Patent Description:
Briefly summarized, embodiments of the present invention are directed to a low-profile access port for subcutaneous implantation within the body of a patient, as defined in claim <NUM>. The dependent claims refer to preferred embodiments. The access port includes a receiving cup that provides a relatively large subcutaneous target to enable a catheter-bearing needle to access the port without difficulty. In addition, the access port includes a valve/seal assembly to permit pressurized fluid injection through the port while preventing backflow.

In one embodiment, therefore, a low-profile access port comprises a body including a conduit with an inlet port at a proximal end thereof, and a receiving cup. The receiving cup is concavely shaped to direct a catheter-bearing needle into the conduit via the inlet port. The receiving cup is oriented substantially toward a skin surface when subcutaneously implanted within the patient to ease needle impingement thereon. A valve/seal assembly disposed in the conduit enables passage of the catheter therethrough while preventing fluid backflow.

In another embodiment, a low-profile access port for subcutaneous implantation within the patient is disclosed and comprises a body including a conduit with an inlet port at a proximal end thereof, and a receiving cup. The receiving cup is funnel shaped to direct a catheter-bearing needle into the conduit via the inlet port. The conduit is defined by the body and extends from the inlet port to an outlet defined by a stem. A bend in the conduit enables catheter advancement past the bend while preventing needle advancement. A valve/seal assembly is also disposed in the conduit and enables passage of the catheter therethrough while
preventing fluid backflow. The body includes radiopaque indicia configured to enable identification of the access port via x-ray imaging.

In light of the above, embodiments herein are generally directed to a vascular access device, also referred to herein as an access port, for subcutaneous implantation within the body of a patient. The implanted access port is transcutaneously accessible by a catheter-bearing needle, such as a peripheral intravenous ("PIV") catheter, so as to place the PIV catheter into fluid communication with the access port. A fluid outlet of the access port is operably connected to an in-dwelling catheter disposed within the vasculature of a patient, in one embodiment, to enable the infusion into and/or removal of fluids from the patient's vasculature to take place via the PIV catheter.

These and other features of embodiments of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of embodiments of the invention as set forth hereinafter.

Reference will now be made to figures wherein like structures will be provided with like reference designations. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the present invention, and are neither limiting nor necessarily drawn to scale.

For clarity it is to be understood that the word "proximal" refers to a direction relatively closer to a clinician using the device to be described herein, while the word "distal" refers to a direction relatively further from the clinician. For example, the end of a catheter placed within the body of a patient is considered a distal end of the catheter, while the catheter end remaining outside the body is a proximal end of the catheter. Also, the words "including," "has," and "having," as used herein, including the claims, shall have the same meaning as the word "comprising.

Embodiments of the present invention are generally directed to an access port for subcutaneous implantation within the body of a patient. The implanted access port is transcutaneously accessible by a catheter-bearing needle, such as a peripheral intravenous ("PIV") catheter, so as to place the PIV catheter into fluid communication with the access port. A fluid outlet of the access port is operably connected to an in-dwelling catheter disposed within the vasculature of a patient, in one embodiment, to enable the infusion into and/or removal of fluids from the patient's vasculature to take place via the PIV catheter.

In accordance with one embodiment, the access port defines a low profile so as to facilitate ease of placement within the subcutaneous tissue of the patient. Further, the access port is configured to provide a relatively large subcutaneous target to enable the PIV catheter or other suitable catheter-bearing needle to access the port without difficulty. In addition, the access port includes a valve/seal assembly to permit the injection of fluids through the access port at a relatively high flow rate, such as about <NUM> per second at a pressure of about <NUM> psi (also referred to herein as "power injection"). Possible applications for the access port described herein include administration of medicaments and other fluids to the patient, pheresis/apheresis, fluid aspiration, etc..

Reference is first made to made to <FIG>, which show various details of an access port, generally designated at <NUM>, in accordance with one embodiment. As shown, the port <NUM> includes a body <NUM> that is defined in the present embodiment by a first portion 12A and a second portion 12B (<FIG>). In the present embodiment the port body <NUM> includes a metal such as titanium, and as such, the second portion 12B is press fit into engagement with the first portion 12A to define the body, though it is appreciated that the port body can include a variety of other materials, including metals, thermoplastics, ceramics, etc..

The port body <NUM> defines in the present embodiment a substantially concavely-shaped receiving cup <NUM> for receiving and directing a catheter-bearing needle (<FIG>) to operably connect with the port <NUM>, as described further below. In particular, the substantially concave shape of the receiving cup <NUM> is configured to direct a catheter-bearing needle (<FIG>) impinging thereon toward an inlet port <NUM> that serves as an opening for a conduit <NUM> defined by the port body <NUM>. The open and shallow nature of the receiving cup <NUM> together with its substantially upward orientation (i.e., toward the skin surface of the patient), so that it is substantially parallel to the skin surface when subcutaneously implanted under the skin of the patient (i.e., the receiving cup is substantially parallel to the skin surface when the skin is at rest, or undeformed by digital pressure or manipulation), enables the receiving cup to present a large, easily accessible target for the needle when introduced into the skin, as seen in <FIG> further shows that the port <NUM> defines a relatively low profile height, which enables relatively shorter needle lengths to be used for accessing the port after implantation.

Palpation features <NUM> are included with the port body <NUM> to assist a clinician to locate and/or identify the port <NUM> via finger palpation after implantation under the skin of the patient. In detail, the palpation features <NUM> in the present embodiment include a bump 26A disposed near the proximal end of the receiving cup <NUM> and a ridge 26B disposed above and curving around a distal portion of the receiving cup. <FIG> shows that the palpation features extend above the general upper plane defined by the port <NUM> so as to facilitate palpation of the features by a clinician in order to locate the position and/or orientation of the receiving cup <NUM>. Note that a variety of other sizes, configurations, numbers, etc., of palpation features can be included on the port in addition to what is shown and described herein.

A guide groove <NUM> is defined on the receiving cup <NUM> and is longitudinally aligned with the inlet port <NUM> of the conduit <NUM>. The guide groove <NUM> is defined as a depression with respect to adjacent portions of the surface of the receiving cup <NUM> and extends distally along the receiving cup surface from a proximal portion of the receiving cup so as to provide a guide path to guide the distal tip of the catheter-bearing needle toward the inlet port <NUM> once impingement of the needle into the guide groove is made. This in turn reduces the chance the needle will slide across and off the receiving cup <NUM> during insertion. Note that these and other similar features, though differing in shape and configuration, can also be included on the other ports disclosed herein.

