U.S. patent application number 12/096264 was filed with the patent office on 2008-12-11 for wound treatment device with elastically deformable vacuum-generating element.
Invention is credited to Birgit Riesinger.
Application Number | 20080306456 12/096264 |
Document ID | / |
Family ID | 36371881 |
Filed Date | 2008-12-11 |
United States Patent
Application |
20080306456 |
Kind Code |
A1 |
Riesinger; Birgit |
December 11, 2008 |
Wound Treatment Device with Elastically Deformable
Vacuum-Generating Element
Abstract
The invention relates to a wound treatment device (100) with at
least one elastically deformable vacuum-generating element which
can be actuated directly by hand and which is arranged on and
connected directly to a film-like wound-covering element (2) that
covers the wound chamber (1). The vacuum-generating element is a
hollow body (4.1) whose cavity (7), in the state with the device
applied to the patient's body, communicates directly with the wound
chamber (1) via an opening (3) formed on the wound-covering element
(2). At least one absorption body (5) that absorbs the wound
secretions is positioned in the wound chamber (1) and is surrounded
by a finely porous sleeve (6) that is permeable to liquid. The
hollow body (4.1) is provided with at least one valve (12).
Inventors: |
Riesinger; Birgit;
(Ostbevern, DE) |
Correspondence
Address: |
RANKIN, HILL & CLARK LLP
38210 Glenn Avenue
WILLOUGHBY
OH
44094-7808
US
|
Family ID: |
36371881 |
Appl. No.: |
12/096264 |
Filed: |
December 14, 2006 |
PCT Filed: |
December 14, 2006 |
PCT NO: |
PCT/EP06/12041 |
371 Date: |
July 31, 2008 |
Current U.S.
Class: |
604/316 ;
604/543 |
Current CPC
Class: |
A61F 13/0209 20130101;
A61F 2013/0054 20130101; A61B 90/05 20160201; A61M 1/009 20140204;
A61M 1/08 20130101; A61F 2013/00165 20130101; A61F 13/00068
20130101; A61F 2013/00536 20130101; A61F 13/0203 20130101; A61F
2013/00557 20130101; A61M 1/0088 20130101; A61M 1/0072 20140204;
A61M 1/0003 20130101; A61M 2205/075 20130101; A61M 1/0011 20130101;
A61M 1/0009 20130101 |
Class at
Publication: |
604/316 ;
604/543 |
International
Class: |
A61M 1/00 20060101
A61M001/00 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 14, 2005 |
DE |
20 2005 019 670.3 |
Claims
1. A wound treatment device having at least one elastically
deformable vacuum producing element, which can be operated directly
by hand, arranged on a film-like wound cover element, which is
adapted to cover a wound cavity in a patient's body, and which is
adapted to be connected to the patient's body tubelessly, wherein
the vacuum producing element is a hollow body having a cavity that
is adapted to communicate with the wound cavity via an opening
worked into the wound cover element when the wound cover element is
placed on the patient's body, and wherein the wound treatment
device further comprises at least one absorption body that is
adapted to be placed in the wound cavity to absorb wound
secretions, the absorption body being surrounded by a fine-pore,
liquid-permeable envelope.
2. The wound treatment device according to claim 1, wherein the
hollow body is in the shape of a bell or tray.
3. The wound treatment device according to claim 1, wherein the
hollow body is in the shape of a bellows.
4. The wound treatment device according to claim 1, wherein the
hollow body has the shape of a ball or a pear.
5. The wound treatment device according to claim 1, wherein the
hollow body has a collar, which is joined to the wound cover
element.
6. The wound treatment device according to claim 1, wherein the
hollow body is designed as a single piece with the wound cover
element.
7. The wound treatment device according to claim 1, wherein the
hollow body is supported against a cushion ring.
8. The wound treatment device according to claim 1, wherein the
cushion ring is elastic.
