Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • 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
  • A61J15/00—Feeding-tubes for therapeutic purposes
  • A61J15/0003—Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • 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
  • A61J15/00—Feeding-tubes for therapeutic purposes
  • A61J15/0026—Parts, details or accessories for feeding-tubes
  • A61J15/003—Means for fixing the tube inside the body, e.g. balloons, retaining means
  • A61J15/0046—Expandable retainers inside body lumens of the enteral tract, e.g. fixing by radially contacting a lumen wall
  • A61J15/0049—Inflatable Balloons

Definitions

• Transnasal tube device for access to a body cavity of a patient
• the invention relates to a transnasal tube device for access to a body cavity of a patient through the esophagus according to the preamble of claim 1 and to a method for manufacturing a transnasal tube device.
• a transnasal tube device of this kind comprises a tube having a first, proximal end and a second, distal end.
• a port is arranged at the first, proximal end of the tube for feeding a medical solution into the tube.
• a inflation device is arranged on the tube, the inflation device comprising an inflatable chamber which is configured to, in a first, deflated state, assume a first volume to allow a passing of the tube through the esophagus towards a body cavity to be accessed by the transnasal tube device and, in a second, inflated state, assume a second volume larger than the first volume.
• a medical solution such as a nutritional feeding solution for the enteral feeding of a patient, a medication or a biotic solution
• a body cavity of a patient such as the patient's gastric tract (the patient's stomach) or the patient's intestinal tract (e.g. the patient's jejunum).
• the transnasal tube device with its tube is guided through the nose or mouth (oral) and the esophagus into the body cavity to be accessed, for example the patient's stomach or the patient's jejunum.
• the medical solution may be delivered through the tube directly into the accessed body cavity.
• the inflation device may be arranged on the second, distal end of the tube, the inflation device having an inflatable chamber which may be inflated to, in the second, inflated state, have a volume preventing a withdrawing of the second, distal end of the tube from the accessed body cavity.
• the inflation device with its inflatable chamber is brought into the first, deflated state having a reduced volume (with respect to the second, inflated state) such that the tube with its second, distal end may easily and safer be guided through the esophagus.
• Conventional transnasal tubes use, as inflation devices, inflatable balloons made of a silicon rubber having medium/high elasticity. Such balloons for example are inflated using an isotonic solution, causing potentially a substantial filling volume and weight within the accessed body cavity in the inflated state.
• US 4,943,275 discloses a balloon assembly having an intrinsic curvature adapted to a passage in a blood vessel.
• US 5,308,326 discloses a balloon tamponade device for treating bleeding sites within the upper digestive tract of a patient comprising a tube having proximal and distal open ends and at least one inflatable balloon mounted over the tube.
• US 6,213,975 discloses an intra-aortic balloon catheter having an ultrathin stretch blow molded balloon membrane.
• the inflatable chamber is defined by a membrane envelope made of a material having a Shore-hardness equal to or greater than 60.
• the Shore-hardness is a characteristic value for material properties of elastomers and plastics. It is specified in the DIN 53505 and DIN EN ISO 868 standards.
• the Shore- hardness-tester (or thoroughDurometer“) consists of a spring-loaded indenter, which elastic indentation is inversely related to the Shore-hardness of the material.
• the scale is from 0 to 100. A high figure means a high hardness.
• Shore A hardness applies to soft elastomers
• Shore D applies to materials having increased hardness. If not specified otherwise, it in the following is referred to Shore A.
• the inflation device with its inflatable chamber may in particular be arranged in the proximity of the distal end of the tube by which a desired body cavity is accessed. Once the body cavity is accessed the inflatable chamber may be inflated to assume the second, inflated state such that the transnasal tube device is retained within the accessed body cavity and/or, for example, a reflux of liquid is prevented by the inflatable chamber blocking a fluid path for example through the esophagus.
• the inflatable chamber By forming the inflatable chamber by means of a membrane envelope made of a material having a substantial hardness, the inflatable chamber preferably is substantially not expandable beyond the second, inflated state.
• the inflatable chamber may be inflated to assume the second, inflated state having a defined volume, but may substantially be not expanded beyond this second, inflated state.
• the inflatable chamber, in the second, inflated state hence assumes a predefined shape for example within an accessed body cavity, which may be adapted to anatomic needs of the patient and the body cavity to be accessed.
