U.S. patent application number 14/178132 was filed with the patent office on 2014-06-12 for wound treatment apparatus.
This patent application is currently assigned to KCI Licensing, Inc.. The applicant listed for this patent is KCI Licensing, Inc.. Invention is credited to Keith Patrick Heaton, Kenneth William Hunt.
Application Number | 20140163492 14/178132 |
Document ID | / |
Family ID | 10783845 |
Filed Date | 2014-06-12 |
United States Patent
Application |
20140163492 |
Kind Code |
A1 |
Hunt; Kenneth William ; et
al. |
June 12, 2014 |
WOUND TREATMENT APPARATUS
Abstract
A therapeutic apparatus for stimulating the healing of a wound
site includes a polyurethane foam positioned at the wound site and
a connector having a disc-like cup and an elbow-shaped spout. The
connector is positioned in contact with the polyurethane foam, and
the elbow-shaped spout is configured for connection to a tube that
is capable of delivering negative pressure through the elbow-shaped
spout and to the polyurethane foam. The therapeutic apparatus
further includes a drape having a hole, the drape being positioned
over the connector such that the elbow-shaped spout extends through
the hole in the drape.
Inventors: |
Hunt; Kenneth William;
(Wimbourne, GB) ; Heaton; Keith Patrick; (Poole,
GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
KCI Licensing, Inc. |
San Antonio |
TX |
US |
|
|
Assignee: |
KCI Licensing, Inc.
San Antonio
TX
|
Family ID: |
10783845 |
Appl. No.: |
14/178132 |
Filed: |
February 11, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12711182 |
Feb 23, 2010 |
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14178132 |
|
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|
11713485 |
Mar 2, 2007 |
7670323 |
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12711182 |
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|
09613497 |
Jul 11, 2000 |
7316672 |
|
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11713485 |
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09078223 |
May 13, 1998 |
6142982 |
|
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09613497 |
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PCT/GB96/02802 |
Nov 14, 1996 |
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09078223 |
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Current U.S.
Class: |
604/319 |
Current CPC
Class: |
A61M 1/0056 20130101;
A61M 2209/088 20130101; A61M 2205/3379 20130101; A61M 1/0088
20130101; A61M 1/0049 20130101; A61M 2205/583 20130101; A61M
2205/18 20130101; A61M 1/0037 20130101; A61M 2205/581 20130101;
A61M 2205/3344 20130101; A61M 1/0066 20130101; A61M 1/0023
20130101; A61M 2205/8206 20130101; A61M 1/0052 20140204; A61M 27/00
20130101; A61M 2205/3351 20130101; Y10S 604/902 20130101; A61M
2205/15 20130101 |
Class at
Publication: |
604/319 |
International
Class: |
A61M 1/00 20060101
A61M001/00 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 14, 1995 |
GB |
9523253.4 |
Claims
1.-22. (canceled)
23. A method for securing a suction device to a wound site, the
method comprising: applying a connector to an open-celled polymer
foam positioned at the wound site such that a flange of the
connector contacts the open-celled polymer foam, the connector
having a centrally-positioned spout configured to receive a suction
tube; and sealing the connector at the wound site with a drape such
that the centrally-positioned spout extends through a hole of the
drape.
24. The method of claim 23 further comprising: prior to applying
the suction head, positioning the open-celled polymer foam at the
wound site.
25. The method of claim 23, wherein sealing the connector at the
wound site further comprises: adhesively securing the drape to the
flange of the connector, the open-celled polymer foam, and skin
surrounding the wound site.
26. The method of claim 23, wherein sealing the connector at the
wound site further comprises: stretching the drape over the
connector and the open-celled polymer foam; and adhesively securing
the drape to skin surrounding the wound site.
27. The method of claim 23, wherein the open-celled polymer foam is
a reticulated, polyurethane foam.
28. The method of claim 23, wherein the open-celled polymer foam is
a polyvinyl alcohol foam.
