U.S. patent application number 13/113834 was filed with the patent office on 2011-12-22 for access port identification systems and methods.
This patent application is currently assigned to C.R. Bard, Inc.. Invention is credited to Murtaza Yusuf Amin, Matt Draper, Kelly B. Powers.
Application Number | 20110311337 13/113834 |
Document ID | / |
Family ID | 42936559 |
Filed Date | 2011-12-22 |
United States Patent
Application |
20110311337 |
Kind Code |
A1 |
Amin; Murtaza Yusuf ; et
al. |
December 22, 2011 |
ACCESS PORT IDENTIFICATION SYSTEMS AND METHODS
Abstract
An access port for subcutaneous implantation is disclosed. Such
an access port may comprise a body for capturing a septum for
repeatedly inserting a needle therethrough into a cavity defined
within the body. Further, the access port may include at least one
feature structured and configured for identification of the access
port subsequent to subcutaneous implantation. Methods of
identifying a subcutaneously implanted access port are also
disclosed. For example, a subcutaneously implanted access port may
be provided and at least one feature of the subcutaneously
implanted access port may be perceived. Further, the subcutaneously
implanted access port may be identified in response to perceiving
the at least one feature. In one embodiment, an identification
feature is engraved or otherwise defined by the access port, so as
to be visible after implantation via x-ray imaging technology.
Inventors: |
Amin; Murtaza Yusuf;
(Farminton, UT) ; Draper; Matt; (North Salt Lake,
UT) ; Powers; Kelly B.; (North Salt Lake,
UT) |
Assignee: |
C.R. Bard, Inc.
Murray Hill
NJ
|
Family ID: |
42936559 |
Appl. No.: |
13/113834 |
Filed: |
May 23, 2011 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
12420028 |
Apr 7, 2009 |
7947022 |
|
|
13113834 |
|
|
|
|
11368954 |
Mar 6, 2006 |
7785302 |
|
|
12420028 |
|
|
|
|
60658518 |
Mar 4, 2005 |
|
|
|
Current U.S.
Class: |
413/2 |
Current CPC
Class: |
A61M 2039/0045 20130101;
A61M 2205/582 20130101; A61M 39/0208 20130101; A61M 2205/6054
20130101; A61M 5/007 20130101; A61M 2039/0238 20130101; A61M
39/0247 20130101 |
Class at
Publication: |
413/2 |
International
Class: |
B21D 51/30 20060101
B21D051/30 |
Claims
1. A method of making an access port for providing subcutaneous
access to a patient, comprising: providing a metallic body defining
a fluid cavity accessible by inserting a needle through a septum;
and creating a recessed identification feature in a bottom surface
of the metallic body, the recessed identification feature
observable via x-ray imaging technology subsequent to subcutaneous
implantation of the access port, the recessed identification
feature identifying the access port as a power-injectable port.
2. The method according to claim 1, wherein the creating step
includes utilizing a marking method selected from the group
consisting of: engraving, milling, machining, chemical etching,
laser etching, molding, stamping, and combinations thereof.
3. The method according to claim 1, wherein the bottom surface is
an external surface of the metallic body.
4. The method according to claim 1, wherein the bottom surface is
an internal surface of the fluid cavity.
5. The method according to claim 1, wherein the recessed
identification feature includes one or more alphanumeric
characters.
6. The method according to claim 5, wherein the one or more
alphanumeric characters includes the letters "C" and "T."
7. The method according to claim 1, wherein the recessed
identification feature indicates an orientation of the access port
when the access port is imaged by x-ray imaging technology.
8. The method according to claim 1, wherein the recessed
identification feature is created below the fluid cavity, and is
bound by an outer perimeter of the fluid cavity.
9. The method according to claim 1, wherein the provided metallic
body comprises titanium.
10. The method according to claim 9, wherein the created recessed
identification feature has a depth in the range of about 0.009 inch
to about 0.011 inch when the thickness of the bottom surface is
about 0.020 inch.
11. The method according to claim 9, wherein the created recessed
identification feature has a depth in the range of about 0.015 inch
to about 0.021 inch when the thickness of the bottom surface is
about 0.030 inch.
12. The method according to claim 1, wherein the providing step
includes: providing a metallic base defining the fluid cavity; and
coupling a cap to the base such that a septum is disposed between
the cap and the base, and the septum is accessible through an
opening in the cap.
13. The method according to claim 13, wherein the bottom surface is
an external surface of the base.
14. The method according to claim 14, wherein the coupling step
includes press-fitting the base into the cap such that the external
surface of the base is flush with a lower surface of the cap.
15. The method according to claim 1, wherein the recessed
identification feature is created below an outlet stem of the port,
outside an outer perimeter of the fluid cavity.
16. The method according to claim 15, further comprising creating a
second recessed identification feature in a top surface of the
metallic body such that the second recessed identification is
vertically aligned with the first recessed identification
feature.
17. The method according to claim 15, wherein the recessed
identification feature includes one or more alphanumeric
characters.
18. The method according to claim 17, wherein the one or more
alphanumeric characters includes the letters "C" and "T."
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 12/420,028, filed Apr. 7, 2009, now U.S. Pat. No. 7,947,022,
which is a continuation-in-part of U.S. application Ser. No.
11/368,954, filed Mar. 6, 2006, now U.S. Pat. No. 7,785,302, which
claims the benefit of U.S. Provisional Application No. 60/658,518,
filed Mar. 4, 2005. Each of the afore-referenced applications is
incorporated, in its entirety, by this reference.
BRIEF DESCRIPTION OF THE DRAWINGS
[0002] FIG. 1A shows a perspective view of an embodiment of an
access port according to the instant disclosure;
[0003] FIG. 1B shows a schematic side cross-sectional view the
access port shown in FIG. 1A;
[0004] FIG. 2 shows a perspective view of an embodiment of an
access port according to the instant disclosure;
[0005] FIG. 3 shows a perspective view of an access port according
to the instant disclosure;
[0006] FIG. 4 shows a perspective view of an access port according
to the instant disclosure;
[0007] FIG. 5 shows a perspective view of an access port according
to the instant disclosure;
[0008] FIG. 6A shows a perspective view of an access port according
to the instant disclosure;
[0009] FIG. 6B shows a side view of the access port shown in FIG.
