U.S. patent application number 12/698241 was filed with the patent office on 2012-06-21 for catheter device.
This patent application is currently assigned to COLOPLAST A/S. Invention is credited to Lars Bogelund Jensen, Allan Tanghoj.
Application Number | 20120157973 12/698241 |
Document ID | / |
Family ID | 42541024 |
Filed Date | 2012-06-21 |
United States Patent
Application |
20120157973 |
Kind Code |
A9 |
Tanghoj; Allan ; et
al. |
June 21, 2012 |
CATHETER DEVICE
Abstract
A kit for preparing a medical catheter from catheter sections
comprises a tubular protective member surrounding a first, proximal
one of the catheter sections. The kit further comprises a joint for
interconnecting the catheter sections, the joint defining a
substantially liquid tight seal at one end of a substantially
annular and longitudinally extending cavity provided between the
proximal end portion of the first catheter section and an inner
wall of the tubular protective member. Following removal of the
tubular protective member, one of the catheter sections is exposed
and ready for insertion into the urehtra.
Inventors: |
Tanghoj; Allan; (Kokkedal,
DK) ; Jensen; Lars Bogelund; (Roedovre, DK) |
Assignee: |
COLOPLAST A/S
Humlebaek
DK
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20100204682 A1 |
August 12, 2010 |
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Family ID: |
42541024 |
Appl. No.: |
12/698241 |
Filed: |
February 2, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10722574 |
Nov 28, 2003 |
7682353 |
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12698241 |
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10184081 |
Jun 28, 2002 |
8066693 |
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10722574 |
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09893514 |
Jun 29, 2001 |
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10184081 |
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10026819 |
Dec 27, 2001 |
7311698 |
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09893514 |
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10026819 |
Dec 27, 2001 |
7311698 |
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10722574 |
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Current U.S.
Class: |
604/544 |
Current CPC
Class: |
A61M 2025/0175 20130101;
A61M 2025/0025 20130101; A61M 25/0023 20130101; A61M 25/0009
20130101; A61M 25/002 20130101; A61M 2202/0496 20130101; A61M
25/0067 20130101; A61M 25/0054 20130101; A61F 5/44 20130101; A61M
25/01 20130101; A61M 25/0017 20130101; A61M 2205/04 20130101 |
Class at
Publication: |
604/544 |
International
Class: |
A61M 25/16 20060101
A61M025/16 |
Foreign Application Data
Date |
Code |
Application Number |
Jun 29, 2001 |
DK |
PA200101041 |
Claims
1. A kit for preparing a catheter for draining a human bladder, the
kit comprising at least two catheter sections defining a
longitudinally extending passage therein, the sections being
arranged in a coextending fashion with a tubular protective member
surrounding a first, proximal one of said catheter sections, the
kit further comprising a joint for interconnecting the first and
the second catheter section, the joint defining a substantially
liquid tight seal at a distal end of a substantially annular and
longitudinally extending cavity provided between the proximal end
portion of the first catheter section and an inner wall of the
tubular protective member, the tubular protective member being
removably connected to the joint and/or to the second catheter
section, so that, when the tubular protective member is removed, a
proximal end portion of the first catheter section is exposed and
ready for indertion into the human urethra.
2. A kit according to claim 1, wherein the sections are adapted to
be moved between at least two positions with respect to each other,
and wherein the second section, in a first position with respect to
the first section, surrounds the first section and in a second
position with respect to the first section, forms an extension for
the first section.
3. A kit according to claim 2, wherein the joint is a telescopical
joint providing a liquid tight seal between the first catheter
section and the second catheter section while the sections are
moved between the first position and the second position.
4. A kit according to claim 2, wherein the first and second
catheter section is provided with co-operating locking means for
locking the position of the first section with respect to the
second section, when the sections are in the second position with
respect to each other.
5. A kit according to claim 3, wherein, when the tubular protective
member has been removed, the telescopical joint defines a liquid
tight seal between the second catheter section and an ambient
atmosphere.
6. A kit according to claim 1, wherein a distal end of the second
catheter section is provided with a removable liquid-tight
seal.
7. A kit according to claim 2, wherein the tubular protective
member is engaging the first catheter section so as to allow the
first catheter section to be moved between the first and second
position via the tubular protective member.
8. A kit according to claim 2, wherein the tubular protective
member is adapted to be disengaged from the first catheter section,
when the first catheter section reaches the second position.
