CONNECTION ASSEMBLY FOR ESTABLISHING A FLUIDIC CONNECTION BETWEEN A MEDICAL DEVICE AND A PATIENT-SIDE COUPLING UNIT
20220203060 · 2022-06-30
Inventors
Cpc classification
A61B5/097
HUMAN NECESSITIES
A61M2025/0004
HUMAN NECESSITIES
A61M2207/00
HUMAN NECESSITIES
International classification
Abstract
A connection device for establishing a fluid connection between a medical device and a patient-side coupling unit includes a supply hose (3) connected to a patient-side connection piece (2) and connectable to the medical device. An adapter tube (13.1) of an adapter (10.1) holds a patient-side end section (EA) of a fluid measuring hose (6.1). An adapter tube holder (12.1, 12.2) of the adapter (10.1) encloses the adapter tube (13.1). The adapter tube holder (12.1, 12.2) holds the end section of the fluid measuring hose (6.1) in a predefined position relative to the patient-side connection piece (2). A measuring fluid connection can be established between the medical device and a predefined fluid sampling position (X) by the fluid measuring hose (6.1). This fluid sampling position (X) is in the interior of the patient-side connection piece (2).
Claims
1. A connection device for establishing a fluid connection between a medical device and a patient-side coupling unit, the connection device comprising: a supply hose connected to or connectable to the medical device; a patient-side connection piece connected to the supply hose, wherein the supply hose and the patient-side connection piece together are configured to establish at least one fluid connection between the medical device and the patient-side coupling unit; a flexible fluid measuring hose; and an adapter comprising a rigid adapter tube and an adapter tube holder, wherein the patient-side connection piece holds the adapter tube holder, wherein the adapter tube holds a patient-side end section EA of the fluid measuring hose, wherein the adapter tube holder fully or at least partially encloses the adapter tube and holds the end section of the fluid measuring hose, which end section is held by the adapter tube, in a predefined position relative to the patient-side connection piece, wherein the connection device is configured to establish a measuring fluid connection, comprising the fluid measuring hose, between a fluid measuring device and a predefined fluid sampling position, which fluid sampling position is located in an interior of the patient-side connection piece, and wherein a patient-side end of the adapter tube is located at the fluid sampling position.
2. A connection device in accordance with claim 1, wherein a distance occurs between the end section of the fluid measuring hose held by the adapter tube and the fluid sampling position, wherein the adapter tube bridges the distance, and wherein the measuring fluid connection further comprises the adapter tube.
3. A connection device in accordance with claim 1 wherein a patient-side end of the fluid measuring hose is located at the fluid sampling position in addition to the patient-side end of the adapter tube being located at the fluid sampling position.
4. A connection device in accordance with claim 1 wherein the adapter tube fluid-tightly encloses the held end section of the fluid measuring hose or the held end section of the fluid measuring hose fluid-tightly encloses the adapter tube.
5. A connection device in accordance with claim 1 wherein an end piece of the supply hose is fluid-tightly connected to the adapter tube holder.
6. A connection device in accordance with claim 1 wherein the adapter tube is arranged at least partially in the interior of the patient-side connection piece.
7. A connection device in accordance with claim 1, wherein the internal diameter of the adapter tube is increasable against a restoring force, and wherein the patient-side end section of the fluid measuring hose is clamped, based on the restoring force, in an interior of the adapter tube.
8. A connection device in accordance with claim 1 wherein the fluid sampling position is located in the interior of the patient-side connection piece and at a location spaced from a patient-side end of the patient-side connection piece.
9. A connection device in accordance with claim 1 wherein the patient-side connection piece has a central axis, which is parallel to a flow direction of fluid, wherein the fluid measuring hose is positioned such that a distance develops between the fluid measuring hose and the central axis of the patient-side connection piece, and wherein the adapter tube is in fluid communication with a connection tube, which is positioned at right angles or obliquely to the central axis of the patient-side connection piece.
10. A connection device in accordance with claim 9, wherein a distance occurs between the held end section of the fluid measuring hose and the fluid sampling position, wherein the fluid connection comprises the adapter tube and the perpendicularly or obliquely positioned connection tube in addition to the fluid measuring hose.
11. A connection device in accordance with claim 1, wherein the patient-side connection piece and the adapter are permanently or rigidly connected to one another.