29. A method for administering negative pressure wound site therapy
to a wound site, the method comprising: positioning an open-celled
polymer foam at the wound site; applying a connector having a
flange and a centrally-positioned spout to the open-celled polymer
foam such that a flange of the connector contacts the open-celled
polymer foam; securing the connector at the wound site with a drape
such that the centrally-positioned spout extends through a hole of
the drape; and applying a negative pressure to the wound site
through the centrally-positioned spout and open-celled polymer
foam.
30. The method of claim 29 further comprising: maintaining the
negative pressure at the wound site with the drape positioned over
the connector.
31. The method of claim 29, wherein sealing the suction head at the
wound site further comprises: adhesively securing the drape to the
flange of the connector, the open-celled polymer foam, and skin
surrounding the wound site.
32. The method of claim 29, wherein sealing the connector at the
wound site further comprises: stretching the drape over the
connector and the open-celled polymer foam; and adhesively securing
the drape to skin surrounding the wound site.
33. The method of claim 29, wherein the open-celled polymer foam is
a reticulated, polyurethane foam.
34. The method of claim 29, wherein the open-celled polymer foam is
a polyvinyl alcohol foam.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 12/711,182, filed Feb. 23, 2010, which is a continuation
of U.S. patent application Ser. No. 11/713,485, filed Mar. 2, 2007,
which is a continuation of U.S. patent application Ser. No.
09/613,497, filed Jul. 11, 2000, now U.S. Pat. No. 7,316,672, which
is a continuation of U.S. patent application Ser. No. 09/078,223,
filed on May 13, 1998, now U.S. Pat. No. 6,142,982, which is a
continuation of International Application No. PCT/GB96/02802, filed
Nov. 14, 1996, which claims priority to British Patent Application
No. GB9523253.4, filed Nov. 14, 1995. All of the above-mentioned
applications are hereby incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to the healing of wounds and, more
particularly, to apparatus for stimulating the healing of
superficial wounds.
[0004] 2. Description of Related Art
[0005] PCT Application No. GB95/01983 (WO 96/05873) describes
apparatus for stimulating the healing of wounds comprising a porous
pad which is permeable to fluids for introduction into the wound, a
dressing for covering the wound and providing an air-tight seal
around the wound, a drainage tube connecting the pad to a suction
pump so that negative pressure can be applied to the wound to draw
fluids therefrom, and a canister for collecting fluids sucked from
the wound. The apparatus described in the above application has
proved to be clinically effective but there are some limitations in
its use.
[0006] The apparatus described in the above PCT application is
effective for treating a wide variety of different types and sizes
of wounds. However, it may require the patient to undergo treatment
on the apparatus for a long period. In cases where the patient is
confined to bed this may not be a major problem but where the
patient is mobile it means that he or she would be confined for
long periods while the treatment takes place.
SUMMARY
[0007] According to one aspect of the present invention there is
provided a portable therapeutic apparatus for stimulating the
healing of superficial wounds in a person, which comprises a
housing containing a suction pump and a canister for containing
fluids drawn from the wound by said pump, said canister including
means for connection to a dressing in the region of the wound and a
harness or belt for supporting the housing on the person.
[0008] Typically, the housing will have a curved surface on the
side intended to be supported against the person's body so as to
make the apparatus more comfortable to wear. In addition, controls
and indicators indicating the status of the treatment being applied
to the wound are preferably located on the supper side of the
housing so that the patient can easily see, e.g. the level of
suction pressure being applied and the program for such
treatment.
[0009] The suction pump is conveniently driven by an electric motor
and batteries for such motor being contained within the housing.
However, it is generally more convenient to provide a separate
housing for the batteries since these can be placed on the belt or
harness in such a way as to balance the weight of the housing,
preferably in a housing shaped similarly to the housing for the
pump and canister.
[0010] The canister should be removably mounted within the housing,
e.g. by means of a latch or similar release mechanism, so that the
canister can be readily removed and replaced when full.
[0011] In a portable therapeutic apparatus (in contrast with a
static apparatus of the kind described in the above PCT application
which cannot be easily carried by the patient), it is less easy to
determine the pressure prevailing at the wound site being treated.
