U.S. patent application number 13/105681 was filed with the patent office on 2011-09-01 for medical line anchoring system.
This patent application is currently assigned to Venetec International, Inc.. Invention is credited to Steven F. Bierman.
Application Number | 20110213310 13/105681 |
Document ID | / |
Family ID | 25345006 |
Filed Date | 2011-09-01 |
United States Patent
Application |
20110213310 |
Kind Code |
A1 |
Bierman; Steven F. |
September 1, 2011 |
MEDICAL LINE ANCHORING SYSTEM
Abstract
An anchoring system includes a simply-structured device which
permits a portion of a catheter tube or similar medical article to
be easily anchored to a patient, desirably without the use of tape
or needles and suturing. A unitary retainer desirably includes a
base connected to a cover by way of a flexible hinge. The retainer
is attached to a flexible anchor pad including an adhesive bottom
surface, which can be attached to the patient's skin. A catheter is
secured to a fitting, which in turn mounts to the retainer.
Mounting the fitting to the retainer can be accomplished by
inserting posts of the retainer through holes of the fitting, or by
mounting the fitting within a channel defined by mounting
structures integral to the retainer. The cover is then positioned
over the base, by bending the flexible hinge, and latched to the
base. Several embodiments of the latching mechanism are disclosed.
In one form, the latching mechanism includes one or more posts on
the base which can be releasably locked into corresponding slotted
holes in the cover.
Inventors: |
Bierman; Steven F.; (Del
Mar, CA) |
Assignee: |
Venetec International, Inc.
Covington
GA
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Family ID: |
25345006 |
Appl. No.: |
13/105681 |
Filed: |
May 11, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11837426 |
Aug 10, 2007 |
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13105681 |
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11687580 |
Mar 16, 2007 |
7666167 |
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11837426 |
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11204586 |
Aug 16, 2005 |
7247150 |
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11687580 |
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10209209 |
Jul 30, 2002 |
6929625 |
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11204586 |
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09797341 |
Mar 1, 2001 |
6447485 |
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10209209 |
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08865231 |
May 29, 1997 |
6213979 |
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09797341 |
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Current U.S.
Class: |
604/180 ;
604/174 |
Current CPC
Class: |
Y10S 128/26 20130101;
A61M 2025/0253 20130101; A61M 2025/0246 20130101; A61M 2025/024
20130101; A61M 2025/026 20130101; A61M 25/02 20130101; A61M
2025/0266 20130101 |
Class at
Publication: |
604/180 ;
604/174 |
International
Class: |
A61M 39/00 20060101
A61M039/00 |
Claims
1. A retainer for securing a medical line having a fitting to the
body of a patient, the retainer comprising: a base that defines a
receiving area for receiving a portion of the fitting; a cover
coupled to the base; means for releaseably latching the cover to
the base without substantially moving the received portion of the
fitting; and means for limiting longitudinal movement of the
medical fitting in both longitudinal directions relative to the
retainer and in a non-occlusive manner, said movement limiting
means being located at least partially beneath the cover when the
cover is latched to the base.
2. A retainer as in claim 1 additionally comprising a flexible
anchor pad having an adhesive layer on one side, and the retainer
is attached to the flexible anchor pad on an opposite side.
3. A retainer as in claim 1, wherein the cover is permanently
linked to the base.
4. A retainer as in claim 3, wherein the cover and the base are
integrally formed such that the retainer has a unitary
construction.
5. An anchoring system for securing a medical line to the body of a
patient, the system comprising: a medical line including a fitting;
and a retainer including a base that defines a receiving area for
receiving a portion of the fitting of the medical line, a cover
coupled to the base, the cover being movable between a closed
position, in which at least a portion of the cover extends over at
least a portion of the receiving area, and an open position, in
which the receiving area is at least partially open, a coupling
operating between the base and the cover to releasably connect a
portion of the cover to the base with the cover in the closed
position and without substantially moving the received portion of
the fitting, and interacting structure which is adapted to engage
at least a portion of the fitting in a non-occlusive manner and to
inhibit longitudinal movement of the fitting through the retainer
when the fitting is placed within the receiving area, the
interacting structure being located at least partially beneath the
cover with the cover in the closed position.
6. The anchoring system of claim 5, wherein the fitting comprises a
wing clamp and a rigid box clamp engaged with the wing clamp, and
at least one hole extends through corresponding wings of the box
clamp and the wing clamp.
7. The anchoring system of claim 5, wherein the fitting comprises a
rigid clamp having a longitudinal groove sized to receive the
medical line.
8. The anchoring system of claim 5, wherein the cover is smaller
than the base.
9. The anchoring system of claim 5, wherein the cover has a width
sufficient to stabilize a section of the fitting located within the
retainer.
10. The anchoring system of claim 5, wherein the interacting
structure comprises at least one post extending at least partially
between the cover and the base with the cover in the closed
position.
11. The anchoring system of claim 5, wherein the interacting
structure includes at least two posts disposed on the base.
12. The anchoring system of claim 5, wherein the coupling comprises
a post extending from the base and a corresponding opening in the
cover.
13. The anchoring system of claim 5, wherein the interacting
structure comprises at least one post disposed on the base and
configured to extend into at least one hole of the fitting.
14. The anchoring system of claim 13, wherein the post comprises a
shaft and a radial extension, the shaft engaging with the fitting
and the radial extension engaging with a cover surface with the
cover in the closed position.
15. The anchoring system of claim 13, wherein the cover has width
in a longitudinal direction that is wider than a width of the at
least one post.
16. The anchoring system of claim 13, wherein the coupling
comprises the at least one post and at least one opening sized to
receive at least a portion of the post with the cover in the closed
position.
17. An anchoring system for securing a medical article to the body
of a patient, the medical article having an irregularly shaped
fitting that is non-uniform in its circumference, the anchoring
system comprising: an anchor pad having an upper surface and a
lower surface; and a retainer comprising, a base being coupled to
the anchor pad, a plurality of irregularly shaped walls extending
generally perpendicular to the base and being arranged relative to
each other so as to secure the irregularly shaped fitting
therebetween, at least a portion of the secured irregularly shaped
fitting having a lateral width greater than a distance between said
irregularly shaped walls, and a cover movable coupled to the base
so as to move between a first position and a second position at
least when the irregularly shaped fitting is not disposed between
the irregularly shaped walls, the cover lying above at least part
of the base when in the first position.
18. An anchoring system according to claim 17, wherein the cover is
coupled to the base by a flexible coupling.
19. An anchoring system according to claim 17 further comprising at
least one post arranged between the base and the cover when the
cover is in the first position, wherein the post extends generally
upward from the base.
20. An anchoring system according to claim 19, wherein the cover
includes a receptacle for receiving at least a portion of the post
when the cover is in the first position.
Description
RELATED CASES
[0001] This application is a continuation of co-pending U.S.
application Ser. No. 11/837,426, filed 10 Aug. 2007, which is a
continuation of U.S. application Ser. No. 11/687,580, filed 16 Mar.
2007, now U.S. Pat. No. 7,666,167, which is a continuation of U.S.
application Ser. No. 11/204,586, filed 16 Aug. 2005, now U.S. Pat.
No. 7,247,150, which is a continuation of U.S. application Ser. No.
10/209,209, filed 30 Jul. 2002, now U.S. Pat. No. 6,929,625, which
is a continuation of U.S. application Ser. No. 09/797,341, filed 1
Mar. 2001, now U.S. Pat. No. 6,447,485, which is a divisional of
U.S. application Ser. No. 08/865,231, filed 29 May 1997, now U.S.
Pat. No. 6,213,979, each of which is hereby incorporated by
reference in its entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to anchoring systems for
anchoring medical lines to patients.
[0004] 2. Description of Related Art
[0005] It is very common in the treatment of patients to utilize
intravenous (IV) catheters to introduce fluids and medications
directly into the bloodstream. In many cases, and particularly with
respect to cardiac therapy, the IV catheter is introduced into a
central or larger vein located close to the patient's heart. A
typical catheter utilized in connection with a central vein is
referred to as a "central venous catheter" ("CVC"). A venous
catheter peripherally inserted into the central circulation through
a vein in the arm is commonly referred to as a "peripherally
inserted central catheter" ("PICC").
[0006] In these cases, long-term IV infusion typically requires
that the catheter remain in place for many days. In order to secure
such an IV catheter in position at the insertion site, the catheter
often is provided with an integrated or a movable flexible clamp
with winged extensions which are sutured to the patient's skin. In
other applications, the flexible clamp is covered by a rigid box
clamp, which receives the catheter/clamp combination in a
friction-fit manner. The rigid box clamp and the flexible clamp
have lateral, aligned holes in them, which allow the combination to
be sutured to the patient's skin. Although this technique securely
attaches the central venous catheter to the patient, it obviously
is painful and uncomfortable for the patient. This prior retention
procedure is also time consuming and inconvenient, poses the risk
of needle-stick to the health care provider, and risks suture-site
infection to the patient. In addition, suture material tends to
exhibit poor gripping on medical tubes and can cut through the
winged extension of the flexible clamp.
