U.S. patent application number 14/382971 was filed with the patent office on 2015-02-12 for wound care arrangement and covering unit therefor.
The applicant listed for this patent is LOHMANN & RAUSCHER GMBH. Invention is credited to Federico Danei, Peter Grillitsch, Sonja Kainz, Erik Steinlechner.
Application Number | 20150045752 14/382971 |
Document ID | / |
Family ID | 47827132 |
Filed Date | 2015-02-12 |
United States Patent
Application |
20150045752 |
Kind Code |
A1 |
Grillitsch; Peter ; et
al. |
February 12, 2015 |
WOUND CARE ARRANGEMENT AND COVERING UNIT THEREFOR
Abstract
The invention relates to a wound care arrangement comprising a
covering unit that can be fixed on the skin surrounding a wound and
that serves for producing a closed wound space comprising the
wound, and a suction connection via which a vacuum can be produced
in the wound space, wherein the covering unit is permeable to water
vapor at least in sections.
Inventors: |
Grillitsch; Peter; (Wien,
AT) ; Danei; Federico; (Wien, AT) ;
Steinlechner; Erik; (Baden, AT) ; Kainz; Sonja;
(Wien, AT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
LOHMANN & RAUSCHER GMBH |
SCHONAU/TRIESTING |
|
AT |
|
|
Family ID: |
47827132 |
Appl. No.: |
14/382971 |
Filed: |
March 5, 2013 |
PCT Filed: |
March 5, 2013 |
PCT NO: |
PCT/EP2013/000636 |
371 Date: |
September 4, 2014 |
Current U.S.
Class: |
604/319 |
Current CPC
Class: |
A61M 1/0092 20140204;
A61M 1/0088 20130101; A61M 2205/3344 20130101; A61F 13/00068
20130101; A61M 2205/7536 20130101; A61F 13/0216 20130101; A61F
2013/00263 20130101 |
Class at
Publication: |
604/319 |
International
Class: |
A61F 13/02 20060101
A61F013/02 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 5, 2012 |
EP |
12002332.0 |
Claims
1. Wound care arrangement having a covering unit that can be
attached to the skin surrounding a wound and used for producing an
enclosed wound space comprising the wound, and a suction connection
across which a negative pressure can be generated in the wound
space, characterized in that the covering unit is water vapor
permeable, at least in sections.
2. Wound care arrangement according to claim 1, characterized in
the water vapor permeability of the covering unit is, at least in
sections, more than 300 g/m2/24 h or more, in particular 500
g/m2/24 h or more, particularly preferred 750 g/m2/24 h.
3. Wound care arrangement according to claim 1 or 2, characterized
in that the water vapor permeability of the covering unit is less
than 10,000 g/m2/24 h, in particular less than 5,000 g/m2/24 h.
particularly preferred 3,000 g/m2/24 h or less.
4. Wound care arrangement according to one of the preceding claims,
characterized in that the covering unit comprises a preferably
transparent cover film having a thickness of 0.5 .mu.m to 200
.mu.m, in particular 1 .mu.m to 100 .mu.m.
5. Wound care arrangement according to one of the preceding claims,
characterized in that the elongation at rupture of the covering
unit is 100% or more.
6. Wound care arrangement according to one of the preceding claims,
characterized in that the static friction coefficient of the
covering unit is between 0.8 and 1.5 (ASTM 1894-08).
7. Wound care arrangement according to one of the preceding claims,
characterized in that the static friction coefficient of the
covering unit is between 0.7 und 1.2 (ASTM 1894-08).
8. Wound care arrangement according to one of the preceding claims,
characterized in that the covering unit comprises a polyurethane
polymer, in particular an aromatic polyurethane polymer.
9. Wound care arrangement according to one of the preceding claims,
characterized by a filler material for filling the wound space
placed between the wound base and the covering unit, preferably, on
the side of the suction connection facing the filler material, a
drainage layer being provided for introduction of the exudate to be
removed by aspiration from the filler material into at least one
aspiration orifice of the suction connection.
10. Wound care arrangement according to one of the preceding
claims, characterized in that the covering unit is associated with
an adhering fastening means for the adhesive attachment of the
covering unit to the skin surrounding the wound.
11. Wound care arrangement according to claim 10, characterized in
that the fastening means comprises a separate adhesive film, in
particular a polyurethane film, by means of which the wound
covering can be attached after application to the wound with
respect to the skin surrounding the wound.
12. Wound care arrangement according to one of the preceding
claims, characterized in that the covering unit comprises a film
tube, into which a human extremity can be introduced.
13. Wound care arrangement according to claim 12, characterized in
that for forming a truncated arrangement, one axial end of the film
tube is closed, in particular hermetically.
