U.S. patent application number 10/909469 was filed with the patent office on 2007-07-26 for universal catheter anchoring system.
Invention is credited to Steven Bierman, Wayne Mitchell, Richard Pluth.
Application Number | 20070173765 10/909469 |
Document ID | / |
Family ID | 26909696 |
Filed Date | 2007-07-26 |
United States Patent
Application |
20070173765 |
Kind Code |
A2 |
Bierman; Steven ; et
al. |
July 26, 2007 |
UNIVERSAL CATHETER ANCHORING SYSTEM
Abstract
A method of securing a medical article to the body of a patient
is disclosed in which an anchoring device comprising an anchor and
a retainer is used. The retainer is attached to an upper surface of
the anchor and comprises a base, a cover and a post. The base is
disposed on the upper surface of the anchor and the cover is
connected to the base so as to move between an open and a closed
position. When the cover is in the closed position, it lies above
at least part of the base. The post is attached movably to either
the base or the cover and is arranged so as to lie at least
partially between the cover and the base when the cover is in the
closed position. When securing a medical article, the cover is
placed in the open position and the medical article placed onto the
retainer. The cover may then be closed over the medical article and
the anchoring device attached to the patient.
Inventors: |
Bierman; Steven; (Del Mar,
CA) ; Mitchell; Wayne; (Cardiff, CA) ; Pluth;
Richard; (San Diego, CA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20050010173 A1 |
January 13, 2005 |
|
|
Family ID: |
26909696 |
Appl. No.: |
10/909469 |
Filed: |
August 2, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
09/897717 |
Aug 3, 2004 |
6770055 |
|
|
10909469 |
Aug 2, 2004 |
|
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09/513054 |
Jun 24, 2003 |
6582403 |
|
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09/897717 |
Jun 29, 2001 |
|
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60/215100 |
Jun 29, 2000 |
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Current U.S.
Class: |
604/174 |
Current CPC
Class: |
A61M 2025/0266 20130101;
A61M 2025/0246 20130101; A61M 25/02 20130101; A61M 2025/024
20130101 |
Class at
Publication: |
604/174 |
International
Class: |
A61M 5/32 20060101
A61M005/32 |
Claims
1-4. (canceled)
5. The retainer of claim 49 additionally comprising a post, wherein
the post is movably coupled to the base member.
6.-48. (canceled)
49. A securement device for securing a medical article to a
patient, the medical article having an elongated body with a pair
of lateral wings, comprising: an adhesive bottom layer for
attaching to the skin of a patient; a base member disposed above
the adhesive bottom layer; and a first cover member and a second
cover member being arranged generally in a side-by-side
relationship with a gap existing between the cover members, each
cover member cooperating with the base member to define a space of
sufficient size to receive a wing of the medical article with at
least a portion of the elongated body being disposed generally
within the gap.
50. The securement device of claim 49, wherein the first and second
cover members move less than 180 degrees between a closed position
and an open position.
51. The securement device of claim 49, wherein the first and second
cover members have lateral lengths such that at least portions of
the covers do not interact with each other at least when the
medical article is secured within the securement device and the
covers are closed.
52. The securement device of claim 49, wherein each of the first
and second cover members includes a skirt that extends about the
base member, the skirts interacting with the medical article so as
to inhibit movement of the medical article in at least a
longitudinal direction relative to the securement device.
53. The securement device of claim 49, wherein the gap is sized to
receive a bulky central portion of the elongated body of the
medical article.
54. A securement device for securing a medical article which has a
pair of laterally extending wings, to the body of a patient,
comprising: an adhesive to attach the securement device to the body
of the patient; a lower member disposed above the adhesive; and a
cover assembly disposed above the lower member, the cover assembly
including two covers, each cover being connected to the base and
having at least two positions, a first position and a second
position, at least a portion of each wing being disposed between
the cover assembly and the base at least when the medical article
is secured within the retainer and the two covers are in the second
position, the covers having a lateral length such that at least
portions of the covers do not interact with each other at least
when the medical article is secured within the securement device
and the two covers are in the second position.
55. The securement device of claim 54 further comprising flexible
couplings between the cover assembly and the lower member.
56. The securement device of claim 54, wherein the covers move less
than 180 degrees between the first and second positions.
57. The securement device of claim 54 further comprising a skirt
extending about the base so as to inhibit movement of the secured
medical article relative to the securement device in at least one
direction.
58. The securement device of claim 57, wherein the skirt extends
from the cover in at least a transverse direction generally toward
the lower member so as to inhibit longitudinal movement of the
secured medical article relative to the securement device.
59. The securement device of claim 54 further comprising a flange
attached to the cover, the flange facilitating movement of the
cover relative to the lower member.
60. The securement device of claim 54, wherein the lower member is
rigid.
61. A securement device for securing a medical article having a
pair of laterally extending wings to a patient, comprising: a first
portion and a second portion disposed on the first portion, at
least two parts of the second portion generally opposing each other
and being spaced apart to define a gap therebetween, the two parts
of the second portion being movable relative to the first portion
so as to receive a pair of wings between the first and second
portions with a portion of the medical article being positioned in
the gap, the two parts of the second portion being independently
movable relative to each other, and the second portion extending
over and about at least a portion of both wings when the wings are
received between the first and second portions.
62. The securement device of claim 61 further comprising an
adhesive to attach the securement device to a body of the patient,
and wherein the first portion is a base and the second portion is a
cover assembly.
63. The securement device of claim 61, wherein the second portion
comprises a skirt, the skirt extending about the wings so as to
inhibit longitudinal movement of the secured medical article in at
least one direction relative to the securement device.
64. The securement device of claim 63, wherein the skirt extends in
at least a transverse direction generally toward the first portion
so as to inhibit longitudinal movement of the secured medical
article relative to the securement device.
65. The securement device of claim 61 further comprising a flange
attached to the second portion, the flange facilitating movement of
the second portion relative to the first portion.
66. A securement system comprising: a medical article having a
central portion and two wings extending in a opposite lateral
directions therefrom, the central portion having a transverse
height greater than a transverse height of the two wings; an
adhesive to attach the securement device to the body of the
patient; and a lower member disposed above the adhesive; and a
cover assembly disposed above the lower member and including two
covers, the covers having lateral lengths such that a gap is formed
between the covers at least when the medical article is secured
within the securement device and the covers are in a closed
position, the covers being disposed at a transverse height that is
greater than the transverse height of the two wings and less than
the transverse height of the central portion of the medical article
at least when the medical article is secured within the securement
device and the covers are in the closed position so that at least a
portion of the central portion of the medical article is disposed
in the gap.
67. The securement system of claim 66 further comprising skirts,
the skirts defining a receiving space on the retainer, and wherein
the two covers are arranged over the lower member so as to cover at
least a portion of the receiving space when in the closed position,
and wherein a first portion of the receiving space receives at
least a portion of one of the wings and a second portion of the
receiving space receives at least a portion of the other wing.
Description
RELATED CASES
[0001] This application is a continuation of U.S. patent
application Ser. No. 09/897,717, filed on Jun. 29, 2001, issued as
U.S. Pat. No. 6,770,055 on Aug. 3, 2004, which is a
continuation-in-part of U.S. patent application Ser. No.
09/513,054, filed on Feb. 24, 2000, issued as U.S. Pat. No.
6,582,403 on Jun. 24, 2003 and also claims priority under 35 U.S.C.
.sctn.119(e) from Provisional Application No. 60/215,100 filed on
Jun. 29, 2000, entitled "IMPROVEMENTS TO UNIVERSAL CATHETER
ANCHORING DEVICE," all of which are hereby expressly incorporated
by reference in their entireties.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates in general to a universal
anchoring system for securing a medical article to a patient and,
in particular, to a universal anchoring system for securing a
catheter to a patient to inhibit movement or migration of the
catheter relative to the patient.
[0004] 2. Description of Related Art
[0005] It is common in the treatment of patients to utilize
catheters to introduce fluids and medications directly into the
patient or to withdraw fluids from the patient. An example of a
typical catheter is a central venous catheter, or CVC, which is
used to introduce fluids through a central vein.
[0006] In most cases, the catheter remains in place for many days.
In order to secure the catheter in position at the insertion site,
a healthcare worker often secures the catheter to the patient using
tape. That is, the healthcare worker commonly places long pieces of
tape across the portion of the catheter near the insertion site in
a crisscross pattern to secure the catheter to the patient's skin.
This securement inhibits disconnection between the catheter and the
insertion site, and also prevents the catheter from snagging on the
bed rail or other objects.
[0007] Tape, however, often collects dirt and other contaminates.
Normal protocol therefore requires periodic (e.g., daily) tape
changes to inhibit bacteria and germ growth at the securement site.
These frequent tape changes often excoriate the patient's skin.
Additionally, valuable time is spent by healthcare workers applying
and reapplying the tape. Because many healthcare workers find the
taping procedure cumbersome and difficult to accomplish when
wearing gloves, they often remove their gloves when taping. Not
only does this increase the amount of time spent on the taping
procedure, but it also subjects the healthcare worker to an
increased risk of infection. Moreover, even if healthcare workers
remain gloved, contact between the adhesive surface of the tape and
the latex gloves can cause micro-holes in the gloves, subjecting
the healthcare worker to possible infection.
[0008] A variety of catheter securement devices have been developed
to obviate the need for frequent application of tape to secure a
catheter to a patient. One such securement device provides a
flexible clamp with winged extensions that are sutured to the
patient's skin. In some applications, the winged extensions are
integrally formed with catheter. In other applications, the
flexible clamp is covered by a rigid fitting, which receives the
catheter/clamp combination in a friction-fit manner. The rigid
fitting and flexible clamp are formed with lateral, aligned holes,
which allow the combination to be sutured to the patient's skin.
Although these suturing devices securely attach the catheter to the
patient, it is obviously painful and uncomfortable for the patient.
These devices are also time consuming and inconvenient to secure,
pose the risk of needle-stick to the health care provider, and risk
suture-site infection to the patient.
[0009] In addition, suture material tends to exhibit poor gripping
on medical tubes and can cut through the winged extension of the
flexible clamp if a rigid clamp is not used. However, the use of a
rigid fitting complicates the securement procedure by adding yet
another component that can be dropped on the floor and become
unsterile. In addition, the sutured securement of the flexible
clamp and/or the rigid fitting assembly does not permit easy
release of the catheter from the patient for dressing changes and
insertion site cleaning. A removal instrument (e.g., sterile
scissors) also is generally required for suture removal.
[0010] Rather than suturing lateral, aligned holes to a patient's
skin, other catheter securement devices provide an adhesive layer
or resilient band interposed between the flexible clamp and the
patient's skin. See, for example, U.S. Pat. Nos. 5,342,317;
5,192,274; 5,084,026; 4,449,975; and 4,250,880. Many of these
securement devices, however, suffer from one or more of the
following disadvantages: are time consuming and inconvenient to
secure; have multiple parts, which can be dropped and become none
sterile; and require removal instruments (e.g., hemostat or
scissors) to disengage the catheter from the securement device.
