U.S. patent application number 13/171319 was filed with the patent office on 2011-10-20 for securement device for indwelling catheters or introducers.
This patent application is currently assigned to Maddoc Medical Products, Inc.. Invention is credited to Alan Kessler.
Application Number | 20110257600 13/171319 |
Document ID | / |
Family ID | 34887407 |
Filed Date | 2011-10-20 |
United States Patent
Application |
20110257600 |
Kind Code |
A1 |
Kessler; Alan |
October 20, 2011 |
SECUREMENT DEVICE FOR INDWELLING CATHETERS OR INTRODUCERS
Abstract
A securement device for indwelling catheters or introducers has
a pad with an adhesive backing for securement to the skin of a
patient. A base is mounted on the pad having one or more spaced
holes therethrough with an elongated strand extending through said
hole or holes. The strand may be wrapped around or passed through a
connector mounted on the base and the free end(s) thereof may be
tied to the strand or to another strand arising from the base.
Inventors: |
Kessler; Alan; (Los Angeles,
CA) |
Assignee: |
Maddoc Medical Products,
Inc.
Los Angeles
CA
|
Family ID: |
34887407 |
Appl. No.: |
13/171319 |
Filed: |
June 28, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12617559 |
Nov 12, 2009 |
7972310 |
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13171319 |
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11687583 |
Mar 16, 2007 |
7628771 |
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12617559 |
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10789892 |
Feb 26, 2004 |
7204827 |
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11687583 |
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Current U.S.
Class: |
604/180 ;
604/174 |
Current CPC
Class: |
A61M 25/02 20130101;
Y10S 128/06 20130101; Y10S 128/26 20130101; A61M 2025/028
20130101 |
Class at
Publication: |
604/180 ;
604/174 |
International
Class: |
A61M 25/02 20060101
A61M025/02 |
Claims
1. A retainer for securing a medical article to the body of a
patient, the retainer comprising: a base having a receiving surface
configured to support at least a portion of the medical article; a
flexible strand coupled to the base at a location below the
receiving surface, the flexible strand passing through at least a
portion of the base and having a free end; and a post disposed on
the base and having a distal end, the distal end having a receiving
member configured to receive the free end of the flexible
strand.
2. The retainer of claim 1 further comprising a tab having a hole,
the flexible strand passing through the hole.
3. The retainer of claim 1 further comprising a plurality of
protrusions extending upward from the base.
4. The retainer of claim 3, wherein the post is substantially
perpendicular to at least a portion of the receiving surface and
the distal end extends upward at least as far as the plurality of
protrusions.
5. The retainer of claim 1, wherein the base is made of an
elastomer.
6. The retainer of claim 1, wherein the receiving member is a hole,
and wherein the flexible strand is sized to pass through the
hole.
7. The retainer of claim 1, wherein the receiving surface comprises
a concave portion.
8. The retainer of claim 7, wherein the concave portion has a
raised midpoint.
9. The retainer of claim 1, wherein the base comprises a first
member and a second member, the first member being less elastic
than the second member, the second member having the receiving
surface.
10. A securement device for securing a medical article to the body
of a patient, the securement device comprising: a lower support
plate; an upper support base defining a receiving area for
supporting at least a portion of the medical article; a post
extending from the lower support plate and through the upper
support plate, the post having a receiving member; and a strand
coupled to the lower support plate and having a free end, the free
end being configured to couple to the receiving member.
11. The securement device of claim 10 further comprising a flexible
pad supporting the lower support plate and having a bottom adhesive
surface, at least a portion of the bottom adhesive surface being
covered with an adhesive for securing to the body of the
patient.
12. The securement device of claim 10, wherein the lower support
plate comprises at least one laterally extending cantilevered
section, wherein the strand is coupled to the cantilevered
section.
13. The securement device of claim 12, wherein the laterally
extending cantilevered section is biased to maintain tension on the
strand when the strand is coupled to the receiving member.
14. The securement device of claim 12, wherein the upper support
base comprises a laterally extending cantilevered section, the
laterally extending cantilevered section of the lower support plate
being disposed between the laterally extending cantilevered section
of the upper support base and at least a portion of the medical
article.
15. The securement device of claim 12, wherein the lower support
plate additionally comprises a second laterally extending
cantilevered section, the securement device additionally comprising
a second strand coupled to the second cantilevered section.
16. The securement device of claim 15, wherein the first and second
cantilevered sections are laterally displaced in generally opposite
directions from a center of the receiving area.
17. The securement device of claim 10, wherein the receiving member
is a hole.
