U.S. patent application number 15/212765 was filed with the patent office on 2016-11-10 for implantable dual reservoir access port.
The applicant listed for this patent is Medical Components, Inc.. Invention is credited to Raymond Bizup, Cristian M. Ciuciu, Christopher Linden.
Application Number | 20160325084 15/212765 |
Document ID | / |
Family ID | 44816398 |
Filed Date | 2016-11-10 |
United States Patent
Application |
20160325084 |
Kind Code |
A1 |
Linden; Christopher ; et
al. |
November 10, 2016 |
Implantable Dual Reservoir Access Port
Abstract
A dual reservoir access port includes a base having proximal and
distal fluid reservoirs. The fluid reservoirs each comprise a
bottom and a side wall. A dual prong outlet stem projects from a
distal end of the base and comprises a first prong and a second
prong. A first fluid channel extends through the first prong to the
distal reservoir, and a second fluid channel extends through the
second prong to the proximal fluid reservoir. A puncture shield is
disposed between at least a portion of the second fluid channel and
the bottom of the distal fluid reservoir. A needle-penetrable
septum is disposed atop of each of the fluid reservoirs. A cap is
placed over and around the port base compressing and sealing the
septa against the base. A locking collar may be placed over a dual
lumen catheter to lock the catheter to the dual prong outlet
stem.
Inventors: |
Linden; Christopher;
(Allentown, PA) ; Bizup; Raymond; (Feasterville,
PA) ; Ciuciu; Cristian M.; (Huntingdon Valley,
PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medical Components, Inc. |
Harleysville |
PA |
US |
|
|
Family ID: |
44816398 |
Appl. No.: |
15/212765 |
Filed: |
July 18, 2016 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
13092892 |
Apr 22, 2011 |
|
|
|
15212765 |
|
|
|
|
61327249 |
Apr 23, 2010 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2039/0072 20130101;
A61M 2205/60 20130101; A61M 2039/0036 20130101; A61M 2039/0081
20130101; A61M 39/0208 20130101; A61M 39/02 20130101; A61M
2039/0226 20130101; A61M 2207/00 20130101; A61M 2039/0211 20130101;
A61M 39/10 20130101; A61M 5/007 20130101; A61M 2039/0054 20130101;
A61M 39/1011 20130101; A61M 2205/582 20130101; A61M 2039/0223
20130101 |
International
Class: |
A61M 39/02 20060101
A61M039/02; A61M 5/00 20060101 A61M005/00; A61M 39/10 20060101
A61M039/10 |
Claims
1-25. (canceled)
26. A septum, comprising: a needle penetrable body having a ring of
material disposed around a circumference of the needle penetrable
body, the ring of material comprising: an upper surface having an
upper sealing ring; a lower surface having a bottom sealing ring;
and, a lateral sealing ring disposed about a circumference of the
ring of material
27. The septum recited in claim 25, wherein radial compression
around the circumference of the needle penetrable body facilitates
self-sealing of the septum.
28. The septum recited in claim 25, wherein the upper sealing ring
has a rounded edge and the lower sealing ring has a rounded
edge.
29. The septum recited in claim 25, wherein the lateral sealing
ring has a rectangular cross section.
30. The septum recited in claim 25, wherein the lateral sealing
ring is a thin strip of material.
31. The septum recited in claim 25, wherein the upper surface is
flat and the lower surface is flat.
32. A septum adapted for use with an access port, comprising: a
needle penetrable body comprising: an upper dome; an upper
compression zone; a flange, wherein the flange further comprises a
flange upper surface having an upper sealing ring, a flange lower
surface having a bottom sealing ring, and a lateral sealing ring
disposed about a circumference of the flange; and, a lower plug;
and, wherein the lower plug extends into a portion of a fluid
reservoir of the access port when the septum is placed into the
access port.
33. The septum recited in claim 32, wherein the lower plug has an
outer diameter slightly larger than an inner diameter of the fluid
reservoir of the access port.
34. The septum recited in claim 32, wherein the upper dome is
textured to provide tactile feedback.
35. An access port, comprising: a base having at least one fluid
reservoir; a cap placed on top of the base, the cap having an
opening for each fluid reservoir; a septum comprising: an upper
dome; an upper compression zone; a flange, comprising: a flange
upper surface having an upper sealing ring, a flange lower surface
having a bottom sealing ring, and a lateral sealing ring disposed
about a circumference of the flange; wherein the septum is placed
within a portion of the at least one fluid reservoir so that a
bottom of the flange is placed on an upper surface of the base;
and, a lower plug to extend into a portion of the at least one
fluid reservoir; and, wherein the cap is placed over the septum to
compress the septum against the base.
36. The septum recited in claim 35, wherein the upper sealing ring
and the lateral sealing ring make contact with the cap and deform
to form fluid tight seals.
37. The septum recited in claim 35, wherein the bottom sealing ring
makes contact with a top surface of the base and deforms to make a
fluid tight seal.
38. The septum recited in claim 35, wherein the lower plug radially
compresses against sidewalls the at least one reservoir.
39. The septum recited in claim 35, wherein the upper dome is
textured to provide tactile feedback.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent
Application No. 61/327,249, entitled "Implantable Dual Reservoir
Access Port" and filed Apr. 23, 2010, the contents of which
application are incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to implantable access ports
for the infusion of fluids into a patient and/or withdrawal of
fluids from the patient and, more specifically, to dual reservoir
vascular access ports.
BACKGROUND OF THE INVENTION
[0003] Implantable vascular access ports are used extensively in
the medical field to facilitate the performance of recurrent
therapeutic tasks. A typical access port comprises a
needle-impenetrable housing having a fluid reservoir that is sealed
by a needle penetrable septum. The access port also includes an
outlet stem which projects from the housing and provides a fluid
passageway that communicates with the fluid reservoir. The outlet
stem is used to couple the housing to a catheter. Specifically, the
vascular access port is attached to the proximal end of the
catheter. The distal end of the catheter is placed into a vessel.
The access port is generally implanted subcutaneously at a location
that is easily accessible.
[0004] Once the vascular access system is implanted, a non-coring
needle, e.g., a Huber needle, attached to a feed line may be used
to access the implanted vascular access port, by penetrating the
septum, to deliver a desired medication. Alternatively, bodily
fluids can be withdrawn from the location where the distal end of
the catheter is placed.
[0005] Many conventional access ports in use contain a single fluid
reservoir through which medication can be delivered to a patient.
Such structures can, however, be severely limiting to medical
practitioners. For example, it is often desirable to deliver
medications that are incompatible when mixed together in a single
fluid reservoir prior to infusion into the body of the patient.
Alternatively, it may be desirable to use one lumen to deliver
medication to a patient and use a second lumen to withdraw blood
samples for testing. In fact, some medical institutions have
policies that require that one lumen of an implantable port is
dedicated for infusion and the other is dedicated solely for the
withdrawal of blood samples. Such plural functions cannot be
performed through the use of a single reservoir access port.
[0006] Conventional dual reservoir access ports have been
developed. A conventional dual reservoir access port typically
comprises a port base having a pair of separate reservoirs formed
therein: a medial fluid reservoir and a lateral fluid reservoir.
Each of the fluid reservoirs has a corresponding access opening
that is sealed by an individual septum. The individual septa are
secured in place by a cap that engages the port base. In some other
designs, a single septum (e.g., compound septum) can be used to
seal both reservoirs.
[0007] An outlet stem housing a pair of fluid passageways projects
from the exterior of the port base, which outlet stem may be
between the pair of fluid reservoirs, or at the distal end of the
access port and in-line with the two fluid reservoirs. When the
outlet stem is placed between the fluid reservoirs, the fluid
reservoirs are arranged side-by-side, and the outlet stem projects
from a longitudinal side of the housing. This placement of the
outlet stem causes the fluid reservoirs to be spaced relatively far
apart, increasing the overall size of the access port.
[0008] During the implantation procedure for a conventional
implantable access port having a single reservoir, a subcutaneous
pocket is first created to receive and house the access port. This
is done by making an incision in the skin of the patient at the
intended implantation site for the access port. The access port is
then inserted beneath the skin through the incision. The outlet
stem of the access port is usually received within the pocket last,
after the proximal end of the access port is placed in the
subcutaneous pocket. A catheter is then coupled to the outlet stem
of the access port.
[0009] To implant a conventional side-by-side access port, an
incision must be made at the implantation site that is at least as
long as the access port. Only in this way can the access port be
received through the incision followed by the outlet stem. The
longer the incision, the longer the healing process before the
access port can be freely utilized and the greater the potential
for infection or other complications.
SUMMARY OF THE INVENTION
[0010] In accordance with an aspect of the present invention there
is provided an access port base comprising a proximal end, a distal
end, a proximal fluid reservoir, a distal fluid reservoir, a dual
prong outlet stem projecting from the distal end of the access port
base, a first fluid channel, a second fluid channel, and a puncture
shield. The proximal fluid reservoir comprises a bottom wall at a
bottom of the proximal fluid reservoir and is disposed at the
proximal end of the access port base. The distal fluid reservoir
comprises a bottom wall at a bottom of the distal fluid reservoir
and is disposed at the distal end of the access port base. The dual
prong outlet stem comprises a first prong comprising a first distal
tip, and a second prong comprising a second distal tip. The first
fluid channel extends through the first prong and a first portion
of the access port base and provides a first fluid pathway from the
first distal tip of the first prong to the distal fluid reservoir.
