Patent Description:
The dependent claims are directed to optional features and preferred examples. In aspects of the present invention, there are provided devices according to the independent claims. Preferred examples are set out in the dependent claims and in the remaining part of the 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. 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 an aspect of the invention a device is provided that allows immediate subcutaneous dialysis access while allowing patients to bathe and shower. Such a device reduces costs and time associated with cleaning and maintenance relative to traditional tunneled dialysis catheter positioned external to the body.

In an aspect of the invention, a device is provided enabling long-term dialysis while minimizing skin trauma. Typical infusion or apheresis port interfaces forces a clinician to access the approximately the same locus every time the port is accessed. Dialysis is typically required multiple times per week. Embodiments of an implantable dialysis port is provided that allows for multiple needle insertion sites, thereby reducing trauma to a single locus on the skin.

In an aspect of the invention, 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 an aspect of the invention, 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 an aspect of the invention, a low-profile access port is disclosed and comprises a body including a first set of receiving cups, a first set of inlet ports, each receiving cup of the first set of receiving cups in fluid communication with an inlet port of the first set of inlet ports, each receiving cup concavely shaped to direct an impinging needle toward the inlet port. A first conduit in fluid communication with each inlet port of the first set of inlet ports, the first conduit extending from the first set of inlet ports to a first outlet of a port stem and a catheter in fluid communication with the first outlet. A second set of receiving cups are in fluid communication with an inlet port of the second set of inlet ports, and a second conduit in fluid communication with each inlet port of the second set of inlet ports, the second conduit extending from the second set of inlet ports to a second outlet of the port stem.

In some embodiments, the first set of receiving cups may be proximal to the second set of receiving cups. A perimeter of each receiving cup of the first set of receiving cups lies in a plane, and wherein the plane of the perimeter of each receiving cup is angled with respect to one another. A perimeter of each receiving cup of the first set of receiving cups lies in a plane, and wherein the plane of the perimeter of each receiving cup is co-planar with respect to one another. A perimeter of each receiving cup of the first set of receiving cups includes a cutout, the cutout between adjacent receiving cups providing communication therebetween.

In an aspect of the invention, a vascular access device for subcutaneous implantation is disclosed and comprises a catheter having a first lumen and a second lumen, an elongate body defining a first elongate chamber and a second elongate chamber, the first elongate chamber in fluid communication with the first lumen and the second elongate chamber in fluid communication with the second lumen. A needle penetrable septum is disposed over an opening in an upper surface of the elongate body, the opening providing access to the first elongate chamber and the second elongate chamber. A needle impenetrable guide disposed over the opening and the needle penetrable septum, the needle impenetrable guide including a plurality of first openings positioned over the first elongate chamber, and a plurality of second openings positioned over the second elongate chamber.

In some embodiments, the elongate body has a length and a width, the length more than two times greater than the width. The first elongate chamber and the second elongate chamber extend in a side-by-side arrangement relative to a longitudinal axis of the elongate body. The first elongate chamber and the second elongate chamber are in a tandem arrangement relative to a longitudinal axis of the elongate body such that the first elongate chamber is proximal to the second elongate chamber. The impenetrable needle guide is disposed at least partially within the needle penetrable septum. The impenetrable needle guide does not penetrate the needle penetrable septum. The plurality of first openings are parallel to the plurality of second openings.

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 embodiment 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, e.g. dialysis or similar extracorporeal treatment.

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/dialysis or similar extracorporeal treatments that enable fluid to be infused into or removed from the patient's vasculature , fluid aspiration, etc..

Reference is first made to <FIG>, which show various details of an access port, generally designated at <NUM>, in accordance with one example useful for understanding the invention. As shown, the port <NUM> includes a body <NUM> that is defined in the present example by a first portion 12A and a second portion 12B (<FIG>). In the present example of 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 example 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. It will be appreciated that the port <NUM>, port body <NUM>, funnel <NUM>, portions thereof, or the like, can be constructed of a suitable biocompatible material. Further, the port <NUM>, or portions thereof can include metals, for example titanium. Such metals can be biocompatible, radiopaque, and/or resistant to gouging from an impinging needle, as will be discussed in more detail herein. By way of example, the port <NUM>, port body <NUM>, funnel <NUM>, portions thereof that include titanium, can be machined, can be formed by injection-molding powdered titanium, or manufactured via other suitable methods.

