Patent Description:
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.

By means of a transnasal tube device of this kind a medical solution, such as a nutritional feeding solution for the enteral feeding of a patient, a medication or a biotic solution, shall be delivered into 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). For this, 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. Once the tube is placed within the patient, the medical solution may be delivered through the tube directly into the accessed body cavity.

When placing a transnasal tube device of this kind in a patient it for example is to be ensured that the transnasal tube device, with the distal end of the tube, remains in the accessed body cavity such that the medical solution securely is delivered into the body cavity of interest. For this 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. For guiding the transnasal tube device through the esophagus towards the body cavity to be accessed, 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.

<CIT> discloses a balloon assembly having an intrinsic curvature adapted to a passage in a blood vessel.

<CIT> 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.

<CIT> discloses an intra-aortic balloon catheter having an ultrathin stretch blow molded balloon membrane.

Alternative examples of transnasal tubes can be found in <CIT>, <CIT>, and/or <CIT>. <CIT> additionally discloses teachings on the desired hardness on balloon cuffs.

It is an object of the instant invention to provide a transnasal tube device and a method for manufacturing a transnasal tube device which allow providing a inflation device having improved characteristics with respect to the retaining of the distal end of the tube within an accessed body cavity and/or which reliably allow to for example prevent a reflux of liquid from an accessed body cavity.

This object is achieved by means of a transnasal tube device comprising the features of claim <NUM>.

Accordingly, the inflatable chamber is defined by a membrane envelope made of a material having a Shore-hardness equal to or greater than <NUM>.

The Shore-hardness is a characteristic value for material properties of elastomers and plastics. It is specified in the DIN <NUM> and DIN EN ISO <NUM> standards. The Shore-hardness-tester (or "Durometer") consists of a spring-loaded indenter, which elastic indentation is inversely related to the Shore-hardness of the material. The scale is from <NUM> to <NUM>. A high figure means a high hardness.

Generally, different Shore-hardness scales exist. Shore A hardness applies to soft elastomers, whereas 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.

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. In contrast to an expandable balloon made of for example silicon rubber, 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 <NUM>, preferably greater than <NUM>. Polyurethane is a polymer composed of organic units joined by carbamate (urethane) links. For example thermoplastic polyurethane may be used. By using a polyurethane material the inflation device may exhibit a high strength and increased durability and may have a beneficial dimensional stability.

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. Within such a 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.

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.

In the second, inflated state the inflatable chamber may be fully or only partially filled. 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. 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.

Because 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.

In one embodiment, 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.

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. 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. For example, in one embodiment, 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. For this, 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.

In particular, through the second lumen air may be guided to inflate the inflatable chamber to assume the second, inflated state. Because 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.

In one embodiment, 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. 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.

In addition or alternatively, 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. In this way a medical solution delivered via the tube towards the body cavity (e.g. the patient's stomach) may be prevented from flowing upwards through the esophagus. For this, 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.

In one embodiment, in addition 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 <NUM>, preferably greater than <NUM>, 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. In the second, inflated state 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.

The object is also achieved by a method for manufacturing a transnasal tube device for access to a body cavity of a patient through the esophagus, comprising:.

Herein, 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 <NUM>.

The advantages and advantageous embodiments described above for the transnasal tube device equally apply also to the method, such that it shall be referred to the above. The idea underlying the invention shall subsequently be described in more detail with reference to the embodiments shown in the drawings.

With reference to the illustrative drawing of <FIG>, a transnasal tube device <NUM> comprises a tube <NUM> to be guided through the nose <NUM> and the esophagus <NUM> of the patient <NUM> towards a body cavity such as the patient's stomach <NUM> or the patient intestinal tract <NUM>, in particular the patient's jejunum.

Via the transnasal tube device <NUM> a medical solution such as a nutritional feeding solution for the enteral feeding of the patient <NUM>, a medication or biotics may be fed directly into the body cavity <NUM>, <NUM> accessed by the transnasal tube device <NUM>, a suitable feeding device for this being connectable to a port <NUM> at a first, proximal end <NUM> of the tube <NUM> for feeding the medical solution into the tube <NUM> towards a second, distal end <NUM> of the tube <NUM> placed within the body cavity <NUM>, <NUM> to be accessed.

