APPARTUS FOR NEGATIVE PRESSURE TREATMENT AND INSTILLATION OF WOUNDS

Abstract

An apparatus for negative pressure treatment and instillation of wounds. The apparatus includes a dressing for covering a wound in a fluid-tight manner, a drain line for extracting fluid from the wound, a negative pressure unit for generating negative pressure in the drain line, an instillation line for providing an instillation fluid, an optional rinse line for providing a rinse fluid, and a main line connected to the dressing. The main line (60) has a single lumen and is connectable via a connection element (64) to two of the following lines, drain line (20), instillation line (40), and rinse line (50). Also, a method for operating this apparatus.

Claims

1. An apparatus for negative pressure treatment and instillation of wounds, comprising a dressing for covering a wound in a fluid-tight manner, a drain line for extracting fluid from a wound, a negative pressure unit for generating negative pressure in said drain line, an instillation line for providing an instillation fluid, a rinse line for providing a rinse fluid, a main line connected to said dressing, the main line comprising a single lumen and connectable via a connection element to two of the following lines, drain line, instillation line, and rinse line.

2. The apparatus according to claim 1, wherein the main line is connectable via the connection element either to the drain line and the instillation line (40) or to the instillation line and the rinse line.

3. The apparatus according to claim 2, wherein the main line is connectable via the connection element to the instillation line and the rinse line.

4. The apparatus according to claim 1, further comprising a pressure sensor for measuring the pressure in one or more of a group consisting of the drain line, the instillation line (40), the rinse line and the main line.

5. The apparatus according to claim 1, further comprising a valve that is arranged in the instillation line and prevents a backflow of fluid into the instillation line.

6. The apparatus according to claim 1, further comprising an instillation container connected to the instillation line for receiving an instillation fluid.

7. The apparatus according to claim 1, further comprising a valve that is arranged in the rinse line for preventing a backflow of fluid into the rinse line.

8. The apparatus according to claim 1, further comprising a ventilation valve arranged in the rinse line with which the fluid communication within the rinse line can be interrupted.

9. The apparatus according to claim 1, further comprising a pump arranged in the instillation line (40), the rinse line (50), or the main line for generating a fluid flow.

10. The apparatus according to claim 1, further comprising a unit for controlling the fluid flow through the main line so that either the instillation fluid or the rinse fluid is alternately passed through the main line.

11. The apparatus according to claim 1, further comprising a collection container connected to the drain line for receiving the fluid extracted from the wound.

12. The apparatus according to claim 1, further comprising a bypass line which establishes fluid communication between the rinse line and the negative pressure unit.

13. A method for operating an apparatus for negative pressure treatment and instillation of wounds, the apparatus including a dressing for covering a wound in a fluid-tight manner, a drain line for extracting fluid from said would, a negative pressure unit for generating negative pressure in said drain line, an instillation line for providing an instillation fluid, a rise line for providing a rinse fluid, a main line connected to said dressing, the main line comprising a single lumen and connectable via the connection element either to the drain line and the instillation line or to the instillation line and the rinse line, the rinse line and the main line being connectable via the connection element to the instillation line and the rinse line, the method comprising: a) filling the dressing with instillation fluid from the main line, b) passing a rinse fluid through the rinse line, the main line, the dressing and the drain line during simultaneous, continuous, or intermittent operation of said negative pressure unit.

14. The method according to claim 13, where step a) is preceded by: a1) building up negative pressure in the dressing (10) by operating the negative pressure unit, and a2) filling the instillation line and the main line with instillation fluid.

15. The method according to claim 13, where step b) is followed by: c) building up negative pressure in the dressing by operating the negative pressure unit, d) passing a rinse fluid through the rinse line, the main line, the dressing and the drain line.

16. The method according to claim 15, wherein: steps a) to d) are repeated several times, the fill quantity of instillation fluid in the dressing is determined when step a) is carried out for the first time, and in the further repetitions of step a) the dressing is filled with the previously determined fill quantity of instillation fluid.

