US20170197072A1 - Implantable dual reservoir access port - Google Patents

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.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• 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
• 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
• 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.
• 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 Alternatively, bodily fluids can be withdrawn from the location where the distal end of the catheter is placed.
• 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.
• 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.
• 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 s 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.
• 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.
• 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
• 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.
• 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 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.
• 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
• 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:
• 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;
• FIG. 2 is a perspective view of the embodiment of the dual reservoir access port ofFIG. 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;
• FIG. 3 is a cross-sectional view of the embodiment of the dual reservoir access port ofFIG. 1 taken along a section line A-A illustrated inFIG. 2, in accordance with an exemplary embodiment of the present invention;
• FIG. 4A is a cross-sectional view of the embodiment of the dual reservoir access port ofFIG. 1 taken along a section line C-C illustrated inFIG. 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 ofFIG. 1 taken along a section line D-D illustrated inFIG. 3, in accordance with an exemplary embodiment of the present invention;
• FIGS. 4C-4G illustrate exemplary cross-sectional views of further embodiments of the dual reservoir access port ofFIG. 1 taken along the section line C-C illustrated inFIG. 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 ofFIG. 1 taken along a section line E-E illustrated inFIG. 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 ofFIG. 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 ofFIG. 1 taken along a section line F-F illustrated inFIG. 3, in accordance with an exemplary embodiment of the present invention;
• FIG. 6 is an elevation view of a dual prong outlet stem of the embodiment of the dual reservoir access port ofFIG. 1, in accordance with an exemplary embodiment of the present invention;
• FIG. 7A is another elevation view of the dual prong outlet stem of the dual reservoir access port ofFIG. 1 from a line G-G shown inFIG. 6, in accordance with an exemplary embodiment of the present invention;
• FIG. 7B is a cross-sectional view of the dual prong outlet stem ofFIG. 6 taken along a section line H-H, in accordance with an exemplary embodiment of the present invention;
• FIG. 7C is a cross-sectional view of the dual prong outlet stem ofFIG. 6 taken along a section line I-I illustrated inFIG. 7A, in accordance with an exemplary embodiment of the present invention;
• FIG. 8 is a cross-sectional view of the dual lumen catheter ofFIG. 1 taken along a section line B-B illustrated inFIG. 2, in accordance with an exemplary embodiment of the present invention;
• 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 ofFIG. 1, in accordance with an exemplary embodiment of the present invention;
• 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 ofFIG. 1, in accordance with an exemplary embodiment of the present invention;
• FIG. 10A is a cut away view of one embodiment of a septum used with the dual reservoir access port ofFIG. 1, in accordance with an exemplary embodiment of the present invention;
• FIG. 10B is an enlarged cross-sectional view of an assembled cap, septum, and base portion of the dual reservoir access port ofFIG. 1 indicated by portion J inFIG. 4A, in accordance with an exemplary embodiment of the present invention;
• FIG. 11A illustrates an exemplary perspective view of a further embodiment of the puncture shield ofFIG. 5B, in accordance with an exemplary embodiment of the present invention;
• FIG. 11B illustrates an exemplary cross-sectional view of a further embodiment of the dual reservoir access port ofFIG. 1, taken along a section line similar to A-A illustrated inFIG. 2, the cross-sectional view showing the puncture shield ofFIG. 11A disposed within the dual reservoir access port, in accordance with an exemplary embodiment of the present invention;
• 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;
• FIG. 12B illustrates an exemplary front, planar view of the exemplary dual prong outlet stem ofFIG. 12A from a section line K-K illustrated inFIG. 12A, in accordance with an exemplary embodiment of the present invention; and
• FIG. 12C illustrates an exemplary cross-sectional view of the exemplary dual prong outlet stem ofFIG. 12A taken along a section line L-L illustrated inFIG. 12B, in accordance with an exemplary embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
• 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.
• 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.
• 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.
• 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.
• Illustrated inFIG. 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 adual reservoir port100, a dualprong outlet stem200, alocking collar300, and a dual lumen catheter400. Thedual reservoir port100 further comprises acap110, two individual needlepenetrable septa130, and aport base150.
• Theport base150 comprises a distal fluid reservoir151 located at a distal end160A of theport base150 and a proximal fluid reservoir157 located at a proximal end160B of theport base150. The distal reservoir151 and the proximal reservoir157 are generally of cylindrical shape, each having a generally flat bottom wall153159, respectively, and asidewall152158, 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 reservoirs151157 may be of different shapes. In the embodiment illustrated inFIG. 1, the distal reservoir151, the proximal reservoir157, and the dualprong outlet stem200 are arranged in-line with each other. The distal reservoir151 and the proximal reservoir157 are separated by a dividing wall155. Preferably, the length of the dividing wall155 is narrower than the maximum width of the distal reservoir151 and the proximal reservoir157, thereby creating a narrowedmidsection163 in theport base150.
• The needlepenetrable septa130 are placed atop each of the distal reservoir151 and the proximal reservoir157. In the particular embodiment shown, each of theindividual septa130 comprises anupper dome131, anupper compression zone139, aflange133, and alower plug137. Theupper dome131 provides tactile feedback to a medical practitioner as to the center of theindividual septum130. Theflange133 comprises a ring of thin material that is disposed around the circumference of each of thesepta130. Theflange133 further comprises atop surface135 and a bottom surface136 (illustrated inFIG. 10A). Thebottom surface136 of theflange133 of eachsepta130 is placed on an upper surface154 of theport base150. Thelower plug137 of theflange133 extends into a portion of the respective distal or proximal reservoirs151157. The outer diameter of thelower plug137 is preferably sized to be slightly larger than the inner diameter of the distal and proximal reservoirs151157, so that when placed in the reservoirs, radial compression is achieved against thelower plug137 of each of thesepta130.
