MEDICAL DEVICE FOR PLACING A CATHETER

Abstract

The disclosure relates to a medical device for placing a catheter in an umbilical cord blood vessel of a newborn, wherein the medical device comprises a longitudinal axis, a proximal and a distal end, the medical device being designed as a sheath to enclose a portion of an umbilical cord. The medical device comprises a first unit comprising a clamping device for clamping the umbilical cord, and/or a second unit, comprising a severing device for severing the umbilical cord to form an umbilical cut surface, and a third unit comprising a hooking device for spreading the umbilical cut surface.

Claims

1. A medical device for placing a catheter in an umbilical cord blood vessel of a newborn, wherein the medical device comprises a longitudinal axis, a proximal and a distal end, and being sheath-like designed to enclose a portion of an umbilical cord, wherein the medical device comprises the following: a first unit, comprising a clamping device for clamping the umbilical cord, and/or a second unit, comprising a severing device for severing the umbilical cord to form an umbilical cut surface, and a third unit, comprising a hooking device for spreading the umbilical cut surface.

2. The medical device according to claim 1, wherein the first unit is arranged at the proximal end of the device and the second unit is arranged at the distal end of the device, wherein the third unit is arranged between the first and the second unit of the device.

3. The medical device according to claim 1, wherein the first, second and third units are connectable to one another via connecting elements, such, that the first unit is attachable in the device by rotation against the second and/or the third unit.

4. The medical device according to claim 1, wherein the first, second and third units are connectable to one another via connecting means, such that the first unit is attachable in the device by rotation against the second and/or the third unit, wherein the connecting elements are selected from rotational connection elements, bayonet connection elements, rail connection elements, hook connection elements and/or magnet connection elements.

5. The medical device according to claim 1, wherein the sheath is closed for threading the umbilical cord into the sheath.

6. The medical device according to claim 1, wherein the sheath is designed such, that it can be opened or slid open or pushed open along the longitudinal axis of the device and can be locked again to close the sheath for placing the device around a section of the umbilical cord.

7. The medical device according to claim 1, wherein the sheath can be opened or slid open or pushed open along the longitudinal axis of the device and can be locked again to close the sheath for placing the device around a section of the umbilical cord, wherein the first, second and third unit each comprises sheath closing elements for opening or slide open the sheath, wherein the sheath closing elements are selected from clamp, click, hinge, hook, and rail elements.

8. The medical device according to claim 1, wherein the clamping device comprises a tie or an air cushion for clamping the blood vessels in the umbilical cord at the proximal end of the medical device.

9. The medical device according to claim 1, wherein the clamping device is designed such that the umbilical cord is clamped by equatorial rotation of the first unit against the second and/or third unit.

10. The medical device according claim 1, wherein the severing device comprises cutting elements.

11. The medical device according to claim 1, wherein the severing device comprises cutting elements selected from a knife-like cutting element, a scissor-like cutting element or a thread-like cutting element.

12. The medical device according to claim 1, wherein the severing device comprises a cutting element selected from a knife-like cutting element, wherein the knife-like cutting element is movably attached to a rail or the knife-like cutting element is movably attached to a hinge or the knife-like cutting element is spring-loaded.

13. The medical device according to claim 1, wherein the severing device of the second unit is designed, such, that the umbilical cord is clamped by equatorial rotation of the second unit against the first and/or the third unit, and wherein the second unit is detachably arranged on the device.

14. The medical device according to claim 1, wherein the hooking device comprises at least three hook elements.

15. The medical device according to claim 1, wherein the hooking device comprises at least four, five, six, seven, eight, nine or ten hook elements each having a first fastening end and a second hooking end.

16. The medical device according to claim 1, wherein the hooking device comprises hooking elements and a ring element, wherein the hooking elements are each attached to the ring element via a first fastening end, which is attached to the hooking device circumferentially in hinges around the sheath, and wherein a second hooking end of the hooking elements is designed for getting hooked into the umbilical cord tissue.

17. The medical device according to claim 1, wherein the hooking device comprises hooking elements and a ring element, wherein the hooking elements are each attached to the ring element via a first fastening end, which is attached to the hooking device circumferentially in hinges around the sheath, and wherein a second hooking end of the hooking elements is designed for getting hooked into the umbilical cord tissue, wherein the ring element is in distal and proximal longitudinal direction of the medical device is slidably arranged on the hooking device such that by moving the ring element from a distal position to a proximal position the hook elements get hooked in the umbilical cord and can spread the umbilical cut surface.

