U.S. patent application number 15/211172 was filed with the patent office on 2017-01-19 for wound care connection device and wound care kit.
The applicant listed for this patent is LOHMANN & RAUSCHER GMBH. Invention is credited to ARNO HERZELE, CHRISTOPH HOFSTETTER.
Application Number | 20170014615 15/211172 |
Document ID | / |
Family ID | 53682395 |
Filed Date | 2017-01-19 |
United States Patent
Application |
20170014615 |
Kind Code |
A1 |
HOFSTETTER; CHRISTOPH ; et
al. |
January 19, 2017 |
WOUND CARE CONNECTION DEVICE AND WOUND CARE KIT
Abstract
The invention relates to a device for connecting multi-lumen
lines for the medical field, in particular for wound care in the
field of vacuum therapy, having a preferably one-piece basic body,
designed for tight and preferably releasable connection of at least
two line lumens, wherein the basic body, for furnishing a
distributor chamber for at least one, preferably two, three, or
more lumens, opening into it, of the connected line and preferably
at least one channel for removing a fluid from and introducing it
into the distributor chamber, and when the line is connected, the
distributor chamber is sealed off in fluid-tight fashion from at
least one line lumen in such a way that a fluid exchange between
the distributor chamber and this line lumen is prevented.
Inventors: |
HOFSTETTER; CHRISTOPH;
(WIEN, AT) ; HERZELE; ARNO; (BRUNN AM GEBIRGE,
AT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
LOHMANN & RAUSCHER GMBH |
SCHOENAU AN DER TRIESTING |
|
AT |
|
|
Family ID: |
53682395 |
Appl. No.: |
15/211172 |
Filed: |
July 15, 2016 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 13/00068 20130101;
F16L 19/065 20130101; A61M 39/105 20130101; A61M 1/0058 20130101;
A61M 1/0086 20140204; A61M 39/12 20130101 |
International
Class: |
A61M 39/10 20060101
A61M039/10; A61M 1/00 20060101 A61M001/00; A61F 13/00 20060101
A61F013/00 |
Foreign Application Data
Date |
Code |
Application Number |
Jul 16, 2015 |
EP |
15002121.0 |
Claims
1-18. (canceled)
19. A connection device for a multi-lumen tube sheath having a
central lumen and at least one additional lumen radially offset
from the central lumen, the connection device comprising: a central
collar defining a distributor chamber; at least one connection
fitting extending coaxially from the central collar; at least one
chamber bushing extending coaxially from the central collar and
spaced apart from the connection fitting to form an annular gap
between the connection fitting and the chamber bushing; and wherein
when a multi-lumen tube sheath is introduced into the annular gap,
the connection fitting is inserted into the central lumen, the at
least one additional lumen is in communication with the distributor
chamber, and the central lumen and the at least one additional
lumen are sealed off from one another in a fluid-tight fashion.
20. The device of claim 19 further comprising a stop that limits
the introduction of the tube sheath into the annular gap.
21. The device of claim 20 wherein the stop is a radial shoulder on
the connection fitting.
22. The device of claim 20 further comprising a window in the
central collar through which visual monitoring of the contact of
the tube sheath end with the stop is enabled.
23. The device of claim 19 further comprising a sealing device in
the annular gap.
24. The device of claim 23 wherein the sealing device is a sealing
shell received in the annular gap, the sealing shell having at
least one sealing lamella surrounding the chamber bushing axis and
coming into contact with the outer boundary face of the tube sheath
when it is introduced.
25. The device of claim 24 wherein the sealing shell further
comprises an encompassing bead and the chamber bushing further
comprises a radially inner indention, wherein a ring snap
connection is formed between the sealing shell and the chamber
bushing.
26. The device of claim 25 wherein the encompassing bead has at
least one opening whereby the encompassing bead does not completely
surround the sealing shell.
27. The device of claim 23, wherein the sealing device comprises a
polygonal lamella seal.
28. The device of claim 23, wherein the sealing device comprises a
round lamella.
29. The device of claim 23, wherein the sealing device is a
face-end seal.
30. The device of claim 23, wherein the sealing device is an
o-ring.
31. The device of claim 23, wherein the sealing device is a radial
shaft seal.
32. The device of claim 19 further comprising a securing device
that is adjustable between a release position, which enables the
introduction of a multi-lumen tube into the annular gap, and a
securing position, which secures a multi-lumen tube within the
connection device.
33. The device of claim 32 wherein the securing device comprises a
clamping bushing extending coaxially to the chamber bushing.
34. The device of claim 33 further comprising at least two clamping
tongues extending from the chamber bushing, wherein the clamping
tongues are offset radially inward when the clamping bushing is
moved from the release position to the securing position.
35. A connection device for connecting two multi-lumen tube sheaths
each having a central lumen and at least one additional lumen
radially offset from the central lumen, the connection device
comprising: a central collar defining a distributor chamber; a pair
of connection fittings extending coaxially and in opposite
directions from the central collar, the connection fittings
defining a continuous bore; a pair of chamber bushings extending
coaxially from the central collar and spaced apart from the
connection fittings to form an annular gap between each of the
connection fittings and the chamber bushings; and wherein when two
tube sheaths are introduced into the annular gaps, the connection
fittings are inserted into the central lumens of the tube sheaths,
the at least one additional lumen of each sheath is in
communication with the distributor chamber, and the central lumens
and the at least one additional lumens are sealed off from one
another in a fluid-tight fashion.
