Probe device for insertion into a body of a patient, and tube/connector assembly

20200306503 · 2020-10-01

    Inventors

    Cpc classification

    International classification

    Abstract

    A probe device serves for insertion into a body of a patient. The probe device has a suction conduit between a distal suction feed port and a proximal suction attachment port for the attachment of a vacuum source. Moreover, the probe device has a feed conduit between a proximal feed attachment port, for the attachment of a feed source, and the distal suction feed port. This results in a probe device and a tube/connector assembly, which can be a component thereof, of which the versatility is improved in particular in the area of a medical application or an application in which biocompatibility is important.

    Claims

    1. A probe device for insertion into a body of a patient with a suction conduit between a distal suction/feed port and a proximal suction attachment port for the attachment of a vacuum source, with a feed conduit between a proximal feed attachment port for the attachment of a feed source and the distal suction/feed port.

    2. The probe device according to claim 1, wherein the feed conduit has a feed tube section extending between the feed attachment port and the suction/feed port, and wherein a jacket wall of the feed tube section has a jacket opening through which the suction conduit opens out from the feed conduit.

    3. The probe device according to claim 2, wherein a suction tube section in an area of the jacket opening is formed integrally on the feed tube section.

    4. The probe device according to claim 1, wherein the feed conduit has a feed tube section extending between the feed attachment port and the suction/feed port in two tube sub-sections, and wherein the suction conduit opens out from a tube transition section between the two tube sub-sections.

    5. The probe device according to claim 4, comprising a three-way connector by which a suction/feed tube section, which has the suction/feed port, a suction attachment tube section, which has the suction attachment port, and a feed attachment tube section, which has the feed attachment port, are interconnected for fluid transfer.

    6. The probe device according to claim 4, wherein the two tube sub-sections are adhesively bonded to the tube transition section.

    7. The probe device according to claim 4, wherein a suction tube section is integrally formed on the tube transition section.

    8. The probe device according to claim 4, wherein a suction tube section is adhesively bonded to the tube transition section.

    9. A tube/connector assembly with a tube section for predefining a fluid channel section, with a tube connector for continuing the fluid channel section and for connecting the tube section to an external tube, wherein the tube section has a material composition containing silicone and BaSO.sub.4, wherein the tube connector is connected to the tube section in a fluid-tight manner via an overmould section which covers a transition between the tube connector and the tube section and is connected on the one hand in a fluid-tight manner to the tube connector and is connected on the other hand in a fluid-tight manner to the tube section, wherein the overmould section has a material composition containing silicone and BaSO.sub.4.

    10. The assembly according to claim 9, designed for use in a probe device for insertion into a body of a patient with a suction conduit between a distal suction/feed port and a proximal suction attachment port for the attachment of a vacuum source, with a feed conduit between a proximal feed attachment port for the attachment of a feed source and the distal suction/feed port.

    Description

    BRIEF DESCRIPTION OF THE DRAWING

    [0024] FIG. 1 shows an interrupted side view of an embodiment of a tube/connector assembly in the form of a probe device designed as a feeding probe assembly for insertion into a body of a patient in order to deliver a liquid nutrient to a patient;

    [0025] FIG. 2 shows an axial section through the assembly according to FIG. 1 along line II-II;

    [0026] FIG. 3 shows the detail III from FIG. 2;

    [0027] FIG. 4 shows the detail IV from FIG. 2;

    [0028] FIG. 5 shows an enlarged detail of a tube connector of the assembly, shown in a detail corresponding to FIG. 3;

    [0029] FIG. 6 shows a perspective view of the tube connector;

    [0030] FIG. 7 shows, in a view similar to FIG. 1, a further embodiment of a tube/connector assembly in the form of a feeding probe assembly;

    [0031] FIG. 8 shows a section along line VIII-VIII from FIG. 7;

    [0032] FIG. 9 shows the detail IX from FIG. 8;

    [0033] FIG. 10 shows the detail X from FIG. 8;

    [0034] FIG. 11 shows, in a view similar to FIG. 1, a further embodiment of a tube/connector assembly in the form of a feeding probe assembly;

    [0035] FIG. 12 shows a section along line XII-XII from FIG. 11;

    [0036] FIG. 13 shows the detail XIII from FIG. 12;

    [0037] FIG. 14 shows the detail XIV from FIG. 12;

    [0038] FIG. 15 shows, in a view similar to FIG. 1, a further embodiment of a tube/connector assembly in the form of a feeding probe assembly;

    [0039] FIG. 16 shows a section along line XVI-XVI from FIG. 15;