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 example 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 example is about <NUM> degrees, but can vary from this in other examples, including angles less than <NUM> degrees in one example. The magnitude of angle θ<NUM> depends in one example 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 example 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 example, 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 example 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 example, the seal <NUM> and valves 34A, 34B include silicone, though other suitably compliant materials can be employed.

The port <NUM> in the present example 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 example useful for understanding the invention. 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 example 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 example. 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 example includes a thermoplastic, such as an acetyl resin in the present example. As such, the first and second body portions 112A, 112B are ultrasonically welded to one another to define the body <NUM>, in the present example. 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 example, 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 example, 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 example, 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 example useful for understanding the invention. As shown, in the present example 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 examples 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 example, 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 example 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 examples.

<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 example 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 example useful for understanding the invention, 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 example useful for understanding the invention, 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 example useful for understanding the invention, 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 example, 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 example useful for understanding the invention, 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 example, 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 examples useful for understanding the invention 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 example, 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 example, 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 example useful for understanding the invention. As shown, the port <NUM> includes a body <NUM> that is defined in the present example by a first portion 512A and a second portion 512B (<FIG>). In the present example 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 example 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 examples herein. Further, in another example 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 example is about <NUM> degrees, but can vary from this in other examples, including angles less or more than <NUM> degrees in one example. The magnitude of the predetermined angle at the bend <NUM> depends in one example 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 example 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 example, 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 example, 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 example 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 example, 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 example, 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 example, the silicone oil is infused into the silicone.

The port <NUM> in the present example 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 example 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 example is molded in a molding process over the body <NUM>. In another example, 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 example useful for understanding the invention. 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 example a needle inserted substantially orthogonally through the skin of the patient can impinge the receiving cup of the access port. In another, example, 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 example, 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 example, 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 example. ) 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 example, 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 example 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 examples 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 examples described herein, in one example 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 examples, 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 example useful for understanding the invention. As shown, the port <NUM> includes a body <NUM> that is defined in the present example by two similarly shaped portions: a single first portion 812A and a single second portion 812B (<FIG>). In the present example 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 example 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 example 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 example, 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 example 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.

In an example, the receiving cup <NUM> is covered by a septum <NUM>. The septum <NUM> can be a self-sealing, needle penetrable septum, capable of receiving multiple needle piercings to allow access to the receiving cup <NUM> there below. Accordingly, the septum <NUM> can be made of a suitable needle-penetrable material, such as silicone, or the like. The septum <NUM> includes an outer surface <NUM> and an inner surface <NUM> opposite that of the outer surface <NUM> and substantially facing receiving cup <NUM>. Either of the outer or inner surfaces <NUM>, <NUM> can be flat or slightly convex. In an example, the inner surface <NUM> is substantially flat while the outer surface <NUM> is convex to align with the rounded outer surface of the overmolded portion <NUM> and provide a continuous outer profile to the port <NUM>. Advantageously, the septum <NUM> completes a convexly rounded outer profile to the port <NUM> that allows for a smooth implantation of the device within a tissue pocket and reduces patient discomfort after port implantation within the patient body. Further the septum <NUM> can prevent tissue ingrowth into the receiving cup <NUM>, and associated conduits <NUM>, that would otherwise obstruct the path of the needle entering the device. Accordingly, the septum <NUM> prevents additional surgeries required to remove such obstructions or to replace the device <NUM> prematurely. It will be appreciated that septum <NUM> can also be applied to any example 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 example is about <NUM> degrees, but can vary from this in other examples, including angles smaller or greater than <NUM> degrees in one example. The magnitude of the predetermined angle at the bend <NUM> depends in one example 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 example 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 example 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 example, 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 example, though other relationships are possible, including the use of two single-slit valves sandwiched together with one another. Note that in the present example the slit valve <NUM> includes a central depression (as in previous examples, 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 examples.

As with previous examples, 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 example 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 example, 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 example, 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 example, the silicone oil is infused into the silicone.