This is because the pressure will depend, in part, upon the
hydrostatic height between the pump and the wound being treated and
this height may vary during the treatment, depending upon the
patient's movements. Apparatus in accordance with the invention
overcomes this problem by providing an additional conduit
connecting the wound site or an area close thereto to a
pressure-detecting means, preferably located in the housing. The
pressure-detecting means can be linked to a microprocessor
programmed to maintain such pressure within a predetermined range
irrespective of the movement of the patient. This can be done by,
for example, signaling the pump to increase its speed where the
hydrostatic pressure increases between the pump and the wound site
or, conversely, reducing its speed where the hydrostatic pressure
is reduced. This feature can also be used in a static therapeutic
apparatus of the kind described in the above-mentioned
application.
[0012] In the apparatus described in the above PCT application, the
level of liquid in the canister is monitored by capacitance
measurement. It has now been found that a simpler way of
determining when the canister is filled is by measuring or
detecting the pressure drop across the canister. The pressure drop
can be increased by providing a filter barrier in the region of the
outlet end of the canister.
[0013] Thus, when the liquid reaches a level within the canister so
as to substantially occlude the filter, a sharp pressure change
occurs in the conduit between the canister and the pump. By
monitoring this pressure change, the point at which the canister is
filled can be accurately determined.
[0014] Other features which are considered as characteristic for
the invention are set forth in the appended claims.
[0015] Although the invention is illustrated and described herein
as embodied in a wound treatment apparatus, it is nevertheless not
intended to be limited to the details shown, since various
modifications and structural changes may be made therein without
departing from the spirit of the invention and within the scope and
range of equivalents of the claims.
[0016] The construction and method of operation of the invention,
however, together with additional objects and advantages thereof
will be best understood from the following description of specific
embodiments when read in connection with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 is a schematic layout of the apparatus in accordance
with the invention,
[0018] FIG. 2A and B are pictorial representations of the housing
of the pump and canister,
[0019] FIGS. 3A and B are pictorial representations of the
apparatus supported on a belt and harness, respectively,
[0020] FIG. 4 is an exploded view of the housing showing the
contents,
[0021] FIGS. 5A to 5F show various views of a preferred form of the
canister and a section of a multi-lumen tube,
[0022] FIGS. 6A to 6D show various views of a foam dressing
connector for connecting the housing to the dressing,
[0023] FIG. 6E shows a section of a modified multi-lumen tube,
and
[0024] FIGS. 7A and 7B show a plan and perspective view of a
surgical drape for use with the apparatus.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0025] Referring to the drawings, the portable therapeutic
apparatus comprises a housing 210 (best shown in FIGS. 2A and 2B),
having rounded corners and a side 211 which is concavely curved in
order to fit comfortably to the wearer's body.
[0026] The shaping of the housing with curved surfaces is to avoid
sharp corners or edges which could dig in to the user or his
career. The supper surface 212 is generally flat and has an LCD
screen 213 on which details such as applied pressure can be
displayed. Control buttons 214 are provided to adjust pressures and
treatment intervals. Provision is made for housing a canister
within the housing and a snap release cover 215 is arranged for
removing or introducing the canister.
[0027] FIGS. 3A and 3B show schematically ways in which the housing
210 may be supported on the patient's body. In FIG. 3A the housing
210 is supported on a belt 216 and its weight is balanced by a
similarly rounded casing 217 containing a rechargeable battery
pack. FIG. 3B shows an alternative arrangement in which the housing
is supported on a harness 218 and again a battery pack is contained
in a housing 219, also supported on the harness.
[0028] FIG. 4 shows an exploded view of the housing 210 indicating
the main components within the housing. The housing consists of
front and rear shell mouldings 1 and 2 having an external bet clip
21 for attachment to a belt or harness.
[0029] Within the housing shell 1 is located a suction pump 6 with
associated electric motor 6A and the pump is connected by a silicon
rubber tube 103 to a canister spigot 7A in a cavity 20 for the
canister 100. Also connected to a second canister spigot 7B via a
tube 10 is a pressure relief valve and both tubes 103 and 10 are
connected via T-connectors T to pressure transducers (not shown). A
microprocessor 4 is mounted on a PCB board S and a membrane
assembly 3 incorporates an LCD indicator and control buttons.