6A;
[0010] FIG. 7 shows a perspective view of an access port according
to the instant disclosure;
[0011] FIG. 8 shows a simplified perspective view of a cap for
forming an access port according to the instant disclosure;
[0012] FIG. 9 shows a simplified perspective view of a cap for
forming an access port according to the instant disclosure;
[0013] FIG. 10 shows a simplified perspective view of a cap for
forming an access port according to the instant disclosure;
[0014] FIG. 11 shows a simplified perspective view of a cap for
forming an access port according to the instant disclosure;
[0015] FIG. 12 shows a simplified perspective view of a cap for
forming an access port according to the instant disclosure;
[0016] FIG. 13 shows a simplified perspective view of a cap for
forming an access port according to the instant disclosure;
[0017] FIG. 14 shows a simplified perspective view of a cap for
forming an access port according to the instant disclosure;
[0018] FIG. 15A shows a perspective view of an embodiment of an
access port according to the instant disclosure;
[0019] FIG. 15B shows a top elevation view of the access port shown
in FIG. 15A;
[0020] FIG. 16 shows a perspective view of an access port according
to the instant disclosure;
[0021] FIG. 17 shows a perspective view of an access port according
to the instant disclosure;
[0022] FIG. 18 shows a perspective view of an access port according
to the instant disclosure;
[0023] FIG. 19 shows a perspective view of an access port according
to the instant disclosure;
[0024] FIG. 20 shows a perspective view of an access port according
to the instant disclosure;
[0025] FIG. 21 shows a perspective view of an access port according
to the instant disclosure;
[0026] FIG. 22 shows a perspective view of another embodiment of an
access port according to the instant disclosure;
[0027] FIG. 23 shows a top elevation view of the assembled access
port shown in FIG. 22;
[0028] FIG. 24 shows a simplified representation of a transverse
cross section of the access port shown in FIGS. 22 and 23;
[0029] FIGS. 25-51 show perspective views of additional embodiments
of an access port.
[0030] FIG. 52 shows a bottom perspective view of an access port
according to one embodiment;
[0031] FIG. 53A shows a top view of the access port shown in FIG.
52;
[0032] FIG. 53B shows a bottom view of the access port shown in
FIG. 52;
[0033] FIG. 54A represents a radiographic image of the access port
shown in FIG. 52 when viewed from above the access port;
[0034] FIG. 54B represents a radiographic image of the access port
shown in FIG. 52 when viewed at an angle of approximately 20
degrees;
[0035] FIG. 54C represents a radiographic image of the access port
shown in FIG. 52 when viewed at an angle of approximately 50
degrees;
[0036] FIG. 55 shows a cross-sectional view of the access port
shown in FIG. 52;
[0037] FIGS. 56A and 56B show cross-sectional views of example
embodiments of engraved features on an access port surface;
[0038] FIG. 57A shows a top perspective view of an access port
according to one embodiment;
[0039] FIG. 57B shows a bottom perspective view of the access port
shown in FIG. 57A;
[0040] FIG. 57C shows a bottom view of the access port shown in
FIG. 57A;
[0041] FIG. 58A shows a top perspective view of another embodiment
of an access port;
[0042] FIG. 58B shows a bottom perspective view of the access port
shown in FIG. 58A;
[0043] FIG. 58C shows a bottom view of the access port shown in
FIG. 58A;
[0044] FIG. 59A shows a side view of an embodiment of an access
port;
[0045] FIG. 59B shows a bottom view of the access port shown in
FIG. 59A;
[0046] FIG. 60A shows a bottom perspective view of an additional
embodiment of an access port;
[0047] FIG. 60B shows a bottom view of the access port shown in
FIG. 60A;
[0048] FIG. 61A shows a bottom perspective view of an additional
embodiment of an access port;
[0049] FIG. 61B shows a bottom view of the access port shown in
FIG. 61A;
[0050] FIG. 62A shows a bottom view of an additional embodiment of
an access port;
[0051] FIG. 62B shows a side view of the access port shown in FIG.
62A;
[0052] FIG. 62C shows an end view of the access port shown in FIG.
62A;
[0053] FIG. 63A shows a bottom view of another embodiment of an
access port;
[0054] FIG. 63B shows a side view of the access port shown in FIG.
63A; and
[0055] FIG. 63C shows an end view of the access port shown in FIG.
63A.
DETAILED DESCRIPTION
[0056] The instant disclosure relates generally to percutaneous
access and, more specifically, to methods and devices associated
with percutaneous access. Generally, the instant disclosure relates
to an access port for subcutaneous implantation. In one embodiment,
an access port may allow a physician or other medical personnel to
obtain long term percutaneous access to the interior of a patient's
body. Employing an access port for percutaneous access may reduce
the opportunity for infection by inhibiting fluid connections (that
extend into the interior of a patient's body) from the patient's
skin and from the external environment. The access device allows
access to the interior of the patient without requiring a needle to
pierce the skin. Further, internal components, such as a catheter
or a valve, may be replaced without a surgical procedure. Features
or aspects of the instant disclosure may apply to any such access
ports for subcutaneous access to a patient, without limitation. The
access port may be injected by hand (e.g., via a syringe including
a needle) for example, or may be injected and pressurized by
mechanical assistance (e.g., a so-called power injectable
port).
[0057] Power injectable ports may be employed in, among other
processes, for example, computed tomography ("CT") scanning
processes. More particularly, a so-called "power injector" system
may be employed for injecting contrast media into a peripherally
inserted intravenous (IV) line. For example, such power injectors
or injection systems may be commercially available from Medrad,
Inc., a subsidiary of Schering AG, Germany and may be marketed
under the trademark STELLANT.RTM.. Because fluid infusion
procedures are often defined in terms of a desired flow rate of
contrast media, such power injection systems are, in general,
controllable by selecting a desired flow rate.
[0058] More specifically, the instant disclosure relates to an
access port having at least one perceivable or identifiable feature
for identifying the access port, wherein the identifiable feature
is perceivable after the access port is implanted within a patient.
For example, at least one or perhaps multiple identifiable
feature(s) of an access port contemplated by the instant disclosure
may be correlative to information (e.g., a manufacturer's model or
design) pertaining to the access port. Thus, an identifiable
feature from an access port of a particular model may be unique in
relation to most if not all other identifiable features of another
access port of a different models or design. Of course, the at
least one identifiable feature of an access port contemplated by
the instant disclosure may be further correlative with any
information of interest, such as type of port, catheter type, date
of manufacture, material lots, part numbers, etc. In one example,
at least one identifiable feature of an access port may be
correlative with the access port being power injectable. In this
way, once at least one identifiable feature of an access port is
observed or otherwise determined, correlation of such at least one
feature of an access port may be accomplished, and information
pertaining to the access port may be obtained.