• Thecap110 is of a generally elongated domed shape and comprises a distal opening111 at adistal end170A of thecap110, aproximal opening113 located at a proximal end170B of thecap110, and askirt120. The distal opening111 and theproximal opening113 are generally circular in shape, and receive theupper domes131 of thesepta130 for the distal and proximal reservoirs151157, respectively. The shape of the distal and proximal openings111113 may also conform to any alternative shape of the distal and proximal reservoirs151157. The distal opening111 and theproximal opening113 are also each encircled by a respective generally flat top rim112A112B. The rims are separated by a divider114. The distal opening111 and theproximal opening113 also each have aninterior sidewall115116, respectively. In the embodiment shown, thesidewalls115116 are angled, i.e., thesidewalls115116 are of a generally truncated cone shape, encircling a narrower top opening and a wider bottom opening. Theinterior side walls115116 contact a top portion of theupper compression zone139 of theindividual septa130.
• Thecap110 is placed over theindividual septa130 and theport base150, engaging theport base150 through a locking mechanism to secure thesepta130 to theport base150. In this particular embodiment, a number of receivinggrooves161 are disposed on the exterior side wall of theport base150. The receivinggrooves161 engage locking ribs162 (illustrated inFIGS. 4A and 4B) disposed on the corresponding interior wall of thecap110. When thecap110 is locked to theport base150, thecap110 compresses thesepta130 against theport base150, creating a fluid seal between thedistal septum130 and both the distal reservoir151 and thecap110 and a fluid seal between aproximal septum130 and both the proximal reservoir157 and thecap110. In an exemplary embodiment, thecap110 may be solvent bonded to theport base150.
• Theskirt120 generally follows the outer contour of theport base150. Theskirt120 preferably also has a narrowedmidsection122 at roughly the middle point of theimplantable port100 corresponding to the narrowedmidsection163 in theport base150. The narrowedmidsection122 of theskirt120 provides a medical practitioner tactile feedback as to the center of theimplantable port100, thereby facilitating identification of the distal reservoir151 and the proximal reservoir157. Theskirt120 preferably includes a plurality of suture holes121 for suturing theimplantable port100 to the surrounding tissue when implanted in a patient.
• The dualprong outlet stem200 is attached to the distal end160A of theport base150. The dualprong outlet stem200 comprises anupper prong210 and alower prong220. Theupper prong210 and thelower prong220 have aproximal base230 that connects to theport base150. Thelower skirt portion120 preferably includes an opening125 for receiving theproximal stem base230 of the dualprong outlet stem200. Theupper prong210 and thelower prong220 have a generally semicircular (D-shaped) cross section, and a slight taper toward their respectivedistal tips216 and226. Thedistal tips216 and226 form the distal tip of the dualprong outlet stem200. In an exemplary embodiment, the dualprong outlet stem200 is formed integrally with thebase150. In another exemplary embodiment, the dualprong outlet stem200 is formed separately from thebase150 and solvent bonded to thebase150.
• The dualprong outlet stem200 is designed to receive the dual lumen catheter400. The dual lumen catheter400 has a proximal end430 that connects to the dualprong outlet stem200. Each of the lumens of the dual lumen catheter has an opening at the distal tips410420 of the lumens of the catheter400. The proximal end430 of the catheter lumens is designed to fit over the upper andlower prongs210220 of the dualprong outlet stem200.
• Each lumen of the dual lumen catheter400 has a distal opening at respective distal tips410420. In the embodiment shown inFIG. 1, the distal openings410420 are staggered. In this particular example, the distal tips410420 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 catheter400 along the dividing wall, thereby creating staggered distal openings at the distal tips410420. 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 tips410420 of the dual lumen catheter400.
• Depicted inFIG. 2 is a perspective view of thedual reservoir port100 assembled and attached to the dual lumen catheter400 using thelocking collar300, in accordance with an exemplary embodiment of the present invention. During assembly, each of thesepta130 are placed onto the respective reservoirs151157, and thecap110 is placed over thesepta130 and locked onto theport base150, thereby compressing and securing theindividual septa130 between theport base150 and thecap110. Theupper domes131 of theindividual septa130 protrude from the distal opening111 and theproximal opening113 of thecap110. The lower plugs137 of theindividual septa130 protrude into a portion of the reservoirs151157.
• When connecting the dual lumen catheter400 to the assembleddual reservoir port100, the proximal end430 of the dual lumen catheter400 is slipped onto the dualprong outlet stem200, with theupper prong210 placed in one lumen, and thelower prong220 placed in the other lumen of the catheter400. Thelocking collar300 is slipped over the proximal end430 of the dual lumen catheter400 toward the dualprong outlet stem200, thereby securing the dual lumen catheter400 on the dualprong outlet stem200.
• FIG. 3 illustrates an exemplary cross-sectional view of thedual reservoir port100 taken along a section line A-A illustrated inFIG. 2, in accordance with an exemplary embodiment. As can be seen inFIG. 3, thecap110 is snapped onto theport base150 securing theindividual septa130. Theupper domes131 of thesepta130 protrude from their respective distal opening111 andproximal opening113 of thecap110.FIG. 3 also illustrates that, for this particular embodiment, the dualprong outlet stem200 is constructed as one piece with theport base150, i.e., it is integrally formed with theport base150.
• Referring toFIGS. 1 and 3 together, there are illustrated theupper prong210 andlower prong220 of thedual prong stem200, in accordance with an exemplary embodiment of the present invention. Anupper fluid channel171 extends through theupper prong210 and a portion164A (illustrated inFIG. 5A) of theport base150 to provide a first, upper fluid passageway or pathway173 (illustrated inFIG. 5A) for fluid communication between the distal opening in thedistal tip216 of theupper prong210 and the distal reservoir151. Theupper fluid channel171 opens to the distal reservoir151 at aproximal opening218 in a lower portion of theside wall152 of the distal reservoir151 close to the bottom153 of the distal reservoir151.
• Alower fluid channel172 extends through thelower prong220 and a portion164B (illustrated inFIGS. 5B-5C) of theport base150 to provide a second, lower fluid passageway or pathway174 (illustrated inFIGS. 5B-5C) for fluid communication between the distal opening in thedistal tip226 of thelower prong220 and the proximal reservoir157. Thelower fluid channel172 opens to the proximal reservoir157 at aproximal opening228 in a lower portion of the side wall158 of the proximal reservoir157 and close to the bottom159 of the proximal reservoir157.
• Theupper prong210 and thelower prong220 and theupper fluid channel171 and thelower fluid channel172 are stacked vertically, i.e., one is disposed above the other, in the exemplary embodiments shown inFIGS. 1 and 3. Alternatively, the prongs of the dualprong outlet stem200 may be arranged horizontally, or with a horizontal or vertical offset with respect to each other. The portion164B of thelower fluid channel172 is located beneath the distal reservoir151. The material thickness between the bottom153 of the distal reservoir151 and the top of thelower fluid channel172 is rather thin. Without the precautions described below, there is a perceived risk that a needle entering into the distal reservoir151 may puncture through and enter thelower fluid channel172, compromising the fluid separation of the distal and proximal reservoirs151157.