[0030] The apparatus may include means for recording pressures and
treatment conditions given to a particular patient which may be
printed out subsequently by the physician. Alternatively, the
equipment may include a modem and a telephone jack so that the
conditions under which the patient has been treated can be
interrogated by the physician from a distant station.
[0031] Canister 100 is a push fit into the cavity 20 and its lower
end is supported in a cover 30. The cover 30 incorporates fingers
31 which are releasably engageable with lips 32 to hold the
canister in position. The canister and the latch mechanism is
arranged so that when the latch is engaged, the spigots 7A and 7B
are in sealing engagement or abutment with tubular protrusions 33
and 34 formed in the top of the canister.
[0032] The method of operation of the apparatus can be appreciated
from the schematic layout in FIG. 1, in which the canister 100 is
connected via tube 101 to a porous dressing 102 at the wound site.
Suction is applied to the wound site via the canister by a tube
103, connected to the pump 6. The pressure in the tube 103 is
detected by the transducer 105.
[0033] A second tube 106 is connected to the wound site 102 at one
end, and also to a pressure relief valve 8 and to a second
transducer 108. Tubes 106 and 101 can be combined in a
multi-partitioned tube in a manner to be described later. By means
of tube 106 and transducer 108 the pressure at the wound site can
be measured or monitored. A filter 109 is placed at or close to the
outlet end of the canister 100 to prevent liquid or solid particles
from entering the tube 103. The filter is a bacterial filter which
is hydrophobic and preferably also lypophobic.
[0034] Thus, aqueous and oily liquids will bead on the surface of
the filter. During normal use there is sufficient air flow through
the filter such that the pressure drop across the filter is not
substantial.
[0035] As soon as the liquid in the canister reaches a level where
the filter is occluded, a much increased negative pressure occurs
in tube 103 and is detected by transducer 105. Transducer 105 is
connected to circuitry which interprets such a pressure change as a
filled canister and signals this by means of a message on the LCD
and/or buzzer that the canister requires replacement. It may also
automatically shut off the working of the pump.
[0036] In the event that is desired to apply intermittent suction
to the wound site, a pressure relief valve 8 enables the pressure
at the wound site to be brought to atmospheric pressure rapidly.
Thus, if the apparatus is programmed, for example, to relieve
pressure at 10 minute intervals, at these intervals valve 8 will
open for a specified period, allow the pressure to equalize at the
wound site and then close to restore the suction. It will be
appreciated that when the constant suction (or negative pressure)
is being applied to the wound site, valve 8 remains closed and
there is no leakage from atmosphere. In this state, it is possible
to maintain negative pressure at the wound site without running the
pump continuously, but only from time to time, to maintain a
desired level of negative pressure (i.e. a desired pressure below
atmospheric), which is detected by the transducer 105. This saves
power and enables the appliance to operate for long periods on its
battery power supply.
[0037] Instead of running two separate tubes to the wound site, it
is preferable to contain tubes 106 and 101 in a single tube which
is connected through the canister.
[0038] Thus, for example, tubes 103 and 101 may comprise an
internal tube surrounded by an annular space represented by tube
106. This is illustrated in FIGS. 5A to 5F and in a modified form
of FIG. 6E.
[0039] In an alternative embodiment, the multi-lumen tube may be
constructed as shown in FIG. 6E. In this embodiment, the internal
bore 606 comprises the line 101 (see FIG. 1) and is used to extract
fluids from the wound site. Air flow (represented by line 106 in
FIG. 1) passes down conduits 607 located within the walls of the
tube. By spacing the conduits 607 at 90.degree. intervals around
the tube, the risk of arresting the air flow by kinking or twisting
the multi-lumen tube is minimized.