[0011] Additionally, no standard exists regarding spacing of the
lateral holes of the catheters and catheter fittings. Manufacturers
invariably produce catheters and catheter fittings with holes
having varying geometries and distances therebetween. Prior
securement devices thus become dedicated to fit and secure only
certain catheters.
SUMMARY OF THE INVENTION
[0012] The present invention provides a simply-structured anchoring
system that secures a catheter in a fixed position, but easily
releases the catheter for dressing changes or other servicing. The
present invention also recognizes that prior art catheter anchoring
systems have been dedicated to a particular catheter, catheter
fitting or catheter manufacturer. Thus, the present anchoring
system also can cooperate with the suture or mounting holes of many
different catheter and catheter fitting designs. In particular, the
present anchoring system can be adjusted so as to be used with a
variety of catheters and/or catheter fittings which have varying
distances between the suture or mounting holes of the catheter
and/or fitting. The present invention also provides a technique for
anchoring medical articles to a patient in a fixed position and
allowing for the release of those articles.
[0013] One aspect of the present invention involves an anchoring
system for securing a medical article to the body of a patient. The
anchoring system comprises an anchor pad having an upper surface
and a lower surface. At least a portion of the lower surface has an
adhesive surface to attach the anchor pad to the body of the
patient. A retainer is mounted on the upper surface of the anchor
pad and is capable of receiving a portion of the medical article.
The retainer includes a base, a cover, and a post. The base is
disposed on the upper surface of the anchor pad and the cover is
movable connected to the base so as to move between an open
position and a closed position. The cover lies above at least part
of the base when in the closed position. The post is movably
coupled to one of the base and the cover and is arranged on the
retainer so as to at least partially lie between the cover and the
base when the cover is in the closed position.
[0014] In accordance with another aspect of the present invention,
an anchoring system is provided for securing a medical article to
the body of a patient. The anchoring system comprises an anchor pad
having an upper surface and a lower surface. At least a portion of
the lower surface has an adhesive surface to attach the anchor pad
to the body of the patient. A retainer is mounted on the upper
surface of the anchor pad and is capable of receiving a portion of
the medical article. The retainer includes a base, a post, and a
cover assembly. The cover assembly includes including at least two
covers, each cover being connected to the base by a hinge
mechanism. Each cover being movable between at least two positions:
an open position and a closed position. The post is coupled to one
of the base and covers and is arranged on the retainer so as to at
least partially lie between the base and at least one of the covers
when the cover is in the closed position.
[0015] One aspect of the present invention accordingly involves an
anchoring system for securing a medical article to the body of a
patient. The anchoring system comprises an anchor pad, a retainer,
and a post subassembly. The retainer is mounted on the upper
surface of the anchor pad and includes a base, a cover assembly,
and a latching mechanism. The base receives the medical article to
be secured, and the cover assembly can be moved between an open and
a closed position. In the open position, the medical article can be
inserted or removed from the retainer. In the closed position, a
channel is formed within which the medical article is held
securely. The latching mechanism operates between the base and the
cover assembly to hold it in the closed position. The post
subassembly includes a number of posts that protrude into the
channel of the retainer and interact with the medical article to
prevent any inadvertent motion.
[0016] In one preferred mode, the post subassembly includes posts
that are movable with respect to the base of the retainer and to
each other, so as to accommodate mounting or suture hole spacings
of various distances. In another mode, the post subassembly
includes posts that are fixed relative to the base.
[0017] In a preferred mode, the cover assembly of the retainer is
divided into two separate covers which are independently latched to
the base and which can independently be adjusted between the open
and closed positions.
[0018] In accordance with each of the aspects of the invention
summarized above, the anchoring system can also include a fitting.
The fitting can be part of the medical line itself or can be a
separate component that can be attached to the medical line. For
example, in one mode, the medical article can be a catheter with an
integral fitting. The fitting can also be a removable fitting
(e.g., a movable wing clamp) that is releasably attached to the
catheter. As such, these components can comprise an anchoring
system kit, where one or more sizes of fittings are included in the
kit in order to accommodate catheters of differing sizes.
[0019] In accordance with another aspect of the invention, a method
for anchoring a medical article using an anchoring device is
presented. The anchoring device has an anchor and a retainer. The
retainer has a base and at least one cover. A post is disposed
either upon the base or the cover and when the cover is moved into
a closed position, the post lies at least partially between the
cover and the base. When securing a medical article, the cover is
placed in an open position, a portion of a medical article is
placed within the base, and then the cover is closed to engage the
retainer with the medical article and the anchoring device may then
be secured to the patient.
[0020] In accordance with a further aspect of the method, the
anchor may be an anchor pad with an adhesive surface which is
attached to the skin of a patient and upon which the retainer is
mounted.
[0021] In accordance with another further aspect of the method, a
second post may be provided on the retainer of the anchoring
device.
[0022] In another further aspect of the method, a second cover may
be provided on the anchoring device.
[0023] In accordance with another aspect of the method described
above, a lower support member may be provided which lies between
the base of the retainer of the anchoring device and the
anchor.
[0024] In a further aspect of the method, the lower support member
may be formed unitarily with the base of the retainer.
[0025] Further aspects, features and advantages of the present
invention will become apparent from the detailed description of the
preferred embodiments that follow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] The above mentioned and other features of the invention will
now be described with reference to the drawings of a preferred
embodiment of the present anchoring system. The illustrated
embodiment of the anchoring system is intended to illustrate, but
not to limit the invention. The drawings contain the following
figures:
[0027] FIG. 1 is a perspective view of an anchoring system in
accordance with a preferred embodiment of the present invention
including a pair of movable posts and a pair of separate covers
illustrated in an open position and with a corner of an anchor pad
turned up to illustrate its lower surface;
[0028] FIG. 2 is a perspective view of the anchoring system of FIG.
1 shown with the covers in a closed position;
[0029] FIG. 3 is a perspective view of the anchoring system of FIG.
1 illustrated with the covers in the open position and an exemplary
catheter illustrated by phantom lines in an inserted position
within the retainer;
[0030] FIG. 4 is a perspective view of the anchoring system of FIG.
3 shown with the covers in the closed position and the exemplary
catheter (again shown in phantom lines) positioned in and retained
by the retainer;
[0031] FIG. 5 is a top plan view of the base and covers of the
retainer of FIG. 1 shown with one cover in the open position and
one cover in the closed position;
[0032] FIG. 6 is a cross sectional side view of the retainer of
FIG. 5 taken along line 6-6;
[0033] FIG. 7 is a front elevational view of the retainer of FIG.
5;
[0034] FIG. 8 is an enlarged view of the area encircled by line 8-8
of FIG. 5 and illustrates the structure of a post opening within
the base of the retainer;
[0035] FIG. 9 is a front elevational view of a post platform of the
retainer of FIG. 1;
[0036] FIG. 10 is a side elevational view of the post platform of
FIG. 9;
[0037] FIG. 11 is a top plan view of the post platform of FIG.
9;
[0038] FIG. 11A is a top plan view of an alternate post platform
for use with the retainer of FIG. 1;
[0039] FIG. 11B is a front elevational view of the post platform of
FIG. 11A;
[0040] FIG. 11C is a side elevational view of the post platform of
FIG. 11A;
[0041] FIG. 12 is a top plan view of the assembled retainer of FIG.
1, including the base, covers and post platform, shown with an
exemplary catheter in the channel of the retainer and the covers in
the open position;
[0042] FIG. 13 is a front plan view of another post platform using
fixed position posts, suitable for use with the base and cover of
FIG. 1;
[0043] FIG. 14 is a side elevational view of the fixed post
platform of FIG. 13;
[0044] FIG. 15 is a top plan view of the fixed post platform of
FIG. 13;
[0045] FIG. 16 is a cross-sectional view of the fixed post platform
of FIG. 15 taken along line 16-16;
[0046] FIG. 17 is a bottom plan view of the assembled retainer of
FIG. 1, showing the placement of the movable post platform of FIG.
9 within the groove of the retainer base;
[0047] FIG. 18 is a bottom plan view of an assembled retainer using
the fixed post platform of FIG. 13 within the groove of the
retainer base;
[0048] FIG. 19 is a perspective view of an anchoring system in
accordance with an additional preferred embodiment of the present
invention including a fixed post and a movable post, with the cover
in a closed position;
[0049] FIG. 20 is a perspective view of the anchoring system of
FIG. 19 shown with the cover in an open position;
[0050] FIG. 21 is an exploded perspective view of the retainer of
FIG. 19, illustrating the movable post detached from the
retainer;
[0051] FIG. 22 is a front elevational view of the retainer of FIG.
19, with the cover shown in a fully open position;
[0052] FIG. 23 is a top plan view of the retainer of FIG. 22, with
the cover fully open;
[0053] FIG. 24 is a cross-sectional view of the retainer taken
along line 24-24 of FIG. 19 showing the movable post within a track
of the retainer;
[0054] FIG. 25 is a perspective view of the movable post of FIG.
21;
[0055] FIG. 26 is a front plan view of the assembled retainer of
FIG. 19 with the cover shown in the closed position;
[0056] FIG. 27 is a top plan view of the retainer of FIG. 19 shown
in the fully open position with an exemplary catheter shown
inserted into the channel of the open retainer;
[0057] FIG. 28 is a perspective view of the anchoring system of
FIG. 19 shown with the cover in a partially open position and with
an exemplary catheter shown in phantom lines within the channel of
the retainer;
[0058] FIG. 29 is a perspective view of the anchoring system of
FIG. 28 shown with the cover in a closed position;
[0059] FIG. 30 is a partial, perspective view of the latching
mechanism of the retainer of FIG. 19 shown in a partially open
position; and
[0060] FIG. 31 is a bottom plan view of the anchor pad, showing a
release liner;
[0061] FIG. 32 is a top plan view of a unitary base and lower
support member for an alternate retainer;
[0062] FIG. 33 is an inverted front elevational view of the unitary
base and lower support member of FIG. 32;
[0063] FIG. 34 is a perspective view of the unitary base and lower
support member of FIG. 32.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0064] The present embodiment of the catheter anchoring system,
which is generally designated by reference numeral 10, is disclosed
in the context of use with an exemplary CVC (as shown in FIG. 3 and
designated by reference numeral 12). The principles of the present
invention, however, are not limited to catheters. Instead, it will
be understood by one of ordinary skill in this art, in view of the
present disclosure, that the anchoring system and/or retainer
disclosed herein also can be successfully utilized in connection
with other types of medical articles, including, but not limited
to, other types of catheters, fluid drainage and delivery tubes and
electrical wires. For example, but without limitation, the retainer
disclosed herein also can be configured to receive and secure
peripheral catheters, peripherally inserted central catheters,
hemodialysis catheters, surgical drainage tubes, feeding tubes,
chest tubes, nasogastric tubes, scopes, as well as electrical wires
or cables connected to external or implanted electronic devices or
sensors. One skilled in the art may also find additional
applications for the devices and systems disclosed herein. Thus,
the illustration and description of the anchoring system in
connection with a CVC is merely exemplary of one possible
application of the anchoring system.