36. The connection device of claim 35, wherein the length of one of
the connection fittings is different from the length of the other
connection fitting, whereby the forces required to release the tube
sheathes from the connection fittings are unequal.
37. A device for connecting multi-lumen lines for the medical
field, in particular for wound care in the field of vacuum therapy,
the device comprising: a one-piece basic body designed for tight
and releasable connection of at least two multi-lumen lines, the
basic body furnishing at least one distributor chamber for at least
one line lumen to open into and a channel for removing a fluid from
or introducing a fluid to the distributor chamber; wherein when a
multi-lumen line is connected to the basic-body, the distributor
chamber is sealed off in fluid-tight fashion from at least one line
lumen such that fluid exchange between the distributor chamber and
the at least one line lumen is prevented.
38. The device of claim 37 wherein the basic body furnishes two or
more distributor chambers, of which at least two are connected with
each other via at least one channel.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is based on and claims priority to European
Patent Application Serial No. 15 002 121.0, filed on Jul. 16, 2015,
which is incorporated herein by reference in its entirety.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] Not applicable.
BACKGROUND OF THE INVENTION
[0003] The invention relates to a device for connecting multi-lumen
lines in the medical field, in particular for wound care in vacuum
therapy, having a preferably one-piece basic body designed for
tightly and preferably releasably connecting at least two line
lumens, and to a treatment kit for vacuum therapy having at least
one connection device of the invention and at least one multi-lumen
line connectable thereto.
[0004] In vacuum therapy, in order to promote the wound healing
process, a vacuum is created in the area of a wound that is to be
treated. To that end, the wound area is connected by a tube to a
corresponding pump, with which exudate from the wound area can
simultaneously be aspirated away. Additionally, it may be necessary
to measure the pressure in the wound area via a separate line
lumen, to ventilate the wound area via separate line lumens, and to
supply wound cleaning agents, medications, or the like, etc. For
individual indications, it may be advantageous to maintain a
continuous flow in the area of the wound area. For other
indications, it may be appropriate to maintain a constant vacuum.
Finally, in some indications, it is also appropriate to generate
and reduce the vacuum in a predetermined chronological order; that
is, to apply an intermittent vacuum in the area of the wound
area.
[0005] It has proved advantageous if two, three or more line lumens
are used for ventilation, while the vacuum can be generated via a
line lumen with a larger line cross section.
[0006] For the purpose of the vacuum therapy, the line lumens must
be connected to a suitable vacuum therapy apparatus. Care should be
taken that the connection on the one hand hold firmly, but on the
other that it can be opened as needed manually/in controlled
fashion easily, quickly, and in an uncomplicated way.
[0007] With the vacuum therapy apparatus, on the one hand the
vacuum is generated and on the other, optionally ventilation, or
ventilation and/or pressure measurement of the wound area and/or
other of the tasks described above are performed. Moreover, in many
cases it is necessary for two-, three- or multi-lumen lines to be
connected to one another, for instance if the position of the
vacuum therapy apparatus changes in relation to the patient and the
length of the line has to be adapted accordingly. Already existing
lines can then continue to be used, if extension lines with
suitable devices are connected tightly to them.
[0008] In EP 2 240 233 B1, a two-part connection or connection
device for the multi-lumen lines is described in which the
individual lumens of the line are realized in the form of
individual tubes. In this device, the individual tubes of a
multi-lumen line are brought into engagement in sealing fashion
with a plurality of inner tube connection plug elements in a
portion of an internal connection part; the individual inner tube
connection plug elements are brought into engagement with outer
tube connection tap elements, to which the individual tubes of the
other multi-lumen line are connected. In these connection devices,
two connection pieces must be joined together and also joined to
the individual tubes of the multi-lumen lines by the user.
[0009] A connection device for a multi-lumen tube, in which the
lumens are located in the interior of the line or tube, is
described in EP 2 240 234 B1. This known device is in two parts and
contains a connection piece to be inserted and a receiving
connection piece, each piece having a plurality of flow channels,
which must correspond exactly to the number and the shape and
dimensions design (round, oval; diameter, etc.) of the lumens
present in the line. In EP 2 536 448 B1, a coupling part for
separate tubes is described, which has a device that enables fluid
delivery from a service channel into a drainage channel but
prevents fluid from flowing in the reverse direction.
[0010] In WO 2010/127461 A1, a two-piece coupling arrangement is
described, with which multi-lumen tubes (preferably those that have
a central drainage line and three additional lines arranged around
that drainage line) can be connected to one another. Both the
drainage line and the additional lines can discharge into a common
chamber in order to measure the pressure there. In a connection
device of U.S. Pat. No. 8,002,313 B2, a chamber is provided in
which the lumens of a first and second tube can communicate with
one another, even when the tubes are mounted radially offset from
one another.
