Patent Description:
An assembly of this kind in the form of a feeding probe assembly is known from <CIT>. <CIT> describes a fluid transfer assembly. <CIT> discloses a coaxial catheter with Y-shaped branch elements. <CIT> describes a catheter adapter. <CIT> discloses an apparatus and a method for the treatment of the gastrointestinal tract. <CIT> discloses an aspiration needle with a side port. <CIT> discloses a method and a device for obtaining prostatic material. <CIT> discloses a fluid management system. <CIT> discloses a method and a pump apparatus for combined gastro-intestinal feeding and aspiration. <CIT> discloses a medical lavage apparatus and methods. <CIT> discloses a catheter assembly including a multi-lumen configuration. <CIT> discloses a feeding tube with an inflatable balloon component. <CIT> discloses a coupling for a flexible tubing. <CIT> discloses a catheter system. <CIT> discloses a feeding probe for parenteral feeding of a patient, and its use. <CIT> discloses an enteral feeding tube assembly and a suction tube therefor. <CIT> discloses a dual cannula system for enteric feeding. <CIT> discloses a multifunctional anti-slip fixed type stomach tube. <CIT> discloses a stomach tube for pollution abatement. <CIT> discloses a double-port stomach tube. <CIT> discloses a catheter coupling system.

It is an object of the present invention to improve the versatility of such a device, in particular in the area of a medical application, or an application in which biocompatibility is important.

According to the invention, this object is achieved by the probe device having the features set out in Claim <NUM>.

According to the invention, it has been found possible that requirements placed on a probe device to be inserted into a body of a patient, namely suction on the one hand and feeding or nurturing on the other hand, can be combined with each other. The probe device constitutes both a suction conduit, through which secretions in particular can be aspirated from the body of the patient, and also a feed conduit. The probe device can be configured in form of a catheter. The probe device can be configured in the form of a three-way probe. The probe device can have a Y-shaped configuration. An acute angle of such a Y-shaped configuration can lie between the feed attachment port and the suction attachment port. This acute angle can lie in the range of between <NUM>° and <NUM>°. The probe device can also be made from a plastics material. Components of the probe device can be produced from silicone and/or a silicone-free plastics material, as is explained in more detail below in conjunction with a tube/connector assembly. Alternatively, components of the probe device can also be configured as metal components or metal-containing components, as is likewise explained in detail below in conjunction with the tube/connector assembly. The feed conduit has a feed tube section extending between the feed attachment port and the suction/feed port, wherein the feed tube section has a material composition containing silicone and BaSo<NUM>, wherein the feed attachment port is connected to the feed tube section in a fluid-tight manner via an overmould section which covers a transition between the feed attachment port and the feed tube section and is connected on the one hand in a fluid-tight manner to the feed attachment port and is connected on the other hand in a fluid-tight manner to the feed tube section, wherein the overmould section has a material composition containing silicone and BaSO<NUM>.

In a probe device according to Claim <NUM>, the suctioning function can be provided without the production of a probe unit providing the feeding function having to be greatly modified.

An integrally formed suction tube section according to Claim <NUM> is cost-effective in terms of production.

A tube transition section according to Claim <NUM> extends the design options in terms of the configuration of the probe device.

This applies in particular to the use of a three-way connector according to Claim <NUM>. A three-way connector of this kind at the same time constitutes the tube transition section. The three-way connector can also be designed in the form of a three-way valve customary in medical technology. A connection of the three-way connector to the tube sections that are to be attached can be performed in the manner explained below in conjunction with the tube/connector assembly.

An adhesively bonded connection according to Claim <NUM> is secure. A connection technique of the kind described in <CIT> can be used. As an alternative or in addition to an adhesively bonded connection, the tube sections can also be connected by means of overmoulding.

An adhesively bonded suction tube section according to Claim <NUM> again extends the design options for the probe device. Here too, an overmoulding connection can be used alternatively or in addition.