The port <NUM> in the present example 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 example is molded in a molding process over the body <NUM>. In another example, 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 example 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 example useful for understanding the invention, wherein the port body <NUM> defines a relatively slimmer profile than the example 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 example, 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 example, 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 example. 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 example useful for understanding the invention. As shown, the port <NUM> includes a body <NUM> that is defined in the present example by a first portion 612A and a relatively smaller second portion 612B that is partially received within the first portion. In the present example 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 example 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 example 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 example, 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 examples.

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 example 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 example 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 example 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 example, 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 example, the valve/seal assembly includes a single seal and a single, dual-slit valve, as in previous examples.

In the present example, 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 example, 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 example, the silicone oil is infused into the silicone. Also, and as has been mentioned with other examples, 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 example useful for understanding the invention. As shown, the port <NUM> includes a body <NUM> that is defined in the present example 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 example 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 example 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 examples, 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 examples 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 example 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 example 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 example, 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 example, 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 examples herein are therefore contemplated.

As with previous examples, 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 example 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 example, 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 example, 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 example, the silicone oil is infused into the silicone.

Though not explicitly shown here, the port <NUM>, as with other examples herein, can include radiopaque indicia configured to enable the port to be radiographically identified after implantation into the patient body. In one example, 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 example.

<FIG> depict details of various possible configurations for the valve/seal assembly, according to examples useful for understanding the invention. 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.

Reference is now made to <FIG>, which show various details of a multi-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 912A and a relatively smaller second portion 912B that is partially received within the first portion 912A. In the present embodiment, the port body first and second portions 912A, 912B 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>. However, it will be appreciated that the port body can include a variety of other suitable materials, including metals, thermoplastics, ceramics, etc., and can include other joining methods including snap-fitted, adhesive, ultrasonic or other welding, interference fit, etc., as discussed herein.

The port body first portion 912A defines in the present embodiment a plurality of 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 in sets, or groups, so as a first set of receiving cups 914A and second set of receiving cups 914B are substantially aligned along a longitudinal axis of the port <NUM>, such that a first set 914A is proximal to second set of receiving cups 914B, though other positional arrangements for the receiving cups are possible, including side-by-side, spaced-apart, staggered, etc. As shown in <FIG>, each set of receiving cups 914A, 914B include three individual receiving cups <NUM>, although it will be appreciated that a greater or fewer number of receiving cups <NUM> within each set 914A, 914B are contemplated and fall within the scope of the present invention.

In an embodiment, port body <NUM> includes sets of receiving cups 914A, 914B that include individually defined receiving cups <NUM> similar to those shown in <FIG>. In an embodiment, as shown in <FIG>, each of the receiving cups <NUM> within a set 914A, 914B can be joined to one another along cutouts <NUM>. This enables the receiving cups <NUM> to reside relatively close to one another and provide port body <NUM> with a relatively slimmer profile than that of an embodiment where receiving cups <NUM> are individually defined. The receiving cups <NUM> of each set 914A, 914B can be joined to one another along the cutouts <NUM> via welding, adhesive, forming the welding cups together as a single component. In an embodiment each set of receiving cups 914A, 914B are formed as a single monolithic piece. In an embodiment, port body second portion 912B is formed as a single monolithic piece.

The substantially funneled-shape of each receiving cup <NUM> is configured to direct the catheter-bearing needle <NUM> impinging thereon toward a corresponding inlet port <NUM> for each cup <NUM>. Each set of receiving cups 914A, 914B then communicates with a single conduit <NUM>, i.e. conduit 918A, 918B respectively. The conduits 918A, 918B, in turn communicate with a corresponding stem fluid outlet 924A, 924B of port stem <NUM>, as described herein. Further, each of the conduits <NUM> can include valve/seal assemblies <NUM>, also as described herein. Accordingly, a given conduit, e.g. 918A or 918B, can accessed by any of the receiving cups within a corresponding set of receiving cups 914A, 914B. One embodiment of suitable internal inlet port <NUM> / conduit <NUM> routing is disclosed in <FIG>.