• the membrane envelope may for example be made from a material comprising polyurethane having a Shore-hardness greater than 60, preferably greater than 64, even more preferably greater than 70.
• Polyurethane is a polymer composed of organic units joined by carbamate (urethane) links.
• thermoplastic polyurethane may be used.
• the membrane envelope may for example be formed as a foil integrally with the tube, wherein the material of the tube may however differ from the material of the membrane envelope.
• the membrane envelope may be formed for example using a (thermal) molding technique such as a stretch blow or stretch molding technique.
• a stretch molding technique such as a stretch blow or stretch molding technique.
• the material may be first molded into a preform using an injection molding process.
• Such a preform may then later be fed into a reheat stretch blow molding machine to blow the preform using high pressure air into a suitable blow mold.
• the inflatable chamber In the second, inflated state the inflatable chamber hence assumes a defined shape formed and defined by the molding technique.
• the shape of the inflation device in the second, inflated state of the membrane envelope is known and reproducible, allowing defining the membrane envelope according to anatomic needs and a specific application of the transnasal tube device.
• the inflatable chamber may be fully or only partially filled.
• the inflatable chamber In a fully filled state the inflatable chamber can substantially not be compressed, wherein even in the fully filled state a rather low gas pressure may be applied for filling the inflatable chamber.
• the inflatable chamber In a partially filled state the inflatable chamber does not comprise its full volume defined by the shape of the membrane envelope, but encompasses only a partial volume.
• the inflatable chamber may be filled with a rather low pressure, a long-term use of the transnasal tube device for example within a patient is possible, for example over multiple days or even weeks - in contrast to for example cardiac applications in which generally only a short-term use over a rather short period of time is required.
• the inflatable chamber may be dimensionally stable even over the extended period of time of use.
• the inflatable chamber in the second, inflated state, may have a cylindrical shape or a spherical shape or any other shape desirable shape for a specific application, dependent also on a specific anatomic need.
• the inflatable chamber may comprise different portions, for example a first spherical portion adjoined by a second, cylindrical portion. Such portions may serve different purposes, the first portion for example functioning as a retention device, the second portion in contrast providing for a reflux prevention.
• the anatomic adaption of the inflatable chamber may furthermore be achieved or supported in that the inflatable chamber may provide for a sufficient retention even if it is only partially filled.
• the inflatable chamber In the second, inflated state the inflatable chamber is filled for example with air, wherein a rather low pressure may be sufficient for filling the inflatable chamber.
• the volume of the inflatable chamber In the first, deflated state the volume of the inflatable chamber is reduced with respect to the volume of the inflatable chamber in the second, inflated state, hence allowing to pass the tube of the transnasal tube device in particular through the esophagus during placement of the transnasal tube device in the patient's body for accessing a body cavity of interest.
• the tube of the transnasal tube device may in particular be a multi-lumen tube.
• the tube may comprise a first lumen for administering a medical solution, such as a nutritional feeding solution, a medication or biotics, into a body cavity accessed by the transnasal tube device.
• feeding equipment may for example be connected to the port of the tube at the first, proximal end of the tube, allowing feeding a medical solution to be delivered to the patient into the tube.
• a second lumen in contrast, may be in fluid connection with the inflatable chamber of the inflation device, such that via the second lumen the inflatable chamber may be transferred from its first, deflated state to its second, inflated state and vice versa.
• air may be guided to inflate the inflatable chamber to assume the second, inflated state.
• the inflatable chamber preferably comprises a predefined shape formed by a suitable molding technique of a material having an increased hardness, a filling of the inflatable chamber at rather low pressure using air or even a partial filling may be sufficient.
• a suction device may be connected to the second lumen of the tube at the first, proximal end of the tube, the suction device for example being constituted as a syringe which may be used to suck a predefined amount of air from the inflatable chamber such that the inflation device assumes the first, deflated state.
• the suction device for example being constituted as a syringe which may be used to suck a predefined amount of air from the inflatable chamber such that the inflation device assumes the first, deflated state.
• the suction device for transferring the inflatable chamber, after passing the tube towards the body cavity to be accessed, to the second, inflated state the amount of air previously sucked from the inflatable chamber using the suction device may be refilled into the inflatable chamber, having the advantage that the filling state of the inflatable chamber in the second, inflated state is exactly known.
• Such suction device for example formed by a syringe, is cost-effective and may easily and intuitively be operated manually by a user.