14. Wound care arrangement according to one of the preceding
claims, characterized in that the covering unit is associated with
a support arrangement, in particular supporting film, which is
detachable from the wound after application to it.
15. Wound care arrangement according to one of the preceding
claims, characterized in that the suction connection has an
aspiration orifice facing the wound space during use and a
connecting device preferably designed as a tube stub for producing
a connection between the aspiration orifice and an aspiration
tube.
16. Wound care arrangement according to claim 15, characterized in
that the aspiration orifice penetrates a flanged contact area of
the suction connection and the contact area has, preferably
surrounding the aspiration orifice and preferably equipped with an
adhesive means, a fastening area, by means of which the suction
connection can be glued to a boundary area of the covering unit
facing away from the wound space.
17. Wound care arrangement according to one of the claims 12 to 16,
characterized in that the film tube is completely closed in the
peripheral direction and preferably after application to the wound,
is cut open, in order to obtain a perforation associated with the
aspiration orifice, the perforation preferably being surrounded by
the fastening area of the suction connection during use.
18. Covering unit for use in a wound care arrangement according one
of the preceding claims, characterized by a water vapor permeable
polyurethane film having water vapor permeability of preferably
3000 g/m2/24 h.
Description
[0001] The invention relates to a wound care arrangement having a
covering unit that is attachable to the skin surrounding a wound
and used for producing an enclosed wound space comprising the wound
and a suction connection, across which a negative pressure can be
generated in the wound space, as well as a covering unit for such a
wound care arrangement.
[0002] Such wound care arrangements are particularly used within
the scope of the so-called vacuum therapy. It has been found that,
in particular, the healing of chronic wounds can be promoted by
applying negative pressure to these wounds. For this purpose, it
has furthermore been proven to be advantageous if the wound is
covered or filled by an open-cell foam or gauze as filler material,
for generating an enclosed wound space comprising the wound and, as
the case may be, the filler material, is covered, and on the side
of the covering unit, facing away from the wound or the filler
material, a suction connection is installed, across which the wound
space can be connected to a suction device designed for generating
a negative pressure. In other arrangements, a flange of the suction
connection is covered by the covering unit or taken up in a pocket
surrounding an opening of the cover. The suction connection may,
for instance, be equipped with a tube connectable, on the one hand,
to a connecting device of the suction connection designed for
example in the form of a tube stub and, on the other hand, to a
suction device. The covering unit may, for instance, be embodied as
a film-like material that is hermetically applied to the skin area
adjacent to the wound.
[0003] Wound care arrangements which are usable within the scope of
vacuum therapy are, for instance, described in EP 0620 720 B1. The
disclosure content of this document is hereby incorporated into the
specification herein by express reference with respect to the
details of the foaming means and the suction device usable within
the scope of the vacuum therapy.
[0004] DE 10 2009 019 646 A1 describes a contact layer for
improving the exudate management to be inserted between the filler
material and the wound base and forms a drainage chamber between
the filler material and the wound base. The disclosure content of
this document is expressly incorporated into the specification
herein with respect to the details of the contact layer or wound
cover forming the drainage chamber.
[0005] Suction connections usable within the scope of vacuum
therapy and connectable, via a tube, to a suction device, are, for
instance, described in WO 03/073970 A1, in 2008/014358 A2 and in WO
2009/124548 A1. A suction connection, called suction head, having
projections used for flow control in the area of the boundary area
of the suction connection facing the wound is described in EP 1 018
967 B1. Furthermore, a suction connection having a contact surface
to be applied to the filler material, in the form of a disc-like
shell, is specified in EP 1 088 569 B1. In the case of a suction
connection described in WO 2010/008167 A2, on the boundary area
facing the filler material, channels delimited by ridges are formed
that are intended for moving the wound exudate in the direction of
an aspiration opening.
[0006] WO 2010/011148 A1 describes a wound care arrangement which
can be used within the scope of vacuum therapy and has an
impermeable tube which can be pulled over an extremity of the human
body as well as a perforated body to be arranged between the wound
and the tube. Using the perforated body, between the impermeable
tube and the wound base, a space is created in which, via a suction
connection that can be hermetically applied to the impermeable
tube, a negative pressure can be generated. EP 1 162 932 81
describes a wound care arrangement having an envelope of a plastic
material and a fluid absorbing material contained in the envelope.
The wound care arrangement described in this document is intended
for the protection of wounds. Because it is lacking a tube
connection, it is not suitable for use in vacuum therapy. In
previously unpublished European patent application having the
filing number 11001737.3, a wound care arrangement according to the
Preamble of claim 1 is described. The disclosure content of this
application is incorporated by express reference into the
specification herein as far as the characteristics of the suction
connection are concerned. When using conventional wound care
arrangements, in many cases excessive drying out and sometimes also
wound maceration are observed during vacuum therapy.