The tube/connector assembly can be in the form of a feeding or nurturing probe assembly for delivering a liquid nutrient to a patient. The tube section can be a tubular tube of a feed probe for predefining a delivery channel section for the liquid nutrient. This delivery channel section can be connected to a source of liquid nutrient. An inner lumen of the tube section can be fluidically connected to the area surrounding the tube section via at least one opening. Such an opening can extend radially in relation to a fluid channel axis or tube axis. Several such openings can be present. In this case, the openings can be arranged axially offset in relation to one another and/or can be mutually offset in the circumferential direction about the tube axis. A high degree of biocompatibility of the assembly is achieved through the silicone content of the tube section. The overmould section ensures a leaktight and in particular tension-resistant connection of the tube section to the tube connector. A surface of the tube connector to be overmoulded can be modified with the aid of a pre-treatment method. By such a pre-treatment method, the adherence, in particular of the overmould section, to the tube connector can be improved. The pre-treatment method can be a corona treatment, a plasma treatment, X-ray sterilization or a post-curing/tempering method. The tube connector can be produced from an in particular silicone-free plastics material. In this case, the tube connector can easily be connected in a fluid-tight manner to a likewise silicone-free external tube. The tube section can have a Shore A hardness in the range of between <NUM> and <NUM>, in the range of between <NUM> and <NUM>, and in particular in the region of <NUM>. The plastics material of the tube connector can have a Shore A hardness in the range of between A20 and A90, in the range of between A30 and A60, and in particular in the region of A40. The plastics material of the tube connector can have a modulus of elasticity, in particular a modulus of elasticity in tension, in the range of between <NUM>,<NUM> MPa and <NUM>,<NUM> MPa, and in particular in the range of between <NUM>,<NUM> MPa and <NUM>,<NUM> MPa. The plastics material of the tube connector can be resistant up to a maximum temperature of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or <NUM>. The tube connector can alternatively also be produced from silicone or from a non-plastic, for example from stainless steel. The silicone material of the tube section and/or of the overmould section can be a high-temperature vulcanizing silicone (HTV silicone), platinum-crosslinked silicone and/or peroxide-crosslinked silicone. The BaSO<NUM> fraction of the material composition of the tube section and of the overmould section leads to a stabilization of the connection and can, for example, lead to improved adhesion between the overmould section and the tube connector. Moreover, the BaSO<NUM> fraction can improve the curing conditions of the component having this fraction. BaSO<NUM> can moreover be used as X-ray contrast medium.

The advantages of a probe device comprising such a tube-connector assembly correspond to those tubes that have already been explained above with reference to the probe device and the tube/connector assembly.

The overmould section of the tube/connector assembly can have a material composition containing liquid silicone. The use of liquid silicone has been found to be particularly advantageous in the production of the overmould section.

In the area of the transition, an end wall of the tube section of the tube/connector assembly can abut a facing end of the tube connector. An abutting arrangement of this kind permits simple production of the assembly. Alternatively, it is possible to arrange the tube section and the tube connector partially overlapping each other, such that, for example, the tube section is partially pushed onto the connector. An alternative arrangement of this kind can improve the adhesion between the tube section and the connector.

The end of the tube connector of the tube/connector assembly facing towards the transition can have at least one projection via which the tube section bears on the tube connector. Projections of this kind allow material of the overmould section to penetrate between the tube section and the tube connector in the area of the transition, which can lead to stabilization of the connection between these two components and to a tension-resistant connection. The at least one projection can protrude axially from the end face of the tube connector directed towards the transition. At least two such projections can be present. The projections can be integrally formed on a main body of the tube connector. Three, four, five or more projections of this kind can be provided.

The material composition of the tube section can have BaSO<NUM> in the range of between <NUM> percent by weight and <NUM> percent by weight. The material composition of the overmould section can have BaSO<NUM> in the range of between <NUM> percent by weight and <NUM> percent by weight. Such percentages of BaSO<NUM> have proven to be particularly advantageous for the production of a secure connection between the tube section and the tube connector. The BaSO<NUM> fractions can be in the range of between <NUM> percent by weight and <NUM> percent by weight and in particular between <NUM> percent by weight and <NUM> percent by weight.