[0065] Each of the embodiments described herein employs some basic
concepts characteristic of the present anchoring system, namely
releasable engagement of the catheter to the patient. The
releasable engagement is achieved by cooperation among a base, at
least one cover and at least one post element. This cooperation
allows the catheter to be disconnected from the anchoring system
and from the patient, for any of a variety of known purposes. For
instance, the healthcare worker may want to remove the catheter
from the anchoring system to ease disconnection of the catheter
from the insertion point or to clean the patient. The disengagement
of the catheter from the anchoring system, however, can be
accomplished without removing the anchoring system from the
patient.
[0066] Common to each the described embodiments, the present
anchoring system inhibits axial movement of the catheter with
respect to the anchoring system, and hence, with respect to the
insertion site on the patient. Transverse and lateral movement is
generally arrested by the holding effect provided by the base and
cover assembly, as well as by the cooperative interaction between
at least one post member and an opening on the catheter and/or
catheter fitting. That is, the base and cover assembly surround the
catheter while the post(s) extends through a corresponding suture
or mount opening(s) formed on the catheter and/or catheter fitting.
Longitudinal movement is similarly arrested by the interaction
between the post(s) and the opening(s).
[0067] In one form, the present anchoring system also is adapted to
receive at least several different types or styles of catheters
and/or catheter fittings. In particular, the spacing between the
posts and/or the spacing between a post and either the cover
assembly or base can be varied in order to accommodate catheters
and/or catheter fittings with differing spacings between the suture
holes. This feature can also be used to accommodate catheters
and/or catheter fittings having different sizes and/or shapes. In
one of the embodiments described below, the retainer includes two
posts, each of which is movable with respect to the other and also
with respect to the cover assembly and the base of the retainer. In
another embodiment, one of the posts is fixed and the other is
movable. The spacing between the posts, as well as the spacing
between the movable post and the adjacent base/cover structure, can
be varied by moving the one post. In other variations, the post(s)
can be fixed to a cover or base section which can move relative to
another section of the retainer to changes the position of the
post(s) on the retainer. So configured, the lateral width between
posts can be adjusted to receive and secure a variety of catheters
and/or catheter fittings. Various other aspects of the present
invention, however, can be used apart from this "universal"
feature, as will be apparent from the discussion of the embodiments
below.
[0068] To assist in the description of these components of the
anchoring system 10 (see FIG. 3), the following coordinate terms
are used. A "longitudinal axis" is generally parallel to the
section of the catheter 12 retained by the anchoring system 10. A
"lateral axis" is normal to the longitudinal axis and is generally
parallel to the plane of the anchor pad 14. A "transverse axis"
extends normal to both the longitudinal and lateral axes. In
addition, as used herein, "the longitudinal direction" refers to a
direction substantially parallel to the longitudinal axis; "the
lateral direction" refers to a direction substantially parallel to
the lateral axis; and "the transverse direction" refers to a
direction substantially parallel to the transverse axis. Also, the
terms "proximal" and "distal," which are used to describe the
present anchoring system 10, are used consistently with the
description of the exemplary applications. Thus, proximal and
distal are used in reference to the center of the patient's body.
The terms "upper," "lower," "top," "bottom," and the like, which
also are used to describe the present anchoring system 10, are used
in reference to the illustrations of the embodiments. A detailed
description of the anchoring system 10, and its associated method
of use, now follows.
Dual Cover Retainer System
[0069] With reference to FIGS. 1 and 2, the anchoring system 10 is
constructed in accordance with a preferred embodiment of the
present invention. The system comprises an anchor pad 14 and a
retainer 16 that includes a base 18, a cover assembly 19 and at
least one post. In the illustrated embodiment, the post is part of
a post platform that is attached to the retainer base 18 when the
retainer 16 is assembled. The post, as noted below, can be part of
the base 18 and/or the cover assembly or be a separate individual
piece. The retainer 16 is configured to accept and to retain and
secure a section of a catheter 12 (shown in FIG. 3) within the
anchoring system 10. Alternatively, the same arrangement can be
used to secure a detachable catheter fitting which is attached to a
catheter to be retained, as described below.
[0070] As illustrated in FIGS. 3 and 4, the catheter 12 or fitting
is inserted into the base 18 of the retainer 16 while the cover
assembly 19 is in an open position, as shown in FIG. 3. As
illustrated, the cover assembly 19 in the present embodiment
comprises two separate covers 20, 22, each independently attached
to the base 18. Once the catheter 12 or fitting is positioned on
the base, the covers 20, 22 are moved into a closed position over
the base 18 and catheter 12 to inhibit transverse motion of the
catheter 12. This can be seen in FIG. 4. The catheter 12 or fitting
also is retained laterally and longitudinally by its interaction
with one or more posts of the retainer 16 and by its interaction
with the surrounding sections of the base 18 and/or the covers 20,
22.
[0071] The retainer 16 is disposed upon an upper surface of the
anchor pad 14. The lower side 23 of the anchor pad 14 includes an
adhesive surface which adheres to the skin of the patient in order
to maintain the position of the retainer 16, and hence the catheter
12, with respect to the patient.
[0072] As is seen in FIG. 1, the anchor pad 14 is a substantially
flat piece of material with transversely opposing sides. The
proximal or lower side 23 of the pad faces toward the skin of the
patient, and is preferably covered with an adhesive surface
suitable for attaching the anchor pad 14 to the skin of the
patient. The upper or distal side 24 of the pad faces away from the
skin of the patient and supports the retainer 16.
[0073] The anchor pad 14 preferably comprises a laminate structure
with an upper foam layer (e.g., closed-cell polyethylene foam) and
a lower adhesive layer. The lower adhesive layer constitutes the
lower surface 23 of the anchor pad 14. The lower surface 23
desirably is a medical-grade adhesive and can be either diaphoretic
or nondiaphoretic, depending upon the particular application. Such
foam with an adhesive layer is available commercially from Tyco
Adhesives of Norwood, Mass.
[0074] A surface of the upper foam layer constitutes the upper
surface 24 of the anchor pad 14. The upper surface 24 can be
roughened by chemical priming or corona-treating the foam with a
low electric charge. The roughened or porous upper surface 24 can
improve the quality of the adhesive joint (which is described
below) between the base 18 and the anchor pad 14. In the
alternative, the flexible anchor pad 14 can comprise a
medical-grade adhesive lower layer, an inner foam layer and an
upper paper or other woven or nonwoven cloth layer.
[0075] A removable paper or plastic release liner 26 desirably
covers the adhesive lower surface before use. The liner 26
preferably resists tearing and desirably is divided into a
plurality of pieces to ease attachment of the pad to a patients
skin. In the illustrated embodiment, the liner is split along a
centerline 28 of the flexible anchor pad 14 in order to expose only
half of the adhesive lower surface at one time.
[0076] The length of each liner piece, as measured in the lateral
direction, extends beyond the centerline 28 of the anchor pad 14
and is folded over, or back onto the liner. This folded over
portion defines a pull-tab 30 to facilitate removal of the liner
piece 26 from the adhesive lower surface. A healthcare worker uses
the pull-tab 30 by grasping and pulling on it so that the liner
piece 26 is separated from the lower surface. The pull-tab
eliminates the need to pick at a corner edge or other segment of
the liner in order to separate the liner from the adhesive layer.
The pull-tab 30 of course can be designed in a variety of
configurations. For example, the pull-tab need not be located along
a centerline of the anchor pad 14; rather, the pull-tab can be
located along any line of the anchor pad 14 in order to ease the
application of the anchor pad 14 onto the patient's skin at a
specific site. For example, an area of a patient's skin with an
abrupt bend, such as at a joint, can require that the pull-tab be
aligned toward one of the lateral ends of the anchor pad 14 rather
than along the centerline.
[0077] The anchor pad 14 also preferably includes a concave section
32 that narrows the center of the anchor pad 14 proximate to the
retainer 16. In the illustrated embodiment of FIG. 2, the anchor
pad 14 is formed generally into a crescent shape that includes a
concave section 32 on one side of the retainer and a convex section
34 on the other. This shape permits the pad 14 to be placed on the
patient such that the arms of the crescent extend away from the
insertion site.
[0078] The retainer is preferably centered upon the anchor pad 14
about an axis which bifurcates the crescent shape. Consequently the
lateral sides of the anchor pad 14 have more contact area, both
forward and rearward of the retainer 16 in the longitudinal
direction, which provides greater stability and adhesion to a
patient's skin while still permitting the retainer 16 to be located
near the insertion site. Although not illustrated, the anchor pad
14 also can include suture and/or breather holes to the sides of
the retainer 16.
[0079] With reference now to FIGS. 5-8, the base 18 and the cover
assembly 19 principally define the retainer 16. As noted above, the
cover assembly 19, in the illustrated embodiment, comprises two
covers 20, 22, each of which is connected to the base at a folding
hinge 36. This arrangement allows the base 18 and the covers 20, 22
to be formed as a unitary piece. This can be accomplished by any of
a variety of ways well known to those skilled in the art. For
instance, the base 18 and the cover assembly can be injection
molded in order to reduce fabrication costs. As shown in FIG. 5,
one cover 20 is in a closed position, while the other cover 22 is
in an open position.
[0080] As will become apparent, several features of the cover
assembly and base 18 are desirably flexible. Suitable materials
which are both sufficiently strong but flexible include without
limitation: plastics, polymers, or composites such as
polypropylene, polyethylene, polycarbonate, polyvinylchloride,
acrylonitrile butadiene styrene, styrene butadiene, nylon, olefin,
acrylic, polyester, moldable silicon, thermoplastic urethane,
thermoplastic elastomers, thermoset plastics and the like. The
retainer 16 is preferably formed by injection molding using a
styrene butadiene polymer, such as KRO3 resin, available
commercially from Phillips Petroleum of Houston, Tex. However,
other materials can be used, and the retainer can comprise a
multi-piece base or cover as well.
[0081] In the embodiment illustrated in FIG. 5, the base 18
includes an elongated body of a generally hollow, generally
parallelepiped shape. The base 18 can be configured in a variety of
shapes, however, such as circular, square, or trapezoidal, in order
to suit a particular application. For example, the base 18 may be
configured to generally match the shape of the anchor pad 14 (shown
in FIG. 1) or the shape of the winged catheter fitting (not shown).