12. A connection device in accordance with claim 1 wherein the adapter tube is permanently or rigidly connected to the patient-side end section of the fluid measuring hose.
13. A connection device in accordance with claim 1 wherein the fluid measuring hose passes through the interior of the supply hose.
14. A connection device in accordance with claim wherein the supply hose is configured as a multi-lumen supply hose, wherein the multi-lumen supply hose provides at least two lumina, which are fluid-tightly separated from one another, and wherein the fluid measuring hose passes through one of the lumina.
15. A system comprising: a patient-side coupling unit; and a connection device connected to the patient-side coupling unit, the connection device comprising: a supply hose connected to or connectable to a medical device; a patient-side connection piece connected to the supply hose, wherein the supply hose and the patient-side connection piece together are configured to establish at least one fluid connection between the medical device and the patient-side coupling unit; a flexible fluid measuring hose; an adapter comprising a rigid adapter tube and an adapter tube holder, wherein the patient-side connection piece holds the adapter tube holder, wherein the adapter tube holds a patient-side end section of the fluid measuring hose, wherein the adapter tube holder at least partially encloses the adapter tube and holds the end section of the fluid measuring hose, which end section is held by the adapter tube, in a predefined position relative to the patient-side connection piece, wherein the connection device is configured to establish a measuring fluid connection comprising the fluid measuring hose between a fluid measuring device and a predefined fluid sampling position, which fluid sampling position is located in an interior of the patient-side connection piece, and wherein a patient-side end of the adapter tube is located at the fluid sampling position.
16. A system according to claim 15, further comprising: a medical device; and a fluid measuring device wherein the fluid measuring device is in a data connection with the medical device at least from time to time, wherein the supply hose establishes at least one fluid connection between the medical device and a patient, and wherein the connection device establishes a measuring fluid connection comprising the fluid measuring hose between the fluid measuring device and a predefined fluid sampling position.
17. A process for manufacturing a connection device the process comprising the steps of: providing a connection device comprising: a supply hose connected to or connectable to a medical device; a patient-side connection piece connected to the supply hose, wherein the supply hose and the patient-side connection piece together are configured to establish at least one fluid connection between the medical device and the patient-side coupling unit; a flexible fluid measuring hose; an adapter comprising a rigid adapter tube and an adapter tube holder, wherein the patient-side connection piece is configured to hold the adapter tube holder, wherein the connection device is configured to establish a measuring fluid connection comprising the fluid measuring hose between a fluid measuring device and a predefined fluid sampling position, which is located in an interior of the patient-side connection piece, and wherein a patient-side end of the adapter tube is located at the fluid sampling position; pushing the fluid measuring hose into the supply hose such that a patient-side end section of the fluid measuring hose protrudes over the supply hose after the pushing in; moving the adapter relative to the supply hose such that the protruding patient-side end section of the fluid measuring hose is pushed into the adapter tube during the movement; connecting the adapter to the patient-side connection piece; and connecting the adapter to the supply hose wherein the adapter tube holder at least partially encloses the adapter tube and holds the end section of the fluid measuring hose, which end section is held by the adapter tube, in a predefined position relative to the patient-side connection piece.
18. A process in accordance with claim 17, wherein the fluid measuring hose passes through the interior of the supply hose.
19. A process in accordance with claim 18, wherein the supply hose is configured as a multi-lumen supply hose; wherein the multi-lumen supply hose provides at least two lumina, which are fluid-tightly separated from one another; and the fluid measuring hose passes through one of the lumina.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0058] In the drawings:
[0059]
[0060]
[0061]
[0062]
[0063]
[0064]
[0065]
[0066]
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[0070]
DESCRIPTION OF PREFERRED EMBODIMENTS
[0071] Referring to the drawings,
[0072] The present invention is used in the exemplary embodiment in a connection device, which connects a patient to a medical device or, more precisely, which establishes a fluid circuit between the patient and the medical device. In one configuration, the medical device comprises a ventilator. The ventilator controls especially the breathing phases of the patient and/or supports and/or stimulates his breathing. In another configuration, the medical device comprises an anesthesia apparatus, with which a patient can be anesthetized.