As best seen in <FIG>, the port body <NUM> further defines the conduit <NUM> as a pathway into which a transcutaneously inserted catheter can pass so as to place the catheter in fluid communication with the port <NUM>. As shown, the conduit <NUM> is in communication with the receiving cup <NUM> via the inlet port <NUM>. A first conduit portion 18A of the conduit <NUM> distally extends from the inlet port <NUM> in an angled downward direction from the perspective shown in <FIG> to a bend <NUM>, where a second conduit portion 18B of the conduit angles slightly upward and changes direction at a predetermined angle θ<NUM>. Note that angle orientation θ<NUM> in one embodiment is about <NUM> degrees, but can vary from this in other embodiments, including angles less than <NUM> degrees in one embodiment. The magnitude of angle θ<NUM> depends in one embodiment on various factors, including the size of the catheter and/or needle to be inserted into the port conduit, the size of the conduit itself, etc..

The conduit <NUM> then extends to and through a cavity 20A defined by a valve housing <NUM> of the port body. The conduit <NUM> extends to a distal open end of the stem <NUM> of the port <NUM>. The conduit <NUM> is sized so as to enable the catheter <NUM> (<FIG>) to pass therethrough, as will be seen.

As mentioned, the valve housing <NUM> defines a cavity 20A through which the conduit passes and which houses a valve/seal assembly <NUM>. The valve/seal assembly <NUM> includes a sealing element, or seal <NUM>, which defines a central hole through which the catheter <NUM> can pass, a first slit valve 34A and a second slit valve 34B. The seal <NUM> and valves 34A, 34B are sandwiched together in one embodiment and secured in place within the cavity 20A as shown in <FIG>. The slits of the slit valves 34A, 34B are rotationally offset from one another by about <NUM> degrees in the present embodiment, though other relationships are possible.

The seal <NUM> and valves 34A, 34B of the valve/seal assembly <NUM> cooperate to enable fluid-tight passage therethrough of the catheter <NUM> (<FIG>) while also preventing backflow of fluid through the valve/seal assembly. Indeed, in one embodiment the seals disclosed herein prevent fluid flow around the external portion of the catheter when the catheter is disposed through the seal, while the valves are suitable for preventing fluid flow when no catheter passes through them. As such, when the catheter <NUM> is not inserted therethrough the valve/seal assembly <NUM> seals to prevent passage of air or fluid. In the present embodiment, the seal <NUM> and valves 34A, 34B include silicone, though other suitably compliant materials can be employed.

The port <NUM> in the present embodiment includes an overmolded portion <NUM> that covers the port body <NUM>. The overmolded portion <NUM> includes silicone or other suitably compliant material and surrounds the body <NUM> as shown so as to provide a relatively soft surface for the port <NUM> and reduce patient discomfort after port implantation. The overmolded portion <NUM> includes two predetermined suture locations <NUM>, best seen in <FIG>, for suturing the port <NUM> to patient tissue, though sutures may be passed through other portions of the overmolded portion, if desired. The overmolded portion <NUM> further defines a relatively flat bottom surface 36A so as to provide a stable surface for the port <NUM> in its position within the tissue pocket after implantation. In contrast, the port shown in <FIG> includes a bottom surface with a slightly rounded profile.

<FIG> depicts details regarding the insertion of the catheter <NUM> disposed on the needle <NUM>, according to one embodiment. After locating the port <NUM> via through-skin palpation of the palpation features <NUM>, a clinician uses the catheter-bearing needle <NUM> to pierce a skin surface <NUM> and insert the needle until a distal tip 42A thereof impinges on a portion of the receiving cup <NUM>, as shown. Note that, because of the orientation of the receiving cup <NUM> as substantially parallel to the skin surface, the needle <NUM> can impinge on the receiving cup at an insertion angle θ<NUM> that is relatively steep, which facilitates ease of needle insertion into the body. Indeed, in one embodiment a needle inserted substantially orthogonally through the skin of the patient can impinge the receiving cup of the access port.

The needle <NUM> is manipulated until the distal tip 42A is received into the guide groove <NUM>, which will enable the distal tip to be guided along the groove to the inlet port <NUM>. The needle <NUM> is then inserted through the inlet port <NUM> and into the first portion 18A of the conduit <NUM> until it is stopped by the bend <NUM>. The needle <NUM> can then be proximally backed out a small distance, and the catheter <NUM> advanced over the needle such that the catheter bends and advances past the bend <NUM> into the second portion 18B of the conduit <NUM>. Catheter advancement continues such that a distal end 40A of the catheter <NUM> advances into and past the hole of the seal <NUM> and through both slits of the slit valves 34A, 34B of the valve/seal assembly <NUM>. Once the distal end 40A of the catheter <NUM> has extended distally past the valve/seal assembly <NUM>, further advancement can cease and fluid transfer through the catheter <NUM> and port <NUM> can commence, including infusion and/or aspiration through the stem <NUM>. Once fluid transfer is completed, the catheter <NUM> can be withdrawn proximally through the valve/seal assembly <NUM> and the conduit, then withdrawn through the surface <NUM> of the skin and out of the patient.

<FIG> depict details of an access port <NUM> according to another embodiment. Note that various similarities exist between the port <NUM> and the other ports shown and described herein. As such, only selected port aspects are discussed below. As shown, the port <NUM> includes a body <NUM> that in turn includes a first body portion 112A and a second body portion 112B, best seen in <FIG>. The body <NUM> in the present embodiment includes a thermoplastic, such as an acetyl resin in the present embodiment. As such, the first and second body portions 112A, 112B are ultrasonically welded to one another to define the body <NUM>, in the present embodiment. As before, a receiving cup <NUM> is included with the body <NUM> and is operably connected to a conduit <NUM> via an inlet port <NUM>. Also, note that a variety of materials can be used to define the port body, receiving cup, conduit, etc..

A valve/seal assembly <NUM> is disposed within a cavity 120A that is defined by a valve housing <NUM>, which in the present embodiment, is defined by the first body portion 112A. The valve/seal assembly <NUM> includes a proximal seal <NUM> with a central hole for catheter passage, two slit valves 134A, 134B each with a slit arranged at a <NUM>-degree offset with respect to the other, and a distal seal <NUM> with a central hole, also referred to herein as a sphincter seal.

The distal seal <NUM> includes on its distal surface a frustoconical portion 135A disposed about the seal central hole that is configured to provide a sphincter-like seal about the outer surface of a catheter when it extends through the valve/seal assembly. The frustoconical portion 135A is disposed such that any back-flowing fluid impinging on the frustoconical portion will cause the seal to secure itself about the outer surface of the catheter in an even tighter engagement, thus preventing backflow past the catheter outer surface when high fluid pressures are present, such as in the case of power injection. As mentioned, other valve/seal combinations can also be included in the valve/seal assembly.

In the present embodiment, the receiving cup <NUM> and portion of the conduit <NUM> proximal to the valve/seal assembly <NUM> both include a needle-impenetrable lining that prevents the distal end of a needle from gouging the surface when impinging thereon. This, in turn, prevents the undesirable creation of material flecks dug by the needle. Various suitable materials can be employed for the needle-impenetrable material, including glass, ceramic, metals, etc. In one embodiment, the components of the port <NUM> are all non-metallic such that the port is considered MRI-safe, by which the port does not produce undesired artifacts in MRI images taken of the patient when the port is in implanted therewithin.