[0011] It is also prior art to realize multi-lumen lines in the
form of tubes that are penetrated axially by a plurality of lumens.
In that case, it is no longer necessary to join individual tubes to
one another. Instead, it suffices to connect just one multi-lumen
tube. In these known multi-lumen tubes, a central lumen may be
provided, which extends coaxially to the tube axis. Further lumens
of the tube can be located radially offset from one another and
penetrate the tube sheath, defining the central lumen, in the axial
direction parallel to the tube axis. It is especially advantageous
to have an odd number of additional lumens, especially preferably
three additional lumens. The radially offset additional lumens can
be equipped with a smaller cross section than the central lumen.
Two, three or more radially located, circumferentially offset
additional lumens may be provided. When such multi-lumen tubes are
connected, in particular when such multi-lumen tubes are joined,
care must be taken that the individual lumens of the one tube
communicate fluidically with the corresponding lumen of the other
tube, without there being an unwanted connection between tube
lumens that serve different purposes. For instance, in many cases
care must be taken that the central lumen used to generate the
vacuum not enter into communication with the radially offset
additional lumens, and at the same time, the radially offset
additional lumens of the multi-lumen tubes to be joined together
must be joined to one another as well.
[0012] This joining proves problematic in many cases, because it
requires a positionally correct location of the individual tube
lumens relative to one another, especially the radially offset
additional lumens, which extend eccentrically, or in other words
non-concentrically, to the tube axis. The individual radially
offset additional lumens can be located on a circumference of the
tube sheath, the circumference being concentric with the tube
axis.
BRIEF SUMMARY OF THE INVENTION
[0013] In view of these problems in the prior art, the object of
the invention is to furnish a connection device for multi-lumen
lines for wound care, in particular in the field of vacuum therapy,
which enables simple connection of the lines while reliably
ensuring the desired separation among individual line lumens.
[0014] According to the invention, this object is attained by a
refinement of the known connection devices, which is characterized
essentially in that the basic body is designed to furnish a
distributor chamber for at least one lumen of the connected line,
the at least one lumen opening into that chamber, and preferably to
furnish at least one channel for removing and introducing a fluid
from or into the distributor chamber, and when the line is
connected, the distributor chamber is sealed off in fluid-tight
fashion from at least one line lumen in such a way that a fluid
exchange between the distributor chamber and this line lumen is
prevented.
[0015] The invention is based on the recognition that the
connection or communication of multi-lumen lines need not take
place via direct connection of the individual line lumens or by
direct communication of the individual line lumens; it can also
happen with an interposed distributor chamber. By incorporating
such a distributor chamber, a reliable communication can be
effected even without exact alignment of the individual lumen
orifices. For instance, it is possible for individual eccentrically
located additional lumens of a multi-lumen tube to discharge into a
common distributor chamber, which is sealed off from a
communication region for a central lumen of the tube. On the other
hand, the channel provided for introducing a fluid into or removing
it from the distributor chamber can discharge into a different
distributor chamber, which in turn is in communication with
orifices of eccentrically located additional lumens of a different
multi-lumen tube. In this way, the radially offset additional
lumens can be made to communicate fluidically by the interposition
of at least one distributor chamber, without requiring the
individual radially offset additional lumens to be aligned with one
another in a predetermined rotary position.
[0016] In the context of the invention it is also possible to join
tubes to a variable number of radially offset additional lumens. If
one end of a tube, having three radially offset additional lumens,
opens into the distributor chamber and on the other side one end of
the tube is to be joined together with a different number of
radially offset additional lumens, such as five additional lumens,
a reliable fluid exchange can take place between the additional
lumens via the distributor chamber.
[0017] Moreover, it is possible for such tubes to communicate with
one another while avoiding an unwanted fluid exchange, where two,
three or more "central" lumens are surrounded by radially offset
additional lumens; the central lumens are also separate from one
another and from the radially offset additional lumens.
[0018] The term "fluid" in the context of the present invention
disclosure means a liquid and/or a gas.
[0019] In addition to the distributor chamber, optionally formed
together with the line, the basic body can have at least one
connection fitting, designed for connecting at least one line
lumen, in particular the central lumen of a multi-lumen tube, which
connection fitting is preferably designed for introduction into at
least one line lumen, in particular the central line lumen of the
multi-lumen tube. The distributor chamber can surround the
connection fitting at least partially, preferably completely. With
the aid of the connection fitting, a reliable separation between
the central lumen and the radially offset lumens of a multi-lumen
tube is ensured. For connecting tubes with two, three or more
central lumens, an equivalent number of connection fittings may be
provided.
[0020] If the basic body has a channel for introducing and removing
a fluid into and from the distributor chamber, then the channel can
be formed in a collar that at least partly surrounds the connection
fitting. The collar widens the connection fitting radially. The
channel located therein can extend approximately parallel to the
connection fitting and the tube axis or line axis of the connected
line.