[0073] The connection device comprises [0074] a patient-side port, which is connected or can be connected to a patient-side coupling unit, which is not shown in
[0077] In one configuration, the connection device can be used several times. In another configuration, the entire connection device as well as the patient-side coupling unit are connected in advance into a system, and this system is transported in a suitable jacket to a location of use, it is removed from the jacket there, is connected to the patient-side coupling unit and to the medical device, it is used once to establish a fluid connection and is then disposed of.
[0078] A multi-lumen hose is defined as a hose that has at least two lumina over the entire length of the hose, wherein each lumen is separated from the other lumen or from each other lumen in a fluid-tight manner. Different fluid streams can flow as a result through the hose simultaneously, for example, in two different directions and/or such that the streams are formed by different fluids and/or at different flow rates. In particular, a ventilation circuit can be formed for a patient with a single supply hose if this is configured as a multi-lumen hose. The multi-lumen hose is configured in the exemplary embodiment as a coaxial hose. It is also possible that a membrane divides the hose along the entire length into at least two lumina, wherein each lumen adjoins from the inside an outer wall of the hose and adjoins the membrane.
[0079] The coaxial hose according to the exemplary embodiment comprises [0080] an inner hose, which forms an inner lumen, as well as [0081] an outer hose, which forms an outer lumen.
[0082] The outer hose fully encloses coaxially the inner hose in the exemplary embodiment. The inner hose with the inner lumen is used in the exemplary embodiment for the inhalation (breathing in), and the outer hose with the outer lumen is used for the exhalation (breathing out). It is also possible to use the two lumina the other way around or to use two parallel hoses. The two hoses are separated from one another in a fluid-tight manner.
[0083]
[0094] The Y-piece 2 is connected on one side both to the inner hose and to the outer hose and accommodates both the inner lumen L.e and the outer lumen L.a. On the other side, the Y-piece 2 connects both lumina L.e and L.a to a connection piece to the patient-side coupling unit. The designation Y-piece is therefore used. The pieces 8 and 9 on one side and 2 on the other side are connected to one another in a fluid-tight manner, the connection being permanent or detachable. The Y-piece 2 comprises in the exemplary embodiment a part 2.1 with a larger diameter, which is connected to the coaxial hose 3, and an axially adjoining part 2.2 with a smaller diameter, which is connected to the connection piece. For example, the tubular connection piece can be inserted into corresponding recesses of the smaller part 2.2. The Y-piece 2 belongs to the patient-side connection piece of the connection device in the exemplary embodiment.
[0095]
[0099] The connection piece 5 is connected to the Y-piece in a fluid-tight manner, the connection being permanent or detachable. This coaxial hose 3 is flexible and can be brought into nearly any desired shape. Furthermore, a mouthpiece 20, which belongs to the patient-side coupling unit, and a T-piece 7, which belongs to the device-side port, are shown.
[0100] While the patient P is being ventilated and/or anesthetized, a gas, which is in connection with the ventilation and/or anesthesia of the patient P, shall be tested. For example, the percentage of carbon dioxide or the concentration of an anesthetic in the air fed to the patient P and/or in the air exhaled by the patient P shall be tested. Similar external conditions shall be present during this testing over a rather long time period, especially in order to make it possible to reliably assess the current status of the patient P.
[0101]
[0105] A problem that may result in case of the use of a connection device with a gas measuring hose 6.1, 6.2, 6.3 results from a curvature, which is imposed to the gas measuring hose 6.1, 6.2, 6.3 by the manufacture and the transportation to a location of use. As a rule, a roll with a long hose is manufactured. A segment of this long, rolled-up hose is cut off and used as a gas measuring hose 6.1, 6.2, 6.3. The present invention makes it possible to maintain a gas measuring hose 6.1, 6.2, 6.3 with a course that is selected from these three possible courses despite the curvature imposed on it. The position at which gas to be tested enters into the gas measuring hose 6.1, 6.2, 6.3 relative to the Y-piece 2 remains unchanged thanks to the present invention despite the imposed curvature even if the connection device is being moved.
[0106] The T-piece 7 between the coaxial hose 3 and the medical device 1 makes it possible to pass a gas measuring hose 6.1, 6.2 with the course in the interior of the coaxial hose 3 out of the coaxial hose 3. Gas to be tested enters into the gas measuring hose 6.1, 6.2 at the patient-side end.