[0059] In one embodiment, at least one feature may be perceived by
palpation (i.e., to examine by touch), by way of other physical
interaction, or by visual observation. Accordingly, a person of
interest may touch or feel the access port through the skin to
perceive at least one identifying characteristic thereof. In
another embodiment, at least one identifiable feature may be
perceived via x-ray or ultrasound imaging. In yet a further
embodiment, at least one identifiable feature may be perceived
through magnetic, light, or radio energy interaction or
communication with the access port.
[0060] Turning to the embodiment wherein at least one feature may
be perceived through palpation, other physical interaction, or
visual observation, a topography or exterior surface feature of an
access port contemplated by the instant disclosure may be
configured for perception. For example, referring to FIGS. 1A and
1B, an exemplary access port 10 contemplated by the instant
disclosure is shown. FIGS. 1A and 1B show a perspective view and a
schematic side cross-sectional view, respectively, of an access
port 10 for allowing percutaneous or otherwise internal access to a
patient's body. Access port 10 includes a housing or body 20
defined by a cap 14 and a base 16. Cap 14 and base 16, as known in
the art, may be configured for capturing therebetween a septum 18.
As shown in FIG. 1A, cap 14 and base 16 may matingly engage one
another along a mating line 15. Cap 14 and base 16 may be secured
or affixed to one another via mechanical fasteners such as screws
or other fastening devices, may be adhesively affixed to one
another, or may be affixed to one another as known in the art.
Further, cap 14, base 16, and septum 18 may collectively define a
cavity 36 in fluid communication with a lumen 29 of outlet stem
31.
[0061] The body 20 may be implanted in a patient 7, as shown in
FIG. 1B, to dispose the cavity 36 subcutaneously within the patient
7. Also, suture apertures 66 (FIG. 1A) may be used to affix the
access port 10 within the patient 7, if desired. After the body 20
is implanted in a patient 7, the upper surface of the septum 18 may
be substantially flush with the surface of the skin 6 of the
patient 7 and may be repeatedly punctured for creating a
percutaneous passageway from the exterior of the skin of the
patient into the cavity 36. The outlet stem 31 may create a
fluid-communicative passageway from the cavity 36 through the
outlet stem 31 and into the interior of the patient 7. A catheter
may be coupled to the outlet stem 31 for fluid communication with
the cavity 36 and for transferring fluid from the cavity 36 to a
desired remote location from the cavity 36 and within a patient
7.
[0062] Body 20 of access port 10 may comprise a bio-compatible
material such as polysulfone, titanium, or any other suitably
bio-compatible material as known in the art. Accordingly, the body
20 may be formed from a bio-compatible plastic material. If
desired, the body 20 may comprise a penetrable material for
penetration by sutures or needles. In another embodiment, and as
discussed further hereinbelow, body 20 may comprise an impenetrable
material such as, for instance, a metal if desired. Body 20 may
include a concave bottom or, in another embodiment, may include a
flat bottom, without limitation.
[0063] According to the instant disclosure, access port 10 may
comprise a body 20 exhibiting at least one identifiable feature.
More particularly, as shown in FIG. 1A, body 20 may exhibit a
partial generally pyramidal shape (i.e., a polygonal base having
surfaces for each side of the polygon extending toward a common
vertex otherwise known as a frustum). Generally, a body 20 of an
access port 10 may exhibit a partial pyramidal shape extending
between a generally quadrilateral shaped base positioned at
reference plane 11 and a generally quadrilateral shaped upper base
positioned at reference plane 9. Reference planes 9 and 11 will not
be shown in FIGS. 2-21, for clarity; however, reference to planes 9
or 11 with respect to FIGS. 2-21, as used herein, will refer to
corresponding reference planes analogous to reference planes 9 and
11 as shown in FIGS. 1A and 1B.
[0064] As shown in FIG. 1A, the exterior of access port 10 is
substantially defined by four substantially planar side surfaces 50
connected to one another by radiuses 32. In addition, the upper
topography 61 of access port 10 is defined by upper surface 60 in
combination with chamfers 46A and 46B and may be further defined by
the upper surface of septum 18. Explaining further, the outer
periphery of upper topography 61 may be described as a generally
quadrilateral exterior formed by side regions 54 and having rounded
corner regions 30 adjacent side regions 54. Such a configuration
may provide an access port having at least one feature that may be
perceived by palpation.
[0065] It may be appreciated that there are many variations to the
geometry of access port 10 as shown in FIG. 1A. For instance, while
the body 20 of access port 10 may be described as a partially
pyramidal shape or frustum, the instant disclosure is not so
limited. Rather, one or more of side surfaces 50 may be oriented at
as may be desired, without reference to any other side surfaces 50.
Accordingly, for example, one of surfaces 50 may be substantially
vertical while the remaining surfaces 50 may be oriented at
respective, selected angles. Furthermore, it should be understood
that FIG. 1A is merely exemplary and that the dimensions and shape
as shown in FIG. 1A may vary substantially while still being
encompassed by the instant disclosure.
[0066] FIG. 2 shows a perspective view of another embodiment of
access port 10 according to the instant disclosure. As shown in
FIG. 2, the exterior of access port 10 is substantially defined by
a generally parallelogram-shaped base (positioned at reference
plane 11 as shown in FIGS. 1A and 1B) extending generally
pyramidally to a generally parallelogram-shaped upper surface
(positioned at reference plane 9 as shown in FIGS. 1A and 1B). As
shown in FIG. 2, radiuses 42 may be larger than radiuses 32 as
shown in FIG. 1A. Furthermore, the upper topography 61 of access
port 10 as shown in FIG. 2 may include rounded corner regions 40
which are larger than rounded corner regions 30 as shown in FIG.
1A. Thus, FIG. 2 shows an exemplary embodiment of an access port 10
that may be perceivably distinguishable from access port 10 as
shown in FIGS. 1A and 1B. For example, a difference between one
exterior of an access port contemplated by the instant disclosure
and another exterior of a different access port contemplated by the
instant disclosure may be determined by way of palpation.
