U.S. patent application number 12/246303 was filed with the patent office on 2009-05-07 for dual reservoir implantable access port.
Invention is credited to Michael Fowler, Barry G. Hanson, Blaine Johnson, Brian Keese, James Steve Kenny, Daniel K. Recinella, A. David Smith.
Application Number | 20090118683 12/246303 |
Document ID | / |
Family ID | 40526986 |
Filed Date | 2009-05-07 |
United States Patent
Application |
20090118683 |
Kind Code |
A1 |
Hanson; Barry G. ; et
al. |
May 7, 2009 |
DUAL RESERVOIR IMPLANTABLE ACCESS PORT
Abstract
An implantable access port for use in transferring fluid
transdermally between an external fluid storage or dispensing
device and a site within a patient is disclosed. The access port
includes a body, at least two reservoirs defined within the access
port body, and at least one septum secured to the body and
enclosing the reservoirs within the body. The access port also
includes reservoir outlets defined within the reservoirs. The
access port also has body conduits defined within the body and in
fluid communication with the reservoir outlets and external
openings defined in the exterior of the body. An implantable access
port and system for use in apheresis is also provided that includes
an implantable access port, at least one needle, and a catheter
that is fluidly connected to the access port.
Inventors: |
Hanson; Barry G.;
(Thomaston, GA) ; Keese; Brian; (Molena, GA)
; Smith; A. David; (Fayetteville, GA) ; Fowler;
Michael; (Fayetteville, GA) ; Johnson; Blaine;
(Columbus, GA) ; Recinella; Daniel K.;
(Queensbury, NY) ; Kenny; James Steve;
(Fayetteville, GA) |
Correspondence
Address: |
Ballard Spahr Andrews & Ingersoll, LLP
SUITE 1000, 999 PEACHTREE STREET
ATLANTA
GA
30309-3915
US
|
Family ID: |
40526986 |
Appl. No.: |
12/246303 |
Filed: |
October 6, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60977736 |
Oct 5, 2007 |
|
|
|
61044752 |
Apr 14, 2008 |
|
|
|
61056920 |
May 29, 2008 |
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Current U.S.
Class: |
604/288.01 ;
604/288.03 |
Current CPC
Class: |
A61M 39/0208 20130101;
A61M 2039/0232 20130101; A61M 2039/0238 20130101; A61M 2039/0211
20130101 |
Class at
Publication: |
604/288.01 ;
604/288.03 |
International
Class: |
A61M 31/00 20060101
A61M031/00 |
Claims
1. An implantable vascular access port, comprising: a body
comprising: an upper surface; an opposed lower surface; a side wall
extending therebetween the upper and lower surfaces, the side wall
defining a pair of ports; a first reservoir defined therein a
portion of the upper surface of the body; a second reservoir
defined therein a portion of the upper surface of the body; a first
body conduit extending between the first reservoir and a first port
of the pair of ports; and a second body conduit extending between
the second reservoir and a second port of the pair of ports; at
least one septum configured to be seated within an upper portion of
at least one of the first or second reservoirs; and a retainer
defining a first retainer opening and a second retainer opening,
wherein the first and second retainer openings are separated by a
common dividing member, wherein the retainer is mountable thereon
the body such that the first retainer opening overlies the first
reservoir and the second retainer opening overlies the second
reservoir, and wherein the at least one septum is sealingly secured
therebetween the retainer and the body.
2. The access port of claim 1, further comprising an outlet stem
comprising: a proximal end; an opposing distal end; a first stem
conduit extending therethrough the outlet stem from the proximal
end to the distal end; and a second stem conduit extending
therethrough the outlet stem from the proximal end to the distal
end, wherein the proximal end of the outlet stem is connected to
and overlies the pair of ports such that the first body conduit is
in fluid communication with the first stem conduit and the second
body conduit is in fluid communication with the second stem
conduit.
3. The access port of claim 2, wherein a distal portion of the
outlet stem is configured to matably attach to a dual lumen
catheter.
4. The access port of claim 1, wherein at least a portion of the
dividing member of the retainer projects outwardly from a plane
defined by the upper surface of the body.
5. The access port of claim 1, wherein the first and second
reservoirs are each substantially D-shaped in a cross-section.
6. The access port of claim 5, wherein the D-shaped first and
second reservoirs each comprise a substantially straight wall
portion and a substantially arcuate wall portion in the
cross-section, wherein the first and second reservoirs are defined
within the body with the respective straight wall portions parallel
to and spaced from a plane bisecting the center of the body at a
predetermined distance, and wherein at least a portion of the
respective straight wall portion of the first and second reservoirs
form a common wall.
7. The access port of claim 1, wherein each respective first and
second reservoir has a reservoir wall surface, and wherein a
portion of the reservoir wall surface of each respective first and
second reservoir forms a common wall.
8. The access port of claim 7, wherein at least a portion of the
common wall extends substantially along a longitudinal axis of the
body.
9. The access port of claim 8, wherein at least a portion of the
common wall extends substantially normal to the upper surface of
the body.
10. The access port of claim 7, wherein at least a portion of the
common wall extends substantially parallel to the respective first
and second body conduits.
11. The access port of claim 10, wherein at least a portion of the
first and second body conduits are defined therein a portion of the
common wall.
12. The access port of claim 7, wherein the at least one septum is
substantially cylindrical, having a bottom portion and an opposed
top portion, wherein the bottom portion of the septum defines a
first male protrusion and a spaced second male protrusion, wherein
the first male protrusion is configured to be sealingly seated
within the upper portion of the first reservoir and the second male
protrusion is configured to be sealingly seated within the upper
portion of the second reservoir.
13. The access port of claim 12, wherein the top portion of the
septum defines a third male protrusion and a spaced fourth male
protrusion, wherein at least a portion of the third male protrusion
of the septum is configured to be at least partially received
therein the first opening of the retainer and at least a portion of
the second male protrusion is configured to be at least partially
received therein the second opening of the retainer.
14. The access port of claim 7, wherein the at least one septum
comprises a first septum and a second septum.
15. The access port of claim 14, wherein a bottom portion of the
first septum is configured to be seated within a portion of the
first reservoir, and wherein a bottom portion of the second septum
is configured to be seated within a portion of the second
reservoir.
16. The access port of claim 14, wherein each of the first and
second septum is substantially D-shaped.
17. The access port of claim 1, wherein at least one of the body,
the retainer, and the at least one septum comprises at least one
feature that is structured to identify the access port subsequent
to subcutaneous implantation.
18. The access port of claim 17, wherein the at least one feature
comprises at least one of: a protrusion, a protruding region, a
circumferentially extending protrusion, a recess, a recessed
region, a circumferentially extending recess, at least one suture
aperture, an overhanging rim feature, a lip feature, an undulation,
and adjacent features of different elevation.
19. The access port of claim 17, wherein the at least one feature
comprises a marking thereon the access port that is formed of
material that is visible under application of x-ray or ultrasound
technology.
20. The access port of claim 17, wherein the at least one feature
is configured to identify the access port as a CT port that is
power injectable subsequent to subcutaneous implantation.
21. The access port of claim 1, wherein at least one of the body,
the retainer, and the at least one septum comprises means for
identifying the access port subsequent to subcutaneous
implantation.