9. A kit according to claim 2, wherein a distal end of the first
catheter section seals an opening in a distal end of the second
catheter section while the first catheter section is in the first
position.
10. A kit according to claim 9, wherein annular cavity in one end
is sealed by a seallngly engagement between the tubular protective
member and the first catheter section when the tubular protective
member is engaging the first catheter section.
11. A Kit according to claim 9, wherein the annular cavity is open
to the ambient atmosphere when the tubular member disengages the
first catheter section.
12. A kit according to claim 1, wherein the catheter has a
hydrophilic surface, and wherein a liquid swelling medium is
provided in the annular cavity.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to an elongated tubular
catheter member for draining bodily fluids, e.g. from the
bladder.
BACKGROUND OF THE INVENTION
[0002] Catheters for draining the bladder are increasingly used for
intermittent as well as indwelling or permanent catheterisation.
Typically catheters are used by patients suffering from urinary
incontinence or by disabled individuals like para- or tetraplegics
who may have no control permitting voluntary urination and for whom
catheterisation may be the way of urinating.
[0003] Catheterisation is thus increasingly becoming a daily-life
procedure significantly improving quality of life for a large group
of patients.
[0004] Typically, catheters are designed for one-time use and
accordingly the costs for producing, packing and sterilising a
catheter is an important issue. Existing catheters are made from a
single piece of a continuous catheter tube. Typically, the
thickness of the catheter tube is constant throughout its
length.
[0005] The length of the catheter enables insertion of a certain
length into the urethra until urine starts to flow. At this point,
a certain over-length of the catheter should be available. The
over-length supports for the user to firmly hold the catheter and
to guide the urine to a place of disposal and to withdraw the
catheter safely and without any risk of the catheter disappearing
into the urethra.
[0006] Existing catheters are designed to minimise the risk of
sores in the mucous membrane and to give substantially no sensation
of pain during insertion. Accordingly known catheters are typically
provided with a smooth and slippery surface optimised for safe and
comfortable insertion into the urethra. Therefore, it may often be
difficult, not least for the disabled user, to handle the catheter
by manipulation of the slippery over-length.
[0007] It is often important that the tubular member does not
collapse or kink and thereby blocks the passage for the urine to
drain through the catheter. Existing catheters are therefore
typically made from a form stabile and relatively hard but still
bendable tube e.g. made from PVC, PU or PE. Since the hardness of
the tubes is selected relatively high with the view to avoid
kinking, the catheters may collapse if they are bend with a too
small radius of curvature.
[0008] Accordingly, existing catheters not only have a considerable
length but they are also typically packed in an elongate condition.
Therefore the existing catheters may be troublesome to handle and
to bring along, not least for the individuals for whom
catheterisation is a daily-life procedure, wherein catheterisation
takes place several times a day and wherein the used catheters must
be disposed via the garbage collection.
DESCRIPTION OF THE INVENTION
[0009] It is an object of preferred embodiments of the present
invention to overcome the above described disadvantages of the
known catheters.
[0010] Accordingly, the invention provides a kit for preparing a
catheter for draining a human bladder, the kit comprising at least
two catheter sections defining a longitudinally extending passage
therein, the sections being arranged in a coextending fashion with
a tubular protective member surrounding a first, proximal one of
said catheter sections, the kit further comprising a joint for
interconnecting the first and the second catheter section, the
joint defining a substantially liquid tight seal at a distal end of
a substantially annular and longitudinally extending cavity
provided between the proximal end portion of the first catheter
section and an inner wall of the tubular protective member, the
tubular protective member being removably connected to the joint
and/or to the second catheter section, so that, when the tubular
protective member is removed, a proximal end portion of the first
catheter section is exposed and ready for insertion into the human
urethra.
[0011] In particular, the catheter may be provided so that the
sections are adapted to be moved between at least two positions
with respect to each other. One position being a position wherein
the second section surrounds the first section and the other
position being a position wherein the second section forms an
extension for the first section.
[0012] The joint between the first section and the second section
may be a telescopical joint providing a liquid tight seal between
the sections while the they are moved between the first position
and the second position. As an example, the first section may be
provided with a piston seal adapted to slide along the inner
surface of the second section while the first section is being
pulled out of second section between the first and second
position.
[0013] In order to allow the user to insert the first section into
a body canal, a locking arrangement of may be provided for locking
the position of the first section with respect to the second
section, when the sections are in the second position, i.e. when
the catheter is in a configuration ready for insertion into the
body canal.