[0007] In view of these problems in the prior art, the object of
the invention is based on providing a wound care arrangement, by
means of which, using vacuum therapy, the healing of wounds can be
reliably promoted.
[0008] According to the invention, this objective is achieved by an
enhancement of the prior art wound care arrangements, being
essentially characterized in that the covering unit is water vapor
permeable, at least in sections.
[0009] This invention is based on the consideration that the
requirements to be established as a principle for a wound cover for
vacuum therapy, according to which it is necessary to create a
hermetic and watertight wound space which is additionally intended
to also be germ-proof, biocompatible and eudermic, is not unduly
affected if, accepting impairment of the seal, the covering unit is
designed permeable to water vapor. The water vapor permeability
allows, on the one hand, excessive drying out of the wound as a
result of moisture being transported from the environment into the
wound space, on the other hand, however, also allows maceration of
the wound by removal of excessive moisture by the cover. By using a
water vapor permeable covering unit, it is possible to establish a
healing promoting environment in the wound area or wound space. In
addition, as a result of the water vapor permeability of the wound
cover, any potential impairment of the skin surrounding the wound
to which the covering unit is applied, is also reduced.
[0010] The desired adjustment of the environment in the wound space
can be implemented in a particularly reliable manner, if the water
vapor permeability of the covering unit, at least in sections, is
300 g/m.sup.2/24 h or more, particularly 500 g/m.sup.2/24 h,
particularly preferred 750 g/m.sup.2/24 h.
[0011] In order to avoid excessive drying out of the wound, the
water vapor permeability of the covering unit is expediently less
than 10,000 g/m.sup.2/24 h, particularly less than 5,000
g/m.sup.2/24 h, particularly preferred 3,000 g/m.sup.2/24 h or
less. The water vapor permeability data refer to measurements
according to DIN EN ISO 13726-2.
[0012] If the wound is in the area of a joint, it will also be
necessary to assure that the covering unit is sufficiently
deformable. This can be assured if the covering unit is provided
with a resilient cover film having a thickness of 0.5 .mu.m to 200
.mu.m, in particular 1 to 100 .mu.m. In the interest of wound
observation without removal of its wound care arrangement, it has
proven to be advantageous if a transparent cover film is used. In a
particularly preferred embodiment of the invention, the covering
unit comprises a polyurethane polymer, particularly an aromatic
polyurethane polymer.
[0013] As already explained above related to prior art wound care
arrangements, it has proven to be advantageous if a filler material
designed for filling the wound between the wound base and the
covering unit is provided, preferably, on the suction connection
side facing the filler material, a drainage layer for introducing
the exudate to be aspirated from the filler material in at least
one aspiration orifice of the suction connection being provided. If
such a suction connection is provided, neither channel forming
projections are required on the suction connection boundary area
facing the filler material nor any expansion of the suction surface
in the form of a disc-like shell. Rather, it is sufficient if the
boundary area of the aspiration connection facing the filler
material is designed flanged and plane and is penetrated by the
suction opening, because the introduction of the wound exudate from
the filler material is not caused by any special quality of the
connection, but by the drainage layer arranged between the
connection and the filler material. If the suction connection
contact surface to be applied to the drainage layer is designed
plane, i.e. without any projections, whether in the form of ridges
delimiting channels or in the form of annular projections, as with
the disc-like shells according to EP 1 088 569 B1, the impression
of protruding structures into the drainage layer is prevented and,
as a result, reliable functioning of the drainage layer is
assured.
[0014] At this point, supplementally, it is also noteworthy that
the use of water vapor permeable covering units can not only be
used for creating a desired environment in the wound space, but
also for minimizing stress on the skin surrounding the wound,
because damage to the skin, as observed with impermeable covering
units, can be ruled out.
[0015] The covering unit of a wound care arrangement according to
the invention is intended to be attachable to the skin surrounding
the wound. For this purpose, the covering unit per se may be
equipped with an adhesive coating. The application of the covering
unit according to the invention is, however, simplified if the
covering unit, in the form of an uncoated, as the case may be,
tubular cover film, is associated with a separate adhesive film, in
particular an adhering polyurethane film, by means of which, after
application to the wound, the wound covering can be attached to the
skin surrounding the wound. The adhesive film may be provided in
the form of a film ribbon. Within the scope of the invention, in
particular, the Applicant's adhesive film offered and sold under
the trade name Suprasorb F can be used as adhesive film. Related
thereto, it is also noteworthy that the water vapor permeability of
the covering unit is substantially affected by an adhesive coating.
It may be reduced to less than one third of the uncoated covering
unit.