22. An implantable vascular access port, comprising: a body
comprising: an upper surface; an opposed lower surface; a side wall
extending therebetween the upper and lower surfaces, the side wall
defining a pair of ports; a first reservoir defined therein a
portion of the upper surface of the body; a second reservoir
defined therein a portion of the upper surface of the body, wherein
each of the first and second reservoirs are substantially D-shaped
in cross-section, and wherein at least a portion of the respective
first and second reservoir are separated by a common wall; a first
body conduit extending between the first reservoir and a first port
of the pair of ports; and a second body conduit extending between
the second reservoir and a second port of the pair of ports; at
least one septum configured to be seated within an upper portion of
at least one of the first or second reservoirs; and a retainer
defining a first retainer opening and a second retainer opening,
wherein the first and second retainer openings are separated by a
common dividing member, wherein the retainer is mountable thereon
the body such that the first retainer opening overlies the first
reservoir and the second retainer opening overlies the second
reservoir, and wherein the at least one septum is sealingly secured
therebetween the retainer and the body.
23. The access port of claim 22, wherein the at least one septum is
substantially cylindrical, having a bottom portion and an opposed
top portion, wherein the bottom portion of the septum defines a
first D-shaped male protrusion and a spaced second D-shaped male
protrusion, wherein the first male protrusion is configured to be
sealingly seated within the upper portion of the first reservoir
and the second male protrusion is configured to be sealingly seated
within the upper portion of the second reservoir.
24. The access port of claim 23, wherein the top portion of the
septum defines a third D-shaped male protrusion and a spaced fourth
D-shaped male protrusion, wherein at least a portion of the third
male protrusion of the septum is configured to be at least
partially received therein the first opening of the retainer and at
least a portion of the second male protrusion is configured to be
at least partially received therein the second opening of the
retainer.
25. The access port of claim 24, wherein the bottom portion of the
septum defines an upper shoulder surface extending about and
between the respective first and second D-shaped male protrusions,
which is configured to sealing seat against portions of the body
when the retainer is connected to the body, and wherein the top
portion of the septum defines a lower shoulder surface extending
about and between the respective third and fourth D-shaped male
protrusions, which is configured to sealing seat against portions
of the retainer when the retainer is connected to the body.
26. The access port of claim 22, further comprising an outlet stem
comprising: a proximal end; an opposing distal end; a first stem
conduit extending therethrough the outlet stem from the proximal
end to the distal end; and a second stem conduit extending
therethrough the outlet stem from the proximal end to the distal
end, wherein the proximal portion of the stem is connected to and
overlies the pair of ports such that the first body conduit is in
fluid communication with the first stem conduit and the second body
conduit is in fluid communication with the second stem conduit.
27. The access port of claim 26, wherein at least a portion of the
common wall extends substantially along a longitudinal axis of the
body.
28. The access port of claim 27, wherein at least a portion of the
common wall extends substantially normal to the upper surface of
the body.
29. The access port of claim 27, wherein at least a portion of the
common wall extends substantially parallel to the respective first
and second body conduits.
30. The access port of claim 29, wherein at least a portion of the
first and second body conduits are defined therein a portion of the
common wall.
31. The access port of claim 22, wherein at least one of the body,
the retainer, and the substantially cylindrical septum comprises
means for identifying the access port subsequent to subcutaneous
implantation.
32. The access port of claim 31, wherein the means for identifying
the access port subsequent to subcutaneous implantation comprises
at least one of the following: a protrusion, a protruding region, a
circumferentially extending protrusion, a recess, a recessed
region, a circumferentially extending recess, at least one suture
aperture, an overhanging rim feature, a lip feature, an undulation,
and adjacent features of different elevation.
33. The access port of claim 31, wherein the means for identifying
the access port subsequent to subcutaneous implantation comprises a
marking thereon the access port that is formed of material that is
visible under application of x-ray or ultrasound technology.
34. The access port of claim 31, wherein the means for identifying
the access port subsequent to subcutaneous implantation is
configured to identify the access port as a CT port that is power
injectable subsequent to subcutaneous implantation.
35. A system for use in apheresis, wherein the system comprises a
vascular access port comprising: a body comprising: an upper
surface; an opposed lower surface; a side wall extending
therebetween the upper and lower surfaces, the side wall defining a
pair of ports; a first reservoir defined therein a portion of the
upper surface of the body; a second reservoir defined therein a
portion of the upper surface of the body; a first body conduit
extending between the first reservoir and a first port of the pair
of ports; and a second body conduit extending between the second
reservoir and a second port of the pair of ports; at least one
septum configured to be seated within an upper portion of at least
one of the first or second reservoirs; a retainer defining a first
retainer opening and a second retainer opening, wherein the first
and second retainer openings are separated by a common dividing
member, wherein the retainer is mountable thereon the body such
that the first retainer opening overlies the first reservoir and
the second retainer opening overlies the second reservoir, and
wherein the at least one septum is sealingly secured therebetween
the retainer and the body; at least one needle; and a catheter in
fluid communication with the pair of ports of the body, wherein the
catheter comprises a catheter shaft, and wherein the catheter
defines at least one lumen extending therethrough in fluid
communication with at least one reservoir.
36. The system of claim 35, wherein the at least one needle is at
least 14 gauge in size.
37. The system of claim 35, wherein the catheter shaft is at least
10 Fr in size.
38. A method of identifying a subcutaneously implanted vascular
access port, comprising: a) providing a subcutaneously implanted
vascular access port comprising: a body comprising: an upper
surface; an opposed lower surface; a side wall extending
therebetween the upper and lower surfaces, the side wall defining a
pair of ports; a first reservoir defined therein a portion of the
upper surface of the body; a second reservoir defined therein a
portion of the upper surface of the body; a first body conduit
extending between the first reservoir and a first port of the pair
of ports; and a second body conduit extending between the second
reservoir and a second port of the pair of ports; at least one
septum configured to be seated within an upper portion of at least
one of the first or second reservoirs; and a retainer defining a
first retainer opening and a second retainer opening, wherein the
first and second retainer openings are separated by a common
dividing member, wherein the retainer is mountable thereon the body
such that the first retainer opening overlies the first reservoir
and the second retainer opening overlies the second reservoir, and
wherein the at least one septum is sealingly secured therebetween
the retainer and the body; and b) perceiving at least one feature
of at least one of the body, the retainer, and the at least one
septum of the subcutaneously implanted vascular access port; and c)
identifying the subcutaneously implanted vascular access port in
response to perceiving the at least one feature of the at least one
of the body, the retainer, and the at least one septum.
39. The method of claim 38, wherein perceiving the at least one
feature comprises employing at least one of palpation, x-ray,
ultrasound, and RFID technology.
40. The method of claim 38, wherein perceiving the at least one
feature comprises perceiving at least one of the following: a
protrusion, a protruding region, a circumferentially extending
protrusion, a recess, a recessed region, a circumferentially
extending recess, at least one suture aperture, an overhanging rim
feature, a lip feature, an undulation, and adjacent features of
different elevation.
41. The method of claim 38, wherein identifying the subcutaneously
implanted vascular access port comprises identifying the
subcutaneously implanted vascular access port as being a CT port
that is power injectable in response to perceiving the at least one
feature.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to Provisional Patent
Application Ser. No. 60/977,736, which was filed on Oct. 5, 2007,
Provisional Patent Application Ser. No. 61/044,752, which was filed
on Apr. 14, 2008, and Provisional Patent Application Ser. No.
61/056,920, filed May 29, 2008, which applications are incorporated
in their entirety in this document by reference.
FIELD OF THE INVENTION
[0002] The invention relates in general to medical devices. More
particularly, the invention relates to a dual reservoir implantable
access port for use in accessing either the vasculature or a
selected treatment site within the body of a patient.