SUMMARY OF THE INVENTION
[0007] A need therefore exists for a simply-structured anchoring
system that affixes a medical line in a fixed position, but
releases the medical line for dressing changes or other
servicing.
[0008] On aspect of the present invention thus involves an
anchoring system for securing a medical line to the body of a
patient. The system comprises a retainer including a base that
defines a receiving area for receiving a portion of the medical
line. A cover is permanently coupled to the base. The cover is
movable between a closed position, in which at least a portion of
the cover extends over at least a portion of the receiving area,
and an open position, in which the receiving area is at least
partially open. A mechanism operates between the base and the cover
to releasably the cover to the base with the cover in the closed
position. Interacting structure is located generally beneath the
cover with the cover in the closed position. The interacting
structure is adapted to limit movement of the medical line through
to the retainer when the catheter is placed within the receiving
area.
[0009] Another aspect of the present invention involves an
anchoring system for securing a medical line to the body of a
patient. The system includes a fitting adapted to engage with the
medical line and having at least one opening. A retainer comprises
a base including a platform and at least one post extending from
the platform and arranged to interact with the hole of the fitting.
A cover is movably coupled to the base so as to be moved between an
open position and a closed position. A latching mechanism operates
between the cover and the base to releasably latch the cover to the
base in the closed position.
[0010] In accordance with an additional aspect of the present
invention, an anchoring system for securing a medical line to the
body of a patient is provided. The anchoring system comprises an
adaptor having an adaptor body with a longitudinal axis defined
between first and second ends. A first connector is located at the
first end of the adaptor for connection to a first medical line,
and a second connector is located at the second end for connection
to a second medical line. A retainer includes a base and a cover
permanently coupled to the base. The cover is movable between an
open position and a closed position. A latching mechanism
releasably latches the cover to the base in the closed position.
And a channel is arranged to lie between the base and the cover in
the closed position. The channel is shaped to retain the adaptor
between the cover and the base with the cover in the closed
position to inhibit movement of the adapter in a direction
generally parallel to the adapter's longitudinal axis. An adhesive
layer is attached to the retainer and is adapted to adhesively
secure the retainer to the body of a patient.
[0011] A preferred method of anchoring a medical line to a patient
involves providing a retainer including a base having a plurality
of posts, and a cover attached to the base by a flexible leash. The
provided cover also includes a corresponding plurality of openings
with each opening comprising a slot. The retainer is coupled to an
adhesive layer. The anchoring system is positioned on the body of
the patient, and the adhesive layer is attached to the body of the
patient. A medical device is arranged between the posts of the
base. The cover is positioned over the base to bring the openings
of the cover in proximity with the posts of the base. The cover is
shifted relative to the base to engage the posts with the slots of
the openings.
[0012] 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
[0013] The above-mentioned and other features of the invention will
now be described with reference to the drawings of several
preferred embodiments of the present anchoring system. The
illustrated embodiments of the anchoring system are intended to
illustrate, but not to limit the invention. The drawings contain
the following figures:
[0014] FIG. 1A is a perspective view of an anchoring system in
accordance with a preferred embodiment of the present invention and
illustrates a retainer of the anchoring system in an open position
together with an exemplary catheter wing clamp fitting (the
components of which are illustrated as exploded above the
retainer);
[0015] FIG. 1B is a bottom plan view of a cover of the retainer of
FIG. 1A;
[0016] FIG. 2 is a perspective view of the anchoring system of FIG.
1A with the cover of the retainer shown in a partially closed
position;
[0017] FIG. 3 is a cross-sectional view of the anchoring system of
FIG. 2, with the retainer shown in a completely closed position and
the catheter wing clamp fitting assembled and anchored therein;
[0018] FIG. 4A is a perspective view of a retainer in accordance
with another preferred embodiment of the present invention, shown
in an open position;
[0019] FIG. 4B is a bottom plan view of a cover portion of the
retainer of FIG. 4A;
[0020] FIG. 5 is a perspective view of the retainer of FIG. 4A,
shown in a partially closed position;
[0021] FIG. 6 is a perspective view of a retainer in accordance
with another preferred embodiment of the present invention, shown
in an open position;
[0022] FIG. 7 is a perspective view of the retainer of FIG. 6,
shown in a closed position;
[0023] FIG. 8 is a cross-sectional view of the retainer of FIG. 7,
taken along the line 8-8;
[0024] FIG. 9 is a cross-sectional view of the retainer according
to FIG. 8, but with a tang shown in a release position;
[0025] FIG. 10A is a prospective view of an anchoring system in
accordance with an additional preferred embodiment of the present
invention and illustrates a retainer of the anchoring system in an
open position and together with an exemplary catheter adaptor;
[0026] FIG. 10B is a bottom plan view of a cover portion of the
retainer of FIG. 10A;
[0027] FIG. 11 is a prospective view of the retainer of FIG. 10A,
shown in a partially closed position with the cover interacting
with the catheter adapter; and
[0028] FIG. 12 is a cross-sectional view of the retainer according
to FIG. 11, shown in a completely closed position, with the
catheter adaptor anchored therein.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0029] The present embodiments of the medical line anchoring system
are disclosed in the context of an exemplary central line catheter.
The principles of the present invention, however, are not limited
to PICCs or CVCs. Instead, it will be understood by one of skill in
this art, in light of the present disclosure, that the anchoring
systems and retainers disclosed herein also can be successfully
utilized in connection with other types of medical lines, including
tubes for fluid communication and electrical wires. For example,
but without limitation, the retainers disclosed herein can retain
CVCs, PICCs, Foley catheters, and hemodialysis catheters, surgical
drainage tubes, feeding tubes, chest tubes, nasogastric tubes,
scopes, as well as with 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 8 in connection with a catheter is mainly
exemplary of one possible application of the system.
[0030] Each of the embodiments described herein employ the same
basic concepts characteristic of the improved anchoring system,
namely releasable attachment of a medical line to a patient. The
anchoring systems also all include interacting structure that
operates between a retainer of the anchoring system and a fitting
which in some applications is releasably attached to the medical
line and in other applications is integrally formed with the
medical line. The interacting structure between the retainer and
the fitting generally inhibits relative movement between the
medical line and the anchoring system in at least one degree of
freedom.
[0031] To assist in the description of the components of the
anchoring systems and retainers disclosed herein, the following
coordinate terms are used. A longitudinal axis is generally
parallel to a section of the medical line to be retained by the
anchoring system, generally in the plane of a retainer base
(discussed below). A lateral axis is generally perpendicular to the
longitudinal axis within the plane of the base. A transverse axis
extends transverse to both the longitudinal and lateral axes. A
number of the figures illustrate this coordinate system to the side
of the anchoring system. 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" refer to a direction substantially
parallel to the transverse axis. These coordinates are used to
describe structures and movement of the anchoring system of each
embodiment. A detailed description of each embodiment, and its
associated method of use, now follows.
[0032] FIGS. 1 to 3 illustrate an anchoring system 8 constructed in
accordance with a preferred embodiment of the present invention.
The system 8 includes a retainer 10 which is configured to retain a
catheter, either directly or by way of a fitting 11. In the
illustrated embodiment, the fitting 11 comprises a catheter box
clamp 12 and a soft wing clamp 13 for use with a central line
catheter 15.
[0033] The retainer 10 includes a base 14. The base 14 of the
retainer 10 is attached to an anchor pad 16, which forms a part of
the anchoring system 8. The base 14 desirably is secured to the
anchor pad 16 by a solvent bond adhesive, such as cyanoacrylate or
other bonding material. One such adhesive is available commercially
as Part No. 4693 from the Minnesota Mining and Manufacturing
Company (3M).
[0034] The anchor pad 16 comprises a flexible structural layer for
securing the retainer 10 to a patient's skin. The pad desirably
comprises a laminate structure with an upper cellulose foam layer
(e.g., closed-cell polyethylene foam), and a bottom adhesive layer.
The adhesive 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 New Dimensions in Medicine of Columbus, Ohio.
Although not illustrated, it will be understood that the retainer
and/or anchor pad can include suture holes in addition to the
adhesive layer to further secure the anchor pad to the patient's
skin.
[0035] An upper surface of the foam layer is roughened by
corona-treating the foam with a low electric charge. The roughened
or porous upper surface of the anchor pad 16 improves the quality
of the adhesive joint formed by the cyanoacrylate (or by another
type of adhesive or bonding material) between the base 14 to the
anchor pad 16. In the alternative, the flexible anchor pad 16 can
comprise a medical-grade adhesive bottom layer, an inner cellulose
foam layer and an upper paper or other woven or non-woven cloth
layer.
[0036] A removable paper or plastic backing 17 desirably covers the
bottom adhesive surface before use. The backing 17 preferably
resists tearing and is divided into a plurality of pieces to ease
attachment of the pad to a patient's skin. Desirably, the backing
17 is split along a center line 18 of the flexible anchor pad 16 in
order to expose only half of the adhesive bottom surface at one
time. The backing 17 also advantageously extends beyond at least
one edge of the anchor pad 16, as illustrated, to facilitate
removal of the backing 17 from the adhesive layer.