[0014] In order to allow the user to pull the first catheter
section out of the second catheter section without touching the
insertable part of the catheter, the tubular protective member may
preferably be provided to engage the first catheter section in a
locking engagement. Thereby, it will be allowed to use the tubular
protective member to pull the first catheter section out of the
second catheter section.
[0015] When the first catheter section has been pulled out of the
first catheter section, i.e. when the sections are in the second
position, i.e. in the position wherein the second catheter section
forms an extension for the first catheter section, the tubular
protective member should be allowed to disengage the first catheter
section. When the tubular protective member has been removed, the
catheter is in a "ready to insert" state.
[0016] In order to use the second catheter section as a sealing
envelope or package for the first catheter section, i.e. for the
insertable catheter section, the distal end of the first catheter
section may preferably be adapted to seal an opening in a distal
end of the second catheter section while the sections are in the
first position and not to seal set opening when the sections are in
the second position. When the sections are brought into the second
position, i.e. when the catheter is "ready for insertion", the
opening in the distal end of the second section may be used for
draining the bodily liquids, e.g. urine out of the catheter.
[0017] In order to allow the annular cavity to be used e.g. for
carrying a frictional reducing substance, e.g. a water or saline
solution for a hydrophilic catheter, a hydrogel or similar
lubricating substance, the kit may preferably be provided with a
sealing engagement between the tubular protective member and the
first catheter section when the tubular protective member is
engaging the first catheter section. When the tubular protective
member is disengaged from the first catheter section, i.e. after
the catheter has reached its "ready for insertion state", the the
annular cavity is open to the ambient atmosphere thus exposing the
insertable tip of the first catheter section and allowing the user
to drain surplus friction reducing substances.
[0018] In one embodiment, the first catheter section is provided
with a hydrophilic surface and the friction reducing substance
provided in the annular cavity is a liquid swelling medium, e.g.
water or a saline solution.
[0019] The catheter sections could be provided in the form of
oblong tubular, hollow sections wherein the passage is defined
inside the sections or the sections may comprise an oblong solid
kernel with one or more vanes extending radially from the kernel
and along the entire length thereof. The vanes thus defines a
number of draining passages for draining urine between the kernel
and a bodily draining passage, e.g. the urethra. The advantage of
using a passage defined between a solid kernel and a wall of the
urethra is that the flow of bodily fluid cleans the urethra and
thus reduces the risk of infection compared with a traditional
catheter, wherein the bodily fluid is drained inside the catheter
isolated from the body canal.
[0020] A rigidity of substantially the full length of the catheter
allows for manipulatiOn of the catheter as ne uniform catheter
tube. Thereby, insertion of the proximal end of the catheter may be
performed without touching the part of the catheter which is going
to be inserted into the urethra. Preferably the catheter is
provided with a bending moment defined as the product between
E-modulus and moment of inertia of at least 1 MPamm.sup.4. Since
the proximal (inserted) end of the catheter, for male individuals,
must pass prostate in a curved passage, the proximal end portion of
the catheter, e.g. the first 10-50 mm., such as 20-40 mm., such as
25-35 mm, such as the first 30 mm. of the catheter may be provided
with an even lower bending moment defined as the product between
E-modulus and moment of inertia of less than e.g. 0.6 MPamm.sup.4
oreven less than 0.3 MPamm.sup.4. Other parts of the catheter, e.g.
a distal end portion where the urine is drained into the lavatory,
a bag or similar place of disposal, may similarly be provided with
a reduced bending moment.
[0021] The cross-sectional flow area or the hydraulic radius
defined as the ratio of the cross-sectional flow area to the wetted
perimeter, may be selected independently upon the length, e.g. on
the basis of the size of the urethra, which size depends on the
individual using the catheter. Each of the sections may have either
the same cross-sectional flow area or hydraulic radius or each
section may have individual cross-sectional flow areas or hydraulic
radiuses. However, at least one part of one section should have a
cross-sectional shape and size adapted for the size of urethra or
an artificial urinary canal. Similarly one section should
preferably have a length selected on the basis of the length of the
urethra or the urinary canal. Thereby it may be achieved that only
one section is to be inserted and therefore no transition between
sections needs to be inserted. However, especially for male
individuals where urethra is particularly long, a catheter having
an inserted length divided in two sections or more may be provided.