BACKGROUND OF THE INVENTION
[0003] The use of implantable access ports in the art of drug
therapy is well known, in which an access port is implanted beneath
the subcutaneous layers of a patient's skin. The known access ports
are constructed to provide for repeated access to the vascular
system of a patient, or a selected treatment site within the
patient's body. The use of these devices reduces the trauma
otherwise associated with multiple punctures of the skin, or the
inconvenience of an externalized catheter for patient treatment
purposes. For example, implantable access ports are used to
facilitate frequent blood sampling, or to provide for the delivery
of medications, nutritions, blood products, and imaging solutions
into the patient's blood stream, or to a desired treatment site
within the patient. Access to the implanted access port is
typically accomplished by percutaneous needle insertion through the
patient's skin into the access port through a penetrable septum or
other similar structure by using a non-coring hypodermic
needle.
[0004] Implantable access ports can also be used for apheresis, an
extracorporeal procedure in which the blood of a donor or patient
is passed through an apparatus that filters or separates out one or
more components of the blood that contribute to a disease state and
returns the remainder of the blood to the patient's blood
circulation. Invasive apheresis treatments typically are
administered frequently and can be painful as a result of the
multiple venous punctures to the patient's skin. In order to most
effectively perform apheresis procedures, the access ports should
be capable of producing adequate blood flow rates and accommodating
appropriately sized needles and catheters.
[0005] Implantable access ports are supplied as sterile devices,
are generally provided for single patient use only, and can be
available in a variety of port materials, including polysulfone,
acetal plastic and titanium. Available catheter materials can
comprise, without limitation, polyurethane and silicone. Suture
holes are typically formed in the access port as a part of the base
portion thereof and are used to facilitate the anchorage of the
access port to the patient's underlying fascia, for example muscle.
Implantable access ports are available in single, dual, and low
profile models, and are available with attachable, or attached
catheters. Implantable access ports are also currently available as
power injectable ports for use in, for example, computed tomography
("CT") scanning processes.
[0006] Dual model implantable access ports are comprised of two
distinct fluid reservoirs contained within a single casing. These
devices are useful when a health care provider needs to perform
multiple functions that cannot be performed using a typical single
reservoir model access port, for example to withdraw blood and
administer medication via separate reservoirs. In conventional dual
model access ports, each of the fluid reservoirs is circular in
shape. This arrangement, however, leads to an increase in size of
the geometric footprint of the access port because of the space
created between the two circular reservoirs.
[0007] What is needed, therefore, is a dual model implantable
access port that reduces the size of the geometric footprint of the
access port, thereby reducing the size of incision necessary to
implant the device in a patient, reducing patient discomfort and
other potential medical complications. What is also needed is a
dual reservoir implantable access port with a minimal geometric
footprint that produces adequate blood flow rates for the
performance of apheresis procedures, which can reduce trauma to
patients and improve patient outcomes.
SUMMARY OF THE INVENTION
[0008] The present invention is an implantable access device for
allowing repeated access to, and for use in transferring a fluid
transdermally between an external fluid storage or dispensing
device and a site, space, device, or other object, fluid, tissue or
region within the body of a patient, and which access port
overcomes some of the design deficiencies of known access ports and
systems used for apheresis.
[0009] According to one embodiment, an implantable access port
comprises a body comprising at least two reservoirs, at least one
septum configured for enclosing each of the reservoirs, and a
retainer for securing the septum to the body. In a further
embodiment, the access port comprises a body, two D-shaped
reservoirs defined within the body, at least one septum secured to
the body and adapted to sealingly enclose the reservoirs, and two
body conduits defined within the body that are in communication
with the reservoir outlets and extend to, and are in communication
with, a pair of ports defined in the side wall of the body. The
pair of ports are further constructed and arranged to be placed in
sealed fluid communication with an outlet stem.
[0010] According to various embodiments of the present invention,
the D-shaped fluid reservoirs are axially aligned such that the
space between the reservoirs is reduced, thereby reducing the
overall size and geometric footprint of the implantable access port
device. Thus, the size of the incision required to insert the
device into a patient can be reduced.
[0011] In a further aspect, the vascular access port disclosed
herein is used for apheresis and is part of a system or kit that
also includes at least one needle and is connected to a
catheter.
[0012] Additional advantages of the invention will be set forth in
part in the description which follows, and in part will be obvious
from the description, or may be learned by practice of the
invention. The advantages of the invention will be realized and
attained by means of the elements and combinations particularly
pointed out in the appended claims. It is to be understood that
both the foregoing general description and the following detailed
description are exemplary and explanatory only and are not
restrictive of the invention, as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate embodiments of
the invention and together with the description, serve to explain
the principles of the invention.
[0014] FIG. 1A is a perspective view of a body of an implantable
access port having dual D-shaped reservoirs formed therein,
according to one embodiment of the present invention.
[0015] FIG. 1B is a top plan view of the body of FIG. 1A.
[0016] FIG. 1C is a front elevational view of the body of FIG.
1A.
[0017] FIG. 1D is a side elevational view, in cross section, of the
body of FIG. 1A taken along line A-A of FIG. 1B.
[0018] FIG. 2A is a perspective view of a retainer of an
implantable access port having a protrusion that divides the
retainer access opening into two D-shaped sections, according to
one embodiment of the present invention.
[0019] FIG. 2B is a top plan view of the retainer of FIG. 2A.
[0020] FIG. 2C is a side elevational view of the retainer of FIG.
2A.
[0021] FIG. 3A is top view of an outlet stem of an implantable
access port, according to one embodiment of the present
invention.
[0022] FIG. 3B is a side elevational view of the outlet stem of
FIG. 3A.
[0023] FIG. 3C is a top cross-sectional view taken of the outlet
stem of FIG. 3A, taken along line A-A of FIG. 3B.
[0024] FIG. 3D is a front view of the outlet stem of FIG. 3A.
[0025] FIG. 4A is a perspective view of a D-shaped septum of an
implantable access port, according to one embodiment of the present
invention.
[0026] FIG. 4B is a top plan view of the septum of FIG. 4A.
[0027] FIG. 4C is a side elevational view of the septum of FIG.
4A.
[0028] FIG. 5A is a perspective view of a circular septum of an
implantable access port having dual D-shaped raised portions,
according to one embodiment of the present invention.
[0029] FIG. 5B is a top plan view of the septum of FIG. 5A.
[0030] FIG. 5C is a side elevational view of the septum of FIG.
5A.
[0031] FIG. 6A is a perspective view of a locking sleeve of an
implantable access port, according to one embodiment of the present
invention.
[0032] FIG. 6B is a top view of the locking sleeve of FIG. 6A.
[0033] FIG. 6C is a front elevational view of the locking sleeve of
FIG. 6A.
[0034] FIG. 6D is a side cross-sectional view of the locking sleeve
of FIG. 6A taken along line A-A of FIG. 6C.
[0035] FIG. 7A is a side elevational view of an embodiment of an
implantable access port, shown in a disassembled condition,
according to one embodiment of the present invention.
[0036] FIG. 7B is a side elevational view of an embodiment of an
implantable access port, shown in an assembled condition, according
to one embodiment of the present invention.
[0037] FIG. 7C is a perspective view of an embodiment of an
implantable access port, shown in an assembled condition, according
to one embodiment of the present invention.
[0038] FIG. 7D is a front elevational view of an embodiment of an
implantable access port, shown in an assembled condition, according
to one embodiment of the present invention.
[0039] FIG. 7E is a front cross-sectional view, taken along line
A-A of FIG. 7C, of an embodiment of an implantable access port,
shown in an assembled condition, according to one embodiment of the
present invention.
[0040] FIG. 7F is a side cross-sectional view, taken along line B-B
of FIG. 7C, of an embodiment of an implantable access port, shown
in an assembled condition, according to one embodiment of the
present invention.