For placing the transnasal tube device <NUM> within the patient <NUM>, the tube <NUM> is guided through the nose <NUM> and through the esophagus <NUM> towards the body cavity <NUM>, <NUM> to be accessed. Once the second, distal end <NUM> of the tube <NUM> has entered the body cavity <NUM>, <NUM> to be accessed, the position of the second, distal end <NUM> of the tube <NUM> is to be secured within the body cavity <NUM>, <NUM> to be accessed by means of a inflation device <NUM>, which may be altered in its shape between a first, deflated state (which allows a passing of the tube <NUM> through the nose <NUM> and the esophagus <NUM>) and a second, inflated state in which the volume of the inflation device <NUM> is increased with respect to the first, deflated state such that a withdrawal of the tube <NUM> with its second, distal end <NUM> through in particular the esophagus <NUM> is prevented.

An embodiment of a transnasal tube device <NUM> is shown in <FIG>. The tube <NUM> of the transnasal tube device <NUM>, in this embodiment, is formed as a multi-lumen tube having a first lumen <NUM> for guiding a medical solution from the port <NUM> at the first, proximal end <NUM> of the tube <NUM> towards the second, distal end <NUM> of the tube <NUM> and a second lumen <NUM> being, at the first, proximal end <NUM> of the tube <NUM> in fluid connection with a connector <NUM> and at the second, distal end <NUM> of the tube <NUM> with an inflatable chamber <NUM> enclosed by a membrane envelope <NUM> of the inflation device <NUM>.

The membrane envelope <NUM> is made of a material having a Shore-hardness equal to or greater than <NUM>, preferably greater than <NUM>, even more preferably greater than <NUM>. The material may for example be a polyurethane material, the membrane envelope <NUM> being formed for example by a stretch blow molding technique to assume a predefined shape in its second, inflated state.

As illustrated in <FIG>, the inflatable chamber <NUM> defined by the membrane envelope <NUM> in its first, deflated state (dashed lines in <FIG>) has a reduced volume V1 with respect to the second, inflated state (solid lines in <FIG>), the membrane envelope <NUM> in the first, deflated state being situated approximate the tube <NUM> at the second, distal end <NUM> such that the radial diameter of the tube <NUM> is substantially not increased by the inflation device <NUM> on the second, distal end <NUM> of the tube <NUM>, hence allowing to easily pass the tube <NUM> through the nose <NUM> and the esophagus <NUM> for accessing the desired body cavity <NUM>, <NUM>.

In the second, inflated state (solid lines in <FIG>) the inflatable chamber <NUM> in contrast is inflated for example with air such that the inflatable chamber <NUM> assumes an increased volume V2, the shape of the membrane envelope <NUM> being defined by the forming of the membrane envelope <NUM> during manufacturing, for example using a stretch blow molding technique. Due to the substantial hardness of the material of the membrane envelope <NUM> the inflatable chamber <NUM> may substantially not expand beyond the second, inflated state such that the inflation device <NUM> in the second, inflated state assumes a known, defined shape within the body cavity <NUM>, <NUM> accessed by the tube <NUM>.

The membrane envelope <NUM> of the inflation device <NUM> may, in the second, inflated state, assume for example a substantially spherical shape as in the embodiment of <FIG> or a substantially cylindrical shape as in the embodiment of <FIG>, the shape of the membrane envelope <NUM> being defined by the molding technique used to manufacture the inflation device <NUM> on the tube <NUM>. The shape of the membrane envelope <NUM> may for example be adapted to anatomic needs and a specific application of the transnasal tube device <NUM>.

The membrane envelope <NUM> may suitably be molded integrally with the tube <NUM> on the second, distal end <NUM> of the tube <NUM>. The tube <NUM> and the membrane envelope <NUM> herein may be formed using different materials.