<FIG> depicts additional features of the port <NUM> according to another embodiment. As shown, in the present embodiment the receiving cup <NUM> includes radiopaque indicia <NUM> to indicate a characteristic of the port <NUM>. Here, the radiopaque indicia <NUM> includes a "C" and a "T" that are formed by a radiopaque material, such as tungsten, bismuth trioxide, etc., so as to be visible after port implantation via x-ray imaging technology. For instance, the radiopaque material can be formed as an insert that is insert-molded included in the port body, as an initially flowable material that is injected into a cavity of the port body before hardening, etc. In embodiments where the port body is metallic, the radiopaque indicia can be formed by etching, engraving, or otherwise producing a relative thickness difference between the indicia and the surrounding port body material so as to produce an x-ray-discernible contrast that shows up in an x-ray image.

In the present embodiment, the CT radiopaque indicia <NUM> indicate to an observer that the port is capable of power injection of fluids therethrough. In addition to this characteristic, other characteristics can be indicated by various other types of indicia as appreciated by one skilled in the art.

Further, in the present embodiment the top view of the port <NUM> of <FIG> indicates that the port body <NUM> in the region surrounding the receiving cup <NUM> defines a generally triangular shape, which can be palpated by a clinician after implantation and can indicate not only the location of the receiving cup, but also a particular characteristic of the port, such as its ability to be used for power injection. Of course, the receiving cup may define shapes other than triangular in other embodiments.

<FIG> further shows that distributed about the perimeter of the receiving cup <NUM> are three palpation features <NUM>, namely, three suture plugs 126A disposed in corresponding holes defined in the port body <NUM>. The suture plugs 126A include raised silicone bumps in the present embodiment and can serve to locate the position of the receiving cup <NUM> post-implantation when they are palpated by a clinician prior to needle insertion into the patient. Various other palpation features could be included with the port, in other embodiments.

<FIG> depicts details of a low-profile port <NUM> according to one embodiment, including a body <NUM> defining a concavely-shaped receiving cup <NUM> and an inlet port <NUM> positioned slightly off-center with respect to the receiving cup. A stem <NUM> is included as a fluid outlet.

<FIG> depicts the low-profile port <NUM> according to another embodiment, wherein the body <NUM> defining additional surface features, including a raised palpation feature <NUM> distal to the receiving cup <NUM>. In light of <FIG> and <FIG>, it is thus appreciated that the port can be configured in a variety of shapes and configurations to provide a low-profile solution for providing vascular access. Note also that the receiving cup shape, design, and configuration can vary from is explicitly shown and described herein.

<FIG> and <FIG> depict various details of a low-profile dual-body access port <NUM> according to one embodiment, wherein each of the port bodies <NUM> defines a receiving cup <NUM> that is laterally facing and includes an inlet port <NUM> leading to a conduit <NUM>. The conduit <NUM> extends distally to a valve/seal assembly <NUM> disposed in a valve housing <NUM>, which in the present embodiment, is defined by a portion of the body <NUM>. The conduit <NUM> extends through the port <NUM>. A compliant overmolded portion <NUM> covers portions of each body <NUM> of the port <NUM> and operably joins the bodies to one another. The bodies <NUM> can include any suitable material, including metal, thermoplastic, etc..

<FIG> and <FIG> depict various details of a low-profile dual-body access port <NUM> according to one embodiment, wherein a port body <NUM> defines dual fluid paths. Each fluid path includes a receiving cup <NUM> defined by the body <NUM> and facing a substantially upward orientation from the perspective shown in <FIG> and <FIG>. An inlet port <NUM> is included with each receiving cup <NUM> and defines the opening to a conduit <NUM>. Each conduit <NUM> extends distally to a valve/seal assembly <NUM> disposed in a valve housing <NUM>, which in the present embodiment, is defined by a portion of the body <NUM>. The conduit <NUM> extends through the port <NUM>. The body <NUM> can include any suitable material, including metal, thermoplastic, etc..

Reference is now made to <FIG>, which depict various details of embodiments generally directed to vascular access devices, also referred to herein as access ports, for subcutaneous implantation within the body of a patient. The implanted access ports to be described are transcutaneously accessible by a catheter-bearing needle, such as a peripheral intravenous ("PIV") catheter, so as to place the PIV catheter into fluid communication with the access port. A fluid outlet of the access port is operably connected to an in-dwelling catheter disposed within the vasculature of a patient, in one embodiment, to enable the infusion into and/or removal of fluids from the patient's vasculature to take place via the PIV catheter.

In accordance with one embodiment, the access port defines a relatively low profile so as to facilitate ease of placement within the subcutaneous tissue of the patient. Further, the access port is configured to provide a relatively large subcutaneous target to enable the PIV catheter or other suitable catheter-bearing needle to access the port without difficulty. In addition, the access port includes a valve/seal assembly to permit power injection of fluids through the access port. As before, possible applications for the access port described herein include administration of medicaments and other fluids to the patient, pheresis/apheresis, fluid aspiration, etc..

Reference is first made to <FIG>, which show various details of a vascular access device (also "access port" or "port"), generally designated at <NUM>, in accordance with one embodiment. As shown, the port <NUM> includes a body <NUM> that is defined in the present embodiment by a first portion 512A and a second portion 512B (<FIG>). In the present embodiment the port body <NUM> includes a metal such as titanium, and as such, the second portion 512B is press fit into engagement with the first portion 512A to define the body, though it is appreciated that the port body can include a variety of other materials, including metals, thermoplastics, ceramics, etc..

The port body first portion 512A defines in the present embodiment a substantially funnel-shaped receiving cup <NUM> for receiving and directing a catheter-bearing needle (<FIG>) to operably connect with the port <NUM>, as described further below. In particular, the substantially funnel shape of the receiving cup <NUM> is configured to direct the catheter-bearing needle (<FIG>) impinging thereon toward an inlet port <NUM> that serves as an opening for a conduit <NUM> defined by the port body <NUM>. The open and shallow nature of the receiving cup <NUM>, angled toward the skin surface of the patient enables the receiving cup to present a large, easily accessible target for the needle when introduced into the skin, as seen in <FIG>. <FIG> further show that the port <NUM> defines a relatively low profile height, which enables relatively shorter needle lengths to be used for accessing the port after implantation. Note that palpation features can be included with the port body <NUM> to assist a clinician to locate and/or identify the port <NUM> via finger palpation after implantation under the skin of the patient, as with other embodiments herein. Further, in another embodiment a guide groove can be defined on the receiving cup <NUM> to be longitudinally aligned with the inlet port <NUM> of the conduit <NUM>, similar to that shown in the access port <NUM> of <FIG>.