[0067] In another embodiment, in another aspect contemplated by the
instant disclosure, a template may be employed for perceiving at
least one feature of an access port. For instance, a
complementarily-shaped template may be positioned over and abutted
against an access port contemplated by the instant disclosure so as
to determine if the access port matches or substantially
corresponds to the shape of the template. Such a process may
reliably indicate or perceive at least one feature of an access
port contemplated by the instant disclosure. Of course, a plurality
of templates corresponding to different models of access ports may
be serially engaged with an unknown access port so as to perceive
at least one feature thereof. Such a process may allow for
identification (e.g., of a model or manufacturer) of an access port
contemplated by the instant disclosure.
[0068] In another aspect contemplated by the instant disclosure, an
upper topography of an access port may include at least one feature
for identifying the access port. For example, as shown in FIG. 3,
upper surface 60 of access port 10 may be nonplanar. More
specifically, upper surface 60 may be tapered or may arcuately
extend downwardly (i.e., toward reference plane 11 as shown in
FIGS. 1A and 1B) as it extends radially inwardly toward septum 18.
Otherwise, access port 10, as shown in FIG. 3, may be configured
substantially as described hereinabove with reference to FIGS. 1A
and 1B. Thus, upper surface 60 is one exemplary example of at least
one perceivable feature for identification of an access port
contemplated by the instant disclosure.
[0069] In yet a further embodiment of an access port contemplated
by the instant disclosure, side regions 54 extending between
rounded corner regions 30 may exhibit at least one perceivable
feature. For example, as shown in FIG. 4, access port 10 may
include one or more side regions 54 that extend arcuately between
adjacent rounded corner regions 30. Otherwise, access port 10, as
shown in FIG. 4, may be configured substantially as described
hereinabove with reference to FIGS. 1A and 1B. Side regions 54 may
be congruent or symmetric with respect to one another or, in
another embodiment, may be configured differently with respect to
one another, without limitation.
[0070] FIG. 5 shows a further exemplary embodiment of an access
port contemplated by the instant disclosure. More specifically,
access port 10, as shown in FIG. 5, includes side regions 54 that
form recessed regions 72 between adjacent rounded corner regions
30. Put another way, the upper topography 61 may include
alternating recessed regions 72 and protruding regions 70
positioned generally about a periphery of septum 18. Otherwise,
access port 10, as shown in FIG. 5, may be configured substantially
as described hereinabove with reference to FIGS. 1A and 1B. Such a
configuration may provide an access port having at least one
identifiable feature.
[0071] In a further embodiment of an access port contemplated by
the instant disclosure, FIGS. 6A and 6B show a perspective view and
a side view, respectively, of an access port 10 generally
configured as is described with reference to FIG. 5 but having an
elongated body 20E. More specifically, elongated body 20E of access
port 10, as shown in FIGS. 6A and 6B, includes a side surface 50E
that extends generally from upper topography 61 downwardly (i.e.,
toward reference plane 11 as shown in FIGS. 1A and 1B) and having a
slope (e.g., an angle with respect to a vertical axis normal to an
upper surface of septum 18) which is different from the other side
surfaces 50. Otherwise, access port 10, as shown in FIG. 6, may be
configured substantially as described hereinabove with reference to
FIGS. 1A and 1B. Such a configuration may provide an elongated body
20E of an access port 10 having an elongated side portion.
[0072] Of course, one or more side surfaces of an access port
according to the instant disclosure may be configured for forming a
body exhibiting a selected shape as may be desired. An elongated
body portion of an access port contemplated by the instant
disclosure may form, in combination with other features as
described hereinabove or, in another embodiment, taken alone, at
least one perceivable feature for identification of an access port
according to the instant disclosure.
[0073] FIG. 7 shows a further embodiment of an access port
encompassed by the instant disclosure. Particularly, as shown in
FIG. 7, access port 10 may include an upper body portion 20a and a
lower body portion 20b. Furthermore, each of upper body portion 20a
and lower body portion 20b may exhibit a partial pyramidal shape
(i.e., a frustum), wherein the body portions 20a and 20b are
stacked vertically with respect to one another. Accordingly, upper
body portion 20a may form an overhanging rim feature 76 extending
along a periphery of access port 10. Explaining further, lower body
portion 20b may have an exterior substantially defined by side
surfaces 50b and rounded corner regions 30b, while upper body
portion 20a may have an exterior substantially defined by side
surfaces 50a, rounded corner regions 30a, and upper topography 61.
It may be appreciated that overhanging rim feature 76 may be sized
and configured for perception via palpation. Such a configuration
may provide a suitable access port for delivery of a beneficial or
medicinal substance, the access port being identifiable (e.g., by
model number, manufacturer, etc.) after implantation.
[0074] It should be understood that the instant disclosure
contemplates access ports having an exterior geometry that is not
quadrilateral in nature. Rather, the instant disclosure
contemplates that an access port may have an exterior which is
generally cylindrical, generally conical, generally elliptical,
generally oval, or an exterior that is otherwise arcuate in nature.
Specifically, the instant disclosure contemplates that an access
port having a substantially rounded or arcuate exterior may include
at least one feature configured for identification of the access
port after implantation. For example, as shown in FIG. 8, shows a
cap 14 that exhibits an exterior surface 78 that is substantially
conical. Cap 14 may be assembled to a suitable base (not shown) for
capturing a septum (not shown) as described hereinabove to form an
access port 10 as generally described with reference to FIGS.
1-7.
[0075] The instant disclosure further contemplates that at least
one protrusion, protruding region, recess, recessed region,
undulation, or adjacent features of different elevation may
comprise a feature for identifying an access port contemplated by
the instant disclosure. More specifically, upper topography 61C, as
shown in FIG. 8, may include a plurality of protrusions 80.
Protrusions 80 may exhibit partially spherical upper surfaces that
transition into a lower portion of cap 14. In further detail,
protrusions 80 may be circumferentially spaced about the periphery
of septum (not shown) as may be desired. In one embodiment, a
plurality of protrusions 80 may be symmetrically circumferentially
spaced about the periphery of septum (not shown). More generally,
at least one protrusion 80 may be sized, configured, and positioned
for forming at least one identifiable feature of an access port. Of
course, at least one protrusion 80 may be structured for
facilitating comfort of a patient within which the access port is
implanted. As may be appreciated, at least one protrusion 80 or
more than one protrusion 80 may be included in an upper topography
61C of an access port (not shown) contemplated by the instant
disclosure.
