U.S. patent application number 11/012299 was filed with the patent office on 2016-01-28 for plaster for tracheostoma valves.
The applicant listed for this patent is Jan-Ove Persson. Invention is credited to Jan-Ove Persson.
Application Number | 20160022940 11/012299 |
Document ID | / |
Family ID | 20288266 |
Filed Date | 2016-01-28 |
United States Patent
Application |
20160022940 |
Kind Code |
A9 |
Persson; Jan-Ove |
January 28, 2016 |
Plaster for tracheostoma valves
Abstract
A plaster for attaching a trachestoma valve in connection with a
traceostoma on a person's neck. The plaster comprises a socket and
an annular flange, communicating with a central opening of the
flange which is connected with a single-coated adhesive tape, which
extends radially beyond the edge of the flange. The connection
includes a first annular joint at or inwardly of the outer
periphery of the flange, and a second annular joint located between
the outer periphery of the flange and the inner periphery of the
flange spaced radially from the first annular joint. A protecting
liner covers the adhesive on the tape.
Inventors: |
Persson; Jan-Ove; (Hoor,
SE) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Persson; Jan-Ove |
Hoor |
|
SE |
|
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Prior
Publication: |
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Document Identifier |
Publication Date |
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US 20100258135 A1 |
October 14, 2010 |
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Family ID: |
20288266 |
Appl. No.: |
11/012299 |
Filed: |
December 16, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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PCT/SE2003/000840 |
May 23, 2003 |
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11012299 |
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Current U.S.
Class: |
128/207.16 ;
156/242; 156/60 |
Current CPC
Class: |
Y10T 156/10 20150115;
A61M 16/0468 20130101; A61M 2207/00 20130101; A61M 16/047
20130101 |
International
Class: |
A61M 16/20 20060101
A61M016/20; B32B 37/24 20060101 B32B037/24; B32B 37/00 20060101
B32B037/00 |
Foreign Application Data
Date |
Code |
Application Number |
Jun 19, 2002 |
SE |
0201907-3 |
Claims
1-17. (canceled)
18. A plaster for attaching a tracheostoma valve or the like on a
person's neck in connection with a tracheostoma, having a proximal
side and a distal side and comprising: a socket open at both ends
thereof for mounting the valve to the plaster; an annular first
flange integrally connected with a proximal end of the socket at an
inner periphery of the first flange concentrically surrounding said
proximal end, the first flange being angled or curved towards a
wall of the socket; an annular tape attached to a proximal side of
the first flange and covering said proximal side, and an adhesive
on a proximal side of said tape, wherein the annular tape is a
single coated adhesive tape attached to the first flange by a first
annular joint at or inwardly of the outer periphery of the first
flange, and extends radially beyond the edge of the first flange,
and the annular tape is attached to the first flange by a second
annular joint located between said outer periphery of the first
flange and said inner periphery of the first flange spaced radially
from said first annular joint, a protecting liner covering the
adhesive on the tape.
19. The plaster of claim 18, wherein the plaster is of disposable
type.
20. The plaster of claim 18, wherein the connection between the
first flange and the adhesive tape is spaced radially from the
inside surface of the socket.
21. The plaster of claim 20, wherein said spacing is at least 2
mm.
22. The plaster of claim 21, wherein the adhesive tape is fixed to
the first flange by means of at least one weld formed by ultrasonic
and/or by heat.
23. The plaster of claim 21, wherein the adhesive tape is fixed to
the first flange by gluing.
24. The plaster of claim 18, wherein a distance between a base
plane and a top plane is between 2 and 15 mm, and preferably
between 3 and 10 mm.
25. The plaster of claim 18, wherein a second flange is generally
conical and inclined at an angle to the central axis of the socket
between 30.degree. and 80.degree. and more preferably between
50.degree. and 70.degree..
26. The plaster of claim 18, wherein a second flange forms a
curvature in cross section.
27. The plaster of claim 18, wherein the first flange is made of a
relatively soft polymer.
28. The plaster of claim 27, wherein the first flange is made of
polyethylene.
29. The plaster of claim 18, wherein the adhesive tape extends from
near the central opening of the first flange beyond the outer edge
of the first flange and is mainly plane in the area outside the
area of the second flange.
30. The plaster of claim 18, wherein a removable liner made of
formable material covers the adhesive of the adhesive tape.
31. The plaster of claim 30, wherein the liner follows the shape of
the adhesive tape.
32. A method for the manufacture of the plaster of claim 18,
wherein a liner covering the adhesive of the adhesive tape is
imparted the same form as the tape.
33. The method of claim 32, wherein the adhesive tape and the liner
are formed by cold or thermo pressing.