In this specific case it will be appropriate to provide a
transition between the sections which at least on the outer surface
of the catheter have substantially no recess or sharp edge.
[0022] At least one of the catheter sections may be provided in a
length in the range of 50-90 mm, such as in the range of 55-85 mm,
such as in the range of 60-80 mm, such as with a length in the size
of 70 mm, which length has been found to be a suitable insertable
length for most female individuals. For male individuals, catheter
sections may be provided in a length in the range of 180-250 mm,
such as in the range of 190-240 mm, such as in the range of 200-230
mm such as in the size of 220 mm. For the male individuals it may
further be preferred to provide at least a part of the inserted end
of the catheter in a material or in dimensions so that a the tube
becomes very flexible, without kinking. This will ease the passage
of the catheter past prostate.
[0023] The outer cross-sectional shape of at least one of the
sections should preferably be substantially circular with a
cross-sectional area in the range of 0.5 mm.sup.2-30 mm.sup.2.
[0024] Even more preferred is to provide at least one of the
sections with a hydraulic radius ("cross-sectional
area"/"circumferential length") in the size of 0.2-1.5 mm.
Alternatively, at least one of the sections should have a
cross-sectional shape matching the shape of urethra or an
artificial urinary canal, still with a cross-sectional area in the
range of 0.5 mm.sup.2-30 mm.sup.2. or a hydraulic radius in the
size of 0.2-1.5 mm. However, the other of the sections does not
necessarily have to have the same cross-sectional shape, nor the
same hydraulic radius. The wall thickness of the catheter should
preferably be in the range between 0.5-1.5 mm.
[0025] The catheter or at least a part of the catheter could be
made from a thermoplastic elatomeric material, other thermoplastic
materials, curable elastomeric materials, polyamide resins or
elastomers or any mixture thereof, i.e. the group may comprise
materials like, PVC, PU, PE, latex, and/or Kraton.TM..
[0026] In one embodiment, the catheter may be divided in separate
catheter sections. Each catheter section has at least one end
provided with means for connecting the section with another section
corresponding to an adjacent part of the catheter. As an example
the catheter may be divided into two tubular connectable pieces
connected by connecting means.
[0027] Preferably, the connecting means are provided with a
rigidity allowing for manipulation of at least one of the catheter
sections by manipulation of one of the other catheter sections. At
least the connection between each of the pieces should provide
sufficient rigidity to allow one proximal section to be inserted
into the urethra by manipulation of one of the other sections.
[0028] Therefore, the connection is preferably provided so that at
least the part of the catheter extending the connection zone, has a
bending moment defined as the product between E-modulus and moment
of inertia of at least 0.6 MPamm.sup.4 such as at least 1
MPamm.sup.4. In order not to have the individual sections falling
apart during use, the connection should preferably be adapted to
take up an axial force of at least 0.5 Newton or at least to take
up an axial force larger than the axial force required for
withdrawal of the catheter from the urethra or artificial urinary
canal.
[0029] The pieces may be connected e.g. telescopically or via a
hinge enabling one of two sections to rotate in relation to the
other of the two sections. It is appreciated that the sections are
in fixed engagement so that they do not disconnect during use of
the catheter, while urine is drained through the catheter. However,
since the urine is always drained in one direction, the connection
does not necessarily have to be liquid-tight. As an example a
telescopic connection may be established by inserting the section
adapted for insertion into urethra into a distal section. The flow
direction of the urine will at least substantially prevent the
connection from leaking even though the connection as such is not
completely liquid tight.
[0030] However, a completely sealed connection may provide an even
safer catheter with a reduced risk of contaminating hands etc.
[0031] In one embodiment wherein the two catheter sections are
arranged in a telescopic fashion, the first catheter section may be
intended for insertion into the human urethra, whereas the second
catheter section is usually intended for forming a prolongation of
the catheter outside the human urethra during use of the catheter.