The tube/connector assembly can have a plug for the distal closure of the tube section, wherein the plug has a material composition containing silicone and BaSO<NUM>. Such a plug closes a distal end of the tube section, such that this end can then be better guided, in particular in a medical application. The material composition of the plug can be the same as that of the overmould section. The material composition of the plug can be the same as that of the tube section.

The material composition of the plug of the tube/connector assembly can have liquid silicone. The material composition of the plug can have <NUM> percent by weight to <NUM> percent by weight of BaSO<NUM>. The advantages of such material compositions of the plug correspond to tube that have been explained above in conjunction with the tube section and the overmould section.

The tube connector of the tube/connector assembly can be produced from polybutylene terephthalate (PBT). A tube connector of this kind is stable and non-ageing and, in the case of a medical application, sufficiently biocompatible. Alternatively, the tube connector can be produced, for example, from a cyclo-olefin copolymer (COC), polycarbonate (PC), polyamide (PA), polyphenylene ether (PPE), polyphenylene oxide (PPO), polyphenylene sulphide (PPS) or also PEEK (polyether ether ketone). If the tube connector is produced from plastic, the latter can be a fibre-free or a fibre-reinforced plastic, in particular a glass-fibre-reinforced plastic. In principle, the tube connector can also be produced from a material other than plastic, for example from stainless steel.

Illustrative embodiments of the invention are explained in more detail below with reference to the drawing, in which:.

A first embodiment of a tube/connector assembly <NUM> is explained below with reference to <FIG>.

This tube/connector assembly <NUM> is in the form of a feeding probe assembly for delivering a liquid nutrient to a patient. The tube/connector assembly <NUM> represents a probe device for insertion into a body of a patient. The assembly <NUM> has a tube section <NUM> in the form of a tubular tube of the feeding probe. The tube section <NUM> serves to predefine a delivery channel section of the assembly <NUM> for the liquid nutrient. The tube section <NUM> is configured such that it is designed for enteral feeding, in particular for insertion through the nose. A gastric, duodenal or jejunal probe can be formed by means of the tube section. The tube section has a material composition containing silicone and barium sulphate BaSO<NUM>. A Shore A hardness of the tube section <NUM> can be in the range of between <NUM> and <NUM>, in the range of between <NUM> and <NUM>, for example <NUM>. The material composition can contain <NUM> percent by weight to <NUM> percent by weight of BaSO<NUM> and accordingly <NUM> percent by weight to <NUM> percent by weight of silicone. In addition to a silicone/BaSO<NUM> material fraction, other material components can also form the material composition of the tube section <NUM>, in particular further fillers.

The assembly <NUM> also has a tube connector <NUM> made of a silicone-free plastics material. The tube connector <NUM> serves to continue the fluid channel section and to connect the tube section <NUM> to an external tube <NUM> indicated by broken lines in <FIG>. The tube connector <NUM> is produced from polybutylene terephthalate (PBT). The external tube <NUM> is in turn fluidically connected to a source of liquid nutrient. The tube connector <NUM> thus serves to attach a feed source to the probe device <NUM>.

The tube connector <NUM> is connected to the tube section <NUM> in a fluid-tight manner via an overmould section <NUM>. The latter covers a transition <NUM> (cf. <FIG>) between the tube section <NUM> and the tube connector <NUM>.