In the illustrated embodiment, a parallelepiped shape is preferably
used to allow the base 18 and covers 20, 22 to be integrally formed
and to capture the somewhat rectangular shape of the catheter
fitting wings (see FIG. 12).
[0082] As understood from FIGS. 5-7, a bottom wall 37 of the base
18 includes a substantially flat bottom surface 38 with the
exception of a recess 40 that extends upward. The recess 40 extends
laterally from one lateral side of the base 18 to the other along
the bottom side 38 of the base 18, and has a longitudinal width and
transverse depth sufficient to receive the post(s) and/or a post
platform, as described below.
[0083] The base 18 also includes one or more openings to facilitate
connection of the post(s) (described below) to the base 18. These
holes extend through the bottom wall 37 of the base 18 and open
into a hollow receiving space 42 defined within the retainer 16. In
the illustrated embodiment, a central circular opening 44 is formed
in the center of the recess 40; however, this opening can be
disposed at other locations on the base 18.
[0084] As will be described in greater detail below, the retainer
16 includes at least one post, which in some modes of the invention
is movable relative to the base 18. The base 18 accordingly
includes at least one additional opening to receive the post. This
opening can have a complementary shape to that of the post or can
be enlarged relative to or have a different geometry than the shape
of the post. In the mode of the invention where the post is
movable, the opening desirably has a shape that is elongated in at
least one direction so as to allow the post to move in such
direction.
[0085] In the embodiment illustrated in FIGS. 1-12, the base 18
includes two additional openings 46 to receive two posts. While
only a single post and hence a single opening is required, the
illustrated embodiment uses two posts and two openings. Each post
opening 46 is provided for a corresponding post such that the
corresponding post protrudes through the bottom wall 37 of the base
18 when the retainer 16 is assembled. The retainer 16, however, can
include more than two post-opening pairings in some applications of
the present anchoring system, as will be understood by one of
ordinary skill in the art.
[0086] As best seen in FIGS. 5 and 8, each post opening 46 in the
illustrated embodiment includes a substantially circular region 48
and an elongated slot 50 extending from the substantially circular
region 48. The substantially circular region 48 has a diameter
larger than the width of the elongated slot 50, and the elongated
slot 50 has a width larger than the diameter of the corresponding
post.
[0087] The present embodiment is configured with the slot 50
extending from the circular region 48 in a lateral direction in
order to accommodate differing lateral spacing between mounting
holes among different catheters or catheter fittings. As noted
previously, however, these slots could also extend longitudinally
or in a direction skewed relative to the longitudinal and lateral
axes in order to suit a particular application. Also, the slot 50
in the illustrated embodiment extends from the substantially
circular region 48 outwardly relative to the center of the base 18,
but the circular region 48 can be located at other positions along
the corresponding slot 50 (e.g., at the outer lateral end of the
slot). In addition, more than one slot can extend from the circular
region 48.
[0088] As best seen in FIG. 8, one edge of the slot has a scalloped
shape. Each scallop has a radius of curvature generally matching a
radius of a corresponding post that slides through the slot 50. The
distance D between the lateral end point 52 of each scallop and the
opposing edge of the slot 50 preferably is less than a diameter of
the corresponding post so as to inhibit unintentional movement of
the post within the slot 50, as described below.
[0089] As seen in FIGS. 5-7, the base 18 includes upstanding front
and back walls 54, 56 that are spaced from the central opening 44
in the longitudinal direction, and extend upward from the lower
wall 37 of the base 18. An opening 58, 60 generally bifurcates each
wall 54, 56, respectively, to allow the catheter to pass through
one wall 54, through the receiving space 42 and above the lower
wall 37 of the base 18, and then out the opposite wall 56.
[0090] Sidewalls 62, 64 of the base 18 are spaced lateral from the
central opening 44 and extend upward from the lower wall of the
base 18. These sidewalls 62, 64 are continuous with the front and
back walls 54, 56 of the base. The corners between the sidewalls
62, 64 and the front and back walls 54, 56 preferably are
rounded.
[0091] The base 18 has an open upper end that is generally defined
by the upper edges of the walls 54, 56, 62, 64. Thus, while not
truly parallelepiped, the retainer 16 does have a generally
rectangular box-like shape without an upper wall and with the
central openings 58, 60 formed in the front and back walls 54,
56.
[0092] The base 18 also includes holes 66 which allow portions of
the front and rear walls 54, 56 of the base 18 to flex in a
longitudinal direction more easily. This feature is advantageous to
the operation of the latching mechanism, described below.
[0093] The longitudinal, lateral and transverse dimensions of the
retainer 16 desirably are as small as possible, while still
receiving and stabilizing the catheter 12, including its wings. In
particular, the longitudinal dimension of the base 18, which is
defined between the front and back walls 54, 56, preferably is long
enough to stabilize the retained length of catheter 12. That is,
the length of catheter 12 which is secured within the retainer 16,
is sufficient to inhibit rocking of the catheter 12 relative to the
retainer 16. The longitudinal dimension of the base 18 also is
sufficient to receive the largest length of catheter wings for
which the retainer 16 is designed.
[0094] The lateral dimension of the base 18, which is defined
between the sidewalls 62, 64, similarly is sized to accommodate the
largest width of catheter wings for which the retainer 16 is
designed. It is also preferred that the lateral dimension be
sufficient to provide a convenient and natural grip of the base 18
of the retainer 16 while manipulating the covers 20, 22 and/or
posts of the retainer 16. The lateral dimension also preferably
provides sufficient width to mount hinges and latch mechanisms in
the present embodiment, as described below.
[0095] The transverse height of the base 18 preferably corresponds
to the thickest catheter wing for which the retainer 16 is
designed. While the catheter body may have a larger size than its
wing thickness, the base 18 accommodates this through its open
central region between the covers 20, 22. The base 18 thus needs
not have a greater transverse height than that of the catheter 12,
and consequently, the profile of the retainer 16 is minimized.
[0096] The receiving space 42 is formed on the base 18 between the
lateral walls 62, 64 of the base 18. The receiving space 42 is
desirably formed so as to accept and retain a portion of the
catheter or catheter fitting, and in particular the wings thereof,
without occluding the lumen of the catheter.
[0097] As seen in FIGS. 5 and 7, the covers 20, 22 have a size and
shape that desirably is coextensive with the longitudinal dimension
of the base 18. Although each cover 20, 22 preferably extends
longitudinally at least as far as the base does, the cover 20, 22
need not span the entire lateral dimension of the base. This will
be discussed below. In some modes it is desirable for the covers
20, 22 to be larger longitudinally than the base 18. By protruding
beyond the longitudinal dimension of the base 18, the covers 20, 22
can also include a flange 68 that is useful in operation of the
latch mechanism of the cover. This will be discussed below. In
other modes, the cover need not include the flanges 68.
[0098] Each cover 20, 22 preferably is connected to the base 18 by
at least one hinge 36 to provide each cover 20, 22 with at least
two positions: an open position, in which the receiving area 42 of
the base 18 is exposed and into which a catheter or fitting may be
inserted; and a closed position, in which the cover 20, 22 is
located over the base 18 and covers at least a portion of the
receiving area 42. In the closed position, the covers 20, 22 are
held in place by a latch mechanism, described below, to inhibit the
unintentional transverse release of the catheter or catheter
fitting from the receiving area 42 of the base 18. The covers
desirably are sufficiently sized to accommodate the necessary latch
mechanism components and to extend over or around at least a
portion of the posts 70 (and possibly receive upper ends of the
posts) when in the closed position. As explained in greater detail
below, the interaction between the upper portions of the posts 70
and the covers 20, 22 inhibits movement or play of the post upper
ends relative to the covers 20, 22. Consequently, this interaction
inhibits the posts 70 from deflecting or bending, at least in the
longitudinal direction, when the catheter is tugged to maintain a
secure connection between the posts 70 and the catheter 12.
[0099] In the embodiment shown in FIGS. 5-7, each cover 20, 22 of
the cover assembly 19 has a hinge 36 and a latch mechanism, such
that each cover can be independently placed into an open or a
closed position. In this embodiment, the covers 20, 22 do not
contact one another when both are in the closed position, as shown
in FIGS. 2 and 4. Although both covers extend from the lateral
sides 62, 64 of the base 18 toward the center of the retainer 16,
by reducing the lateral dimension of the covers 20, 22 such that
the components do not interact when closed, it becomes possible to
effectively secure catheters or fittings that extend transversely
beyond the height which could be contained below the covers if the
covers were to meet. By allowing such "centrally bulky" catheters
or fittings to be accepted, the anchoring system 10 is more
universal and has a lower profile as noted above. An example of how
the retainer 16 and posts hold a catheter 12 is shown in FIG.
4.
[0100] On each cover 20, 22, a recess 72 is formed which will lie
over the post opening 46 on the corresponding half of the base 18
when the cover is in the closed position. This recess 72 preferably
extends from a point directly above the substantially circular
region 48 of the post opening 42 and along the length of the
elongated slot 50 of the corresponding post opening. The recess 72
desirably is deep enough and wide enough along its length to freely
receive the upper end of the corresponding post 70, which protrudes
through the corresponding post opening 46, such that the post 70
does not interfere with the movement of the cover 20, 22 into the
closed position. The recess 72 also receives the upper end of the
post 70 when the cover 20, 22 is closed to inhibit the post 70 from
bending in the longitudinal direction. Of course, in some
applications, the post 70 can extend through the cover 20, 22
without interfering with movement of the cover and with the cover
capturing a portion of the post to inhibit bending of the post in
the longitudinal direction.
[0101] As can be seen in FIG. 7, the covers 20, 22 are coupled to
the base 18 by flexible couplings or hinges 36. Each hinge 36
preferably comprises a flexible band that can take any number of
forms to mechanically connect the cover 20, 22 to the base 18 while
permitting pivotal movement of the cover 20, 22 relative to the
base 18 so as to enable engagement or disengagement of these parts,
as described below.
[0102] In the illustrated embodiment, the band is formed of
flexible material, desirably of the same material from which the
base 18 and cover 20, 22 are comprised. Advantageously, the hinges
36 are integrally molded with the base 18 and the covers 20, 22 to
form a unitary member, as noted above. The hinges 36 are located at
an outer edge of the base 18 and the cover assembly 19; however,
the hinges 36 need not be laterally located at an extreme end of
the base 18 or cover assembly 19. The illustrated embodiment shows
the hinges 36 positioned near the same plane as the upper edges of
the base 18 for ease of manufacture.