Together with <FIG>, reference is also made to <FIG>. As best seen in <FIG>, the port body <NUM> further defines the conduit <NUM> as a pathway into which a transcutaneously inserted catheter can pass so as to place the catheter in fluid communication with the port <NUM> and the indwelling catheter attached to the stem <NUM> thereof. As shown, the conduit <NUM> is in fluid communication with the receiving cup <NUM> via the inlet port <NUM>. A first conduit portion 518A of the conduit <NUM> distally extends from the inlet port <NUM> in an angled downward direction from the perspective shown in <FIG> to a bend <NUM>, where a second conduit portion 518B of the conduit extends substantially horizontally (from the perspective shown in <FIG>) at a predetermined angle with respect to the first conduit portion. Note that predetermined angle at the bend <NUM> in one embodiment is about <NUM> degrees, but can vary from this in other embodiments, including angles less or more than <NUM> degrees in one embodiment. The magnitude of the predetermined angle at the bend <NUM> depends in one embodiment on various factors, including the size of the catheter and/or needle to be inserted into the port conduit, the size of the conduit itself, etc..

The conduit <NUM> then extends to and through a cavity 520A defined by a valve housing <NUM> of the port body <NUM> where a third conduit portion 518C extends to a distal open end of the stem <NUM> of the port <NUM>. In the present embodiment the conduit <NUM> is sized so as to enable the catheter <NUM> (<FIG>) to pass therethrough to a predetermined point, as will be seen.

As mentioned, the valve housing <NUM>, defined by portions of the first and second portions 512A, 512B of the body <NUM> defines a cavity 520A through which the conduit <NUM> passes and which houses a valve/seal assembly <NUM>. The valve/seal assembly <NUM> includes a sealing element, or seal <NUM>, which defines a central hole 532A (<FIG>) through which the catheter <NUM> (<FIG>) can pass, and a slit valve <NUM> including two intersecting slits 534A (<FIG>). The seal <NUM> and valve <NUM> are sandwiched together in one embodiment, with the seal <NUM> disposed proximal to the valve <NUM>, and secured in place within the cavity 520A as shown in <FIG>. The slits 534A of the slit valve <NUM> are orthogonally offset from one another by about <NUM> degrees in the present embodiment, though other relationships are possible. Note that the valve <NUM> includes a central depression <NUM> to ease the transition of passage of the catheter <NUM> from the seal <NUM> to the valve.

The seal <NUM> and valve <NUM> of the valve/seal assembly <NUM> cooperate to enable fluid-tight passage therethrough of the catheter <NUM> (<FIG>) while also preventing backflow of fluid through the valve/seal assembly. Indeed, in one embodiment the seals disclosed herein prevent fluid flow around the external portion of the catheter when the catheter is disposed through the seal <NUM>, while the valve <NUM> is suitable for preventing fluid flow when no catheter passes through them. As such, when the catheter <NUM> is not inserted therethrough the valve/seal assembly <NUM> seals to prevent passage of air or fluid through the conduit <NUM>. In the present embodiment, the seal <NUM> and valve <NUM> are composed of silicone, such as SILASTIC® Q7-<NUM> liquid silicone rubber available from Dow Corning Corporation, though other suitably compliant materials can be employed. In one embodiment, silicone oil, such as NuSil Technology Med <NUM> silicone oil, is included with the seal <NUM> and valve <NUM> to enhance lubricity and extend component life. In another embodiment, the silicone oil is infused into the silicone.

The port <NUM> in the present embodiment includes an overmolded portion <NUM> that covers a majority portion of the port body <NUM>. The overmolded portion <NUM> includes silicone, such as SILASTIC® Q7-<NUM> liquid silicone rubber or other suitably compliant material and surrounds the body <NUM> as shown so as to provide a relatively soft surface for the port <NUM> and reduce patient discomfort after port implantation within the patient body. The overmolded portion <NUM> includes in one embodiment predetermined suture locations <NUM>, best seen in <FIG>, for suturing the port <NUM> to patient tissue, though sutures may be passed through other portions of the overmolded portion, if desired. The overmolded portion <NUM> further defines a relatively flat bottom surface 536A so as to provide a stable surface for the port <NUM> in its position within the tissue pocket after implantation into the patient body.

<FIG> and <FIG> show that the first body portion 512A defines a securement ridge <NUM> that serves as an anchor to prevent relative movement between the overmolded portion <NUM> and the body <NUM>. The securement ridge <NUM> can vary in shape, number, configuration, etc. Note that the overmolded portion <NUM> in one embodiment is molded in a molding process over the body <NUM>. In another embodiment, the overmolded portion <NUM> is separately formed then adhesively attached to the body <NUM>, such as via Med A adhesive. These and other configurations are therefore contemplated.

<FIG> depict details regarding the insertion of the catheter <NUM> disposed on the needle <NUM> into the port <NUM> (already subcutaneously implanted into the body of the patient), according to one embodiment. After locating the port <NUM> (optionally via through-skin palpation of palpation features, such as a top portion of the overmolded portion <NUM> and/or the receiving cup <NUM>), a clinician uses the catheter-bearing needle <NUM> to pierce a skin surface and insert the needle until a distal tip 42B thereof impinges on a portion of the receiving cup <NUM>, as shown in <FIG>. Note that, because of the orientation of the receiving cup <NUM> is angled substantially toward the skin surface, the needle <NUM> can impinge on the receiving cup at an insertion angle that is relatively steep, which facilitates ease of needle insertion into the body. Indeed, in one embodiment a needle inserted substantially orthogonally through the skin of the patient can impinge the receiving cup of the access port. In another, embodiment, the insertion angle of the needle <NUM> can be relatively shallow, similar to current insertion angles for IV catheters.

The needle <NUM> is manipulated by the clinician and guided by impingement on the receiving cup <NUM> until the needle distal tip 42B is guided to the inlet port <NUM>. The needle <NUM> is then inserted through the inlet port <NUM> and into the first portion 518A of the conduit <NUM> until it is stopped by the bend <NUM>, as seen in <FIG>. The needle <NUM> can then be proximally backed out a small distance, and the catheter <NUM> advanced over the needle such that the catheter bends and advances past the bend <NUM> into the second portion 518B of the conduit <NUM>, as seen in <FIG>. Catheter advancement continues such that a distal end 40B of the catheter <NUM> advances into and past the hole 532A of the seal <NUM> and through both slits 534A of the slit valve <NUM> of the valve/seal assembly <NUM>. Note that the length of the second conduit portion 518B is sufficient to enable the cross-sectional shape of the distal portion of the catheter <NUM> to return to a substantially round shape from the oval shape imposed thereon as a result of its passage through the conduit bend <NUM>.

Once the distal end 40B of the catheter <NUM> has extended distally past the valve/seal assembly <NUM>, further advancement is prevented by impingement of the catheter distal end against an annular stop surface <NUM> included in the third conduit portion 518C defined by the stem <NUM>, as shown in <FIG> and in more detail in <FIG>. In one embodiment, the stop surface <NUM> is defined as an annular shoulder and is sized so as to stop advancement of one size of catheter, such as <NUM> Gauge catheter, while allowing a <NUM> Gauge catheter to pass. In another embodiment, no stop surface is included in the conduit <NUM>, thus enabling the catheter <NUM> to advance completely past the distal end of the stem <NUM>, if desired. Note that the port conduit can be configured to accept one or more of a variety of catheter Gauge sizes, including <NUM> Gauge, <NUM> Gauge, <NUM> Gauge, etc..