• FIG. 4A is a cross-sectional view of the embodiment of the dual reservoir access port ofFIG. 1 taken along a section line C-C illustrated inFIG. 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 ofFIG. 1 taken along a section line D-D illustrated inFIG. 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 ofFIG. 1 taken along a section line E-E illustrated inFIG. 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 ofFIG. 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 ofFIG. 1 taken along a section line F-F illustrated inFIG. 3, in accordance with an exemplary embodiment of the present invention.
• A cross section of theupper fluid channel171 is visible inFIG. 4A. As illustrated inFIG. 4A, theupper fluid channel171 comprises a lumen171.1 which is of a generally semicircular cross section171.2, i.e., it has a semicircular or D-shaped lumen171.1, throughout the length of theupper fluid channel171. Because theupper fluid channel171 forms the first, upper fluid pathway173, the fluid pathway173 also comprises the lumen171.1 with the generally semicircular cross section171.2 throughout the length of the fluid pathway173.
• Cross sections of thelower fluid channel172 are illustrated inFIGS. 4A-4B. As illustrated inFIG. 4A, thelower fluid channel172 comprises a lumen172.1 in a portion164D (illustrated inFIG. 5B) of thebase150. The lumen172.1 is of a generally semicircular cross section172.2 in the portion164D. As illustrated inFIG. 4B, thelower fluid channel172 further comprises a lumen172.3 in a portion164B of the base150 between the portion164D and the proximal fluid reservoir157. The lumen172.3 is of a generally semicircular cross section172.4 in this portion. It is to be understood that thelower fluid channel172 in this portion is the same as in a portion164E of the base150E outside the portion164D between the portion164D and thedistal tip226. Thus, thelower fluid channel172 comprises the lumen172.3 in the portion164E having a semi-circular cross section172.4.
• Referring toFIGS. 3, 4A, and 5B-5C together, there is illustrated anexemplary puncture shield140, in accordance with an exemplary embodiment of the present invention.FIG. 4A illustrates an exemplary cross-sectional view of thepuncture shield140 taken along the section line C-C shown inFIG. 3. As illustrated inFIG. 4A, thepuncture shield140 comprises a lumen140.1 which is of a generally semicircular cross section140.2, i.e., it has a semicircular or D-shaped lumen140.1, throughout the length of thepuncture shield140.FIGS. 5A-5B illustrate exemplary cross-sectional views of the dualreservoir access port100 ofFIG. 1.
• As seen in these figures, at least a portion144A of thepuncture shield140 is disposed within the portion164C of thelower fluid channel172 directly underneath the bottom153 of the distal reservoir151 to protect against potential needle penetration into thelower fluid channel172. Thepuncture shield140 is also disposed between the bottom153 of the distal fluid reservoir151 and the secondfluid pathway174. It is to be understood that thepuncture shield140 may extend through thelower fluid channel172 beyond thewalls152 of the distal fluid reservoir151, such as through the portion164D illustrated inFIGS. 5B-5C. In an exemplary embodiment, thepuncture shield140 is a metal or metal alloy tube lining at least the portion164C of thelower fluid channel172 directly underneath the distal reservoir151.
• It is to be understood that the upper and lowerfluid channels171172 may also have alternatively shaped lumens171.1,172.1, and172.3, 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 thepuncture shield140 can be of other sizes and shapes, such as C-shaped, stadium shaped, oval, triangular, rectangular, or trapezoidal, to match the lumens171.1,172.1, and172.3 if they are C-shaped, stadium shaped, oval, triangular, rectangular, or trapezoidal.
• Still other configurations of thepuncture shield140 are contemplated. Referring now toFIG. 4C, there is illustrated a view of a cross section of another exemplary puncture shield, generally designated as140a, in accordance with an exemplary embodiment of the present invention. The cross-section is taken along section line C-C shown inFIG. 3. The puncture shield140ais disposed in theport base150 between the bottom153 of the distal reservoir151 and thelower fluid channel172 to protect against needle penetration into thelower fluid channel172. The puncture shield140acomprises a curved strip of material that covers the top of thelower fluid channel172 for at least the portion164C that is underneath the bottom153 of the distal reservoir151.
• Referring now toFIG. 4D, there is illustrated a view of a cross section of another exemplary puncture shield, generally designated as140b, in accordance with an exemplary embodiment of the present invention. The cross-section is taken along the line C-C shown inFIG. 3. The puncture shield140bis disposed in theport base150 between the bottom153 of the distal reservoir151 and thelower fluid channel172 to protect against needle penetration into thelower fluid channel172. The puncture shield140bcomprises a flat strip of material that covers the top of thelower fluid channel172 for at least the portion164C that is underneath the bottom153 of the distal reservoir151.
• Referring now toFIG. 4E, there is illustrated a view of a cross section of another exemplary puncture shield, generally designated as140c, in accordance with an exemplary embodiment of the present invention. The cross-section is taken along line C-C shown inFIG. 3. The puncture shield140cis disposed in theport base150 underneath the bottom153 of the distal reservoir151 to protect against needle penetration into thelower fluid channel172. The puncture shield140ccomprises a tube of material that surrounds thelower fluid channel172 for at least the portion164C that is underneath the bottom153 of the distal reservoir151.
• Referring now toFIG. 4F, there is illustrated a view of a cross section of another exemplary puncture shield, generally designated as140d, in accordance with an exemplary embodiment of the present invention. The cross-section is taken along the line C-C shown inFIG. 3. The puncture shield140dis disposed at the bottom153 of the distal reservoir151 to protect against needle penetration into thelower fluid channel172. Specifically, the puncture shield140dis a material that lines the bottom153 of the distal reservoir151. In an exemplary embodiment, the puncture shield140dis generally circular.
• Referring now toFIG. 4G there is illustrated a view of a cross section of another exemplary puncture shield, generally designated as140e, in accordance with an exemplary embodiment of the present invention. The cross-section is taken along line C-C shown inFIG. 3. The puncture shield140cis disposed in theport base150 underneath the bottom153 of the distal reservoir151 to protect against needle penetration into thelower fluid channel172. The puncture shield140ecomprises a disk of material that covers the top of thelower fluid channel172 for at least the portion164C that is underneath the bottom153 of the distal reservoir151.
• In the embodiments of the puncture shields shown inFIGS. 3, 4A, and 4C-4G, the puncture shields are formed from a material that is harder than the material forming theport base150. 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 thepuncture shield140 and140a-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 inFIGS. 3, 4A, and4C-4G are for preventing penetration into thelower fluid channel172 by an infusion needle accessing the distal reservoir151.