[0016] The wound care arrangement according to the invention is
particularly advantageous and suitable for the treatment of wounds
on extremities, such as foot, ankle, lower leg, arm, hand. For this
purpose, the covering unit may have a water vapor permeable film
tube, into which this extremity can be introduced. The tubular
covering unit is pulled over the extremity and, with respect to the
wound, is positioned in such a way that the wound is covered and
sealed by the covering unit. Subsequently, the covering unit can be
attached to the skin adjacent to the wound using the adhesive film.
For this purpose, the adhesive film is pulled off a reel and wound
on one end of the tube in such a way that, on the one hand, it
adheres to the tube and, on the other hand, to the skin.
[0017] The application of the covering unit can be simplified if
one axial end of the film tube is closed, particularly
hermetically, to form a stocking-like arrangement. This can be done
by welding (ultrasonic, heat, RF) or by gluing (for example using a
polyurethane adhesive, hot melt adhesives and/or adhesive tape). In
that case, the covering unit need only be sealed on one side by an
adhesive film bandage.
[0018] In the interest of simple application of the covering unit,
expediently, it has a sliding friction coefficient in the range
between 0.7 and 1.2, measured according to ASTM 1894-08. In this
respect, sufficient stability of the covering unit can be achieved
if the static friction coefficient is between 0.8 and 1.5,
particularly preferred between 1 and 1.25, measured according to
ASTM 1894-08. In this respect, furthermore, it has been found to be
expedient if the elongation at rupture of the covering unit is more
than 100%.
[0019] The application of the covering unit to the extremity
bearing the wound can be further simplified if, after application
to the wound, the often only very thin covering unit is provided
with a support arrangement that is detachable from the wound, in
particular a support film. The support film with which the covering
unit may be provided, as the case may be, may be produced of
transparent polyester or of a multilayer material (e.g. polyester
core, bilaterally polyethylene coated) and be attached to the
film-like covering unit by a lamination process. After introduction
of the extremity affected by the wound into the covering unit and
before sealing by adhesive film bandages, the support film must be
detached, in order to assure a successful therapy process.
[0020] The suction connection of a wound care arrangement according
to the invention has an aspiration orifice which faces the wound
space during use and, preferably designed as a tube stub, a
connecting device for establishing a connection between the
aspiration orifice and an aspiration tube, the tube stub being
arranged on the side of the suction connection facing away from the
wound space. In this arrangement, the aspiration orifice may
penetrate a flanged contact area of the suction connection, the
contact area having a fastening area that preferably surrounds the
aspiration orifice and preferably provided with an adhesive means,
by means of which the suction connection can be glued to a boundary
area of the covering unit facing away from the wound space.
Alternatively the contact area may also, at least partially, be
covered by the covering unit.
[0021] The film tube of a wound care arrangement according to the
invention may have a prepared perforation for establishing a
connection between the aspiration tube to be connected to the tube
stub and the wound space. However, this complicates the application
of the covering unit in a proper position in the area of the wound.
For this reason, within the scope of the invention, it is
particularly preferred if the film tube is completely closed in the
circumferential direction and has only at least one axial opening,
through which the extremity can be introduced into the tube, the
perforation in the film tube associated with the aspiration orifice
not being produced until after application to the wound, (and) for
this purpose, the film tube can, for example, be cut open and in
use, the perforation expediently surrounded by the fastening area
of the suction connection.
[0022] Hereinafter, suction connections usable particularly
advantageously within the scope of the invention are explained in
detail.
[0023] In accordance with a particularly simple application of
wound care arrangements according to the invention, it has proven
to be expedient if the drainage layer to be provided, as the case
may be, is attached to the contact surface, in particular glued, to
the contact surface, welded, clamped and/or sewn to the contact
surface. The overall arrangement, consisting of suction connection
and drainage layer, can then be positioned as a whole at the
desired location on the filler material or the covering unit.
[0024] As explained above related to the covering unit designed
according to the invention, it has been found that during the
vacuum therapy, air introduction into the wound area, continuously
taking place simultaneous with the generation of negative pressure,
further improves the healing process. A wound care arrangement
according to a particularly preferred embodiment of the invention,
therefore, has a suction connection which has, in addition to an
aspiration orifice used for suctioning off the exudate, an aeration
orifice arranged in particular in the flanged contact area of the
suction connection and used for aeration of the wound. Continuous
introduction of air into the wound area, made possible by the
aeration orifice, causes a controlled and continuous pressure drop
during connection of a suction device to the aspiration orifice. As
a result, in particular associated with the use of a water vapor
permeable covering unit, the removal of the exudate can be further
improved. The pump used for suctioning off the exudate then
generates a greater through-flow and an improved suction effect. It
is activated more frequently and suctions off more.