Advantageously, this allows a user to access a conduit <NUM> via multiple needle entry points. Accordingly, the port <NUM> is suitable for implantation under the skin of a dialysis patient, or patient undergoing similar extracorporeal treatments that require infusion and removal of fluids from the vasculature. Multiple needle entry points can be used and can be alternately selected over the course of multiple dialysis treatments so that no single locus of the patient's skin needs to be consecutively penetrated by a needle in order to access a given conduit <NUM>.

In an embodiment, each the receiving cups <NUM> within a set can be oriented along a similar plane, such that they are co-aligned. In an embodiment, each of the receiving cups <NUM> within a set are angled with respect to one another such that a perimeter <NUM> of a first receiving cup <NUM> lies in an imaginary plane 990A that is non-parallel the planes defined by the perimeters of the other receiving cups <NUM> within the set, for example plane 990B defined by a second receiving cup <NUM>, as described herein (<FIG>). Such a configuration results in each of the receiving cups <NUM> within a set 914A, 914B being angled away from one another. 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. Further, the angled receiving cups <NUM> provide a greater skin surface with which to access the port <NUM>. Accordingly, repeated access can be achieved using a greater number of needle access points so that no single locus of the patient's skin needs to be consecutively penetrated by a needle, allowing previous sites to heal. Note that the receiving cups can be angled in various different configurations in addition to what is shown and described herein.

Although two sets of three receiving cups each are shown, it will be appreciated that any number of receiving cups, or number of sets thereof, fall within the scope of the present invention. Accordingly, in an embodiment, one set of receiving cups may be configured for blood withdrawal, and the other set configured for blood return.

Reference is now made to <FIG> which illustrates an embodiment of a subcutaneous catheter assembly. The catheter assembly comprises a catheter <NUM>, a bifurcation hub <NUM>, an extension leg <NUM>, such as extension legs 70A, 70B, and a port <NUM>. The catheter <NUM> can be a multi-lumen catheter, such as a dual lumen dialysis catheter where each lumen is fluidly connected with an extension leg 70A, 70B. A port <NUM> is fluidly connected with a proximal end of the extension leg <NUM> and can be configured for receiving dialysis needles or large gauge over-the-needle intravenous catheters. Accordingly, a first port 10A can be accessed to fluid removal and a second port 10B can be access for fluid return. Each port <NUM> can include palpation features, indicia, guide grooves, radiopaque markers, or other features of other embodiments as disclosed herein.

Advantageously, the length and flexibility of the extension legs <NUM> allow an amount of variation in positioning of the ports 10A, 10B relative to each other. Accordingly, the ports can be positioned to alter the access locus on the patient's skin without having to reposition the entire device. Further, individual ports <NUM> can be replaced as needed without having to replace the entire device. It will be appreciated that alternate embodiments of port as disclosed herein can be used in place of port <NUM>. Further, catheters with different numbers of lumens and gauge sizes can also be used and fall within the scope of the present invention.

Reference is now made to <FIG>, which show various details of a multi-lumen vascular access device, generally designated at <NUM> in accordance with one example useful for understanding the invention. The port <NUM> is configured to be surgically implanted under the skin of a patient, and includes a port body <NUM> fluidly connected with an in-dwelling, multi-lumen catheter <NUM> disposed within the vasculature of a patient. The port body <NUM> comprises two elongate, compliant arms, 1014A, 1014B, each of which define a lumen 1020A, 1020B therein, which are fluidly connected with a lumen of the in-dwelling, multi-lumen catheter <NUM>, by way of a bifurcation hub <NUM>. The arms <NUM>, including the lumens <NUM> disposed therein, extend proximally from a proximal end of the bifurcation hub <NUM> along a longitudinal axis. Although <FIG> show two arms extending side by side along a longitudinal axis, other numbers of arms <NUM> and configurations thereof are contemplated. For example, at least one arm <NUM> can extend at an angle relative to the longitudinal axis. A proximal end of each of the arms 1014A, 1014B, terminates in an end cap 1018A, 1018B. The end cap <NUM> can be formed of the same or of a different material from that of the arms and can be attached thereto using adhesive, welding, bonding, or similar suitable techniques. In an example, the caps are formed monolithically with the arms <NUM>. The port <NUM>, or portions thereof, can be formed of any suitable biocompatible material, as discussed herein.