18. The medical device according to any of claim 1, wherein the sheath comprises a substantially cylindrical shape.

19. A method for placing a catheter in an umbilical cord blood vessel of a newborn using the medical device according to claim 1, comprising the following steps: placing the medical device according to claim 1 around the umbilical cord of a newborn; actuating the first unit to effect clamping of blood vessels of the umbilical cord at the proximal end of the device; actuating the second unit comprising the severing device to effect cutting the umbilical cord and to form an umbilical cut surface; removing the second unit from the device; actuating the third unit to effect spreading of the umbilical cut surface; and placing the catheter in an umbilical cord blood vessel.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0090] FIG. 1 a schematic drawing of a first embodiment of the first unit of the medical device comprising a clamping device for clamping the umbilical cord;

[0091] FIGS. 2A-2C schematic drawings of a first embodiment of the second unit of the medical device comprising a severing device for severing the umbilical cord to form an umbilical cut surface;

[0092] FIG. 3 a schematic drawing of a first embodiment of the third unit of the medical device comprising a hooking device, for spreading the umbilical cord cut;

[0093] FIG. 4 a schematic drawing of a first embodiment of the medical device for placing a catheter in an umbilical cord blood vessel of a newborn;

[0094] FIG. 5 a schematic drawing of a first embodiment of the medical device for placing a catheter in an umbilical cord blood vessel of a newborn, wherein the device being opened; and

[0095] FIGS. 6A-6C schematic drawings of the movement mechanism of the third unit of the medical device.

DETAILED DESCRIPTION

[0096] Functionally equivalent elements are identified in all figures with the same reference signs, also in different embodiments.

[0097] FIG. 1 shows a schematic drawing of a first embodiment of the first unit 100 of the medical device, which comprises a clamping device 10, for clamping the umbilical cord, in particular the blood vessels.

[0098] FIG. 1 shows the first unit 100, which is formed cylindrical. The unit 100 comprises two subunits 14 and 16, which are connected by a hinge 12. In an embodiment not shown, the first unit 100 can be arranged without a hinge 12. For this, the umbilicus is threaded into first unit 100. The hinge 12 offers the advantage that the unit 100 can be placed easy around the umbilicus. The unit 100 or the subunits 14 and 16 are closed by a sheath closing mean 18. This closure 18 can be opened again when required.

[0099] The first unit 100 comprises a clamping device 10, which is arranged in the first unit 100. This clamping device 10 is designed for clamping the umbilical cord. According to the disclosure clamping means that the blood vessels, which are located in the umbilicus, are clamped off. This prevents bleeding of the newborn. The clamping device 10 may comprise, for example, a tie 11 or an air cushion. A tie/ribbon 11 can be arranged in the first unit 100 via a loop guide, such that a loop is pulled around the umbilicus by pulling the tie 11, which leads to clamping of the blood vessels. Furthermore, the clamping device 10 can also be designed as an air cushion. The air cushion according to this embodiment is arranged such that the umbilicus of the newborn is clamped by filling the cushion with air. The vessels can be reopened again by the targeted escape of air.

[0100] The clamping device 10 is shown in FIG. 1 as a tie 11. This tie 11 is intended to clamp the blood vessels securely, such that bleeding of a newborn is prevented. The clamping device 10 is also designed such that the blood vessels are at least partially reopened when a catheter is placed. Thus, the clamping device 10 can therefore be opened and closed reversibly. The tie 11 is arranged in the first unit 100 such that the umbilicus is clamped by pulling the tie 11. Here, the umbilicus is not ruptured. Furthermore, the clamping device 10 ensures that the clamping device 10 is not released in undesirable ways.

[0101] Preferably, the first unit 100 is applied as close as possible to the body of the newborn.

[0102] In the shown embodiment the first unit 100 comprises also connecting means 19. These connecting means 19 serves to fasten/connect the first unit 100 to/with the third unit. The connecting means 19 are formed as bayonet lock. The two units can be connected easily and fast by inserting the third unit, which comprises the corresponding bolts, into the others and rotating it in the opposite direction.

[0103] FIG. 2A-2C shows a schematic drawing of the first embodiment of the second unit 200 of the medical device, which comprises a severing device 20 for severing the umbilical cord to form an umbilical cut surface. The figures show in particular the mechanism of the severing device 20.