[0025] For avoiding contamination of the wound, the aeration
orifice is expediently associated with an antibacterial filter
which may be arranged in the aeration opening or cover the aeration
orifice. The filter is expediently hydrophobic and for obtaining
the desired filtering action, has a pore size of 0.001 .mu.m, in
particular 0.005 .mu.m, preferably 0.02 .mu.m, particularly
preferred 0.1 .mu.m to 5 .mu.m. With a pore size of less than 0.001
.mu.m, the desired aeration is impaired. With a pore size of more
than 5 .mu.m, it is almost impossible to attain the antibacterial
effect. The filter material may, in particular, contain
polytetrafluoroethylene. The choice of the filter pore size also
affects the air through-flow in the wound area, pore size reduction
causing a reduction of the introduced air.
[0026] As an addition or an alternative to the aeration orifice,
the wound care arrangement may also include, facing the aspiration
orifice, a multilumen tube which may, in particular, comprise three
lumens, only one of which is used for the suctioning of the
exudate, another one for the controlled air supply and a third one
for measuring the pressure directly at the wound. By using the
multilumen tube, the suction action can be improved without causing
the suction connection to need any structural modifications. The
suction effect, is, however, even further improved by using an
additional aeration orifice. Further enhancement is achievable if
the tube stub used as connecting device has a lumen number
corresponding to the multilumen tube.
[0027] In the interest of optimal wound care without removing a
wound care arrangement according to the invention, it has been
proven to be expedient if, in addition to the aspiration orifice,
the suction connection additionally has, designed for supplying a
wound care product and preferably perforating the contact area, a
feed port which has, associated to it, in a particularly preferred
embodiment of the invention, on the side facing away from the
contact area, an additional connecting device, such as perhaps an
additional tube stub, for establishing a connection between the
feed port and a feed tube. Via the feel port, a rinse, as the case
may be including medications, disinfectants and similar, may for
example be introduced into the wound area. Like the aspiration
orifice, the feed port may also be covered by the drainage layer.
Within the scope of the invention, it is, however, particularly
preferred if this opening is not covered by the drainage layer, in
order to improve the diffusion of the rinse into the wound
area.
[0028] For further enhancement of the exudate management, the wound
care arrangement according to the invention may have a contact
layer causing wound side drainage, arranged between the wound base
and the filler material.
[0029] Within the scope of the invention, it has been found to be
particularly advantageous if the drainage layer and/or the contact
layer, in accordance with the wound covers according to DE 10 2009
019 646 A1, has two ribbon-like elements running approximately
parallel to each other, between which a drainage chamber is formed,
the depth of which in a downward direction extending approximately
perpendicular to the ribbon-like elements, assures a capillary
effect being exerted on the exudates taken up into the drainage
chamber. For this purpose, the depth of the drainage chamber may be
5 mm or less and 0.5 mm or more. In this arrangement, each of the
ribbon-like elements expediently has an opening allowing passage of
body fluid into the drainage chamber, at least one opening being
embodied by a channel that extends, originating from one of the
ribbon-like elements, in the direction of the inner boundary area
of the other ribbon-like element situated opposite and ending in
the drainage chamber, its channel wall being designed in one piece
with the ribbon-like element, in particular by perforation of the
ribbon-like element.
[0030] In the interest of a particularly pronounced capillary
action, it has proven to be advantageous if the cross-sectional
area of the channel in a plane extending perpendicular to the
downward direction, starting at the ribbon-like element, in the
direction of the other boundary area situated opposite, is reduced,
in particular for obtaining a capillary action promoting the entry
of body fluid into the drainage chamber. In this arrangement, at
least one ribbon-like element may comprise a plurality of openings,
preferably arranged grid-like, the distance between adjacent
openings being 15 mm or less, preferably 5 mm or less, particularly
3 mm or less, the mouths of the openings which are arranged in a
ribbon-like element being arranged in a projection along the
downward direction between the mouths of the openings arranged in
the other ribbon-like element arranged in a longitudinal
projection, at least one channel extending in the downward
direction across 50% or more of the total depth of the drainage
chamber.
[0031] The channel wall of the channels forming the opening, in an
intersecting plane extending parallel to the downward direction, is
designed arched, at least in sections, and continuously turns into
the boundary area of the ribbon-like element. Additional
characteristics of contact and/or drainage layers usable according
to the invention are provided in DE 10 2009 019 646 A1, the
disclosure content of which is hereby incorporated into the
specification herein by express reference.
[0032] If the drainage layer only partially covers the contact
surface of the suction connection, preferably covering at least the
suction opening and the filter, and a fastening area surrounding
the drainage layer is provided on the contact area of the suction
connection, the suction connection with this fastening area can be
glued to the covering unit. For this purpose, the fastening area of
the suction connection can be provided with a suitable adhesive.