[0107] While the patient P is being ventilated and/or anesthetized, a flow of gas is flowing from the medical device 1 through the coaxial hose 3 to the patient-side port and back again. This gas flow is called rinsing flow or circulating flow and it prevents a backup of gas in the connection device and it preferably has a constant volume flow rate.
[0113] Two embodiments of the present invention will be described below with reference to
[0114]
[0115]
[0116] The adapter 10.1 according to the first configuration, which is shown in
[0120] In the embodiment shown, the tube 13.1 protrudes over both sleeves 12.1, 12.2 towards the Y-piece 2. It is also possible that the tube 13.1 closes flush with the sleeve 12.2 or ends in the interior of the sleeve 12.1 or 12.2. The adapter 10.1 is preferably configured such that the central axes of both sleeves 12.1 and 12.2 and of the tube 13.1 are identical.
[0121] The external diameter of the smaller sleeve 12.1 is equal to the internal diameter of the inner end piece 9 in one configuration. In another configuration, the external diameter of the sleeve 12.1 is somewhat larger than the internal diameter of the end piece 9, at least at the end that adjoins the sleeve 12.2. If the sleeve 12.1 is pushed into the end piece 9, the sleeve 12.1 is compressed, or the end piece 9 is expanded.
[0122] The inner sleeve 12.1 is accommodated by the inner end piece 9 in a fluid-tight manner in all embodiments. The external diameter of the larger sleeve 12.2 is equal to the internal diameter of the segment of the Y-piece 2, which segment points towards the hose 3, or it is somewhat larger, so that the second sleeve 12.2 is received by the Y-piece 2 in a fluid-tight manner. The external diameter of the second sleeve 12.2 is preferably approximately equal to the external diameter of the inner end piece 9, so that the second sleeve 12.2 closes in a fluid-tight manner with the inner end piece 9.
[0123] In one embodiment, the adapter 10.1 is permanently connected to the Y-piece 2. It is possible that the adapter 10.1 and the Y-piece 2 are made in one piece. It is even possible that the two components 10.1 and 2 have a monolithic configuration, i.e., they are manufactured during the manufacture in a single process step and from the same material.
[0124] It is also possible that the adapter 10.1 is detachably or non-detachably connected to the Y-piece 2. An already existing Y-piece 2 can be connected with a novel type of adapter 10.1 in this alternative embodiment. It is possible, but not necessary thanks to the advantageous configuration of the present invention, to modify the Y-piece 2.
[0125] In the embodiment that is shown in
[0126] The tube 13.1 preferably encloses a patient-side end section of the gas measuring hose 6.1 in a fluid-tight manner. It is also possible that the gas measuring hose is connected to the tube 13.1 in a fluid-tight manner without an overlap.
[0127] In a preferred embodiment, the gas measuring hose 6.1 is permanently or detachably connected to the tube 13.1, for example, by means of a clip connection. Thanks to the present invention, it is, however, likewise possible that the gas measuring hose 6.1 is only pushed into the tube 13.1 and is held detachably, e.g., by a suitable snap holder. Thanks to the detachable connection, it is easier to clean the connection device. Both configurations reliably prevent the gas measuring hose 6 from slipping out of the tube 13.1.
[0128] The connection device is preferably assembled as follows in both configurations: [0129] The gas measuring sleeve 6.1 is pushed from the device-side port through the inner lumen L.e towards the patient-side port until it protrudes to a sufficiently great extent over the inner end piece 9. [0130] The adapter 10.1 is pushed towards the gas measuring hose 6.1 from the other side. In one configuration, the adapter 10.1 with the Y-piece 2 is pushed towards the gas measuring hose 6.1. [0131] A part of the protruding end of the gas measuring hose 6 is preferably connected permanently or detachably to the adapter 10.1. [0132] The first sleeve 12.1 of the adapter 10.1 is pushed fully into the inner end piece 9 and is connected to this end piece 9 in one configuration. [0133] The gas measuring hose 6.1 is located now in the inner lumen L.e and is held by the tube 13.1 in the inhalation course as shown.
[0134] In one configuration, the adapter 10.1 can again be pulled out of the inner end piece 9, for example, in order to clean the connection device and to attach it again.