Once the catheter <NUM> is positioned as shown in <FIG>, the needle <NUM> can be fully removed and fluid transfer through the catheter <NUM> and port <NUM> can commence, including infusion and/or aspiration through an indwelling catheter attached to the stem <NUM>. (Note that the needle <NUM> can be removed at another stage of the catheter insertion procedure, in one embodiment. ) Dressing of the catheter <NUM> can also occur as needed. Once fluid transfer is completed, the catheter <NUM> can be withdrawn proximally through the valve/seal assembly <NUM> and the conduit <NUM>, then withdrawn through the surface of the skin and out of the patient.

<FIG> depicts that, in the present embodiment, the receiving cup <NUM> includes radiopaque indicia <NUM> to indicate a characteristic of the port <NUM>. Here, the radiopaque indicia <NUM> includes an "IVCT" alphanumeric designation that is defined as a depression or recess into the titanium material forming the first body portion 512A so as to be visible after port implantation via x-ray imaging technology. The "IVCT" designation indicates that the port <NUM> is configured for power injection and is further configured to receive therein a peripheral IV catheter.

In another embodiment the radiopaque indicia <NUM> can be included by employing radiopaque material that can be formed as an insert that is insert-molded included in the port body, such as an initially flowable material that is injected into a cavity of the port body before hardening, etc. In embodiments where the port body is metallic, the radiopaque indicia can be formed by metal injection molding, machining, etching, engraving, or otherwise producing a relative thickness difference between the indicia and the surrounding port body material so as to produce an x-ray-discernible contrast that shows up in an x-ray image, similar to FIG.

In addition to above designation, other characteristics can be indicated by various other types of radiopaque indicia as appreciated by one skilled in the art.

As in other embodiments described herein, in one embodiment the perimeter of the receiving cup (or other suitable location) can include palpation features, such as three raised bumps in the overmolded portion <NUM> to assist in locating the position of the receiving cup <NUM> post-implantation when they are palpated by a clinician prior to needle insertion into the patient. Various other palpation features could be included with the port, in other embodiments, including disposal on the receiving cup itself, etc..

<FIG> depict details of a guide device <NUM> that can be placed on the patient skin atop the implanted location of the port <NUM> shown in <FIG> to assist in guiding the needle <NUM> through the skin so as to impinge on the receiving cup <NUM>, as desired. As shown, the guide device <NUM> includes a body <NUM> that defines a cavity <NUM> into which a portion of the subcutaneous implanted port <NUM> will reside when the guide device is pressed on the skin over the port. A notch <NUM> is included on the body <NUM>, partially bordered by a ridge <NUM>. The notch <NUM> enables the needle <NUM> to be passed therethrough so as to be inserted through the skin and into port <NUM>. A marker line <NUM> is included on the ridge <NUM> to assist the clinician in placing the needle <NUM> at the proper orientation and location for impingement on the receiving cup <NUM>, as desired. Note that the shape, size, and other configuration of the guide device can vary from what is shown and described herein.

Reference is now made to <FIG>, which show various details of a dual-lumen vascular access device, generally designated at <NUM>, in accordance with one embodiment. As shown, the port <NUM> includes a body <NUM> that is defined in the present embodiment by two similarly shaped portions: a single first portion 812A and a single second portion 812B (<FIG>). In the present embodiment the port body first and second portions 812A, 812B include a metal such as titanium, and as such, the second portion is press fit into engagement with the first portion to define the body, though it is appreciated that the port body can include a variety of other materials, including metals, thermoplastics, ceramics, etc., and can include other joining methods including adhesive, ultrasonic or other welding, interference fit, etc..

Both port body first portions 812A define in the present embodiment a substantially funnel-shaped receiving cup <NUM> for receiving and directing the catheter-bearing needle <NUM> (<FIG>) to operably connect with the port <NUM> in a manner similar to that already described above. In particular, the substantially funnel shape of each receiving cup <NUM> is configured to direct the catheter-bearing needle <NUM> impinging thereon toward an inlet port <NUM> that serves as an opening for a respective conduit <NUM> defined by the port body <NUM>. The open and shallow nature of each receiving cup <NUM>, angled toward the skin surface of the patient enables the receiving cup to present a large, easily accessible target for the needle when introduced into the skin and directed toward the subcutaneously implanted access port <NUM>. <FIG> further shows that the access port <NUM> defines a relatively low profile height, which enables relatively shorter needle lengths to be used for accessing the subcutaneous access port after implantation.

Note that, as already mentioned, palpation features can be included with the port body <NUM> in one embodiment to assist a clinician to locate and/or identify the port <NUM> via finger palpation after implantation under the skin of the patient. Note that a variety of sizes, configurations, numbers, etc., of palpation features can be included on the port. In another embodiment, a guide groove can be defined on the receiving cup <NUM> to be longitudinally aligned with the inlet port <NUM> of the conduit <NUM>, as discussed in connection with the embodiment of <FIG>. The guide groove can be defined as a depression with respect to adjacent portions of the surface of the receiving cup <NUM> and extend distally along the receiving cup surface from a proximal portion of the receiving cup so as to provide a guide path to guide the distal tip of the catheter-bearing needle toward the inlet port <NUM> once impingement of the needle into the guide groove is made. This in turn reduces the chance the needle will slide across and off the receiving cup <NUM> during insertion. Note that these and other similar features, though differing in shape and configuration, can also be included on the other ports disclosed herein.

As best seen in <FIG>, the port body <NUM> further defines the two conduits <NUM>, each conduit serving as a pathway into which a transcutaneously inserted catheter can be partially inserted so as to place the catheter in fluid communication both with the port <NUM> and an indwelling dual-lumen catheter operably attached to two fluid outlets 824A of a stem <NUM> of the port. As shown, the conduit <NUM> of each port body first portion 812A is in fluid communication with its respective receiving cup <NUM> via the inlet port <NUM>. A first conduit portion 818A of the conduit <NUM> distally extends from the inlet port <NUM> in an angled downward direction from the perspective shown in <FIG> to a conduit bend <NUM>, where a second conduit portion 818B of the conduit extends at a predetermined angle with respect to the first conduit portion. Note that predetermined angle at the bend <NUM> in one embodiment is about <NUM> degrees, but can vary from this in other embodiments, including angles smaller or greater than <NUM> degrees in one embodiment. The magnitude of the predetermined angle at the bend <NUM> depends in one embodiment on various factors, including the size of the catheter and/or needle to be inserted into the port conduit, the size of the conduit itself, etc. Note also that the conduit bend <NUM> serves as a needle-stop feature, preventing the needle <NUM> from advancing along the conduit <NUM> past the bend <NUM>.

