This application claims priority to International Application Serial No. PCT/CH2008/000465 filed Nov. 4, 2008, which claims priority to Swiss Patent Application No. 01734/07 filed Nov. 8, 2007, the contents of which are incorporated by reference herein in their entirety.
The invention relates to a test unit for wound drainage dressings.
It is known to treat large or poorly healing wounds using a vacuum drainage device. WO 94/20041, for example, describes this. A cover, for example a film or a stiff cap, is placed over the wound, such that a wound space is obtained. A drainage tube is inserted into the wound space from the outside and is connected to a suction pump in order to suck wound secretions out of the wound. In order to fill the wound space and, in particular, to distribute the vacuum uniformly across the surface of the wound, a wound dressing is placed on the wound. This wound dressing is usually composed of a foam insert with suitably configured pores. This foam insert can at the same time serve as an absorption body for the wound secretions.
Corresponding wound drainage dressings are known, for example, from WO 2006/056294, U.S. Pat. No. 7,070,584, EP 1 284 777 and EP 0 620 720. A wound drainage dressing with a foam insert outside the airtight top layer is described in WO 2006/052839. Wound drainage dressings of more complicated configuration are disclosed, for example, in WO 03/086232 and US 2002/0065494.
Many suggestions have therefore been made as to how wound drainage dressings of this kind could be configured. However, it is difficult to establish which wound drainage dressing is best used on which wound and with which suction pressure.
It is therefore an object of the invention to make available a device which permits uniform testing and optimized use of wound drainage dressings under conditions as close as possible to those encountered in practice.
The test unit according to the invention for wound drainage dressings comprises:
The cavity and the channels simulate the wound. The cavity substantially simulates the wound bed, and the channels the pores in the wound floor.
Wound liquids of different compositions can be introduced into the simulated wound via the at least one supply line. It is possible to choose whether the wound liquid is supplied continuously, at predetermined time intervals or just once. The support surface permits easy and quick application of wound drainage dressings that are to be tested. These wound drainage dressings can be covered by an air-permeable, self-adhesive film, which is affixed to the support surface. However, they can also be used in the test unit along with the specific covers recommended by the manufacturer, for example rigid caps. In this case, the cap is simply affixed to the support surface, for example by means of an airtight, self-adhesive film.
The main body of the test unit preferably has a plane-parallel base plate, a supply plate and, arranged between these, a sealing plate, said supply plate having the channels and at least one recess for forming the cavity. The main body therefore has a relatively simple structure and can be produced inexpensively. It is also easy to clean, since the channels and the recess are easily accessible when the main body has been unscrewed.
Another advantage of the main body in this configuration is that several supply plates can be used with the same base plate and intermediate plate. In this way, the test unit is able to simulate a wide variety of sizes and arrangements of cavities and channels.
The test system according to the invention for wound drainage dressings has a test unit of this kind It further comprises at least one liquid reservoir, which is able to be connected to the at least one supply line, and a drainage container, which is able to be connected to the support surface via a vacuum line and a vacuum attachment.
The test system can be operated with a wide variety of suction pumps, in order also to take account of the effect of these suction pumps in the wound drainage. However, it is preferably used with a pump that comprises control and evaluation electronics or that can be connected to these. In this way, it is possible to control and document the degree of the applied vacuum, the duration of the applied vacuum, optionally any pressure changes or pulse sequences, and the supplied liquid. Of course, the volumetric flow and the flow rate of the suctioned drainage liquid are also measured and recorded and, if appropriate, additionally processed in the evaluation electronics.
The test unit according to the invention permits, among others, the following measurement possibilities:
The test unit according to the invention and the test system thus permit uniform testing of known wound drainage dressings. They permit more optimized use of these wound drainage dressings. Moreover, they are an important aid in the development of new wound drainage dressings and covers and also in the development of new suction pumps and new methods of wound drainage.
Other advantageous embodiments are set forth in the dependent claims.