The port <NUM>, or portions thereof, can include palpation features <NUM>. For example, bifurcation hub <NUM>, end caps <NUM>, or combinations thereof can include palpation features that can indicate a position and/or orientation of the port body <NUM>, arms <NUM>, or the like, as discussed herein. Further, port <NUM>, portions thereof, or indicia included therewith, can include metals, such as titanium, that are radiopaque thus allowing the port <NUM> to be located and identified using a suitable imaging modality, as discussed herein. For example, end cap <NUM>, arm <NUM>, bifurcation hub <NUM>, or combinations thereof, can include a radiopaque material to indicate a position and/or orientation of the port <NUM>, subsequent to subcutaneous implantation, using a suitable imaging modality, e.g. x-ray, CAT, PET, MRI, ultrasound, or the like. To note, the bifurcation hub <NUM> and the end cap <NUM> can include differently shaped palpation features <NUM> / radiopaque indicia to indicate to a user a flow direction. A needle <NUM> can then be inserted at an obtuse angle relative to the flow direction. It will be appreciated that the needle <NUM> can also be inserted substantially orthogonal to the longitudinal axis of the port <NUM>.

A portion of the arms <NUM> can include a self-sealing, needle penetrable material, such as silicone, or the like. The self-sealing, needle penetrable material can be disposed in an upper wall <NUM> of the arms <NUM>. Further, a lower wall <NUM> of the arms can include a needle-impenetrable material, for example, plastic, metal, or the like. The upper and lower walls <NUM>, <NUM> can be defined relative to the transverse axis. As noted the arms <NUM> are compliant, this enables the arms to conform to the specific contours of the patient's body where it is subcutaneously implanted. Accordingly, while the material of the lower wall <NUM> is needle impenetrable, the material is also sufficiently compliant to conform to the patient's body. In an example, a portion of the inner surface of the lumen <NUM> includes a needle impenetrable material, such as those discussed herein, that prevents the distal end of a needle from gouging the inner surface of the lumen when impinging thereon. This, in turn, prevents the undesirable creation of material flecks dug by the needle.

After locating the port <NUM> via through-skin palpation or imaging, a clinician uses the catheter-bearing needle <NUM> to pierce a skin surface <NUM> and an upper wall of the port arm <NUM>, the latter including a needle-penetrable material. The needle <NUM> is inserted until a distal tip 42A thereof impinges on a lower wall <NUM> of the arm <NUM>, which is formed of a needle-impenetrable material.

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 into the lumen <NUM> of the arm <NUM>. Once the distal end 40A of the catheter <NUM> is in fluid communication with the arm lumen <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 and then withdrawn through the surface <NUM> of the skin and out of the patient.

Advantageously, the port <NUM> provides a relatively large area with which a clinician can access the port while maintaining a low profile. This allows a clinician to access the dialysis device at different positions during the course of multiple dialysis treatments, by inserting the needle in different locations along the arms <NUM>.

Reference is now made to <FIG>, which show various details of a vascular access dialysis device, generally designated at <NUM>, in accordance with one embodiment. The port <NUM> is configured to be surgically implanted under the skin of a patient, and includes a port body <NUM> fluidly connected at a distal end with an in-dwelling, multi-lumen catheter <NUM> disposed within the vasculature of a patient. The port body <NUM> defines an elongate chamber <NUM>, such as a first and second elongate chamber 1114A, 1114B. Each chamber is in fluid communication with a lumen of the in-dwelling catheter <NUM> by way of conduit <NUM>, defined in port body <NUM>, which extends from chamber <NUM> to a fluid outlet of stem <NUM>.

Each elongate chamber <NUM> can extend longitudinally in a side by side arrangement. In an embodiment, as shown in <FIG>, each elongate chamber <NUM> can be arranged in tandem such that one is more proximal than the other, as will be discussed in more detail herein. A lower surface of each chamber <NUM> can be shaped as an elongate funnel shape so as to direct a needle impinging thereon towards an inlet <NUM> of conduit <NUM>. In an embodiment, the chamber defines a substantially flat or even lower surface extending along the longitudinal axis. In an embodiment, the chamber defines a U-shaped cross sectional shape as shown in <FIG>.