[0076] FIG. 9 shows another embodiment of a cap 14 including at
least one protrusion 80E for forming and identifying an access port
contemplated by the instant disclosure after implantation thereof
within a patient. Protrusions 80E may extend circumferentially
about a center of revolution. Thus, protrusions 80E may exhibit a
body 87 portion circumferentially extending between rounded ends
83. Further, cap 14 may have an exterior surface 78 that is
substantially symmetric about an axis of revolution. More
generally, body 20 may extend from a generally circular, generally
elliptical, or generally oval base positioned at a lower extent 71
of the cap 14 to an upper generally circular, generally elliptical,
or generally oval cross section that is smaller than a cross
section of the base and is positioned at an upper extent 73
(without considering protrusions 80E) of the cap 14. In addition,
side surface 51, as shown in FIG. 9, extends arcuately between the
base and the upper topography 61 of cap 14. Side surface 51 may
extend in a generally tapered or conical fashion, may exhibit a
radius or other arcuate shape, or may otherwise transition between
a cross section of the base of the access port to a cross section
proximate the upper topography 61C thereof.
[0077] Further, FIG. 10 shows an embodiment of a cap 14 for forming
an access port contemplated by the instant disclosure having an
upper topography 61C thereof comprising alternating
circumferentially extending protrusions 80E and circumferentially
extending recesses 82, wherein the circumferentially extending
protrusions 80E are circumferentially larger than the
circumferentially extending recesses 80E. In another embodiment of
an access port contemplated by the instant disclosure, FIG. 11
shows a perspective view of a cap 14 having an upper topography 61C
thereof comprising alternating circumferentially extending
protrusions 80E and circumferentially extending recesses 82,
wherein the circumferentially extending protrusions 80E and the
circumferentially extending recesses 82 are substantially equal in
(circumferential) sized or extension. In yet a further embodiment
of a cap 14 for forming an access port contemplated by the instant
disclosure, FIG. 12 shows a perspective view of a cap 14 having an
upper topography 61C thereof comprising three circumferentially
extending protrusions 80E and three circumferentially extending
recesses 82, arranged so as to alternate circumferentially, wherein
the circumferentially extending protrusions 80E and the
circumferentially extending recesses 82 are substantially equal in
(circumferential) size.
[0078] FIG. 13 shows a perspective view of an additional embodiment
of an cap 14 for forming an access port contemplated by the instant
disclosure including an upper topography 61C including
circumferentially extending protrusions 80T and circumferentially
extending recesses 82T, wherein transition regions 81 are provided
between circumferentially extending protrusions 80T and
circumferentially extending recesses 82T. Such transition regions
81, as shown in FIG. 13, may taper or generally smoothly transition
between a circumferentially extending protrusion 80T and a
circumferentially extending recess 82T. Also, FIG. 14 shows a
perspective view of an additional embodiment of a cap 14 for
forming an access port contemplated by the instant disclosure
including an upper topography 61C including protrusion regions 96
and recessed regions 98 that transition between one another and
alternate circumferentially so as to form an undulating topography
comprising upper topography 61C. Such an undulating topography, as
shown in FIG. 14, generally smoothly transitions between
circumferentially adjacent protrusion regions 96 and recessed
regions 98.
[0079] In a further embodiment of an access port contemplated by
the instant disclosure, FIGS. 15A and 15B show a perspective view
and a top elevation view, respectively, of an access port 10
generally configured as is described with reference to FIG. 5 but
may include at least one nonplanar side surface. In another
embodiment, access port 10 as shown in FIG. 15 may be configured as
shown in FIGS. 1-4 or FIGS. 6-7, or any embodiments described
hereinbelow, without limitation. More specifically, elongated body
20 of access port 10, as shown in FIGS. 15A and 15B, includes three
side surfaces 50R that extend arcuately (as shown in FIG. 15B).
Such a configuration may provide an access port 10 that is
identifiable subsequent to implantation. In yet another embodiment
of an access port contemplated by the instant disclosure, FIG. 16
shows a perspective view of an access port 10 including a side wall
100 that truncates a portion of a radius 32 formed between side
surfaces 50 of access port 10. It may also be noted that such an
access port 10 may include three suture apertures 66, which may,
taken alone or in combination with at least one other feature,
comprise at least one identifiable feature of an access port
contemplated by the instant disclosure. In addition, as shown in
FIG. 16, outlet stem 31 may extend from side wall 100.
[0080] In a further embodiment of an access port contemplated by
the instant disclosure, FIG. 17 shows a perspective view of an
access port 10 wherein cap 14 and base 16, when assembled to one
another along mating line 15, form a flange feature or lip feature
102 that extends about at least a portion of the periphery of the
access port 10. As shown in FIG. 17, lip feature 102 extends
substantially about the periphery of the access port 10, proximate
to the mating line 15 between cap 14 and base 16. Such a feature
may comprise at least one identifiable feature of an access port
contemplated by the instant disclosure. Thus, it may be appreciated
that a peripheral discontinuity between the cap 14 and base 16 may
be formed generally along the mating line 15 therebetween. In the
embodiment of an access port as shown in FIG. 7, an overhanging rim
feature 76 may comprise a peripheral discontinuity or, in the
embodiment of an access port as shown in FIG. 17, a lip feature 102
may comprise a peripheral discontinuity.
[0081] In a further embodiment of an access port contemplated by
the instant disclosure, FIG. 18 shows a perspective view of an
access port 10 wherein at least a portion of at least one side
surface 50 is concave. As shown in FIG. 18, concave region 106 of
side surface 50 is concave. Concavity (i.e., a concave region 106)
may be exhibited over at least a portion of a side surface of an
access port of any of the embodiments as shown herein, without
limitation. Thus, at least one side surface 50 of an access port
contemplated by the instant disclosure having at least at least a
portion thereof that is concave is one exemplary example of at
least one perceivable feature for identification of an access port
contemplated by the instant disclosure.
[0082] In a further embodiment of an access port contemplated by
the instant disclosure, FIG. 18 shows a perspective view of an
access port 10 wherein at least a portion of at least one side
surface 50 is concave. As shown in FIG. 18, region 106 of side
surface 50 is concave. Concavity may be exhibited over at least a
portion of a side surface of an access port of any of the
embodiments as shown herein, without limitation. Thus, at least one
side surface 50 of an access port contemplated by the instant
disclosure having at least at least a portion thereof that is
concave is one exemplary example of at least one perceivable
feature for identification of an access port contemplated by the
instant disclosure.