18. A securement system for securing a medical line to the body of
a patient, the securement system comprising: a medical article
having a tubular body; a pad comprising a bottom adhesive surface,
at least a portion of the bottom adhesive surface being covered
with an adhesive for securing to the body of a patient; a platform
member supported by the pad and having a receiving surface
configured to support at least a portion of the medical article; a
flexible strand coupled to the platform member at a location below
the receiving surface, the flexible strand comprising a free end;
and a post disposed on the platform member and having a distal end,
the distal end being configured to receive the free end.
19. The securement system of claim 18, wherein the medical article
further comprises an annular groove and an inlet port, and wherein
the flexible strand contacts the annular groove.
20. The securement system of claim 18, wherein the platform member
comprises a laterally extending cantilevered section, and wherein
the strand is coupled to the cantilevered section.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of copending application
Ser. No. 12/617,559, filed Nov. 12, 2009, and titled SECUREMENT
DEVICE FOR INDWELLING CATHETERS OR INTRODUCERS, which is a
continuation of application Ser. No. 11/687,583, filed Mar. 16,
2007, and titled SECUREMENT DEVICE FOR INDWELLING CATHETERS OR
INTRODUCERS, now issued as U.S. Pat. No. 7,628,771, which is a
divisional of application Ser. No. 10/789,892, filed Feb. 26, 2004,
and titled SECUREMENT DEVICE FOR INDWELLING CATHETERS OR
INTRODUCERS, now issued as U.S. Pat. No. 7,204,827, each of which
is hereby incorporated by reference in its entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The invention relates to securement devices; and, more
particularly, to anchoring systems for anchoring or securing
medical articles to the body of a patient.
[0004] 2. Description of the Related Art
[0005] It is well known in the treatment of patients to introduce
fluids and medications directly into the bloodstream. Many devices
are known for quickly and easily securing a catheter, tube, etc. to
the skin of a patient without suturing.
[0006] Various devices have been suggested in the past which
require carefully machining of parts of said medical articles to
form apertured ears or tabs to anchor the securement strands to a
catheter or the like. Certain securement devices require specially
manufactured strands or posts with protuberances. Other securement
devices are specifically adapted to a particular type of catheter
or the like thus not easily accommodating catheters of different
configurations.
[0007] These devices do not put tension on the strands holding the
catheter in place.
[0008] There is a need for a securement device for percutaneous
sheath introducers and other medical devices which uses flexible
strands for securement means thus allowing versatility and
flexibility and does not require careful and expensive machining of
the medical articles to be secured. Such a device should easily
accommodate catheters of varying configurations.
SUMMARY OF THE INVENTION
[0009] It is an object of this invention to provide a securement
device for indwelling catheters or introducers and other medical
articles which uses strands of material as the securement means of
tying a catheter or the like in position on the body of a
patient.
[0010] It is another object of this invention to provide such a
device having a base secured to a pad adapted to be secured to the
body of a patient, the base holding a catheter or the like in a
firm fixed position on the base.
[0011] It is still another object of this invention to carry out
the foregoing objects placing tension on the strands holding a
catheter or the like in place on the base.
[0012] These and other objects are preferably accomplished by
providing a pad having an adhesive backing for securement to the
skin of a patient. A base is mounted on the pad having a one or
more holes therethrough with an elongated strand(s) extending down
through said hole or holes. The strand may be wrapped around a
connector mounted on the base and tied to itself or two or more
such strands, the free ends thereof tied to secure the connector to
the base.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a perspective view of a securement device in
accordance with the teachings of the invention;
[0014] FIG. 2 is a perspective view of the device of FIG. 1 showing
a connector mounted thereto;
[0015] FIG. 3 is an exploded view of the base, pad and backing of
the device of FIGS. 1 and 2 illustrating a pair of flexible strands
extending through aligned holes in the base and pad;
[0016] FIG. 4 is a side view, in section, illustrating the interior
structure of the base of the device of FIGS. 1 to 3;
[0017] FIGS. 5 and 6 are top plan views of two different
modifications of the base alone of the device of FIGS. 1 to 4;
[0018] FIG. 7 is a perspective view of a portion of another
embodiment of the base of FIG. 1;
[0019] FIG. 8 is a view similar to FIG. 5 showing still another
modification of the base of FIG. 1; and
[0020] FIG. 9 is a side view, in section, of the base of FIG.