Alternatively, instead of an adhesive, double-sided adhesive tape
can be used. In this arrangement, the adhesive (for example
acrylate, silicone, polyurethane) can be applied partially (e.g. in
rings), in porous form or over the entire surface. The adhesive
tape may also be applied partially (e.g. in rings) or over the
entire surface. The double-sided adhesive tape may additionally be
coated using the same adhesive on both sides (e.g. acrylate,
silicone, polyurethane), or the two sides may be coated using two
different adhesives (especially having silicone adhesive on the top
side in contact with contact surface 12 and acrylic adhesive on the
bottom.) Both adhesive and adhesive tape may be provided with a
detachable protective layer.
[0033] If the drainage layer completely covers the contact area of
the suction connection, the covering unit, for example designed
film-like, may be glued to a fastening area of the suction
connection facing away from the contact surface and surrounding the
connecting device of the suction connection which is designed, for
instance, in the form of a tube stub.
[0034] As in the case of prior art wound care arrangements for use
in vacuum therapy, the filler material of wound care arrangements
according to the invention may include open-cell foam or gauze.
[0035] As evident from the preceding explanation of wound care
arrangements according to the invention, a covering unit according
to the invention for use in a wound care arrangement according to
the invention is essentially characterized in that it has a water
vapor permeability of preferably 300 g/m.sup.2/24 h or more, being
able to be embodied as polyurethane film, in particular as a film
tube having dimensions adjusted to the dimensions of human
extremities. The polyurethane film of covering unit according to
the invention is preferably waterproof, biocompatible, and has a
thickness between 0.5 .mu.m and 200 .mu.m, in particular between 1
and 100 .mu.m. The water vapor permeability is expediently less
than 2000 g/m.sup.2/24 h, especially less than 1500 g/m.sup.2/24 h.
The elongation at rupture of a covering unit according to the
invention can be more than 100%, the static friction coefficient
being between 0.8 and 1.5 and the sliding friction coefficient
expediently between 0.7 and 1.2. A wound care arrangement according
to the invention can be used as follows:
[0036] After applying a conventional negative pressure therapy
bandage or after applying or inserting a filler material on or in
the wound, a wound located on an extremity is inserted into the
tubular cover film in such a way that the film covers the entire
wound area and the tubular cover film projects over the edges of
the wound. Taking into account its flexibility, the film is
expediently dimensioned in such a way that it is seated tight and
gap-free at the wound edges. The length of the tubular film can
also be supplied in the form of a continuous tube and fabricated on
site by cutting. The film thus covered by the filler material and
the cover film is connected by its two axial ends, sealing it to
the skin surrounding the wound, using customary commercial adhesive
film bandages, for example under the trade name Suprasorb F from
Lohmann & Rauscher GmbH. For this purpose, the film bandages
are applied in such a way that they adhere to the cover film on the
one hand and to the skin on the other hand. By using water vapor
permeable covering units within the scope of the invention,
complete sealing of the wound area by adhesive film bandages is
avoided. This promotes wound healing. The cover film can be applied
on a support film before and during positioning with respect to the
wound. The support film must be detached after introduction of the
extremity affected by the wound and before sealing by adhesive film
bandages, in order to assure a successful therapy process. If the
film tube used as covering unit tube is closed at one of its axial
ends in the case of pre-formation of a truncated structure, for
example by welding or by gluing, only one axial end of the film
tube will be connected to the skin surrounding the wound, sealing
it.
[0037] Hereinafter, the invention is explained with reference to
the drawing, to which express reference is made with respect to all
details essential to the invention and not explicitly highlighted
in the specification. Shown in the drawing:
[0038] FIG. 1 shows a suction connection of a wound care
arrangement according to the invention according to a first
embodiment,
[0039] FIG. 2 shows a suction connection of a wound care
arrangement according to the invention according to a second
embodiment,
[0040] FIG. 3 shows a suction connection of a wound care
arrangement according to the invention according to a third
embodiment,
[0041] FIG. 4 shows a wound care arrangement embodied using the
suction connection according to FIG. 3,
[0042] FIG. 5 shows a suction connection of a wound care
arrangement according to the invention according to a fourth
embodiment,
[0043] FIG. 6 shows a wound care arrangement having a suction
connection according to FIG. 5,
[0044] FIG. 7 shows a suction connection of a wound care
arrangement according to the invention according to a fifth
embodiment,
[0045] FIG. 8 shows a wound care arrangement having a suction
connection according to FIG. 7, and
[0046] FIG. 9 shows a suction connection of a wound care
arrangement according to the invention according to a sixth
embodiment.
[0047] FIG. 10 shows embodiments of covering units according to the
invention for wound care arrangements according to the invention,
and
[0048] FIG. 11 shows exemplary embodiments of wound care
arrangements according to the invention.
[0049] FIG. 1a) shows a view of a suction connection 10 of a wound
are arrangement according to the invention from the bottom, FIG.