Each chamber <NUM> includes a septum <NUM>, formed of a self-sealing, needle-penetrating material, such as silicone. The port <NUM> includes a needle guide <NUM> disposed either above or below the septum <NUM>. The needle guide <NUM> can be formed of a needle impenetrable material. In an embodiment, the needle guide <NUM> can be formed either as a separate piece from that of port body <NUM> or formed monolithically therewith. In an embodiment, the needle guide <NUM> be formed as a separate piece from that of the septum <NUM> and disposed either above or below the septum <NUM>. In an embodiment, the septum <NUM> is overmolded onto the needle guide <NUM> such that the needle guide is disposed within the septum <NUM>. In an embodiment, the needle guide <NUM> includes a rail that longitudinally bisects the septum and laterally divide the septum into a plurality of distinct access areas, or openings.

The needle guide <NUM> can guide the clinician to penetrate the septum at different positions, thereby avoiding repeated needle penetrations being concentrated at a single locus. The elongate wells <NUM> and associated septa, provide a larger area with which to access the port while also maintaining a slim overall profile. The needle guide <NUM> can guide a clinician to access the port at a different position, thus promoting tissue healing. For example, dialysis is performed every <NUM>-<NUM> days, the clinician can access the device at a first position 1144A proximate the proximal end of the needle guide <NUM>. During subsequent dialysis treatments, the clinician can use the needle guide <NUM> to direct subsequent access points, or openings, at increasingly distal positions from the first 1144A, such as position 1144B. Accordingly, subsequent access points can migrate distally until the most distal positon is reached 1144N. At which point the skin adjacent a first access point 1144A will have had a chance to heal and the clinician can re-access the initial access point 1144A. Further, the width of the wells <NUM> and associated septa <NUM> can allow some variation in needle access within a given position <NUM> so that the septum is not traversed in exactly the same position each time, thus improving septum longevity.

In an embodiment, as shown in <FIG>, each elongate chamber <NUM> can be arranged in tandem such that a first chamber 1114A is more proximal than a second chamber 1114B. In such an example, the proximal most chamber 1114A can include a conduit 1118A, defined by the port body <NUM>, which extends past the more distal chamber 1114B and is fluidly connected with the stem <NUM>. <FIG> shows a first vertical cut away view of the port <NUM> where a first chamber 1114A includes a first conduit 1118A extending through first side of the port <NUM> and connecting with a first fluid outlet 1124A at the stem <NUM>. <FIG> shows a second vertical cut away view of the port <NUM> where a second chamber 1114B includes a second conduit 1118B extending through second side of the port <NUM> and connecting with a second fluid outlet 1124B at the stem <NUM>. In an exemplary embodiment, <FIG> shows a horizontal cutaway view of an internal chamber <NUM> / conduit <NUM> routing. Advantageously, the tandem configuration allows for a wider septa <NUM>, providing more variation in injection sites at a given position. As such, a particular injection locus on a septum is not degraded from repeated needle penetrations, thereby promoting septa longevity.

It will be appreciated that the port body <NUM> can be formed of a suitable biocompatible material, as discussed herein. The port body <NUM> can be formed of a needle impenetrable material, optionally each chamber <NUM> can include a needle impenetrable material lining an inner surface thereof, as discussed herein. As shown, port <NUM> includes two wells <NUM> formed in a port body <NUM> as a single monolithic piece, although it will be appreciate that any number of wells can be formed in the port <NUM> and fall within the scope of the present invention. In an embodiment, the port <NUM> can include a single chamber <NUM> formed in the port body <NUM>. In an embodiment, the port <NUM> can include wells <NUM> formed as separate structures that are each connect to a lumen of a multi-lumen catheter, or an extension leg of a bifurcated catheter. In an embodiment, each chamber can be designed with different characteristics for different purposes. For example, a first chamber can be designed for blood withdrawal and a second chamber for blood return, or they may be reversibly separable. As in other embodiments, one side may be used for blood withdrawal and the other side for blood return.