For transferring the inflation device <NUM> in from the first, deflated state of the membrane envelope <NUM> to the second, inflated state and vice versa a suction device <NUM> for example in the shape of a syringe may be connected to the connector <NUM> being in fluid connection via a line <NUM> with the second lumen <NUM> of the tube <NUM>. The suction device <NUM> may be used to suck air from the inflatable chamber <NUM> for transferring the inflation device <NUM> to the first, deflated state, the suction device <NUM> for example being applicable to suck a predefined amount of air from the inflatable chamber <NUM> such that the first, deflated state is obtained. To then transfer the inflation device <NUM> to the second, inflated state, after placement of the tube <NUM> within the patient <NUM>, the amount of air previously withdrawn from the inflatable chamber <NUM> is refilled into the inflatable chamber <NUM> by delivering the air from the suction device <NUM> into the inflatable chamber <NUM> (for example by pressing on a piston of the syringe forming a suction device <NUM>), such that the chamber <NUM> is filled by a known amount of air at a known pressure.

The first lumen <NUM>, at a first end <NUM>, is in fluid connection with the port <NUM>, such that a delivery device may be connected to the port <NUM> for feeding a medical solution into the first lumen <NUM> at the first end <NUM>, a second end <NUM> of the first lumen <NUM> forming an opening at the second, distal end <NUM> of the tube <NUM> for passing the medical solution into the body cavity <NUM>, <NUM> accessed by the tube <NUM>.

The second lumen <NUM> at a first end <NUM> is in fluid connection with the connector <NUM> for connection to the suction device <NUM>. At a second end <NUM> the second lumen <NUM> opens into the inflatable chamber <NUM> such that air may be passed through the second lumen <NUM> to/from the inflatable chamber <NUM>.

The shape of the inflation device <NUM> with its membrane envelope <NUM> may be adapted to anatomic needs of the patient <NUM> and to a specific application, for example for placement of the tube <NUM> within the stomach <NUM> of the patient <NUM>. In addition or alternatively to providing a retention function the membrane envelope <NUM> may be shaped, in particular when placing the tube <NUM> to access the patient's stomach <NUM>, to prevent a reflux from the stomach <NUM> into the esophagus <NUM>, which is to be avoided in particular when feeding a medical solution via the tube <NUM> into the stomach <NUM>. For this, the inflation device <NUM> in the second, inflated state may be formed to block the entrance of the esophagus <NUM> at the stomach <NUM> such that fluid may not enter from the stomach <NUM> into the esophagus <NUM>.

The embodiments of <FIG> are functionally identical, besides the different shape of the inflation device <NUM>, the membrane envelope <NUM> in the second, inflated state having a spherical shape in the embodiment of <FIG> and a cylindrical shape in the embodiment of <FIG>.

The inflatable chamber <NUM> of the inflation device <NUM> may be placed at different locations on the tube <NUM> of the transnasal tube device <NUM> and may provide for different functions, dependent also on the application of the transnasal tube device <NUM>.

In an embodiment shown in <FIG> the inflatable chamber <NUM> assumes, in the second inflated state, a substantial spherical shape and is placed close to the distal end <NUM> of the tube <NUM>. When the tube <NUM> is placed in the patient <NUM> to access the patient's stomach <NUM>, the chamber <NUM> is inflated such that its diameter is larger than the diameter of the esophagus <NUM> such that the tube <NUM> with its distal end <NUM> is retained within the patient's stomach <NUM>.

In the embodiment of <FIG> the inflatable chamber <NUM> primarily serves to prevent a reflux through the esophagus <NUM> when placing the tube <NUM> of the transnasal tube device <NUM> within the patient's stomach <NUM>. For this the inflatable chamber <NUM> may assume, in the second inflated state, a substantially cylindrical shape which may adapt to the specific anatomy of the esophagus <NUM> such that the esophagus <NUM> is blocked and a reflux through the esophagus <NUM> is prevented, hindering an aspiration and a potential infection of the patient's lungs.

