having a sealed proximal end portion. A fixing portion 426, as previously described with respect to the embodiment shown in Figure 14, surrounds a portion of the GJ tubing device 420 near the sealed proximal end portion of the rescue tube 428. The fixing portion 426 may include marks or markings indicating where it must be cut during the replacement procedure, or optionally, the device may be configured to be cut anywhere within the fixing portion.

[0045] In this example, the GJ tube apparatus 420 was initially positioned through small holes formed in the abdominal wall 422 and the stomach wall 424. Typically, such positioning is performed using radiography, which may be assisted by fabricating all or part of the GJ tube apparatus 420 from an X-ray opaque material. The GJ tube apparatus 420 is initially positioned so that the sealed end portion of the rescue tube 428 is positioned inside the abdomen, and optionally inside the stomach. In some examples, the rescue tube may generally be made from a less flexible material than the main body of the GJ tube apparatus. Thus, the portion of the GJ tube apparatus including the rescue tube may be more rigid, which may reduce the irritation that may be caused by having a more rigid GJ tube positioned outside the body, which would be more difficult to secure than a more flexible GJ tube when they are placed inside the abdomen and / or stomach.

[0046] The replacement process begins by releasing any fixation features (tape, inflated balloon portion, etc.) and withdrawing the GJ tube device 420 until at least a portion of the fixation portion 426 is exposed and accessible (as shown in Figure 19). The exact distance the GJ tube must be withdrawn may vary from application to application, but may be anywhere between approximately 5 cm and 20 cm. The distance the GJ tube device 420 is withdrawn from the abdominal wall will typically be less than the distance the distal end of the GJ tube device is withdrawn past the pyloric valve / pylorus to reduce the risk of accidentally withdrawing the tube too far and requiring radiographic assistance to ensure proper placement of the new tube. Once accessible, a fixation clip 432 is placed on the GJ tube device 420 distal to the fixation portion 426 to prevent the tube from returning to the abdominal wall. Once fixed, the GJ tube device may be cut, for example, with scissors or a surgical knife or scalpel. The cutting line 430 may be made at any point along the body of the GJ tube 420, including the fixing portion 426, thereby sealing the end of the rescue tube 428. Department The GJ tube device is replaced after it is cut and removed, thereby creating an exposed opening 436 to the rescue tube 428 into which a guide wire may be inserted. Optionally, the GJ tube device 420 includes markings for a cutting line 430, which may include colored marks, raised or grooved surfaces formed in the tube body, or a combination thereof, to indicate a preferred cutting zone or line.

[0047] This specification is for illustrative purposes only and should not be construed in any way to narrow the scope of the disclosure. It will therefore be apparent to those skilled in the art that various modifications may be made to embodiments of the disclosure without departing from the full and fair scope and spirit of the disclosure. Other aspects, features, and advantages will become apparent in the examination of the accompanying drawings and claims. Where used herein, the articles “a” and “an” are intended to include one or more items and may be used interchangeably with “one or more.” Where only one item is intended, the term “one” or similar wording is used. Furthermore, where used herein, terms such as “has,” “have,” and “having” are intended to be non-restrictive. In addition, the phrase “based on” is intended to mean “at least partially based on” unless explicitly stated otherwise.

Claims

1. A device body having an outer wall, a first proximal end, and a second distal end, wherein the outer wall includes an inflatable balloon portion, A first tube having an opening at the proximal end of the main body of the device and an opening in the outer wall of the inflatable balloon portion, A second tube having an opening at the proximal end and an opening between the proximal end and the distal end, A third tube having an opening at its proximal end and an opening at its distal end, A guide tube having a closed proximal end and a distal end on the opposite side, disposed between the proximal end and the distal end of the main body of the device. Equipped with, Cutting the main body of the device creates an opening in the guide tube. Gastrojejunal (GJ) tube device.

2. The exterior wall includes at least one cutting mark that includes tactile and / or color characteristics, The GJ tube apparatus according to claim 1.

3. When the GJ tube device is placed, the distal end of the guide tube is positioned within the patient's small intestine. The GJ tube apparatus according to claim 1.

4. The distal end of the aforementioned guide tube is further provided with a one-way valve assembly. The GJ tube apparatus according to claim 1.

5. The length of the induction tube is 50% to 80% of the length of the main body of the device. The GJ tube apparatus according to claim 1.

6. The closed proximal end of the guide tube is positioned between at least one cutting mark of the GJ tube device and the proximal end. The GJ tube apparatus according to claim 1.

7. The main body of the apparatus is formed from a first material, The induction tube is formed from a second material different from the first material. The GJ tube apparatus according to claim 1.

8. The second tube includes a gastric feeding tube. The gastric feeding tube and the guide tube are separated by a plug. The GJ tube apparatus according to claim 1.

9. The GJ tube device body further includes an enlarged fixing portion between the proximal end and the distal end. The GJ tube apparatus according to claim 1.

10. The fixed portion includes at least one of the color features, texture features, and cut mark features. The GJ tube apparatus according to claim 8.

11. The fixing portion of the GJ tube device is provided with a clip that engages with the distal GJ tube device, A guide wire is inserted through the opening of the guide tube and exits from the distal end of the guide tube, Further including, The GJ tube apparatus according to claim 8.

12. The apparatus body having an outer wall, a first proximal end, and a second distal end, and an inflatable balloon portion, A first tube that forms an inflatable fluid lumen extending between the proximal end of the main body of the device and the inflatable balloon portion, A second tube forming a gastric supply lumen, which begins at the proximal end of the device body and ends at a gastric supply port formed between the proximal and distal ends of the device body, A third tube forming a jejunal supply lumen, which begins at the proximal end of the device body and ends at the jejunal supply port formed at the distal end of the device body, A guide tube that forms a retrieval lumen, starting at the closed-blind end and extending to the distal end positioned distal to the gastric supply port. A GJ tube apparatus having, At least one fixing clip and Equipped with, Gastrojejunal (GJ) tube replacement kit.

13. The length of the induction tube is 50% to 80% of the length of the GJ tube device body. The kit according to claim 12.

14. The kit according to claim 12, wherein the GJ tube includes an enlarged diameter fixing portion.

15. The diameter-expanding fixing portion of the GJ tube includes at least one of the following: color features, texture features, and cutting mark features. The kit according to claim 14.

16. The GJ tube device further includes a one-way valve assembly positioned at the distal end of the guide tube. The kit according to claim 12.

17. The aforementioned one-way valve assembly is recessed from the distal end to the proximal end of the GJ tube device. The kit according to claim 16.

18. The apparatus body has an outer wall, a first proximal end, and a second distal end, A first tube of the device body forming a lumen having a first opening at the proximal end of the device body and a second opening at the distal end of the device body, A second tube of the device body having an open first end at the proximal end of the device body and a closed second end disposed between the proximal end and the distal end of the device body, forming a lumen, A third tube of the device body having a closed first end disposed between the proximal end and distal end of the device body and a second end opposite to the distal end of the device body, forming a lumen. Equipped with, Medical device.

19. The closed second end of the second tube is an inflatable balloon portion, A fourth tube of the device body having a first end that opens at the proximal end of the device body, forming a lumen, A plurality of supply ports are disposed between the proximal end of the device body and the closed first end of the third tube. Furthermore, The medical device according to claim 18.

20. To limit the cutting of the device body, an anti-cutting structure is positioned between the proximal end and the distal end of the device body. Further including, The medical device according to claim 18.

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