9. The wound treatment device according to claim 1, wherein the
wound treatment device is provided with at least one valve.
10. The wound treatment device according to claim 9, wherein the
valve is arranged on the hollow body.
11. The wound treatment device according to claim 9, wherein the
valve is a one-way valve.
12. The wound treatment device according to claim 1, wherein the
absorption body is sheetlike in a nonswollen condition.
13. The wound treatment device according to claim 1, wherein the
absorption body has a shape other than sheetlike in a nonswollen
condition.
14. The wound treatment device according to claim 1, wherein the
absorption body is interspersed with superabsorbing particles.
15. The wound treatment device according to claim 14, wherein the
envelope has pores whose size does not greatly exceed that of the
superabsorbing particles.
16. The wound treatment device according to claim 1, wherein the
absorption body is a textile.
17. The wound treatment device according to claim 1, wherein the
absorption body consists of or contains alginate fibers.
18. The wound treatment device according to claim 1, wherein the
absorption body is spongelike.
19. The wound treatment device according to claim 1, wherein the
absorption body is gel-like.
20. The wound treatment device according to claim 1, wherein the
absorption body and/or the envelope is enriched with metallic
nanoparticles.
21. The wound treatment device according to claim 1, wherein the
opening of the wound cover element is covered by a window, wherein
the hollow body is arranged on the window, and wherein the window
can be removed or swiveled away from the wound cover element.
22. The wound treatment device according to claim 1, wherein the
hollow body is provided with a bottom element, and wherein an
opening is provided in the bottom element.
23. The wound treatment device according to claim 1, wherein the
absorption body contains carboxymethylcellulose.
24. The wound treatment device according to claim 1, wherein the
absorption body is enriched with natural hyaluronic acid.
25. The wound treatment device according to claim 1, wherein the
absorption body contains an addition of synthetic high-molecular
hyaluronic acid substrate(s).
26. The wound treatment device according to claim 1, wherein the
absorption body contains honey and/or its derivatives and/or
propolis.
27. The wound treatment device according to claim 1, wherein the
absorption body contains pharmaceutically active plant additives.
Description
[0001] The invention concerns a wound treatment device with at
least one elastically deformable vacuum producing element, which
can be operated directly by hand, being arranged on a film-like
wound cover element, covering the particular wound cavity, and
being connected to the latter tubelessly.
[0002] A wound treatment device of the above mentioned kind is
found in DE 198 44 355 A1. The vacuum producing element shown in
FIG. 2 is glued directly to the wound cover film. The vacuum
producing element is a bell-shaped hollow body, filled with a
precompressed sponge, which swells up during the suction process
only when a water-soluble plate located between the sponge and the
wound surface dissolves. The precompressed sponge also presses
against the entire inner surface of the hollow body. The
compression and subsequent expanding of the sponge in the direction
of the wound can also occur without a water-soluble plate if the
sponge is compressed only when the bandage is put in place and the
sponge is accommodated in the hollow body. The drawback in both
instances is that the compressed sponge upon expanding presses
against the sensitive wound surface.
[0003] The problem of the invention is to design an improved wound
treatment device with vacuum producing element, integrated with the
wound cover film, wherein the precompressed filling can be done
away with.
[0004] This problem is solved by a wound treatment device of this
kind, wherein [0005] the vacuum producing element is a hollow body,
whose cavity in the condition placed on the patient's body is in
direct contact with the wound cavity via an opening worked into the
wound cover element, [0006] at least one absorption body to absorb
the wound secretions is placed in the wound cavity, being
surrounded by a fine-pore, liquid-permeable envelope.