Reference is now made to FIG. 36A-37E, which shows details of an indwelling catheter assembly <NUM>, in accordance with one example useful for understanding the invention. The catheter assembly <NUM> includes a port <NUM> fluidly connected to a catheter <NUM> by way of locking member <NUM>. <FIG> shows an exploded view of the catheter assembly <NUM> including the port <NUM>, the locking member <NUM> and a proximal end of the catheter <NUM>. The port <NUM> includes a body <NUM> that is defined by a similarly shaped first conduit 1212A and second conduit 1212B. A distal end of each of the first and second conduits 1212A, 1212B engages a distal portion 1236B of an outer shell <NUM>. The distal end of the outer shell <NUM> includes a distal receiving slot <NUM> which engages a proximal end of a stem assembly <NUM>. The stem assembly <NUM> includes a housing 1224C which is configured to receive a first and second stem 1224A, B at a distal end thereof.

Each of the first and second conduits 1212A, B, outer shell portions 1236A, B, and stem assembly <NUM>, can be press fitted into engagement with each other. Further, the first and second conduits 1212A, 1212B, can include a metal, such as titanium. It will be appreciated that the port body <NUM>, or portions thereof, can include a variety of materials, including metals, thermoplastics, ceramics, etc., and can include other joining methods including snap-fitted, adhesive, ultrasonic or other welding, interference fit, etc. as discussed herein. In an example useful for understanding the invention, the port <NUM> further includes a portion of the outer shell <NUM> that is overmolded onto a portion of the port body <NUM>. For example, proximal portion 1236A of the outer shell <NUM> is formed of a compliant material, such as silicone, or similar suitable material as discussed herein and is overmolded onto the port body <NUM>.

<FIG> show further details of the port <NUM> of the catheter assembly <NUM>. Each of the first and second conduits 1212A, 1212B define 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 herein. 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>. 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>.

Each of the first and second conduits 1212A, 1212B further include a valve/seal assembly <NUM>, such as valve/seal assembly 1222A, 1222B. Each valve/seal assembly <NUM> includes a seal <NUM> and a valve <NUM> disposed in a valve/seal housing <NUM>. Each valve seal housing <NUM> is disposed at a distal end of the respective first and second conduits 1212A, 1212B and secured in place with a nozzle <NUM>, e.g. nozzle 1221A, B. A distal end of the nozzle <NUM> is received within a proximal end of the outer shell distal portion 1236B. Accordingly, the port body <NUM>, including the respective valve/seal assemblies <NUM>, nozzles, <NUM> and stem <NUM> define lumen 1218A, 1218B that extend from an inlet port 1216A, 1216B to a respective outlet of stem 1224A, 1224B. Note that features of other examples described herein, for example palpation features, indicia, septa, guide grooves, valves, seals, etc., can be included with the port <NUM>.

<FIG> shows details of an exemplary multi-lumen catheter <NUM>. The catheter <NUM> includes an elongate tube extending from a proximal end to a distal end and can define at least one lumen. Although <FIG> shows a dual-lumen catheter it will be appreciated that catheters with greater or fewer lumens are contemplated to fall within the scope of the present invention. A proximal end <NUM> is configured to fluidly communicate with stem assembly <NUM>. In an example, a first stem 1224A communicates with a first lumen 1254A and a second stem 1224B communicates with a second lumen 1254B.

The catheter <NUM> includes an annular collar <NUM> disposed proximate a proximal end which co-operates with a locking member <NUM>, and will be discussed in more detail herein. The catheter <NUM> also includes a cuff <NUM>. The cuff <NUM> can be made of, for example DACRON™, or similar suitable material. The cuff <NUM> serves as an ingrowth cuff to further secure the catheter upon implantation within the body.

Referring to <FIG>, the catheter assembly <NUM> further includes a locking member <NUM> that fits over the catheter <NUM> and engages the port body <NUM>, securing the catheter <NUM> thereto. To note, <FIG> shows the stem assembly housing 1224C, locking member <NUM> and catheter <NUM>, with the first and second stems 1224A, B removed for clarity. The locking member <NUM> includes a channel <NUM> extending from a proximal end to a distal end of the locking member <NUM>, and is designed to receive a catheter disposed therethrough. A circumference of the channel <NUM> is sized to fit snugly about a circumference of the catheter <NUM>. The locking member <NUM> includes an annular abutment <NUM> disposed towards a distal end of the channel <NUM> and extending radially inward. The annular abutment <NUM> abuts against an annular collar <NUM> of the catheter and inhibits longitudinal distal movement of the catheter relative to the locking member <NUM>.