[0040] FIG. 5E is a plan view of the top of a preferred shape of
canister, the generally triangular shape in section being chosen to
fit better the space within the cavity 20 (see FIG. 4). Tubular
protrusions on the top of the canister are connected internally of
the canister with respectively conduits 124 and 121 (see sectional
view of FIG. 5B), thus maintaining a separation between the tubes
which are represented by lines 103 and 106 in FIG. 1. At the base
of the canister, a moulding 125 facilitates connection to a
multi-partitioned tube 126 shown in FIG. 5F. Tube 126 has a central
bore 127 which is sized to fit over a spigot 128 in moulding 125.
At the same time, the external wall of tube 126 seals against the
inner wall 129 of moulding 125. Thus, compartment 124 will connect
with central bore 127 and the compartment 121 will connect with the
annular spaces 130 of tube 126. In this way, a conduit 130
corresponds with line 106 and central bore 127 with line 101 as
shown in FIG. 1.
[0041] The partitioned tube need not continue all the way to the
wound site 102, but can be connected to a short section of single
bore tube close to the wound site.
[0042] In the event of an air leak in the dressing at the wound
site 102, this can be detected by both transducers 105 and 108
reading sufficient negative pressure for a specific time period and
then triggering a leak alarm, i.e. a message on the LCD, preferably
also with an audible warning.
[0043] Typically, the pump 6 is a diaphragm pump but other types of
pumps and equivalent components to those specifically employed may
be substituted.
[0044] FIGS. 6A-6D show various views of a connector for attaching
the multi-lumen tube at the wound site. FIG. 7A and 7B show a plan
and perspective view of a surgical drape for attaching the
connector to a porous dressing at the wound site. The connector
comprises a moulded plastics disc-like cup 601 having a centrally
positioned spout 602. The spout 602 is sized to accept, as a
closely sliding fit, the end of a multi-lumen tube, e.g., of the
kind shown in FIGS. 5F or 6E.
[0045] In use, a porous dressing is cut to correspond with the
extent of the wound and pressed onto the wound as shown in FIG. 10
of our above cited PCT application WO 96/05873. Instead of
introducing the lumen into the foam dressing, the cup 601 is
pressed onto the porous dressing and secured by a surgical drape.
However, if desired, the end of the lumen can be passed into the
spout and additionally pressed into the foam. A surgical drape such
as shown in FIGS. 7A and 7B, can be used to secure the connector,
lumen and dressing. The drape comprises a polyurethane film 701
coated on one side with a pressure-sensitive acrylic resin
adhesive. A hole 702 is cut through all layers of the drape and the
hole is dimensioned to correspond approximately with the outer
cross-section of the spout 602. Film 701 has an overall size which
allows it to be adhered to the patient's skin around the wound
site, while at the same time, securing the connector to the porous
dressing. A sufficient overlap around the wound is provided so that
an airtight cavity is formed around the wound.
[0046] In an alternative form, the drape can be made in two parts,
e.g. by cutting along the line X-X in FIG. 7A. With this
arrangement, the wound can be sealed by overlapping two pieces of
surgical drape so that they overlap each other along a line Y-Y as
shown in FIG. 6D.
[0047] The surgical drape may include a protective film 703, e.g.
of polyethylene, and a liner 704 which is stripped off prior to use
to expose the pressure-sensitive adhesive layer. The polyurethane
film may also include handling bars 705, 706, which are not coated
with adhesive, to facilitate stretching of the film over the wound
site. The dressing is preferably a pad of porous, flexible plastics
foam, e.g. reticulated, open intercommunicating cellular flexible
polyurethane foam, especially of the kind described in the
above-mentioned PCT Application WO 96/05873.
[0048] Alternatively, a reticulated intercommunicating cellular
foam made from flexible polyvinylacetate or polyvinylalcohol foam
may be used. The latter is advantageous because it is hydrophilic.
Other hydrophilic open celled foams may be used.
[0049] In another method of therapy, the foam dressing may be
sutured into a wound after surgery and the foam dressing connected
to the pump unit by the multi-lumen catheter. Negative pressure can
then be applied continuously or intermittently for a period
determined by the surgeon, e.g. from about 6 hours to 4 to 5 days.
After this period, the dressing is removed and the wound
re-sutured.
[0050] This therapy improves the rate of granulation and healing of
wounds after surgery.
* * * * *