[0037] In the illustrated embodiment, the anchor pad 16 also
desirably includes a pair of opposing concave sections that narrows
the center of the anchor pad proximate to the base 14. As a result,
the peripheral ends of the anchor pad 16 have more contact area to
provide greater stability and adhesion to a patient's skin, while
allowing the retainer 10, which is located at center section of the
anchor pad 16, to be placed adjacent to an insertion site of the
catheter 15.
[0038] Although the anchor pad 16 has not been shown in the other
drawings that illustrates this embodiment, nor in some of the
drawings illustrating the other embodiments, it will be understood
that a similar flexible anchor pad is included to secure the
retainer to the patent's skin with each embodiment.
[0039] The base 14 and the catheter 15 desirably include
interacting structure to couple the catheter 15 to the base 14. As
will be clear from the disclosure below, the interacting structure
mounts the medical line either directly or by way of a fitting
(e.g., the box clamp 12 and soft wing clamp 13) to the base 14. In
the latter case, a portion of the interacting structure desirable
is formed on the fitting and another portion of the interacting
structure is formed on the retainer. The term "mount," when used
with reference to the relation between the catheter or fitting and
the retainer, does not necessarily imply that the catheter 15 or
fitting 11 are immobilized or fixed. Rather, this term is meant to
describe the condition in which the interacting structure inhibits
movement of the catheter 15 relative to the retainer 10 in at least
one degree of freedom (e.g., rotational, lateral, longitudinal or
transverse). In the illustrated embodiment, as well as in those
later described, the interacting structure inhibits movement of the
catheter 15 at least in the longitudinal direction.
[0040] In the illustrated embodiment, a portion of the interacting
structure on the base 14 comprises at least one post 20 which
extends upwardly from a relatively rigid platform 21. The base 14
desirably includes a pair of posts 20. The base can also include
additional posts to suit a specific application. For example, where
the retainer is designed to secure a relatively large fitting, the
base can include four posts arranged at the corners of a rectangle,
for greater stability. And, three posts can be used to firmly
anchor a Y-site fitting.
[0041] Each post 20 includes a shank or shaft 25, attached to and
extending upwardly from the platform 21. The posts 20 can have a
variety of lengths and a variety of distances between them,
depending upon the particular application and the particular
fitting 11 with which they are to interact to mount the catheter
11. For anchoring catheters and medical tubing, each post 20
desirably has a length of about 4 mm to 20 mm, and more
particularly a length of about 6 mm; however, longer or shorter
lengths also are possible. The posts 20 are laterally spaced at
least wide enough to accommodate the medical line to be anchored,
and in the illustrated embodiments, the posts 20 are spaced to
accommodate the fitting 11 which secures the medical line.
Desirably, the posts 20 are spaced apart by a distance between 5 mm
and 40 mm, and more particularly by a distance equal to about 15
mm. The shaft 25 of each post 20 has a diameter sufficient to
perform its structural function, as described in more detail below,
and depends upon the material chosen for the base 14 and shafts 25.
The illustrated posts 20 comprise a polymer plastic material, with
a diameter between 0.5 mm and 3 mm and particularly about 1.7
mm.
[0042] At least one protrusion extends radially from the shaft. In
the illustrated embodiment, the protrusion comprises an enlarged
tip or head 26 at the end distal from the platform 21. As seen in
FIG. 1, at least a portion of the head 26 of each post 20 is larger
than the diameter of the shaft 25, desirably having a maximum
diameter of 1.1 to 1.5 times the diameter of the shaft 25. In the
illustrated embodiment, the head 26 has a generally hemispherical
shape with a smooth surface and a maximum diameter at an
overhanging lower surface or underside 30. It will be understood,
however, that the head 26 can take a variety of other shapes, such
as for example, solid or hollow conicals, arrowheads, barbs,
spheres, mushroom heads, and other types of radially projecting
structures. A relatively blunt end of the head 26 is preferred to
avoid snagging on materials such as a health care provider's latex
gloves or sheets on the patient's bed.
[0043] A cover 22 is flexibly coupled to the base 14 by way of a
flexible coupling. In the illustrated embodiment, the coupling
comprises a flexible leash 24. The leash 24 can take any number of
forms to mechanically connect the base 14 to the cover 22 while
permitting movement of the cover 22 relative to the base 14 so as
to enable engagement or disengagement of these parts, as described
below. In the illustrated embodiment, the leash 24 comprises a band
of flexible material. The leash 24 desirably is integrally molded
with the base 14 and the cover 22. The illustrated leash 24 has a
longitudinal width of about 0.5 mm to 5 mm, desirably about 1 mm,
and a similar depth or transverse dimension. The length of the
leash 24 depends in part upon the height of the post 20. Desirably,
the leash 24 is longer than the height of the post 20, to allow
some leeway in engaging or disengaging the base 14 with the cover
22, as will be understood by one of skill in the art in light of
the disclosure herein. While the leash 24 desirably is generally
oblong in cross-section, as illustrated, and fixes an orientation
of the cover 22 relative to the base 14, it will be understood that
the leash can also have a string-like (e.g., rounded) configuration
and allow rotation about the lateral axis.
[0044] The cover 22 comprises an elongate member which can be
formed of the same polymer or plastic material as the base 14, and
desirably is integrally molded with the base 14. The cover 22
desirably has a shape that is generally coextensive with the
platform 21 of the base 14. The cover 22 can be smaller; however,
the cover should have a length in the lateral direction at least
large enough to extend over the space between the posts 20 and a
width in the longitudinal direction that is wider than the posts
20. The width of the cover 22 desirably is sufficient to stabilize
a section of the catheter 15 within the retainer 10. In particular,
the width of the cover 22 preferably generally matches the
longitudinal length of the fitting 11. The corners of the cover are
also desirably rounded to avoid snagging on materials such as the
latex gloves worn by the health care provider, bed sheets, etc. In
the illustrated embodiment, the cover 22 generally has an
elliptical shape for this purpose.
[0045] As shown in FIG. 2, the illustrated cover 22 also desirably
includes a textured portion 48, such as that formed by longitudinal
ridges 50 in the cover surface at an end of cover 22 opposite of
the leach 24. It will be understood that any well known form of
texturing such as, for example, a roughened surface can be used in
place of ridges. The textured portion 48 improves the health care
provider's grip on the cover 22.
[0046] The base 14 and cover 22 are further releasably connected by
a latching mechanism. The latching mechanism permits the cover 22
to be engage with the base 14 in a closed position, as illustrated
in FIG. 3. The cover 22 also can be disengaged from the base 14 and
moved to an open position, as shown in FIG. 1A.
[0047] The latching mechanism includes interengaging structures
formed on the base 14 and on the cover 22. In the illustrated
embodiment, the portion of the latching mechanism on the base 14 is
formed by at least one of the posts 20 with it enlarged head 26.
Desirably, the latching mechanism involves the posts 20 that lie on
opposite sides of the catheter 15 when the catheter 15 is properly
positioned on the retainer 10.
[0048] A cover portion of the latching mechanism includes at least
one opening 32 formed in the cover 22, and desirably includes the
same number of openings 32 as there are posts 20 on the base 14.
The illustrated cover 22 thus includes two openings 32 with
corresponding points of the openings 32 being spaced by
approximately the same distance as the two posts 20 on the base 14,
desirably by between about 5 mm and 40 mm, and particularly about
15 mm. Each opening 32 is arranged in the cover 22 to cooperate
with the corresponding post 20. It will be understood that, in
other arrangements of the latching mechanism are possible where the
posts are on the cover, the openings are formed in the base, as
described in more detail below.
[0049] Each opening 32 shown in FIGS. 1-3 is defined by a central
hole 34 with at least one slot 36 extending to one side, desirably
laterally adjacent to and intersecting with the central hole 34 at
a narrow waist opening 37. The central hole 34 is sized and shaped
to accommodate the largest diameter of the post head 26. The
illustrated slot 36 extends in the lateral direction from the
central hole 34 with the lateral axis of the slot 36 being
substantially collinear with a center line of the cover 22
extending in the lateral direction. It will be understood that the
slots 36 on the cover 22 can extend from the central hole 34 in any
direction, though both slots 36 desirably extend in the same
general direction. In other arrangements, more than one slot can
extend from each central hole.
[0050] The width of the illustrated slot 36 in the longitudinal
direction is smaller than the central hole 34 and is smaller than
the largest diameter of the head 26. The slot width desirably
ranges from slightly smaller to slightly larger than the diameter
of the shaft 25.
[0051] The interengagement between the posts 20 and the openings 32
on the cover 22 thus form the latching mechanism that releasably
secures the cover 22 to the base 14. When the post shaft 25 is
positioned in the slot 36, the cover 22 can not be lifted from the
retainer base 14 in the transverse direction, as described in more
detail below.
