# US 2021/0275400 A1 · Apparatuses for use with Replacement Gastrostomy Tubes for Status Indication, Durability and Design of Temporary Distal Tips > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2021/0275400 A1 - Document ID: US20210275400A1 - Status: Published application - Kind: A1 - Application number: 16/807,693 - Filed: 2020-03-03 - Published: 2021-09-09 - Earliest claimed: 2020-03-03 - Inventors: Ethan Hiram Dubin - Web page: https://patentgrep.com/patent/US20210275400A1 ## CPC - A61J 15/0015: {Gastrostomy feeding-tubes (insertion tools or methods A61B17/34)} - A61B 17/3415: {for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters (A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06)} - A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)} - A61J 15/0042: {inflatable} - A61J 15/0049: {Inflatable Balloons (balloon catheters A61M25/10)} - A61J 15/0088: {for sensing parameters related to the device} - A61B 2017/00473: {Distal part, e.g. tip or head (A61B2017/00464 takes precedence)} - A61M 25/0069: {Tip not integral with tube} - A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract Assembly of devices, and a kit, for use in replacement gastrostomy tube therapy, consisting of: 1) a Replacement Gastrostomy Tube status device comprising an evaluation module able to trigger an alarm that indicates the inflation status of a retention balloon; 2) a temporary distal “tip” structure for use in centering the Replacement Gastrostomy Tubes in vivo; and 3) a gastrostomy tube comprising a mesh latticework structure to increase the structural integrity of the Replacement Gastrostomy Tubes; and/or a pH sensor measuring acidity of fluid at distal tube opening. The module/unit comprises a battery powered, visual light, auditory signal or network-connected communication to convey the retention balloon's inflation status. The temporary distal “tip” structure includes various tapers, with minimal distal area, to facilitate placement of the Replacement Gastrostomy Tube via a self-centering function, in which the tip is chemically or mechanically released into a digestive tract, or withdrawn externally after a Replacement Gastrostomy Tube is positioned in vivo. ## Claims ### Claim 1 An assembly for use in Replacement Gastrostomy Tube therapy, comprising one or more of: a. an Replacement Gastrostomy Tube status device comprising a sensing module able to trigger an alarm that indicates the under inflation status of a retention balloon; b. a temporary distal “tip” structure able to assist with the proper placement/centering of a Replacement Gastrostomy Tube in vivo; c. a gastrostomy tube comprising, 1) a mesh latticework structure to increase the structural integrity of the Replacement Gastrostomy Tube; and/or 2) a pH sensor able to measure the acidity of fluid at distal tube opening. ### Claim 2 (depends on 1) The assembly of claim 1, wherein the Replacement Gastrostomy Tube status device comprises from end-to-end, a. a pressure sensing unit 5 that receives electrical input from a distal retention balloon fluid pressure sensor, wherein said sensing unit is able trigger an alarm when a fluid pressure passes a threshold level; b. a battery 6 able to power the Replacement Gastrostomy status device, optionally including any form of indication signaling a low-battery status; c. an electrical circuit 7 comprising a processor, a memory, and a wired or wireless transmitter able to receive input from sensing unit 5, and able to compute when the fluid pressure threshold level is reached; d. an alarm unit able to trigger an alarm when the fluid pressure threshold level is reached, said alarm being optionally configurable by a user for alarm type and, when applicable, alarm volume. ### Claim 3 (depends on 2) The assembly of claim 2, wherein the sensing unit further comprises electrical circuitry to wirelessly transmit the alarm, and/or the current Replacement Gastrostomy Tube fluid pressure level, and/or a history of the Replacement Gastrostomy Tube fluid pressure level to a remote computer, wherein said computer comprises one or more of: a remote server, and a user electronic computing device. ### Claim 3 (depends on 9) 10. The assembly of claim 9, wherein the mesh latticework structure is constructed of any material sufficient to create increased structural integrity to resist deformation of the replacement gastrostomy tubes. ### Claim 4 (depends on 1) The assembly of claim 1, wherein the alarm further comprises a local auditory signal with optionally configurable volume, and/or a visual signal detectable by the user. ### Claim 4 (depends on 1) 11. The assembly of claim 1, wherein the gastrostomy tube comprises a pH-sensitive material within the interior lumen of a replacement gastrostomy tube comprising translucent tube walls, wherein the pH sensitive material and a change in a color of the material, is visible through the translucent tube walls. ### Claim 5 (depends on 1) The assembly of claim 1, wherein the temporary, separable distal tip is constructed in a shape, size and material which can be mechanically, forcibly and/or chemically dislodged from a replacement gastrostomy tube in vivo, either through a distal or external (proximal) tube opening ### Claim 6 (depends on 5) The assembly of claim 5, wherein the distal tip comprises biocompatible, biodegradable material sand a shape that is able to dissolve safely in a patient's digestive system when the tip is dislodged from the tube into the patient's stomach. ### Claim 7 (depends on 5) The assembly of claim 5, wherein the tip is constructed in a shape, size and material which can, based on common principles of the art, be safely withdrawn through a distal opening in the replacement gastrostomy tube via pulling the tip out of the tube using a mechanical attachment. ### Claim 8 (depends on 7) The assembly of claim 7, wherein the mechanical attachment comprises a flexible, rod-like structure affixed to the rear-side of the tip, and able to push and pull the tip within the tube. ### Claim 9 (depends on 1) The assemble of claim 1, wherein the gastrostomy tube is comprised including a mesh-latticework structure embedded along the replacement gastrostomy tube of customary design as referenced in prior art having a main feeding tube incorporating a tubular lattice-work layer at any point on or between the interior lumen of the tube and the exterior boundary of the circumference of the tube, and extending any of the length or ports of the tube, such that commonly found flexibility of the tube is substantially retained while creating enhanced resistance to deformation from an original shape and circumference of the tube. ### Claim 12 A method of using as assembly in a Replacement Gastrostomy Tube therapy, comprising a. providing an assembly comprising one or more of: a Replacement Gastrostomy Tube status device comprising a sensing module able to trigger an alarm that indicates the under inflation status of a retention balloon; a temporary distal “tip” structure able to indicate the proper centering of the Replacement Gastrostomy Tube in vivo; a gastrostomy tube comprising, a mesh latticework structure to increase the structural integrity of the Replacement Gastrostomy Tube; and/or a pH sensor material able to measure the acidity of fluid at a distal tube opening; b. Inserting the assembly into a Replacement Gastrostomy Tube during preparation for insertion into a body of such a tube c. Detecting by the clinician, one or more of: an alarm for when the retention balloon is underinflated due to loss of fluid; the distal tip is in position on the distal Replacement Gastrostomy Tube end, and the Replacement Gastrostomy Tube is properly centered during insertion; a pH level of the material after inserting the Replacement Gastrostomy Tube into a patient's body.