• The use of a puncture shield allows a minimal distance between the bottom153 of the distal reservoir151 and the top of thelower fluid channel172, which translates to an overall low profile of the dualreservoir access port100 according to an exemplary embodiment of the present invention. In the embodiment shown inFIGS. 3 and 4A, this distance is approximately 0.020 inches. The resulting dualreservoir access port100 has an overall height similar to a single reservoir low profile access port.
• Referring again toFIG. 4A, there is also illustrated the arrangement of thecap110, theport base150, and theindividual septum130. Thecap110 is snapped on theport base150, compressing theindividual septum130 to effect a fluid seal. Receivinggrooves161 along the exterior wall of theport base150 engage lockingribs162 on the corresponding interior surface of thecap110 providing a locking mechanism in this embodiment.FIG. 4B also illustrates the receivinggrooves161 along the exterior wall of theport base150, whichgrooves161 engage the lockingribs162 on the corresponding interior surface of thecap110 to provide the locking mechanism.
• FIG. 5A illustrates an exemplary view of a cross section of the dualreservoir access port100 taken along the section line E-E illustrated inFIG. 3, in accordance with an exemplary embodiment of the present invention. As illustrated inFIG. 5A, theupper fluid channel171 extends from thedistal tip216 of theupper prong210 of thestem200 through the portion164A of thebase150 and to the distal reservoir151. Theupper fluid channel171 opens to the distal reservoir151 via theopening218 in the distal side of thesidewall152 of the reservoir151. As shown inFIG. 5A, theupper fluid channel171 provides a first, upper fluid pathway173 from thedistal tip216 of theupper prong210 of thestem200 through the portion164A of thebase150 and to the distal reservoir151.
• FIG. 5B illustrates an exemplary view of a cross section of the dualreservoir access port100 also taken along the section line E-E illustrated inFIG. 3, in accordance with an exemplary embodiment of the present invention. The view inFIG. 5B differs from that inFIG. 5A because of the illustration of thelower fluid channel172 and thepuncture shield140 inFIG. 5B in dashed lines. Thelower fluid channel172 and thepuncture shield140 are shown in dashed lines to indicate that they lie below the bottom153 of the distal fluid reservoir151. Specifically, the portion164C of thefluid channel172 and thepuncture shield140 lie directly below the distal reservoir151. Thelower fluid channel172 opens to the proximal reservoir157 via theopening228 in the distal side of the sidewall158 of the reservoir157.
• FIG. 5C illustrates an exemplary view of a cross section of thedual reservoir port100 taken along the section line F-F illustrated inFIG. 3, in accordance with an exemplary embodiment of the present invention. As illustrated inFIG. 5C, thelower fluid channel172 extends from the distal tip of thelower prong226 of thestem200 through the portion164B of thebase150 and to the distal reservoir157. Thelower fluid channel172 opens to the proximal reservoir157 via theopening228 in the distal side of the sidewall158 of the reservoir157.
• At least two embodiments for thepuncture shield140 being disposed within thelower fluid channel172 are contemplated. In one embodiment, the portion164D of thelower fluid channel172 in which thepuncture shield140 is disposed is notched so that the inner lumen140.1 of thepuncture shield140 has the same cross section140.2 as the cross section172.4 of the inner lumen172.3 of thelower fluid channel172 in the portion164E. Thefluid channel172 outside the portion164D and the lumen140.1 of thepuncture shield140 together form the lower, secondfluid pathway174, which comprises a lumen174.1 having a cross section174.2. In this embodiment, the cross section174.2 of theeffective fluid channel174 is the same at all points between thedistal tip226 and theopening228.
• FIGS. 5B and 5C illustrate such embodiment. As seen in the figures, the cross section172.2 of the lumen172.1 of thefluid channel172 in the portion164D is oversized to accommodate thepuncture shield140 lining thefluid channel172 in the portion164D. The cross section172.4 of the lumen172.3 of thefluid channel172 outside the portion164D is equal to the cross section140.2 of the lumen140.1 of thepuncture shield140, i.e., the cross section174.2 of the lumen174.1 of thefluid pathway174 remains constant throughout its entire length.
• In another embodiment, thelower fluid channel172 contains no notch in the portion164D. Thus, the cross section172.2 is the same as the cross section172.4. The cross section of thelower fluid channel172 is constant along all lengths of thelower fluid channel172 from thedistal tip226 to theopening228. Thepuncture shield140 is fitted in thelower fluid channel172. Thus, the cross section140.2 of the lumen140.1 of thepuncture shield140 is smaller than the cross sections172.2 and172.4. The lumen174.1 of the lower, secondfluid pathway174 is narrowed in the portion164D such that the cross section174.2 of the lower, secondfluid pathway174 is narrower in the portion164D than the cross section172.4.
• When implanted in a patient, either or both of the reservoirs of thedual reservoir port100 can be accessed from outside through a non-coring infusion needle, e.g., by a needle500 illustrated inFIG. 11B. The infusion needle that is used to penetrate the needle penetrableindividual septa130 is typically the type referred to as a Huber needle. Because of their self-sealing nature, theindividual septa130 can withstand repeated penetration of such an infusion needle without leaking Radial compression around the circumference of theindividual septa130 facilitates the self-sealing of thesepta130.
• When an infusion needle is tapped into the distal reservoir151, fluid infused into the distal reservoir151 travels through the upper fluid pathway173 and into the lumen of the dual lumen catheter400 that is connected to theupper prong210 of the dualprong outlet stem200. Likewise, when an infusion needle is tapped into the proximal reservoir157, fluid infused into the proximal reservoir157 travels through thelower fluid pathway174 and into the lumen of the dual lumen catheter400 that is connected to thelower prong220 of the dualprong outlet stem200.
• The arrangement of straightfluid channels171172 or fluid pathways173174 in the dual reservoirimplantable port100 provides low resistance for fluid passing through the dualreservoir access port100. 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.
• 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 dualreservoir access port100 of the present invention provides straightfluid channels171172 and fluid pathways173174 for both of the distal and proximal reservoirs151157, whichfluid channels171172 and fluid pathways173174 are free from twists and turns. Thefluid channels171172 or fluid pathways173174 of the dual reservoirimplantable port100 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.
• 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. Thedual port100 of the present invention minimizes width as thelower fluid channel172 is not disposed in thewall152. It also minimizes height as thepuncture shield140 and its variations allow for a minimum distance between the bottom153 of the distal reservoir151 and thelower fluid channel172. Decreased height and width allows for smaller incision size.
• 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.