[0007] The aim is to achieve a new kind of wound treatment device,
in which the wound exudate is taken up by the absorption body,
while at the same time the suction function is supported by a
simplified vacuum system which can be activated by hand. The
absorption body can be a sheetlike shape, whose final volume
increases greatly in the course of the absorption process, without
exerting a noteworthy pressure on the wound surface. However, if a
pressure is to be exerted on the wound, one can at least resort to
an additional absorption body, encased or not, which can be placed
directly on the wound surface, i.e., underneath the mentioned flat
absorption body. The additional absorption body can also take on
the function of a trapping layer for the coarse, clumplike
secretions. The absorption body can be placed dry or slightly
premoistened on the wound surface.
[0008] The additional absorption body can be a perforated pouch
containing absorbent particles, a shaped piece of foam plastic or
fleece, possible with superabsorbent particles. Superabsorbing foam
plastic beads can be poured into the pouch.
[0009] The encased absorption body can be one which is interspersed
with superabsorbents. The envelope can have pores whose size does
not greatly exceed that of the superabsorbing particles. In this
way, the wound secretions sucked up remain inside the envelope
until the absorption body is removed from the wound and help
improve the climate of the wound space, i.e., maintain the moist
surroundings. The wound exudate does not necessarily have to be
taken away through an additional conduit, unless there is an excess
of wound exudate.
[0010] The absorption body can be made from various medically safe
materials, such as open-cell foam plastic, gel or textile.
Preferably, it consists of at least one layer of a fleecelike
textile material containing cellulose and having superabsorbent
particles, which is easy to work and make ready. The absorption
body can consist of or contain alginate fibers. It is expressly
pointed out that the absorption body (or bodies) placed in the
wound cavity or in the cavity of the hollow body is (are) not
precompressed.
[0011] Finally, the shaped absorbing piece or the pouch with
absorber particles contained therein can be placed directly on the
wound, without having to use the mentioned encased sheetlike
absorption body.
[0012] In order to kill germs, the encased absorption body and/or
the additional absorption body of fleece or foam plastic or an
antiadhesive film element which can be placed directly on the wound
can be provided with substances containing silver or copper, for
example, in nanocrystalline form. As the antiadhesive film element,
one can use a perforated so-called wound spacer grid, which is
arranged between the wound surface and the absorption body.
Substances containing zinc are also possible, and can support the
wound healing process.
[0013] Furthermore, the absorption body can contain
carboxymethylcellulose, natural or synthetic hyaluronic acid, honey
and/or its derivatives, propolis and/or pharmaceutically active
plant extracts, such as Aloe vera.
[0014] The compressible hollow body can have any desired external
shape, provided that it is connected tubelessly to the wound cover
element and sits stable thereupon. The hollow body can have the
shape of a prism, such as a cuboid. Preferably, the hollow body is
configured as an elastically deformable solid of revolution, such
as one made of elastomer. The hollow solid of revolution can be
spherical, cylindrical or conical, but it can also have the shape
of a pear or oval cylinder. An especially advantageous
configuration of the hollow body is a cuboidal or somewhat
cylindrical bellows, which can be deformed essentially only in one
direction, say, perpendicular to the emplaced would cover
element.
[0015] Preferably, the hollow body is joined to a circumferential
flat collar, which can be joined to the wound cover element
directly or via a cushion ring. The cushion ring can have a flat to
round or toroidal cross section. The task of the cushion ring is to
gently transfer the pressure on the hollow body when pressed by
hand against the patient's skin and to distribute it evenly. The
cushion ring can be made from any desired deformable and especially
elastomeric material, such as rubber or plastic.
[0016] The hollow body can also be designed as a single piece with
the wound cover element. This can be the case, in particular, for
the smaller sizes of wound cover element. A single-piece
configuration can furthermore pertain to a product which is
assembled from the hollow body, the wound cover element, and the
encased absorption body. Here, "single-piece" refers to a one-part
design, e.g., a molded piece.
[0017] The wound treatment device can be provided with at least one
window arranged on the wound cover element and able to be removed
or swiveled, on which the mentioned hollow body sits. In this case,
the wound cover element has at least one recess to accommodate the
window.