1b) a view of suction connection 10 according to FIG. 1a) the top,
and FIG. 1c) a sectional view of a suction connection 10 according
to the invention.
[0050] The suction connection 10 shown in FIG. 1 has a flanged
contact area 11 with a circular disk-shaped plane contact surface
12 without any projections. Contact surface 12 is perforated by an
aspiration orifice 14. In this arrangement, the likewise circular
suction connection 14 is arranged in the center of contact surface
12. Aspiration orifice 14 ends in a connecting device 20, which is
designed like a tube stub and causes a deflection by 90.degree. of
the exudate flow that is aligned perpendicular to contact surface
12, so that, after deflection, the flow is aligned approximately
parallel to contact surface 12. Tube stub 20 has, at its end that
faces away from aspiration orifice 14, a connecting area 22 with an
expanded inside diameter, into which a suction tube 30 can be
inserted airtight. The deflection of the aspiration flow by means
of tube stub 20 causes alignment of aspiration tube 30 in a
direction running parallel to contact surface 12. This allows
low-interference application of suction connection 10 and
aspiration tube 30 connected thereto to the body of the
patient.
[0051] In the embodiment shown in FIG. 1c), aspiration tube 30 is
dimensioned in such a way that its inner boundary area is aligned
with an inside surface area of tube stub 20 adjacent to connection
area 22 of tube stub 20, in order to minimize thereby the flow
resistance for the wound exudate.
[0052] In the embodiment according to FIG. 2a), a central area of
contact surface 12, comprising aspiration opening 14, is covered by
a drainage layer 40 designed for the introduction of wound exudate
into aspiration opening 14. Drainage layer 40 is glued to contact
surface 12 and annularly surrounded by a fastening area 16 of
contact surface 12.
[0053] In the embodiment according to FIG. 2b), contact surface 12
is completely covered by drainage layer 40. On the boundary area of
suction connection 10 facing away from contact surface 12,
surrounding tube stub 20, a fastening area 16 is provided, which,
just like fastening area 16, can be provided with an adhesive
layer, which can be covered by a detachable protective layer in a
wound care arrangement according to the invention, before using
suction connection 10.
[0054] The suction connection according to FIG. 3 essentially
differs from the suction connection according to FIGS. 1 and 2 in
that, in addition to an aspiration orifice 14, contact area 11 also
has an aeration orifice 80, by means of which the wound can be
aerated in a controlled manner, in order to improve in this way the
flow conditions in the wound area in the interest of improving
exudate removal. Aeration orifice 80 has a greater diameter than
aspiration opening 14. The edge surrounding contact area 11 may
have a shoulder which, according to FIGS. 4 and 5, can be used as
support surface for an antibacterial filter 82. This increases the
flow resistance in the area of aeration orifice 80, which can,
however, can be recompensed by adjusting the diameter of aeration
orifice 80.
[0055] Within the scope of the invention, the flow resistance of
filter 82 can be utilized to control the air flow. In doing so, the
flow resistance is increased by reducing the filter pore size. This
control enhances the generation of negative pressure with
simultaneous aeration. If too large an aeration orifice 80 is
selected, the negative pressure cannot be generated without using a
filter. Aeration orifice 80 may also be arranged above the water
vapor permeable cover film 60 (in a plan view). It is essential for
the wound to be supplied with air. For this purpose, it may be
expedient to provide a hole somewhat offset in cover film 60, so
that the air can freely flow to aeration orifice 80.
[0056] In the embodiment shown in the drawing, the antibacterial
filter 82 is made of polytetrafluoroethylene and has a pore size in
the range of 0.001 .mu.m, especially 0.005 .mu.m, preferably 0.02
.mu.m, particularly preferred 0.1 .mu.m to 5 .mu.m, In the wound
care arrangement according to FIGS. 6a and 6b, it is covered by
drainage layer 40. As explained with reference to FIG. 4, the
suction connection according to FIG. 3 as well as the suction
connection according to FIG. 1 can be attached in such a way that
it is glued to a cover film 60.
[0057] The embodiment according to FIG. 5 essentially differs from
the embodiment according to FIG. 3 in that the aspiration tube is
implemented as a three-lumen tube 32 and, as schematically
indicated in FIG. 6, the middle and largest lumen 34 is used for
generating the negative pressure in the wound area, a small lumen
36 can be used for aerating the wound, and an additional smaller
lumen 38 is intended for measuring the pressure in the wound area.
Connection area 22 also comprises lumens 24, 26 and 28
corresponding to the lumens 32, 34 and 36.
[0058] The embodiment according to FIGS. 5 and 6 additionally
comprises, in addition to aeration lumen 26, an aeration orifice
80, in order to allow further improving the exudate management.