[0041] FIG. 7G is a top cross-sectional view, taken along line A-A
of FIG. 7D, of an embodiment of an implantable access port, shown
in an assembled condition, according to one embodiment of the
present invention.
[0042] FIG. 8 illustrates a prior art dual reservoir implantable
access port comprising two, side-by-side circular reservoirs.
[0043] FIG. 9 illustrates an additional embodiment of the bottom
surface of the dual reservoir implantable access port with indicia
on the bottom of the port indicating CT injectability of the
port.
[0044] FIG. 10 illustrates a dual reservoir implantable access port
known in the art, used in apheresis, and comprising two
side-by-side circular reservoirs with a needle inserted into each
septum.
[0045] FIG. 11 illustrates one embodiment of the dual reservoir
port of FIGS. 1 through 7G, to be used with apheresis, with a
needle inserted into each septum of the vascular access port.
[0046] FIG. 12 is a schematic illustration of a dual reservoir
implantable access port being used in an apheresis procedure.
[0047] FIG. 13 is a perspective view of an access port having
exemplary identification means marked on a bottom surface
thereof.
[0048] FIG. 14 is a bottom elevational view of a disk for insertion
therein an exemplary access port, having identification means
marked on a bottom surface thereof the disk.
[0049] FIG. 15 is an exploded view of the access port of FIG.
13.
DETAILED DESCRIPTION OF THE INVENTION
[0050] The present invention may be understood more readily by
reference to the following detailed description and the examples
included therein and to the Figures and their previous and
following description. Before the systems, devices, and/or methods
are disclosed and described, it is to be understood that the
systems, devices, and/or methods are not limited to specific
methods as such may, of course, vary. It is also to be understood
that the terminology used herein is for the purpose of describing
particular embodiments only and is not intended to be limiting.
[0051] Ranges may be expressed herein as from "about" one
particular value, and/or to "about" another particular value. When
such a range is expressed, another embodiment includes from the one
particular value and/or to the other particular value. Similarly,
when values are expressed as approximations, by use of the
antecedent "about," it will be understood that the particular value
forms another embodiment. It will be further understood that the
endpoints of each of the ranges are significant both in relation to
the other endpoint, and independently of the other endpoint.
[0052] "Optional" or "optionally" means that the subsequently
described event or circumstance may or may not occur, and that the
description includes instances where said event or circumstance
occurs and instances where it does not. In the present invention,
"D-shaped" can mean semi-circular, partially circular,
semi-elliptical, partially elliptical, kidney-shaped,
crescent-shaped, tear-drop shaped with at least one substantially
straight portion (e.g., semi-heart shaped), or any other shape
comprising a straight portion and an arcuate or curved portion.
[0053] Reference is now made, in detail, to the drawings, in which
like reference numerals indicate like parts or elements throughout
the several views. As illustrated in the Figures, an implantable
access port 100 is illustrated having a body 110, a retainer 120,
an outlet stem 130, a septum 150, a locking sleeve 160 and a gasket
170. It will be appreciated that the implantable access port,
according to various embodiments, can comprise some or all of these
components.
[0054] For example, in one embodiment, an implantable access port
is provided for use in transferring fluid transdermally between an
external fluid storage or dispensing device and a site within a
patient's body. In another embodiment, the access port can be used
for performing apheresis procedures. In these embodiments, the
access port can comprise a body, a retainer, and a septum. The body
can further have an upper surface, a lower surface and a side wall
extending therebetween the upper and lower surfaces. Optionally, at
least portions of the respective upper and lower surfaces of the
body can be substantially planar.
[0055] In one embodiment, the body comprises a first reservoir that
is defined therein a portion of the upper surface of the body. The
first reservoir extends thereinto the body and has a first
reservoir wall. In this aspect, at least a portion of the first
reservoir wall can be smooth surfaced. Likewise, a second reservoir
can be defined therein a second portion of the upper surface of the
body. The second reservoir extends thereinto the body and has a
second reservoir wall. In this aspect, at least a portion of the
second reservoir wall can be smooth surfaced.
[0056] In a further aspect, a pair of ports can be defined therein
the side wall of the body. In yet another aspect, a first body
conduit can be provided that extends between the first reservoir
and a first port of the pair of ports of the body, and is thus in
fluid communication with the first reservoir and the exterior of
the body. A second body conduit can likewise be provided that
extends between the second reservoir and a second port of the pair
of ports of the body, and is thus in fluid communication with the
second reservoir and the exterior of the body.
[0057] As described above, the body 110 of an access port 100,
according to various embodiments of the present invention,
comprises a plurality of reservoirs, which includes at least a
first reservoir and a second reservoir. For example, and as
exemplarily as illustrated in FIGS. 1A and 1B, a body can comprise
first and second reservoirs, 112 and 113. Each reservoir is defined
therein and extends therein the upper surface of the body, and has
a reservoir wall surface and a reservoir base 116, as illustrated
in FIG. 1D. In one aspect, the reservoir base is substantially
perpendicular to at least a portion of the reservoir wall surfaces
of the respective first and second reservoirs. In one exemplary
aspect, the first and second reservoirs can have a substantially
D-shape.
[0058] In a further aspect, a portion of the reservoir wall surface
of each respective first and second reservoir forms a common wall.
In a further aspect, it is contemplated that at least a portion of
the common wall can extend substantially along a longitudinal axis
of the body. In yet another aspect, at least a portion of the
common wall can extend substantially normal to the upper surface of
the body.
[0059] It is also contemplated that at least a portion of the
common wall can extend substantially parallel to the respective
first and second body conduits. Optionally, at least a portion of
the first and second body conduits can be defined therein a portion
of the common wall.
[0060] In one embodiment, the D-shaped reservoirs are defined
within the body such that they are spaced about the longitudinal
axis of the body (such as shown in the top plan view of FIG. 1B).
It is contemplated that each of the dual D-shaped reservoir can be
of a different size or shape, such as, for example, symmetrical,
non-symmetrical, or of different durometers, widths, and heights.
According to various embodiments, by aligning the D-shaped
reservoirs (regardless of whether they are symmetrical, or
similarly sized or shaped) relative to the longitudinal axis of the
body, the total width of the access port can be significantly
reduced (i.e., the distance measured across both reservoirs).
[0061] In this aspect and as one will appreciate, each D-shaped
first and second reservoirs comprise a substantially straight wall
portion and a substantially arcuate wall portion in the
cross-section. In a further aspect, the first and second reservoirs
are defined within the body with the respective straight wall
portions parallel to and spaced from a plane bisecting the
longitudinal axis or center of the body at a predetermined
distance. As one will appreciate, at least a portion of the
respective straight wall portion of the first and second D-shaped
reservoirs form the common wall.
[0062] For example and not intended to be limiting, the width of
the exemplified dual D-shaped reservoir access port can range from
about 1 inch to about 1.3 inches. In a further embodiment, the
width can range from about 1.1 to 1.2 inches, such as approximately
1.15 inches. In a particular embodiment, the width is approximately
1.146 inches. Widths of known access ports generally exceed 1.6
inches. Accordingly, as taught herein, the geometric footprint of
the dual reservoir access port is reduced compared to the geometric
footprint of known dual reservoir access ports, such as that
illustrated in FIG. 8. This design is beneficial during apheresis
because it reduces the trauma to the patient during the apheresis
procedure by having a smaller geometric footprint, and the
reservoir design is beneficial because it allows access of large
needles into the reservoir during apheresis.