[0103] As best understood from FIG. 5, the width of the hinges 36,
as measured in the longitudinal direction, is desirably less than
that of either the base 18 or the covers 20, 22 to allow some
leeway or play when engaging or disengaging the cover 20, 22 to the
base 18. That is, this shape allows the hinge 36 to twist to some
degree to compensate for some manufacturing tolerances; however,
the hinges can have at least as large of a longitudinal dimension
as the base 18 and/or the covers 20, 22.
[0104] The hinges 36 are desirably integrally formed along common
corresponding exterior surfaces of the covers 20, 22 and base 18.
Each hinge 36 has a generally U-shape 74 when the cover is closed,
and extends from both the base 18 and the cover 20, 22 in the
lateral direction to the side of the retainer 16. A gap,
corresponding to a transverse height of the hinge 36, exists
between the base 18 and covers 20, 22. This gap, however, can be
reduced or eliminated from the retainer for some applications by
using a different hinge design.
[0105] The hinges 36 enable each cover 20, 22 to move between the
open position and the closed position. The open position, shown by
cover 22 in FIGS. 5 and 7, is characterized by exposing the
corresponding post in the transverse direction. When both covers
are in the open position, as shown in FIG. 3, the retainer 16 is
capable of receiving a portion of the catheter 12. The closed
position, shown FIGS. 4, 5 and 7, is characterized by the cover 20
lying in contact or in near contact with the base 18 so as to
position the post within the recess 72 in the cover 20. When both
covers 20, 22 are in the closed position, as shown in FIG. 4, the
retainer 16 surrounds the received portion of the catheter 12.
[0106] The hinges 36 need not provide 180.degree. of movement for
the covers 20, 22 relative to the base 18 to establish a closed
position and a fully open position. For instance, the hinges 36 can
permit a smaller degree of movement (e.g., 90.degree.) between the
base 18 and the covers 20, 22 while still providing enough space to
transversely insert the catheter 12 into the retainer 16 when both
covers 20, 22 are open.
[0107] To hold the covers 20, 22 to the base 18 and to effectively
retain the catheter 12 or catheter fitting within the retainer 16,
the base and cover include structures that interengage when the
covers are in the closed position. As can be seen in FIG. 6, a
latch mechanism 80 is provided for securing the covers 20, 22 in
the closed position relative to the base 18. The latch mechanism 80
comprises at least one movable keeper 82 and at least one latch 84.
In the illustrated embodiment of FIG. 6, the keeper 82 is disposed
on the cover 20 while the latch 84 is disposed on the base 18.
However, those skilled in the art will recognize that the keeper
can be disposed on the base and the latch can be disposed on the
cover.
[0108] Each keeper 82 extends from the cover 20 toward the base 18
of the retainer 16 from the lower side of the cover 20 ("lower" as
seen when the cover is in the closed position as in FIG. 6). In
addition to extending from the cover 20, each keeper 82 has at the
end farthest from the cover a tang 86 that extends in the direction
toward the corresponding latch 84. This tang 86 is rounded as seen
in FIG. 6; however, the tang can have a surface that lies generally
normal (e.g., .+-.15.degree. from perpendicular) to the transverse
axis.
[0109] The latch 84 comprises a protrusion 88 that is formed on the
base 18 at a location that will interact with the tang 86 of the
keeper 82 when the cover 20 is in the closed position. This can be
seen in FIG. 6. In the illustrated embodiment, a protrusion 88 is
formed on the front and back walls 54, 56 of the base 18. The latch
84 is located along the wall 54, 56 of the base at a position
adjacent to a hole 66 in the base 18. By positioning the latch 84
at such a location, it is more able to flex in the longitudinal
direction. This is because the hole 66 reduces the resistance of
the base 18 in that region to deformation.
[0110] As the cover 20 is moved into the closed position, the
keeper 82 will flex as the tang 86 moves past the protrusion 88 of
the latch 84, and then will relax or spring back into its original
state once the tang 86 has moved past the protrusion 88. This will
prevent the cover 20 from unintentionally moving out of the closed
position. The lower side of the protrusion 88 preferably has a
complimentary shape to that of the top of the tang 86 to promote
engagement between them when the cover is closed. In the
illustrated embodiment, the protrusion 88 is preferably rounded in
the same manner as the tang 86 of the keeper 82. In another
variation, the protrusion has a generally flat lower surface that
is upwardly included at about 10.degree. relative to the plane of
the bottom wall 37 and the upper surface of the tang 86 has a
similar complimentary surface that slopes downward by
10.degree..
[0111] In order to allow disengagement of the latching mechanism
80, it is necessary for the keeper 82 to flex as the tang 68 moves
past the protrusion 88 of the latch 84. In one mode of operation,
this can be accomplished by pressing upon a flange 68 or other
extension of the cover 20. By pressing upon the flange 68, the
cover 20 bends, moving the tang 86 of the keeper 82 away from the
protrusion 88 of the latch 84, and allowing the cover 20 to be
moved out of the closed position without exerting excessive force
upon the cover. Desirably, such a flange 68 is formed integrally
with the cover 20 of the retainer 16. The reduced thickness of the
cover 20 along its center section, which is created by the recess
72, aids in the cover bending in this manner,
[0112] As best seen in FIG. 7, each cover 20, 22 also includes an
overhang 90 formed on its inner edge (i.e., the edge closest to the
central opening 44). This overhang 90 preferably is sized to allow
the fingertip or fingernail of the healthcare worker to slip
underneath the overhang to pull up the cover 20, 22 in another mode
of opening the cover. The upward force applied causes the tang 86
to slide over the protrusion 88 to disengage the latching mechanism
80. As a result, the overhang 90 provides another way to open the
cover 20, 22.
[0113] In the illustrated embodiment, each cover 20, 22 has two
keepers 82, requiring two latches 84 on the base. The latch
mechanisms 80 on each cover are formed as mirror images of each
other.
[0114] In order to aid the manufacture and assembly of the
retainer, the posts may be formed as part of a post platform 92. An
embodiment of the post platform 92, which includes a plurality of
movable posts 70, is illustrated in FIGS. 9, 10 and 11. The post
platform 92 includes an attachment button 94 for connecting the
platform 92 to the base 18, posts 70 that are configured to extend
through the post openings 46 in the base 18, and connectors 96
which at least initially hold the posts 70 to the attachment button
94. In the illustrated embodiment, the platform 92 is attached to
the base 18 from below by aligning the attachment button 94 with
the central opening 44 in the base 18, inserting the posts 70
through the post openings 46, and pressing the platform 92 upward
into the recess 40 on the lower side of the base 18. When fully
inserted, the larger radius on the upper portion of the attachment
button 94 will snap into position in the central circular opening
44. In one variation, the upper portion of the attachment button 94
can be disposed within a countersink formed on the upper side of
the bottom wall 37. The pair of posts 70 then protrudes through the
post openings 46 of the base, and may move laterally within the
lateral extent of their respective post openings 46 in the base
18.
[0115] While the present embodiment shows posts 70 that are
connected to the attachment button 94 and to each other, this
arrangement is not necessary for advantageous operation of the
retainer. Those of ordinary skill in the art will appreciate that
the connected arrangement of the posts 70 on the platform 92 is
largely to facilitate manufacture and construction of the
retainer.
[0116] The attachment button 94 comprises a cylindrical peg of a
diameter to allow it to be inserted through the central circular
opening 44 of the base 18 from the lower, or proximal, side. A
distal portion of the cylindrical peg has a larger radius than the
proximal portion of the attachment button. This upper portion is
also of slightly larger radius than the central circular opening 44
in the base 18. The upper edge of the attachment button 94 is
preferably chamfered to allow the button to be easily inserted
through the central circular opening 44 of the base. Once inserted
into the central circular opening, the larger radius at the distal
portion of the button 94 will prevent the button from being pulled
out of the base 18 in the proximal direction.
[0117] The connectors 96, illustrated in FIG. 11, comprise
extensions from the lowest portion of the attachment button 94
which extend laterally therefrom and connect to the lowest portion
of the posts 70. Desirably, these connectors 96 allow the distance
at which the posts 70 are disposed from the attachment button 94 to
vary after the retainer is assembled.
[0118] One way to accomplish this is illustrated in the embodiment
of FIGS. 9, 10 and 11. Each connector 96 comprises a leash that
extends parallel to the base 18 of the retainer away from the
attachment button 94 at an angle to the lateral direction. The
leash can be straight when fully extended or can follow a
semi-looped or curved path. This path can also assume a zigzag or
similar shape. The shape of the leash allows the lateral extension
of the leash to be adjusted by permitting the leash to flex. In the
illustrated embodiment, each connector 96 can have enough
flexibility to allow it to remain intact while spanning distances
ranging from the farthest lateral position in the post opening 46,
to the minimum lateral distance defined by the circular portion 48
of the post opening. In the illustrated embodiment, this is
accomplished by allowing the leash to bend and fold back upon
itself. In a variation, the leashes can be configured to bias the
posts 70 inward or outward. In another variation, however, once the
posts 70 are assembled in the base, the posts do not need to be
tethered together, and the leashes can be designed to break after
assembly.
[0119] One of the posts 70 is disposed at the lateral end of each
connector 96. The posts 70 comprise substantially cylindrical
members that extend transversely in the distal direction from a
lowest portion that is attached to the corresponding connector 96
of the post platform 92. The posts 70 desirably also include a
flange 98, located distally along the length of the cylinder such
that it will lie above the bottom wall 37 of the base 18 when the
platform 92 is inserted into the retainer base 18. This flange 98
is preferably sized to have a radius larger than the radius of the
elongated slot 50 portion of the post opening 46, but smaller than
the circular section 48 of the post opening 46. In this manner, the
flange 98 can be inserted through the circular section 48 of the
post opening 46 along with the post 70, and then remain above the
base 18 of the retainer when the post 70 is moved to a position
along the length of the elongated slot 50. The flange 98 stabilizes
the post 70 and maintains its proper orientation with regard to the
base 18, i.e., the flange 98 maintains the post 70 in a
transversely upright position and inhibits significant rocking of
the post.
[0120] It is also possible to make use posts which do not possess a
flange. An example of such a post platform is shown in FIGS.
11A-11C. This post platform is used in substantially the same
manner as the platform 92 shown in FIGS. 9-11, but does not make
use of flanges to stabilize the posts. Such flange-less posts are
suitable for use with bases in which the post openings 46 do not
include circular regions 48, but only consist of an elongated slot
50. An example of such a base is shown and discussed below.
[0121] The circular region 48 of the post opening 46 is located at
the innermost lateral position that a post 70 would be desirably
located, and the track 50 extends to the outermost lateral position
that a post 70 would be desirably located. By moving the post
laterally, it can be positioned as desired at any location along
the length of the slot 50. Along the length of the slot 50 are
positioned the series of protrusions or scallop end points 52 which
extend into the slot 50 and effectively narrow the width of the
slot at the position of each protrusion 52, as noted above. At the
locations of the protrusions 52, the width of the slot 50 is
comparable to, or slightly narrower than, the width of the posts 70
which will extend through the post opening 46. This arrangement
provides a ratcheting action for positioning the post 70 at the
desired location, and then retaining the post at said location.