8.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0021] Referring now to FIG. 1, a securement device 10 is shown
adapted to be used in connection with a catheter type conventional
fluid line connector 12 (FIG. 2). It is to be understood that,
although illustrated as to be used with a catheter, the securement
device 10 herein can be used with other types of medical devices or
articles such as, for example, CVCs, PICCs, Foley catheters,
hemodialyses catheters, surgical drainage tubes, feeding tubes,
chest tubes, nasogastric tubes, or with wires or cables coupled to
external or implanted electronic devices or sensors. Thus, as used
herein, "medical devices or articles" means generally any suitable
or generic type catheter, fluid supply and drainage line,
connector, adaptor, electrical wire or cable, etc. which may be
retained by the securement device herein and used to introduce
fluids or allow drainage or the like through medical devices into
or out of the patient's body.
[0022] Securement device 10 thus includes a base 14 adapted to be
secured to an anchor pad 25 (FIG. 3) and one or more filaments or
strands, such as 2 strands 16, 24 (FIGS. 2 and 3) that extend from
base 14.
[0023] Base 14 is secured to anchor pad 25 which is configured as
shown (generally referred to as a butterfly configuration) and
secured thereto in any suitable manner, such as by a solvent bond
adhesive.
[0024] One or more holes 26 through 29 (FIG. 3) are provided
through pad 25 aligned with holes 18 to 21 (FIG. 1), respectively,
in base 14.
[0025] In the example shown, two such strands 16, 24 are shown
adapted to be fed through holes 18 through 21 (FIG. 1) in base 14
and aligned holes 26 to 29 in pad 25. Thus, one strand 16 may be
fed alone through aligned holes 19, 27 and up through aligned holes
29, 21 and the other strand may extend down through aligned holes
18, 26 and up through aligned holes 28, 20. Of course, any suitable
number of strands and holes may be used.
[0026] Each strand 16, 24 may have a pointed distal end 22 (FIG. 2)
which may be hardened, such as a lacquered tip. Any suitable strand
length may be used depending on the application.
[0027] The anchor pad 25 may be of flexible material as is well
known in the art and may comprise a layer of a closed cell,
low-density polyethylene foam and a bottom layer of a medical grade
adhesive. A removable paper or plastic backing 30 (see FIGS. 3 and
4), conforming to anchor pad 25, covers the bottom adhesive surface
of pad 25 before use. The backing 30 is of a suitable material to
resist tearing and may be divided into a plurality of pieces, such
as 2, for ease in attachment of pad 25 to the patient's skin.
Preferably, backing 30 is of 2 pieces, adhesively attached to the
bottom of pad 25 at its center 31 (FIG. 3) having end portions
unattached to pad 25 which can be pulled apart to expose one half
of the adhesive pad at a time. Other means may be used, such as a
single piece of backing which has a portion extending beyond the
edge of pad 25 to ease removal as is well known in the art.
[0028] Base 14 is comprised of two parts (FIG. 3), an upper support
base 32 secured to a lower part or support plate 33 which in turn
is secured to pad 25. Plate 33 is preferably of a polycarbonate
material glued or otherwise secured to pad 25.
[0029] Support base 32 may be of a suitable molded polymeric
material having an upper surface covering with a plurality of
upstanding generally conically shaped protrusions 34 (FIG. 4)
extending upwardly therefrom.
[0030] A spring beam 35 is mounted internally or integrated into
support plate 33 for reasons to be discussed.
[0031] Holes 18 through 21 in support base 32 are aligned with like
holes (FIG. 3) through support plate 33 which holes are also
aligned with holes 26 to 29, as previously discussed.
[0032] As seen in FIG. 4, holes 18 to 21 are circular through the
beam 35. The edges of each hole are radiused (see radiused wall
portion 38--FIG. 4).
[0033] As seen in FIG. 4, the protrusions 34 may vary in overall
height and are preferably of a suitable elastomeric material.
Strands 16, 24 may be of any suitable material, such as silk. Silk
is less likely to slide during use. Thus, strand 24 extends through
hole 19 in upper support base 32, down through aligned hole 39 in
support plate 33, about the underside of spring beam 35 (which thus
provides tension when strand 24 is tied), up through hole 40 in
support plate 33, and through aligned hole 21 in support base 32
and upwardly as shown. Alternatively, all strands could extend up
and be knotted at the respective holes 19, 21 or glued to the
underside of the support plate 33.
[0034] As discussed, any suitable materials may be used, such as a
fabric material for pad 25 with a base 14 of polycarbonate or
similar material glued to pad 25. The radiused edges 38 of the
holes eliminate sharp cutting edges. Strands or sutures 16, 24 may
be No. 1 braided silk sutures. Support base 32 may be of any
suitable polymeric material, such as a material of about 35A
Durometer.
[0035] As seen in FIG. 4, upper support base 32 is slightly concave
at its middle 100.