In use, that is in the second mutual configuration of the two
catheter sections, the second catheter section preferably coextends
with the first catheter section away from a distal end of the first
catheter section. In the first mutual configuration, which usually
is the configuration in which the telescopic kit is stored and
transported, at least a portion of the first catheter section may
be surrounded by the second catheter section. In the first mutual
configuration, the tubular protective member is provided between an
outer surface of the first catheter section and an inner wall of
the second catheter section. The dimensions of the tubular
protective member and the catheter sections may be such that, in
the second mutual configuration, a substantially annular and
longitudinally extending cavity is formed between an outer surface
of the first catheter section and an inner wall of the second
catheter section. The first catheter section may have a hydrophilic
surface, and a liquid swelling medium may be provided in the
annular cavity, so as to swell the hydrophilic surface of the first
catheter section, whereby the first catheter section being
encapsulated in the tightly sealed annular cavity may be preserved
in its wet, swelled condition for a period of 1-5 years, such as
3-5 years, or more. A tight sealing of the annular cavity is
desired for all kinds of catheter surfaces, including hydrophilic
and hydrophobic catheter surfaces, in order to prevent
contamination to enter into the cavity. Thus, in the first mutual
condition, the telescopical joint may serve to define a liquid and
contamination tight seal between the second catheter section and an
ambient atmosphere.
[0032] A distal end of the second catheter section is preferably
provided with a tight seal which may be tight to both liquids and
contamination, and which may be removable, so that when a distal
end of the second catheter section is inserted into, e.g., a urine
collection bag, a passage for urine is formed at the location from
which the seal has been removed. The tubular protective member is
preferably removable when the first and second catheter sections
are in the second mutual position, so that, when the tubular
protective member is removed, the proximal end portion of the first
catheter section is exposed and ready for insertion into the human
urethra. The distal end of the second catheter section may as an
alternative be provided into one piece with a collection bag. As an
example, the second catheter section may be provided with a plastic
welding-flange for adhesively bonding a plastic collection bag to
the second catheter section.
[0033] According to another preferred embodiment, the catheter may
comprise at least two sections not being separated but being
divided by a bendable zone. The bendable zone could e.g. be a
bellow shaped section or the zone could be an area wherein the
thickness of the tubular material is smaller and wherein the zone
accordingly has a lower bending moment. The zone could e.g. be
provided in a more resilient or flexible material allowing for
bending the catheter tube without kinking or damaging the tube.
[0034] In general, the problems of introducing a catheter into
urethra depend not only of the size of the introduced part of the
catheter but also on the slipperiness of the introduced part. The
catheter section or at least a part of the catheter section or
sections adapted for insertion into urethra or an artificial
urinary canal may provide a surface slipperiness for easy and safe
insertion. However, it has been found that lubricated or slippery
surfaces, are difficult to handle, not least for a user having
reduced dexterity. It is therefore an object of the present
invention to provide a catheter with an inserted part being treated
so as to provide a slippery surface and another part not being
treated, so as to provide a surface which may easily be handled.
The division of the catheter into one part being treated and one
part not being treated may preferably follow the aforementioned
division of the catheter with the purpose of making the catheter
collapsible or separable. According to an alternative embodiment,
the parts may be provided in the form of one part being smooth and
another part being provided with a rough surface.
[0035] According to a preferred embodiment, at least one of the
sections is provided with gripping means easing a firm grip in the
catheter. Not least for the disabled user, the gripping means will
improve the value of the catheter considerably. Gripping means may
be provided as a radially extending flange or flanges or as a zone
having a large outer cross sectional diameter. The catheter, or at
least one of the catheter sections, may also be provided with means
for engaging an external handle. As an example, one of the tubular
catheter tubes may be provided with a ring-shaped bulge for
attaching a handle. The ring-shaped bulge could be provided as a
short tubular piece of plastic with a larger radial size than the
catheter, the catheter being inserted and glued into the short
piece of plastic.
[0036] A section provided with a hydrophilic surface treated with a
liquid swelling medium may provide an excellent lubrication for the
insertion and also provide compatibility with the body tissue. It
is therefore a further preferred embodiment of the invention to
provide at least one of the sections with a hydrophilic surface
layer.
[0037] One of the catheter sections could be used as a sterile
package for the other sections, e.g. by arranging the sections in a
telescopic manner inside one section, closing and sealing that
section in both ends, e.g. by a peelabie and optionally a
metallised foil e.g. made from a thermoplastic elatomeric material,
other thermoplastic materials, curable elastomeric materials,
polyamide resins or elastomers or any mixture thereof, i.e. the
group may comprise materials like, PVC, PU, PE, latex, and/or
Kraton.TM., thereby allowing for sterilising the assembly by
radiation.
[0038] The liquid swelling medium for the hydrophilic surface may
be provided in the package for initiation of the low friction
character already when the catheter is being packed. The liquid
swelling medium may simply be a saline solution, a bactericidal
solution capable of swelling the hydrophilic surface and capable of
keeping the surface in a sterile condition or it may be pure water.