[0021] It has proved especially advantageous if the distributor
chamber is defined by a chamber bushing beginning at the collar and
extending approximately parallel to the connection fitting, and if
between the connection fitting and the chamber bushing, an annular
gap is designed for receiving a sheath, penetrated by at least one
lumen, of a multi-lumen line. The axial end, facing away from the
collar, of the connection fitting and/or of the chamber bushing can
be chamfered to facilitate introducing a multi-lumen tube; the
inside diameter of the chamber bushing optionally tapers beginning
at its end facing away from the collar, in the direction of the
collar, or the outside diameter of the connection fitting,
beginning at the end facing away from the collar, increases in the
direction of the collar, so that the width of the annular gap
decreases in the direction of the collar.
[0022] When devices of the invention are used for connecting
multi-lumen lines, the distributor chamber can be embodied
especially simply if a stop is provided that limits the
introduction of the sheath into the annular gap, is located at an
axial spacing from the collar, and is preferably embodied as a
radial shoulder on the connection fitting and/or of the chamber
bushing. Then the distributor chamber is defined by the fitting,
the chamber bushing, the collar, and the sheath end face contacting
the stop; an axial spacing between the collar and the sheath end
face is specified by the position of the stop.
[0023] In particular in this last-described embodiment of the
invention, it has proved expedient if the basic body is made at
least partly of transparent material and/or has a window, so that
the introduction of the tube end into the annular gap can be
observed and monitored. It has proved especially appropriate if the
basic body, at least in the vicinity of the stop, is formed of
transparent material and/or is equipped with at least one
observation window. As already mentioned above, the connection
fitting serves as a seal between the central lumen of a multi-lumen
tube and the radially offset additional lumens, which discharge
into the distributor chamber. Furthermore, with the aid of the
connection fitting, a sealing separation between the distributor
chamber and the central tube lumen is also effected. The sealing
closure can be effected especially simply and reliably if the
connection fitting tapers in the direction toward its axial end
facing away from the collar, so that when the central lumen is
slipped onto the connection fitting or when the connection fitting
is introduced into the central lumen, the central lumen is
stretched. As a result, a firm seat of the central lumen on the
connection fitting is achieved, and the sealing effect
develops.
[0024] Sealing the distributor chamber from the environment can be
achieved if a sealing device is provided which when the sheath is
introduced into the annular gap comes into contact with an end face
of the sheath; the sealing device expediently comes into contact
only with a radially outer ring of the end face, without closing
the radially offset additional lumens of the tube connection, as
will be explained hereinafter in conjunction with FIG. 4c. In
addition or alternatively, for sealing off the distributor chamber
from the environment, the connection device of the invention can
have a sealing device that preferably completely surrounds the
sheath and that, when the sheath is introduced into the annular
gap, comes into contact with an outer boundary face, surrounding
the line axis, of the sheath. This sealing device can have a
sealing shell that is received in the annular gap between the
connection fitting and the chamber bushing and has at least one and
preferably two, three or more axially spaced-apart sealing lips or
lamellas that surround the bushing axis and come into contact with
the outer boundary face of the sheath. These sealing lips or
lamellas can be embodied elastically and can be injected by an
injection-molding process into a solid sealing shell body. Then,
the fixed sealing shell body on the one hand and sealing lips or
lamellas on the other enter into a solid connection with one
another. The thus-formed sealing shell can then be introduced into
the basic body.
[0025] The sealing shell can be clipped into a surrounding inner
groove of the chamber bushing via an annular snap connection, to
obtain a positive connection. In addition or alternatively, it may
also be joined to the basic body materially or nonpositively.
However, the above-addressed positive connection between the
sealing shell and the chamber bushing has proved especially
expedient. If the sealing shell has two, three or more axially
offset sealing lips, then a pressure gradient occurs between the
individual chambers defined by the sealing lips, which ensures an
especially tight communication or connection of the multi-lumen
line.
[0026] With regard to the annular snap connection, the sealing
shell on its radially outer sheath face preferably has an annular
bead that is complementary to the inner groove of the chamber
bushing and surrounds it azimuthally. The embodiment may be made
such that this annular bead enters into a fluid-tight engagement
with the inner groove. Alternatively, however, it may be
advantageous to provide an axial interruption or opening in the
annular bead, at at least one point and preferably at two
diametrically opposed points. As a result, it is true that the
tightness of the engagement between the bead of the sealing shell
and the groove of the chamber bushing is undone. However, it is
then possible for an ethylene dioxide (EO) sterilization to take
place through the interruption or opening.
[0027] For relieving the sealing communication between the
connection device on the one hand and the multi-lumen line on the
other, it has proved especially advantageous if a securing device
that is adjustable between a release position, which enables the
connection of the multi-lumen line, and a preferably acoustically
confirmable securing position, which secures the connected line to
the basic body, is provided. This securing device can be embodied
on the order of a clamping mechanism, with which the line lumen is
held on the connection device independently of the sealing
connection. This securing device can have a clamping bushing which
extends coaxially to the chamber bushing and is rotatable and/or
axially displaceable between the release position and the securing
position. The clamping bushing can cooperate with a clamping body
which is mounted on the basic body of the connection device and
which, in the securing position, is forced against the outer
boundary face of the line.
[0028] The clamping body can have at least one clamping tongue,
embodied preferably in one piece with the chamber bushing and from
there extending approximately parallel to the bushing axis in the
direction of an axial end of the connection device, and the end of
the clamping tongue remote from the chamber bushing is forced
radially inward toward the bushing axis into the securing position
by adjusting the securing device.