The second fluid channel extends through the second prong and a
second portion of the access port base and provides a second fluid
pathway from the second distal tip of the second prong to the
proximal fluid reservoir. A first portion of the second fluid
channel is disposed in the bottom wall of the distal fluid
reservoir beneath the distal fluid reservoir. At least a portion of
the puncture shield is disposed in the bottom wall of the distal
fluid reservoir between the distal fluid reservoir and the second
fluid pathway.
[0011] In accordance with another aspect of the present invention
there is provided an access port comprising a base, a first
needle-penetrable septum disposed atop a distal fluid reservoir of
the base, a second needle-penetrable septum disposed atop a
proximal fluid reservoir of the base, and a cap securing the first
and second needle-penetrable septa to the base. The base comprises
a proximal end, a distal end, the proximal fluid reservoir, the
distal fluid reservoir, a dual prong outlet stem, a first fluid
channel, a second fluid channel, and a puncture shield. The
proximal fluid reservoir comprises a bottom wall at a bottom of the
proximal fluid reservoir and is disposed at the proximal end of the
base. The distal fluid reservoir comprises a bottom wall at a
bottom of the distal fluid reservoir and is disposed at the distal
end of the base. The dual prong outlet stem projects from the
distal end of the base and comprises a first prong comprising a
first distal tip, and a second prong comprising a second distal
tip. The first fluid channel extends through the first prong and a
first portion of the base and provides a first fluid pathway from
the first distal tip of the first prong to the distal fluid
reservoir. The second fluid channel extends through the second
prong and a second portion of the base and provides a second fluid
pathway from the second distal tip of the second prong to the
proximal fluid reservoir. A first portion of the second fluid
channel is disposed in the bottom wall of the distal fluid
reservoir beneath the distal fluid reservoir. At least a portion of
the puncture shield is disposed in the bottom wall of the distal
fluid reservoir between the distal fluid reservoir and the second
fluid pathway. The cap secures the first and second
needle-penetrable septa to the base to form a fluid seal between
the first septum and the distal fluid reservoir and between the
second septum and the proximal fluid reservoir. The cap comprises a
distal opening corresponding to the first needle-penetrable septum
and the distal fluid reservoir, a proximal opening corresponding to
the second needle-penetrable septum and the proximal fluid
reservoir, and a lower skirt portion.
[0012] In accordance with yet another aspect of the present
invention there is provided an access port comprising a base, a
first needle-penetrable septum disposed atop a distal fluid
reservoir of the base, a second needle-penetrable septum disposed
atop a proximal fluid reservoir of the base, and a cap securing the
first and second needle-penetrable septa to the base. The base
comprises a proximal end, a distal end, the proximal fluid
reservoir, the distal fluid reservoir, a dual prong outlet stem, a
first fluid channel, a second fluid channel, and means for
preventing puncture of the second fluid channel. The proximal fluid
reservoir comprises a bottom wall at a bottom of the proximal fluid
reservoir and is disposed at the proximal end of the base. The
distal fluid reservoir comprises a bottom wall at a bottom of the
distal fluid reservoir and is disposed at the distal end of the
base. The dual prong outlet stem projects from the distal end of
the base and comprises a first prong comprising a first distal tip,
and a second prong comprising a second distal tip. The first fluid
channel extends through the first prong and a first portion of the
base and provides a first fluid pathway from the first distal tip
of the first prong to the distal fluid reservoir. The second fluid
channel extends through the second prong and a second portion of
the base and provides a second fluid pathway from the second distal
tip of the second prong to the proximal fluid reservoir. A first
portion of the second fluid channel is disposed in the bottom wall
of the distal fluid reservoir beneath the distal fluid reservoir.
The cap secures the first and second needle-penetrable septa to the
base to form a fluid seal between the first septum and the distal
fluid reservoir and between the second septum and the proximal
fluid reservoir. The cap comprises a distal opening corresponding
to the first needle-penetrable septum and the distal fluid
reservoir, a proximal opening corresponding to the second
needle-penetrable septum and the proximal fluid reservoir, and a
lower skirt portion.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] For the purpose of illustration, there are shown in the
drawings certain embodiments of the present invention. In the
drawings, like numerals indicate like elements throughout. It
should be understood, however, that the invention is not limited to
the precise arrangements, dimensions, and instruments shown. In the
drawings:
[0014] FIG. 1 is an exploded view of an exemplary embodiment of a
dual reservoir access port assembly comprising a dual reservoir
access port, a dual lumen catheter, and a locking collar, in
accordance with an exemplary embodiment of the present
invention;
[0015] FIG. 2 is a perspective view of the embodiment of the dual
reservoir access port of FIG. 1 in which the dual reservoir access
port is assembled and attached to the dual lumen catheter via the
locking collar, in accordance with an exemplary embodiment of the
present invention;
[0016] FIG. 3 is a cross-sectional view of the embodiment of the
dual reservoir access port of FIG. 1 taken along a section line A-A
illustrated in FIG. 2, in accordance with an exemplary embodiment
of the present invention;
[0017] FIG. 4A is a cross-sectional view of the embodiment of the
dual reservoir access port of FIG. 1 taken along a section line C-C
illustrated in FIG. 3, in accordance with an exemplary embodiment
of the present invention;
[0018] FIG. 4B is a cross-sectional view of the embodiment of the
dual reservoir access port of FIG. 1 taken along a section line D-D
illustrated in FIG. 3, in accordance with an exemplary embodiment
of the present invention;
[0019] FIGS. 4C-4G illustrate exemplary cross-sectional views of
further embodiments of the dual reservoir access port of FIG. 1
taken along the section line C-C illustrated in FIG. 3, in
accordance with an exemplary embodiment of the present
invention;
[0020] FIG. 5A is a cross-sectional view of the embodiment of the
dual reservoir access port of FIG. 1 taken along a section line E-E
illustrated in FIG. 3, in accordance with an exemplary embodiment
of the present invention;
[0021] FIG. 5B is a cross-sectional view of the embodiment of the
dual reservoir access port of FIG. 5A, additionally showing a
puncture shield and a fluid pathway in dashed lines, in accordance
with an exemplary embodiment of the present invention;
[0022] FIG. 5C is a cross-sectional view of the embodiment of the
dual reservoir access port of FIG. 1 taken along a section line F-F
illustrated in FIG. 3, in accordance with an exemplary embodiment
of the present invention;
[0023] FIG. 6 is an elevation view of a dual prong outlet stem of
the embodiment of the dual reservoir access port of FIG. 1, in
accordance with an exemplary embodiment of the present
invention;
[0024] FIG. 7A is another elevation view of the dual prong outlet
stem of the dual reservoir access port of FIG. 1 from a line G-G
shown in FIG. 6, in accordance with an exemplary embodiment of the
present invention;
[0025] FIG. 7B is a cross-sectional view of the dual prong outlet
stem of FIG. 6 taken along a section line H-H, in accordance with
an exemplary embodiment of the present invention;
[0026] FIG. 7C is a cross-sectional view of the dual prong outlet
stem of FIG. 6 taken along a section line I-I illustrated in FIG.
7A, in accordance with an exemplary embodiment of the present
invention;
[0027] FIG. 8 is a cross-sectional view of the dual lumen catheter
of FIG. 1 taken along a section line B-B illustrated in FIG. 2, in
accordance with an exemplary embodiment of the present
invention;
[0028] FIG. 9A is a cross-sectional side view of the dual lumen
catheter and locking collar in preparation to be connected to the
dual prong outlet stem of the dual reservoir access port of FIG. 1,
in accordance with an exemplary embodiment of the present
invention;
[0029] FIG. 9B is a cross-sectional side view of the catheter and
locking collar attached to the dual prong outlet stem of the dual
reservoir access port of FIG. 1, in accordance with an exemplary
embodiment of the present invention;
[0030] FIG. 10A is a cut away view of one embodiment of a septum
used with the dual reservoir access port of FIG. 1, in accordance
with an exemplary embodiment of the present invention;
[0031] FIG. 10B is an enlarged cross-sectional view of an assembled
cap, septum, and base portion of the dual reservoir access port of
FIG. 1 indicated by portion J in FIG. 4A, in accordance with an
exemplary embodiment of the present invention;
[0032] FIG. 11A illustrates an exemplary perspective view of a
further embodiment of the puncture shield of FIG. 5B, in accordance
with an exemplary embodiment of the present invention;
[0033] FIG. 11B illustrates an exemplary cross-sectional view of a
further embodiment of the dual reservoir access port of FIG. 1,
taken along a section line similar to A-A illustrated in FIG. 2,
the cross-sectional view showing the puncture shield of FIG. 11A
disposed within the dual reservoir access port, in accordance with
an exemplary embodiment of the present invention;
[0034] FIG. 12A illustrates an exemplary elevation view of a
further exemplary embodiment of a dual prong outlet stem, in
accordance with an exemplary embodiment of the present
invention;
[0035] FIG. 12B illustrates an exemplary front, planar view of the
exemplary dual prong outlet stem of FIG. 12A from a section line
K-K illustrated in FIG. 12A, in accordance with an exemplary
embodiment of the present invention; and
[0036] FIG. 12C illustrates an exemplary cross-sectional view of
the exemplary dual prong outlet stem of FIG. 12A taken along a
section line L-L illustrated in FIG. 12B, in accordance with an
exemplary embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0037] The words "proximal" and "distal" refer to directions away
from and closer to, respectively, a physician implanting the access
port assembly. Specifically to this invention, the distal end of
the exemplary dual reservoir access port refers to the end of the
access port that connects to a catheter, and the proximal end of
the catheter refers to the end of the catheter that connects to the
access port assembly.