The second conduit portion 818B of each port body first portion 812A distally extends to a cavity 820A defined by the press-fit junction of the port body first portion and the second portion 812B, as seen in <FIG>. Two third conduit portions 818C are defined by the second portion 812B of the port body <NUM> and extend from each of the cavities 820A in a partially arcuate fluid path to the distally-disposed fluid outlets 824A of the stem <NUM>. In the present embodiment the conduit <NUM> is sized so as to enable the catheter <NUM> (<FIG>) to pass therethrough and past the cavity 820A.

As mentioned, the cavities 820A, each defined by the junction of the respective first portion 812A and the second portion 812B of the port body <NUM>, each define a space through which the conduit <NUM> passes and in which is housed a valve/seal assembly <NUM>. In the present embodiment and as best seen in <FIG>, the valve/seal assembly <NUM> includes a sealing element, or seal <NUM>, which defines a central hole 832A through which the catheter <NUM> (<FIG>, <FIG>) can pass, and a slit valve <NUM> including two orthogonally intersecting slits 834A through which the catheter also passes. The seal <NUM> and slit valve <NUM> are sandwiched together in one embodiment, with the seal disposed proximal to the slit valve, and secured in place within the correspondingly sized cavity 820A as shown in <FIG>.

As mentioned, the slits 834A of the slit valve <NUM> are orthogonally offset from one another by about <NUM> degrees in the present embodiment, though other relationships are possible, including the use of two single-slit valves sandwiched together with one another. Note that in the present embodiment the slit valve <NUM> includes a central depression (as in previous embodiments, such as is shown in <FIG>, for instance) to ease the transition of passage of the catheter <NUM> from the seal <NUM> to the valve. More than one seal and/or slit valve may be employed in the valve/seal assembly in other embodiments.

As with previous embodiments, the seal <NUM> and slit valve <NUM> of the valve/seal assembly <NUM> cooperate to enable fluid-tight passage therethrough of the catheter <NUM> (see, e.g., <FIG>) while also preventing backflow of fluid through the valve/seal assembly. Indeed, in one embodiment the seals disclosed herein prevent fluid flow around the external portion of the catheter when the catheter is disposed through the seal <NUM>, while the valve <NUM> is suitable for preventing fluid flow when no catheter passes through them. As such, when the catheter <NUM> is not inserted therethrough the valve/seal assembly <NUM> seals to prevent passage of air or fluid through the conduit <NUM>. In the present embodiment, the seal <NUM> and valve <NUM> are composed of silicone, such as SILASTIC® Q7-<NUM> liquid silicone rubber available from Dow Corning Corporation, though other suitably compliant materials can be employed. In one embodiment, silicone oil, such as NuSil Technology Med <NUM> silicone oil, is included with the seal <NUM> and valve <NUM> to enhance lubricity and extend component life. In another embodiment, the silicone oil is infused into the silicone.

The port <NUM> in the present embodiment includes an overmolded portion <NUM> that covers a portion of the port body <NUM>, including a majority portion of each of the two first portions 818A. The overmolded portion <NUM> includes silicone, such as SILASTIC® Q7-<NUM> liquid silicone rubber or other suitably compliant material and surrounds the portions of the body <NUM> as shown in <FIG> so as to provide a relatively soft surface for the port <NUM> and reduce patient discomfort after port implantation within the patient body. The overmolded portion <NUM> further enables a clinician to suture through one or more of various portions of the overmolded portion to enable the port <NUM> to be secured within a subcutaneous patient tissue pocket. The overmolded portion <NUM> further defines a relatively flat bottom surface 836A so as to provide a stable surface for the port <NUM> in its position within the tissue pocket after implantation into the patient body.

<FIG> shows that the first body portions 812A each define a securement ridge <NUM> that serves as an anchor to prevent relative movement between the overmolded portion <NUM> and the body <NUM>. The securement ridge <NUM> can vary in shape, number, configuration, etc. Note that the overmolded portion <NUM> in one embodiment is molded in a molding process over the body <NUM>. In another embodiment, the overmolded portion <NUM> is separately formed then adhesively attached to the body <NUM>, such as via Med A adhesive. These and other configurations are therefore contemplated.

<FIG> shows that underside surfaces of the receiving cups <NUM> include a radiopaque indicia <NUM> configured to enable the port <NUM> to be radiographically identified after implantation into the patient body. In the present embodiment each of the indicia <NUM> includes the letters "IV" and "CT" to indicate suitability of the port <NUM> to receive peripheral IV catheters and that the port is capable of power injection of fluids therethrough. Of course, a variety of other indicia, including letters, numbers, symbols, etc., may be used.

<FIG> depict various details of the port <NUM> according to another embodiment, wherein the port body <NUM> defines a relatively slimmer profile than the embodiment shown in <FIG>, made possible by defining a cutout <NUM> on both receiving cups <NUM> of each first portion 812A of the port body <NUM>. This enables the receiving cups <NUM> to reside relatively close to one another. The receiving cups <NUM> can be joined to one another along the cutouts <NUM> via welding, adhesive, forming the welding cups together as a single component, etc..

In one embodiment, it is appreciated that the receiving cups <NUM> can be oriented in other configurations. <FIG> gives an example of this, wherein a partially exploded view of the port <NUM> is shown without the overmolded portion <NUM> present, and thus including the two first portions 812A and the second portion 812B. As shown, the receiving cups <NUM> are angled with respect to one another such that a perimeter 814A of a corresponding one of the receiving cups lies in an imaginary plane 890A that is non-parallel to another plane 890B in which a perimeter 814B of the other receiving cup lies. This is in contrast to another embodiment, such as that shown in <FIG>, wherein the receiving cups <NUM> substantially lie in a single imaginary plane. The configuration of <FIG> results in the receiving cups <NUM> being angled away from one another, as shown in <FIG> (note that the first body portion 812A shown disconnected (for clarity) from the second body portion 812B is to be connected to the second body portion in substantially the same orientation as shown in <FIG>). This, in turn, desirably results in a slightly lower height profile for the access port <NUM>, and can also result in the needle <NUM> inserted therein residing relatively closer to the patient skin, in one embodiment. Note that the receiving cups can be angled in various different configurations in addition to what is shown and described herein.

Reference is now made to <FIG>, which depict details of a dual-lumen vascular access device, generally designated at <NUM>, in accordance with one embodiment. As shown, the port <NUM> includes a body <NUM> that is defined in the present embodiment by a first portion 612A and a relatively smaller second portion 612B that is partially received within the first portion. In the present embodiment the port body first and second portions 612A, 612B include a metal such as titanium, and as such, the second portion is press fit into engagement with the first portion to define the body, though it is appreciated that the port body can include a variety of other materials, including metals, thermoplastics, ceramics, etc., and can include other joining methods including adhesive, ultrasonic or other welding, interference fit, etc..