    [0040] FIG. 17 shows the detail XVII from FIG. 16;

    [0041] FIG. 18 shows the detail XVIII from FIG. 16;

    [0042] FIG. 19 shows, in a view similar to FIG. 2, a further embodiment of a probe device with a suction conduit configured additionally to a feed conduit;

    [0043] FIG. 20 shows, in a view similar to FIG. 2, a further embodiment of a probe device with a suction conduit configured additionally to a feed conduit;

    [0044] FIG. 21 shows the detail XXI from FIG. 20;

    [0045] FIG. 22 shows, in a view similar to FIG. 2, a further embodiment of a probe device with a suction conduit configured additionally to a feed conduit;

    [0046] FIG. 23 shows the detail XXIII from FIG. 22;

    [0047] FIG. 24 shows, in a view similar to FIG. 2, a further embodiment of a probe device with a suction conduit configured additionally to a feed conduit;

    [0048] FIG. 25 shows the detail XXV from FIG. 24.

    DESCRIPTION OF THE PREFERRED EMBODIMENTS

    [0049] A first embodiment of a tube/connector assembly 1 is explained below with reference to FIGS. 1 to 6.

    [0050] This tube/connector assembly 1 is in the form of a feeding probe assembly for delivering a liquid nutrient to a patient. The tube/connector assembly 1 represents a probe device for insertion into a body of a patient. The assembly 1 has a tube section 2 in the form of a tubular tube of the feeding probe. The tube section 2 serves to predefine a delivery channel section of the assembly 1 for the liquid nutrient. The tube section 2 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.sub.4. A Shore A hardness of the tube section 2 can be in the range of between 40 and 90, in the range of between 60 and 80, for example 70. The material composition can contain 2 percent by weight to 60 percent by weight of BaSO.sub.4 and accordingly 40 percent by weight to 98 percent by weight of silicone. In addition to a silicone/BaSO.sub.4 material fraction, other material components can also form the material composition of the tube section 2, in particular further fillers.

    [0051] The assembly 1 also has a tube connector 3 made of a silicone-free plastics material. The tube connector 3 serves to continue the fluid channel section and to connect the tube section 2 to an external tube 4 indicated by broken lines in FIG. 1. The tube connector 3 is produced from polybutylene terephthalate (PBT). The external tube 4 is in turn fluidically connected to a source of liquid nutrient. The tube connector 3 thus serves to attach a feed source to the probe device 1.

    [0052] The tube connector 3 is connected to the tube section 2 in a fluid-tight manner via an overmould section 5. The latter covers a transition 6 (cf. FIG. 3) between the tube section 2 and the tube connector 3.

    [0053] In the assembly 1, the tube section 2 and the tube connector 3 bear on each other end to end at the transition 6. This end-to-end contact is formed on the tube connector 3 by several projections 8 which protrude axially from an end wall 7 and which are integrally formed on a main body of the tube connector 3. An end wall of the tube section 2 facing towards the tube connector 3 thus abuts at least one of the projections 8 in the area of the transition 6. In the embodiment shown, the tube connector 3 has a total of four such projections 8. These are distributed uniformly in the circumferential direction around a fluid channel axis 9 of the assembly 1, as can be seen from the perspective view according to FIG. 6. In the area of the transition 6, an internal diameter of the fluid channel section of the tube connector 3 narrows over several steps 10, 11. A first cone section 12 of the tube connector 3 in this case lies between the narrowing steps 10 and 11. A second cone section 13 is present between the narrowing step 11 and the end wall 7. The cone angles of the cone sections 12 and 13 are different from each other. The cone angle of the second cone section 13 is greater than that of the first cone section 12, such that the fluid channel of the tube connector 3 narrows more strongly in the area of the second cone section 13 than it does in an area of comparable axial extent of the first cone section 12. In the production of the overmould section 5, the second cone section 13 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.

    [0054] The overmould section 5 is connected in a fluid-tight manner on the one hand to the tube section 2 and on the other hand to the tube connector 3. In the area of the transition 6, material of the overmould section 5 penetrates in the circumferential direction between mutually adjacent projections 8 and thereby ensures stabilizing, possibly also meshing, of the components 2, 3 and 5.

    [0055] The overmould section 5 has a material composition with silicone and BaSO.sub.4. The silicone can be liquid silicone (LSRliquid silicone rubber). For the percentages of silicone/BaSO.sub.4 in the material composition of the overmould section 5, and for possible additional material components, reference is made to the details given above concerning the tube section 2.