[0135] It is not necessary in the first embodiment for an end of the gas measuring hose 6.1 to be positioned in the desired position X, which is shown in
[0136] In the shown embodiment of the first configuration, the tube 13.1 tapers when viewed in a direction from the coaxial hose 3 towards the Y-piece 2. It is also possible that the tube 13.1 has the same diameter over the entire length or it tapers in the other direction, i.e., towards the coaxial hose 3. It is also possible that the tube 13.1 has a convex configuration and it clamps the patient-side end of the gas measuring hose 6 in a central area of the tube 13.1.
[0137]
[0138] In one embodiment, a segment 13.4 in the interior of the sleeve 12.1 and/or 12.2 protrudes over the connection tube 13.2, cf. top part of
[0139] The connection device with the adapter 10.2 can be assembled in exactly the same manner as the connection device with the adapter 10.1. The gas is taken again at position X, without it being necessary to move the gas measuring hose 6 itself to this position X. Gas to be tested rather flows from the measurement position X through the tube 13.1, it is deflected by the connection tube 13.2 and it then flows through the gas measuring hose 6.2 to the gas measuring device 4.
[0140]
[0141]
[0142] It is common to the three configurations of the first embodiment that the gas flows from position X through an inner hollow tube 13.1 and optionally through a connection tube 13.2, 13.3 to the gas measuring hose 6.1, 6.2, 6.3. The patient-side end of the tube 13.1 is always located in the measurement position.
[0143] The adapters 11.1, 11.2, 11.3 of the second embodiment comprise instead of an inner hollow tube 13.1 a tubular guide element 14.1, wherein the gas measuring hose 6.1, 6.2, 6.3 is led through the interior of this guide tube 14.1 up to the measurement position X. Identical parts have identical reference numbers. The patient-side end of the gas measuring hose 6.1, 6.2, 6.3 and preferably also the patient-side end of the guide tube 14.1 are consequently located in the measurement position X. A patient-side segment of the gas measuring hose 6.1, 6.2, 6.3 is connected to the interior of the guide tube 14.1, for example, by bonding or welding or clipping or by a snap holder. It is possible that the guide tube 14.1 comprises two half tubes connected to one another, which clamp between them a patient-side end of the gas measuring hose 6.1, 6.2, 6.3.
[0144] The second configuration makes it possible for the gas measuring hose 6.1, 6.2, 6.3 and the guide tube 14.1 to overlap over a longer section than the gas measuring hose 6.1, 6.2, 6.3 and the tube 13.1 of the first configuration. As a result, more space is available for a permanent or detachable connection. The guide tube 14.1 compensates a curvature imposed on the gas measuring hose 6.1, 6.2, 6.3.
[0145] The adapter 11.1 brings about an inhalation course of the gas measuring hose 6.1 (
[0146] The adapter 11.1 and the adapter 11.3 have a modified first sleeve with an interior space 15.1 tapering conically towards the patient-side end. The first sleeve may have exactly the same configuration as the first sleeve 12.1 of the adapter 10.1.
[0147] An opening 14.2 is prepared in the guide tube 14.1 of the adapter 11.2. The gas measuring hose 6.2 is passed through this opening 14.2 in order to bring about the exhalation course. A connection tube 13.2 may also be provided instead of the opening 14.2 just like in case of the adapter 10.2.
[0148] While specific embodiments of the invention have been shown and described in detail to illustrate the application of the principles of the invention, it will be understood that the invention may be embodied otherwise without departing from such principles.