[0018] A vacuum indicator can be connected or connectable to the
valve, by which the patient himself or the doctor can read off the
vacuum level and change it if necessary by activating the hollow
body or the valve. The vacuum indicator can be part of an external
pump. The vacuum producing element itself, i.e., the hollow body,
can take on the supplemental function of a vacuum indicator if it
is appropriately scaled. For example, the vacuum indicator can be a
scaled glass tube with piston, connected directly to the valve.
[0019] With the wound treatment device according to the invention,
the following kinds of wounds can be treated: [0020] mechanical
wounds such as cuts and puncture injuries, bite wounds, gunshot
wounds, abrasions; [0021] iatrogenic wounds; [0022] thermal wounds,
such as burns; [0023] chemical wounds, such as acid or alkali
burns; [0024] open wounds; [0025] perforating wounds and
others.
[0026] Some additional selected usage possibilities are listed
below: [0027] as a dressing to treat an edematous or inflammatory
altered wound region; [0028] as a dressing to treat a microbially
laden wound surface, by using the suction force to take germs or
cell fragments with enclosed, dehydrated or [missing words?] into
anaerobic regions of the swollen absorption body; [0029] as a
dressing to remove inflammatory cytokins, matrix metalloproteases,
TIMPs, degraded fibronectin (holds the tissue together) or other
substances causing chronicity; [0030] as a dressing to regulate the
air humidity, since the absorption body releases the aqueous
components back into the air through their vapor pressure; [0031]
as a dressing on top of a primary applied wound spacer grid or a
gauze as a secondary dressing having no immediate sheetlike contact
with the wound; [0032] as a dressing beneath a film permeable to
water vapor to achieve a breathable dressing; [0033] as a dressing
during a compression therapy; [0034] as a dressing during a maggot
therapy promoting epithelial cell migration and granulation, in
which the larvae of Lucilia sericata are used; this involves, in
particular, acute and chronic wound infections. Instead of larvae,
a substance secreted by the maggots can be used, namely, their
saliva.
[0035] The benefits of the invention consist, in particular, in
that: [0036] thanks to the use of the encased absorption body, the
moist environment within the wound cavity can be maintained, [0037]
the absorption process can be supported by the air evacuation,
[0038] the air evacuation can be done by the patient; it is enough
to exert a pressure by hand or finger on the bellows or the ball of
the hollow body; [0039] the absorption body can serve as a
storeroom for the wound exudate; the liquids need not be carried
away from the wound region; instead, they can be gathered close to
the wound; [0040] the time and the costs of the wound treatment can
be reduced.
[0041] Sample embodiments of the invention are explained more
closely hereafter by means of the drawing. The figures show:
[0042] FIG. 1, a wound treatment device with a bell-shaped hollow
body, glued onto the skin of the patient, in a schematic
representation;
[0043] FIG. 2, the wound treatment device per FIG. 1 in a
perspective view;
[0044] FIG. 3, the wound treatment device per FIG. 1 with a
thickening arranged in its apex region, in a schematic
representation;
[0045] FIG. 4, the wound treatment device per FIG. 1 in use;
[0046] FIG. 5, the wound treatment device per FIG. 1 in a top view
of the wound cover element;
[0047] FIG. 6, the wound treatment device per FIG. 1, with a
cushion ring, in a schematic representation;
[0048] FIG. 7, the cushion ring in top view of its flat side;
[0049] FIG. 8, a cross section A-A per FIG. 7;
[0050] FIG. 9a, a second embodiment of the bell-shaped hollow body,
with inward pointing projections, in a schematic view;
[0051] FIG. 9b, the hollow body per FIG. 9a with swollen absorption
body;
[0052] FIG. 10a to 10c, a further, single-piece embodiment of the
wound treatment device, likewise in a schematic representation;
[0053] FIG. 11a to 12, a fourth, bellows-like embodiment of the
wound treatment device, in a schematic representation;
[0054] FIG. 13, a wound treatment device with a cuboidal,
bellows-like hollow body, in a perspective view;
[0055] FIG. 14, the wound treatment device per FIG. 11, with a
cushion ring, in a schematic representation; in a schematic
representation;
[0056] FIG. 15, a wound treatment device with a ball-shaped hollow
body, in a schematic representation; and
[0057] FIG. 16, a hollow body with bottom plate element, likewise
in a schematic representation.