[0083] In a further embodiment of an access port contemplated by
the instant disclosure, FIG. 19 shows a perspective view of an
access port 10 generally configured as is described with reference
to FIGS. 6A and 6B. More specifically, elongated body 20ER, as
shown in FIG. 19 includes a side surface 50ER that extends
arcuately from upper topography 61 of access port 10 downwardly
(i.e., toward reference plane 11 as shown in FIGS. 1A and 1B). Such
a configuration may provide an elongated body 20E of an access port
10 having an elongated side portion.
[0084] It should be understood from the above-described various
embodiments of an access port contemplated by the instant
disclosure that many variations, additions, or different features
may be encompassed by the instant disclosure. Thus, the instant
disclosure is not limited to the several above-described exemplary
embodiments.
[0085] For example, as shown in FIG. 20, which shows a top
elevation view of an access port 10 contemplated by the instant
disclosure, an access port 10 may include a side wall 100 that at
least partially truncates a radius 32 between side surfaces 50,
outlet stem 31 extending from side wall 100, and at least one of a
concave region 106 and an arcuate surface 50R. Further, as shown in
FIG. 20, suture apertures 66 may be positioned so as to identify
the access port 10 after subcutaneous implantation.
[0086] Additionally, the instant disclosure contemplates access
ports having an exterior geometry that is polygonal in nature.
Specifically, the instant disclosure contemplates that an access
port contemplated by the instant disclosure may exhibit a generally
triangular exterior. Thus, as shown in FIG. 21, body 20 may exhibit
a generally pyramidal or tapered shape (i.e., a polygonal base
having surfaces for each side of the polygon extending toward a
common vertex). Generally, a body 20T of an access port 10 may
extend between a generally triangularly-shaped base and a
relatively smaller, generally triangularly-shaped upper base.
Accordingly, the exterior of access port 10 may be substantially
defined by three side surfaces (e.g., 50, 50R, 102, 50E) having
radiuses 32 extending therebetween. In addition, the upper
topography 61 of access port 10 may be defined by upper surface 60
in combination with side regions 54 and rounded corner regions 30.
Such a configuration may provide an access port having at least one
feature that may be perceived by palpation.
[0087] FIGS. 22 and 23 show a perspective view and a top elevation
view of another embodiment of an access port including a generally
triangular exterior geometry. More particularly, as shown in FIGS.
22 and 23, a cap 14 and base 16 (collectively forming a housing)
may capture a septum 118 to form an access port 10. Further, outlet
stem 31 may include a stem base that may be positioned within and
sealed to an outlet recess 93 formed within base 16. The outlet
stem 31 may be in fluid communication with a cavity formed within
the access port 10. Optionally, suture plugs 89 may be positioned
within suture cavities 91 formed in base 16. Suture plugs 89 may
comprise a pliant material (e.g., silicone, rubber, etc.) that may
provide some resilience between sutures coupling the access port 10
(i.e., the base 16) to a patient. In further detail, a side
periphery 95 (e.g., one or more side walls) of access port 10 may
be generally triangular. Thus, cap 14 and base 16 may collectively
form a generally triangular housing or body of access port 10.
Also, the instant disclosure contemplates that side periphery 95
may increase or decrease in cross-sectional size (e.g., by tapering
or arcuately transforming) between upper surface 161 of cap 14 and
lower surface 151 of base 16. As shown in FIGS. 22 and 23, a
transverse cross section (taken in a selected plane substantially
parallel to lower surface 151 of base 16) of access port 10 may be
larger proximate to lower surface 151 of base 16 and may be
relatively smaller proximate upper surface 161 of cap 14.
[0088] Additionally, FIG. 24 shows a simplified representation of a
transverse cross section of access port 10. As shown in FIG. 24,
side periphery 95 of access port 10 may define three side regions
103 that extend between associated vertex regions 101. In addition,
in one embodiment and as shown in FIG. 24, side periphery 95 may
define a substantially equilateral generally triangular shape. As
one of ordinary skill in the art will appreciate, side regions 103
may arcuately extend between associated vertex regions 101; thus,
side regions 103 may form "sides" of a generally triangular shape.
Further, although vertex regions 101 are rounded, it may be
appreciated that such vertex regions 101 form an intersection
between adjacent side regions 103. Accordingly, one of ordinary
skill in the art will appreciate that the phrase "generally
triangular," as used herein, encompasses any generally three-sided
geometry wherein adjacent sides intersect, without limitation. For
example, the phrase "generally triangular" encompasses three sided
polygons, circular triangles, equilateral triangles, etc., without
limitation.
[0089] The instant disclosure also contemplates that at least one
feature of an access port contemplated by the instant disclosure
may not be observable visually or by palpation but, rather, may be
otherwise observable. For example, the instant disclosure
contemplates that at least one feature of an access port may be
observable through interaction with an imaging technology such as
x-ray or ultrasound. For example, in one embodiment, a metal
feature (e.g., a plate or other metal geometry) may be included by
an access port contemplated by the instant disclosure. As may be
appreciated, such a metal feature may be represented on an x-ray
generated by exposure of the access port to x-ray energy while
simultaneously exposing x-ray sensitive film to x-ray energy
passing through the access port. Further, the instant disclosure
contemplates that a size, shape, or both size and shape of a metal
feature of an access port may be configured for enhancing
identification of an access port. For example, assuming that a
metal feature comprises a metal plate, a size, shape, or both may
be selectively tailored for identification of an access port.
Similarly, a feature of an access port contemplated by the instant
disclosure may be tailored for detection via ultrasound
interaction. Such a feature may comprise an exterior topographical
feature. In another embodiment, such a feature may comprise a
composite structure including two or more materials that form an
interface surface that may be identified by ultrasound imaging.