• the inflation device with its inflatable chamber, may in one embodiment provide for a retaining of the tube within the body cavity accessed by the transnasal tube device. For this the inflatable chamber is brought into the second, inflated state such that due to the increased volume of the inflatable chamber the tube may not be withdrawn from the body cavity.
• the inflatable chamber may be shaped in a defined way to provide for a blocking of for example the esophagus such that a reflux through the esophagus is prevented.
• a medical solution delivered via the tube towards the body cavity e.g. the patient's stomach
• the inflatable chamber may have a predefined cylindrical or spherical shape fitted to the entrance of the esophagus such that a reliable blocking of the esophagus may be achieved.
• a second inflatable chamber in between the first, proximal end and the second, distal end may be placed on the tube, the second inflatable chamber having similar characteristics to the inflatable chamber on the second, distal end of the tube, being made in particular from a material having a Shore- hardness greater than 60, preferably greater than 64, even more preferably greater than 70, the material for example comprising polyurethane.
• the second inflatable chamber may also be in fluid connection with the second lumen of the tube such that the inflatable chamber at the second, distal end and the second inflatable chamber in between the first, proximal end and the second, distal end of the tube may be inflated together via the second lumen.
• the inflatable chamber may be placed at or close to the distal end of the tube or may be placed at a different location on the tube.
• the inflatable chamber may be formed to be inflated within the patient's nose or mouth, within the esophagus, within the gastric tract or within the intestinal tract of a patient. In the first, deflated state the transnasal tube device may easily be guided towards the body cavity to be accessed.
• the inflatable chamber may be fully or partially filled such that the tube is retained within a body cavity accessed by the transnasal tube device and/or a fluid path for example in the esophagus or within the intestinal tract is blocked such that a reflux of liquid is prevented, for example in order to prevent an aspiration and a bacterial infection in the lungs.
• a method for manufacturing a transnasal tube device for access to a body cavity of a patient through the esophagus comprising:
• the inflation device comprising an inflatable chamber which is configured to, in a first, deflated state, assume a first volume to allow a passing of the tube through the esophagus towards a body cavity to be accessed by the transnasal tube device and, in a second, inflated state, assume a second volume larger than the first volume.
• the method is characterized by forming the inflatable chamber by a membrane envelope made of a material having a Shore-hardness equal to or greater than 60.
• Fig. 1 shows a schematic drawing of a transnasal tube device placed on a patient
• Fig. 2 shows a schematic view of an embodiment of a transnasal tube device
• Fig. 3 shows a schematic view of another embodiment of a transnasal tube device
• Fig. 4 a schematic view of a transnasal tube device having an inflatable chamber close to a distal end of a tube serving to retain the tube within the patient's stomach;
• Fig. 5. a schematic view of a transnasal tube device having an inflatable chamber close to a distal end of a tube serving to block a fluid path through the esophagus for preventing a reflux
• Fig. 6 a schematic embodiment of a transnasal tube device having an inflatable chamber comprising multiple portions for on the one hand providing for a retention and on the other hand preventing a reflux;
• Fig. 7 a schematic view of a transnasal tube device having an inflatable chamber for providing for a retention in the intestinal tract of a patient;
• Fig. 8 a schematic view of an embodiment of a transnasal tube device having an inflatable chamber providing for a blockage of a fluid path through the patient's nose;
• Fig. 9 a schematic view of a transnasal tube device having an inflatable chamber comprising multiple portions
• Fig. 10 a schematic view of a transnasal tube device and having an inflatable chamber comprising a substantially spherical shape
• Fig. 1 a schematic view of a transnasal tube device having an inflatable chamber comprising a substantially cylindrical shape.
• a transnasal tube device 1 comprises a tube 10 to be guided through the nose 23 and the esophagus 22 of the patient 2 towards a body cavity such as the patient's stomach 20 or the patient intestinal tract 21 , in particular the patient's jejunum.
• a medical solution such as a nutritional feeding solution for the enteral feeding of the patient 2
• a medication or biotics may be fed directly into the body cavity 20, 21 accessed by the transnasal tube device 1 , a suitable feeding device for this being connectable to a port 1 1 at a first, proximal end 100 of the tube 10 for feeding the medical solution into the tube 10 towards a second, distal end 101 of the tube 10 placed within the body cavity 20, 21 to be accessed.
• the tube 10 is guided through the nose 23 and through the esophagus 22 towards the body cavity 20, 21 to be accessed.