[0038] A dual reservoir access port (also referred to herein as a
"dual reservoir port," "access port," or "implantable port") with
an outlet stem arranged in-line with its two fluid reservoirs has a
distinct advantage in that the incision required for implantation
is only as wide as the width of the access port, and not the length
of the access port. In addition, the in-line port design also
provides improved cosmetics and aesthetics.
[0039] Compared to a conventional side-by-side dual reservoir
access port, the in-line configuration of the dual reservoirs leads
to difficulties in arranging internal fluid passageways.
Particularly, because the distal reservoir in an in-line dual
reservoir access port is located between the proximal reservoir and
the outlet stem, internal fluid passageways must be carefully
designed to connect the proximal reservoir to the outlet stem.
[0040] A conventional in-line dual reservoir access port generally
employs an internal fluid passageway that goes around the distal
reservoir. Such fluid passageway around the distal reservoir is
usually small and tortuous, which poses difficulties for certain
medical procedures.
[0041] Illustrated in FIG. 1 is an exploded view of the elements of
an exemplary embodiment of a dual reservoir access port assembly,
in accordance with an exemplary embodiment of the present
invention. The dual reservoir access port assembly comprises a dual
reservoir port 100, a dual prong outlet stem 200, a locking collar
300, and a dual lumen catheter 400. The dual reservoir port 100
further comprises a cap 110, two individual needle penetrable septa
130, and a port base 150.
[0042] The port base 150 comprises a distal fluid reservoir 151
located at a distal end 160A of the port base 150 and a proximal
fluid reservoir 157 located at a proximal end 160B of the port base
150. The distal reservoir 151 and the proximal reservoir 157 are
generally of cylindrical shape, each having a generally flat bottom
wall 153 159, respectively, and a sidewall 152 158, respectively.
Alternatively, the reservoirs may be of any other shape, such as
generally D-shaped, C-shaped, stadium shaped, oval, triangular,
rectangular, or trapezoidal. Additionally, the distal and proximal
reservoirs 151 157 may be of different shapes. In the embodiment
illustrated in FIG. 1, the distal reservoir 151, the proximal
reservoir 157, and the dual prong outlet stem 200 are arranged
in-line with each other. The distal reservoir 151 and the proximal
reservoir 157 are separated by a dividing wall 155. Preferably, the
length of the dividing wall 155 is narrower than the maximum width
of the distal reservoir 151 and the proximal reservoir 157, thereby
creating a narrowed midsection 163 in the port base 150.
[0043] The needle penetrable septa 130 are placed atop each of the
distal reservoir 151 and the proximal reservoir 157. In the
particular embodiment shown, each of the individual septa 130
comprises an upper dome 131, an upper compression zone 139, a
flange 133, and a lower plug 137. The upper dome 131 provides
tactile feedback to a medical practitioner as to the center of the
individual septum 130. The flange 133 comprises a ring of thin
material that is disposed around the circumference of each of the
septa 130. The flange 133 further comprises a top surface 135 and a
bottom surface 136 (illustrated in FIG. 10A). The bottom surface
136 of the flange 133 of each septa 130 is placed on an upper
surface 154 of the port base 150. The lower plug 137 of the flange
133 extends into a portion of the respective distal or proximal
reservoirs 151 157. The outer diameter of the lower plug 137 is
preferably sized to be slightly larger than the inner diameter of
the distal and proximal reservoirs 151 157, so that when placed in
the reservoirs, radial compression is achieved against the lower
plug 137 of each of the septa 130.
[0044] The cap 110 is of a generally elongated domed shape and
comprises a distal opening 111 at a distal end 170A of the cap 110,
a proximal opening 113 located at a proximal end 170B of the cap
110, and a skirt 120. The distal opening 111 and the proximal
opening 113 are generally circular in shape, and receive the upper
domes 131 of the septa 130 for the distal and proximal reservoirs
151 157, respectively. The shape of the distal and proximal
openings 111 113 may also conform to any alternative shape of the
distal and proximal reservoirs 151 157. The distal opening 111 and
the proximal opening 113 are also each encircled by a respective
generally flat top rim 112A 112B. The rims are separated by a
divider 114. The distal opening 111 and the proximal opening 113
also each have an interior sidewall 115 116, respectively. In the
embodiment shown, the sidewalls 115 116 are angled, i.e., the
sidewalls 115 116 are of a generally truncated cone shape,
encircling a narrower top opening and a wider bottom opening. The
interior side walls 115 116 contact a top portion of the upper
compression zone 139 of the individual septa 130.
[0045] The cap 110 is placed over the individual septa 130 and the
port base 150, engaging the port base 150 through a locking
mechanism to secure the septa 130 to the port base 150. In this
particular embodiment, a number of receiving grooves 161 are
disposed on the exterior side wall of the port base 150. The
receiving grooves 161 engage locking ribs 162 (illustrated in FIGS.
4A and 4B) disposed on the corresponding interior wall of the cap
110. When the cap 110 is locked to the port base 150, the cap 110
compresses the septa 130 against the port base 150, creating a
fluid seal between the distal septum 130 and both the distal
reservoir 151 and the cap 110 and a fluid seal between a proximal
septum 130 and both the proximal reservoir 157 and the cap 110. In
an exemplary embodiment, the cap 110 may be solvent bonded to the
port base 150.
[0046] The skirt 120 generally follows the outer contour of the
port base 150. The skirt 120 preferably also has a narrowed
midsection 122 at roughly the middle point of the implantable port
100 corresponding to the narrowed midsection 163 in the port base
150. The narrowed midsection 122 of the skirt 120 provides a
medical practitioner tactile feedback as to the center of the
implantable port 100, thereby facilitating identification of the
distal reservoir 151 and the proximal reservoir 157. The skirt 120
preferably includes a plurality of suture holes 121 for suturing
the implantable port 100 to the surrounding tissue when implanted
in a patient.
[0047] The dual prong outlet stem 200 is attached to the distal end
160A of the port base 150. The dual prong outlet stem 200 comprises
an upper prong 210 and a lower prong 220. The upper prong 210 and
the lower prong 220 have a proximal base 230 that connects to the
port base 150. The lower skirt portion 120 preferably includes an
opening 125 for receiving the proximal stem base 230 of the dual
prong outlet stem 200. The upper prong 210 and the lower prong 220
have a generally semicircular (D-shaped) cross section, and a
slight taper toward their respective distal tips 216 and 226. The
distal tips 216 and 226 form the distal tip of the dual prong
outlet stem 200. In an exemplary embodiment, the dual prong outlet
stem 200 is formed integrally with the base 150. In another
exemplary embodiment, the dual prong outlet stem 200 is formed
separately from the base 150 and solvent bonded to the base
150.
[0048] The dual prong outlet stem 200 is designed to receive the
dual lumen catheter 400. The dual lumen catheter 400 has a proximal
end 430 that connects to the dual prong outlet stem 200. Each of
the lumens of the dual lumen catheter has an opening at the distal
tips 410 420 of the lumens of the catheter 400. The proximal end
430 of the catheter lumens is designed to fit over the upper and
lower prongs 210 220 of the dual prong outlet stem 200.
[0049] Each lumen of the dual lumen catheter 400 has a distal
opening at respective distal tips 410 420. In the embodiment shown
in FIG. 1, the distal openings 410 420 are staggered. In this
particular example, the distal tips 410 420 are produced by
skiving, i.e., using a sharp instrument to remove a portion of the
exterior wall of one lumen of the dual lumen catheter 400 along the
dividing wall, thereby creating staggered distal openings at the
distal tips 410 420. Other catheter tip configurations, e.g., blunt
tip, split tip, etc., and manufacturing techniques, such as
cutting, welding, attaching, etc., can be adapted to produce the
distal catheter tips 410 420 of the dual lumen catheter 400.
[0050] Depicted in FIG. 2 is a perspective view of the dual
reservoir port 100 assembled and attached to the dual lumen
catheter 400 using the locking collar 300, in accordance with an
exemplary embodiment of the present invention. During assembly,
each of the septa 130 are placed onto the respective reservoirs 151
157, and the cap 110 is placed over the septa 130 and locked onto
the port base 150, thereby compressing and securing the individual
septa 130 between the port base 150 and the cap 110. The upper
domes 131 of the individual septa 130 protrude from the distal
opening 111 and the proximal opening 113 of the cap 110. The lower
plugs 137 of the individual septa 130 protrude into a portion of
the reservoirs 151 157.