[0059] The embodiment according to FIG. 7 essentially differs from
the embodiment according to FIG. 3 in that, in addition to the
aspiration opening 14 and the aeration orifice 80, additionally a
feed port 100 into contact area 11 of suction connection 10 is
provided, which is associated with another tube stub 110 for
connecting feed port 100 to another tube 130. Via tube 130, the
additional tube stub 110 and feed port 100, wound care agents, such
as a rinse, as the case may be, mixed with medications,
disinfectants or the like, can be introduced into the wound area.
The embodiment according to FIG. 7 can be used even without using a
separate aeration orifice 80 because feed port 100 can also be used
for aeration. For the purpose of good exudate management, it has,
however, proven to be particularly expedient if, in addition to
aspiration opening 14, both an aeration orifice 80 and a feed port
100 are provided in contact area 11 of suction connection 10.
[0060] As evident from FIG. 8, the rinse can be introduced into the
area of the wound via the additional tube 130 and the additional
tube stub 110 using an appropriate metering element 114. For this
purpose, it has proven to be particularly expedient if the feed
port 100 is not covered by drainage layer 40, in order to assure
thereby the removal by aspiration of wound exudate without being
affected by the supplied rinse and in order to prevent the supplied
rinse from being immediately removed again by aspiration.
[0061] The embodiment according to FIG. 9 differs from the
embodiment explained with reference to FIG. 7 in that a three-lumen
tube 132 is used, the design and functioning of which are
comparable to the design according to FIG. 5. For this purpose, the
design according to FIG. 9 has a three-lumen tube for removal for
removal by aspiration of wound exudate, aeration of the wound area
and an aeration orifice 80 pressure measurement as well as a feed
port 100. This allows assuring optimal wound management.
[0062] The embodiments explained with reference to FIGS. 3 to 9
have, in contrast to the embodiments explained with reference to
FIGS. 1 and 2, a contact area of a shape that differs from
circular, being approximately rhombic in shape. The corners of the
rhombs are rounded. The rhombic shape provides a longitudinal axis,
which allows the arrangement of aspiration orifice, aeration
orifice and feed port in a line.
[0063] The covering unit illustrated in FIG. 10a) is embodied as a
film tube 200, which may take on circular cylinder jacket shape.
The two ends 210 and 212 of the film tube shown in FIG. 10-a) are
designed open in such a way that the tube as a whole can be pulled
over one extremity. The covering unit according to the invention
according to FIG. 10b) essentially differs from the covering unit
according to FIG. 10a) in that the upper end 210' of the hollow
tube 200 is closed.
[0064] In the embodiment according to FIG. 10c), the covering unit
embodied as film tube is spreadable as a truncated in the form of a
cone jacket, i.e. tapered. In this arrangement, one end, such as
upper end 310, may be closed, while the other one, such as the
lower end 312, may be designed to be open. Particularly preferred,
the end having the smaller cross-section will be closed. In that
case, the film tube can be slipped over a foot somewhat like a
stocking or, as the case may be, over a hand, like a glove.
[0065] In FIG. 11, various exemplary embodiments of wound care
arrangements according to the invention are illustrated. In this
case, FIG. 11a) shows the application in the area of the knee
joint. It can be seen that the covering unit in analogy to the
covering unit shown in FIG. 10c) or 10a) is designed tubular and
open at both ends and is attached to the surrounding skin by the
ends opposite each other using adhesives means.
[0066] In the exemplary embodiment according to FIG. 11b), the
wound care arrangement is applied to an ankle, In this example, the
cover unit is embodied like a closed film tube, which is attached
to the surrounding skin in the area of the user's calf.
[0067] Finally, in the exemplary embodiment shown in FIG. 11c), the
wound care arrangement is applied to the forearm of a patient. In
this example, the covering unit is designed as a film tube open at
both ends, the film tube being designed tapered according to the
illustration in FIG. 10c) and attached to the surrounding skin by
the two opposite edges.
[0068] The invention shall not be limited to the embodiments
explained with reference to the drawing. In particular, the use of
tubular cover film is intended, which may even, if appropriate, be
mounted to support film, the support film being detachable from the
cover film after application of the cover film to the wound. For
this purpose, expediently, in the peripheral direction, completely
closed film tubes will be used, which only have, at least on one
axial end, an opening, the opening in the film tube required for
drainage of the exudate via the suction connection being formed
after application of the film tube to the wound. For this purpose,
the film tube may for example be cut open at the appropriate
location. Besides polyurethane film, other skin-compatible and
water vapor permeable film can be used. It is essential that the
covering unit delimits the enclosed wound space substantially
airtight and waterproof, is germ-proof, has appropriate water vapor
permeability, is biocompatible and eudermic as well as cuttable
and, if necessary, can be easily applied using additional support
film.
* * * * *