[0063] In another embodiment, and as best illustrated in FIG. 1D,
the reservoir side walls of the respective first and second
reservoirs extend therefrom the reservoir base 116 such that there
are no angular corners or junctions formed where the reservoir wall
surface joins the reservoir base. In this fashion, there are no
defined angular corners or junctions that can in turn lead to the
occlusion of blood or other substances in the reservoir as these
fluids are passed into or drawn from out of the access port.
[0064] Referring to FIGS. 1A and 7E, a first and second port of the
pair of ports are defined within the side wall of the body 110 and,
thus, are in fluid communication with respective first and second
reservoirs 112 and 113. In one aspect, the first and second ports
are in fluid communication with the respective first and second
reservoirs via the respective first and second body conduits, 114
and 115, such as shown in FIG. 7G.
[0065] In a particular embodiment, a portion of each body conduit
is defined in a portion of the respective reservoir. In one aspect,
a portion of each body conduit is defined in a portion of reservoir
wall surface proximate a point where the upright portion of the
reservoir wall surface, the curved portion of the reservoir side
surface, and the reservoir base meet. As described above, in one
aspect, the reservoir side surface can be substantially
smooth-surfaced and thus the "corner" at which juncture of the
respective surfaces can be substantially rounded. In this aspect,
it is not contemplated that the juncture be limited to an angular
corner. In this embodiment, a flow path is provided within the
reservoir that cleanly flushes the reservoir as the respective body
conduit extends from a "corner" of the reservoir and thus can
provide improved flushing of the reservoir.
[0066] Referring now to FIGS. 2A-2C and FIG. 7A, in one embodiment
the access port retainer 120 is configured to fixedly mount thereon
portions of the body 110. In a further embodiment, the retainer is
configured to seal the at least one septum therebetween portions of
the retainer and portions of the body. As illustrated in FIGS. 2A
and 2B, a retainer can define at least one retainer opening
extending therethrough the retainer. In a further embodiment, the
retainer can define first and second retainer openings such that
when the retainer is operatively mounted thereon the body, the
first retainer opening substantially overlies the first reservoir,
and the second retainer opening substantially overlies the second
reservoir. In one aspect, the first and second retainer openings
are separated by a common dividing member. In this aspect, it is
contemplated that the first and second openings can be D-shaped
openings 122 and 123 separated by the dividing member 126. In one
aspect, the retainer can be configured such that the dividing
member is formed to substantially overlie the common wall formed by
the first and second reservoirs of the body.
[0067] In one embodiment, an upper surface of the dividing member
can be substantially co-planar with a top surface of the periphery
of the retainer. Optionally, as illustrated in FIG. 2C, at least a
portion of the dividing member 126 can be raised above (i.e.,
protrude outwardly from) a plane defined by the periphery of the
retainer.
[0068] Optionally, the retainer, according to a further embodiment,
can comprise one or more suture holes 124 as illustrated in FIG.
2B. So provided, the access port can be sewn to the fascia of a
patient by passing appropriate sutures through the suture holes to
fasten the access port to the underlying muscle and/or tissues of
the patient.
[0069] As illustrated in FIGS. 1C, 7F and 7G, the access port body
110 is configured to matably receive an outlet stem 130 such that
the outlet stem is placed into fluid communication with the pair of
ports in the exterior side wall of the access port body, and thus
into fluid communication with the respective first and second
reservoirs 112 and 113 through the respective first and second body
conduits 114 and 115.
[0070] FIGS. 3A-3D illustrate an embodiment of the outlet stem 130.
An outlet stem, in one aspect, is configured to matably attach or
mount to a portion of the body 110, such that it overlies the pair
of ports defined therein the body. For example and without
limitation, the outlet stem can comprise a face portion 132 that is
shaped and sized to be received by a recessed portion of the access
port body 110. The outlet stem, in one embodiment, comprises a
first stem conduit and a second stem conduit 134 and 135, such as
illustrated in FIG. 3C, that each extend therethrough the outlet
stem from the proximal end to the opposing distal end of the outlet
stem. A proximal portion of the outlet stem can, in one embodiment,
be threaded, such as shown in FIGS. 3A and 3B. In another aspect,
the opposing distal portion of the outlet stem can comprise two
prongs 136 and 137. It is contemplated that a respective one of the
first and second stem conduits can pass through each of the
respective prongs. For example, a first stem conduit 134 can extend
from the proximal end, through a first prong 136, to the distal end
of the stem. Likewise, a second stem conduit 135 can extend from
the proximal end, through a second prong 137, to the distal end of
the stem.
[0071] In one embodiment, the distal portion of the outlet stem,
such as, for example and without limitation, the outlet stem prongs
136 and 137, is configured to matably attach to a dual lumen
catheter (not shown), such as those known in the art. Thus, in one
aspect, the outlet stem serves as a fluid conduit that is
configured to provide fluid communication between each fluid
reservoir of the access port body and a respective lumen of a dual
lumen catheter.
[0072] The septum, according to various embodiments, can comprise a
penetrable septum of those types well known in the art. An
embodiment of an access port septum 140 is illustrated in FIGS.
4A-4C. In this embodiment, the septum is substantially D-shaped,
such as illustrated in FIG. 4B. The periphery of the D-shaped
septum can be recessed such as to define a shoulder surface 144
extending along the periphery and to define a raised, D-shaped male
protrusion 142, as illustrated in FIG. 4C. When the access port is
in an assembled condition, as described further herein below, a
portion of the retainer surrounding the respective retainer opening
120 is configured to engage the shoulder surface of the septum.
[0073] In another embodiment of the access port septum, the at
least one septum can be substantially cylindrical in shape. The
septum, in one aspect, has a bottom portion and an opposed top
portion. In this embodiment, as illustrated in FIGS. 5A-5C, the
bottom portion of the septum defines a first male protrusion and a
spaced second male protrusion. In this aspect, the first male
protrusion is configured to be sealingly seated within the upper
portion of the first reservoir and the second male protrusion is
configured to be sealingly seated within the upper portion of the
second reservoir.
[0074] In one aspect, the respective first and second male
protrusions can be substantially D-shaped, or otherwise configured
to be received therein the upper portions of the respective first
and second reservoirs. In a further aspect, the bottom portion of
the septum can define an upper shoulder surface 158, 156 extending
about and between the respective first and second D-shaped male
protrusions. The upper shoulder surface is configured to sealingly
seat against portions of the body when the retainer is connected to
the body.
[0075] Similarly, the top portion of the septum defines a third
male protrusion and a spaced fourth male protrusion. In this
aspect, at least a portion of the third male protrusion of the
septum is configured to be at least partially received therein the
first opening of the retainer and at least a portion of the second
male protrusion is configured to be at least partially received
therein the second opening of the retainer.
[0076] In one aspect, the respective third and fourth male
protrusions can be substantially D-shaped, or otherwise configured
to be received therein the respective first and second retainer
openings. In a further aspect, it is also contemplated that the top
portion of the septum can define a lower shoulder surface 158, 156
extending about and between the respective third and fourth
D-shaped male protrusions, which is preferably configured to
sealingly seat against portions of the retainer when the retainer
is connected to the body.
[0077] FIGS. 6A-6D illustrate an exemplary locking sleeve 160 of an
access port. The locking sleeve, in one embodiment, is
substantially frusto-conical in shape. The locking sleeve can
define an aperture extending therethrough the locking sleeve in a
direction substantially parallel to a longitudinal axis of the
locking sleeve. Thus, the locking sleeve, in one embodiment,
comprises an outer surface and an inner surface. According to a
further embodiment, at least a portion of the inner surface can be
threaded, such as illustrated in FIG. 6D. As described further
below, a locking sleeve can be configured to secure select
conventional dual lumen catheters to the outlet stem 130.