The locking member <NUM> includes an upper and lower portion <NUM>, <NUM> that extend proximally to define an upper and lower surface of the locking member <NUM>, respectively. The upper and lower portions <NUM>, <NUM> further define openings in the left and rights sides of the locking member <NUM>. The openings extend proximally, from a distal end, to a point that is proximal of the distal end and are configured to receive a portion of the stem assembly housing 1224C.

The locking member <NUM> further includes protrusions <NUM> disposed at a distal end of the locking member <NUM> and extend transversely inwards. Protrusions 1272A, 1272B extend transversely downwards from a distal end of the upper portion <NUM>, and protrusions 1272C, 1272D extend transversely upwards from a distal end of the lower portion <NUM>. The protrusions <NUM> co-operate with slots <NUM> disposed in an upper and lower surface of the port housing 1224C, such that each protrusion 1272A-D engages a corresponding slot 1274A-D.

The locking member <NUM> includes a resilient material such that an upper and lower portions <NUM>, <NUM> are able to flex slightly. Accordingly, as the locking member <NUM> is urged distally to engage the housing 1224C the upper and lower portions <NUM>, <NUM> flex outward allowing the housing 1224C to be received within the space defined by the upper and lower portions <NUM>, <NUM> of the connector. Further, the protrusions <NUM> can include a chamfer to facilitate sliding over a distal portion of the housing 1224C and engage the slots <NUM>. Accordingly, the locking member can securely engage the housing 1224C and can align the catheter <NUM> with the stem <NUM>.

Advantageously, the catheter assembly <NUM> provides a modular construction where individual components can be press fitted or snap fitted into place, although other methods of attaching are also contemplated. Accordingly, this facilitates manufacture and assembly together with improved associated costs. Moreover, being formed of a modular construction allows individual components to be modified and changed to suit different specifications with minimal interference to the manufacturing process. For example, port body <NUM> can be configured to receive different gauge needles, catheters, or the like by exchanging the body conduits 1212A, 1212B, nozzles, <NUM>, valve assemblies <NUM>, or the like. Similarly, the catheter <NUM> and stem assemblies <NUM> can be easily exchanged for catheters of different characteristics such as different gauges, thicknesses, physical characteristics (e.g. materials, durometers), lumens characteristics, tip characteristics, or the like.

The port <NUM>, locking member <NUM> and catheter <NUM> can also co-operate to define a substantially smooth outer profile to the catheter system <NUM>. This advantageously facilitates implantation within a tissue pocket and reduces patient discomfort once implanted. Further, a smooth outer profile allows any palpation features disposed there on to be more pronounced and therefore more easily discernable by a clinician.

Claim 1:
A low-profile access port (<NUM>), comprising:
a body (<NUM>) including:
a first set of receiving cups (914A);
a second set of receiving cups (914B);
a first set of inlet ports, each receiving cup of the first set of receiving cups (914A) in fluid communication with an inlet port of the first set of inlet ports, each receiving cup of the first set of receiving cups (914A) concavely shaped to direct an impinging needle toward a respective inlet port of the first set of inlet ports;
a second set of inlet ports, each receiving cup of the second set of receiving cups (914B) in fluid communication with an inlet port of the second set of inlet ports, each receiving cup of the second set of receiving cups (914B) concavely shaped to direct an impinging needle toward a respective inlet port of the second set of inlet ports; and
a first conduit (918A) in fluid communication with each inlet port of the first set of inlet ports, the first conduit extending from the first set of inlet ports to a first outlet (924A) of a port stem (<NUM>);
a second conduit (918B) in fluid communication with each inlet port of the second set of inlet ports, the second conduit extending from the second set of inlet ports to a second outlet of the port stem; and
a catheter in fluid communication with the first outlet.