[0104] The second unit 200 is formed cylindrically and comprises two subunits 22 and 24, which are connected by a hinge 12. The severing device 20 is also arranged at the hinge 12, such, that it can be guided over the hinge 12. The subunits 22 and 24 can be locked by a sheath closing mean 18. The sheath closing mean 18 is formed as a simple hooking lock, which can be opened and closed again as required.

[0105] The severing device 20 is suitable for severing the umbilical cord to form an umbilical cut surface. The severing device 20 comprises cutting means 25 among other things. In these figures the severing device 20 is shown as scissor-like cutting means 25. Other preferred cutting means 25 are knife-like cutting means or thread-like cutting means. The cutting means 25 can be a scalpel, scissors, metallic thread or the like. The severing device 25 is arranged in the second unit 200 and can be activated by a simple movement mechanism. Preferably, the cutting means 25 are inserted in the second unit 200 such that the umbilicus can be cut by moving the second unit 200 or the cutting means 25 with one hand. Preferably, the cutting surface is smooth such that the umbilical vessels are not frayed. In a particular embodiment, the severing device 20 can be activated by rotating the second unit 200.

[0106] The cutting means 25 in FIG. 2A to 2C comprises two or more blades 26 and one lever end 27 each. The blades 26 with their lever ends 27 are movably connected via a hinge 12. The blades 26 are formed curved. This provides the advantage that they can be attached in the cylindrically shaped subunits 22 and 24 and that the umbilicus can be cut preferentially. According to another embodiment, the blades 26 can comprise a different shape (not shown).

[0107] The blades 26 can be pushed against each other like scissors such that the umbilical cord can be severed. FIG. 2A shows the lever ends 27 of the knife blades 26. These protrude, while the knife blades 26 in the second unit 200 are attached such that the knife blades 26 cannot cut in this position. The knife blades 26 are also shifted against each other by the opposite guidance of the lever ends 27, such that they can sever the umbilical cord. This is shown in FIGS. 2B and 2C.

[0108] The cutting means 25 are preferably arranged at the proximal end of the second unit 200, such that after cutting the umbilicus a part of the umbilicus falls off together with the second unit 200. According to a preferred embodiment the second unit 200 with its proximal end is as close as possible to the distal end of the third unit. According to this embodiment, the spreading of the umbilical cut surface can be carried out particularly advantageously. The further away the second unit 200 and the third unit are from each other, the more difficult it is to spread the umbilical cut surface.

[0109] According to a not shown embodiment, the severing device 20 may comprise a cutting mean 25 which is guided along a rail.

[0110] FIG. 3 shows a schematic drawing of a first embodiment of the third unit 300 of the medical device comprising a hooking device 30 for spreading the umbilical cord cut.

[0111] The third unit 300 is cylindrical and comprises two subunits 32 and 34, which are connected by a hinge 12. The hooking device 30 is partly arranged around and inside the subunits 32 and 34. The subunits 32 and 34 with the hooking device 30 can be closed by a sheath lock 18. The sheath lock 18 is designed as a simple reclosable hooking lock.

[0112] The hooking device 30 is designed such that it is suitable for spreading an umbilical cut surface. The hooking device 30 comprises, among other things, hook elements 36, which are attached to a ring element 38. The ring element 38 is arranged to the cylindrical sheath or to the subunits 32 and 34 of the third unit 300. The hook elements 36 are attached to the ring element 38 at their fastening end 48. The second hook end 44 of the hook elements 36 is arranged on the inside of the sheath. These hook ends 44 are designed such that they can hook into the umbilical tissue.

[0113] The third unit 300 also comprises connecting means 40. These connecting means 40 are intent to fasten the third unit 300 to the first unit and/or the second unit. The connecting means 40 are designed as bayonet fasteners, in which case the third unit 300 comprises the bolt. Accordingly, the first or second unit could comprise notches in which the bolts can be inserted and twisted into each other. This allows the units to be connected easy and fast.

[0114] FIG. 3 also shows that the hook elements 36 are arranged in a type of guide rail, which allows the ring element 38 to be guided in the distal and proximal longitudinal directions. If the ring element 38 is moved from the distal end to the proximal end, the hook elements 36 hook into the umbilical tissue and spread it open. The mechanism or movement sequence of the spreader is shown schematically in FIGS. 6A to 6C.

[0115] FIG. 4 shows a schematic drawing of the medical device 400 for placing a catheter in an umbilical cord blood vessel of a newborn. The umbilical cord blood vessels are two arteries and one vein.