• Referring now toFIG. 6, there is illustrated an elevation view of theoutlet stem portion200 of the dualreservoir access port100, in accordance with an exemplary embodiment of the present invention. As can be seen inFIG. 6, theupper prong210 has a roundedlocking ridge212 disposed around its exterior surface. Thelower prong220 also has a roundedlocking ridge222 disposed around its exterior surface. Therounded locking ridge212 of theupper prong210 and therounded locking ridge222 of thelower prong220 are offset from each other, i.e., the rounded lockingridges212222 are not located at the same distance from thedistal end216226 of the upper andlower prongs210220 of the dualprong outlet stem200. In this particular example, therounded locking ridge212 of theupper prong210 is located proximal, i.e., closer, to thestem base230 compared to therounded locking ridge222. Therounded locking ridge222 of thelower prong220 is located closer to the distal end of thelower prong220 than the lockingridge212. Therounded locking ridge222 is at a first distance from the distal end of thelower prong220, and therounded locking ridge212 is at a second distance from the distal end of theupper prong210 greater than the first distance. The lockingridges212222 have semi-circular cross sections.
• FIG. 7A is another exemplary elevation view of the dual prongoutlet stem portion200 of the dualreservoir access port100 from the line G-G illustrated inFIG. 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 stem200 of the dualreservoir access port100 taken along the section line I-I shown inFIG. 7A, in accordance with an exemplary embodiment of the present invention. As illustrated inFIG. 7A, each of the upper andlower prongs210220 of the dualprong outlet stem200 has a generally semicircular shape.
• Referring now toFIGS. 7A and 7C together, there are illustrated locking ridges of the upper andlower prongs210220 in further detail. Specifically, the locking ridge of theupper prong210 includes therounded locking ridge212 illustrated inFIG. 6 (also referred to herein as an “exterior curved locking ridge”) located on the curved outer surface of theupper prong210 and a further locking ridge214 (an “interior straight locking ridge”) located on the flat side of theprong210 facing theprong220. Similarly, the locking ridge of thelower prong220 includes therounded locking ridge222 illustrated inFIG. 6 (also referred to herein as an “exterior curved locking ridge”) located on the curved outer surface of thelower prong220 and a further locking ridge224 (an “interior straight locking ridge”) located on the flat side of theprong220 facing theprong210.
• The lockingridges212214 for both theupper prong210 of the dualprong outlet stem200 and the lockingridges222224 of thelower prong220 can be seen to encircle the exterior circumference of therespective prong210220. The exterior curved lockingridge212 of theupper prong210 follows the exterior curved contour of the exterior of theupper prong210, and the interiorstraight locking ridge214 of theupper prong210 follows the generally flat side of theupper prong210 that faces thelower prong220. The exterior curved lockingridge222 of thelower prong220 follows the exterior curved contour of the exterior of thelower prong220, and the interior straight locking224 ridge of thelower prong220 follows the generally flat side of thelower prong220 that faces theupper prong210. In this view, the lockingridges212214 of theupper prong210 are offset from the lockingridges222224 of thelower prong220, and are closer to thestem base230. The curved and flat outer surfaces of the stems define the fluid channels within theprongs210220.
• In this particular embodiment, the upper andlower prongs210220 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 andlower prongs210220, the lockingridges212214 of theupper prong210 are of a slightly larger circumferential length than the lockingridges222224 of thelower prong220. Namely, the arc length of the lockingridge212 is greater than the arc length of the lockingridge222, and the length of the lockingridge214 is greater than the length of the lockingridge224. The upper and lowerfluid channels171 and172 are of a generally constant size throughout theirrespective prongs210220.
• Referring now toFIG. 7B, there is illustrated a view of a cross section of the dual prongoutlet stem base230 taken along the section line H-H illustrated inFIG. 6. As shown inFIG. 7B, theupper fluid channel171 and thelower fluid channel172 respectively comprise semicircular cross sections171.2 and172.2 in thebase230. In this embodiment, theupper fluid channel171 is stacked vertically over thelower fluid channel172.
• FIG. 8 illustrates an exemplary view of a cross section of the dual lumen catheter400 taken along the section line B-B illustrated inFIG. 2, in accordance with an exemplary embodiment of the present invention. The dual lumen catheter400 comprises an exterior wall480, which surrounds two lumens440 and450, which are separated from one another by a dividing wall470. The exterior wall480 of the dual lumen catheter400 is generally of a circular or oval cross section. The lumens440450 are generally D-shaped or C-shaped, though other shapes may also be used. The lumens440450 may be of equal sizes. The interior dimensions of the lumens440450 are comparable to the exterior dimensions of the upper andlower prongs210220 of the dualprong outlet stem200.
• FIG. 9A is an exemplary cross-sectional side view of an example where a dual lumen catheter400 and lockingcollar300 are in position to be connected to the dual prong outlet stem200 of the dualreservoir access port100, in accordance with an exemplary embodiment of the present invention. Thelocking collar300 comprises two generally hollow cylindricalshaped end sections310 and a narrow waist320. The twoend sections310 are identical to each other, i.e., thelocking collar300 is symmetrical about a middle point of the waist320. Thelocking collar300, therefore, can be used in either direction. The symmetrical shape greatly simplifies the connection of the dual lumen catheter400 to thedual reservoir port100, since a medical practitioner does not have to distinguish the orientation of thelocking collar300 during the implantation procedure.
• The narrow waist320 of thelocking collar300 has a smaller inner diameter than theend sections310. In the embodiment shown inFIG. 9A, the interior of both of theend sections310 gradually narrows to the inner diameter of the narrow waist320. The inner diameter of the narrow waist320 is slightly larger than the combined outer diameter of the upper andlower prongs210220 between the offset lockingridges212214 of theupper prong210 and the lockingridges222224 of thelower prong220. The width of the narrow waist320 is approximately equal or slightly shorter than the offset distance between lockingridges212214 of theupper prong210 and the lockingridges222224 of thelower prong220.
• The narrow waist320 is designed to fit between the rounded locking ridge of theupper prong212 and the rounded locking ridge of thelower prong222 in its locking position, thereby frictionally securing the dual lumen catheter400 to the dualprong outlet stem200. When a medical practitioner connects the dual lumen catheter400 to the dualreservoir access port100, he first slips each lumen440450 of the dual lumen catheter400 onto theupper prong210 andlower prong220 of the dualprong outlet stem200, respectively, and pushes the dual lumen catheter400 over the lockingridges212214 of theupper prong210 and the lockingridges222224 of thelower prong220. The taper that is incorporated in the upper andlower prongs210220 facilitates this operation. The practitioner then slides thelocking collar300 over the set of the lockingridges222224. Thelocking collar300 is in the locked position when thelocking collar300 rests between the lockingridges212214 and the lockingridges222224. In the particular embodiment shown inFIG. 9A, the maximum ridge-to-ridge distance (measured from the midpoint of the lockingridges212214 of theupper prong210 to the midpoint of the lockingridges222224 of the lower prong220) is approximately 0.128 inches, and the interior width of the narrow waist320 (including the ramps on either side of the midpoint of the locking collar300) is also approximately 0.128 inches.