[0122] Because the material of the base 18 and post 70 are slightly
elastic, it is possible to push the post along the slot 50 past a
protrusion 52 into the section of the slot that is wider between
the protrusions, even if the width of the slot at the protrusion is
slightly narrower than the diameter of the post 70. However, once
in the desired position along the length of the slot 50, the
protrusions 52 will inhibit unintended lateral motion of the post
70 from its location. This ratcheting arrangement allows effective
positioning of the posts 70 to any desired lateral position between
protrusions 52 without undesirable inadvertent motion of the posts
once positioned.
[0123] Although the number of posts 70 shown in the instant
embodiment is two, any number of posts may be used to accommodate a
specific purpose. For example, if a particular catheter fitting
contained four holes, a retainer designed to retain that fitting
would desirably have four posts extending through four post
openings in the base of the retainer. Similarly, if a "Y" shaped
catheter or fitting was to be retained, three posts could be used
to provide the desired stability.
[0124] The post 70 and/or the post platform 92 can be formed from a
variety of materials using various known manufacturing methods. For
example, the post 70 and/or post platform 92 can be injected
molded. Suitable materials for such include without limitation:
plastics, polymers, or composites such as polypropylene,
polyethylene, polycarbonate, polyvinylchloride, acrylonitrile
butadiene styrene, styrene butadiene, nylon, olefin, acrylic,
polyester, moldable silicon, thermoplastic urethane, thermoplastic
elastomers, thermoset plastics and the like. The posts and post
platform 92 are preferably formed by injection molding using a
nylon, such as Zytel 101 L, available commercially from E.I. du
Pont Company of Wilmington, Del. However, other materials can be
used, and the post platform can comprise a multi-piece
assembly.
[0125] After the post platform 92 has been attached to the retainer
base 18, the retainer 16 then is attached to the upper surface 24
of the anchor pad 14. The base 18 desirably is secured to the upper
surface 24 by a solvent bond adhesive, cyanoacrylate or other
bonding material. One such adhesive is available commercially as
Part No. 4693 from the Minnesota Mining and Manufacturing Company
(3M). With certain types of polymer (e.g., a styrene butadiene
polymer), a UV cured adhesive also can be used, as known in the
art. It is important when attaching the base 18 to the anchor pad
14 that the post platform 92 is not secured to the anchor pad as
well. The posts 70 in this mode must be free to slide within the
recess 40 on the underside of the base 18 and within the post
openings 46 for the posts 70 to be properly movable between
different desired locations.
[0126] The anchoring system 10 can optionally include a fitting for
mounting the catheter to the retainer 16. If used, the fitting can
take the form of a conventional box clamp and a soft wing clamp.
Box clamps and soft wing clamps are commercially available from
Arrow.RTM. for use with its CVC. Other clamps with suture wing
extensions are currently in commercial use with Quinton.RTM.
Hemodialysis catheters, Cook.RTM. PICC's, Baxter.RTM. CVCs and B.
Braun.RTM. CVCs. Those skilled in the art will find application for
the present invention with any of these or other clamp
configurations. As will be clear from a discussion below, the
fitting can also be replaced with an inter-line connector or
adaptor, such as those used to connect the catheter to a supply,
delivery or drainage line.
[0127] When the anchoring system 10 is assembled as described
above, the receiving space 42 formed between the base 18 and covers
20, 22 when they are in the closed position defines a channel. The
channel is capable of receiving a portion or length of the catheter
and is generally configured to house, grip and secure the affected
catheter portion. In the illustrated embodiment, the channel has a
generally symmetrical shape. However, other cross-sectional shapes
may be used for particular applications, such as for supporting a
Y-site catheter.
[0128] Although the shape of the channel may vary depending upon
its application (i.e., depending upon a shape of the retained
portion of the medical article for which the retainer is designed
to be used), the length of the channel, as mentioned above, is
desirably sufficient in the longitudinal direction to stabilize the
catheter, rather than acting as a fulcrum for the catheter, as was
discussed above. That is, the retainer 16 receives a sufficient
length of the catheter to inhibit movement of the catheter in the
lateral, longitudinal and transverse direction (i.e., to inhibit
yaw, pitch and axial movement of the catheter), without kinking the
catheter.
[0129] The internal width of the channel can be varied by adjusting
the position of the posts 70. By moving or sliding the posts along
their slots 50, the distance between the posts can be varied. This
is especially important when the anchoring system 10 is used with a
wide variety of catheters and catheter fittings that may not have
similar juncture configurations or suture hole spacing.
[0130] With the covers 20, 22 in the closed position, a section of
the catheter 12 is captured within the retainer 16. Thus, the
retainer at least restricts, if not prevents, transverse and
lateral movement of the retained section of the catheter.
Transverse movement is also restricted when the covers 20, 22 are
open by the height of the posts 70, which inhibit upward migration
of the catheter 12 and/or catheter fitting. Inhibiting movement of
the catheter in the longitudinal direction when the catheter 12 is
secured within the retainer 16 is desirably accomplished by the
posts 70 and holes.
Operation
[0131] In operation, as best seen in FIGS. 3, 4, and 12, the covers
20, 22 are moved toward the closed position. The relatively thin
strip of material forming the hinge 36 allows the hinge to bend
when finger pressure is exerted on the covers to close them. The
tangs 86 at the end of the keepers 82 contact the protrusions 88 of
the latches 84 on the base 18 when the covers 20, 22 near their
closed position. Continued pressure forces the keepers 82 inward
(toward each other) to permit the tangs 86 to pass beyond the
protrusions 88. The tangs 86 snap over the protrusions 88 under the
spring force provided by the deflected keepers 82 when the covers
20, 22 sit atop the base 18. The interaction between the tangs 86
and the corresponding surfaces of the latches 84 hold the covers in
this position.
[0132] To open the latch mechanism 80, a healthcare worker presses
inwardly on the protruding flanges 68 of the covers 20, 22 or lifts
up the covers 20, 22, as described above. The resulting inwardly
directed force deflects the keepers 82 and moves the tangs 86
inward to clear the protrusions 88 of the latches 84. The
healthcare worker can then open the covers and expose the posts 70
and the base 18.
[0133] This releasable engagement between the covers 20, 22 and the
base 18 allows the same retainer 16 to be used for an extended
period of time, while permitting repeated attachment and
reattachment of the catheter 12 or fitting to the anchoring system
10. In addition, the hinges 36 which connect the covers 20, 22 to
the base 18 ensure that the covers will not be lost or misplaced
when the catheter 12 is detached from the anchoring system 10. The
healthcare worker wastes no time in searching for a misplaced
cover, or in orienting a cover prior to latching, and he or she is
not required to carry a separate instrument to detach the catheter
from the anchoring system.
[0134] A healthcare worker may secure a catheter (or other medical
article) to a patient using the above-described anchoring system
(or a readily apparent modification thereof). The healthcare worker
first opens the retainer 16 to expose the posts 70. Once opened, a
catheter 12 may be transversely aligned over the posts 70, as shown
in FIG. 3 and FIG. 12. The catheter 12 may then be placed into the
channel formed between the posts 70. Optionally, openings formed on
either the catheter 12 or a fitting can then be slid over the posts
to further secure the catheter to the retainer 16. Once the
catheter is so secured by the posts, the covers 20, 22 are closed
and latched in the manner described above, as seen in FIG. 4.
[0135] If the catheter 12 is pulled in the longitudinal direction,
the holding effect of the posts 70 and holes prevent the catheter
from pulling through the retainer 16. The retainer thus inhibits
longitudinal movement of the catheter relative to the retainer.
Interaction between the base 18, covers 20, 22, posts 70 and holes
restrict movement of the catheter 12 in the transverse and lateral
directions. The interaction between the posts 70 and the covers 20,
22 also inhibits significant bending of the post upper ends in the
longitudinal direction which, if allowed, would permit the catheter
to slide off the posts.
[0136] Importantly, the base 18 and covers 20, 22 do not crimp or
kink the catheter body when it is inserted within the channel and
about the posts 70. Moreover, although the posts do bear against
the catheter body, their limited pressure does not significantly
occlude the corresponding catheter lumen(s).
Fixed Position Post Platform
[0137] A variation to that described above is produced using the
same anchor pad 14, base 18 and covers 20, 22, but substituting a
different post platform 100 for that described above. Specifically,
the post platform of this alternate embodiment does not provide for
movable posts; the posts are in fixed positions on the platform,
and therefore, the user cannot adjust the spacing of the posts.
[0138] An example of a post platform 100 consistent with the
present embodiment can be seen in FIGS. 13 to 16. The platform 100
still consists of connectors 102, an attachment button 104, and
posts 106. However, instead of the connectors being flexible
leashes that allow the distance between the post 106 and the
attachment button 104 to be adjusted, the connector 102 comprises a
lateral extension of the lowest portion of the attachment button
104 that also acts as the lowest portion of each post 106. Because
there is no need for flexibility, the geometry of the connector is
simplified. This fixed post arrangement also provides for greater
stability for the posts 106 than the movable position post platform
92 does. It is most significant to note that in such an embodiment
there is no need for the flange 98 described with reference to
FIGS. 9 and 10 above. Not only is this flange not needed to provide
longitudinal and lateral stability to the post 106 as it extends
through the base 18, but the presence of such a flange would
actually prevent the insertion of the post platform 100 into the
base 18 in any case where the posts 106 were not positioned
directly beneath the circular region 48 of the post opening 46. By
eliminating the flange 98, the fixed position post platform 100 may
be manufactured with any spacing desired between the posts 106, as
long as the position of the posts falls somewhere along the length
of the post opening 46 in the base 18 of the retainer 16.
[0139] The greater stiffness and stability provided by producing a
fixed position post platform 100 allows the retainer 16 to be more
easily assembled. While it also eliminates the possibility of
adjusting the position of the posts 106 to accommodate different
sized catheters or catheter fittings, it allows a simpler design to
be used when the locations of the posts are known in advance to be
at a fixed position.
[0140] Additionally, the use of a fixed position post platform 100
simplifies the process of adhesively attaching the base 18 to the
anchor pad 14 because there is no need to avoid attaching the
underside of the post platform 100 to the anchor pad 14. Compare
FIGS. 17 and 18. In the movable post arrangement, shown in FIG. 17,
the post platform 92, and particularly the connectors 96, must be
free to flex and extend in order for the posts 70 to move. However,
in the fixed position post platform 100 (shown in FIG. 18), no
motion is possible. Therefore it is acceptable and even desirable
for the post platform 100 to be bonded to the anchor pad 14 in the
same manner as the base 18 of the retainer is attached to the
anchor pad 14.