The swelling may also be initiated already before packaging of the
catheter, the catheter then being packed in a substantially gas
impermeable package for conservation of the moistened surface.
Furthermore, the liquid swelling medium may be provided in a
capsule or container packed together with the catheter for swelling
of the hydrophilic material immediately prior to the insertion.
[0039] With the catheter there may be provided a supporting member
for being introduced into a first conduit of the catheter, the
conduit being for draining urine, the supporting member being
provided with an outer cross-sectional shape and radial size
substantially equal to the inner cross-sectional shape and size of
the elongate tube so as to support said tube against collapsing
during bending of the tube, the supporting member having a
flexibility allowing curling.
[0040] The flexible elongated tube could have the shape of a
regular catheter of the known kind. Preferably, the tube or at
least a part of the tube is made from a thermoplastic elatomeric
material, other thermoplastic materials, curable elastomeric
materials, polyamide resins or elastomers or any mixture thereof,
i.e. the group may comprise materials like, PVC, PU, PE, latex,
and/or Kraton.TM..
[0041] The supporting member supports the catheter to avoid
collapsing when the catheter is bend, e.g. for the purpose of
packing the catheter in user friendly short packages. The
supporting member may be either solid or the supporting member may
be hollow and thus defining a second conduit. The solid supporting
member should be adapted for removal prior to draining of the
bladder, whereas a hollow supporting member may remain inside the
tube while the bladder is emptied through the first and second
conduit.
[0042] The supporting member may as an example be glued inside the
elongated tube or the supporting member may even be moulded into
the tube during the process of producing the tube. The supporting
member may even be completely integrated in the elongated tube.
[0043] The supporting member could be made from any suitable
material such as e.g. plastic, steel, aluminium, a thermoplastic
elatomeric material, other thermoplastic materials, curable
elastomeric materials, polyamide resins or elastomers or any
mixture thereof. As an example, the supporting member may be a
helical spring provided in a length in the range of 20-60 mm, such
as in the range of 30-50 mm, such as in the range of 35-45 mm. The
spring should be positioned inside the elongated tube in the zone
where it is desired to bend the catheter, e.g. midway along the
longitudinal axis of the elongated tube. During use, the urine is
drained through the first conduit of the elongated tube and past
the supporting member through the second conduit.
[0044] In one embodiment, the supporting member is provided in a
length in the range of 60-120 mm, such as in the range of 70-110
mm, such as in the range of 80-100 mm. and the supporting member
may even be extending out of the discharge end of the elongated
tube. This will enable the user to remove the supporting member
during the process of inserting the catheter into urethra.
[0045] The supporting member may be provided with gripping means
for easing withdrawal of the supporting member from the discharge
end during insertion of the catheter.
[0046] A method for producing a urinary catheter comprising a
proximal insertion section defining an inner elongated passage for
urine, and at least one opening near a proximal end of the proximal
insertion section for allowing urine to pass from the human bladder
into the inner elongated passage, may comprise the steps of: [0047]
providing a mould, defining the shape of at least the proximal
insertion section, [0048] forming the proximal insertion section by
injection moulding, [0049] removing the proximal insertion section
from the mould.
[0050] Whereas longitudinally extending catheters made from
plastics materials have hitherto been manufactured by a relatively
costly process involving extruding the catheter body, forming a
rounded tip thereof by heat treatment, cutting transversely
extending passages for urine near the tip of the catheter by means
of a cutting tool, and rounding edges of the transversely extending
passages by heat treatment, the method according to the fourth
aspect of the invention has the advantage that it allows for a more
efficient and more accurate controllable manufacturing process with
less waste of material and fewer production steps.
[0051] The catheter may further comprise a connector part for
connecting the proximal insertion section to a further catheter
section or to a urinary collection bag. The connector part may be
made from the same material as the proximal insertion section,
whereby, at the step of forming the proximal insertion section, the
proximal insertion section and the connector part may be formed
substantially simultaneously. Alternatively, the connector part may
be made from a material different from the material of the proximal
insertion section, whereby the connector part and the proximal
insertion section are formed in distinct process steps, for example
in a multi-component injection moulding process.