In the assembly <NUM>, the tube section <NUM> and the tube connector <NUM> bear on each other end to end at the transition <NUM>. This end-to-end contact is formed on the tube connector <NUM> by several projections <NUM> which protrude axially from an end wall <NUM> and which are integrally formed on a main body of the tube connector <NUM>. An end wall of the tube section <NUM> facing towards the tube connector <NUM> thus abuts at least one of the projections <NUM> in the area of the transition <NUM>. In the embodiment shown, the tube connector <NUM> has a total of four such projections <NUM>. These are distributed uniformly in the circumferential direction around a fluid channel axis <NUM> of the assembly <NUM>, as can be seen from the perspective view according to <FIG>. In the area of the transition <NUM>, an internal diameter of the fluid channel section of the tube connector <NUM> narrows over several steps <NUM>, <NUM>. A first cone section <NUM> of the tube connector <NUM> in this case lies between the narrowing steps <NUM> and <NUM>. A second cone section <NUM> is present between the narrowing step <NUM> and the end wall <NUM>. The cone angles of the cone sections <NUM> and <NUM> are different from each other. The cone angle of the second cone section <NUM> is greater than that of the first cone section <NUM>, such that the fluid channel of the tube connector <NUM> narrows more strongly in the area of the second cone section <NUM> than it does in an area of comparable axial extent of the first cone section <NUM>. In the production of the overmould section <NUM>, the second cone section <NUM> is able to seal off an inner shaping body which predefines the fluid channel and which is pulled back out of the fluid channel after production.

The overmould section <NUM> is connected in a fluid-tight manner on the one hand to the tube section <NUM> and on the other hand to the tube connector <NUM>. In the area of the transition <NUM>, material of the overmould section <NUM> penetrates in the circumferential direction between mutually adjacent projections <NUM> and thereby ensures stabilizing, possibly also meshing, of the components <NUM>, <NUM> and <NUM>.

The overmould section <NUM> has a material composition with silicone and BaSO<NUM>. The silicone can be liquid silicone (LSR - liquid silicone rubber). For the percentages of silicone/BaSO<NUM> in the material composition of the overmould section <NUM>, and for possible additional material components, reference is made to the details given above concerning the tube section <NUM>.

The assembly <NUM> moreover has a plug <NUM> for distal closure of a free end of the tube section <NUM>. The plug <NUM> also has a material composition containing silicone and BaSO<NUM>. The silicone can be liquid silicone. For the percentages of silicone/BaSO<NUM> in the material composition of the plug <NUM>, and for possible additional material components, reference is made to the details given above concerning the tube section <NUM>.

A lumen of the tube section <NUM> is fluidically connected to a surrounding area of the tube section <NUM> via a plurality of through-openings <NUM>. In an embodiment of the tube section <NUM> not shown here, there is precisely one through-opening <NUM>. In one embodiment of the tube section <NUM>, there can also be more than two through-openings <NUM>. The through-openings <NUM> extend radially in relation to the fluid channel axis <NUM>. The through-openings <NUM> are axially offset with respect to each other. The through-openings <NUM> are offset in the circumferential direction around the fluid channel axis <NUM>. The one or more through-openings <NUM> constitute a feed port of the probe device <NUM>.

The plug <NUM> is rounded at its free end. The complementary end of the plug <NUM> arranged inside the lumen of the tube section <NUM> is provided with a concave recess 14a. In the embodiment shown, the recess 14a has the shape of a hollow hemisphere. The recess 14a predefines a bearing position of a guide wire 14b (indicated by broken lines in <FIG>) for the insertion of the tube section <NUM>. By virtue of the concave design of the recess 14a, a distal end of the guide wire 14b bears securely on the plug <NUM> and not on an inner wall of the tube section <NUM>.

A further embodiment of a tube/connector assembly <NUM> is explained below with reference to <FIG>. Components and functions corresponding to tube already explained above with reference to <FIG> have the same reference numbers and are not discussed again in detail.

Compared to the assembly <NUM>, the fluid channel in the area of the tube section <NUM> of the assembly <NUM> has an enlarged internal diameter. In contrast to the plug <NUM> of the assembly <NUM>, which does not cover the outer face of the tube section <NUM>, a plug <NUM> of the assembly <NUM> does cover a distal end area E of the tube section <NUM>.