[0051] When connecting the dual lumen catheter 400 to the assembled
dual reservoir port 100, the proximal end 430 of the dual lumen
catheter 400 is slipped onto the dual prong outlet stem 200, with
the upper prong 210 placed in one lumen, and the lower prong 220
placed in the other lumen of the catheter 400. The locking collar
300 is slipped over the proximal end 430 of the dual lumen catheter
400 toward the dual prong outlet stem 200, thereby securing the
dual lumen catheter 400 on the dual prong outlet stem 200.
[0052] FIG. 3 illustrates an exemplary cross-sectional view of the
dual reservoir port 100 taken along a section line A-A illustrated
in FIG. 2, in accordance with an exemplary embodiment. As can be
seen in FIG. 3, the cap 110 is snapped onto the port base 150
securing the individual septa 130. The upper domes 131 of the septa
130 protrude from their respective distal opening 111 and proximal
opening 113 of the cap 110. FIG. 3 also illustrates that, for this
particular embodiment, the dual prong outlet stem 200 is
constructed as one piece with the port base 150, i.e., it is
integrally formed with the port base 150.
[0053] Referring to FIGS. 1 and 3 together, there are illustrated
the upper prong 210 and lower prong 220 of the dual prong stem 200,
in accordance with an exemplary embodiment of the present
invention. An upper fluid channel 171 extends through the upper
prong 210 and a portion 164A (illustrated in FIG. 5A) of the port
base 150 to provide a first, upper fluid passageway or pathway 173
(illustrated in FIG. 5A) for fluid communication between the distal
opening in the distal tip 216 of the upper prong 210 and the distal
reservoir 151. The upper fluid channel 171 opens to the distal
reservoir 151 at a proximal opening 218 in a lower portion of the
side wall 152 of the distal reservoir 151 close to the bottom 153
of the distal reservoir 151.
[0054] A lower fluid channel 172 extends through the lower prong
220 and a portion 164B (illustrated in FIGS. 5B-5C) of the port
base 150 to provide a second, lower fluid passageway or pathway 174
(illustrated in FIGS. 5B-5C) for fluid communication between the
distal opening in the distal tip 226 of the lower prong 220 and the
proximal reservoir 157. The lower fluid channel 172 opens to the
proximal reservoir 157 at a proximal opening 228 in a lower portion
of the side wall 158 of the proximal reservoir 157 and close to the
bottom 159 of the proximal reservoir 157.
[0055] The upper prong 210 and the lower prong 220 and the upper
fluid channel 171 and the lower fluid channel 172 are stacked
vertically, i.e., one is disposed above the other, in the exemplary
embodiments shown in FIGS. 1 and 3. Alternatively, the prongs of
the dual prong outlet stem 200 may be arranged horizontally, or
with a horizontal or vertical offset with respect to each other.
The portion 164B of the lower fluid channel 172 is located beneath
the distal reservoir 151. The material thickness between the bottom
153 of the distal reservoir 151 and the top of the lower fluid
channel 172 is rather thin. Without the precautions described
below, there is a perceived risk that a needle entering into the
distal reservoir 151 may puncture through and enter the lower fluid
channel 172, compromising the fluid separation of the distal and
proximal reservoirs 151 157.
[0056] FIG. 4A is a cross-sectional view of the embodiment of the
dual reservoir access port of FIG. 1 taken along a section line C-C
illustrated in FIG. 3, in accordance with an exemplary embodiment
of the present invention. FIG. 4B is a cross-sectional view of the
embodiment of the dual reservoir access port of FIG. 1 taken along
a section line D-D illustrated in FIG. 3, in accordance with an
exemplary embodiment of the present invention. FIG. 5A is a
cross-sectional view of the embodiment of the dual reservoir access
port of FIG. 1 taken along a section line E-E illustrated in FIG.
3, in accordance with an exemplary embodiment of the present
invention. FIG. 5B is a cross-sectional view of the embodiment of
the dual reservoir access port of FIG. 5A, additionally showing a
puncture shield and a fluid pathway in dashed lines, in accordance
with an exemplary embodiment of the present invention. FIG. 5C is a
cross-sectional view of the embodiment of the dual reservoir access
port of FIG. 1 taken along a section line F-F illustrated in FIG.
3, in accordance with an exemplary embodiment of the present
invention.
[0057] A cross section of the upper fluid channel 171 is visible in
FIG. 4A. As illustrated in FIG. 4A, the upper fluid channel 171
comprises a lumen 171.1 which is of a generally semicircular cross
section 171.2, i.e., it has a semicircular or D-shaped lumen 171.1,
throughout the length of the upper fluid channel 171. Because the
upper fluid channel 171 forms the first, upper fluid pathway 173,
the fluid pathway 173 also comprises the lumen 171.1 with the
generally semicircular cross section 171.2 throughout the length of
the fluid pathway 173.
[0058] Cross sections of the lower fluid channel 172 are
illustrated in FIGS. 4A-4B. As illustrated in FIG. 4A, the lower
fluid channel 172 comprises a lumen 172.1 in a portion 164D
(illustrated in FIG. 5B) of the base 150. The lumen 172.1 is of a
generally semicircular cross section 172.2 in the portion 164D. As
illustrated in FIG. 4B, the lower fluid channel 172 further
comprises a lumen 172.3 in a portion 164B of the base 150 between
the portion 164D and the proximal fluid reservoir 157. The lumen
172.3 is of a generally semicircular cross section 172.4 in this
portion. It is to be understood that the lower fluid channel 172 in
this portion is the same as in a portion 164E of the base 150E
outside the portion 164D between the portion 164D and the distal
tip 226. Thus, the lower fluid channel 172 comprises the lumen
172.3 in the portion 164E having a semi-circular cross section
172.4.
[0059] Referring to FIGS. 3, 4A, and 5B-5C together, there is
illustrated an exemplary puncture shield 140, in accordance with an
exemplary embodiment of the present invention. FIG. 4A illustrates
an exemplary cross-sectional view of the puncture shield 140 taken
along the section line C-C shown in FIG. 3. As illustrated in FIG.
4A, the puncture shield 140 comprises a lumen 140.1 which is of a
generally semicircular cross section 140.2, i.e., it has a
semicircular or D-shaped lumen 140.1, throughout the length of the
puncture shield 140. FIGS. 5A-5B illustrate exemplary
cross-sectional views of the dual reservoir access port 100 of FIG.
1.
[0060] As seen in these figures, at least a portion 144A of the
puncture shield 140 is disposed within the portion 164C of the
lower fluid channel 172 directly underneath the bottom 153 of the
distal reservoir 151 to protect against potential needle
penetration into the lower fluid channel 172. The puncture shield
140 is also disposed between the bottom 153 of the distal fluid
reservoir 151 and the second fluid pathway 174. It is to be
understood that the puncture shield 140 may extend through the
lower fluid channel 172 beyond the walls 152 of the distal fluid
reservoir 151, such as through the portion 164D illustrated in
FIGS. 5B-5C. In an exemplary embodiment, the puncture shield 140 is
a metal or metal alloy tube lining at least the portion 164C of the
lower fluid channel 172 directly underneath the distal reservoir
151.
[0061] It is to be understood that the upper and lower fluid
channels 171 172 may also have alternatively shaped lumens 171.1,
172.1, and 172.3, such as circular, oval, C-shaped, oval,
elliptical, or stadium-shaped (rectangular with semi-circular ends)
cross sections. It is also to be understood that the puncture
shield 140 can be of other sizes and shapes, such as C-shaped,
stadium shaped, oval, triangular, rectangular, or trapezoidal, to
match the lumens 171.1, 172.1, and 172.3 if they are C-shaped,
stadium shaped, oval, triangular, rectangular, or trapezoidal.
[0062] Still other configurations of the puncture shield 140 are
contemplated. Referring now to FIG. 4C, there is illustrated a view
of a cross section of another exemplary puncture shield, generally
designated as 140 a, in accordance with an exemplary embodiment of
the present invention. The cross-section is taken along section
line C-C shown in FIG. 3. The puncture shield 140 a is disposed in
the port base 150 between the bottom 153 of the distal reservoir
151 and the lower fluid channel 172 to protect against needle
penetration into the lower fluid channel 172. The puncture shield
140 a comprises a curved strip of material that covers the top of
the lower fluid channel 172 for at least the portion 164C that is
underneath the bottom 153 of the distal reservoir 151.
[0063] Referring now to FIG. 4D, there is illustrated a view of a
cross section of another exemplary puncture shield, generally
designated as 140 b, in accordance with an exemplary embodiment of
the present invention. The cross-section is taken along the line
C-C shown in FIG. 3. The puncture shield 140 b is disposed in the
port base 150 between the bottom 153 of the distal reservoir 151
and the lower fluid channel 172 to protect against needle
penetration into the lower fluid channel 172. The puncture shield
140 b comprises a flat strip of material that covers the top of the
lower fluid channel 172 for at least the portion 164C that is
underneath the bottom 153 of the distal reservoir 151.