[0058] FIGS. 1 and 2 show a first embodiment (reference number 100)
of the wound treatment device, consisting of a film-like wound
cover element 2, a bell-shaped hollow body 4.1 and an absorption
body 5. The hollow body 4.1 is made as a molded piece of
polyethylene in the deep drawing process. The wall thickness of the
translucent hollow body is 0.8 mm. The spherical molded piece
passes into a peripheral flat collar 14, which is glued onto the
wound cover element 2 by means of a medically safe adhesive. The
wall of the hollow body bounds a cavity 7, which is in direct
contact with a wound cavity 1 via an opening 3 made in the wound
cover element 2. The wound cavity 1 is defined by a wound surface,
designated as 24, and the wound cover element 2.
[0059] The hollow body 4.1 is provided with a oneway valve 12,
which allows the flow through of air and--if necessary--excess
wound secretions, if the hollow body is connected via an
additionally provided conduit 19 to a corresponding mechanical or
electrical suction device (not shown), in one direction (arrow R).
Thus, a return flow from the outside is prevented. Even so, another
oneway valve 13 (see FIG. 2) can be provided, with which the
pressure inside the hollow body and thus in the wound cavity 1 can
be regulated. Medications can be dispensed via a conduit 23,
indicated by broken line.
[0060] FIGS. 1, 3 and 4 shows the wound treatment device 100 in
use. First, the opening 3 on the filmlike wound cover element 2 is
cut out according to the wound size and the wound cover element 2
is glued onto the skin of the patient. The absorption body 5 is
laid flat in the wound cavity 1 underneath the wound cover element
2 and only then is the hollow body 4.1 installed with its flat
collar 14. FIGS. 1 and 3 show this condition. The absorption body 5
is surrounded by a perforated envelope 6, whose dimensions (width
and length, or diameter) are much larger than those of the
absorption body. In the present case, the absorption body 5 is
around 5.5 cm.times.5.5 cm in plan view on its flat side and the
envelope is around 7.0 cm.times.7.0 cm in size.
[0061] According to FIG. 3, the hollow body 4.1 has a thickening 17
in the region of its apex 18, which can facilitate the deformation
of the hollow body when pressing on it by hand, as shown in FIG.
4.
[0062] The embodiment per FIG. 5 calls for arranging the hollow
body 4.1 on a round window 15, which can swivel via a film hinge
20. The window 15 is coated peripherally on its underside with a
release glue 21, so that it can be opened and glued back again as
needed, for example, in order to take out the swollen absorption
body. A pull flap 11 facilitates the handling of the window.
[0063] The hollow body 4.1, as shown in FIG. 6, can be braced
against a cushion ring 8 by its flat collar 14. The cushion ring 8
(see FIGS. 7 and 8) is made from an elastomeric material, which
allows the pressing forces exerted by hand to be distributed over
its entire surface. It is beneficial that the cushion ring 8 can
increase the effective volume of the cavity 7 of the hollow body
4.1.
[0064] FIGS. 9a and 9b show a similar embodiment (designated 200)
of the wound treatment device, in which several spacers 22 are
provided on the inside of the hollow body 4.2. A perforated pouch
10 with a somewhat lens-shaped absorption body 9 contained therein
is laid in the wound cavity 1. When the absorption body 9 swells to
its maximum volume (see FIG. 9b), the spacers 22 prevent the
absorption body 9 from taking up the entire cavity 7, since some
free spaces 16 remain between the envelope 6 and the inner surface
of the hollow body 4.2, making it possible to dispense liquid
medications via the conduit 23 (see FIG. 2) even before removal of
the absorption body 9.