34. The method of claim 32, wherein the forming is effected by one
of the following: a stamp, by vacuum forming, or by blow moulding.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to a plaster for attaching a
tracheostoma valve or the like to a persons neck in connection with
a tracheostoma, comprising a socket open at both ends thereof for
mounting the valve or the like to the plaster, an annular flange
integrally connected with a proximal end of the socket at an inner
periphery of the flange concentrically surrounding said end, the
flange being angled or curved towards the wall of the socket, an
annular tape attached to a proximal side of the flange and covering
said proximal side, and an adhesive on a proximal side of said
tape.
[0002] A plaster of this kind is flangelosed in EP-A1-0 078
685.
BACKGROUND OF THE INVENTION
[0003] Due to disease, often cancer, it may be necessary to remove
the larynx by surgery (laryngectomy). By removal of the larynx
several important functions are lost. The epiglottis and the
closing function thereof is lost, and therefore an opening into
trachea, a tracheostoma, has to be provided in the neck of the
patient in order to create a direct connection with trachea. The
tracheostoma is sometimes lowered (depressed) in relation to the
surface of the patient's neck around the stoma and may have an
irregular form because it is often necessary to remove tissue
around the stoma.
[0004] The vocal cords and thus the ability to speak are also lost.
In order to re-create a kind of speech a fistula is formed by
surgery between oesophagus and trachea, and a voice prosthesis
which is a one-way valve (U.S. Pat. No. 5,578,083) is placed
therein. By means of a finger or a tracheostoma valve the
tracheostoma can be closed off in order to prevent air from going
out through the tracheostoma, air being pressed from the lungs to
oesophagus through the voice prosthesis whereby the mucosa of
oesophagus is starting to vibrate and it is possible to speak (U.S.
Pat. No. 4,325,366).
[0005] It is also known to connect some kind of heat and moisture
exchanger to the tracheostoma. Therefore, the expression
"tracheostoma valve" as used in the present description is meant to
include any other appliance connected to the tracheostoma.
[0006] Irrespectively of the kind of appliance that is connected to
the tracheostoma, the most common way to accomplish said connection
is by means of an annular flange flange attached to the patient's
neck by means of an adhesive. However, there is on the market also
a disposable plaster for attaching tracheostoma valves to the neck,
and this plaster is formed of a single-coated tape fixed to a
flange. The flange forms a socket and a plane flange fixed to the
tape. The plaster has a generally plane surface to be attached to
the skin surrounding the tracheostoma. This type of plaster causes
problems regarding tension and incomplete contact with the skin
close to the tracheostoma due to the fact that the stoma normally
is lowered or depressed.
[0007] Further prior art means for attachment to a patient's neck
in connection with a tracheostoma includes an annular flange and a
socket integral with the flange and projecting from one side
thereof at an angle to the axis of the socket. The tracheostoma
valve is exchangeably received in the socket. The flange is made of
plasticized PVC. A double-coated tape is attached to the flange on
the other side thereof as means for attaching the flange against
the skin surrounding the tracheostoma. The tape must not extend
beyond the edge of the flange, as any exposed adhesive of the tape
will attract dirt and dust discolouring the tape. The flange is to
be reused. Thus, when the tape is to be replaced the patient first
has to remove the double-coated tape from the flange, clean the
flange with a solvent, let the flange dry, and then apply a new
double-coated tape to the flange. This procedure is repeated at
least once a day.
[0008] Though the products of the above type work well in many
respects, there are still some problems. The known products are
normally of a type to be re-used, which means that cumbersome
cleaning by means of unhealthy solvents has to be effected. Often
the patient is elderly and will find problems in performing these
steps. In order that the tape shall adhere to the flange this is
made of plasticized poly-vinyl chloride (PVC). This plastic is
known to cause health problems and accordingly should be avoided.
The tape is fixed to the whole area of the flange, which means that
it relatively easy may come loose from the skin due to the fact
that a large force is concentrated to the tape edge adjacent the
tracheostoma. When the tracheostoma valve is used during speaking
and coughing or is to be removed, the socket is exposed to large
axial forces, putting the tape edge adjacent the socket under
tension. As the flange is relatively small and the adhesive tape
does not extend beyond it or at least not far beyond it, it is
difficult to have sufficient adherence on patients having a large
and irregular tracheostoma. The flange is inclined but since the
tracheostoma often is lowered or depressed and the skin around the
tracheostoma often is relatively plane the inclined flange will
cause surrounding skin to adapt an unnatural form and in this way
creates tensions in the tissues and thus flangeomfort to the
patient. Furthermore, there is an increased risk that the plaster
will more easily loosen from the patient's neck.