• the position of the second, distal end 101 of the tube 10 is to be secured within the body cavity 20, 21 to be accessed by means of a inflation device 15, which may be altered in its shape between a first, deflated state (which allows a passing of the tube 10 through the nose 23 and the esophagus 22) and a second, inflated state in which the volume of the inflation device 15 is increased with respect to the first, deflated state such that a withdrawal of the tube 10 with its second, distal end 101 through in particular the esophagus 22 is prevented.
• a inflation device 15 which may be altered in its shape between a first, deflated state (which allows a passing of the tube 10 through the nose 23 and the esophagus 22) and a second, inflated state in which the volume of the inflation device 15 is increased with respect to the first, deflated state such that a withdrawal of
• the tube 10 of the transnasal tube device 1 is formed as a multi-lumen tube having a first lumen 13 for guiding a medical solution from the port 1 1 at the first, proximal end 100 of the tube 10 towards the second, distal end 101 of the tube 10 and a second lumen 14 being, at the first, proximal end 100 of the tube 10 in fluid connection with a connector 12 and at the second, distal end 101 of the tube 10 with an inflatable chamber 150 enclosed by a membrane envelope 151 of the inflation device 15.
• the membrane envelope 151 is made of a material having a Shore-hardness equal to or greater than 60, preferably greater than 64, even more preferably greater than 70.
• the material may for example be a polyurethane material, the membrane envelope 151 being formed for example by a stretch blow molding technique to assume a predefined shape in its second, inflated state.
• the inflatable chamber 150 defined by the membrane envelope 151 in its first, deflated state has a reduced volume V1 with respect to the second, inflated state (solid lines in Fig. 2), the membrane envelope 151 in the first, deflated state being situated approximate the tube 10 at the second, distal end 101 such that the radial diameter of the tube 10 is substantially not increased by the inflation device 15 on the second, distal end 101 of the tube 10, hence allowing to easily pass the tube 10 through the nose 23 and the esophagus 22 for accessing the desired body cavity 20, 21.
• the inflatable chamber 150 in contrast is inflated for example with air such that the inflatable chamber 150 assumes an increased volume V2, the shape of the membrane envelope 151 being defined by the forming of the membrane envelope 151 during manufacturing, for example using a stretch blow molding technique. Due to the substantial hardness of the material of the membrane envelope 151 the inflatable chamber 150 may substantially not expand beyond the second, inflated state such that the inflation device 15 in the second, inflated state assumes a known, defined shape within the body cavity 20, 21 accessed by the tube 10.
• the membrane envelope 151 of the inflation device 15 may, in the second, inflated state, assume for example a substantially spherical shape as in the embodiment of Fig. 2 or a substantially cylindrical shape as in the embodiment of Fig. 3, the shape of the membrane envelope 151 being defined by the molding technique used to manufacture the inflation device 15 on the tube 10.
• the shape of the membrane envelope 151 may for example be adapted to anatomic needs and a specific application of the transnasal tube device 1.
• the membrane envelope 151 may suitably be molded integrally with the tube 10 on the second, distal end 101 of the tube 10.
• the tube 10 and the membrane envelope 151 herein may be formed using different materials.
• a suction device 16 for example in the shape of a syringe may be connected to the connector 12 being in fluid connection via a line 120 with the second lumen 14 of the tube 10.
• the suction device 16 may be used to suck air from the inflatable chamber 150 for transferring the inflation device 15 to the first, deflated state, the suction device 16 for example being applicable to suck a predefined amount of air from the inflatable chamber 150 such that the first, deflated state is obtained.
• the amount of air previously withdrawn from the inflatable chamber 150 is refilled into the inflatable chamber 150 by delivering the air from the suction device 16 into the inflatable chamber 150 (for example by pressing on a piston of the syringe forming a suction device 16), such that the chamber 150 is filled by a known amount of air at a known pressure.
• the first lumen 13, at a first end 130, is in fluid connection with the port 1 1 , such that a delivery device may be connected to the port 1 1 for feeding a medical solution into the first lumen 30 at the first end 130, a second end 131 of the first lumen 13 forming an opening at the second, distal end 101 of the tube 10 for passing the medical solution into the body cavity 20, 21 accessed by the tube 10.
• the second lumen 14 at a first end 140 is in fluid connection with the connector 12 for connection to the suction device 16.
• the second lumen 14 opens into the inflatable chamber 150 such that air may be passed through the second lumen 14 to/from the inflatable chamber 150.