Description

DESCRIPTION OF THE DRAWINGS

[0071] Preferred embodiments of the invention shall be described below with reference to the drawings which are only used for explanation purposes and are not to be interpreted as being restrictive, where, in the drawings:

[0072] FIG. 1 shows a schematic view of an apparatus according to the invention;

[0073] FIG. 2A shows a schematic view of a first alternative embodiment of the apparatus according to the invention;

[0074] FIG. 2B shows a schematic view of a second alternative embodiment of the apparatus according to the invention;

[0075] FIG. 3C shows a schematic view of a third alternative embodiment of the apparatus according to the invention;

[0076] FIG. 3 shows a schematic view of an alternative embodiment of the apparatus according to the invention and

[0077] FIG. 4A shows a schematic view of a further alternative embodiment of the apparatus according to the invention;

[0078] FIG. 4B shows a schematic view of yet a further alternative embodiment of the apparatus according to the invention.

[0079] FIG. 5 shows a schematic view of a variant of the apparatus according to the invention;

[0080] FIG. 6 shows a schematic view of a variant of the apparatus according to the invention.

DESCRIPTION OF PREFERRED EMBODIMENTS

[0081] The apparatus 1 shown in FIG. 1 comprises a dressing 10 for covering a wound. The dressing 10 typically comprises a flexible elastic plastic cover with which a wound can be covered in a fluid-tight manner, i.e. i.e. in a gas and liquid-tight manner, thus forming a wound space. The dressing 10 further comprises a wound cover, not shown in the drawing, which is arranged within the wound space.

[0082] The dressing 10 is connected via a port—not shown in the drawing—in a fluid-conducting manner to a drain line 20 and a main line 60. The port facilitates the connection and removal of the drain line 20 and the main line 60 to and from the dressing 10.

[0083] The drain line 20 opens with a second end of the line facing away from the dressing into the interior of a collection container 22. The collection container 22 is used to receive the fluid extracted from the wound. The fluid is extracted by negative pressure which is generated by a negative pressure unit 30 that is connected to the collection container in a fluid-conducting manner. The negative pressure unit is arranged within a housing 70.

[0084] In the embodiment shown in FIG. 1, the collection container 22 is attached to the housing 70. It can be designed as a disposable item and removed from the housing and disposed of together with the collected fluid once the maximum filling level has been reached. The collection container, however, can also be reusable in that it can be removed, cleaned and reattached to the housing. The collection container 22 is preferably attached to the housing 70 by way of a snap connection.

[0085] The drain line 20 is connected to the collection container 22 by way of a detachable port 24. Provided on the side of the port facing away from the collection container 22 is a drain valve 21 which blocks the fluid flow in the direction of the dressing, but allows fluid flow in the direction of the collection container.

[0086] The apparatus also comprises a housing 70 which accommodates the negative pressure unit 30. The negative pressure unit 30 is in fluid communication with the collection container 22 and can therefore generate a negative pressure in the collection container 22 which continues via the drain line 20 to the wound space. Arranged between the collection container 22 and the negative pressure unit 30 is a filter 26 which prevents microbial contamination of the collection container 22 or the negative pressure unit 30. A pressure sensor 25 is additionally arranged between filter 26 and negative pressure unit 30.

[0087] The negative pressure unit 30 is also in fluid communication with an outlet opening 31 on the outer side of the housing 70.

[0088] The main line 60 is connected to a connection element 64 which is preferably arranged within the housing. The connection element 64 is, for example, a T- or Y-shaped connection member with a total of three ports for the main line 60, the instillation line 40, and the rinse line 50. The connection element 64 can be arranged such that the port for the main line 60 is exposed on the outer side of the housing 70 and accessible from the outside. In this case, the main line can be detachably connected to the connection element 64 so that the main line 60 can easily be exchanged.