[0064] Referring now to FIG. 4E, there is illustrated a view of a
cross section of another exemplary puncture shield, generally
designated as 140 c, in accordance with an exemplary embodiment of
the present invention. The cross-section is taken along line C-C
shown in FIG. 3. The puncture shield 140 c is disposed in the port
base 150 underneath the bottom 153 of the distal reservoir 151 to
protect against needle penetration into the lower fluid channel
172. The puncture shield 140 c comprises a tube of material that
surrounds the lower fluid channel 172 for at least the portion 164C
that is underneath the bottom 153 of the distal reservoir 151.
[0065] Referring now to FIG. 4F, there is illustrated a view of a
cross section of another exemplary puncture shield, generally
designated as 140 d, in accordance with an exemplary embodiment of
the present invention. The cross-section is taken along the line
C-C shown in FIG. 3. The puncture shield 140 d is disposed at the
bottom 153 of the distal reservoir 151 to protect against needle
penetration into the lower fluid channel 172. Specifically, the
puncture shield 140 d is a material that lines the bottom 153 of
the distal reservoir 151. In an exemplary embodiment, the puncture
shield 140 d is generally circular.
[0066] Referring now to FIG. 4G there is illustrated a view of a
cross section of another exemplary puncture shield, generally
designated as 140 e, in accordance with an exemplary embodiment of
the present invention. The cross-section is taken along line C-C
shown in FIG. 3. The puncture shield 140 c is disposed in the port
base 150 underneath the bottom 153 of the distal reservoir 151 to
protect against needle penetration into the lower fluid channel
172. The puncture shield 140 e comprises a disk of material that
covers the top of the lower fluid channel 172 for at least the
portion 164C that is underneath the bottom 153 of the distal
reservoir 151.
[0067] In the embodiments of the puncture shields shown in FIGS. 3,
4A, and 4C-4G, the puncture shields are formed from a material that
is harder than the material forming the port base 150. More
preferably, the material is one that, at a thin thickness, would
withstand penetration by a infusion needle. In an exemplary
embodiment, titanium is used for the construction of the puncture
shield 140 and 140 a-e. In the examples shown, the titanium
puncture shield has a thickness of approximately 0.005 inches.
Other metals or metal alloys, e.g., stainless steel, may also be
suitable for constructing the puncture shield. The puncture shields
shown in FIGS. 3, 4A, and 4C-4G are for preventing penetration into
the lower fluid channel 172 by an infusion needle accessing the
distal reservoir 151.
[0068] The use of a puncture shield allows a minimal distance
between the bottom 153 of the distal reservoir 151 and the top of
the lower fluid channel 172, which translates to an overall low
profile of the dual reservoir access port 100 according to an
exemplary embodiment of the present invention. In the embodiment
shown in FIGS. 3 and 4A, this distance is approximately 0.020
inches. The resulting dual reservoir access port 100 has an overall
height similar to a single reservoir low profile access port.
[0069] Referring again to FIG. 4A, there is also illustrated the
arrangement of the cap 110, the port base 150, and the individual
septum 130. The cap 110 is snapped on the port base 150,
compressing the individual septum 130 to effect a fluid seal.
Receiving grooves 161 along the exterior wall of the port base 150
engage locking ribs 162 on the corresponding interior surface of
the cap 110 providing a locking mechanism in this embodiment. FIG.
4B also illustrates the receiving grooves 161 along the exterior
wall of the port base 150, which grooves 161 engage the locking
ribs 162 on the corresponding interior surface of the cap 110 to
provide the locking mechanism.
[0070] FIG. 5A illustrates an exemplary view of a cross section of
the dual reservoir access port 100 taken along the section line E-E
illustrated in FIG. 3, in accordance with an exemplary embodiment
of the present invention. As illustrated in FIG. 5A, the upper
fluid channel 171 extends from the distal tip 216 of the upper
prong 210 of the stem 200 through the portion 164A of the base 150
and to the distal reservoir 151. The upper fluid channel 171 opens
to the distal reservoir 151 via the opening 218 in the distal side
of the sidewall 152 of the reservoir 151. As shown in FIG. 5A, the
upper fluid channel 171 provides a first, upper fluid pathway 173
from the distal tip 216 of the upper prong 210 of the stem 200
through the portion 164A of the base 150 and to the distal
reservoir 151.
[0071] FIG. 5B illustrates an exemplary view of a cross section of
the dual reservoir access port 100 also taken along the section
line E-E illustrated in FIG. 3, in accordance with an exemplary
embodiment of the present invention. The view in FIG. 5B differs
from that in FIG. 5A because of the illustration of the lower fluid
channel 172 and the puncture shield 140 in FIG. 5B in dashed lines.
The lower fluid channel 172 and the puncture shield 140 are shown
in dashed lines to indicate that they lie below the bottom 153 of
the distal fluid reservoir 151. Specifically, the portion 164C of
the fluid channel 172 and the puncture shield 140 lie directly
below the distal reservoir 151. The lower fluid channel 172 opens
to the proximal reservoir 157 via the opening 228 in the distal
side of the sidewall 158 of the reservoir 157.
[0072] FIG. 5C illustrates an exemplary view of a cross section of
the dual reservoir port 100 taken along the section line F-F
illustrated in FIG. 3, in accordance with an exemplary embodiment
of the present invention. As illustrated in FIG. 5C, the lower
fluid channel 172 extends from the distal tip of the lower prong
226 of the stem 200 through the portion 164B of the base 150 and to
the distal reservoir 157. The lower fluid channel 172 opens to the
proximal reservoir 157 via the opening 228 in the distal side of
the sidewall 158 of the reservoir 157.
[0073] At least two embodiments for the puncture shield 140 being
disposed within the lower fluid channel 172 are contemplated. In
one embodiment, the portion 164D of the lower fluid channel 172 in
which the puncture shield 140 is disposed is notched so that the
inner lumen 140.1 of the puncture shield 140 has the same cross
section 140.2 as the cross section 172.4 of the inner lumen 172.3
of the lower fluid channel 172 in the portion 164E. The fluid
channel 172 outside the portion 164D and the lumen 140.1 of the
puncture shield 140 together form the lower, second fluid pathway
174, which comprises a lumen 174.1 having a cross section 174.2. In
this embodiment, the cross section 174.2 of the effective fluid
channel 174 is the same at all points between the distal tip 226
and the opening 228.
[0074] FIGS. 5B and 5C illustrate such embodiment. As seen in the
figures, the cross section 172.2 of the lumen 172.1 of the fluid
channel 172 in the portion 164D is oversized to accommodate the
puncture shield 140 lining the fluid channel 172 in the portion
164D. The cross section 172.4 of the lumen 172.3 of the fluid
channel 172 outside the portion 164D is equal to the cross section
140.2 of the lumen 140.1 of the puncture shield 140, i.e., the
cross section 174.2 of the lumen 174.1 of the fluid pathway 174
remains constant throughout its entire length.
[0075] In another embodiment, the lower fluid channel 172 contains
no notch in the portion 164D. Thus, the cross section 172.2 is the
same as the cross section 172.4. The cross section of the lower
fluid channel 172 is constant along all lengths of the lower fluid
channel 172 from the distal tip 226 to the opening 228. The
puncture shield 140 is fitted in the lower fluid channel 172. Thus,
the cross section 140.2 of the lumen 140.1 of the puncture shield
140 is smaller than the cross sections 172.2 and 172.4. The lumen
174.1 of the lower, second fluid pathway 174 is narrowed in the
portion 164D such that the cross section 174.2 of the lower, second
fluid pathway 174 is narrower in the portion 164D than the cross
section 172.4.
[0076] When implanted in a patient, either or both of the
reservoirs of the dual reservoir port 100 can be accessed from
outside through a non-coring infusion needle, e.g., by a needle 500
illustrated in FIG. 11B. The infusion needle that is used to
penetrate the needle penetrable individual septa 130 is typically
the type referred to as a Huber needle. Because of their
self-sealing nature, the individual septa 130 can withstand
repeated penetration of such an infusion needle without leaking
Radial compression around the circumference of the individual septa
130 facilitates the self-sealing of the septa 130.
[0077] When an infusion needle is tapped into the distal reservoir
151, fluid infused into the distal reservoir 151 travels through
the upper fluid pathway 173 and into the lumen of the dual lumen
catheter 400 that is connected to the upper prong 210 of the dual
prong outlet stem 200. Likewise, when an infusion needle is tapped
into the proximal reservoir 157, fluid infused into the proximal
reservoir 157 travels through the lower fluid pathway 174 and into
the lumen of the dual lumen catheter 400 that is connected to the
lower prong 220 of the dual prong outlet stem 200.
[0078] The arrangement of straight fluid channels 171 172 or fluid
pathways 173 174 in the dual reservoir implantable port 100
provides low resistance for fluid passing through the dual
reservoir access port 100. A dual reservoir implantable port
according to the present invention is particularly suitable for
medical applications that may require high infusion flow rate. One
particular example is power injection of contrasting agent for
X-ray Computed Tomography (CT). In some applications, power
injection of contrast agent is required at up to 5 ml/second flow
rate. Contrast agents may also have high viscosity, which may
require power injection equipment to be operated at high back
pressure, and make achieving high injection flow rates
challenging.
[0079] High pressure increases the risk of failure in conventional
infusion systems. Rupture of an implanted port or infusion
catheter, and separation of the catheter from the port may occur.