• the shape of the inflation device 15 with its membrane envelope 151 may be adapted to anatomic needs of the patient 2 and to a specific application, for example for placement of the tube 10 within the stomach 20 of the patient 2.
• the membrane envelope 151 may be shaped, in particular when placing the tube 10 to access the patient's stomach 20, to prevent a reflux from the stomach 20 into the esophagus 22, which is to be avoided in particular when feeding a medical solution via the tube 10 into the stomach 20.
• the inflation device 15 in the second, inflated state may be formed to block the entrance of the esophagus 22 at the stomach 20 such that fluid may not enter from the stomach 20 into the esophagus 22.
• Fig. 2 and Fig. 3 are functionally identical, besides the different shape of the inflation device 15, the membrane envelope 151 in the second, inflated state having a spherical shape in the embodiment of Fig. 2 and a cylindrical shape in the embodiment of Fig. 3.
• the inflatable chamber 150 of the inflation device 15 may be placed at different locations on the tube 10 of the transnasal tube device 1 and may provide for different functions, dependent also on the application of the transnasal tube device 1.
• the inflatable chamber 150 assumes, in the second inflated state, a substantial spherical shape and is placed close to the distal end 101 of the tube 10.
• the chamber 150 is inflated such that its diameter is larger than the diameter of the esophagus 22 such that the tube 10 with its distal end 101 is retained within the patient's stomach 20.
• the inflatable chamber 150 primarily serves to prevent a reflux through the esophagus 22 when placing the tube 10 of the transnasal tube device 1 within the patient's stomach 20.
• the inflatable chamber 150 may assume, in the second inflated state, a substantially cylindrical shape which may adapt to the specific anatomy of the esophagus 22 such that the esophagus 22 is blocked and a reflux through the esophagus 22 is prevented, hindering an aspiration and a potential infection of the patient's lungs.
• the inflatable chamber 150 comprises two chamber portions 152, 153, a first portion 152 having a substantially spherical shape and a second portion 153 having a substantially cylindrical shape.
• first portion 152 a retention function may be achieved for retaining the tube 10 in the patient's stomach 20.
• second portion 153 the esophagus 22 may substantially be blocked such that a reflux up the esophagus 22 is prevented.
• the inflatable chamber 150 may be fully filled or only partially filled for inflating the inflatable chamber 150. In each case a rather low pressure may be sufficient to fill the inflatable chamber 150, wherein a partial filling of the inflatable chamber 150 way furthermore be helpful to adapt the inflatable chamber 150 to the specific anatomy of for example the esophagus 22.
• an inflatable chamber 150 is placed close to the distal end 101 of the tube 10 and serves to retain the tube 10 within the intestinal tract 21 of the patient 2.
• the inflatable chamber 150 may assume, in the second inflated state, a substantial spherical shape.
• the inflatable chamber 150 is placed close to the proximal end 100 of the tube 10, the inflatable chamber 150 in its second, inflated state having a substantially cylindrical shape and serving to block a fluid path through the patient's nose 23.
• one or multiple inflatable chambers 150 can be placed at different locations on the tube 10, in particular close to the distal end 101 , close to the proximal end 100 or in between the distal end 101 and the proximal end 100.
• multiple chambers 150 of equal or different shape and of equal or different function may be provided on the tube 10 on different axial locations.
• inflatable chambers 150 are shown in Figs. 9 to 1 1 , each showing an example of an inflatable chamber 150 in the second inflated state.
• the inflatable chamber 150 comprises different portions 152, 153, a first portion 152 having a substantially spherical shape, whereas a second portion 153 has a substantially cylindrical shape.
• the tube 10 comprises an inflatable chamber 150 having only one portion having a substantially spherical shape.
• the inflatable chamber 150 assumes, in the second inflated state, a substantially cylindrical shape.
• transnasal tube device of the type described herein may be used for different applications, for example for feeding a nutritional solution for the enteral feeding of a patient, for feeding a medication or for feeding biotics.
• the tube may be a single lumen tube or a multi-lumen tube.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Otolaryngology (AREA)
• Pulmonology (AREA)
• Media Introduction/Drainage Providing Device (AREA)

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• 2019
  • 2019-04-04 EP EP19716862.8A patent/EP3784201B1/de active Active
  • 2019-04-04 WO PCT/EP2019/058496 patent/WO2019206593A1/en not_active Ceased

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