Compared to the assembly <NUM>, the fluid channel in the area of the tube section <NUM> of the assembly <NUM> has an enlarged internal diameter. In the assembly <NUM>, the proximal end of the tube section <NUM> is pushed over the facing end portion of the tube connector <NUM> in an axial covering area P. In the assembly <NUM>, the transition <NUM> between the tube connector <NUM> and the tube section <NUM> lies at the place where the proximal end wall of the tube section <NUM> bears on a circumferential rib 6a of the tube connector <NUM>. This transition <NUM> is again covered by the overmould section <NUM>, wherein, on the one hand, a fluid-tight connection of the overmould section <NUM> to the tube connector is formed and, on the other hand, a fluid-tight connection of the overmould section <NUM> to the tube section <NUM> is formed.

The tube connector <NUM> of the assembly <NUM> does not have the projections <NUM>.

Compared to the assembly <NUM>, the fluid channel in the area of the tube section <NUM> of the assembly <NUM> has an enlarged internal diameter.

The transition <NUM> in the assembly <NUM>, as in the assembly <NUM>, is formed by an end portion pushed proximally onto the tube connector <NUM>.

In the area of the proximal covering P of the assembly <NUM>, an internal diameter of the tube section <NUM> increases only marginally, in contrast to the embodiment of the assembly <NUM> where the internal diameter of the tube section <NUM> increases considerably in the area of the proximal covering P as far as the transition <NUM>.

The overmould section <NUM> ensures a fluid-tight, stable and sufficiently durable connection between the tube connector <NUM> and the tube section <NUM> in all of the described assemblies <NUM>, <NUM>, <NUM> and <NUM>. A secure connection is thus provided between the silicone-containing tube section <NUM> and the non-silicone-containing tube connector <NUM>.

A further embodiment of a probe device <NUM> is explained below with reference to <FIG>. Components and functions corresponding to tube already explained above with reference to <FIG> have the same reference numbers and are not discussed again in detail.

The probe device <NUM> has a suction conduit <NUM> between a distal suction/feed port, which is formed by the at least one through opening <NUM>, and a proximal suction attachment port <NUM> for the attachment of a vacuum source (not shown). The suction attachment port <NUM> is designed as funnel connector. A closure plug <NUM> is integrally formed on the suction attachment port <NUM>. The closure plug <NUM> is connected in one piece to the suction attachment port <NUM> via a plastic bottle <NUM>.

Moreover, the probe device <NUM> has a feed conduit <NUM> between a proximal feed attachment port, formed by the tube connector <NUM> and serving for the attachment of the feed source, and the distal suction feed port <NUM>.

Overall, therefore, the probe device <NUM> constitutes a three-way probe which, on the one hand, has a suctioning function via the suction conduit <NUM> when the suction attachment port <NUM> is opened and, on the other hand, has a feeding function via the feed conduit <NUM> when the suction attachment port <NUM> is closed.

The probe device <NUM> is present in a Y shape. The feed conduit <NUM> extends along the tube section <NUM> without branching off. In the area of an entrance <NUM> of a suction tube section <NUM>, the suction conduit <NUM> extends at a bend angle α with respect to the fluid channel axis <NUM> of the tube section <NUM>. The angle α is an acute angle. The angle α can be in the range of between <NUM>° and <NUM>°.

The tube section <NUM> is designed as a feed tube section extending between the feed attachment port <NUM> and the suction/feed port <NUM>. A jacket wall of this tube section <NUM> has a jacket opening <NUM> through which the suction conduit <NUM> opens out from the feed conduit <NUM>.

In the area of the jacket opening <NUM>, i.e. in the area of the entrance point <NUM>, the suction tube section <NUM> if formed integrally on the feed tube section <NUM>. This can be achieved by injection-moulding the suction tube section <NUM> onto the feed tube section <NUM>. The suction tube section <NUM> can be produced from polybutylene terephthalate (PBT) or from silicone. Material variants for the suction tube section <NUM> are a cyclo-olefin copolymer (COC), polycarbonate (PC), polyamide (PA), polyphenylene ether (PPE), polyphenylene oxide (PPO), polyphenylene sulphide (PPS) or also PEEK (polyether ether ketone).