Small and tortuous internal fluid passages, such as those within a
conventional dual reservoir implantable port, aggravate this
difficulty. The dual reservoir access port 100 of the present
invention provides straight fluid channels 171 172 and fluid
pathways 173 174 for both of the distal and proximal reservoirs 151
157, which fluid channels 171 172 and fluid pathways 173 174 are
free from twists and turns. The fluid channels 171 172 or fluid
pathways 173 174 of the dual reservoir implantable port 100
according to the present invention are also of relatively constant
cross-sectional shape and size throughout. This also facilitates
low resistance fluid passage through the fluid channels or
pathways.
[0080] Designing a conventional dual reservoir access port to have
a fluid channel disposed in a sidewall increases the width of the
port, or alternatively, the height of the port. Increased width or
height is not desirable as it requires increased incision size, and
may lead to discomfort in patients. The dual port 100 of the
present invention minimizes width as the lower fluid channel 172 is
not disposed in the wall 152. It also minimizes height as the
puncture shield 140 and its variations allow for a minimum distance
between the bottom 153 of the distal reservoir 151 and the lower
fluid channel 172. Decreased height and width allows for smaller
incision size.
[0081] Further, the conventional dual reservoir access port with
the fluid channel disposed in the sidewall presents other problems.
Generally, an open-top fluid channel formed in the side wall around
the distal reservoir is used in such designs. Such open-top channel
requires a seal to prevent fluid communication with the distal
reservoir. Further, such open-top fluid channel often has a large
dead zone where the fluid channel width transitions to the proximal
reservoir and the port stem. Such dead zones hamper proper flushing
of the port. Particularly, when the proximal reservoir is used for
withdrawing blood, inefficient flushing of the side wall fluid
channel may result in increased risk of clot formation in the fluid
channel and compromise the performance of the access port.
[0082] Referring now to FIG. 6, there is illustrated an elevation
view of the outlet stem portion 200 of the dual reservoir access
port 100, in accordance with an exemplary embodiment of the present
invention. As can be seen in FIG. 6, the upper prong 210 has a
rounded locking ridge 212 disposed around its exterior surface. The
lower prong 220 also has a rounded locking ridge 222 disposed
around its exterior surface. The rounded locking ridge 212 of the
upper prong 210 and the rounded locking ridge 222 of the lower
prong 220 are offset from each other, i.e., the rounded locking
ridges 212 222 are not located at the same distance from the distal
end 216 226 of the upper and lower prongs 210 220 of the dual prong
outlet stem 200. In this particular example, the rounded locking
ridge 212 of the upper prong 210 is located proximal, i.e., closer,
to the stem base 230 compared to the rounded locking ridge 222. The
rounded locking ridge 222 of the lower prong 220 is located closer
to the distal end of the lower prong 220 than the locking ridge
212. The rounded locking ridge 222 is at a first distance from the
distal end of the lower prong 220, and the rounded locking ridge
212 is at a second distance from the distal end of the upper prong
210 greater than the first distance. The locking ridges 212 222
have semi-circular cross sections.
[0083] FIG. 7A is another exemplary elevation view of the dual
prong outlet stem portion 200 of the dual reservoir access port 100
from the line G-G illustrated in FIG. 6, in accordance with an
exemplary embodiment of the present invention. FIG. 7C is an
exemplary view of a cross section of the dual prong outlet stem 200
of the dual reservoir access port 100 taken along the section line
I-I shown in FIG. 7A, in accordance with an exemplary embodiment of
the present invention. As illustrated in FIG. 7A, each of the upper
and lower prongs 210 220 of the dual prong outlet stem 200 has a
generally semicircular shape.
[0084] Referring now to FIGS. 7A and 7C together, there are
illustrated locking ridges of the upper and lower prongs 210 220 in
further detail. Specifically, the locking ridge of the upper prong
210 includes the rounded locking ridge 212 illustrated in FIG. 6
(also referred to herein as an "exterior curved locking ridge")
located on the curved outer surface of the upper prong 210 and a
further locking ridge 214 (an "interior straight locking ridge")
located on the flat side of the prong 210 facing the prong 220.
Similarly, the locking ridge of the lower prong 220 includes the
rounded locking ridge 222 illustrated in FIG. 6 (also referred to
herein as an "exterior curved locking ridge") located on the curved
outer surface of the lower prong 220 and a further locking ridge
224 (an "interior straight locking ridge") located on the flat side
of the prong 220 facing the prong 210.
[0085] The locking ridges 212 214 for both the upper prong 210 of
the dual prong outlet stem 200 and the locking ridges 222 224 of
the lower prong 220 can be seen to encircle the exterior
circumference of the respective prong 210 220. The exterior curved
locking ridge 212 of the upper prong 210 follows the exterior
curved contour of the exterior of the upper prong 210, and the
interior straight locking ridge 214 of the upper prong 210 follows
the generally flat side of the upper prong 210 that faces the lower
prong 220. The exterior curved locking ridge 222 of the lower prong
220 follows the exterior curved contour of the exterior of the
lower prong 220, and the interior straight locking 224 ridge of the
lower prong 220 follows the generally flat side of the lower prong
220 that faces the upper prong 210. In this view, the locking
ridges 212 214 of the upper prong 210 are offset from the locking
ridges 222 224 of the lower prong 220, and are closer to the stem
base 230. The curved and flat outer surfaces of the stems define
the fluid channels within the prongs 210 220.
[0086] In this particular embodiment, the upper and lower prongs
210 220 are slightly tapered on their exterior curved sides and
also on the flat sides that face each other. Because of the slight
taper of the upper and lower prongs 210 220, the locking ridges 212
214 of the upper prong 210 are of a slightly larger circumferential
length than the locking ridges 222 224 of the lower prong 220.
Namely, the arc length of the locking ridge 212 is greater than the
arc length of the locking ridge 222, and the length of the locking
ridge 214 is greater than the length of the locking ridge 224. The
upper and lower fluid channels 171 and 172 are of a generally
constant size throughout their respective prongs 210 220.
[0087] Referring now to FIG. 7B, there is illustrated a view of a
cross section of the dual prong outlet stem base 230 taken along
the section line H-H illustrated in FIG. 6. As shown in FIG. 7B,
the upper fluid channel 171 and the lower fluid channel 172
respectively comprise semicircular cross sections 171.2 and 172.2
in the base 230. In this embodiment, the upper fluid channel 171 is
stacked vertically over the lower fluid channel 172.
[0088] FIG. 8 illustrates an exemplary view of a cross section of
the dual lumen catheter 400 taken along the section line B-B
illustrated in FIG. 2, in accordance with an exemplary embodiment
of the present invention. The dual lumen catheter 400 comprises an
exterior wall 480, which surrounds two lumens 440 and 450, which
are separated from one another by a dividing wall 470. The exterior
wall 480 of the dual lumen catheter 400 is generally of a circular
or oval cross section. The lumens 440 450 are generally D-shaped or
C-shaped, though other shapes may also be used. The lumens 440 450
may be of equal sizes. The interior dimensions of the lumens 440
450 are comparable to the exterior dimensions of the upper and
lower prongs 210 220 of the dual prong outlet stem 200.
[0089] FIG. 9A is an exemplary cross-sectional side view of an
example where a dual lumen catheter 400 and locking collar 300 are
in position to be connected to the dual prong outlet stem 200 of
the dual reservoir access port 100, in accordance with an exemplary
embodiment of the present invention. The locking collar 300
comprises two generally hollow cylindrical shaped end sections 310
and a narrow waist 320. The two end sections 310 are identical to
each other, i.e., the locking collar 300 is symmetrical about a
middle point of the waist 320. The locking collar 300, therefore,
can be used in either direction. The symmetrical shape greatly
simplifies the connection of the dual lumen catheter 400 to the
dual reservoir port 100, since a medical practitioner does not have
to distinguish the orientation of the locking collar 300 during the
implantation procedure.
[0090] The narrow waist 320 of the locking collar 300 has a smaller
inner diameter than the end sections 310. In the embodiment shown
in FIG. 9A, the interior of both of the end sections 310 gradually
narrows to the inner diameter of the narrow waist 320. The inner
diameter of the narrow waist 320 is slightly larger than the
combined outer diameter of the upper and lower prongs 210 220
between the offset locking ridges 212 214 of the upper prong 210
and the locking ridges 222 224 of the lower prong 220. The width of
the narrow waist 320 is approximately equal or slightly shorter
than the offset distance between locking ridges 212 214 of the
upper prong 210 and the locking ridges 222 224 of the lower prong
220.