[0089] The drain line 20 and the main line 60 both run through a coupling 66. Between the coupling 66 and the dressing 10, the drain line 20 and the main line 60 together form a double-lumen tube connection. The coupling 66 allows for simple connection and removal of the double-lumen tube connection to or from the apparatus 1. The double-lumen tube connection forms an entity with the dressing 10. This entity can be designed as a disposable item that can be disposed of after use.

[0090] The connection element 64 is connected with the second of its ports to the instillation line 40. A valve 41 can be arranged in the instillation line 40 in order to prevent a backflow of instillation or rinse fluid into the instillation line 40. The valve can additionally have the function of preventing the instillation fluid from inadvertently passing through in the direction of the dressing 10. The instillation line 40 is connected to an instillation container 42 which is arranged outside the housing 70 in the apparatus shown in the drawing. A port 43 with which the instillation line 40 and the instillation container 42 can be connected to one another is arranged on the outer side of the housing 70. The port 43 is preferably detachable so that the instillation container 42 can be exchanged easily.

[0091] In the apparatus shown in the drawing, the instillation container 42 is a plastic bag or a plastic bottle arranged upside down and is attached above the housing 70 and above the dressing 10. In this manner, a fluid flow is generated by hydrostatic pressure.

[0092] It is also possible that the instillation container 42, similar to the collection container 22, is attached to the housing 70 such that it can be coupled thereonto. In this case, the tube connection between the port 43 and the instillation container 42 is omitted.

[0093] A peristaltic pump 62 which generates a fluid flow in the instillation fluid is arranged at the instillation line 40. The peristaltic pump 62 is controllable so that the fluid flow can be varied in the course of the treatment. Peristaltic pump 62 is arranged on the side of valve 41 facing away from connection element 64.

[0094] In the embodiment shown in the drawing, the peristaltic pump 62 is arranged within the housing 70. However, it is also possible to mount the peristaltic pump 62 on the outer side of the housing 70 or in or on the collection container 22, or to design it as a separate module.

[0095] The connection element 64 is connected with the third of its ports to the rinse line 50. A valve 51 can be arranged in the rinse line 50 in order to prevent a backflow of instillation or rinse fluid into the rinse line 50. The valve 51 is preferably a membrane which seals on contact with moisture. Arranged on the side of the valve 51 facing away from the connection element 64 is a pressure sensor with which the negative pressure in the rinse line 50, the main line 60 connected thereto, and the wound space can be measured. Arranged on the side of the pressure sensor 54 facing away from the connection element 64 is a ventilation valve 52 that can open or interrupt the fluid communication through the rinse line 50. The rinse line 50 is in fluid communication with the ambient air via a port 58. The rinse line 50 and the main line 60 connected thereto can be ventilated in this way. The port 58 comprises a filter element for preventing contamination of the rinse line 50 with microorganisms from the ambient air.

[0096] The rinse line 50 is in fluid communication via a bypass line 80 with the negative pressure unit 30 and the fluid collection container 22 connected thereto. The bypass line 80 can be opened or closed by way of a bypass valve 82. Direct ventilation of the negative pressure unit 30 and the fluid collection container 22 is also possible in this manner. The valve 21 prevents simultaneous ventilation of the drain line 20 and the wound space. The negative pressure unit 30 and the collection container 22 can be ventilated while negative pressure is simultaneously applied in the wound space.

[0097] FIGS. 2A to 2C show different variants of the apparatus according to the invention in a schematic view. Like the embodiment described above, the embodiments according to these variants comprise a housing 70 which accommodates a negative pressure unit (not shown in the drawings). The negative pressure unit is in fluid communication with a collection container 22. The collection container 22 is connected to the dressing 10 via the drain line 20. The dressing 10 is connected to an instillation line 40 and a rinse line 50 via the main line 60 and a connection element 64. The rinse line 50 respectively opens into the housing 70.

[0098] In these variants, the dressing 10 has a single port to which both the drain line 20 and the main line 60 are connected.

[0099] Unlike the embodiment previously shown, the peristaltic pump 62 in this variant is arranged outside the housing 70 and forms a separate module of the apparatus. This module can be configured, for example, like in US 2019/0275219 A1.