BRIEF DESCRIPTION OF THE DRAWINGS
[0052] Preferred embodiments of the invention will now be described
in details with reference to the drawing in which:
[0053] FIG. 1 shows an embodiment of the kit, wherein one catheter
part is inserted for storage into another of the catheter parts
thus substituting a catheter package,
[0054] FIG. 2 shows the embodiment of FIG. 1, wherein the inserted
catheter part is partially withdrawn from one end of the
package,
[0055] FIG. 3 shows the embodiment of FIGS. 1 and 2, wherein the
inserted catheter part is completely withdrawn from the package and
then attached to the other end of the package, the package thus
functions as a handle for manipulation of the catheter,
[0056] FIGS. 4-7 illustrate an embodiment of a kit according to the
invention, wherein the catheter sections are arranged in a
telescopic fashion,
[0057] FIGS. 8-11 show a further embodiment, wherein the catheter
sections are arranged in a telescopic fashion,
[0058] FIGS. 12 and 13 show yet a further embodiment, wherein the
catheter sections are arranged in a coextending fashion.
DETAILED DESCRIPTION OF THE DRAWINGS
[0059] FIG. 1 shows an embodiment of the catheter kit according to
the present invention, wherein the first catheter section, not
shown in FIG. 1, is sterilely packed inside the second catheter
section 21, the second catheter section being sealed in both ends
with sealing caps or foils 22,23.
[0060] Preferably the first section is coated with a hydrophilic
coating, providing a low friction surface of the first catheter
section when treated with a liquid swelling medium. The coating
could be of the kind which sustains being activated with the liquid
swelling medium for longer time, e.g. for several month. Thereby
the liquid swelling medium could be provided in the catheter
package from the time of packaging so as to provide a ready-to-use
catheter. Hydrophilic coatings are known per se, see e.g. the
published patent applications WO 98/58988, WO 98/58989, WO 98/58990
or EP 0570370. For this purpose, the sealing caps or foils should
preferably be provided in a gas impermeable material for
conservation of the humidity and thus the lubricity of the catheter
for longer time, e.g. for several month. As an example, the second
catheter section and/or the sealing caps may be made from a
thermoplastic elatomeric material, other thermoplastic materials,
curable elastomeric materials, polyamide resins or elastomers or
any mixture thereof, i.e. the group may comprise materials like,
PVC, PU, PE, latex, and/or Kraton.TM.. The caps may be provided
with a thickness allowing for sufficient gas impermeability. As an
alternative, they may be made from metallised foils.
[0061] As seen in FIG. 2, the first catheter section is easily
withdrawn from the second catheter section by pulling the cap or
foil 23 which cap or foil engages the distal end of the first
catheter section.
[0062] FIG. 3 shows the assembled catheter after the first catheter
section has been attached to the second catheter section. The foil
or cap 23 can either be removed completely as shown in FIG. 9 or
can at least be penetrated by the connecting means 24 of the second
catheter section.
[0063] FIGS. 4-7 illustrate an embodiment of a catheter kit wherein
the first and second sections 42, 44 are telescopically
interconnected. A tubular protective member 46 surrounds a portion
of the first catheter section 42 and forms a substantially annular
cavity 48 around the first catheter section. In the second mutual
configuration, shown in FIG. 16, in which the kit is intended to be
stored and shipped, the first catheter section 42 and the tubular
protective member 46 are inserted as far as possible into the
second catheter section 44. A hydrophilic swelling medium, such as
water, may be provided in the cavity 48, so that a hydrophilic
surface coating optionally provided at the surface of the first
catheter section 48 is stored in its swelled, i.e. wet condition. A
surplus of hydrophilic swelling medium may be present in the cavity
48 in order to prevent the hydrophilic surface coating from drying
out. A liquid-tight seal 50 is provided at the distal end of the
first catheter section 42. A liquid-tight closing member 52 closes
the distal end of the second catheter section 44. In one
embodiment, the closing member 52 is removable so that a passage is
provided between the second catheter section 44 and a urine
collection bag, or another device for accumulating or conveying
urine, mounted to the distal end of the section catheter section
44, when the closing member 52 is removed. In another embodiment,
the closing member 52 is an integrated part of the second catheter
section 44, in which case a wall 53 of the closing member 52 may be
perforated in order to provide a passage between the second
catheter section 44 and a urine collection bag, or other device for
accumulating or conveying urine, mounted to the distal end of the
section catheter section 44. In yet another embodiment, the closing
member 52 may be substituted by a perforated end wall, e.g. a wall
made from a central plate connected to the outer wall of the second
catheter section 44 at its distal end by means of radially
extending ribs or spokes. In such an embodiment, the first catheter
section 42 and the seal 50 may be formed as a single, integrated
piece.