In the embodiment of <FIG> the inflatable chamber <NUM> comprises two chamber portions <NUM>, <NUM>, a first portion <NUM> having a substantially spherical shape and a second portion <NUM> having a substantially cylindrical shape. By means of the first portion <NUM> a retention function may be achieved for retaining the tube <NUM> in the patient's stomach <NUM>. By means of the second portion <NUM> the esophagus <NUM> may substantially be blocked such that a reflux up the esophagus <NUM> is prevented.

As described above, the inflatable chamber <NUM> may be fully filled or only partially filled for inflating the inflatable chamber <NUM>. In each case a rather low pressure may be sufficient to fill the inflatable chamber <NUM>, wherein a partial filling of the inflatable chamber <NUM> way furthermore be helpful to adapt the inflatable chamber <NUM> to the specific anatomy of for example the esophagus <NUM>.

In the embodiment of <FIG> an inflatable chamber <NUM> is placed close to the distal end <NUM> of the tube <NUM> and serves to retain the tube <NUM> within the intestinal tract <NUM> of the patient <NUM>. For this, the inflatable chamber <NUM> may assume, in the second inflated state, a substantial spherical shape.

In an embodiment shown in <FIG> the inflatable chamber <NUM> is placed close to the proximal end <NUM> of the tube <NUM>, the inflatable chamber <NUM> in its second, inflated state having a substantially cylindrical shape and serving to block a fluid path through the patient's nose <NUM>.

In principle, one or multiple inflatable chambers <NUM> can be placed at different locations on the tube <NUM>, in particular close to the distal end <NUM>, close to the proximal end <NUM> or in between the distal end <NUM> and the proximal end <NUM>. Herein, multiple chambers <NUM> of equal or different shape and of equal or different function may be provided on the tube <NUM> on different axial locations.

Different embodiments of inflatable chambers <NUM> are shown in <FIG>, each showing an example of an inflatable chamber <NUM> in the second inflated state.

In the embodiment of <FIG> the inflatable chamber <NUM> comprises different portions <NUM>, <NUM>, a first portion <NUM> having a substantially spherical shape, whereas a second portion <NUM> has a substantially cylindrical shape.

In the embodiment of <FIG>, the tube <NUM> comprises an inflatable chamber <NUM> having only one portion having a substantially spherical shape.

In the embodiment of <FIG> the inflatable chamber <NUM> assumes, in the second inflated state, a substantially cylindrical shape.

The idea of the invention is not limited to the embodiments described above.

At 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.

Claim 1:
Transnasal tube device (<NUM>) for access to the stomach (<NUM>) of a patient (<NUM>) through the esophagus (<NUM>), comprising:
- a tube (<NUM>) having a first, proximal end (<NUM>) and a second, distal end (<NUM>),
- a port (<NUM>) arranged at the first, proximal end (<NUM>) of the tube (<NUM>) for feeding a medical solution into the tube (<NUM>), and
- an inflation device (<NUM>) arranged on the tube (<NUM>), the inflation device (<NUM>) comprising an inflatable chamber (<NUM>) which is configured to, in a first, deflated state, assume a first volume (V1) to allow a passing of the tube (<NUM>) through the esophagus (<NUM>) towards the stomach (<NUM>) to be accessed by the transnasal tube device (<NUM>) and, in a second, inflated state, assume a second volume (V2) larger than the first volume (V1), wherein the inflatable chamber (<NUM>), in the second, inflated stated is formed to retain the tube in the stomach (<NUM>) and to prevent for reflux,
characterized in
that the inflatable chamber (<NUM>) is defined by a membrane envelope (<NUM>) made of a material having a Shore-hardness A equal to or greater than <NUM>, preferably greater than <NUM>, wherein the membrane envelope (<NUM>) assumes, in the second, inflated state, a predefined shape formed by a molding technique and the inflatable chamber (<NUM>) comprises two chamber portions (<NUM>, <NUM>), a first portion having a substantially spherical shape and a second portion (<NUM>) having a substantially cylindrical shape,.