LIST OF REFERENCE CHARACTERS
[0149] 1 Medical device, comprises in the exemplary embodiment a ventilator, which controls the breathing phases of the patient P and/or stimulates his breathing, and/or an anesthesia apparatus, which anesthetizes the patient P, as well as the gas measuring device 4 [0150] 2 Y-piece, connected to the end piece 9 and to the connection piece 5 in a fluid-tight manner, it accommodates the outer lumen L.a and the inner lumen L.e, is connected to the adapter 10.1, 10.2, 10.3, 11.1, 11.2, 11.3, receives the sleeve 12.2 [0151] 3 Coaxial hose, belongs to the connection device between the patient P and the medical device 1, comprises an inner hose and an outer hose [0152] 4 Gas measuring device for testing a gas, for example, for determining the carbon dioxide concentration in the breathing air or the concentration of anesthetic, it is in a data connection with the medical device 1 [0153] 5 L-shaped connection piece between the Y-piece 2 and the mouthpiece 20, belongs to the patient-side coupling unit [0154] 6.1 Gas measuring hose connects the testing device 4 to the Y-piece 2 with an inhalation course of the gas measuring hose in the inner lumen L.e [0155] 6.2 Gas measuring hose connects the testing device 4 to the Y-piece 2 with an exhalation course of the gas measuring hose in the outer lumen L.a [0156] 6.3 Gas measuring hose connects the testing device 4 to the Y-piece 2 with an external course of the gas measuring hose that extends outside the coaxial hose 3 [0157] 7 T-piece between the coaxial hose 3 and the medical device 1, belongs to the device-side port of the connection device [0158] 8 Rigid end piece of the outer hose of the coaxial hose 3 [0159] 9 Rigid end piece of the inner hose of the coaxial hose 3, it receives the sleeve 12.1 [0160] 10.1 Adapter according to the first configuration of the first embodiment, it comprises a first, smaller sleeve 10.1, a second, larger sleeve 10.2 and a coaxially arranged tube 13.1 in the interior of the two sleeves 10.1, 20.2, it brings about the inhalation course 6.1 [0161] 10.2 Adapter according to the second configuration of the first embodiment, it additionally comprises an obliquely arranged connection tube 13.2, brings about the exhalation course 6.2 [0162] 10.3 Adapter according to the second configuration of the first embodiment, it additionally comprises an obliquely arranged, longer connection tube 13.3, brings about the external course 6.3 [0163] 11.1 Adapter according to the first configuration of the second embodiment, it comprises the two sleeves 10.1, 10.2 and the guide tube 13.1, brings about the inhalation course 6.1 [0164] 11.2 Adapter according to the second configuration of the second embodiment, it brings about the exhalation course 6.2 [0165] 11.3 Adapter according to the second configuration of the second embodiment, it brings about the external course 6.3 [0166] 12.1 First, smaller sleeve, received by the end piece 9 [0167] 12.2 Second, larger sleeve, it adjoins the end piece 9 [0168] 13.1 Coaxially arranged tube, it holds the gas measuring hose 6 in the inner lumen L.e (inhalation course 6.1), has a patient-side end at the measurement position X [0169] 13.2 Obliquely or perpendicularly arranged, shorter connection tube, it holds the gas measuring hose 6 in the outer lumen L.a (inhalation course 6.2), inserted into the tube 13.1 [0170] 13.3 Obliquely or perpendicularly arranged, longer connection tube, it holds the gas measuring hose 6 in a position outside the coaxial hose 3 (external course 6.3), inserted into the tube 13.1 [0171] 13.4 Segment of the tube 13.1 behind the shorter connection tube 13.2 or behind the longer connection tube 13.3 [0172] 14.1 Tubular guide element, it holds the gas measuring hose 6 [0173] 14.2 Opening in the tubular guide element 14.1 [0174] 15.1 Conically tapering interior in the first sleeve 12.1 [0175] 20 Mouthpiece, it belongs to the patient-side coupling unit, can be connected to the connection piece [0176] d Distance between the measurement position X and the patient-side end of the gas measuring hose 6 (first embodiment only) [0177] EA Patient-side end section of the gas measuring hose 6, held by the adapter 10.1, 10.2, 10.3, 11.1, 11.2, 11.3 [0178] En Patient-side end of the Y-piece 2 [0179] L.a The outer lumen formed by the outer hose, the air stream S.a flows through it [0180] L.e The inner lumen formed by the inner hose, the air stream S.e flows through it [0181] M1, [0182] . . . , [0183] M4 Disadvantageous measurement positions [0184] P Patient [0185] S.a Air stream during exhalation (expiratory air stream), flows through the outer lumen L.a [0186] S.e Air stream during the inhalation (inspiratory air stream), flows through the inner lumen L.e [0187] Sp Rinsing flow in the coaxial hose 3 [0188] X Optimal measurement position; position of the patient-side tip of the tube 13.1 (first embodiment) or of the patient-side end of the gas measuring hose 6 (second embodiment)