    [0056] The assembly 1 moreover has a plug 14 for distal closure of a free end of the tube section 2. The plug 14 also has a material composition containing silicone and BaSO.sub.4. The silicone can be liquid silicone. For the percentages of silicone/BaSO.sub.4 in the material composition of the plug 14, and for possible additional material components, reference is made to the details given above concerning the tube section 2.

    [0057] A lumen of the tube section 2 is fluidically connected to a surrounding area of the tube section 2 via a plurality of through-openings 15. In an embodiment of the tube section 2 not shown here, there is precisely one through-opening 15. In one embodiment of the tube section 2, there can also be more than two through-openings 15. The through-openings 15 extend radially in relation to the fluid channel axis 9. The through-openings are axially offset with respect to each other. The through-openings 15 are offset in the circumferential direction around the fluid channel axis 9. The one or more through-openings 15 constitute a feed port of the probe device 1.

    [0058] The plug 14 is rounded at its free end. The complementary end of the plug 14 arranged inside the lumen of the tube section 2 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. 4) for the insertion of the tube section 2. By virtue of the concave design of the recess 14a, a distal end of the guide wire 14b bears securely on the plug 14 and not on an inner wall of the tube section 2.

    [0059] A further embodiment of a tube/connector assembly 16 is explained below with reference to FIGS. 7 to 10. Components and functions corresponding to ttube already explained above with reference to FIGS. 1 to 6 have the same reference numbers and are not discussed again in detail.

    [0060] Compared to the assembly 1, the fluid channel in the area of the tube section 2 of the assembly 16 has an enlarged internal diameter. In contrast to the plug 14 of the assembly 1, which does not cover the outer face of the tube section 2, a plug 17 of the assembly 16 does cover a distal end area E of the tube section 2.

    [0061] A further embodiment of a tube/connector assembly 18 is explained below with reference to FIGS. 11 to 14. Components and functions corresponding to ttube already explained above with reference to FIGS. 1 to 10 have the same reference numbers and are not discussed again in detail.

    [0062] Compared to the assembly 16, the fluid channel in the area of the tube section 2 of the assembly 18 has an enlarged internal diameter. In the assembly 18, the proximal end of the tube section 2 is pushed over the facing end portion of the tube connector 3 in an axial covering area P. In the assembly 18, the transition 6 between the tube connector 3 and the tube section 2 lies at the place where the proximal end wall of the tube section 2 bears on a circumferential rib 6a of the tube connector 3. This transition 6 is again covered by the overmould section 5, wherein, on the one hand, a fluid-tight connection of the overmould section 5 to the tube connector is formed and, on the other hand, a fluid-tight connection of the overmould section 5 to the tube section 2 is formed.

    [0063] The tube connector 3 of the assembly 18 does not have the projections 8.

    [0064] A further embodiment of a tube/connector assembly 19 is explained below with reference to FIGS. 15 to 18. Components and functions corresponding to ttube already explained above with reference to FIGS. 1 to 14 have the same reference numbers and are not discussed again in detail.

    [0065] Compared to the assembly 18, the fluid channel in the area of the tube section 2 of the assembly 19 has an enlarged internal diameter.

    [0066] The transition 6 in the assembly 19, as in the assembly 18, is formed by an end portion pushed proximally onto the tube connector 3.

    [0067] In the area of the proximal covering P of the assembly 19, an internal diameter of the tube section 2 increases only marginally, in contrast to the embodiment of the assembly 18 where the internal diameter of the tube section 2 increases considerably in the area of the proximal covering P as far as the transition 6.

    [0068] The overmould section 5 ensures a fluid-tight, stable and sufficiently durable connection between the tube connector 3 and the tube section 2 in all of the described assemblies 1, 16, 18 and 19. A secure connection is thus provided between the silicone-containing tube section 2 and the non-silicone-containing tube connector 3.

    [0069] A further embodiment of a probe device 20 is explained below with reference to FIG. 19. Components and functions corresponding to ttube already explained above with reference to FIGS. 1 to 18 have the same reference numbers and are not discussed again in detail.

    [0070] The probe device 20 has a suction conduit 21 between a distal suction/feed port, which is formed by the at least one through opening 15, and a proximal suction attachment port 22 for the attachment of a vacuum source (not shown). The suction attachment port 22 is designed as funnel connector. A closure plug 23 is integrally formed on the suction attachment port 22. The closure plug 23 is connected in one piece to the suction attachment port 22 via a plastic bottle 24.

    [0071] Moreover, the probe device 20 has a feed conduit 25 between a proximal feed attachment port, formed by the tube connector 3 and serving for the attachment of the feed source, and the distal suction feed port 15.