[0029] The clamping action can be brought about especially simply
and reliably if the clamping bushing has a clamping ramp associated
with the respective clamping tongue that, from where the ramp
begins, rises in the direction of the end of the ramp in direction
of the bushing axis and comes into contact with a radially widened
region of the clamping tongue, so that an adjustment of the
clamping bushing causes a displacement of the ramp relative to the
clamping tongue, as a result of which a raised area of the clamping
tongue is offset radially inward, beginning when it is in contact
with the beginning of the ramp, in the direction of where it is in
contact with the end of the ramp. The ramp in the clamping bushing
can extend circumferentially. In this embodiment of the invention,
the clamping action is brought about by a rotary motion of the
clamping bushing by means of the bushing axis. Alternatively or in
addition, the clamping ramp can extend in the axial direction.
Then, the clamping action is effected by an axial motion of the
clamping bushing (push or pull motion).
[0030] In all the embodiments of the invention, it has proved
expedient if the motion of the clamping bushing is limited by a
stop. When the clamping bushing comes into contact with the stop, a
noise can be produced, in order to provide an acoustical
confirmation of closure. For especially secure clamping, it has
proved especially expedient if the clamping action wanes somewhat
when the securing position is reached, so that the clamping bushing
can be moved in reverse into the release position again only
counter to a (slight) force exerted from outside. This can be
attained for instance by providing that the ramp end, on reaching
the securing position, slides over the apex of the radially raised
area of the clamping tongue, so that the clamping tongue has
reached its maximum deflection inward even before reaching the
securing position, and springs back again somewhat in the securing
position.
[0031] To facilitate adjusting the securing device from the release
position into the securing position, the clamping tongue can be
placed, with an intentional bending point, against the chamber
bushing. The intentional bending point can be embodied as a
thinning of material at the transition between the chamber bushing
and the clamping tongue.
[0032] As already explained at the outset, generic connection
devices are also used to furnish an optionally separable connection
for multi-lumen tubes. Known connection devices, which enable that
kind of connection, have at least two parts, which have to be
joined tightly together by the user in order to be able to
establish a communication of the tubes with one another. In these
known devices, the various parts are typically firmly joined to the
respective tube ends (for instance by gluing). During vacuum
therapy, however, it is often necessary for the tubes that connect
the vacuum therapy apparatus and the wounds to be shortened at an
arbitrary point and rejoin them, for example whenever the position
of the apparatus changes in relation to the patient. Moreover, an
easy exchange, for instance of the part of a tube toward the wound
or toward the pump, should be ensured. In connection devices that
comprise two or more parts to be joined together, however, this is
possible only with difficulty. This is especially true if the
individual parts of the devices are solidly joined to the ends of
the tubes.
[0033] If the connection device of the invention is designed for
joining multi-lumen lines with two, three or more lumens, it has
proved expedient if the basic body has two, three or more
connection fittings, each of which can be introduced into a central
lumen of a line and are joined together and/or is designed for
furnishing two, three or more distributor chambers, of which
preferably at least two can be joined together via at least one
channel.
[0034] In this way, a one-piece connection device is furnished that
makes it possible to shorten tubes at an arbitrary point and rejoin
them, which makes for easier use, enables more-flexible treatment,
and reduces costs. Moreover, the safety of the system is enhanced,
since because the device is in one piece, the user no longer has to
seal the area joining the separable parts of the known connection
device. This minimizes the risk of user error. Within the scope of
this invention, the term "one-piece connection device" is used for
a device such that the user is able to join all the necessary tube
ends together without having to join individual device parts
together beforehand. In the process the tubes are joined by joining
the tube to a connection region of the connecting device, for
instance by slipping a central tube lumen over onto a connection
fitting of the device.
[0035] In a one-piece connection device of this kind according to
the invention for connecting multi-lumen tubes, connection fittings
extending from the collar in opposite directions from one another
can be provided which are each surrounded by a chamber bushing,
beginning at the collar and extending in opposite directions,
creating two annular gaps between the connection fittings on the
one hand and the chamber bushings on the other; their orifices face
away from one another, and a seal can be inserted into each of
them. Each of the chamber bushings can be assigned a clamping
bushing, and the clamping bushing can be displaced independently of
one another between a securing position and a release position.
Between the clamping bushings, outer boundary faces of the basic
body of a connection device of the invention that are out in the
open can be provided, which makes using the clamping bushings
easier. The exposed area of the basic body can surround the collar
and can have a concave contour, in order to facilitate access to
it. If a connection device for three multi-lumen tubes according to
the invention is to be used, the connection fittings can extend,
beginning at a central region, in the shape of a Y in different
directions. The correct clamping bushings can then be assigned to
each connection fitting. The axial length of the connection
fittings is the same or different, depending on the desired
behavior of the various embodiments in use.