[0078] FIG. 7A illustrates an exemplary assemblage of an
implantable access port. As illustrated, a body 110 is provided,
such as described herein with regard to various embodiments. A
septum, such as a dual septum 150, can be positioned above the
body. In one aspect, the respective first and second d-shaped male
protrusions can be positioned to substantially lie above the
respective D-shaped first and second reservoirs of the body.
Optionally, two separate D-shaped septa 140, such as illustrated in
FIGS. 4A-4C can be provided. In this aspect, the respective first
and second d-shaped male protrusions can be positioned therein
upper portions of the respective D-shaped first and second
reservoirs of the body to enclose the minimal amount of space
required to allow a hypodermic needle (not illustrated) to access a
reservoir through the septum 140 or 150, illustrated in FIGS. 4A-4C
or FIGS. 5A-5C, respectively. As described above, the use of two
D-shaped reservoirs and the corresponding alignment of the D-shaped
portions of the septum, or of individual D-shaped septa, can reduce
the geometric footprint of an implantable access port by at least
30%. The illustrated first and second D-shaped reservoirs 112 and
113 allow for the access of a needle that is 14 gauge or larger in
size, and the septum 140 is capable of receiving such a needle. The
ability of the reservoirs and septum to receive a large needle,
such as a 14 gauge needle or larger, is beneficial during apheresis
because it allows for optimal blood flow.
[0079] Although needles of 14 gauge or larger in size are
recognized as being ideally constructed for use in apheresis
procedures, the language of this specification should not be
construed to limit the types of needles that can be used to
practice the invention disclosed by this application. At any point
in this specification where a specific needle size is referenced,
it is contemplated that a needle of any gauge can be used in the
practice of the disclosed invention.
[0080] The outlet stem 130 can be connected with the body 110, such
as by matably attaching the proximal end of the stem with a portion
of the body. FIGS. 7D and 7G illustrate the location of stem
conduits 134 and 135, in relation to body 110, when the stem 130 is
attached to the body. A retainer 120 can then be positioned over
the septum and mounted to the body, thereby securing the septum
between the retainer and the body. As discussed above, the retainer
can be positioned such that the third and fourth D-shaped male
protrusions of the septum substantially lie below a respective
D-shaped retainer opening of the retainer. Thus, a portion of the
dividing member 126 of the retainer can be positioned within a
portion of the lower shoulder surface 156 therebetween the
respective third and fourth D-shaped male protrusions of the
septum. In this embodiment, the retainer 120 is configured to
engage the lower shoulder surface of the septum. Optionally, if two
D-shaped septa are provided, each septum can be positioned to
substantially lie below a respective D-shaped retainer opening.
According to various embodiments, portions of the retainer are
configured to engage the landing portions of the one or more septa,
thereby securing the septum(a) in place between the retainer and
the body.
[0081] A gasket 170 can then be positioned over the pronged, distal
portion of the stem, and a locking sleeve 160 can be attached to
the stem. In one aspect, the threads of the stem can engage the
inner threaded portion of the locking sleeve, as is known in the
art. A dual lumen catheter can be secured to the stem with the
locking sleeve. As described above, when assembled, each of the
D-shaped reservoirs of the body can be in fluid communication with
a respective lumen of a dual lumen catheter.
[0082] According to various embodiments, some or all of the
components of an implantable access port can be sized to
accommodate the patient in whom the access port will be used, as
well as the necessary treatment to be accomplished with the access
port. For instance, an access port for use with an adult can be of
a larger size than one that is intended for use with a child. This
can be especially beneficial for patients undergoing apheresis,
such as young children, who may lack adequate peripheral vein
access.
[0083] In use, a dual reservoir implantable access port can be
assembled such as described above. An incision can be made at the
implantation site of a patient's body, and the implantable access
port can be positioned therein. Because of the reduced geometric
footprint of the D-shaped dual reservoir access port, when compared
to the geometric footprint of known dual reservoir access ports, a
smaller incision can be made at the implantation site of a patient,
reducing patient discomfort and other potential medical
complications. The access port can be secured at the implantation
site with sutures, such as described above. A dual lumen catheter
can be fed from the implantation site to the necessary treatment
site(s) within the patient's body, and the incision can be closed.
In one exemplary aspect, a catheter that has a catheter shaft of at
least 10 Fr can be used with the vascular access port. In other
exemplary aspects a catheter of 12 Fr or 14 Fr can be used. This is
especially beneficial during apheresis because catheters such as
these allow for greater blood flow rates.
[0084] When a physician, or other person needing to utilize the
access port, needs to administer a treatment and/or draw fluids
from the access port, he or she can locate the access port by
locating a feature configured to identify the position of the
access port (such as a protruding, dividing member 126 of the
retainer), as described further herein below. Once the physician
has located the protrusion, he or she can access one or both of the
D-shaped first and second reservoirs by, for example, injecting a
needle through the respective retainer opening, septum, and into
the respective reservoir. The physician can then administer
treatment to the patient by injecting a fluid into the reservoir;
optionally, the physician can draw fluids that have collected in
the reservoir from the patient. FIG. 11 illustrates an optimal
system 171 for apheresis that comprises a vascular access port 100,
as described herein, that allows for maximal flow rates that are
desirable for apheresis at any blood viscosity without undue
hematocrit, the proportion of blood volume that is occupied by red
blood cells. These flow rates are achievable due to the combination
of the dual reservoir access port described herein, large bore
needles of 14 gauge or larger, and at least a 10 Fr to 12 Fr
catheter. In another aspect, a 12 Fr or a 14 Fr catheter can be
used.
[0085] The manner of fabrication, and materials used in the
construction of the implantable access ports 100 of this invention,
are as described in U.S. Pat. Nos. 4,673,394, and 5,951,512, each
of which is assigned to Horizon Medical Products, Inc. of
Manchester, Ga., and each of which is fully incorporated herein by
reference.
[0086] For example, and not meant to be limiting, the penetrable
septa of the preferred embodiments of this invention can be
comprised of a self-resealing polymer, which is preferably an
elastomer, such as silicon rubber or a latex, and which is adapted
to permit access using a hypodermic needle (not illustrated) into
the reservoir formed within the respective access ports. The body
and retainer are preferably comprised of a biocompatible material,
such as electropolished stainless steel, or other surgical grades
of steel, to also include a biocompatible hard material such as
titanium. Additionally, the access port, with the exception of the
septum, can be manufactured of a suitable plastic material intended
for implantation within a human body, and approved for use
therefore. Also, the body of the access port, in association with
the external opening defined in the side wall of the body, for all
embodiments of the inventive access port, are provided with a
catheter mount of known construction, which for example, can
comprise the locking type of catheter mount illustrated in the '394
patent to Fenton et al., the teaching of which has been
incorporated herein by reference.
[0087] Further aspects of the present invention are directed
generally, to methods and devices associated with the access port
having at least one perceivable or identifiable feature for
identifying the access port after the access port is implanted
within a patient. For example, and not meant to be limiting, at
least one or perhaps multiple identifiable feature(s) of an access
port contemplated by the instant disclosure can be correlative to
information (e.g., a manufacturer's model or design) pertaining to
the access port. Thus, an identifiable feature from a particular
model of an access port can be unique in relation to at least one
of the identifiable features of another model access port.
[0088] In varying aspects, it is contemplated that the at least one
identifiable feature of an access port can be further correlative
with any information of interest, such as type of port, catheter
type, manufacturer, date of manufacture, material lots, part
numbers, etc. In a further aspect, it is contemplated that 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 can be accomplished, and information pertaining to
the access port can be obtained.