The subject matter of the invention is explained below on the basis of preferred illustrative embodiments and with reference to the attached drawings, in which:
a shows a view of the test unit in a first application;
b shows a graph of the measured volumetric values of the first application;
a shows a view of the test unit in a second application;
b shows a graph of the measured volumetric values of the second application;
a shows a view of the test unit in a third application;
b shows a graph of the measured volumetric values of the third application;
a shows a view of the test unit in a fourth application;
b shows a graph of the measured volumetric values of the fourth application;
c shows a graph of the volumetric values measured when using different wound covers;
d shows a graph of the volumetric values measured when using different wound liquids;
e shows a graph of the volumetric values measured when using different vacuums;
f shows a graph of the volumetric values measured when using different vacuums;
a shows a view of the test unit in a fifth application;
b shows a graph of the measured volumetric values of the fifth application;
a shows a view of the test unit in a sixth application;
b shows a graph of the measured volumetric values of the sixth application;
a shows a view of the test unit in a seventh application;
b shows a graph of the measured volumetric values of the seventh application;
a shows a view of the test unit in an eighth application;
b shows a graph of the measured volumetric values of the eighth application;
a shows a view of the test unit in a first arrangement of the wound cover;
b shows a view of the test unit in a second arrangement of the wound cover;
c shows a view of the test unit in a third arrangement of the wound cover;
d shows a graph of the volumetric values measured according to the three arrangements in
a shows a view of the test unit with a suction bar in a first form;
b shows a view of the test unit with a suction bar in a second form;
c shows a view of the test unit with a suction bar in a third form, and
d shows a graph of the volumetric values measured according to the three arrangements in
The main body 1 is also connected to a liquid reservoir system 8 via a connecting line system 7, which has at least one connecting line 70, 71, 72, 73. This liquid reservoir system 8 has at least one liquid reservoir 80, 81, 82, 83. The reservoirs 80, 81, 82, 83 preferably have a level indicator, as can be seen in
The main body 1 has (see
The main body 1 of the test unit is shown in more detail in
The sealing plate 11 is likewise preferably plane-parallel and has through-openings. Connecting screws 14 are guided through these openings in order to screw the base plate 12 to the supply plate 10 in an airtight and liquid-tight manner. For this purpose, threaded holes are provided in the supply plate 10, or threaded bushings 16 are let into the supply plate 10 flush with the lower surface thereof.
The base plate 12 preferably stands on feet 13, which likewise can be screwed, for example, to the base plate 12 via fastening screws 15.
The base plate 12 preferably has no elevations or depressions other than those for connection to feet 13 and to supply plate 10, nor does it have any inner bores or channels. The supply plate 10 is preferably also plane-parallel and has the same shape and surface area as the base plate 12. Both preferably comprise a generally rectangular shape. However, the supply plate 10 has recesses and bores.
As can be seen from
According to the invention, the supply plate 10 has recesses which are closed at the top toward the support surface 100, except for the channels described below, and are open at the bottom toward the sealing plate 11 and base plate 12. These recesses are closed by the sealing plate 11 and the base plate 12 to form cavities 182, 185, 192, 195 completely separate from one another. They can have a wide variety of shapes. In the example shown here, a first cavity 182 and second cavity 185 have a constant rectangular longitudinal section and are adjacent to each other but spaced apart from each other. They here have the same surface area and preferably also the same depth, such that they have the same volume. A third cavity 192 and fourth cavity 195 are each designed so as to be spaced apart from and partially frame one of the first and second cavities 182, 185, respectively. For this purpose, they have a C-shaped longitudinal section, which is again preferably constant. They too preferably have the same volume. However, these cavities can also have other shapes and volumes. It is also possible for more or fewer than these four cavities to the present. They can together have a geometric pattern or have another arrangement in the supply plate 10. Moreover, they can have different depths in relation to the support surface 100 inside the supply plate 10.
These recesses are open toward the outside via the abovementioned supply lines 181, 184, 191, 194. These supply lines 181, 184, 191, 194 are also formed in the supply plate 10 by grooves that are open at the bottom and that merge into closed tubes only in the end-face edge area. These grooves are tightly closed off by virtue of the sealing plate 11 and the base plate 12, except for the supply openings 17. Since no cavities have to be formed and no bores have to be established, the production of the supply plate is made easier and it is also easier to clean.
These supply lines 181, 184, 191, 194 can be of the same length or of different lengths. They preferably extend parallel to the support surface 100, such that the supply of liquid takes place parallel to the surface of the wound dressing. Each supply line preferably leads to a respective cavity and each supply line to a respective supply opening. However, they can also branch and serve several cavities, or a cavity can have several supply lines. All the supply lines preferably have the same internal diameter. However, they can also have different diameters.