[0036] To avoid injuring a patient in the event of an unintended
movement of the vacuum therapy apparatus, it has proved expedient
if the forces required to release the lines from the basic body,
when a securing device has been displaced in the securing position,
differ from one another for at least two securing devices. This can
be attained for instance by providing that the connection fitting
is embodied in various lengths. If the connection fitting extends
as far as the clamping point of the securing device, which is
optionally determined by clamping hooks of the clamping tongues,
the securing device withstands stronger tensile forces on the tube
than in a shorter embodiment of the connection fitting.
Expediently, the clamping at the end of the connection device of
the invention toward the vacuum therapy apparatus is lessened.
Other possibilities for attaining the same effect would for
instance be different thicknesses/degrees of tapering of the
connection fittings, seals of varying softness, different clamps,
different shape of the clamping tongues, the clamping height, etc.
Alternatively or in addition, different release forces can be
attained by means of different thicknesses/degrees of tapering of
the connection fittings, seals with different moduli of elasticity,
different clamping rings, and/or different clamping mechanisms.
[0037] As can be learned from the foregoing explanation of
connection devices of the invention, a treatment kit of the
invention has at least one connection device and at least one
multi-lumen tube connectable to it; the tube can have a central
lumen, defined by a tube sheath, and at least one additional lumen
which penetrates the tube sheath in a direction extending parallel
to the tube axis and parallel to the central lumen; the at least
one additional lumen, after connection to the connection device,
opens into the distributor chamber, and/or the connection fitting
can be introduced into the central lumen. The tube preferably has a
central lumen as well as three symmetrically arranged additional
lumens.
[0038] Additional aspects of the invention, together with the
advantages and novel features appurtenant thereto, will be set
forth in part in the description which follows, and in part will
become apparent to those skilled in the art upon examination of the
following, or may be learned from the practice of the invention.
The objects and advantages of the invention may be realized and
attained by means of the instrumentalities and combinations
particularly pointed out in the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0039] The invention will be explained below in conjunction with
the drawings, to which reference is made regarding all details
essential to the invention that are not described in detail in the
specification. In the drawings:
[0040] FIG. 1 is a schematic view of a multi-lumen tube for a
treatment kit according to the invention for vacuum therapy;
[0041] FIG. 2 is a view of a first embodiment of a connection
device of the invention;
[0042] FIG. 3 is a schematic detail view of a connection device of
the invention;
[0043] FIG. 4 shows sealing devices for a connection device of the
invention;
[0044] FIG. 5 shows securing devices for connection devices of the
invention;
[0045] FIG. 6 shows a further embodiment of a connection device of
the invention; and
[0046] FIG. 7 shows one embodiment of a sealing shell.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENT
[0047] FIG. 1a shows a radial sectional view of a multi-lumen tube
that can be used for a kit according to the invention. FIG. 1b
shows an axial sectional view of the tube of FIG. 1a. The
multi-lumen tube, indicated as a whole by reference numeral 10 and
having a multi-lumen line, has a central lumen 20 surrounded by a
tube sheath 12. The tube sheath 12 is penetrated by a number of
additional lumens 30 located radially offset from the central lumen
20. The additional lumens are offset uniformly from one another in
the circumferential direction. They have a smaller cross-sectional
area than the central lumen 20. The centers of the radially offset
additional lumens 30 are located on a circumference that extends
coaxially to the tube axis.
[0048] In kits of the invention, the central lumen 20 can be used
to create a vacuum in the wound area and to aspirate exudate away
from the wound area, while the radially offset additional lumens 30
can be used for instance to ventilate the wound area for pressure
measurement, and/or for delivering medication and cleaning fluids,
etc. The central lumen 20 on the one hand and the radially offset
lumens 30 on the other must be separated from one another, at least
along the way between the vacuum therapy apparatus and the wound
area.
[0049] In preferred multi-lumen tubes of the invention, a central
lumen 20 and an odd number of symmetrically arranged additional
lumens 30, radially offset from the central lumen 20, are provided.
This ensures an especially secure connection of the wound to the
vacuum therapy apparatus, since as a result of this geometry, even
if the tube becomes clamped or kinked, at least one of the
additional lumens will merely be minimally deformed; thus in a
pressure measurement, for instance, there will be no loss of
information and also, there is no need to fear a disruption of
communication (for instance when ventilating the wound).
[0050] The tube geometry shown in FIG. 1, with three symmetrically
arranged, radially offset additional lumens, has proved especially
advantageous. With this geometry, if kinking occurs, only one or
two of three lumens will be significantly deformed, and the shear
forces inside the tube in the event of clamping and kinking have a
minimal effect on the passability of the lumens.
[0051] The connection device shown in FIG. 2 is designed for
connecting two multi-lumen tubes of the type shown in FIG. 1. The
connection device, identified overall by reference numeral 100,
includes a basic body 110, two sealing shells 140, and two clamping
bushings 160.