[0116] The medical device 400 comprises three units, 100, 200 and 300, which are connected to each other. The connection between the individual units 100, 200 and 300 is reclosable such that the individual units 100, 200 and 300 can be separated from each other and can be reclosed. In particular, the easy separation of the individual units 100, 200 and 300 make this possible. The individual units 100, 200 and 300 can, for example, be separated from each other by rotating them against each other. Other locking units can be, for example, bayonet connections, swivel connections or pull connections. The individual units 100, 200 and 300 are preferably connected to each other such that the lock can be opened or closed with one or two hands.

[0117] The first unit 100 is preferably attached to the proximal end of the umbilicus. The second unit 200 is preferably attached at the distal end of the umbilicus, the third unit 300 being attached between the first unit 100 and the second unit 200 closed around the umbilicus. In this embodiment/view, the medical device 400 is shown in a closed position as a cylindrical sheath, which can be opened and closed along the longitudinal axis. According to this embodiment, it is easy for a treating person to place the medical device 400 around the umbilical cord and then securely close/lock it. Preferably, the closure 18 is designed, such, that the cylindrical sheath cannot open unintentionally during treatment. This sheath lock 18 can, for example, be opened or pushed open. For example, the sheath lock 18 can be formed as a clamp, click, hinge or rail means. According to the disclosure, the sheath locking device is a locking device that is particularly easy to lock. Preferably, the sheath can be closed with one hand.

[0118] According to an embodiment not shown, the medical device 400 may be configured such that it comprises, in addition to the third unit 300, only the first unit 100 or only the second unit 200. Thus, the medical device 400 would consist of only two units.

[0119] The medical device 400 can be available in different sizes. Preferably, the inner diameter of the medical device corresponds about to the umbilicus diameter of the newborn.

[0120] FIG. 5 shows a schematic drawing of the first embodiment of the medical device 400 for placing a catheter in an umbilical cord blood vessel of a newborn, with the device 400 being in an open position.

[0121] The first, second and third units 100, 200 and 300 of the medical device 400 are shown. The individual units 100, 200 and 300 are connected to each other. For sake of clarity, units 100 and 200 are shown to not comprise their clamping- or severing devices in this figure. Otherwise, the depicted medical device 400 corresponds to the one in FIG. 4. In particular, the hook elements 36 can be seen in this figure, which are attached on the ring element 38 or in the third unit 300.

[0122] FIG. 6A-6C show a schematic drawing of the movement mechanism or the movement sequence of the third unit 300 of the medical device 400, which leads to the spreading of the umbilical cut surface 42. This is achieved by a sequence of movements of the hooking device 30 of the third unit 300.

[0123] FIG. 6A shows the cylindrical sheath of the third unit 300 in which the hooking device 30 is provided. The hooking device 30 comprises, among other things, hook elements 36. This hook element 36 comprises a first fastening end 48 and a second hook end 44. Via the first fastening end 48 the hook elements 36 are fastened to a ring element 38. This ring element 38 is arranged circumferentially on the cylindrical sheath. The second hooking end 44 is designed such that it can hook into the umbilical cord tissue 46.

[0124] By moving the ring element 38 in the proximal longitudinal direction, as shown in FIG. 6B, the second hooking end 44 gets hooked into the umbilical cord tissue 46. By moving the ring element 38 further in the proximal direction, the umbilical cut surface 42 is spread out, as shown in FIG. 6C.

[0125] It is to be understood that the foregoing description is of one or more preferred example embodiments of the invention. The invention is not limited to the particular embodiment(s) disclosed herein, but rather is defined solely by the claims below. Furthermore, the statements contained in the foregoing description relate to particular embodiments and are not to be construed as limitations on the scope of the invention or on the definition of terms used in the claims, except where a term or phrase is expressly defined above. Various other embodiments and various changes and modifications to the disclosed embodiment(s) will become apparent to those skilled in the art. All such other embodiments, changes, and modifications are intended to come within the scope of the appended claims.

[0126] As used in this specification and claims, the terms for example, e.g., for instance, and such as, and the verbs comprising, having, including, and their other verb forms, when used in conjunction with a listing of one or more components or other items, are each to be construed as open-ended, meaning that the listing is not to be considered as excluding other, additional components or items. Other terms are to be construed using their broadest reasonable meaning unless they are used in a context that requires a different interpretation.