[0089] As noted above, it is contemplated that the access port of
the present invention can comprise at least one feature of the
access port that is structured to operatively identify the access
port subsequent to subcutaneous implantation. In one exemplary
embodiment, the at least one identifiable feature can be perceived
by palpation (i.e., to examine by touch), by way of other physical
interaction, or by visual observation. In exemplary aspects, that
are not meant to be limiting, the at least one feature of the
access port can comprise at least one of: a protrusion, such as the
protruding dividing member 126 of a retainer, a protruding region,
a circumferentially extending protrusion, a recess, a recessed
region, a circumferentially extending recess, at least one suture
aperture, an overhanging rim feature, a lip feature, an undulation,
and/or adjacent features of different elevation.
[0090] Optionally, at least a portion of the periphery of the
retainer of the access port can include a plurality of protrusions
that can be spaced about the periphery as desired. For example, the
plurality of protrusions can be symmetrically circumferentially
spaced about the periphery. In a varying aspect, the protrusion(s)
can be sized, configured, and positioned for forming the at least
one identifiable feature of an access port. In these various
embodiments, a person of interest can touch or feel the access port
through the skin to perceive at least one identifying feature of
the implanted access port.
[0091] It is also contemplated that the identifiable feature of the
access port, such as the exemplary protrusion(s) can be structured
for facilitating comfort of a patient within which the access port
is implanted. Further, the overall geometry of the access port can
be shaped such that the overall general shape of the access port
can act as the at least one identifiable feature. It is
contemplated that any geometric shape and/or geometric design could
be implemented in the general exterior surface shape of the access
port such that the shape and/or design could function as an
identifiable feature.
[0092] In another embodiment, the at least one identifiable feature
can be perceived via x-ray or ultrasound imaging. For example, the
at least one identifiable feature can comprise a marking on the
access port that is formed of material that is visible under
application of x-ray or ultrasound technology. In an optional
aspect, the at least one identifiable feature can comprise a
marking therein the access port that is formed of material that is
visible under application of x-ray or ultrasound technology. In
this aspect, the "identifiable feature" may not be observable
visually or by palpation but, rather, can be otherwise observable
via conventional imaging technology such as x-ray or
ultrasound.
[0093] For example, in one embodiment, a metalized feature (e.g., a
plate or other metal geometry) can be included by an access port
contemplated by the instant disclosure. As may be appreciated, such
a metal feature can 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 present invention contemplates that a
size, shape, or both size and shape of a metal or metalized feature
of an access port can be configured for enhancing identification of
an access port, i.e., for identifying an implanted access port as a
CT port that is suitable for power injection. In one non-limiting
example, the base of the port can have a scallop-shaped profile for
indicating CT injectability, such as illustrated in FIG. 9.
[0094] In one exemplary aspect of the CT identified access port, a
portion of the access port, such as the bottom side opposite the
septum of the access port, is marked with a "CT" lettering that is
visible under radiological conditions. In one exemplary aspect, the
port can be made of titanium, in which the letters "CT" are etched
into the bottom side of the port, and can act as an identifying
means 243, as illustrated in FIG. 9. As can be appreciated, any
means for identifying the port can be etched into the bottom side
of the port, including one or more alpha-numeric characters, one or
more symbols, or other identifying means. As shown in FIG. 9, the
absence of titanium material in portions of the bottom surface of
the port creates an enhanced contrast under radiological
conditions, under which the letters can be more visible. In one
exemplary aspect, the letters (or other identifying means) can be
etched into the bottom of the port using a machine engraving
process. In one exemplary aspect, the letters can be etched at a
depth of from about 0.010 inches to about 0.020 inches from the
surface of the bottom of the port. In one aspect, the letters can
be etched into the bottom of the port at a depth of approximately
0.015 inches from the surface of the bottom of the port, equal to
approximately half the thickness of the wall of the port, or
approximately 0.030 inches.
[0095] In another exemplary aspect, and not meant to be limiting,
the desired letters could be formed from platinum wire, such as
0.010'' thick platinum wire, which can be adhered to the bottom
side of the access port with an adhesive, such as a silicone
adhesive. Alternatively, the letters can be made from a tungsten
filled room temperature vulcanizing (RTV) silicone rubber that are
cast and then adhered to the back of the port with an adhesive,
such as a silicone adhesive. In another exemplary example, the
bottom side of the port could be engraved to form the "CT"
lettering and then the engraving could be filled with a tungsten
filled RTV silicone. One skilled in the art will appreciate that
the RTV silicone rubber has long been used in the medical device
industry both as an adhesive and as a base compound.
[0096] According to yet another aspect, such as shown in FIGS. 13
through 15, identifying means 343 (such as the letters "CT") can be
carved out of the bottom surface of the port. In one exemplary
aspect, the letters "CT" may be raised letters in relation to the
bottom surface of the port. In one exemplary aspect, the "CT"
letters may be etched out of the bottom of the surface using a
process similar to the machine engraving process, as described
above. In one exemplary aspect, the bottom surface of the port can
have no "CT" letters carved from the bottom surface. In one aspect,
the "CT" letters are positioned therein the center of a first
circular recessed portion defined therein the bottom surface of the
port. A second recessed portion circumferentially surrounds the
first recessed portion. The first recessed portion is defined
therein the bottom surface of the port surface at a greater recess
depth, compared to the second recessed portion that
circumferentially surrounds the first recessed portion. In one
aspect, the first recessed portion is approximately 0.031 inches
from the bottom surface of the port, while the second recessed
portion may be approximately 0.021 inches from the bottom surface
of the port. In one aspect, the diameter of the first recessed
portion is approximately 0.450 inches. In another aspect, the
diameter of the second recessed portion is approximately 0.513
inches. In one aspect, the overall diameter of the bottom of the
port may be approximately 0.825 inches. The above referenced
dimensions for the respective first and second recessed portions
are merely exemplary and are not meant to be limiting.
[0097] In one aspect, as illustrated in FIGS. 13 and 14, a disk 345
is etched through using a machine engraving process, such that an
absence of a portion of the disk material is created, thereby
forming the letters "CT". As illustrated in FIG. 15, in one aspect,
the disk 345 is then inserted therein the first recessed portion of
the port and adhered thereto. In one exemplary aspect, in the
assembled configuration, the outer surface of the disk 345 may lie
flush with the raised "CT" letters from the first recessed portion,
if the "CT" letters are raised in relation to the bottom surface of
the port. In one aspect, the disk 345 may be composed of titanium.
In another aspect, the disk 345 may be composed of any suitable
biocompatible material. As can be appreciated, any means for
identifying the port can be etched into or carved from the bottom
side of the port, including one or more alpha-numeric characters,
one or more symbols, or other identifying means, as described
above. In one aspect, the outer diameter of the disk 345 is
approximately 0.440 inches. In one aspect, the width of the "CT"
letters may be approximately 0.440 inches. In one aspect, the width
of the "CT" letters may be approximately 0.346 inches, and the
height of the "CT" letters may be approximately 0.237 inches. In
one aspect, the thickness of the disk 345 is approximately 0.010
inches. The above referenced dimensions for the width of the
letters are merely exemplary and are not meant to be limiting.
[0098] In one aspect, as illustrated in FIG. 15, a plastic cap 367
is then inserted on top of the disk 345, such that the outer
surface of the plastic cap becomes flush with the bottom surface of
the port. In one aspect, the plastic cap 367 has a first portion
which is configured to fit into the first recessed portion of the
bottom surface of the port, and a second portion which is
configured to fit into the second recessed portion of the bottom
surface of the port. In one aspect, the plastic cap 367 can have an
outer diameter of approximately 0.510 inches and an inner diameter
of approximately 0.489 inches. In one aspect, the plastic cap 367
may have a depth of approximately 0.035 inches. Of course, the
above referenced dimensions for the plastic cap are merely
exemplary and are not meant to be limiting.