• FIG. 9B illustrates a cross-sectional side view of the dual lumen catheter400 and lockingcollar300 attached to thestem200 of the dualreservoir access port100, in accordance with an exemplary embodiment of the present invention. When thelocking collar300 is in the locked position, the upper and lowerexterior locking ridges212222 compress the exterior wall480 of the dual lumen catheter400 against the interior of thelocking collar300, particularly against the narrow waist320. The upper and lowerinterior locking ridges214224 compress the dividing wall470 of the dual lumen catheter400 against the opposite prong. In other words, theinterior locking ridge214 compresses the dividing wall470 against theprong220, and theinterior locking ridge224 compresses the dividing wall470 against theprong210. These multiple compression points contribute to create a fluid tight connection between the dual lumen catheter400 and the dualreservoir access port100.
• In the embodiments shown inFIGS. 6, 7, and 9, the lockingridges212214 of theupper prong210 are closer to thestem base230, and the lockingridges222224 of thelower prong220 are closer to thedistal end216226 of the dualprong outlet stem200. 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.
• FIG. 10A is a cut away view of one embodiment of anindividual septum130 used with an exemplary embodiment of the dualreservoir access port100 of the present invention. Theindividual septum130 comprises anupper dome131, anupper compression zone139, aflange133, and alower plug137. Theflange133 comprises a flatupper surface135 and a flatlower surface136. In this particular embodiment, theflange133 further comprises an upper sealing ring132, alateral sealing ring134, and abottom sealing ring138. The upper and bottom sealing rings132138 are rounded ridges located respectively on the top andbottom surfaces135136 of theflange133. Thelateral sealing ring134 is a thin strip surrounding the outer circumference of theflange133. In the embodiment illustrated inFIG. 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.
• FIG. 10B is an enlarged cross-sectional view of portion J inFIG. 4A, illustrating a portion of theseptum130 assembled into thecap110 andport base150 of one embodiment of the dualreservoir access port100, in accordance with an exemplary embodiment of the present invention. When thecap110 is locked in place against theport base150, thecap110 compresses theindividual septum130 against theport base150. The upper sealing ring132 and thelateral sealing ring134 of theseptum130 make contact with thecap110 and deform to form fluid tight seals. Thebottom sealing ring138 makes contact with the top surface154 of theport base150, and deforms to make a fluid tight seal. Thelower plug137 also radially compresses against thesidewalls152158 of the respective distal and proximal reservoirs151157, further helping to seal the respective reservoirs.
• Referring now toFIG. 11A there is illustrated an exemplary perspective view of alternative embodiment of thepuncture shield140, generally designated as1100, in accordance with an exemplary embodiment of the present invention. Thepuncture shield1100 comprises a pair of end portions1120A and1120B. The end portion1120A comprises a lumen1130A having a D-shaped cross-section1160A, and the end portion1120B comprises a lumen1130B having a D-shaped cross-section1160B.
• The flat-side portions of the D-shaped portions1120A and1120B are seamlessly connected to one another by a flatplanar portion1110. Viewed another way, thepuncture shield1100 is a D-shaped tube with a semi-cylindrical portion removed to leave the flatplanar portion1110 and the end portions1120A and1120B.
• Referring now toFIG. 11B, there is illustrated an exemplary cross-sectional view of an exemplary embodiment of thedual port100, generally designated as100′, in which thepuncture shield140 is replaced with thepuncture shield1100, in accordance with an exemplary embodiment of the present invention. It is to be understood that like elements inFIGS. 1-3 and 5 are illustrated inFIG. 11B. The view inFIG. 11B is of a cross-section of theport100′ taken along a section line similar to the section line A-A illustrated inFIG. 2.
• FIG. 11B illustrates that thepuncture shield1100 is disposed in the portion164D of thebase150 underneath the bottom153 of the distal reservoir151 to prevent a needle500 from penetrating the bottom of the reservoir151 and entering thelower fluid channel172. Thepuncture shield1100 is also disposed between the bottom153 of the distal fluid reservoir151 and the secondfluid pathway174.
• At least a portion1144A of the puncture shield1100 (corresponding to the portion144A of the puncture shield140) is disposed within the portion164C of thelower fluid channel172 directly underneath the distal reservoir151. It is to be understood that thepuncture shield1100 may extend through thelower fluid channel172 beyond thewalls152 of the distal fluid reservoir151, such as through the portion164D illustrated inFIGS. 5B-5C. It also is to be understood that thepuncture shield1100 can be of other sizes and shapes, such as C-shaped, stadium shaped, oval, triangular, rectangular, or trapezoidal, to match the lumens172.1 and172.3 if they are C-shaped, stadium shaped, oval, triangular, rectangular, or trapezoidal.
• Thepuncture shield1100 is formed from a material that is harder than the material forming theport base150. More preferably, the material is one that, at a thin thickness, would withstand penetration by a infusion needle. In an exemplary embodiment, thepuncture shield1100 is a metal or metal alloy tube lining at least the portion164C of thelower fluid channel172 directly underneath the distal reservoir151. In an exemplary embodiment, titanium is used for the construction of thepuncture shield1100. 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.
• With respect toFIGS. 11A and 11B together, the flatplanar portion1110 of thepuncture shield1100 comprises a width1150 which is desirably greater than the width of thefluid channel172 to ensure that thefluid channel172 is fully covered to prevent a needle penetrating through the bottom of the reservoir151 and into thefluid channel172. Thepuncture shield140 comprises alength1140, which is desirably greater than the length of the portion164C of thefluid channel172.
• At least three embodiments for thepuncture shield1100 lining thelower fluid channel172 are contemplated. In one embodiment, the portion164D of thelower fluid channel172 in which thepuncture shield1100 is disposed is notched so that the inner lumen1130A1130B of thepuncture shield1100 in the end portions1120A and1120B has the same cross sections1160A and1160B as the cross section172.4 of the inner lumen172.3 of thelower fluid channel172 in the portion164E. Thefluid channel172 outside the portion164D and the lumen1130A1130B of thepuncture shield1100 together form the lower, secondfluid pathway174, which comprises a lumen174.1 having a cross section174.2. In this embodiment, the cross section174.2 of theeffective fluid pathway174 is the same at all points between thedistal tip226 and theopening228, except in the portion between the end portions1120A and1120B because the lower portion of the notch portion164D is not entirely filled by a corresponding portion of thepuncture shield1100.