[0036] Looking at FIG. 2, the connector 12 has a main hub portion
101 having an inlet port 102 at one end for insertion of a catheter
(not shown) therein and an elongated tubular portion 103 extending
therefrom for fluid instillation. Hub portion 101 also has an
apertured ear 104 on one side of the hub portion 101 and a flexible
inlet tube 105 fluidly coupled to hub portion 101 for introducing
fluids and directing an inserted catheter or wire therein, as is
well known in the art. Of course, any suitable connector or
catheter configuration may be used.
[0037] As seen in FIG. 2, connector 12 rests in the middle or
concave portion 100 of upper support base 32. The protrusions 34
assist in holding the connector 12 in position. The strands 16, 24
extend through the aligned holes in upper support base 32 and lower
support plate 33 and under beams 35.
[0038] Connector 12 may have one or more spaced annular grooves,
such as grooves 106, 107 (FIG. 2). Strands 16, 24 may be tied to
connector 12 in any suitable manner. For example, strand 16 may
first be extended through the hole in apertured ear 104, then
wrapped around groove 106 and the free ends tied. Strand 24 may be
wrapped around groove 107 and the free ends tied. The overall
length of one side of each strand may be easily adjusted to
accommodate tying.
[0039] Although a particular type of connector is disclosed, having
annular grooves, obviously any suitable type of connector may be
used as long as strands 16, 24 can be wrapped around or through the
holes and tied. The hardened ends 22 allow easy insertion through
the aligned holes and the apertured ear.
[0040] The concave center 100 of upper support base 32 acts as an
anti-roll channel for connector 12. This also prevents folding of
the base 32 in the center.
[0041] Although 2 strands 16, 24 may be used to tie connector 12 to
base 32, obviously one may be used. Thus, at least one strand is
sufficient utilizing the teachings of the invention.
[0042] In a further embodiment of the invention, wherein like
numerals refer to like parts of FIGS. 1 to 4, as seen in FIG. 5,
base 110 otherwise identical to base 14, may have the upper surface
111 of upper support base 112 slightly raised, at its center 113,
so that when connector 12 is secured in position, the inlet port
102 is in a slightly elevated position for easy insertion of a
catheter into a connector mounted thereon (not shown).
[0043] Circular holes with radiused sides have been disclosed, as
seen in FIG. 6, wherein like numerals refer to like parts of FIGS.
1 to 4, the holes for passage of the strands therethrough may
include hole portions 200 extending through tabs or ears 201 which
may be cut out of the support base and support plate or a single
structure comprising both support base and support plate as
disclosed below. The hole portions 200 communicate with aligned
holes through the remaining portions of the base 14. The tabs 201
will thus flex slightly when the strands are pulled through the
hole portions 200 and thereby exert a downward force through the
strand on the connector once the strands are tightened around
and/or over the connector. An upward force on the tabs forces the
support base and plate to contour around the connector and thus
prevents rolling of the device on the base.
[0044] In still another embodiment of the invention, as seen in
FIG. 7 wherein like numerals refer to the embodiment of FIG. 1,
base 14 may have hemispherically shaped protrusions, such as
protrusions 300, extending upwardly therefrom instead of conically
shaped protrusions. Also, as seen in FIG. 8, wherein like numerals
refer to like parts of FIG. 1, tabs 400, 400' with holes 401, 401',
respectively, therethrough, similar to tabs 201 and holes 200 in
FIG. 6, may be provided on the upper surface of base 402. The area
403 is concave but raised slightly at the midpoint 404 thereof to
provide a ramp for a connector or the like. That is, the area 403
may slope upwardly from one side 403' to midpoint 404, then slope
downwardly from midpoint 404 to the other side 405'. In this
embodiment, a single strand 405, otherwise identical to strands 16,
24, FIG. 9, may extend up through one hole 401, knotted on the
underside of the lower support plate 33, as at knot 406, extend
through hole 401 in the tab 400 as shown, then extends through hole
401' in post 400' and tied back upon itself, thus retaining a
connector or the like (not shown).
[0045] The strands may be of silk or any flexible material that is
substantially non-extendible about its long axis. The flexible beam
35 conforms to the shape of a connector mounted on the base and
creates and maintains tension in the strands so as to keep any
knots tight and pulls or presses the connector into the conforming
surface preventing rolling. Also, beam 35 may be integral with
plate 33 and base 32 with the hardness of the securement base 14
varying from the top to bottom thereof or of uniform hardness to
allow both the cushioning/conforming effect of said base and the
springlike character of said plate.
[0046] Although a particular embodiment of the invention is
disclosed, variations thereof may occur to an artisan and the scope
of the invention should only be limited by the scope of the
appended claims.
* * * * *