[0052] As best seen from the plan view of FIG. 1B, the cover 22
desirably includes a post retention mechanism to inhibit
unintentional retraction of a post 20 from the slot 36. In the
embodiment of FIGS. 2-3, the retention mechanism includes a lip 38
of cover material that forms a depression 40 (FIG. 3). The
depression 40 is sized slightly smaller than the lower surface 30
of the post head 26. The retention mechanism of the illustrated
slotted hole 36 further comprises the waist opening 37 (FIG. 18),
which has a slightly smaller diameter than the shaft 25. The
longitudinal dimension of the slot 36 widens to slightly larger
than the diameter of the shaft 25 between the lip 38 of the cover
22. While not illustrated, the retention mechanism can also be
formed by arranging the slots at a slight deviation from parallel
to one another to increase the friction between the cover 22 and
the posts 20.
[0053] The retainer 10 also desirably includes a locator device to
locate the cover 22 at a desired distance from the platform 21. In
the illustrated embodiment, each post 20 includes an annular ring
28 positioned between the platform 21 and the head 26 for this
purpose; however, other types of protuberances (e.g., small bumps
or ribs) can also serve this purpose. The annular ring 28 is spaced
below the head 26 along the shaft 25 bra distance sufficient to
accommodate the thickness of the cover 22 when latched together.
The ring 28 desirably is located between about 1 mm and 4 mm below
the lower surface 30 of the head 26. Like the head 26, the annual
ring 28 is larger in diameter than the shaft 25, desirably 1.1 to
2.0 times the diameter of the shaft 25. Most desirably, the ring 28
is slightly larger than the maximum diameter of the head 26.
[0054] As mentioned above, the base 22, leash 24 and cover 22
desirably are integrally formed to make a unitary retainer 10. This
can be accomplished in any of a variety of ways well known to one
of skill in the art. For instance, the entire retainer can be
injection molded, in order to reduce fabrication costs.
Additionally, features such as the leash 24 are desirably flexible.
Suitable plastics which account for these considerations include
polypropylene, polyethylene, and the like. Desirably, the
illustrated retainer 10 comprises injection molded polyethylene or
polypropylene.
[0055] The anchoring system 8 can also include the fitting 11 for
mounting a medical line (e.g., catheter) to the retainer 10. In the
exemplary application illustrated in FIGS. 1-3, the fitting 11
takes the form of the box clamp 12 and the soft wing clamp 13.
Mounting of the fitting 11 (or catheter directly) to the retainer
10 is achieved by way of the interacting structures, a portion of
which comprises surfaces or structures of the retainer 10 and
another portion of which comprises surfaces or structures of the
fitting 11 (or catheter, if directly coupled).
[0056] The box clamp 12, best seen from the view of FIG. 1, is a
relatively small, rigid wing-shaped device having a configuration
similar to that of conventional box clamps in common usage today in
suturing attachment systems. The box clamp 12 includes a central
elongate body 60 having a longitudinal groove 62 formed on the
underside and a box-shaped upper surface 64. The longitudinal
groove 62 is generally U-shaped and is sized to receive the body of
a catheter and/or associated fluid line, and more desirably is
sized to receive the wing clamp 13. At least one end, and
preferably at both ends of the longitudinal groove 62, the body 60
of the box clamp 12 narrows the opening of the longitudinal groove
62. That is, the longitudinal groove 62 at either end extends
through an are which is greater than 180.degree. about an axis of
the longitudinal groove 62. The groove also can have a uniform
cross section along its length so that the wall of the entire
groove extends through an arc greater than 180.degree.. The box
clamp 12 desirably is formed of a relatively rigid material, such
as polycarbonate.
[0057] A pair of lateral wings 66 extend roughly perpendicularly
from the body 60 of the box clamp 12, each including a hole 67
therethrough. Each hole 67 is sized and shaped to receive the head
26 and the collar 28 of one of the posts 20.
[0058] The soft wing clamp 13 has a configuration similar to that
of the box clamp 14, including a central elongate body 70 defining
an inner cavity 72 and an outer surface 74. The inner cavity 72 is
sized to surround a portion of a catheter. The wing clamp 13 is
constructed from a soft, pliable or flexible material such as, for
example, latex or the like. The central elongate body 70 includes a
longitudinal slit 75 along its underside. The slit 75 can be
expanded due to the pliable nature of the wing clamp 13. Thus, the
wing clamp 13 is capable of being placed on and surrounding and
longitudinally contacting in a frictional manner a portion of the
catheter. This frictional contact between the soft wing claim 13
and the catheter generally prevents relative movement between these
articles.
[0059] Lateral wings 76 extend roughly perpendicularly from the
body 70 of the soft wing clamp 13, each including a through-hole
77. Each hole 77 is sized and shaped to receive the head 26 of one
of the posts 20. As the material surrounding the wing hole 67 is
pliable in the illustrated embodiment, the hole 67 can be smaller
than the corresponding box clamp hole 67 and even smaller than the
post head 26, yet still be stretched to receive the post head 26;
the through-hole 77, however, desirably is larger than the post
head 26 and generally equal in size to the corresponding hole 67 in
the box clamp 12.
[0060] The illustrated box clamp 12 and soft wing clamp 13 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 CVCs. The skilled artisan will find
application for the present invention with any of these and many
other clamp configurations. As will be clear from a discussion of
the embodiment of FIGS. 10-12, the fitting 11 (box clamp/soft wing
clamp combination) 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.
[0061] FIG. 3 illustrates the interengagement of the components of
the anchoring system 8, in accordance with the present embodiment.
The box clamp 12 and soft wing claim 13 are shown engaged with the
posts 20 and retained between the base 14 and cover 22 of the
retainer 10.
[0062] As noted, the groove 62 of the box clamp 12 is configured to
receive the soft wing clamp 13. In particular, the groove 62 is
sized and shaped to receive the outer surface 74 of the elongate
body 74 on the soft wing clamp 13. The wings 66 of the box clamp 12
have approximately the same size and shape as the wings 76 of the
soft wing clamp 13. When the wings 66, 76 are aligned, the box
clamp holes 67 are correspondingly aligned with the soft wing clamp
holes 77.
[0063] Together, the box clamp 12 and the soft wing clamp 13 form
the fitting 11 for mounting in the retainer 10. In the illustrated
embodiment, the retainer 10 has been sized for retention of the
conventional box clamp 12 and soft wing clamp 13. Accordingly, the
holes 67, 77 of the fitting 11 are spaced by approximately the same
distance as the posts 20 on the retainer base 14. The box-like
upper surface 64 of the box clamp 12 is sized and shaped to fit
between the posts 20. Accordingly, a lateral dimension of the
elongate body 60 is smaller than the spacing between the posts 20
(i.e., the elongate body 60 is located between and spaced from
holes 67 on the box clamp wings 66), while the height of the
fitting 11 (formed by the height of the box clamp 12 plus the
thickness of the soft wing clamp wings 76) is smaller than the
height of the posts. Desirably, the height of the fitting is
smaller than the height of the shaft 25 up to the underside 30 of
the post head.
[0064] The interaction between the posts 20 and the openings 67, 77
of the fitting 11 mount the fitting 11 on the base 14. Accordingly,
this interacting structure between the retainer 10 and the fitting
11 inhibits movement of the catheter 15 relative to the retainer 11
in at least the longitudinal and lateral directions. It is
understood that the posts need not to extend entire through the
holes for this purpose, though.
[0065] As noted above, the spacing between the posts 20 on the base
14 also dictates the spacing between the openings 32 in the cover
22. Desirably, the slots 36 each extend from the same side, and
desirably laterally, from the central holes 34. Thus, the spacing
between the central holes 34 is approximately equal to the spacing
between the slots 36, which is in turn approximately equal to the
spacing between the posts 20 on the base.
[0066] As also noted above, the leash 24 flexibly connects the
platform 21 of the base 14 to the cover 22. Desirably, the leash 24
connects lateral ends of the base 14 and cover 22, so as not to
interfere with the mounting of the fitting 11 and catheter along
the longitudinal axis. The leash 24 is long enough to permit a
desired parallel spacing of the base 14 from the cover 22 when the
retainer is in a closed position, as illustrated.
[0067] In operation, a catheter (or other medical tube or wire) is
inserted into the patient, and the fitting 11 is secured to the
catheter. The fitting 11 is then retained within the retainer 10,
and the retainer 10 is then secured to the patient. These steps are
described in more detail below. While this sequence is
advantageous, it will be understood that, in other arrangements,
the fitting can be secured to a catheter before or after securing
the fitting to the retainer, depending upon the form of the
fitting. Similarly, and especially for reapplication of a catheter
to the retainer 10, the catheter and fitting 11 can be mounted to
the retainer 10 after the retainer 10 has already been secured to
the patient.
[0068] In the illustrated embodiment, desirably after catheter
insertion, the wing clamp 13 is stretched open at the slit 75 and
fit over the catheter, as in standard practice. The groove 62 of
the box clamp 12 is fitted over the elongate body 70 of the soft
wing clamp 13, providing a tight "snap fit." Some flexibility in
the wing clamp body 70 facilitates this fitting. The relatively
more rigid box clamp body 60, however, exerts relatively more
inward pressure on the catheter than the relatively more flexible
wing clamp 13, such that a better frictional grip holds the
catheter within the fitting 11. It will be understood by one of
skill in this art, however, that the fitting 11 of the present
embodiment can comprise the soft wing clamp 13 alone.