[0141] The fixed position post platform 100 can be formed of any of
the materials noted above in connection with the movable post
platform 92. The fixed position post platform 100 in a preferred
embodiment is injected molded of a Lexan polycarbonate available
commercially from General Electric Company, as Part No. 144R.
Single Movable Post Retainer System
[0142] An additional preferred embodiment of the present invention
can be seen in FIGS. 19 and 20. The anchoring system 210
illustrated includes a retainer 220 and an anchor pad 294. The
retainer 220 is sized and configured with one, and preferably two
or more posts 230, 250 to accept and retain a section of a catheter
212 (FIG. 28) within the anchoring system 210, either directly or
by way of a fitting 214. The retainer 220 comprises a base 222 and
a cover 224. The cover 224 is detachably secured to the base 222
and movable between open and closed positions. The anchor pad 294
secures the retainer 220 to a patient's skin. The anchor pad 294 is
substantially similar to the anchor pad described above for use in
the previous embodiment of the invention.
[0143] Unlike the embodiments described above, this embodiment of
the present invention does not make use of a post platform that
comprises multiple posts. Rather, in the present embodiment, one
post is integrally formed with the base of the retainer, and the
other is inserted laterally into a track that runs along the bottom
of the base. Because the same characteristics of flexibility and
strength and ease of formation are present in this embodiment, the
same materials are most preferable to construct the instant
embodiment as were preferable to construct the prior
embodiments.
[0144] Although the embodiment discussed below is described using
particular ranges of sizes for various components, the sizes given
are merely exemplary. Those skilled in the art will recognize that
the components of any embodiment of the present invention described
herein may be sized however is appropriate to the catheter or other
device to be secured, or as is otherwise necessary according to the
circumstances under which the device is used.
[0145] The illustrated embodiment shows the base 222 including
first and second sides 226, 228. The first side 226 lies generally
between one set of lateral ends of the base 222, and the second
side 228 lies at an opposite set of lateral ends of the base
222.
[0146] FIG. 21 shows a fixed post 230 that is integrally formed
with and extends upwardly from the first side 226 of the base 222.
The base 222 desirably includes a pair of posts (the second,
movable post 250 is detailed below). The base 222, however, can
include additional posts to suit a specific application. For
example, where the retainer 220 is designed to secure a relatively
large fitting, the base 222 can include four posts arranged at the
corners of a rectangle, for greater stability. Similarly, three
posts can be used to firmly anchor a Y-site fitting.
[0147] As shown in FIG. 22, the fixed post 230 includes a shank or
shaft 232, attached to and extending upwardly from the base 222.
The post 230 can have a variety of lengths, depending upon the
particular application and the particular fitting to which they
interact to mount the catheter 212. For anchoring catheters and
medical tubing, the fixed post 230 desirably has a length of about
20 mm or less, and more particularly a length of about 7 mm;
however, longer or shorter lengths are also possible. The shaft 232
of the fixed post 230 has a diameter sufficient to perform its
structural function, as described in more detail below, and depends
on the material chosen for the base and post. The illustrated post
230 comprises a slightly elastic material, with a diameter between
0.5 mm and 3.0 mm and particularly about 1.5 mm. However, the
illustrated embodiment shows the shaft 232 configured substantially
as a cylinder to best match circular holes which are most commonly
used on winged catheters or catheter fittings. However, the shaft
can be configured with a host of other geometries, such as square,
triangular, oval, polygon or the like, to match the hole
configuration of various other catheters or catheter fittings.
[0148] FIG. 23 shows a track 242 formed in the base 222. The track
242 is arranged substantially linearly along the lateral axis and
extends proximal the fixed post 230 to the second side 228 of the
base 222. The track 242 has sufficient width to accommodate a
movable element therein. The edges of the track 242 are of
relatively smooth and solid construction such that the movable
element can move or slide within the track 242 in a fluid manner
without snagging on portions of the track 242.
[0149] The track 242 has a substantially inverse T-shaped
configuration, as can be seen in FIG. 24, with a first channel 246
and a second channel 248. The width of the second channel 248 is
larger than the width of the first channel 246. A portion of the
first channel 246 is desirably coplanar with the surface of the
base 224 and extends toward the anchor pad 294. The first channel
246 desirably has a lateral width of 0.5 mm to 3.0 mm and
particularly about 1.65 mm. The first channel 246 desirably has a
transverse height of 0.1 mm to 0.8 mm and particularly about 0.64
mm and communicates with the second channel 248. The second channel
248 further extends toward the anchor pad 294. The width of the
second channel 248 is desirably between about 0.5 mm and 8.0 mm and
particularly about 3.0 mm. The second channel 248 desirably has a
transverse height of 0.05 mm to 1.0 mm and particularly about 0.64
mm.
[0150] The T-shaped configuration of the track 242, achieved by the
relationship between the first and second channels 246, 248,
inhibits rocking of the movable element and retains it within the
channels (detailed below). This configuration also provides for
easy and inexpensive manufacture because a T-shaped track mold,
desirably extruded by a T-shaped element, has an inherently
stronger construction than other non I-beam structures, such as a
dovetail shape. The track mold is thus less susceptible to damage
from heat and pressure forces which occur during the molding
process. In contrast, if a dovetail shape is used, the thinned
edges become susceptible to melting and other deformations.
Although a T-shaped track configuration is preferred, other track
configurations, such as a dovetail shape, may be used with the
anchoring system.
[0151] FIG. 25 shows a movable post 250 including a shaft 232 sized
and configured similar to the fixed post 230 and positioned along
the base 222. The shaft 232 of the movable post 250 is sized and
configured to be received into the first channel 246 of the track
242. The diameter of the shaft 232 is desirably similar to the
lateral width of the first channel 246, but can have diameter that
is appreciable greater or less than the lateral width of the first
channel 246 depending on the particular application of the
anchoring system and the materials used to form the various
elements of the anchoring system. Desirably, the diameter of the
shaft 232 may be made anywhere from about the same width to 1 mm
less than the lateral width of the first channel 246, and
particularly about 0.13 mm less. This close-fit configuration
provides frictional forces between portions of the shaft 232 and
first channel 242 and allows the post 250 to reluctantly slide
within the first channel 246 of the track 242 while remaining
substantially upstanding about the transverse axis.
[0152] The movable post 250 desirably further includes a platform
252 from which the post 250 extends. The platform 252 extends along
a plane defined by the longitudinal and lateral axes and is sized
and configured to be received into the second channel 248 of the
track 242. Desirably, the relationship between the lateral width of
the platform 252 and the lateral width of second channel 248 is
similar to that of the movable post 250 and first channel 242 in
order to similarly provide a close-fit configuration between the
platform 252 and second channel 248. Thus, the platform 252 can
reluctantly slide within the second channel 248 of the track 242
while remaining substantially upstanding about the transverse axis.
Although the movable post shown in FIG. 25 has a platform whose
length and width are different so as to form an elongated rounded
rectangle, those of skill in the art will recognize that the
platform may take on other shapes, such as square, oval, or
circular without altering the operation of the post within the
track.
[0153] By this post-platform design, the post 250 and platform 252
provides a substantially T-shaped structure that can be
accommodated by the T-shaped track 242. Alternatively, if an
alternative track configuration is used, such as dovetail shape,
the post-platform design is modified to similarly provide a
close-fit relationship with the track, as will be understood by one
skilled in the art.
[0154] As detailed above, the substantially upstanding post 250 and
platform 252, which are respectively closely fit into the smooth
first and second channels 246, 248 of the track 242 cooperate to
provide a movable structure which can reluctantly slide along the
track 242 but which can remain upright, resist axial rocking, and
prevent escape from the track 242 when axial or rotational forces
are applied to the post 250. The reluctant sliding is such that a
force applied by the finger(s) of a healthcare worker can slide the
post 250 and platform 252 along the track 242. Any unintentional
movement of the post 250 and platform 252, without such applied
force, is resisted. The post 250 and platform 252 can also be
reproducibly introduced into, and recalled from, the track 242
(FIG. 21). That is, the post and platform can enter the track 242
along the terminal portion of the track 242, which is co-extensive
with the second side 228 of the base 222, and can similarly exit
the track 242 from this terminal portion.
[0155] The platform 252 is desirably permanently affixed to the
post 250 and formed unitarily therewith. However, the post 250 and
platform 252 may be separately formed and then connected using any
of a variety of suitable attachment means known to those skilled in
the art. For example, the post can have a threaded portion that
screws into a threaded portion of the platform, or the post can
have a notch that is snapped into a recess in the platform.
Chamfers can also be used to guide and position the post with
respect to a seating area on the platform.
[0156] As best seen in FIGS. 22 and 23, the cover 224 has an
elongate shape which desirably is coextensive with the planar size
and shape of the base 222 (i.e., the cover desirably has the same
geometric shape and size as the base 222); however, the cover 224
need not be the same size or shape as the base 222. For instance,
the cover 224 can be sized to extend beyond any of the lateral,
transverse, or longitudinal edges of the base 222 or,
alternatively, can be sized so as to not extend to the lateral,
transverse, or longitudinal edges of the base 222. The cover can
also include a skirt or flange (not shown) that extends over and/or
about the base 222 or any portion thereof.
[0157] The cover 224 desirably has a sufficient size to cover the
posts 230, 250 in the base 222 and to accommodate a portion of the
latch mechanism 270 and hinge 264 which operate between the base
222 and the cover 224 as described below. The cover 224 also
desirably is of a dimension that provides for easy manipulation.
For example, the cover's size easily accommodates the grasp of a
healthcare worker, and allows for manipulation of the device while
wearing surgical gloves.
[0158] The cover 224 includes a first side 254 which lies generally
between one set of lateral ends of the cover 224. The first side
254 of the cover therefore generally corresponds to the first side
226 of the base 222. The cover 224 also has a second side 256. The
second side 256 lies generally between one set of lateral ends of
the cover 224, opposite of the first end, and therefore corresponds
generally to the second side 228 of the base 222.
[0159] Still referring to FIGS. 22 and 23, a dome 257 is formed
between the first side 254 and the second side 256 of the cover
224. The dome 257 provides a transversely extended area that can
accommodate the central portion of larger, bulkier catheters and
catheter fittings. Because many catheters and catheter fittings are
manufactured "centrally bulky," the dome 257 allows these catheters
or catheter fittings to be accepted into the retainer 220 when in
the closed position and assists in the universal aspect of the
present invention.