• In another embodiment, the portion164D of thelower fluid channel172 which is notched is shaped to match the shape of thepuncture shield1100. Thus, the cross section174.2 of theeffective fluid pathway174 is the same at all points between thedistal tip226 and theopening228 and is equal to the cross section172.4. In yet another embodiment, thelower fluid channel172 contains no notch. Thus, the cross section172.2 is the same as the cross section172.4 in the portion164E. The cross section of thelower fluid channel172 is constant along all lengths of thelower fluid channel172 from thedistal tip226 to theopening228. Thepuncture shield140 is fitted in thelower fluid channel172. Thus, the lumen174.1 of theeffective fluid pathway174 has a slightly narrower cross section174.2 where thepuncture shield1100 is disposed in thelower fluid channel172.
• Referring now toFIG. 12A, there is illustrated an exemplary elevation view of an alternative exemplary embodiment of thestem200, designated generally as200′, in accordance with an exemplary embodiment of the present invention. As can be seen inFIG. 12A, theupper prong210 of thestem200′ comprises a firstrounded locking ridge1210A and a second locking ridge1210B disposed around its exterior surface. Thelower prong220 comprises a firstrounded locking ridge1220A and a second rounded locking ridge1210B disposed around its exterior surface. Interiorflat surfaces1212 and1222 of therespective prongs210 and220 are smooth and contain no locking ridges.
• Referring now toFIG. 12B, there is illustrated a front, planar view of thestem200′ from a line K-K illustrated inFIG. 12A, in accordance with an exemplary embodiment of the present invention.FIG. 12C illustrates an exemplary cross-sectional view of the dual prong outlet stem200′ taken along a section line L-L shown inFIG. 12B, in accordance with an exemplary embodiment of the present invention. As illustrated inFIG. 12B, each of the upper andlower prongs210 and220 of the dual prong outlet stem200′ is of generally semicircular shape as is the case with the dualprong outlet stem200.
• FIGS. 12B and 12C together illustrate the locking ridges1210 and1220 of the upper andlower prongs210 and220 in further detail. Specifically, the lockingridges1210A and1210B are each an exterior, curved locking ridge located on the curved outer surface of theupper prong210. Similarly, the lockingridges1220A and1220B are each an exterior, curved locking ridge located on the curved outer surface of thelower prong220. None of the lockingridges1210A and1210B includes an interior, straight locking ridge located on the interiorflat surface1212 of theprong210 facing theprong220, and none of the lockingridges1220A and1220B includes an interior, straight locking ridge located on the interiorflat surface1222 of theprong220.
• The lockingridges1210A and1210B each have a semi-circular cross section, as illustrated inFIG. 12C. Specifically, the lockingridge1210A has a semi-circular cross section1211A, and the locking ridge1210B has a semi-circular cross section1211B. Similarly, the lockingridges1220A and1220B each have a semi-circular cross section. Specifically, the lockingridge1220A has asemi-circular cross section1221A, and the locking ridge1220B has a semi-circular cross section1221B. The semi-circular cross sections1211 and1221 of the locking ridges1210 and1220 facilitate insertion of the catheter400 onto thestem200′ as the catheter400 passes over the rounded surfaces more easily than if the surfaces were barb-shaped. At the same time, the locking ridges1210 and1220 allow for the use of thelocking collar300 to secure the catheter400 to thedual port100. When slipped over the catheter400 disposed on thestem200′, the narrow waist320 of thelocking collar300 is disposed between the lockingridges1210A and1210B and between the lockingridges1220A and1220B.
• The locking ridges1210 of theupper prong210 of the dual prong outlet stem200′ and the locking ridges1220 of thelower prong220 do not encircle the exterior circumference of therespective prong210 and220, unlike the lockingridges212 and222, as described above. The exterior, curved locking ridges1210 of theupper prong210 follow the curved contour of the exterior of theupper prong210. As mentioned above, there is no corresponding interior, straight locking ridge on the flatinside surface1212 of theupper prong210. The exterior, curved locking ridges1220 of thelower prong220 follow the curved contour of the exterior of thelower prong220. As mentioned above, there is no corresponding interior, straight locking ridge on the flatinside surface1222 of thelower prong220.
• In the particular embodiment illustrated inFIGS. 12A-C, the upper andlower prongs210 and220 are slightly tapered on their exterior curved surfaces and also on theflat surfaces1212 and1222 that face each other. Because of the slight taper of the upper andlower prongs210 and220, the locking ridge1210B of theupper prong210 is of a slightly larger arc length than the lockingridge1210A, and the locking ridge1220B of thelower prong220 is of a slightly larger arc length than the lockingridge1220A. The upper and lowerfluid channels171 and172 are of a generally constant size, i.e., cross section, throughout the length of thestem200′ despite the taper. The taper of theprongs210 and220 of thestem200′ facilitates insertion of the catheter400 onto thestem200′. The constant cross-sectional size of thefluid channels171 and172 facilitates proper flow characteristic during infusion.
• The dualprong outlet stem200 and200′ and theport base150 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 stem200 or200′ and theport base150 may be attached together through welding, solvent bonding, adhesion, or other suitable manufacturing methods. To manufacture theport base150 via an injection molding process, a mold is formed and mandrels are inserted into the mold for thefluid channels171172. Thepuncture shield140 or1100 is disposed about the mandrel for thelower fluid channel172. The material forming the port base is injected into the mold. Theport base150 is removed from the mold and mandrels, and thesepta130 are pressed into the reservoirs151 and157. Thecap110, molded separately, is snapped onto theport base150. Preferably, thecap110 is solvent bonded to theport base150. The dualreservoir access port100 or100′ is complete. Alternatively, theport base150, theoutlet stem200 or200′, and thecap110 may be formed integrally, e.g., injection molded using a collapsible core pin, or machined from a stock material.
• In an exemplary embodiment, the dualreservoir access port100 or100′ is formed from biocompatible plastic materials. Thecap110 and theport base150 may be made from polysulfone resin or acetal plastic. Thecap110 and theport base150 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. Eachindividual septum130 is typically made from a silicone elastomer, such as polysiloxanes, and other similar compounds known to those skilled in the art.
• In an exemplary embodiment, the dual lumen catheter400 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 catheter400 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 catheter400 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.
• In the particular embodiment shown inFIGS. 1 and 3, a cavity501 is formed in the dividing wall155 of theport base150 between the reservoirs151 and157. The cavity501 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 cavity501, which provides a serial number of the device, date, and batch information, and identifies theport100 as a dualreservoir access port100 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 cavity501 may be anywhere within the implantable port, as long as it does not interfere with the functionality of the port.
• 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.