[0069] As shown in FIG. 2, the catheter and fitting 11 are then
removably mounted to the retainer 10. In the illustrated
embodiment, the holes 77, 67 are fitted over the posts 20 of the
retainer base 14. Desirably, each slightly smaller wing clamp hole
77 stretches to accommodate the larger diameter head 26 and ring 28
of the post 20. Each box clamp hole 67, on the other hand,
desirably is large enough to receive the head 26 and ring 28
without interference. The fitting 11 is thereby fitted onto the
base 14 with the posts 20 extending through the fitting holes 67,
77 and the bottom surface of the soft wing clamp 13 resting on the
platform 21.
[0070] As illustrated in FIGS. 2 and 3, the cover 22 is latched to
the base 14, with the fitting 11 interposed between the cover and
the base. FIG. 2 shows the cover 22 in a partially closed position,
with the flexible leash 24 bent to position the cover 22 over the
base 14. The openings 32 of the cover 22 are aligned with the posts
20 of the base 14 and the cover 22 is then moved toward the base
such that the head 26 of each post passes through the central hole
34 of one of the openings 32. The size and spacing of the openings
32 and the posts 22 should result in an easy engagement so that
only a light downward force is necessary, thereby avoiding pain or
discomfort to the patient. In this position, the portion of the
cover 22 between the holes 34 can firmly contact a portion of the
fitting 11 in some applications.
[0071] The rings 28 can also support, at least in part, the cover
22, or at least limit the travel of the cover 22 over the posts 20
so as to properly position the cover 22 on the posts 22 generally
beneath the flared heads 26. Once the heads 26 of the posts 20 have
cleared the central holes 34 in the cover 22, the cover 22 contacts
the ring 28.
[0072] The cover 22 is then slid laterally (to the right, in the
views of FIGS. 2 and 3) so that the shaft 25 of each post 20 slides
past the narrow waist opening 37 into the corresponding slot 36.
The cover material at the waist 37 and/or the shaft 25 slightly
compresses as the cover 22 is shifted under force provided by the
health care provider. Desirably, the retainer is arranged such
that, when the posts 20 are engaged with the slots 36, the cover 22
is centered with respect to the base.
[0073] The resulting engagement, shown in FIG. 3, serves to retain
the fitting 11 securely in place within the retainer 10. As the
waist openings 37 are desirably slightly more narrow than the post
shafts 25, the slots 36 provide a friction or snap fit engagement
with the posts 20. The slots 36 are longitudinally more narrow than
the post heads 26, such that the cover 22 cannot be transversely
lifted away from the base 14 in this position. Surfaces of the post
20 abut against surfaces of the cover 22 formed by the lip 38 and
walls 46 of the opening 32. The posts 20 of the base 14 and the
slotted holes 67, 77 of the cover 22 thereby form a latching
structure. The latching structure allows the posts 20 to be easily
inserted into the openings 32 in one position but inhibits
unintentional retraction of the posts 20 from the openings 32 in a
second position.
[0074] Additionally, the underside 30 of the post head 26 seats
against the cover 22 with the periphery of the head 26 at the edge
of the depression 40, as shown. A slight deformation of the head 26
and/or edge of the depression 40 creates increased interference
between the cover 22 and the post heads 26 which aids in
maintaining the cover 22 in place, relative to the posts 20.
[0075] It will be understood that, in other arrangements, the
openings can instead be formed in the base, rather than the cover,
and the posts formed on the cover. In such a case, each opening
would comprise a partial central hole in the base, below which a
hollow space is formed for receiving the heads of downward
extending posts of the cover. The space would also accommodate the
lateral movement of the cover (and consequent lateral movement of
the posts) in order to provide engagement between the shaft of each
post and a narrow slot extending from the opening. In this manner,
the head of one of the posts would be captured within the hollow
space below each slot. The post could not be pulled out of the
hollow space because the rear side of the post head would contact
the portions of the base which define the slot. Such a latching
mechanism is disclosed in copending application Ser. No.
08/587,092, entitled "Catheter Anchoring System", filed on Jan. 15,
1996, in the name of Steven F. Bierman and assigned to the assignee
hereof, which stands allowed as of the filing date of this
application and which is hereby incorporated by reference.
[0076] In initial application, the illustrated retainer 10, with
the fitting 11 and the catheter retained in it as described above,
is secured to the patient by way of the self-adhesive anchor pad
16. The health care provider selects a skin site on which the
retainer 10 will be attached. For use with CVCs and PICCs, the
retainer 10 desirably is applied to the skin of the patient in the
vicinity of the catheter insertion site. The health care provider
then cleanses and prepares the anticipated dressing site according
to well known methods, usually swabbing with alcohol and allowing
the site to dry thoroughly. The health care provider peels away
half of the backing layer 17 from the adhesive surface of the
anchor pad 16, properly locates the pad 16 on the patient, and
presses the exposed adhesive against the patient's skin to secure
the anchor pad 16 to the patient. The second half of the backing
layer 17 is then removed, and the second half of the anchor pad 17
adhered to the patient's skin. The anchor pad 16 should be mounted
on the patient so that catheter overlies the retainer 10 along the
retainer's longitudinal axis.
[0077] When removal of the catheter becomes necessary, the cover 22
simply is slid horizontally in the opposite direction, desirably
with force sufficient to compress cover material at the waists 37,
so that the heads 26 of the posts 20 are once again aligned with
the central holes 34. The cover 22 can then be easily lifted
transversely from the base 14. With the retainer 10 thus unlatched,
the fitting 11 can also be removed. The catheter secured by the
fitting 11 can then be changed or cleaned and replaced in the
retainer 10, without requiring a new retainer.
[0078] It should be noted that a deliberate effort is generally
required to disengage the post shafts 25 from the slots 36, due to
the retention mechanism formed by the narrow neck 37 and/or
depression 40. The retainer 10 thus releasably mounts a catheter
(or other medical line) and can be reused without requiring
reattachment to the patient, while at the same time inhibiting
accidental release of the catheter.
[0079] Significantly, the removed cover 22 remains leashed to the
retainer base 14, which remains attached to the patient. Thus, the
health care provider need not take care to place the cover 22 in a
safe hygienic place, nor keep track of its whereabouts. The cover
22 can simply hang from the base 14 by the leash 24, where it is
easily found and relatched to the base 14 when a new catheter is
engaged. Furthermore, each time the cover is relatched, the cover
22 is automatically correctly oriented, such that the health care
provider need not take care to ensure that the depression 40 is
facing the correct direction, nor to ensure that the slots 36 are
on the correct side.
[0080] Of course, if the medical treatment is completed and there
is no need to reuse the retainer 10, the health care provider can
release the cover from the base in the manner described above. The
medical article then can be lifted from the base. To remove the
anchor pad 16, the health care provider lifts an edge of the pad 16
and gently strokes the undersurface with an alcohol swab while
slowly but continuously lifting the edge. The anchor pad 16 can be
peeled from the patient's skin in this manner. The health care
provider then cleanses and prepares skin using well known hospital
or agency protocols.
[0081] A retainer 10a in accordance with another embodiment of the
invention is illustrated in FIGS. 4A to 5, with FIG. 4A showing a
completely open position of the retainer 10a and FIG. 5 showing the
partially closed position, similar to FIGS. 1-2 above. Though not
illustrated, this retainer 10a also desirably includes a flexible
anchor pad, as illustrated in FIG. 1, for adhesive attachment to
the body of a patient. Only the cover 22a of this embodiment
differs from the above-described embodiment. Accordingly, the above
description applies equally to the embodiment of FIGS. 4-5, unless
otherwise indicated. In addition, like reference numerals are used
to indicate like features of the two embodiments, with the letter
"a" added as a suffix to refer to features of the present
embodiment.
[0082] The cover 22a of this retention mechanism 14a includes a
pair of openings 32a. In contrast to the embodiment discussed
above, each opening 32a comprises a single slot 80 extending from a
longitudinal outer edge 82 of the cover 22a to a terminus 84. The
pair of slots 80 can extend from either of the two outer edges 82,
but both slots 80 desirably extend from the same edge.
[0083] The slots 80 advantageously extend obliquely from the outer
edge 82 of the cover 22a to the slot terminus 84, such that one
side of each slot 80 defines an obtuse angle .alpha. (FIG. 4B) with
the outer edge 82 from which the slot extends, as shown in FIG. 4B.
The termini 84 of the slots 80 desirably are centered on or close
to a lateral line that bisects the cover 22a into longitudinal
halves. Thus, the length of each slot 80 depends upon the obtuse
angle .alpha. between the outer edge 82 and the slot 80. The angle
.alpha. should be small enough and the slot 80 short enough that
the structural integrity of the cover 22a is not compromised. While
illustrated as parallel, the slots 80 can also be arranged at a
slight angle to one another. The width of each slot 80 desirably is
slightly larger than the diameter of the post shaft 25a, and
smaller than the largest dimension of the post head 26a.