[0091] The narrow waist 320 is designed to fit between the rounded
locking ridge of the upper prong 212 and the rounded locking ridge
of the lower prong 222 in its locking position, thereby
frictionally securing the dual lumen catheter 400 to the dual prong
outlet stem 200. When a medical practitioner connects the dual
lumen catheter 400 to the dual reservoir access port 100, he first
slips each lumen 440 450 of the dual lumen catheter 400 onto the
upper prong 210 and lower prong 220 of the dual prong outlet stem
200, respectively, and pushes the dual lumen catheter 400 over the
locking ridges 212 214 of the upper prong 210 and the locking
ridges 222 224 of the lower prong 220. The taper that is
incorporated in the upper and lower prongs 210 220 facilitates this
operation. The practitioner then slides the locking collar 300 over
the set of the locking ridges 222 224. The locking collar 300 is in
the locked position when the locking collar 300 rests between the
locking ridges 212 214 and the locking ridges 222 224. In the
particular embodiment shown in FIG. 9A, the maximum ridge-to-ridge
distance (measured from the midpoint of the locking ridges 212 214
of the upper prong 210 to the midpoint of the locking ridges 222
224 of the lower prong 220) is approximately 0.128 inches, and the
interior width of the narrow waist 320 (including the ramps on
either side of the midpoint of the locking collar 300) is also
approximately 0.128 inches.
[0092] FIG. 9B illustrates a cross-sectional side view of the dual
lumen catheter 400 and locking collar 300 attached to the stem 200
of the dual reservoir access port 100, in accordance with an
exemplary embodiment of the present invention. When the locking
collar 300 is in the locked position, the upper and lower exterior
locking ridges 212 222 compress the exterior wall 480 of the dual
lumen catheter 400 against the interior of the locking collar 300,
particularly against the narrow waist 320. The upper and lower
interior locking ridges 214 224 compress the dividing wall 470 of
the dual lumen catheter 400 against the opposite prong. In other
words, the interior locking ridge 214 compresses the dividing wall
470 against the prong 220, and the interior locking ridge 224
compresses the dividing wall 470 against the prong 210. These
multiple compression points contribute to create a fluid tight
connection between the dual lumen catheter 400 and the dual
reservoir access port 100.
[0093] In the embodiments shown in FIGS. 6, 7, and 9, the locking
ridges 212 214 of the upper prong 210 are closer to the stem base
230, and the locking ridges 222 224 of the lower prong 220 are
closer to the distal end 216 226 of the dual prong outlet stem 200.
This configuration of locking ridges is for illustration purpose
only, and does not limit the scope of the present invention. It is
to be understood that the relative positions of the locking ridges
of the upper prong and the locking ridges of the lower prong can be
reversed and positioned anywhere along the length of the dual prong
outlet stem.
[0094] FIG. 10A is a cut away view of one embodiment of an
individual septum 130 used with an exemplary embodiment of the dual
reservoir access port 100 of the present invention. The individual
septum 130 comprises an upper dome 131, an upper compression zone
139, a flange 133, and a lower plug 137. The flange 133 comprises a
flat upper surface 135 and a flat lower surface 136. In this
particular embodiment, the flange 133 further comprises an upper
sealing ring 132, a lateral sealing ring 134, and a bottom sealing
ring 138. The upper and bottom sealing rings 132 138 are rounded
ridges located respectively on the top and bottom surfaces 135 136
of the flange 133. The lateral sealing ring 134 is a thin strip
surrounding the outer circumference of the flange 133. In the
embodiment illustrated in FIG. 10A, the lateral sealing ring has a
rectangular cross section. It is contemplated that septa with other
shapes or configurations may be used with the present invention
dual reservoir implantable port, as long as fluid tight seals can
be formed atop the distal and proximal reservoirs.
[0095] FIG. 10B is an enlarged cross-sectional view of portion J in
FIG. 4A, illustrating a portion of the septum 130 assembled into
the cap 110 and port base 150 of one embodiment of the dual
reservoir access port 100, in accordance with an exemplary
embodiment of the present invention. When the cap 110 is locked in
place against the port base 150, the cap 110 compresses the
individual septum 130 against the port base 150. The upper sealing
ring 132 and the lateral sealing ring 134 of the septum 130 make
contact with the cap 110 and deform to form fluid tight seals. The
bottom sealing ring 138 makes contact with the top surface 154 of
the port base 150, and deforms to make a fluid tight seal. The
lower plug 137 also radially compresses against the sidewalls 152
158 of the respective distal and proximal reservoirs 151 157,
further helping to seal the respective reservoirs.
[0096] Referring now to FIG. 11A there is illustrated an exemplary
perspective view of alternative embodiment of the puncture shield
140, generally designated as 1100, in accordance with an exemplary
embodiment of the present invention. The puncture shield 1100
comprises a pair of end portions 1120A and 1120B. The end portion
1120A comprises a lumen 1130A having a D-shaped cross-section
1160A, and the end portion 1120B comprises a lumen 1130B having a
D-shaped cross-section 1160B.
[0097] The flat-side portions of the D-shaped portions 1120A and
1120B are seamlessly connected to one another by a flat planar
portion 1110. Viewed another way, the puncture shield 1100 is a
D-shaped tube with a semi-cylindrical portion removed to leave the
flat planar portion 1110 and the end portions 1120A and 1120B.
[0098] Referring now to FIG. 11B, there is illustrated an exemplary
cross-sectional view of an exemplary embodiment of the dual port
100, generally designated as 100', in which the puncture shield 140
is replaced with the puncture shield 1100, in accordance with an
exemplary embodiment of the present invention. It is to be
understood that like elements in FIGS. 1-3 and 5 are illustrated in
FIG. 11B. The view in FIG. 11B is of a cross-section of the port
100' taken along a section line similar to the section line A-A
illustrated in FIG. 2.
[0099] FIG. 11B illustrates that the puncture shield 1100 is
disposed in the portion 164D of the base 150 underneath the bottom
153 of the distal reservoir 151 to prevent a needle 500 from
penetrating the bottom of the reservoir 151 and entering the lower
fluid channel 172. The puncture shield 1100 is also disposed
between the bottom 153 of the distal fluid reservoir 151 and the
second fluid pathway 174.
[0100] At least a portion 1144A of the puncture shield 1100
(corresponding to the portion 144A of the puncture shield 140) is
disposed within the portion 164C of the lower fluid channel 172
directly underneath the distal reservoir 151. It is to be
understood that the puncture shield 1100 may extend through the
lower fluid channel 172 beyond the walls 152 of the distal fluid
reservoir 151, such as through the portion 164D illustrated in
FIGS. 5B-5C. It also is to be understood that the puncture shield
1100 can be of other sizes and shapes, such as C-shaped, stadium
shaped, oval, triangular, rectangular, or trapezoidal, to match the
lumens 172.1 and 172.3 if they are C-shaped, stadium shaped, oval,
triangular, rectangular, or trapezoidal.
[0101] The puncture shield 1100 is formed from a material that is
harder than the material forming the port base 150. More
preferably, the material is one that, at a thin thickness, would
withstand penetration by a infusion needle. In an exemplary
embodiment, the puncture shield 1100 is a metal or metal alloy tube
lining at least the portion 164C of the lower fluid channel 172
directly underneath the distal reservoir 151. In an exemplary
embodiment, titanium is used for the construction of the puncture
shield 1100. An exemplary wall thickness for such titanium tube
puncture shield is approximately 0.005 inches. Other metals or
metal alloys, e.g., stainless steel, may also be suitable for
constructing the puncture shield.
[0102] With respect to FIGS. 11A and 11B together, the flat planar
portion 1110 of the puncture shield 1100 comprises a width 1150
which is desirably greater than the width of the fluid channel 172
to ensure that the fluid channel 172 is fully covered to prevent a
needle penetrating through the bottom of the reservoir 151 and into
the fluid channel 172. The puncture shield 140 comprises a length
1140, which is desirably greater than the length of the portion
164C of the fluid channel 172.
[0103] At least three embodiments for the puncture shield 1100
lining the lower fluid channel 172 are contemplated. In one
embodiment, the portion 164D of the lower fluid channel 172 in
which the puncture shield 1100 is disposed is notched so that the
inner lumen 1130A 1130B of the puncture shield 1100 in the end
portions 1120A and 1120B has the same cross sections 1160A and 1
160B as the cross section 172.4 of the inner lumen 172.3 of the
lower fluid channel 172 in the portion 164E. The fluid channel 172
outside the portion 164D and the lumen 1130A 1130B of the puncture
shield 1100 together form the lower, second fluid pathway 174,
which comprises a lumen 174.1 having a cross section 174.2. In this
embodiment, the cross section 174.2 of the effective fluid pathway
174 is the same at all points between the distal tip 226 and the
opening 228, except in the portion between the end portions 1120A
and 1120B because the lower portion of the notch portion 164D is
not entirely filled by a corresponding portion of the puncture
shield 1100.
[0104] In another embodiment, the portion 164D of the lower fluid
channel 172 which is notched is shaped to match the shape of the
puncture shield 1100. Thus, the cross section 174.2 of the
effective fluid pathway 174 is the same at all points between the
distal tip 226 and the opening 228 and is equal to the cross
section 172.4. In yet another embodiment, the lower fluid channel
172 contains no notch. Thus, the cross section 172.2 is the same as
the cross section 172.4 in the portion 164E. The cross section of
the lower fluid channel 172 is constant along all lengths of the
lower fluid channel 172 from the distal tip 226 to the opening 228.
The puncture shield 140 is fitted in the lower fluid channel 172.
Thus, the lumen 174.1 of the effective fluid pathway 174 has a
slightly narrower cross section 174.2 where the puncture shield
1100 is disposed in the lower fluid channel 172.