The port body first portion 612A defines in the present embodiment two substantially funnel-shaped receiving cups <NUM> for receiving and directing the catheter-bearing needle <NUM> (<FIG>) to operably connect with the port <NUM> in a manner similar to that already described above. The receiving cups <NUM> in the present embodiment are disposed so as to be substantially aligned along a longitudinal axis of the port <NUM>, though other positional arrangements for the receiving cups are possible, including side-by-side, spaced-apart, staggered, etc..

In particular, the substantially funneled-shape of each receiving cup <NUM> is configured to direct the catheter-bearing needle <NUM> impinging thereon toward an inlet port <NUM> that serves as an opening for a respective one of two conduits <NUM> defined by the port body <NUM>, one conduit for each receiving cup. The open and shallow nature of each receiving cup <NUM>, angled toward the skin surface of the patient enables the receiving cup to present a large, easily accessible target for the needle when introduced into the skin and directed toward the subcutaneously implanted access port <NUM>. <FIG> and <FIG> further show that the access port <NUM> defines a relatively low profile height, which enables relatively shorter needle lengths to be used for accessing the subcutaneous access port after implantation.

The port body <NUM> further defines a palpation feature <NUM>, here configured as a raised surface interposed between the longitudinally aligned receiving cups <NUM>. As mentioned above, the palpation feature <NUM> is included with the port body <NUM> to assist a clinician to locate and/or identify the port <NUM> via finger palpation after implantation under the skin of the patient. Note that a variety of sizes, configurations, numbers, etc., of palpation features can be included on the port. In another embodiment, a guide groove can be defined on each receiving cup <NUM> to be longitudinally aligned with the inlet port <NUM> of the conduit <NUM>, as in previous embodiments.

As best seen in <FIG>, and <FIG>, the port body <NUM> further defines the above-mentioned two conduits <NUM>, each conduit serving as a pathway into which a transcutaneously inserted catheter can be partially inserted so as to place the catheter in fluid communication both with the port <NUM> and an indwelling dual-lumen catheter operably attached to two fluid outlets 624A of a stem <NUM> of the port. As shown, the two conduits <NUM> of the port body first portion 612A are in fluid communication with their respective receiving cup <NUM> via the corresponding inlet port <NUM>. A first conduit portion 618A of each conduit <NUM> distally extends from the respective inlet port <NUM> in an angled downward direction from the perspective shown in <FIG> to a conduit bend <NUM> (<FIG>), where the first conduit portion extends distally at a predetermined angle with respect to the first conduit portion proximal to the conduit bend. The magnitude of the predetermined angle at the bend <NUM> depends in one embodiment on various factors, including the size of the catheter and/or needle to be inserted into the port conduit, the size of the port and the conduit itself, etc. Note also that the conduit bend <NUM> serves as a needle-stop feature, preventing the needle <NUM> from advancing along the conduit <NUM> past the bend <NUM>.

The first portion 618A of the relatively more distal of the two receiving cups <NUM> extends to a cavity 620A defined by and proximate to the distal portion of the first portion 612A of the port body <NUM>, as best seen in <FIG>. The first portion 618A of the relatively more proximal of the two receiving cups <NUM> also extends to a cavity 620A that is defined by, but relatively more proximally distant from, the distal portion of the first portion 612A of the port body <NUM> (<FIG>). A second conduit portion 618B is defined for this latter conduit <NUM> by the second portion 612A of the port body <NUM>, as seen in <FIG> and extends distally from its respective cavity 620A until joining with a third conduit portion 618C defined by the second portion 612A of the port body, which extends through the second portion and the stem <NUM> until terminating at a respective one of the fluid outlets 624A (<FIG>).

The conduit <NUM> for the relatively more distal receiving cup <NUM> extends from the cavity 620A to a third conduit portion 618C defined by the second portion 612A of the port body <NUM>, as seen in <FIG>, which extends through the second portion and the stem <NUM> until terminating at a respective one of the fluid outlets 624A. In this way, fluid pathways are defined for each receiving cup <NUM> from the inlet port <NUM> to the stem fluid outlet 624A, as depicted in <FIG>. In the present embodiment the conduit <NUM> is sized so as to enable the catheter <NUM> (<FIG>) to pass therethrough past the cavity 620A.

As mentioned, the cavities 620A, each disposed in the fluid pathway defined by the various portions of the conduits <NUM>, each define a space through which the conduit <NUM> passes and in which is housed a valve/seal assembly <NUM>. In the present embodiment and as best seen in <FIG>, each valve/seal assembly <NUM> includes a sealing element, or seal <NUM>, which defines a central hole 632A (<FIG>) through which the catheter <NUM> (<FIG>, <FIG>) can pass, and two adjacently placed slit valves <NUM>, each slit valve including a single slit 634A (with the valves being arranged such that the slits are orthogonal to one another), through which the catheter also passes. The seal <NUM> and slit valves <NUM> are sandwiched together in one embodiment, with the seal disposed proximal to the slit valve, and secured in place within the correspondingly sized cavity 620A as shown in <FIG>. In another embodiment, the valve/seal assembly includes a single seal and a single, dual-slit valve, as in previous embodiments.

In the present embodiment, the seal <NUM> and valves <NUM> are composed of silicone, such as SILASTIC® Q7-<NUM> liquid silicone rubber available from Dow Corning Corporation, though other suitably compliant materials can be employed. In one embodiment, silicone oil, such as NuSil Technology Med <NUM> silicone oil, is included with the seal <NUM> and valves <NUM> to enhance lubricity and extend component life. In another embodiment, the silicone oil is infused into the silicone. Also, and as has been mentioned with other embodiments, other seal/valve configurations can also be employed in the port <NUM>.

Reference is now made to <FIG>, which show various details of a dual-lumen vascular access device, generally designated at <NUM>, in accordance with one embodiment. As shown, the port <NUM> includes a body <NUM> that is defined in the present embodiment by a first portion 712A defining the majority of the external portion of the port body and a second portion 712B that is matable to the first portion. In the present embodiment the port body first and second portions 712A, 712B include a metal such as titanium, and as such, the second portion is press fit into engagement with the first portion to define the body <NUM>, though it is appreciated that the port body can include a variety of other materials, including metals, thermoplastics, ceramics, etc., and can include other joining methods including adhesive, ultrasonic or other welding, interference fit, etc..

The port body first portion 712A defines in the present embodiment two substantially concavely-shaped receiving cups <NUM>, side-by-side in a spaced-apart arrangement, for receiving and directing the catheter-bearing needle <NUM> (<FIG>) to operably connect with the port <NUM> in a manner similar to that already described above. In particular, the substantially concave shape of each receiving cup <NUM> is configured to direct the catheter-bearing needle <NUM> impinging thereon toward an inlet port <NUM> that serves as an opening for a respective conduit <NUM> defined by the port body <NUM>.

The open and shallow nature of each receiving cup <NUM>, angled toward the skin surface of the patient enables the receiving cup to present a large, easily accessible target for the needle when introduced into the skin and directed toward the subcutaneously implanted access port <NUM>. <FIG> further show that the access port <NUM> defines a relatively low profile height, which enables relatively shorter needle lengths to be used for accessing the subcutaneous access port after implantation. <FIG> depicts details of a bottom portion of the port body <NUM>. Note that in this and other embodiments, the receiving cups can define different surfaces, including funnel-shaped, concave-shaped, hemispherical, etc..