[0084] As best seen from the plan view of FIG. 4B, the opening 32a
desirably includes a retention mechanism, such as to inhibit
retraction of the post 20a from the slot 80. As visible from the
views of FIGS. 4B and 5, each slot 80 is partially defined at the
terminus 84 by a lip 38a of cover material, forming a depression
40a in the cover 22a, similar to the lip 38 and depression 40 shown
in FIGS. 1-3. The depression 40a is sized slightly smaller than the
lower surface 30a of the post head 26a.
[0085] In the illustrated embodiment, the retention mechanism
further comprises one or more protuberances 86 extending at certain
positions from interior walls of the slot 80. As illustrated, the
protuberances 86 desirably are positioned within the slot 80 just
outside the depression 40a. At the protuberances 86, the slot 36a
most desirably has a slightly smaller diameter than the shaft 25a,
while widening to slightly larger than the shaft 25a at the lip
38a. These protuberances 86 define the waist 37a of the opening 32a
for the present embodiment.
[0086] FIG. 5 illustrates the retainer 10a in a partially closed
position. The flexible leash 24a has been bent to swing the cover
22a counterclockwise (in the view of FIG. 5), bringing the openings
32a in proximity to the posts 20a. The cover 22a continues in a
downward arc from the position of FIG. 5 and is shifted slightly
out of alignment with the base 14a until the edge openings of the
openings 32a at the longitudinal edge 82 are adjacent to the
section of the posts 20a between the head 26a and the ring 28a.
[0087] While not illustrated in FIGS. 4A to 5, a catheter fitting
can first be mounted to the retainer 10a prior to latching. For
example, the fitting 11a illustrated in FIGS. 1-3 can be first
secured to the retainer. For such a case, the posts 20a serve as a
portion of an interacting structure and the holes 67a, 77a of the
fitting 11a serve as another portion of the interacting structure.
The interacting structure thus mounts the fitting to the retainer
to inhibit at least one degree of movement of the fitting relative
to the retainer. Alternatively, a portion of the interacting
structure can directly mount a catheter, without the intermediate
fitting.
[0088] The shaft 25a of each post 20a (between the head 26a and the
ring 28a) can be easily inserted into the edge opening of the
openings 32a at the outer edge 82. The cover 22a is then shifted
obliquely such that the shafts 25a slide along the slots 80. The
shafts 25a and/or the protuberances 86 are compressed or the
protuberances are deflected as the shafts 25a slide past the
protuberances 86. After the shafts 25a have passed the
protuberances 86, the shafts and/or the protuberances can regain
their original shape such that the shafts snap into the position
adjacent to the protuberances 86 and engage with the terminus 84 of
the slots 80. When the head 26a is seated at the edge of the
depression 40a, the surfaces of the cover 22a formed by the lip 38a
and the protuberances 86 of the slot 80 abut against the shaft 25a
of the post 20a. The cover 22a is thus latched in a closed
position.
[0089] In order to remove the cover 22a from the base 14a, the
sliding motion of the cover 22a over the posts 20a is simply
reversed until the post shafts 25a exit the openings 32a at the
outer edge 82 of the cover 22a. Note that some deliberate force is
generally required to overcome the retention mechanism. Namely, the
cover 22a is slightly depressed to disengage the underside of the
head 26a from the edge of the depression 40a, and the cover 22a is
slid with sufficient force to deflect or compress the protuberances
86. Any fitting secured therein can then be disengaged from the
opened retainer 10a.
[0090] Where the slots are arranged at a slight angle to one
another, the friction fit of the posts within the slots will
improve, relative to an exactly parallel arrangement. It will be
understood that, in other arrangements, a similar slot can extend
perpendicularly from the longitudinal edge. Alternatively, slots of
each opening can extend from opposite longitudinal edges of the
cover. In the latter arrangement, the cover would be aligned
longitudinally between the posts and the cover twisted to a lateral
alignment, such that the posts each engage the slots on each side.
As will be understood by one of skill in this art, such slots would
desirably extend along the circumference of a circle centered
between the termini.
[0091] In either of the above illustrated embodiments, or in
inverted arrangements with the posts on the cover, the posts serve
both as an interacting structure (for mounting a medical line or
fitting) and as a part of the latching structure (for latching the
cover to the base). It will be understood, however, from the
description of the following two embodiments, that the posts can
serve only as part of the latching structure, or only as part of
the interacting structure. It will further be understood by one of
ordinary skill in this art that the posts can be absent altogether
in other arrangements.
[0092] FIGS. 6-9 illustrate a retainer 10b in accordance with
another embodiment of the present invention. The retainer 10b is
shown in an open position in FIG. 6 and in a fully closed and
latched position in FIG. 7. Other components of the anchoring
system 8b (e.g., anchor pad, catheter adapter) can be the same as
described above with respect to FIGS. 1-3. Accordingly, the above
description applies equally to the embodiment of FIGS. 6-9, unless
otherwise indicated. In addition, like reference numerals are used
to indicate like features among the embodiments, with the letter
"b" added as a suffix to refer to features of the present
embodiment.
[0093] The base 14b includes a pair of posts 20b; however, the base
can include more or less posts depending upon the application of
the anchoring system. Each post 20b has a relatively smooth,
continuous surface up to a tip 90 which need not protrude radially
from the post 20b, unlike the head 26, 26a of the previously
described embodiments. The tip 90 of the post 20b can be a flat
surface or can taper into a hemispherical shape (as shown), a
conical shape or other well known shapes. In the illustrated
embodiment, the posts 20b each consist only of a simple shaft
tapered hemispherically at the tip 90. The posts 20b otherwise
desirably have the same diameter, spacing, and height of the posts
20, 20a of the previous embodiments. The posts 20b are illustrated
as connected to a platform 21b of the base 14a, although it will be
appreciated by those skilled in the art, in light of the above
disclosure, that the posts could be connected to the cover 22b.
[0094] The flexible hinge 24b of this embodiment comprises a
relatively rigid support arm 92 that is integrally joined to the
platform 21b at a base end 94. As shown in FIG. 6, the support arm
92 extends upwardly from the base end 94 to join with the cover 22b
at a thin bridge 96 of cover material. The bridge 96 is formed
along a common exterior surface 98 (see FIG. 7) of the cover 22b
and the support arm 92. The bridge 96 is defined along the apex of
a notch 100 in the material that forms the cover 22b and support
arm 92. The notch 100 can be thought of as the structure formed by
a beveled edge sloping away from an interior surface 102 of the
cover 22b, conjoined at the bridge 96 with a beveled edge sloping
away from an inside surface 104 of the support arm 92. The hinge
24b flexibly connecting the base 14b to the cover 22b thus
comprises the support arm 92, the bridge 96, and the surfaces
forming the notch 100. In other arrangements, however, the hinge of
an embodiment resembling that of FIGS. 6-9 can comprise a structure
similar to a conventional hinge pin-bracket arrangement.
[0095] Desirably, the support arm 92, which terminates at an upper
end at the bridge 96, has the same height as the posts 20b. It will
be understood, however, that the support arm 92 can be higher than
the posts 20b in other arrangements.
[0096] The thickness of the bridge 96 depends upon the material
chosen, and is thick enough to provide the desired strength to
connect the support arm 92 to the cover 22b, but thin enough to
provide flexibility for opening and closing the retainer 10b.
Desirably, the retainer 10b is integrally injection molded of a
resilient polymer material, such as polypropylene or polyethylene.
For such materials, the bridge 96 has a thickness between about 0.5
mm and 2.5 mm, and desirably about 1.5 mm.
[0097] The flexibility of the hinge 24b also depends in part upon
the angle formed by surfaces of the notch 100 when the retainer 10b
is in the open position shown in FIG. 6. Desirably, the notch 100
defines an angle of at least about 90.degree., and particularly
about 115.degree.. Such an arrangement allows the cover 22b to lie
parallel to the platform 21b when the retainer 10b is in the closed
position shown in FIG. 7. It will be understood, however, that in
other arrangements the closed cover need not lie parallel to the
platform 14b (and may take a curvilinear path as described
below).
[0098] As seen in FIG. 7A, the latching mechanism 110b of the
illustrated retainer 10b comprising a fastening pin 112 and a latch
having a receptacle 114. The receptacle 114 is configured to
receive the fastening pin 112. As shown in FIGS. 6-9, the
illustrated fastening pin 112 is integrally connected to the cover
22b and the receptacle 114 is integrally connected to the base 14b.
It will be understood, however, that the pin can instead be
positioned on the base, while the receptacle is positioned on the
cover.