[0052] The basic body 110 has a central collar 112, beginning at
which two connection fittings 114 extend coaxially to one another
in opposite directions from one another. The connection fittings
114 are penetrated by a continuous bore 115. The collar 112
surrounds the connection fittings 114 completely. At a radial
spacing from the connection fittings 114, chamber bushings 116 are
placed against the collar 112. The chamber bushings 116 extend
coaxially to one another and coaxially to the connection fittings
114 in directions opposite one another, beginning at the collar
112. Between the chamber bushings 116 and the connection fittings
114, annular gaps are formed, into which the sheath 12 of the
multi-lumen tube 10 can be introduced. The insertion depth of the
tube into the annular gap is limited by stops 120, which on their
ends facing toward the collar 112 are embodied as radially widened
areas of the connection fittings 114. As indicated at 121, the
chamber bushings, in the vicinity of the collar or of the stops
112, are equipped with windows, which enable visual monitoring of
the contact of the end faces of the tube 10 with the stops 120.
[0053] The sealing shells 140 are inserted into the annular gaps
formed between the connection fittings 114 and the chamber bushings
116, so that the outer boundary faces of the sealing shells, with
the aid of a ring snap connection, rest in positive fashion on the
inner boundary face of the chamber bushings. The sealing shells 140
include a rigid or nondeformable sheath body 142, for instance of
polypropylene, and a plurality of axially spaced-apart deformable
sealing lamellas 144, which when the line 10 has been thrust in
rest on the outer boundary face of the line and thus form a
multi-chamber seal. In other embodiments of the invention, it is
possible for only a sealing lamella to be provided. On the outer
boundary face of the rigid sealing shell 142, an encompassing bead
142a is formed, which to form the ring snap connection is received
in a radially inner indention of the chamber bushing 116.
[0054] FIG. 7 illustrates an embodiment in which the bead 142a is
not embodied as completely surrounding but instead has two
diametrically opposed interruptions or openings 142b. This allows
the passage of sterilization gas in ethylene dioxide (EO)
sterilization.
[0055] Within the scope of the invention, the use of a rigid sheath
body is not absolutely necessary. The seal can also be made in some
other way. For instance, it can be glued, injected directly, or
implemented in the form of a commercially available seal. Moreover,
it is not absolutely necessary that the sealing lamellas be
deformable. It suffices if the tube is resilient. Then the tube
forms the sealing body, which conforms to a rigid structure of the
sealing shell. The insertion depth of the sealing shells 140 is
limited by a stop of the chamber bushings. In this area, the
sealing body that has the sealing lamellas fits over the end face
of the rigid sealing shell 142, to enable face-end sealing of the
annular gap between the connection fittings 114 and the chamber
bushings 116.
[0056] Between the stops that limit the insertion depth of the tube
into the annular gap and the surrounding collar 112, a distributor
chamber 200 is formed once the tube has been inserted. The
distributor chambers 200 formed on both sides of the collar 112
communicate with one another via channels 113 (see FIG. 3). It is
thus possible to join the radially offset additional lumens 30 of
the tube sheaths 12, inserted into the annular gaps, to one another
regardless of the rotary position of the sheaths relative to the
connecting device; sealing the radially offset additional lumens
from the central lumen 20 is made possible with the aid of the
connection fittings 114. The connection fittings 114 are introduced
into the central lumen 20 of the tubes when the tubes 10 are
connected. The outer boundary faces of the connection fittings 114
broaden, beginning at the ends facing away from the collar 112 and
extending toward the collar, so that the central lumen 20 is
widened upon introduction of the connection fittings 114, and a
tight seat of the tubes 10 on the connection fittings 114 is
achieved; at the same time, sealing occurs from contact of the
sealing lamellas 144 with the outer boundary face of the sheath
12.
[0057] On the chamber bushings 116, on their ends facing away from
the collar 112, clamping tongues 130 are located, which are placed
against the chamber bushings 116 via areas of thinned material 132.
The chamber bushings 116 and clamping tongues 130 are surrounded by
clamping bushings 160. In the embodiment of the invention shown in
FIG. 2, the clamping tongues 130, on their ends facing away from
the chamber bushings 116, have thickened areas 136 that radially
widen the clamping tongue 130. In addition, radially on the inside,
the clamping tongues 130 are provided with clamping teeth 138 that
become wider radially inward. The clamping bushings 160 are
equipped on the inner boundary faces with radially inner clamping
rings 162 that reduce the inside diameter of the clamping bushings
160. When the clamping bushings 160, beginning at the release
position shown in FIG. 2, which enables the introduction of the
multi-lumen tube into the annular gaps between the connection
fitting 114 and the chamber bushing 116, are pushed away from the
collar 112, the clamping rings 162 come into contact with the
thickened area 136 and press the clamping tongue 130 as a whole
radially inward; shifting the position of the clamping tongues 130
is facilitated by the intentional bending points 132 in the
transition region between clamping tongues 130 and chamber bushings
160.
[0058] In the course of the axial motion of the clamping bushing
160 relative to the clamping tongue 130, the clamping ring 162
slides over the apex of the thickening 136, so that a return motion
from the securing position thus reached to the release position
shown in FIG. 2 is possible only by overcoming a thrusting force.
Upon reaching the securing position, radially inner stop ribs 164
of the clamping bushing 160 come into contact with radially outer
stop ribs 134 of the chamber bushing 116, so that reaching the
securing position is confirmed acoustically. In the securing
position, the clamping teeth 138 engage the outer boundary face of
the tube sheath 12, so that the tube sheath is secured against
coming loose from the connection device 100. As can be seen in FIG.