    [0072] Overall, therefore, the probe device 20 constitutes a three-way probe which, on the one hand, has a suctioning function via the suction conduit 21 when the suction attachment port 22 is opened and, on the other hand, has a feeding function via the feed conduit 25 when the suction attachment port 22 is closed.

    [0073] The probe device 20 is present in a Y shape. The feed conduit 25 extends along the tube section 2 without branching off. In the area of an entrance 26 of a suction tube section 27, the suction conduit 21 extends at a bend angle with respect to the fluid channel axis 9 of the tube section 2. The angle is an acute angle. The angle can be in the range of between 30 and 60.

    [0074] The tube section 2 is designed as a feed tube section extending between the feed attachment port 3 and the suction/feed port 15. A jacket wall of this tube section 2 has a jacket opening 28 through which the suction conduit 21 opens out from the feed conduit 25.

    [0075] In the area of the jacket opening 28, i.e. in the area of the entrance point 26, the suction tube section 27 if formed integrally on the feed tube section 2. This can be achieved by injection-moulding the suction tube section 27 onto the feed tube section 2. The suction tube section 27 can be produced from polybutylene terephthalate (PBT) or from silicone. Material variants for the suction tube section 27 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).

    [0076] The probe device 20 is used as follows. If the probe device 20 is to be used to aspirate secretions or other foreign bodies, the closure plug 23 is opened and the vacuum source is attached to the suction attachment port 22. With the probe device 20 correctly inserted, the secretions can then be aspirated through the suction feed port 15 and then flow along the suction conduit 21.

    [0077] If the feeding function of the probe device 20 is intended to be used, the closure plug 23 is closed and liquid nutrient is delivered to the patient via the feed attachment port 3, i.e. the tube connector, via the feed conduit 25 and the feed port 15, i.e. the at least one through-opening, as has been explained above in conjunction with the embodiments according to FIGS. 1 to 18.

    [0078] A further embodiment of a probe device 29 is explained below with reference to FIGS. 20 and 21. Components and functions corresponding to ttube already explained above with reference to FIGS. 1 to 19 have the same reference numbers and are not discussed again in detail.

    [0079] In the probe device 29, the feed tube section 2 between the feed attachment port 3 and the suction/feed port 15 is divided into two tube sub-sections 2a, 2b. The suction conduit 21 opens out from a tube transition section 30, which is arranged between the two tube sub-sections 2a, 2b, from the feed conduit 25.

    [0080] The tube transition section 30 is designed as a three-way connector. For fluid transfer, it interconnects a suction/feed tube section, which has the suction/feed port 15, i.e. the tube sub-section 2b, a suction attachment tube section, which has the suction attachment port 22, namely the suction tube section 27, and a feed attachment tube section, which has the feed attachment port 3, namely the tube sub-section 2a. The two tube sub-sections 2a, 2b are connected to the three-way connector 30 via overmould sections 5, as has been described above in particular in conjunction with the embodiments according to FIGS. 12 and 18. 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 30. Together with the tube sub-sections 2a on the one hand and 2b on the other hand, the three-way connector 30 constitutes a tube/connector assembly, as has been explained above with reference to FIGS. 1 to 18.

    [0081] The suction tube section 27 is integrally formed in one piece on the overmould section 5, for example by injection moulding. The two overmould sections 5 for the tube sub-sections 2a, 2b are integrally connected to each other.

    [0082] A further embodiment of a probe device 31 is explained below with reference to FIGS. 22 and 23. Components and functions corresponding to ttube already explained above with reference to FIGS. 1 to 21 have the same reference numbers and are not discussed again in detail.

    [0083] In the probe device 31, the two tube sub-sections 2a, 2b are each adhesively bonded to the tube transition section 30 of the probe device 31. A connection is used of the type known from WO 2012/163 819 A2. The tube sub-sections 2a, 2b are thus inserted into a main body of the tube transition section 30, 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.

    [0084] In the probe device 31, the suction tube section 27 is formed integrally in one piece on the tube transition section 30.

    [0085] A further embodiment of a probe device 32 is explained below with reference to FIGS. 24 and 25. Components and functions corresponding to ttube already explained above with reference to FIGS. 1 to 23 have the same reference numbers and are not discussed again in detail.

    [0086] In contrast to the probe device 31, an adhesively bonded connection of the kind known from WO 2012/163 819 A2 is likewise present between the suction tube section 27 and the tube transition section 30 of the probe device 32. An insertion sub-section 33, via which the suction tube section 27 is inserted into the main body of the tube sub-section 30, has a narrower external diameter compared to the rest of the suction tube section 27.