[0099] The fastening pin 112 includes a bar 116 extending from the
cover 22b (or the base 14b, depending on the position of the
element). At the end distal from the connection to the cover 22b,
the bar 116 connects to an expanded portion or barb 118 which
tapers to a terminus 120 of the pin 112. Like the post head 26, 26a
of the previous embodiments, the barb 118 of the fastening pin 112
can be formed in any of a variety of shapes such as an arrowhead
(as shown), hemispherical, conical or flexible ribs extending
outward from the bar 116. Desirably, the terminus 120 of the
fastening pin 112 is relatively blunt and smooth to prevent it from
puncturing the gloves of a health care provider or catching on
other materials. The barb 118 also desirably includes a sloping or
curved surface 121 leading from the terminus 120 to the maximum
diameter of the barb 118. At least one shoulder is formed behind
the barb 118. In the illustrated embodiment, shoulders are defined
on either side of the bar 116.
[0100] The receptacle 114 of the latch 110b comprises a pair of
opposing tangs 122 that extend to a stem 124 connected to the base
14b (or cover 22b, depending on the position of this element of the
latch). Each tang 122 extends outwardly to a lug 126 that can be
depressed by finger pressure. Desirably, each tang 122 includes an
inner beveled surface 127. These beveled surfaces define an
aperture 128 therebetween which tapers from a wider dimension at
the top to a narrower dimension at the bottom, where it
communicates with a slot 130 located between the opposing stems
124. Each tang defines a downward facing shoulder that cooperates
with one of the shoulders of the fastening pin barb 118, as
described below.
[0101] In operation, a fitting, such as the fitting 11 of FIGS.
1-3, can be first engaged with the posts 20b while the retainer
101) is open (see FIG. 6). Accordingly, the posts 20b of the
illustrated embodiment form a portion of the interacting structure
for inhibiting movement of a medical line fitting relative to the
retainer 10b.
[0102] The cover 22b can then swing to a closed position as shown
in FIG. 7. The relatively thin strip of material forming the bridge
96 allows the hinge 24b to bend when finger pressure is exerted on
the cover 22b to lower it. The angle of the notch 100 further
allows the cover 22 to be closed without compressing material
between the interior surface 102 of the cover and the inner surface
of the support arm 92. While the rigid support arm 92 and the thin
bridge 96 permit only rotational and not lateral movement of the
cover 22b relative to the base 14b, such lateral movement is not
necessary for the illustrated latching mechanism.
[0103] The fastening pin 112 can be inserted into the receptacle
114 by positioning the pin 112 into the aperture 128 and pressing
on the cover 22b. The sloped surfaces 121 of the fastening pin 112
slide over the beveled inner surfaces 127 of the tangs 122. The
interaction of these sloped and beveled surfaces tends to distend
the tangs 122 slightly, thereby allowing the barb 118 to enter the
slot 130. The tangs 122 then snap back into their original position
and engage with the barb 118 of the pin 112 with the corresponding
shoulders abutting, thereby releasably securing the cover 22b to
the base 14b. FIG. 8 illustrates the closed latch 110b.
[0104] When the latch 110b is closed, as shown in FIG. 7, the inner
surface 102 of the cover 22b sits atop the tip 90 of the posts 20b,
since the posts of the illustrated retainer 10b have the same
height as the support arm 92. It will be understood that, in
arrangements where the posts are attached to the cover, the tips
would abut the base when the cover is in the closed position and
latched. Where such contact takes place, a fitting secured between
the cover 22b and the base 14b could not slip off the posts 20b
when the retainer 10b is closed and latched. Furthermore, the posts
20b provide added support for the cover 22b in the closed position
to prevent over-extension of the hinge 24b.
[0105] To release the cover 22b from the base 14b, the health care
provider can press down on the lugs 126, thereby gaining access to
the fitting and/or catheter secured therein. When a lug 126 is
depressed, the attached stem 124 bends outward slightly, causing
the tang 122 to moved outwardly and the slot 128 to expand, as
shown in FIG. 9. To provide friction between the health care
provider's finger and the top of the lug 124, ridges or other types
of roughened surface can be included.
[0106] When only a single lug 124 is depressed, however, the
attached tang 122 is elevated until it contacts the surface of the
element (e.g., the cover) to which the fastening pin 112 is
connected. This degree of elevation of a single tang 122 does not
expand the aperture 128 sufficiently to release the barb 118 of the
fastening pin 112. In contrast, when both lugs 124 are depressed
(not shown), the aperture 128 is sufficiently widened to allow the
fastening pin 112 to be readily extracted from the receptacle 114.
This design prevents inadvertent release of the fastening pin 112
(e.g., when a lug is bumped), but permits easy opening of the
retainer 10b when a health care provider seeks to move the catheter
or other fitting held within the retainer 10b.
[0107] FIGS. 10-12 illustrate an anchoring system 8c in accordance
with another embodiment of the present invention. Like the
anchoring systems described above, the illustrated embodiment
includes a retainer 10c, a fitting or adaptor 11c and an anchor pad
16c. The anchor pad 16c desirably is similar to the anchor pad 16
described with respect to FIG. 1. The retainer 10c and the fitting
11c differ somewhat from the above-described embodiments, though
certain features are the same. Accordingly, the above description
applies equally to the embodiment of FIGS. 10-12, unless otherwise
indicated. In addition, like reference numerals are used for like
features among the embodiments, with the letter "c" added as a
suffix to refer to features of the present embodiment.
[0108] The illustrated posts 20c do not include a locator ring of
material below the head 26c. The illustrated base 14c, including
dimensions of the posts 20c, is otherwise identical to the base 14
described with respect to FIGS. 1-3. Unlike the openings 32, 32a of
the previous embodiments, the illustrated opening 32c is shown
without a lip or depression in the slot 36c. It will be understood,
however, that the slot can also include a depression over which the
post head would seat without departing from the principles of the
present embodiment.
[0109] Like the previous embodiments, the present embodiment
includes interengaging structure to mount the medical line to the
retainer 10c. In the illustrated embodiment, the interacting
structure comprises a channel defined by a mounting structure 140.
The channel is sized and shaped to mount a medical line, such as a
catheter, either directly or indirectly by way of a fitting.
Desirably, the channel defined by the mounting structure 140 is
configured to mate with and mount the adaptor 11c which, in turn,
engages with the medical line. In the illustrated embodiment, the
mounting structure 140 is integrally formed with the cover 22c,
such as by injection molding. It will be understood, however, that
the mounting structure 140 can equally well be formed as part of
the base 14c without materially affecting the function of the
retainer 10c.
[0110] The illustrated mounting structure 140 comprises two
substantially rectangular box-like extensions 141 that extends from
the cover 22c between the two openings 32c. The extensions 141 are
spaced by a distance sufficient to receive the adaptor 11c and
include inner faces 142 configured to mate with surfaces of the
adaptor 11c. The inner faces 142 are more particularly shaped to
inhibit at least one degree of freedom, desirably to inhibit
longitudinal movement of the adaptor 11c when the adaptor is
mounted within the channel (see FIG. 11). The illustrated inner
faces 142 are convex in shape. The channel defined between the
extensions 141, thus, has a minimal width at a central point and
widens toward either longitudinal end. In other arrangements, the
skilled artisan will recognize that a maximum channel width at a
central point will inhibit longitudinal movement of a different
fitting. Where, as illustrated, the mounting structure 140 is
integral with the cover 22c, the extensions 141 desirably are
spaced closely enough to provide a snug or slight interference fit
for the adaptor 11c within the channel.
[0111] The mounting structure 140 (and the channel defined by it)
has a height less than or equal to the height of the post shafts
25c of the base 14c. In the illustrated embodiment, the structure
140 is equal to the height of the shafts 25c, less the thickness of
the cover 22c. An outer surface 144 (FIG. 10) of each of the
illustrated extensions 141 is accordingly configured to mate with
the platform 21c of the base 14c, and is flat in this case.
[0112] The cover 22c is illustrated with a slight hourglass shape,
such as to provide a slight indentation 146 along an edge 148 of
the cover 22c. Desirably, the indentation 146 comprises transverse
ridges 150. This shape facilitates an interengagement between the
fitting 11c and the mounting structure 140 to inhibit movement of
the adaptor 11c at least in the longitudinal direction, as
described below.
[0113] The fitting 11c of the present embodiment is an in-line
adaptor 11c. This adaptor 11c comprises an elongate structure
defining a fluid pathway, and means for connecting the adaptor to
lines at either end. The illustrated adaptor 11c comprises a
medical connector such as those commonly used to connect a supply
line to a catheter.
[0114] Desirably, the adaptor 11c is of a type similar to that
disclosed with respect to FIGS. 11 and 12 of U.S. Pat. No.
5,306,243 ("the '243 patent"), the disclosure of which is hereby
incorporated herein by reference. The adaptor 11c includes a male
connector 160 for connection to a catheter and a female connector
162 for connection to a medical supply or delivery tube (e.g.,
leading to an IV drip or a suction pump). The illustrated male
connector 160 includes a Luer-type fitting 164 with internal
threads and a tapered nose extending outwardly, with an internal
passageway for fluid communication with a catheter.