2, in the release position as well, the clamping bushings are
located at an axial spacing from one another that is defined by the
collar 112 with radial widening. This makes separately actuating
the clamping bushings 160 easier. The collar 112, on its outer
boundary face, has an indentation that eases access to the basic
body.
[0059] As can also be seen in FIG. 2, the connection fittings 114
of the basic body 110 are embodied in various lengths. It is thus
attained that the forces required to release the tubes from the
connection fittings are unequal. The clamping bushings can be
embodied as rounded on the face end, in order to prevent their
catching on other objects. Conversely, in alternative embodiments,
the lengths of the connection fittings 114 are equal. Markings that
indicate the possible directions of motion can be made on the outer
boundary faces of the clamping bushings. These markings can be
embodied for instance in the form of axial double arrows, labels
(up/down) and/or symbols (padlock, etc.). The markings can be
embodied as raised/indented and optionally roughened/polished
surface regions or simply painted on, glued on, etc., in order to
facilitate the use of the connection device. The surface regions of
the clamping bushings can be roughened and/or can contain grooves,
rings, structured areas, etc. (or even have no marking), to prevent
a person's finger from slipping in use.
[0060] In FIG. 4, variations of possible seals between the
multi-lumen tube and the basic body of a connection device of the
invention are shown. FIG. 4a shows a polygonal lamella seal; FIG.
4b shows a seal with a round lamella; FIG. 4c shows a face-end seal
outside the radially offset additional lumens between the end faces
of the tubes and collar 112. FIG. 4d shows a seal via sealing rings
embodied as O-rings. Finally, as in FIG. 4e, a radial shaft seal
can also be used.
[0061] In FIG. 5, variations of securing devices of connection
devices of the invention are shown. FIG. 5a essentially corresponds
to the securing device of FIG. 2; a radially inner clamping ring
162, upon displacement of the clamping bushing 160 from the release
position to the securing position, slides along radially widening
clamping ramps of the clamping tongues 130 and offsets the clamping
tongues 130 radially inward; the clamping teeth 138 enter into
engagement with the outer boundary face of the tube sheath 12. In
the embodiment shown in FIG. 5a, in all four clamping tongues 130
spaced apart from one another in the circumferential direction are
provided; with the aid of the axial motion of the clamping bushing
160, they can be forced against the outer boundary face of the tube
sheath 12. The clamping bushings 160 are pulled apart in the
process, which can be seen by comparing the various views in FIG.
5a. The securing position of the securing device is shown at bottom
right.
[0062] In the embodiment of the invention shown in FIG. 5b, the
securing position is reached by rotation of the clamping bushing.
To that end, in the vicinity of the inner boundary face of the
clamping bushing, clamping ramps extending in the circumferential
direction are provided, which by rotation of the clamping bushing
bring about radial shifting of the clamping tongues 130. An
advantage of this embodiment of the invention is the reduced space
required.
[0063] Finally, the clamping tongues in the embodiment of FIG. 5c
can be radially offset inward by axially compressing the clamping
bushings 160. To that end, corresponding clamping ramps 160a are
provided on the inner boundary face of the clamping bushings 160
and cooperate with thickenings 130a on the outer boundary faces of
the clamping tongues 130.
[0064] The connection device of FIG. 6 is intended for a total of
three multi-lumen tubes. For that purpose, the connection device of
FIG. 6 has a total of three connection fittings 114, 114', 114'',
each surrounded by a chamber bushing 116, 116', 116'',
respectively, so that a total of three annular chambers are
available for introducing tube sheaths of multi-lumen tubes. The
central lumens of the tubes can be joined together via bores that
penetrate the connection fittings. The radially offset additional
lumens can be joined via corresponding channels in the basic body
110. Each connection fitting of the embodiment of the invention
shown in FIG. 6 is assigned clamping tongues 130, 130', 130'' and
clamping bushings 160, 160', 160'' of the type shown in FIGS. 2
through 4. One of the connection fittings 160'' of the connection
device shown in FIG. 6 is embodied as shorter than the other two
connection fittings 160, 160'. That connection fitting serves for
instance to join a multi-lumen tube to the vacuum therapy
apparatus. The connection can be more easily released than that of
the other multi-lumen tubes thrust onto the other connection
fittings, since in these other tubes the connection fittings forms
an abutment for the clamping tongues, so that the clamping force
can be reinforced. Thus a "rated breaking point" can be furnished
in the vicinity of this connection fitting.
[0065] The invention is not limited to the embodiments of the
invention explained in conjunction with the drawings. Connection
devices according to the invention can also be used by directly
connecting a multi-lumen tube to a vacuum therapy apparatus.
Moreover, they can be used for connecting four or more multi-lumen
tubes. An arbitrary number of additional lumens, which are joined
together via distributor chambers, can be used.
[0066] While specific embodiments have been shown and discussed,
various modifications may of course be made, and the invention is
not limited to the specific forms or arrangement of parts and steps
described herein, except insofar as such limitations are included
in the following claims. Further, it will be understood that
certain features and subcombinations are of utility and may be
employed without reference to other features and subcombinations.
This is contemplated by and is within the scope of the claims.
* * * * *