From the cavities 182, 185, 192, 195, capillaries or channels 183, 186, 193, 196 lead outward to the support surface 100. Each cavity has several such channels. The channels of the same cavity can have the same internal diameter or different internal diameters. Similarly, channels of different cavities can have the same diameter or different diameters. They preferably extend in a direction perpendicular to the support surface 100, although they can also extend at an angle thereto. The channels of a cavity preferably form, on the support surface, a geometric pattern, and the latter can be differently configured for each cavity. The channels are preferably distributed as uniformly as possible across the surface area or at least over an area of the respective cavity.
The cavities preferably have a volume of 2 cm3 to 4 cm3. The channels are preferably 3 mm to 8 mm long and have an internal diameter of preferably 1 mm to 1.5 mm. The supply lines preferably have an internal diameter of 2 mm to 4 mm.
In a preferred embodiment, the test unit is heatable, such that the temperatures of the patient can be simulated.
By virtue of this test unit and this test system, it is now possible to test drainage applications. Thus, different test liquids can be introduced in a targeted manner from the liquid reservoirs into individual cavities. These test liquids can simulate wound liquids or treatment liquids.
Different wound dressings can be placed on the support surface and can be covered with different wound covers. Moreover, differently designed vacuum attachments (drains) can be used, which can also be arranged at different locations in relation to the wound dressing and to the filled cavities. By virtue of cavities of different shapes and different sizes, it is possible to simulate different types of wound bed. Moreover, the behavior of the same wound dressings, wound covers and drains can be tested with different suction pumps, different vacuums, suction sequences and different drainage duration.
Such applications are shown in the figures described below. These are to be understood only as examples and are not exhaustive:
a shows a vacuum attachment (drain) 2 in the form of a rectangular bar which has a plurality of suction openings distributed uniformly along the length thereof and which is arranged over a rectangular wound dressing D. This wound dressing D covers the entire channel area of the support surface 100. The same wound liquid is supplied to the four cavities in succession via all of the supply openings, here designated as E1, E2, I1 and 12. In this example, no further liquid is supplied during the suction procedure. In other examples, however, this would be possible. Each individual supply is subjected to a vacuum and the flow behavior is measured. For all four cavities in succession, the same suction sequence is used (i.e., among other things, duration, degree of vacuum, possible variations in the pressure during the suction procedure).
b shows the measured values. The y-axis shows the time, the x-axis shows the volume converted during the suction. This volume is preferably measured in the drainage container. As can be seen, therefore, the distance at which the drain 2 is arranged from the suctioned cavity has an important role.
The same procedure was followed in
The measured values were again plotted in
The same procedure was again followed in the example according to
In the example according to
Thus, in the measurement shown in
a and 10b show an experiment in which three drains 2 arranged at different sites were used in succession, but always the same cavity.
In
Differently configured drains 2 are used in
As will be seen from these examples, wound drainage applications can be tested in a wide variety of ways by simple and inexpensive means.
Number | Date | Country | Kind |
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1734/07 | Nov 2007 | CH | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/CH2008/000465 | 11/4/2008 | WO | 00 | 5/6/2010 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2009/059444 | 5/14/2009 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
6182956 | McMillan | Feb 2001 | B1 |
7070584 | Johnson et al. | Jul 2006 | B2 |
20020065494 | Lockwood et al. | May 2002 | A1 |
20080077091 | Mulligan | Mar 2008 | A1 |
Number | Date | Country |
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29520960 | Jul 1996 | DE |
0117351 | Sep 1984 | EP |
0620720 | Oct 1994 | EP |
1284777 | Feb 2003 | EP |
2305610 | Apr 1997 | GB |
2416909 | Feb 2006 | GB |
2442132 | Mar 2008 | GB |
2007-103609 | Apr 2007 | JP |
1698904 | Dec 1991 | SU |
9420041 | Sep 1994 | WO |
0061333 | Oct 2000 | WO |
03086282 | Oct 2003 | WO |
2005099644 | Oct 2005 | WO |
2006046060 | May 2006 | WO |
2006052839 | May 2006 | WO |
2006056294 | Jun 2006 | WO |
Entry |
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International Search Report for corresponding International Application No. PCT/CH2008/000465, dated Aug. 17, 2009. |
Swiss Search Report for corresponding Swiss Patent Application No. 1734/07, dated Jul. 3, 2008. |
International Preliminary Report on Patentability and Written Opinion for corresponding PCT Application No. PCT/CH2008/000465, dated Jun. 10, 2010. |
Number | Date | Country | |
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20100268197 A1 | Oct 2010 | US |