[0160] A recess 258 is formed as an elongated body on the cover 224
and runs generally parallel to the track 242 when the cover is in
the closed position. The recess 258 is arranged to receive the
distal ends of the posts 230, 250 when the cover 224 is in the
closed position. The recess 258 allows the posts 230, 250 to avoid
contact with or otherwise not impede the cover 224 when the cover
224 is moved to the closed position (the top of the posts 230, 250
may be at a transversely higher elevation than the bottom of the
cover 224) and also inhibits motion of the posts in the
longitudinal direction. The dome 257 may also serve as a partition
to separate the recess 258 into first and second areas, each area
being sized to acconmodate a post.
[0161] The recess 258 desirably has a width slightly larger than
the width of the first channel 246. This larger width compensates
for inclination and "play" in the generally upstanding movable post
250, which may be angled anywhere between slightly greater or less
than normal to the base 222 (generally 75 to 115 degrees). This
play generally results from the close-fit configuration of the post
250 and platform 252, which are desirably configured dimensionally
smaller than their corresponding tracks 246, 248. The transverse
height of the recess 258 is desirably between about 1.0 mm and 2 mm
and particularly about 1.27 mm. The recess 258 may have one or more
chamfered edges (not shown) to transversely guide the post 230 into
the recess 258.
[0162] Although the recess 258 desirably forms an elongated body
running generally parallel to the track 242 when the cover is in
the closed position, a wide variety of other configurations may be
used. For example, the first and second areas of the recess 258 can
be modified so that the second area has a longer longitudinal
length than the first area. So configured, the second area length
can generally correspond to the track 242 length, while the first
area length can generally correspond to the fixed post 230 diameter
(FIG. 26). For another example, the recess may extend to the
terminal ends of the first and second sides 254, 256 of the cover
224 for ease of manufacture. The only requirement of the recess 258
is the capability to receive the posts 230, 250 and allow the cover
224 to move to the fully closed position.
[0163] The flexible couplings that may be used to connect the cover
224 to the base 222 are substantially as described in the previous
embodiments. The difference being that in the present embodiment
the cover 224 comprises only a single piece and hence only a single
hinge 264 is needed.
[0164] The means of operation is significantly the same for this
anchoring system as for the previous system as well. The potential
advantages are simplification of the manufacture and design.
[0165] The latching mechanism 270, while operating in a similar
manner to the previously described embodiments, is slightly
differently constructed in the present embodiment. As best seen in
FIG. 30, each keeper 272 extends toward the base 222 from the
second side 256 of the cover 224. A tang 276 is formed at a lower
end 278 of the keeper 272. Desirably, the lower end 278 of the
keeper 272 is relatively blunt and smooth to prevent it from
puncturing the gloves or skin of a healthcare worker or catching on
other materials. An operator lever 280 extends to the side of the
keeper 272 and includes an enlarged platform or ear 282 at its
outer end such that a component of a lateral force applied to the
lever 280 will cause the keeper 272 to deflect inward. The entire
keeper 272 desirably is formed with the cover 224 to form a unitary
piece.
[0166] The latch mechanism 270 also includes a receptacle 284 that
receives the tang 276 and at least a portion of the keeper 272. The
latch receptacle 284 includes an inner notch 286 into which the
tang 276 snaps into when the cover 224 is in the closed position;
however, the tang 276 can be arranged in the receptacle 284 and the
notch 286 be positioned on the keeper 272 to accomplish the same
effect. The latch 274 desirably is formed with the base 222 as a
unitary piece.
[0167] In the illustrated embodiment, the cover 224 includes two
keepers 272 that are mirror images of each other. And, the latch
274 includes two notches 286, each of which is arranged to receive
one of the keeper tangs 276 when the cover 224 is closed.
[0168] An entrance of the receptacle 284 includes chamfered edges
288. The chamfered edges 288 slope inward toward the center of the
receptacle 284 to cause the keeper 272 to bend inward when inserted
into the latch receptacle 284.
Lower Support Member
[0169] In some cases it may be advantageous to provide a lower
support member which lies between the upper surface of the anchor
pad and the bottom of the retainer base. The lower support member
thereby provides a smooth surface for the bottom of the groove of
the base, rather than having the bottom surface of the groove
formed by the upper surface of the anchor pad. Additionally,
because the lower support member now forms the bottom surface of
the retainer, it is practical to adhere the entire bottom surface
of the retainer to the anchor pad, even in embodiments making use
of movable posts.
[0170] The lower support member 300 as shown in FIGS. 32-34,
comprises a generally flat plate 305 of generally the same planform
shape as the lower portion of the retainer base 318. The lower
support member 300 may preferably be manufactured from the same
materials and using the same techniques as are suitable for the
manufacture of the retainer base 318. In some preferred
embodiments, the lower support member 300 and base 318 may be
manufactured as a unitary piece, and then separated prior to
assembly into the final retainer, as will be discussed below. Such
a unitary lower support member 300 and base 318 are shown in FIGS.
32-34.
[0171] As can be seen in FIGS. 32-34, the lower support member 300
comprises a flat plate 305 and a set of tabs 320 which extend
therefrom. In the illustrated embodiment, the tabs 320 extend in a
direction opposite the direction in which the walls of the base 318
extend from the bottom of the base. However, the tabs 320 need not
extend in this direction if the lower support member 300 is to be
separated from the base 318 prior to assembly. Each tab 320 is
preferably slightly flexible and contains a chamfered tang towards
its tip. For manufacturing purposes it may be desirable to place a
hole 350 on the plate 305 adjacent to each tab 320.
[0172] As also shown in FIGS. 32-34, the base 318 for use with the
lower support member 300 preferably contains slots 340 in positions
which correspond to the positions of the tabs 320 on the lower
support member 300. As mentioned above, the base 318 and lower
support member 300 may be manufactured as a single piece using
injection molding or an other manufacturing process known in the
art. When manufactured as a single piece, the lower support member
300 and base 318 are preferably connected by a thin leash of
material 310, visible in FIGS. 32 and 34. This thin leash 310 may
be broken or cut in order to separate the lower support member 300
from the base 318 prior to assembly. Desirably, the entire leash
310 is removed so that there is no stub of material projecting from
the side of either the lower support member 300 or the base 318 of
the retainer when it is in use upon a patient.
[0173] The base 318 as shown in FIGS. 32-34 also provides generally
the same features as those discussed with respect to the base 18
shown in FIGS. 5-7 above. In particular, the base 318 provides a
groove (not visible) on the underside of the base, as well as post
openings. The post openings, as shown in FIG. 32, need not have a
circular region, but rather only an elongated track 50. The
elongated track 50 may contain a scalloped edge as described above
in order to provide positions into which the posts may snap, or may
have straight sides as shown in FIG. 32. It is also shown that the
covers 20, 22 may be integrally molded with the base 318, as is
described with respect to the base 18 in FIGS. 5-7 above.
[0174] After the base 318 and lower support member 300 are
separated, an appropriate pair of posts 250 or a post platform may
be inserted into position from the underside of the base 318. One
post desirably extends through each of the elongated tracks 50 in
the bottom of the base 318 when the platform or posts are inserted
into the base 318. If a post platform with an attachment button is
used, the attachment button is desirably inserted through the
central circular opening 44 on the bottom of the base. The post
platform may be as described above, or a pair of individual free
standing posts 250 as shown in FIG. 25 may be used. In either case,
it is desirable that the bottom of the platform of the posts lie
within the groove of the base 318.
[0175] Once the post platform or posts 250 are in position, the
lower support member 300 is pressed onto the bottom of the base 318
of the retainer and desirably secured in position. In the
embodiment shown in FIGS. 32-34, the tabs 320 of the lower support
member 300 will be inserted into the corresponding slots 340 in the
bottom of the base. The chamfered tangs of the tabs 320 desirably
cause each tab 320 to deflect as the tang passes through the slot
340, and then snap back toward its original position once the tang
is beyond the slot 340 and within the interior space of the base
318. In this way, the interaction between the tabs 320 and the slot
340 and walls of the base 318 may secure the lower support member
300 upon the base 318.
[0176] The lower support member 300 may also be secured to the base
318 via adhesive. This may be used as an alternative to the use of
tabs 320 and slots 340, or may be used in addition to the tabs 320
and slots 340 to provide improved securement between the lower
support member 300 and the base 318. Desirably, when adhesive is
used with any embodiment using posts which move, either as
independent posts 250, or as in a post platform with connectors as
shown in FIGS. 11A-11C, any adhesive used is preferably placed on a
portion of the base 318 such that it does not interfere with the
free motion of the posts within the groove of the base 318. Those
of skill in the art will recognize that other means may also be
used to attach the lower support member 300 to the bottom of the
base 318. For instance, the lower support member 300 may be secured
to the base 318 by ultrasonic welding.
[0177] Once assembled as described above, the retainer provides a
pair of T-shaped tracks, similar to those described above with
reference to FIG. 24, comprised of the groove of the base, and each
post opening 50. The posts are free to move within these grooves as
described above in order to accommodate medical articles of varying
dimensions and configurations. The usage of the anchoring system
formed using the lower support member 300 and base 318 shown in
FIGS. 32-34 is substantially the same as that described with
respect to FIGS. 5-7 above.
[0178] The various embodiments of anchoring systems and techniques
described above in accordance with present invention thus provide a
sterile, tight-gripping, needle- and tape-free way to anchor a
medical article to a patient. The retainer thus eliminates use of
tape, and if prior protocol required suturing, it also reduces the
risk of accidental needle sticks, suture-wound-site infections and
scarring. In addition, the techniques for the described retainers
can be used with any of a wide variety of catheters, fittings,
tubes, wires, and other medical articles. Patient comfort is also
enhanced and application time is decreased with the use of the
present anchoring system.
[0179] Of course, it is to be understood that not necessarily all
such objects or advantages may be achieved in accordance with any
particular embodiment of the invention. Thus, for example, those
skilled in the art will recognize that the invention may be
embodied or carried out in a manner that achieves or optimizes one
advantage or group of advantages as taught herein without
necessarily achieving other objects or advantages as may be taught
or suggested herein.
[0180] Furthermore, the skilled artisan will recognize the
interchangeability of various features from different embodiments.
For example, the scalloped edge of the elongated tracks may be
adapted for use with the lower support member design shown in FIGS.
32-34. Similarly, the various bases, covers, posts, slots, hinges,
anchor pads, post platforms, lower support members and latching
mechanisms disclosed herein, as well as other known equivalents for
each such feature, can be mixed and matched by one of ordinary
skill in this art to construct anchoring systems in accordance with
principles of the present invention.
[0181] Although this invention has been disclosed in the context of
certain preferred embodiments and examples, it therefore will be
understood by those skilled in the art that the present invention
extends beyond the specifically disclosed embodiments to other
alternative embodiments and/or uses of the invention and obvious
modifications and equivalents thereof. Thus, it is intended that
the scope of the present invention herein disclosed should not be
limited by the particular disclosed embodiments described above,
but should be determined only by a fair reading of the claims that
follow.
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