[0105] Referring now to FIG. 12A, there is illustrated an exemplary
elevation view of an alternative exemplary embodiment of the stem
200, designated generally as 200', in accordance with an exemplary
embodiment of the present invention. As can be seen in FIG. 12A,
the upper prong 210 of the stem 200' comprises a first rounded
locking ridge 1210A and a second locking ridge 1210B disposed
around its exterior surface. The lower prong 220 comprises a first
rounded locking ridge 1220A and a second rounded locking ridge
1210B disposed around its exterior surface. Interior flat surfaces
1212 and 1222 of the respective prongs 210 and 220 are smooth and
contain no locking ridges.
[0106] Referring now to FIG. 12B, there is illustrated a front,
planar view of the stem 200' from a line K-K illustrated in FIG.
12A, in accordance with an exemplary embodiment of the present
invention. FIG. 12C illustrates an exemplary cross-sectional view
of the dual prong outlet stem 200' taken along a section line L-L
shown in FIG. 12B, in accordance with an exemplary embodiment of
the present invention. As illustrated in FIG. 12B, each of the
upper and lower prongs 210 and 220 of the dual prong outlet stem
200' is of generally semicircular shape as is the case with the
dual prong outlet stem 200.
[0107] FIGS. 12B and 12C together illustrate the locking ridges
1210 and 1220 of the upper and lower prongs 210 and 220 in further
detail. Specifically, the locking ridges 1210A and 1210B are each
an exterior, curved locking ridge located on the curved outer
surface of the upper prong 210. Similarly, the locking ridges 1220A
and 1220B are each an exterior, curved locking ridge located on the
curved outer surface of the lower prong 220. None of the locking
ridges 1210A and 1210B includes an interior, straight locking ridge
located on the interior flat surface 1212 of the prong 210 facing
the prong 220, and none of the locking ridges 1220A and 1220B
includes an interior, straight locking ridge located on the
interior flat surface 1222 of the prong 220.
[0108] The locking ridges 1210A and 1210B each have a semi-circular
cross section, as illustrated in FIG. 12C. Specifically, the
locking ridge 1210A has a semi-circular cross section 1211A, and
the locking ridge 1210B has a semi-circular cross section 1211B.
Similarly, the locking ridges 1220A and 1220B each have a
semi-circular cross section. Specifically, the locking ridge 1220A
has a semi-circular cross section 1221A, and the locking ridge
1220B has a semi-circular cross section 1221B. The semi-circular
cross sections 1211 and 1221 of the locking ridges 1210 and 1220
facilitate insertion of the catheter 400 onto the stem 200' as the
catheter 400 passes over the rounded surfaces more easily than if
the surfaces were barb-shaped. At the same time, the locking ridges
1210 and 1220 allow for the use of the locking collar 300 to secure
the catheter 400 to the dual port 100. When slipped over the
catheter 400 disposed on the stem 200', the narrow waist 320 of the
locking collar 300 is disposed between the locking ridges 1210A and
1210B and between the locking ridges 1220A and 1220B.
[0109] The locking ridges 1210 of the upper prong 210 of the dual
prong outlet stem 200' and the locking ridges 1220 of the lower
prong 220 do not encircle the exterior circumference of the
respective prong 210 and 220, unlike the locking ridges 212 and
222, as described above. The exterior, curved locking ridges 1210
of the upper prong 210 follow the curved contour of the exterior of
the upper prong 210. As mentioned above, there is no corresponding
interior, straight locking ridge on the flat inside surface 1212 of
the upper prong 210. The exterior, curved locking ridges 1220 of
the lower prong 220 follow the curved contour of the exterior of
the lower prong 220. As mentioned above, there is no corresponding
interior, straight locking ridge on the flat inside surface 1222 of
the lower prong 220.
[0110] In the particular embodiment illustrated in FIGS. 12A-C, the
upper and lower prongs 210 and 220 are slightly tapered on their
exterior curved surfaces and also on the flat surfaces 1212 and
1222 that face each other. Because of the slight taper of the upper
and lower prongs 210 and 220, the locking ridge 1210B of the upper
prong 210 is of a slightly larger arc length than the locking ridge
1210A, and the locking ridge 1220B of the lower prong 220 is of a
slightly larger arc length than the locking ridge 1220A. The upper
and lower fluid channels 171 and 172 are of a generally constant
size, i.e., cross section, throughout the length of the stem 200'
despite the taper. The taper of the prongs 210 and 220 of the stem
200' facilitates insertion of the catheter 400 onto the stem 200'.
The constant cross-sectional size of the fluid channels 171 and 172
facilitates proper flow characteristic during infusion.
[0111] The dual prong outlet stem 200 and 200' and the port base
150 may be made as a single piece or as separate pieces by molding
or other suitable manufacturing techniques. If made as separate
pieces, the dual prong outlet stem 200 or 200' and the port base
150 may be attached together through welding, solvent bonding,
adhesion, or other suitable manufacturing methods. To manufacture
the port base 150 via an injection molding process, a mold is
formed and mandrels are inserted into the mold for the fluid
channels 171 172. The puncture shield 140 or 1100 is disposed about
the mandrel for the lower fluid channel 172. The material forming
the port base is injected into the mold. The port base 150 is
removed from the mold and mandrels, and the septa 130 are pressed
into the reservoirs 151 and 157. The cap 110, molded separately, is
snapped onto the port base 150. Preferably, the cap 110 is solvent
bonded to the port base 150. The dual reservoir access port 100 or
100' is complete. Alternatively, the port base 150, the outlet stem
200 or 200', and the cap 110 may be formed integrally, e.g.,
injection molded using a collapsible core pin, or machined from a
stock material.
[0112] In an exemplary embodiment, the dual reservoir access port
100 or 100' is formed from biocompatible plastic materials. The cap
110 and the port base 150 may be made from polysulfone resin or
acetal plastic. The cap 110 and the port base 150 may be made from
the same material or different materials. Additional suitable
plastic materials, without limitation, are polyvinylchloride,
polytetrafluoroethylene, polyetheresulfone, polyethylene,
polyurethane, polyetherimide, polycarbonate, polyetheretherketone,
polysulfone, polypropylene, and other similar compounds known to
those skilled in the art. Each individual septum 130 is typically
made from a silicone elastomer, such as polysiloxanes, and other
similar compounds known to those skilled in the art.
[0113] In an exemplary embodiment, the dual lumen catheter 400 is
formed from a biocompatible plastic or elastomer, preferably from a
biocompatible elastomer. Suitable biocompatible plastics include
materials such as, for example, polysiloxanes, silicone,
polyurethane, polyethylene, homopolymers and copolymers of vinyl
acetate such as ethylene vinyl acetate copolymer,
polyvinylchlorides, homopolymers and copolymers of acrylates such
as polymethylmethacrylate, polyethylmethacrylate, polymethacrylate,
ethylene glycol dimethacrylate, ethylene dimethacrylate and
hydroxymethyl methacrylate, polyurethanes, polyvinylpyrrolidone,
2-pyrrolidone, polyacrylonitrile butadiene, polycarbonates,
polyamides, fluoropolymers such as homopolymers and copolymers of
polytetrafluoroethylene and polyvinyl fluoride, polystyrenes,
homopolymers and copolymers of styrene acrylonitrile, cellulose
acetate, homopolymers and copolymers of acrylonitrile butadiene
styrene, polymethylpentene, polysulfones, polyesters, polyimides,
polyisobutylene, polymethylstyrene and other similar compounds
known to those skilled in the art. It should be understood that
these possible biocompatible polymers are included above for
exemplary purposes and should not be construed as limiting.
Preferably, the dual lumen catheter 400 is formed from the
elastomeric material such that they are flexible, durable, soft,
and easily conformable to the shape of the area to be catheterized
in a patient and minimize risk of harm to vessel walls. The dual
lumen catheter 400 is preferably formed of a soft silicone or
polyurethane elastomer which has a hardness of at least about 80-A
on a Shore durometer scale. Such an elastomer can include radio
opaque materials, such as 20% barium sulfate, in the elastomer to
provide radiopacity.
[0114] In the particular embodiment shown in FIGS. 1 and 3, a
cavity 501 is formed in the dividing wall 155 of the port base 150
between the reservoirs 151 and 157. The cavity 501 is sized to
accommodate an identification device, preferably a Radio Frequency
Identification (RFID) chip, such as a micro RFID manufactured by
PositiveID Corporation. The identification device is preferably
hermitically sealed, and stores information relevant to the
implantable port. In an exemplary embodiment, an RFID chip is
installed in the cavity 501, which provides a serial number of the
device, date, and batch information, and identifies the port 100 as
a dual reservoir access port 100 suitable for high pressure
injections. Other information may also be encoded within the
identification device. It is to be understood that the location of
the cavity 501 may be anywhere within the implantable port, as long
as it does not interfere with the functionality of the port.
[0115] These and other advantages of the present invention will be
apparent to those skilled in the art from the foregoing
specification. Accordingly, it will be recognized by those skilled
in the art that changes or modifications may be made to the
above-described embodiments without departing from the broad
inventive concepts of the invention. It should therefore be
understood that this invention is not limited to the particular
embodiments described herein, but is intended to include all
changes and modifications that are within the scope and spirit of
the invention.
* * * * *