[0100] The variants each differ in the arrangement of the connection element 64. According to FIGS. 2A and 2B, the connection element 64 is arranged between the housing 70, the collection container 22, and the peristaltic pump 62. According to FIG. 2A, both the instillation line 40 and the rinse line 50 run outside the collection container 22. According to FIG. 2B, the rinse line 50 runs through the collection container 22. In the variant according to FIG. 2C, the connection element 64 is arranged within the collection container 22 so that the rinse line 50 and the instillation line run within the collection container 22, at least in sections.

[0101] FIG. 3 shows a further variant of the apparatus according to the invention in a schematic view. This variant corresponds to the embodiment according to FIG. 2B, but here the dressing 10 has two separate ports for the drain line 20 and the main line 60, respectively.

[0102] FIGS. 4A and 4B show further variants of the apparatus according to the invention in a schematic view. In these variants, the housing 70 accommodates both the peristaltic pump (not shown in the drawings) as well as the negative pressure unit. In contrast to the variants shown above, the connection element 64 is additionally arranged within the housing 70. The two variants in this respect correspond to the embodiment according to FIG. 1. The difference between the two variants arises from the fact that the main line according to FIG. 4A runs through the collection container 22, whereas according to FIG. 4B it runs outside the collection container 22.

[0103] FIG. 5 shows a further variant of the apparatus according to the invention. This variant corresponds to the embodiment shown in FIG. 1 apart from the following differences. Unlike in the embodiment shown in FIG. 1, the connection element 64 in FIG. 5 is connected to the instillation line 40 and the drain line 20. As a result, the instillation line 40 and the drain line 20 are jointly connected to the single-lumen main line 60. In this way, both the instillation fluid and the wound secretion are extracted from the wound through the lumen of the main line 60 The connection element preferably has a device with which a fluid connection to the drain line 20 or to the instillation line 40 can alternately be established and the fluid connection to the respective other line can be interrupted.

[0104] In this embodiment, the rinse line 50 forms a separate line which is led to the dressing 10 separately from the drain line 20 and the instillation line 40.

[0105] In this embodiment, the pressure is measured by the pressure sensor 54 arranged in the rinse line 50 and/or the pressure sensor 25 arranged in the fluid connection between the collection container 22 and the negative pressure unit 30.

[0106] In one section, the rinse line 50 and the main line 60 form a double-lumen tube connection. This section extends between the coupling 66 and the dressing 10.

[0107] FIG. 6 shows a further variant of the apparatus according to the invention. This variant is similar to the variant according to FIG. 5, except for the fact that the apparatus according to FIG. 6 comprises no rinse line. Like in FIG. 5, however, the apparatus comprises a drain line 20 and an instillation line 40, both of which are connected to the connection element 64 and via the latter to the main line 60. In this way, both the instillation fluid and the wound secretion are extracted from the wound through the lumen of the main line 60 In this embodiment, the dressing 10 is connected to only a single line, the main line 60.

[0108] In this embodiment, the pressure is measured by the pressure sensor 25 arranged in the fluid connection between the collection container 22 and the negative pressure unit 30.

LIST OF REFERENCE NUMERALS

[0109] 1 apparatus [0110] 10 dressing [0111] 20 drain line [0112] 21 drain valve [0113] 22 collection container [0114] 24 port [0115] 25 pressure sensor [0116] 26 filter [0117] 30 negative pressure unit [0118] 31 outlet opening [0119] 40 instillation line [0120] 41 valve [0121] 42 instillation container [0122] 43 port [0123] 50 rinse line [0124] 51 valve [0125] 52 ventilation valve [0126] 54 pressure sensor [0127] 56 ventilation device [0128] 58 filter [0129] 60 main line [0130] 62 pump [0131] 64 connection element [0132] 66 coupling [0133] 70 housing [0134] 80 bypass line [0135] 82 bypass valve