[0099] In the exemplary examples described above, tungsten was
representatively selected as it is readily available and has been
used in many medical applications. Further, if the port is made of
titanium, selecting tungsten allows the lettering to be more
visible under radiology conditions as tungsten is denser than the
titanium. However, one would appreciate that it is contemplated
that other biocompatible dense metals could comprise at least a
portion of a metalized letter.
[0100] In one exemplary aspect, the tungsten that is mixed in the
silicone rubber RTV can be about 25-micron particle size. One
skilled in the art will appreciate that, before vulcanization
(cure), RTV is a relatively soft paste with the consistency similar
to yoghurt. The tungsten can be mixed at relative high
concentrations by weight between about 100 to 500 percent by
weight, and preferably between about 150 to 400 percent by
weight.
[0101] In another example, the identifiable feature of the access
port can be configured for detection via ultrasound interaction. In
one exemplary aspect, such an identifiable feature can comprise an
exterior topographical feature. In another aspect, such an
identifiable feature can comprise a composite structure including
two or more materials that form an interface surface that can be
identified by ultrasound imaging. In yet a further embodiment, the
at least one identifiable feature can be perceived through
magnetic, light, or radio energy interaction or communication with
the access port. In this aspect, it is contemplated that the at
least one identifiable feature comprises a passive RFID tag that is
configured to operate without a separate external power source and
to obtain operating power from a reader located external to the
subject. Exemplary passive RFID tags are typically programmed with
a unique set of data (usually 32 to 128 bits) that cannot be
modified. Read-only tags can operate as an identifier comparable to
linear barcodes that can contain selected product-specific
information. In an alternative aspect, the at least one
identifiable feature of an access port can be correlative with the
access port being power injectable or for indicating that the port
and/or system are capable of being used for apheresis. In this
aspect, it is contemplated that the at least one identifiable
feature of the access port can be configured to identify the access
port as being power injectable subsequent to subcutaneous
implantation.
[0102] In yet another aspect, the at least one identifiable feature
of the access port can be configured to identify the access port as
being compatible for use with apheresis or pheresis-style
procedures. The procedure of implanting the port involves making an
incision in the chest and then forming a pocket distally to the
incision for placement of the port body. An incision can be made in
the neck of a patient at the point of incision into the internal
jugular (IJ) vein where the catheter is to be introduced. A tunnel
can then made under the skin using a tunneling device from the
incision into the chest to the incision in the neck. The catheter
can then be advanced under the skin through this formed tunnel and
into an incision made in the IJ. The catheter can then be advanced
down the IJ and into the right atrium. Because the port has a
detached catheter, the proximal end of the catheter can then be cut
and connected to the port body, as described in the typical
manufacturer's instructions.
[0103] After the port is implanted under the patient's skin,
apheresis can be conducted using the system 171 disclosed in FIG.
11. The system disclosed in FIG. 11 comprises the dual reservoir
access port 100 disclosed herein and illustrated in FIGS. 1-7G. As
also illustrated in FIG. 11, the port 100 comprises septa 152, 154,
housing 11 with dividing member 126, locking sleeve 160, and at
least one needle 143 that is a 14 gauge or larger size needle. In
one exemplary aspect, the needle 143 can be 14 gauge to 22 gauge in
size. In one exemplary aspect, the needle can be 18 gauge to 22
gauge in needle size and can be part of a safety infusion set 138,
such as that illustrated in FIG. 11.
[0104] The system 171 described herein also comprises at least one
short bevel Huber point minimally invasive needle 143 that is
joined to the infusion set 138. The Infusion sets 138 and needles
143 that are used with system 171 described herein are designed to
support the minimum flow rate requirements for apheresis. These
infusion sets 138 and needles 143 provide for optimal flow rate
generation. The system 171 can be used with a dual lumen double-D
catheter with a 12 Fr staggered tip. While such catheters are well
known in the art, using the dual reservoir access port described
herein, in combination with the needles and catheters also
described herein, helps to generate appropriate flow rates while
minimizing pressure and hemolysis. In an alternative aspect, the
vascular access port 100 described herein can also be used with a
triple lumen catheter.
[0105] In one exemplary aspect, the infusion set that is used with
the vascular access port 100 described herein can be a
LifeGuard.RTM. safety infusion set (U.S. Pat. No. 6,676,633,
incorporated herein by reference). The system 171 also comprises a
dual or triple lumen catheter with at least a 10 French (Fr)
catheter shaft 117 (a partial portion of which is shown in FIG.
11). In one exemplary aspect the catheter shaft 117 that is used
with the vascular access port is from 10 Fr to 14 Fr. In another
exemplary aspect, the catheter shaft 117 that is used with the
system 171 is between approximately 12 Fr to 14 Fr.
[0106] The port 100 described herein is configured for use with
adults, as well as pediatric patients in many cases. The size of
the vascular access port 100 described herein is constrained to
minimize invasiveness of the device. The reservoir and outlet of
the port 100 are designed such that pressure constraints are
minimized in order to provide for optimal flow rates.
[0107] To perform any apheresis procedures using the port 100
disclosed herein, the port 100 is accessed with a 14 gauge or
larger needle, as illustrated in FIG. 11. After the dual reservoir
port 100 is accessed using a 14 gauge or larger non-coring needle,
the patient can then be connected to an apheresis machine. During
the apheresis procedure, as illustrated in the flow chart
illustrated in FIG. 12, blood is aspirated through one aspiration
lumen of a vascular access catheter. Although the apheresis process
is illustrated herein using a conventional dual reservoir port,
such as that illustrated in FIG. 10, the apheresis process can be
used with any dual reservoir vascular access port, such as the dual
reservoir access port 100 disclosed herein.
[0108] The aspiration is provided by negative pressure from a
pheresis machine acting on the needle of the system 171. The
aspirated blood then goes to the pheresis machine. During the
pheresis procedure, the pheresis machine filters out impurities,
including stem cells, red or white blood cells, or T cells, for
example. The type of cells sought determines the type of pheresis
that will be performed--for example, plasmapheresis,
plateletpheresis, photopheresis, erythropheresis, and
erythrocytapheresis (RCX). The remaining filtered blood returns to
the patient through the infusion lumen of the catheter. Blood is
then infused through the needle, back into the port, and through a
cannula to the patient. After apheresis, the ports are then flushed
with ten milliliters of normal saline and heparin. This also helps
prevent clotting within the catheter. Using the vascular access
port system 171 described herein in pediatric patients has been
successful in achieving blood flow rates of between 30 and 45
milliliters/minute and maximum pressures below 125-150 for draw and
50-100 for return. The system 171 provided herein allows for
optimal flow rates for apheresis. The flow rates allow for
decreased Hgb S (abnormal hemoglobin) levels and decreased iron
load. This system 171 allows the safe performance of apheresis on
children and adults who cannot benefit from simple transfusions and
have poor peripheral access, and also allows less time spent in the
outpatient unit.
[0109] Although several embodiments of the invention have been
disclosed in the foregoing specification, it is understood by those
skilled in the art that many modifications and other embodiments
will come to mind to which the invention pertains, having the
benefit of the teaching presented in the foregoing description and
associated drawings. It is thus understood that the invention is
not limited to the specific embodiments disclosed hereinabove, and
that many modifications and other embodiments are intended to be
included within the scope of the invention. Moreover, although
specific terms are employed herein, they are used only in a generic
and descriptive sense, and are not intended to be limiting.
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