The probe device <NUM> is used as follows. If the probe device <NUM> is to be used to aspirate secretions or other foreign bodies, the closure plug <NUM> is opened and the vacuum source is attached to the suction attachment port <NUM>. With the probe device <NUM> correctly inserted, the secretions can then be aspirated through the suction feed port <NUM> and then flow along the suction conduit <NUM>.

If the feeding function of the probe device <NUM> is intended to be used, the closure plug <NUM> is closed and liquid nutrient is delivered to the patient via the feed attachment port <NUM>, i.e. the tube connector, via the feed conduit <NUM> and the feed port <NUM>, i.e. the at least one through-opening, as has been explained above in conjunction with the embodiments according to <FIG>.

In the probe device <NUM>, the feed tube section <NUM> between the feed attachment port <NUM> and the suction/feed port <NUM> is divided into two tube sub-sections 2a, 2b. The suction conduit <NUM> opens out from a tube transition section <NUM>, which is arranged between the two tube sub-sections 2a, 2b, from the feed conduit <NUM>.

The tube transition section <NUM> is designed as a three-way connector. For fluid transfer, it interconnects a suction/feed tube section, which has the suction/feed port <NUM>, i.e. the tube sub-section 2b, a suction attachment tube section, which has the suction attachment port <NUM>, namely the suction tube section <NUM>, and a feed attachment tube section, which has the feed attachment port <NUM>, namely the tube sub-section 2a. The two tube sub-sections 2a, 2b are connected to the three-way connector <NUM> via overmould sections <NUM>, as has been described above in particular in conjunction with the embodiments according to <FIG> and <FIG>. Others of the above-described embodiments of overmould sections can also be used to connect the tube sub-sections 2a, 2b to the three-way connector <NUM>. Together with the tube sub-sections 2a on the one hand and 2b on the other hand, the three-way connector <NUM> constitutes a tube/connector assembly, as has been explained above with reference to <FIG>.

The suction tube section <NUM> is integrally formed in one piece on the overmould section <NUM>, for example by injection moulding. The two overmould sections <NUM> for the tube sub-sections 2a, 2b are integrally connected to each other.

In the probe device <NUM>, the two tube sub-sections 2a, 2b are each adhesively bonded to the tube transition section <NUM> of the probe device <NUM>. A connection is used of the type known from <CIT>. The tube sub-sections 2a, 2b are thus inserted into a main body of the tube transition section <NUM>, wherein the insertion sections inside this main body widen towards the inside via a conically widening inner wall. These conical widenings of the insertion sections extend from the respective insertion opening as far as a constriction step and merge via the latter into a fluid passage of the tube transition section. The conical widening forms an annular space, which can be utilized for the insertion of an adhesive.

In the probe device <NUM>, the suction tube section <NUM> is formed integrally in one piece on the tube transition section <NUM>.

Claim 1:
Probe device (<NUM>; <NUM>; <NUM>; <NUM>) for insertion into a body of a patient
- with a suction conduit (<NUM>) between
-- a distal suction/feed port (<NUM>) and
-- a proximal suction attachment port (<NUM>) for the attachment of a vacuum source,
- with a feed conduit (<NUM>) between
-- a proximal feed attachment port (<NUM>) for the attachment of a feed source and
-- the distal suction/feed port (<NUM>),
wherein the feed conduit (<NUM>) has a feed tube section (<NUM>) extending between the feed attachment port (<NUM>) and the suction/feed port (<NUM>), wherein the feed tube section (<NUM>) has a material composition containing silicone and BaSO<NUM>,
characterized in that
the feed attachment port (<NUM>) is connected to the feed tube section (<NUM>) in a fluid-tight manner via an overmould section (<NUM>) which covers a transition (<NUM>) between the feed attachment port (<NUM>) and the feed tube section (<NUM>) and is connected on the one hand in a fluid-tight manner to the feed attachment port (<NUM>) and is connected on the other hand in a fluid-tight manner to the feed tube section (<NUM>),
wherein the overmould section (<NUM>) has a material composition containing silicone and BaSO4.