[0064] As shown in FIG. 5, an outer wall of the second catheter
section 44 forms a handle, the tubular protective member 46 being
arranged so that it extends out of the handle at the proximal end
thereof. The tubular protective member 46 may form a flange at its
proximal end, so as to facilitate a user's extraction of the first
catheter section 42 and the tubular protective member 46 out of the
handle/second catheter section 44. When extracted, the tubular
protective member 46 and thus the first catheter section 42
surrounded thereby coextend with the handle or second catheter
section 44, as illustrated in FIG. 6. A protrusion 47 at the distal
end of the tubular protective member 46 releasably secures the
tubular protective member 46 to the seal 50, see FIGS. 4, 6 and 7.
The seal 50 may be designed so that it engages the proximal end
portion of the second catheter section 44 by a snap action once the
seal 50 and the tubular protective member 46 have reached the fully
extracted position shown in FIG. 6. In the example shown in FIG. 4,
the seal 50 has a groove 51 which, in the extracted position shown
in FIGS. 6 and 7 engages a flange 45 at the proximal end of the
second catheter section 44. Immediately prior to use of the
catheter, the tubular protective member 46 is removed, so that the
first catheter section 42 is exposed, as shown in FIG. 7.
[0065] FIGS. 8-11 illustrate a further embodiment of a catheter
kit, wherein the catheter sections are arranged in a telescopic
fashion. As shown in the exploded view in FIG. 11, the kit
comprises the following parts: a first catheter section 62, a
second catheter section 64 with one or more inner flange portions
65, a guide member 66 with protrusions 67, a joint 69 with a collar
portion 70 and slits 71 for the guide member 66, as well as a
distal closure member 72 and a proximal closure member 73. The kit
is stored and transported in the configuration shown in FIG. 8,
wherein the second catheter section surrounds the first catheter
sectiori 62 and the guide member 66. Prior to use of the catheter,
the distal closure member 72 is removed, and the guide member 66 is
extracted, as shown in FIG. 9. The guide member 66 is extracted as
far as possible, i.e. until the protrusions 67, due to their
elasticity, engage respective grooves (not shown) provided in the
slits 71 of the joint 69, see FIG. 11. The joint 69 is secured from
sliding out of the second catheter section 64 by means of the inner
flange portions 65 of the second catheter section 64. The proximal
closure member 73 is also removed. Next, the guide member 66 is
pushed back into the second catheter section 64. As the guide
member engages the joint which is firmly connected to the distal
end of the first catheter section, the joint 69 and the first
catheter section 62 are pushed out of the distal end of the second
catheter section 64 as the guide member 66 is pushed in the second
catheter section 62. When the collar portion 70 of the joint 69
engages an inner flange or protrusion provided at the proximal end
of the second catheter section 64, the kit is ready for use, and
the first catheter section 62 may be introduced into the urethra of
a human. A urine collection bag or other means for accumulating or
conveying urine may be mounted to the proximal end of the second
catheter section 64.
[0066] The catheter shown in FIG. 12 has a first section 81 forming
the proximal, insertable end of the catheter, and a second,
proximal section 82 forming a handle part of the catheter. The
first and second sections may have different shapes corresponding
to their intended use. The first section is oblong and has an inlet
opening 83 for draining urine from the bladder into an internal
conduit extending through both part of the catheter, and the first
section is slim when compared to the second part. The first section
is covered by a tubular protective member 84 which is detachably
attached to the outer surface of the catheter (in FIG. 1, the
tubular protective member is removed and the catheter is ready for
insertion into the urinary tract). The disclosed tubular protective
member is cylindrical, and has an outward flange 85 supporting
removal of the sleeve from the catheter. An internal conduit
connects the inlet opening with the outlet opening 86 opposite the
inlet opening in the second part. The outlet opening is covered by
a foil 87 which is attached in a manner which allows pealing. A
ribbed portion 8 gives the user a tactile indication of the
transition between the first and the second section. The first and
second sections are joined in a joint 89, e.g. by gluing or
welding. Alternatively, the sections may be made in one piece.
[0067] FIG. 13 shows the catheter of FIG. 12, wherein the tubular
protective member 4 is attached to the catheter. The second section
2 is not covered by the tubular protective member. The tubular
protective member fastens to the second part via an inwardly
extending flange (not shown) engaging the ribbed portion 8.
* * * * *