Claims (21)

1-26. (canceled)

27. An access port base, comprising:

a proximal end having a proximal fluid reservoir comprising a bottom wall at a bottom of the proximal fluid reservoir;

a distal end having a distal fluid reservoir comprising a bottom wall at a bottom of the distal fluid reservoir;

a first fluid channel extending through a first portion of the access port base, the first fluid channel providing a first fluid pathway from the distal end to the distal fluid reservoir;

a second fluid channel extending through a second portion of the access port base, the second fluid channel providing a second fluid pathway from the distal end to the proximal fluid reservoir, a first portion of the second fluid channel disposed in the bottom wall of the distal fluid reservoir beneath the distal fluid reservoir; and

a puncture shield, at least a portion of which is disposed at the bottom wall of the distal fluid reservoir.

28. The access port base ofclaim 27, wherein the puncture shield has a flat planar portion.

29. The access port base ofclaim 27, wherein a top of the puncture shield is in a same geometric plane as a top of the bottom wall of the distal fluid reservoir.

30. The access port base ofclaim 27, wherein the first fluid channel and the second fluid channel are stacked vertically.

31. The access port base ofclaim 27, wherein the first fluid pathway consists of a strait path.

32. The access port base ofclaim 27, wherein the second fluid pathway consists of a strait path.

33. The access port base ofclaim 27, wherein each of the first fluid pathway and second fluid pathway consists of a strait path.

34. The access port base ofclaim 27, wherein the distal fluid reservoir further comprises sidewalls and the puncture shield extends through at least one sidewall.

35. The access port base ofclaim 28, wherein the flat planar portion comprises a width that is greater than a width of at least a portion of the second fluid channel.

36. The access port base ofclaim 27, wherein the puncture shield comprises a length that is greater than a length of the first portion of the second fluid channel.

37. The access port base ofclaim 27, wherein the puncture shield comprises a tube.

38. The access port base ofclaim 27, wherein at least a portion of the puncture shield lines at least a portion of the second fluid channel.

39. The access port base ofclaim 27, wherein at least a portion of the puncture shield has a cross section that matches a cross section of the second fluid channel.

40. An access port base comprising:

a proximal end having a proximal fluid reservoir comprising a bottom wall at a bottom of the proximal fluid reservoir;

a distal end having a distal fluid reservoir comprising a bottom wall at a bottom of the distal fluid reservoir;

a dual prong outlet stem projecting from the distal end, the dual prong outlet stem comprising a first prong comprising a first distal tip, and a second prong comprising a second distal tip;

a first fluid pathway consisting of a straight path from the first distal tip of the first prong leading to a first fluid channel extending through a first portion of the access port base and ending at the distal fluid reservoir;

a second fluid pathway consisting of a straight path from the second distal tip of the second prong to a second fluid channel extending through a second portion of the access port base and ending at the proximal fluid reservoir, a portion of the second fluid channel disposed in the bottom wall of the distal fluid reservoir beneath the distal fluid reservoir; and

a puncture shield, at least a portion of which is disposed at the bottom wall of the distal fluid reservoir.

41. The access port base ofclaim 40, wherein the puncture shield has a flat planar portion.

42. The access port base ofclaim 40, wherein a top of the puncture shield is in a same geometric plane as a top of the bottom wall of the distal fluid reservoir.

43. The access port base ofclaim 40, wherein the first fluid channel and the second fluid channel are stacked vertically.

44. The access port base ofclaim 40, wherein the distal fluid reservoir further comprises sidewalls and the puncture shield extends through at least one sidewall.

45. The access port base ofclaim 41, wherein the flat planar portion comprises a width that is greater than a width of at least a portion of the second fluid channel.

46. The access port base ofclaim 40, wherein the puncture shield comprises a length that is greater than a length of the portion of the second fluid channel disposed in the bottom wall of the distal fluid reservoir.

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