SUMMARY OF THE INVENTION
[0009] One object of the present invention is to provide a plaster
of the kind referred to herein having attachment means that follows
the depressed or lowered tracheostoma and the relatively plane
surrounding skin for optimal adherence without causing any tension
or discomfort to the patient. The attachment means should also be
able to take up much larger forces and not come loose as easily as
prior art products. Furthermore, the plaster should be less
cumbersome to handle for the patient.
[0010] The above objects are attained according to the present
invention by a plaster of the kind referred to which according to
claim 1 is characterized in that the annular tape is a single
coated adhesive tape attached to the flange by a first annular
joint at or inwardly of the outer periphery of the flange and
extends radially beyond the edge of the flange, and that the
annular tape is attached to the flange by a second annular joint
located between said outer periphery of the flange and said inner
periphery of the flange spaced radially from said first annular
joint, a protecting liner covering the adhesive on the tape.
[0011] A further object of the present invention is to provide a
plaster for connection to the tracheostoma which is of disposable
type so that there is no need for the patient to perform the
cumbersome and health jeopardising steps of changing the
double-coated adhesive tape, which by many patients is felt as a
major problem.
[0012] A still further object is to provide a plaster which can
cover also big and irregular tracheostomas.
[0013] Another object is to make the plaster of biocompatible and
environment friendly materials, reducing risks for both patient and
environment.
[0014] Further advantageous features of the invention are defined
in the dependent claims.
[0015] In order to adapt the plaster to different types of
tracheostomas the design of the adhesive tape may be adjusted as to
form and size without the flange being a limiting element as is the
case with prior art devices.
[0016] Further objects and advantages of the present invention will
be obvious to a person skilled in the art when reading the
following detailed description of illustrative embodiments of the
invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] In the accompanying drawings,
[0018] FIG. 1 is a perspective view of a plaster for tracheostoma
valves or the like according to a first embodiment of the invention
as seen from the distal side thereof,
[0019] FIG. 2 is a plan view of the distal side of the plaster of
FIG. 1,
[0020] FIG. 3 is a cross sectional view of the plaster of FIGS. 1
and 2, taken along line A-A of FIG. 2,
[0021] FIG. 4 is a plan view of a second embodiment of a plaster
for tracheostoma valves or the like as seen from the distal
side,
[0022] FIG. 5 is a cross sectional view as in FIG. 3 of the plaster
of FIG. 4.
[0023] FIG. 6 is a perspective view as seen from the distal side of
a plaster according to a third embodiment of the invention,
[0024] FIG. 7 is a perspective view of the plaster in FIG. 6 as
seen from the proximal side thereof,
[0025] FIG. 8 is a perspective view of a fourth embodiment of the
plaster of the invention as seen from the distal side thereof,
[0026] FIG. 9 is a plan view of a fifth embodiment of the plaster
of the invention as seen from the distal side thereof,
[0027] FIG. 10 is a perspective view of the plaster in FIG. 9 as
seen from the distal side thereof, and
[0028] FIG. 11 is a perspective view of the plaster in FIG. 9 as
seen from the proximal side thereof.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0029] The plaster according to the present invention comprises a
central, annular flange 1, which forms a central socket 2 and a
flange 3 concentrically surrounding socket 2. Thus, socket 2 forms
a central opening of flange 1. In the embodiments of FIGS. 1 to 4
flange 3 is inclined at an angle 4 in relation to the central axis
9 of socket 2. The angle 4 may vary but is preferably between
30.degree. and 80.degree. and more preferably between 50.degree.
and 70.degree.. Due to the angle 4 of flange 3 a base plane 11
perpendicular to axis 9 and including the area where socket 2 and
flange 3 are joined, is placed at a distance 10 from a top plane 12
perpendicular to axis 9 and located at the highest or relatively
plane level of the plaster. Distance 10 between base plane 11 and
top plane 12 normally is between 2 and 15 mm, and preferably
between 3 and 10 mm.
[0030] The annular flange 1 is preferably made of low density
polyethylene, which is a very biocompatible and soft polymer. The
flange may also be made of other relatively soft polymers.
[0031] A single-coated adhesive tape 6 which has adhesive on one
side only, as distinct from a double-coated adhesive tape which has
adhesive on both sides thereof is attached to flange 3. Tape 6 is
preferably of a medical grade and extends beyond the edge of flange
3 of the annular flange 1 and has a generally plane form outside
the flange. Tape 6 extends along flange 3 of flange 1 close to the
edge of socket 2, and at the outer periphery it forms two
diametrically opposite enlargements 6A which increase the surface
to be attached to the skin around the tracheostoma by the adhesive
tape. In the manufacture of the plaster the adhesive of tape 6 is
covered by some kind of liner or backing 8 which should be removed
before the tape is attached to the patient. Tape 6 forms a flap 7,
which is not covered by adhesive. This flap 7 facilitates removal
of liner 8 from tape 6. Tape 6 is preferably made of polyethylene
but may also be made of other biocompatible materials.