[0065] Optionally, the absorption bodies 5, 9 can contain a
quantity of nanoparticles of silver, copper or zinc, which are
useful as antibacterial agents.
[0066] FIG. 16 shows a hollow body whose ball-shaped, compressible
part 29 passes into a platelike bottom element 28, on which is
arranged an opening 27, situated in the middle, and making contact
with the wound cavity 1 (not shown). The bottom element 28 makes
possible a uniform distribution of pressure when exerting pressing
force by hand.
[0067] FIGS. 10a, 10b and 10c show a one-piece wound treatment
device 300, consisting of a hollow body 4.1 or 4.2 with a film
segment of the wound cover element, an absorption body 5 glued to
this, and a removable, peripherally arranged, ring shaped
protective film 25. The collar 14 of the hollow body 4.1 is firmly
glued or welded to the wound cover element. Before putting the
wound cover element in place, the protective film 25 is pulled off,
so that a glue layer 26 located on the underside of the wound cover
element is exposed (see FIG. 10b) and the device can be glued onto
the patient's skin all around the wound (see FIG. 10c). The wound
treatment device 300 is designed as a prefabricated disposable
product, which can be made in various sizes.
[0068] FIGS. 11a, 11b and 12 show a wound treatment device 400,
which is basically similar to that shown in FIG. 5, with the
difference that its hollow body 4.3 has the shape of a cylindrical
bellows, which can be deformed basically only in one direction,
corresponding to a pressing force designated as P (see FIG. 11b).
The bellows can be compressed very easily by hand or by finger.
FIG. 12 shows, in turn, the bellows-like hollow body 4.3 in two
positions. The hollow body 4.3 can be swiveled through a very wide
angle a by the film hinge 20.
[0069] The embodiment of FIG. 13 is a wound treatment device 500
having a film-like rectangular window 15, on which a cuboidal
hollow body 4.4 is arranged. The design principle of the wound
treatment device 500 is identical to that of the wound treatment
device 400.
[0070] As FIG. 14 shows, the two hollow bodies 4.3, 4.4 can
likewise be braced against the cushion ring 8 by their flat collar
14. Preferably, the bellows of the hollow body is configured such
that its portion extending from the flat collar 14 has smaller
dimensions (diameter or width) than those of the compressible part.
This configuration makes it possible to shove the finger of the
hand underneath the upper, compressible part and press the bellows
with the thumb, without having to exert pressure on the wound cover
element 2.
[0071] Finally, FIG. 15 shows a wound treatment device 600 whose
hollow body 4.5, provided with the flat collar 14, is roughly pear
shaped. The oneway valve 12 can be seen in the apex region.
[0072] All wound treatment devices 100 to 600 described, and their
parts, come in sterile packaging.
LIST OF REFERENCE SYMBOLS
[0073] 1 wound cavity [0074] 2 wound cover element [0075] 3 opening
[0076] 4.1 to 4.5 hollow body [0077] 5 absorption body [0078] 6
envelope [0079] 7 cavity [0080] 8 cushion ring [0081] 9 absorption
body [0082] 10 pouch [0083] 11 pull flap [0084] 12; 13 oneway valve
[0085] 14 flat collar [0086] 15 window [0087] 16 space [0088] 17
thickening [0089] 18 apex [0090] 19 conduit (additional) [0091] 20
hinge [0092] 21 release glue [0093] 22 spacer [0094] 23 oneway
valve [0095] 24 wound surface [0096] 25 protective film [0097] 26
glue layer [0098] 27 bottom element [0099] 28 opening [0100] 29
part [0101] .alpha. angle [0102] P pressing force [0103] R
direction [0104] 100; 200; 300 wound treatment device [0105] 400;
500; 600
* * * * *