[0115] The female connector 162 comprises external threads 166 and
a membrane 168 for sealing the internal passageway. The membrane
168 can comprise a closed septum, through which a sharp needle is
inserted to provide communication between the supply or delivery
tube and the internal passageway. The membrane 168 can also
comprise a pre-slit membrane, through which a blunt needle provides
communication between the supply or delivery tube and the internal
passageway. Desirably, however, the female connector 162 of the
adaptor 11c comprises an internal needle integral with the internal
passageway, as disclosed in the '243 patent. The membrane 168
comprises a resilient, self-sealing material which is outwardly
biased.
[0116] An adaptor body 170, between the male connector 160 and the
female connector 162, comprises mounting surfaces 172 which form a
portion of the interacting structure of the anchoring system 8c.
The illustrated mounting surfaces 172 comprise opposed concave
surfaces, desirably including ridges (not shown) to facilitate
finger gripping during connection of the adaptor 11c to catheters
or other medical tubes. In this manner, the adaptor body 170 has a
minimal width at a central point and widens toward both the female
connector 162 and the male connector 160. In particular, the widest
points of the illustrated adaptor 11c are wider than the most
narrow portion of the channel between the extensions 141 of the
retainer 10c.
[0117] The mounting surfaces 172 are joined by a top surface 174
and a bottom surface (not shown). The top and bottom surfaces
desirably are flat to mate with the illustrated cover 22c and
platform 21c of the retainer 10c, such that these surfaces also
form a portion of the interacting structure.
[0118] In operation, the adaptor 11c can first be connected to
medical tubes. For example, a catheter can be fitted with a female
connector with external threading, similar to the female connector
162 of the adaptor 11c. Such a connector can be quickly and easily
threaded into the male connector 160 of the adaptor without any
external needles, thus reducing the likelihood of needle sticks to
the health care provider. While the female connector is threaded
into the Luer-type fitting of the male connector 160, the nose of
the male connector 160 forces the membrane 168 backwards over the
internal needle, thus providing fluid communication between the
catheter and the internal passage of the adaptor 11c. Similarly, a
medical delivery/supply line can be fitted with a male connector
similar to the male connector 160 of the adaptor 11c. Such a
connector would then connect with the female connector 162 of the
adaptor 11c, thereby completing fluid communication through the
adaptor 11c between the delivery/supply line and the catheter.
[0119] The adaptor 11c then mounts within the channel defined by
the mounting structure 140 of the retainer 10c. In the illustrated
embodiment, wherein the mounting structure 140 is formed integrally
with the cover 22c, the inner faces 142 of the extensions 141
desirably snugly receive and grip the mounting surfaces 172 of the
adaptor 11c.
[0120] It will be understood by one of skill in the art, however,
that the fit need not be tight enough to inhibit transverse
movement of the fitting or adaptor, particularly where the mounting
structure is integral to the base, rather than integral to the
cover. Desirably, however, the interaction between the mounting
structure inner faces 142 and the adaptor mounting surfaces 172 is
such as to inhibit significant longitudinal movement (e.g., more
than 1-2 mm) of the adaptor 11c. In the illustrated embodiment, the
minimal width of the channel is more narrow than the widest
portions on either end of the adaptor body 170.
[0121] With the adaptor 11c thus mounted to the retainer 10c, the
retainer 10c is then be closed and latched, as described with
respect to the previous embodiments. Where, as illustrated, the
mounting structure 140 is located on the cover 22c, if the mounting
structure 140 is not configured for firm engagement, the health
care provider can hold the adaptor 11c within the channel until the
retainer 10c is latched. FIG. 11 illustrates the retainer 10c in a
partially closed condition.
[0122] FIG. 12 illustrates the retainer 10c latched closed with the
adaptor 11c retained therein. As will be understood by one of skill
in the art, the cover 22c and the base 14c interposed the adaptor
11c between them, preventing transverse movement of the adaptor 11c
relative to the retainer 14c. The channel defined by the mounting
structure 140 inhibits lateral or longitudinal movement of the
adaptor 11c relative to the retainer 14c by the cooperating shape
of the channel and the adaptor 11c (which form the interengaging
structure in this embodiment). Accordingly, the adaptor 11c is
sufficiently restrained to secure a catheter extending therefrom to
the patient. If the catheter had not been secured to the adaptor
prior to engagement of the adaptor to the retainer, the catheter
can be secured after engagement.
[0123] The skilled artisan will appreciate that the retainers
disclosed herein demonstrate versatility in securing a great
variety of medical articles to a patient. Retainers similar to
those of FIGS. 1-9 can be utilized to secure any device which is
provided with holes spaced apart to engage with the posts. The
cover is secured to the base to interpose the device between them.
Many medical devices are already provided with suture holes which
can be fitted over the retainer posts disclosed herein. Other
devices can be modified to include such holes. Other arrangements
to secure a medical article to the posts, either between the posts
or adjacent to a single post, will be readily apparent to those
skilled in the art in light of the disclosure herein.
[0124] Medical devices can be also be provided with surfaces
similar to the mounting surfaces 172 of the illustrated adaptor
11c, for mounting within the integral channel of the retainer 10c
illustrated in FIGS. 10-12. Y-joint adapters, for example, can be
adapted to mount within the channel of the retainer 10c shown in
FIGS. 10-12.
[0125] Alternatively, one of skill in the art will readily
appreciate that the disclosed retainers can be modified, without
departing from the spirit of the invention, to mount and retain
existing medical devices. For example, the integral mounting
structure illustrated in FIGS. 10-12 can be adapted to clamp
existing Y-joint adapters, or to directly mount a catheter or other
medical line without the need for an intermediate fitting. In
addition, the channel can have a semi-tubular shape and include at
least one lateral slot that receives a radially extending member of
the adaptor (e.g., an annular collar). Desirably, any such modified
mounting structure would inhibit longitudinal and lateral movement
of the device or medical line. Transverse movement is inhibited by
closure of the retainer with the device or line sandwiched between
the base and the cover.
[0126] Furthermore, the skilled artisan will recognize the
interchangeability of various features from different embodiments.
For example, the integral mounting structure 140 of FIGS. 10-12 can
be adapted for mounting an adaptor in a retainer having the latch
70 of FIGS. 6-9, thus requiring no posts. Similarly, the various
posts, slotted holes, hinges, anchor pads and fittings 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.
[0127] Although not illustrated, each of the illustrated retainers
can be adapted for use in an anchoring system which includes a
safety loop. An anchor pad larger than the pad 16 illustrated in
FIG. 1 can mount both a retainer, in accordance with one of the
preferred embodiments, and a separate tube clip. The medical line
mounted by the retainer can also be secured less tightly to the
tube clip, with an adequate amount of slack in the line between the
retainer and the clip. The clip and the resultant slack are
desirably located between the retainer and the catheter insertion
site, for example.
[0128] If movement by the patient causes a sudden pull upon
catheter, the catheter slips within the tube clip and the slack
length or "safety loop" of the tube is pulled through the clip.
Friction between the clip and the sliding tube absorbs some of the
force and some of the force causes a slight pull on the adhesive
pad, functioning as a warning to the patient to cease the
undesirable movement.
[0129] Similarly, the retainer itself can be arranged to only
slightly inhibit longitudinal movement of a catheter, such as to
allow some amount of slip in response to large forces. For example,
the fitting of FIGS. 1-3 can comprise a soft wing clamp without the
box clamp. In any of these arrangements, a jerk upon the medical
line can be largely absorbed by allowing some slip, without either
disconnecting the line from the fitting or painfully pulling the
anchor pad from the patient's skin.
[0130] Using a retainer in accordance with the above disclosure, no
painful, invasive or time-consuming sutures or other extensive
procedures involving medical sharps (e.g., suture needles) are
necessary to anchor an elongate medical article to a patient's
skin. In addition, the flexible anchor pad absorbs much of the
force incurred in the installation or removal of the retainer and
the medical device, thereby providing greater comfort for the
patient.
[0131] As common to each of the above-described retainers and
anchoring systems, the present invention provides a sterile,
tight-gripping, needle-free way to anchor medical articles to a
patient. The retainers thus eliminate accidental needle sticks,
suture wound site infections and scarring because sutures are not
required. In addition, the retainers can be used with any of a wide
variety of catheters, tubes, wires, and other medical articles to
provide universal securement using one style of retainer. Also,
patient comfort is enhanced and application time is decreased with
the use of the present retainer.
[0132] The releasable engagement of the cover and the base allow
the same retainer to be used more than once on the same patient at
the application location. That is, a first medical device can be
mounted in the retainer. When the function of the first medical
device is accomplished, the retainer can be unlatched, the first
device removed, and a second medical device can be retained in the
same retainer. Furthermore, the leash or hinge connecting the cover
to the base ensures that the cover will not be lost or misplaced
during a catheter change. The health care provider wastes no time
in searching for a cover, nor in orienting the cover prior to
latching.
[0133] Although this invention has been described in terms of
certain preferred embodiments and suggested possible modifications
thereto, other embodiments and modifications apparent to those of
ordinary skill in the art are also within the scope of this
invention. Accordingly, the scope of the invention is intended to
be defined only by the claims which follow.
* * * * *