[0032] Flange 1 and the adhesive tape 6 are fixed to each other by
means of two annular welds 5A and 5B extending around flange 3 of
flange 1 concentrically with socket 2. One weld 5A is placed
adjacent the outer edge of flange 1 and the other weld 5B at a
relatively short radial distance inwardly of the edge radially
spaced from socket 2. Preferably the radial distance between the
innermost weld 5B and the inside surface of socket 2 is at least 2
mm. The welds may be formed by means of heat or ultrasonic welding
e.g. by using impulse welding or a continuously heated welding
head. As there is a distance between socket 2 and welds 5A, 5B
axial forces on socket 2 will not put the tape edge under large
tension, which is the case in the prior art products where there is
no such distance.
[0033] The embodiment of FIGS. 4 and 5 differs from the embodiment
of FIGS. 1 to 3 regarding the form of the flange 3' of the flange
1'. Flange 3' has a curvature as seen in cross section. The
curvature of flange 3' may vary. In the same way as in the previous
embodiment by the curvature of flange 3' the base plane 11 is
placed at a distance 10 from the top plane 12. Said distance 10
between the two planes 11, 12 is normally between 2 and 15 mm, and
most preferably between 3 and 10 mm.
[0034] In the embodiments shown flange 3 of flange 1 of FIGS. 1 to
3 is generally conical while flange 3' of flange 1' of FIGS. 4 and
5 has a curvature. The person skilled in the art realises that the
flange may have any curvature as long as it has a general
inclination in relation to the central axis 9 of socket 2. As
stated above the purpose of the general inclination is to adapt the
plaster to the form of the tracheostoma which normally is lowered
or depressed in relation to the surrounding skin.
[0035] Conventional paper liners cannot be used with plasters
having a flange 1, 1' with an inclined or curved flange 3, 3'.
Liner 8 most follow the form of the plaster, other-wise the
adhesive will dry at areas with no contact between plaster and
liner. Thus, it should be possible to form the liner 8 so as to
bring the shape thereof into agreement with the shape of the
adhesive tape 6, either by cold forming or by thermo forming. The
forming of the liner 8 and tape 6 may be done by means of a stamp
or by vacuum forming, or blow moulding before, during, or after the
fixation of the tape 6 to the flange 1, 1'. According to a
presently used method liner 8 and tape 6 are formed by cold forming
before securing tape 6 to flange 1, 1'. However, it is always
necessary to adapt the form of liner 8 to the form of the
plaster.
[0036] When the plaster for the tracheostoma valve is to be
applied, liner 8 is first removed. Tape 6 is then applied to the
skin surrounding the stoma. The plaster is placed in a position
where the central socket 2 is aligned with the stoma. Then, the
tracheostoma valve is attached to the socket 2. It is the lower
side of the plaster as seen in FIGS. 2 and 5 which is to be applied
against the skin of the patient. When the plaster is to be replaced
the above procedure is reversed, i.e. first the valve is removed,
then the plaster, including the annular flange 1, is removed and
discarded. Finally a new plaster is applied as stated above. Thus,
the plaster is not to be re-used, avoiding the previous problems
with cleaning of the flange.
[0037] The shape of the tape 6 can be varied in many ways. In FIGS.
6 and 7 the tape and the liner are circular and are substantially
congruent. There are no enlargements as those shown in FIGS. 1, 2
and 4. Liner 8 forms a flap 13 which projects from flap 7 on tape
6. The tape and the liner can easily be gripped at the flaps when
it is desired to remove the liner from the adhesive surface of the
tape.
[0038] In FIG. 8 tape 6 and liner 8 are oval. Flap 7 (and flap 13)
are located at one short side but can as well be located at one
long side of tape 6 and liner 8, respectively, or anywhere on the
periphery of the tape and the liner.
[0039] FIGS. 9 to 11 show a still further shape of tape 6 and liner
8. The shape is basely a rectangular shape with enlargements 6A at
two opposite sides.
[0040] The person skilled in the art realizes that the different
parts may be adapted to the actual patient. Thus, the thickness and
material of the adhesive tape may vary, e.g. due to the sensitivity
of the patient's skin or the like. The extension of the tape
outside the flange may also vary. Also the size and thickness of
the flange may be varied.
* * * * *