[0090] One example embodiment of a feature observable through
interaction with imaging technology contemplated by the instant
disclosure is shown in FIGS. 52, 53A, and 53B. FIG. 52 depicts a
bottom perspective view of an access port 10. FIG. 53A shows a top
view of the access port 10, while FIG. 53B shows a bottom view of
the access port. The access port 10 of FIGS. 52, 53A, and 53B is
similar in some respects to the access port 10 as seen in FIGS. 22
and 23, including a cap 14 and a base 16 that cooperate to define a
body. In the present example embodiment, however, the lower surface
151 of the base 16 includes an identification feature 200, as seen
in FIGS. 52 and 53B. It is contemplated that the identification
feature 200 can be one or more alphanumeric characters, such as the
"CT" depicted. Additionally, the instant disclosure contemplates
the use of other markings, such as one or more symbols, patterns,
characters, designs, a combination thereof, etc. The identification
feature 200 can be of any size, shape, or both in order to tailor
the identification feature for the specific identification of one
or more of a variety of characteristics of the access port.
Specifically, in one embodiment the identification feature 200 can
convey information to a practitioner regarding the
power-injectability of the implanted access port. Note that in the
present embodiment, the identification feature 200 is defined as a
recessed feature, whereas in other embodiments the identification
feature may be defined in other ways, as discussed hereafter.
[0091] As mentioned above, FIG. 53A depicts a top view of the
access port 10. Note that the identification feature 200 is not
observable through the upper surface 161 of the cap 14 or through
the septum 118 without the interaction of imaging technology. As
seen in FIG. 53B, the alphanumeric characters of the identification
feature 200, "CT," are engraved mirror-reversed on the lower
surface 151 of the base 16. The "CT" is engraved mirror-reversed so
that when imaging technology, such as x-ray imaging, is used to
identify a subcutaneously implanted access port, the "CT" will be
visible in the proper orientation. By engraving a desired
identification feature mirror-reversed on the bottom surface of an
access port, a practitioner will be able to determine if there is a
problem with the port after implantation, such as if the access
port has flipped or otherwise become mis-oriented while in the body
of the patient. Thus, if the identification feature is seen
mirror-reversed or askew in an x-ray image, the practitioner can
correct the problem before attempts are made to use the access
port.
[0092] Although also useful in access ports where only a portion of
a port includes a metallic material, e.g., a metal plate, the
engraving technique is well-suited in one embodiment for access
ports that are composed of solid metal, such as titanium, stainless
steel, or other materials that are typically radiopaque, i.e.,
non-transmissive to x-rays in sufficient thickness. FIGS. 54A-54C
are representative images of the access port 10 of FIG. 52, which
includes titanium or other metallic material, as seen via x-ray
imaging after implantation into the patient. The access port 10
includes the identification feature 200 as seen in FIGS. 52 and
53B. Due to the relative thickness of the access port 10, the
material of the base 16 and cap 14 surrounding a cavity periphery
36A of the cavity 36, which is a fluid cavity, is substantially
non-transmissive to x-rays and therefore appears relatively dark in
the x-ray image of FIG. 54A. However, the material of the access
port 10 within the cavity periphery 36A is relatively thinner
through a cavity base 220 (as seen in FIG. 55) than through the
material of the cap 14 and base 16. Thus, additional thinning of
the material when creating the identification feature 200 enables
the identification feature to appear relatively more
radiographically transmissive than the surrounding material of the
cavity base under x-ray imaging. Note that the identification
feature 200 in FIG. 54A is visible in the proper orientation,
indicating that the access port is not flipped.
[0093] FIGS. 54B and 54C are additional representative x-ray images
of the identification feature 200 of the access port 10, wherein
the access port is tilted at angles of approximately 20 and 50
degrees, respectively. Thus, the identification feature 200 is also
useful for determining relative orientation of the access port 10
after implantation.
[0094] FIG. 55 shows a cross-sectional view taken at line 55-55 of
the access port 10 in FIG. 52. In this example embodiment, the
identification feature 200 is disposed beneath the septum 118 and
the cavity 36. FIGS. 56A and 56B further depict enlarged
cross-sectional views of potential cut profiles of the recessed
identification feature 200. FIG. 56A shows a rounded engraving
profile 201, engraved on the lower surface 151 of the base 16 and
used for purposes of aesthetics and ease of manufacturing. For a
relatively more defined contrast under imaging technology, however,
a sharp-edged engraving profile 202 may be used, as seen in FIG.
56B. Note that a variety of cross-sectional recessed profiles may
be employed. This disclosure further contemplates that although
engraving is discussed here, other methods of marking the
identification feature may be used, such as milling, machining,
chemical or laser etching, molding, stamping, etc.
[0095] Regardless of the cut profile used, better contrast is
achieved generally with greater engraving depth X. The optimal
engraving depth X will depend, however, on the thickness of the
overall cavity base 220, which is the portion of the base directly
below the cavity 36, as shown in FIG. 55. For example, in an
embodiment of an access port including titanium, if the overall
thickness of the cavity base 220 is approximately 0.020'' then
sufficient contrast for x-ray imaging purposes can be obtained in
one embodiment by engraving the identification feature 200 to a
depth X (FIGS. 56A, 56B) of between about 0.009'' and about
0.011''. In another example embodiment of an access port including
titanium, where the overall thickness of the cavity base 220 is
approximately 0.030'', sufficient contrast can be obtained by
engraving the identification feature 200 to a depth X of between
about 0.015'' and about 0.021''. One of ordinary skill in the art
will appreciate that the depth of an engraved identification
feature can be varied substantially in order to comply with a
product's safety requirements and still remain within the scope
contemplated by this disclosure. In addition, the depth X of the
identification feature can vary according to the position of the
feature on the access port, the thickness of material to be
penetrated by the imaging technology, the type of material included
in the access port, etc.
[0096] It is also contemplated by this disclosure that the use of
an identification feature in a metallic or other radiopaque access
port can be applied to access ports having a variety of possible
configurations, such as is seen in FIGS. 57A-58C, for example.
FIGS. 57A-57C depict one embodiment, wherein the access port 10
includes an identification feature 200 on a lower surface 251 of a
base or body 116. The access port 10 in FIGS. 57A-57C includes a
retaining ring 230, which seals the septum 118 to the base or body
116, over the cavity 36. In one embodiment, the retaining ring 230
is press fit into the base or body 116 to hold the septum 118 in
place. FIGS. 58A-58C show yet another embodiment, wherein the
access port 10 includes an identification feature 200 on the cavity
base 220 and wherein the cavity base is mated to and flush with a
lower surface 252 of a cap 114 to define a body. In a particular
embodiment, the cavity base 220 is press fit into the cap 114,
though other mating configurations can also be employed.