The port body <NUM> includes a plurality of palpation features <NUM>, here implemented as ridges extending distally from the receiving cups <NUM>, to assist a clinician to locate and/or identify the port <NUM> via finger palpation after implantation under the skin of the patient. Note that a variety of sizes, configurations, numbers, etc., of palpation features can be included on the port.

As best seen in <FIG>, the port body <NUM> further defines the two conduits <NUM>, each conduit serving as a pathway into which a transcutaneously inserted catheter can be partially inserted so as to place the catheter in fluid communication both with the port <NUM> and an indwelling dual-lumen catheter operably attached to two fluid outlets 724A of a stem <NUM> of the port. As shown, each of the two conduits <NUM> of the port body first portion 712A is in fluid communication with its respective receiving cup <NUM> via the inlet port <NUM> and extends distally to a valve/seal assembly <NUM> disposed in a cavity cooperatively defined by the junction of the port body first portion 712A and the second portion 712B. As with other embodiments herein, each conduit <NUM> distally extends from the respective inlet port <NUM> in an angled downward direction from the perspective shown in <FIG> to a conduit bend before continuing to the cavity wherein is disposed the valve/seal assembly. Note that the conduit bend can desirably serve as a needle-stop feature, preventing the needle <NUM> from advancing along the conduit <NUM> past the bend. The conduits distally extend past the valve/seal assembly <NUM> and through the port body second portion 712B to the fluid outlets of the stem <NUM>. In the present embodiment the conduit <NUM> is sized so as to enable the catheter <NUM> (<FIG>) to pass therethrough past the valve/seal assembly <NUM>.

As mentioned, the cavities, each defined by the junction of the respective first portion 712A and the second portion 712B of the port body <NUM>, each define a space through which the conduit <NUM> passes and in which is housed the valve/seal assembly <NUM>. In the present embodiment and as best seen in <FIG>, each of the two valve/seal assemblies <NUM> includes a sealing element, or seal <NUM>, which defines a central hole through which the catheter <NUM> (<FIG>, <FIG>) can pass, and two slit valves <NUM>, each including a single slit and positioned adjacent each other such that the slits are substantially orthogonal to one another, through which the catheter also passes. The seal <NUM> and the slit valves <NUM> are sandwiched together in one embodiment, with the seal disposed proximal to the slit valves, and secured in place within the correspondingly sized cavity as shown in <FIG>.

As mentioned, the slits of the slit valves <NUM> are orthogonally offset from one another by about <NUM> degrees in the present embodiment, though other relationships are possible, including the use of a single slit valve including two orthogonal slits. These and other modifications to this and the other valve/seal assembly embodiments herein are therefore contemplated.

As with previous embodiments, the seal <NUM> and slit valves <NUM> of the valve/seal assembly <NUM> cooperate to enable fluid-tight passage therethrough of the catheter <NUM> (see, e.g., <FIG>) while also preventing backflow of fluid through the valve/seal assembly. Indeed, in one embodiment the seals disclosed herein prevent fluid flow around the external portion of the catheter when the catheter is disposed through the seal <NUM>, while the valve <NUM> is suitable for preventing fluid flow when no catheter passes through them. As such, when the catheter <NUM> is not inserted therethrough the valve/seal assembly <NUM> seals to prevent passage of air or fluid through the conduit <NUM>. In the present embodiment, the seal <NUM> and valve <NUM> are composed of silicone, such as SILASTIC® Q7-<NUM> liquid silicone rubber available from Dow Corning Corporation, though other suitably compliant materials can be employed. In one embodiment, silicone oil, such as NuSil Technology Med <NUM> silicone oil, is included with the seal <NUM> and valve <NUM> to enhance lubricity and extend component life. In another embodiment, the silicone oil is infused into the silicone.

Though not explicitly shown here, the port <NUM>, as with other embodiments herein, can include radiopaque indicia configured to enable the port to be radiographically identified after implantation into the patient body. In one embodiment, the indicia include the letters "IV" and "CT" to indicate suitability of the port <NUM> to receive peripheral IV catheters and that the port is capable of power injection of fluids therethrough. Of course, a variety of other indicia, including letters, numbers, symbols, etc., may be used.

Though single and dual-port configurations have been described herein, it is appreciated that ports including more than two receiving cups are contemplated. Note also that certain of the receiving cups described herein are described as funnel shaped, while other receiving cups are described herein as concavely shaped. It is noted that that the receiving cups can interchangeably include aspects of one or the other, or both, of these receiving cup shapes, according to a particular embodiment.

<FIG> depict details of various possible configurations for the valve/seal assembly, according to example embodiments. In <FIG>, the seal <NUM> includes a central depression <NUM>, similar but relatively steeper than the depression <NUM> of the valve <NUM>. In <FIG>, two seals are included - the seal <NUM> and a second seal <NUM> interposed between the seal <NUM> and the valve <NUM>. The second seal <NUM> includes a central hole 382A that includes a diameter smaller relative to the hole 32A of the seal <NUM>. <FIG> includes a similar configuration, but the hole 382A is similar in size to the hole 32A. A small central depression <NUM> is included on the valve <NUM> in both <FIG>.

In <FIG>, the seal <NUM> includes a relatively small-diameter central hole 32A, and the valve <NUM> includes a relatively large central depression <NUM>. Note that the valve/seal assemblies shown in <FIG> are oriented in the figures such that the catheter pierces the seals and valves in a direction corresponding from the top of the page toward the bottom of the page.

Claim 1:
A low-profile access port (<NUM>) for subcutaneous placement in a patient, comprising:
a body (<NUM>) including:
a receiving cup (<NUM>), the receiving cup being funnel shaped to direct a catheter-bearing needle (<NUM>) into an inlet port (<NUM>) defined in the receiving cup;
a conduit (<NUM>) defined by the body (<NUM>) and extending between the inlet port (<NUM>) and a fluid outlet (824A) defined by a stem (<NUM>) of the body, the conduit defining a bend (<NUM>) distal to the inlet port (<NUM>) and configured to prevent further distal advancement of the needle (<NUM>);
a valve/seal assembly (<NUM>) disposed in the conduit distal to the bend (<NUM>), the valve/seal assembly configured to enable passage of the catheter therethrough, the valve/seal assembly (<NUM>) including:
a seal component (<NUM>) defining a central hole (832A); and
a valve (<NUM>) including two intersecting slits (834A); and
radiopaque indicia (<NUM>) configured to enable identification of the access port via x-ray imaging, the access port further comprising: a stop surface (<NUM>) defined in the conduit (<NUM>) distal to the valve/seal assembly, the access port configured such that the stop surface prevents further distal advancement of the catheter after passage of the catheter through the valve/seal assembly (<NUM>).