[0097] In another embodiment contemplated by the instant
disclosure, FIGS. 59A and 59B show that the location of the
identification feature 200 can vary as well. Rather than placing
the identification feature 200 under the cavity 36, it is possible
to place the identification feature under another portion of the
access port 10, such as under the outlet stem 31 and between the
septum plugs 89, i.e., proximate the outer periphery of the access
port bottom surface. Though the overall thickness of the access
port structure above the identification feature 200 is greater in
this location than if engraved under the cavity 36, the change in
location allows for a relatively deeper engraving, which will
increase contrast without risk of excessive thinning of the cavity
base 220. Additionally, in one embodiment, it is possible to define
the identification feature compositely by engraving into both the
bottom and top surfaces, such that the engravings are vertically
aligned. This enables the remaining material thickness to be
substantially reduced in order to provide relatively greater
radiographic transmission through the identification feature.
[0098] Additionally, the instant disclosure contemplates access
ports having any variety or combination of desired identification
features for indicating power-injectability or other aspect or
characteristic of an access port. Specifically, FIGS. 60A-61B
depict different types of identification features 200, according to
example embodiments. FIGS. 60A-60B depict a symbolic identification
feature 200. FIGS. 61A-61B depict an exemplary embodiment of an
access port 10 including a combination of identification features
200, namely an alphanumeric identification feature 200A and a
patterned identification feature 200B. A patterned or symbolic
identification feature can also be used to help indicate the
orientation of the port or for any other desired reason. It is
understood by the instant disclosure that other symbols, patterns,
marks, and alphanumeric characters can be used both alone and in
any combination with each other on a variety of access port
configurations.
[0099] In additional embodiments, the identification feature can be
defined on an inside bottom surface 36B of the cavity 36 of an
access port 10, or in addition to the identification feature 200
provided on the bottom surface 251. In another embodiment, the
material surrounding the defining edges of the desired radiopaque
alphanumeric character, symbol, pattern, etc., can be removed
instead of removing the desired feature shape itself so as to
define a "positive" relief image of the identification feature.
Such a positive relief identification feature can be defined on a
lower surface of an access port body or on the inside bottom
surface of the cavity, for example.
[0100] In addition to the various types of symbols, patterns,
marks, and alphanumeric characters that are contemplated by the
instant disclosure, FIGS. 62A-63C disclose additional example
embodiments of identifying features on access ports that are
observable via x-ray or other suitable imaging technology.
Specifically, the instant disclosure contemplates the use of
shelled-out cavities 204, wherein portions of the access port 10
are hollowed out. This results in shelled-out cavities 204
extending inward from the lower surface 251 of the base or body 116
or corresponding port lower surfaces of the other embodiments
described herein, including the lower surface 151 of the base 16,
as in FIG. 151, and the lower surface 252 of a cap 114, as in FIGS.
58A-58C. This is done by removing the material surrounding the
cavity 36 without disrupting the cavity periphery 36A or the outer
side surfaces 250 of the access port 10. As seen in FIG. 62B, ribs
240 may be left to support the remaining "shelled" frame of the
access port 10. The definition of such cavities 204 provides a
relative difference in radiopacity of the access port 10 that can
be identified via x-ray imaging. As such, the cavities 204 can be
arranged to define a pattern or to form an indicia for
identification of an aspect or characteristic of the access port
10. Note that in other embodiments, the cavities can be defined so
as to extend from other surfaces of the access port, including the
top and sides thereof.
[0101] In a further aspect contemplated by the instant disclosure,
it is contemplated that a communicative technology may be utilized
wherein information is encompassed by an access port contemplated
by the instant disclosure. Generally, a communication device (e.g.,
a radio beacon, a light-emitting element, an ultrasound emitting
transducer, etc.), may be imbedded or otherwise affixed to an
access port contemplated by the instant disclosure. Such a
communication device may be configured for transmitting information
in response to a given impetus. More specifically, the instant
disclosure contemplates that an access port contemplated by the
instant disclosure may be exposed to a request signal (e.g., a
sound, an impact or an acceleration, light, radio waves, etc.).
Such a request signal may cause the communication device to
transmit information therefrom via sound, light, radio waves, or as
otherwise known in the art. Such information may be employed for
identifying an access port contemplated by the instant
disclosure.
[0102] In one exemplary example, it is contemplated that radio
frequency identification technology may be employed for
identification of an access port contemplated by the instant
disclosure. Particularly, so-called active RFID tags are powered by
an internal battery and are typically read/write devices.
Currently, a suitable cell coupled to suitable low power circuitry
can ensure functionality for as long as ten or more years,
depending upon the operating temperatures and read/write cycles and
usage. So-called passive RFID tags operate without a separate
external power source and obtain operating power generated from the
reader. Passive RFID tags are typically programmed with a unique
set of data (usually 32 to 128 bits) that cannot be modified.
Read-only tags may operate as an identifier comparable to linear
barcodes which may contain selected product-specific information.
Thus, passive RFID tags may be much lighter than active RFID tags,
less expensive, and may offer a virtually unlimited operational
lifetime. The tradeoff is that they have shorter read ranges than
active tags and require a higher-powered reader.
[0103] One advantage of RFID approach is the noncontact,
non-line-of-sight nature of the technology. Tags can be read
through a variety of substances such as snow, fog, ice, paint,
crusted grime, and other visually and environmentally challenging
conditions, where other optically read technologies may be less
effective. RFID tags can also be read in challenging circumstances
at rapid speeds, in most cases responding in less than about 100
milliseconds.
[0104] While certain representative embodiments and details have
been shown for purposes of illustrating aspects contemplated by the
instant disclosure, it will be apparent to those skilled in the art
that various changes in the methods and apparatus disclosed herein
may be made without departing form the scope contemplated by the
instant disclosure, which is defined in the appended claims. For
example, other access port sizes and shapes may be employed; and
various other embodiments and structures may be employed for
forming at least one identifiable feature of an access port
contemplated by the instant disclosure. In particular, FIGS. 25-51
illustrate a number of additional exemplary embodiments of access
port 10. As is apparent from these figures, access port 10 may be
formed in any number of shapes and sizes, such that any number of
modifications and changes are possible to any of the embodiments
described and illustrated herein without departing from the spirit
and scope of the instant disclosure.
* * * * *