Patent Grant
11464960
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.
In some embodiments, 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. The first set of receiving cups are 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 dialysis catheter assembly is disclosed and comprises a catheter having a first lumen and a second lumen, a bifurcation hub having a distal end in communication with a proximal end of the catheter, a first extension leg and a second extension leg connected to a distal end of the bifurcation hub, the first extension leg in fluid communication with the first lumen, the second extension leg in fluid communication with the second lumen. A first port including a first receiving cup defining a first perimeter substantially parallel to the skin surface following implantation of the dialysis catheter assembly, the first port including a first outlet in fluid communication with the first receiving cup, the first outlet in fluid communication with the first extension leg. A second port separated from the first port, the second port including a second receiving cup defining a second perimeter substantially parallel to the skin surface following implantation of the dialysis catheter assembly, the second port including a second outlet in fluid communication with the second receiving cup, the second outlet in fluid communication with the second extension leg.
In some embodiments, the first receiving cup includes a first septum covering the first perimeter, and the second receiving cup includes a second septum covering the second perimeter, the first septum and the second septum providing a continuous outer profile to the first port and the second port.
In an aspect of the invention, a subcutaneous dialysis port is disclosed and comprises, a catheter having a first lumen and a second lumen, a bifurcation hub having a distal end in communication with a proximal end of the catheter. A first elongate arm and a second elongate arm connected to a distal end of the bifurcation hub, the first elongate arm in fluid communication with the first lumen, the second elongate arm in fluid communication with the second lumen, each of the first elongate arm and the second elongate arm including a needle penetrable portion in an upper wall thereof.
In some embodiments, a lower wall of the first elongate arm and the second elongate arm are formed of a compliant material that allows the first and second elongate arm to conform to a contour of a patient's body. The first elongate arm and the second elongate arm each include an end cap disposed at the proximal end thereof, each end cap including at least one of a palpation feature and an indicia, the indicia observable under a suitable imaging modality. The at least one of the palpation feature and the indicia indicating a flow direction to a user. The needle penetrable portion includes a self-sealing silicone material. A lower wall of the first elongate arm and the second elongate arm are formed of a needle impenetrable material.
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 an aspect of the invention, a port assembly is disclosed comprising a first conduit including a first receiving cup at a proximal end and a first nozzle at a distal end, wherein a first valve assembly is disposed between the first receiving cup and the first nozzle. A second conduit including a second receiving cup at a proximal end and a second nozzle at a distal end, wherein a second valve assembly is disposed between the second receiving cup and the second nozzle. An outer shell surrounding the first conduit and the second conduit, the outer shell including a proximal portion surrounding the first receiving cup and the second receiving cup, and the distal portion surrounding the first nozzle and the second nozzle, the proximal portion, the distal portion, the first conduit, and the second conduit connected via press fit engagement.
In some embodiments, the distal portion of the outer shell includes a distal receiving slot designed to receive a stem assembly. The stem assembly includes a housing having a proximal end designed for insertion into the distal receiving slot, and wherein the stem assembly is connected to the distal portion of the outer shell via press fit engagement. The stem assembly includes a first stem and a second stem extending from a distal end of the housing, the first stem in fluid communication with the first receiving cup, and the second stem in fluid communication with the second receiving cup. The port assembly further comprising a catheter including a first lumen designed for insertion over the first stem, a second lumen designed for insertion over the second stem, and a locking member designed to couple the stem assembly to the catheter. The stem assembly includes a first slot on an upper portion and a second slot on a lower portion, and wherein the locking member includes a first protrusion designed to snap-fit in the first slot, and a second protrusion designed to snap-fit in the second slot. The outer shell, the housing, and the locking member together provide a smooth continuous outer surface.
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 (“Hy”) catheter, so as to place the PIV catheter into fluid communication with the access port. A fluid outlet of the access port is operably connected to an in-dwelling catheter disposed within the vasculature of a patient, in one embodiment, to enable the infusion into and/or removal of fluids from the patient's vasculature to take place via the PIV catheter.
These and other features of embodiments of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of embodiments of the invention as set forth hereinafter.
A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
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 5 ml per second at a pressure of about 300 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
The port body 12 defines in the present embodiment a substantially concavely-shaped receiving cup 14 for receiving and directing a catheter-bearing needle (
Palpation features 26 are included with the port body 12 to assist a clinician to locate and/or identify the port 10 via finger palpation after implantation under the skin of the patient. In detail, the palpation features 26 in the present embodiment include a bump 26A disposed near the proximal end of the receiving cup 14 and a ridge 26B disposed above and curving around a distal portion of the receiving cup.
A guide groove 28 is defined on the receiving cup 14 and is longitudinally aligned with the inlet port 16 of the conduit 18. The guide groove 28 is defined as a depression with respect to adjacent portions of the surface of the receiving cup 14 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 16 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 14 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
The conduit 18 then extends to and through a cavity 20A defined by a valve housing 20 of the port body. The conduit 18 extends to a distal open end of the stem 24 of the port 10. The conduit 18 is sized so as to enable the catheter 40 (
As mentioned, the valve housing 20 defines a cavity 20A through which the conduit passes and which houses a valve/seal assembly 22. The valve/seal assembly 22 includes a sealing element, or seal 32, which defines a central hole through which the catheter 40 can pass, a first slit valve 34A and a second slit valve 34B. The seal 32 and valves 34A, 34B are sandwiched together in one embodiment and secured in place within the cavity 20A as shown in
The seal 32 and valves 34A, 34B of the valve/seal assembly 22 cooperate to enable fluid-tight passage therethrough of the catheter 40 (
The port 10 in the present embodiment includes an overmolded portion 36 that covers the port body 12. The overmolded portion 36 includes silicone or other suitably compliant material and surrounds the body 12 as shown so as to provide a relatively soft surface for the port 10 and reduce patient discomfort after port implantation. The overmolded portion 36 includes two predetermined suture locations 38, best seen in
The needle 42 is manipulated until the distal tip 42A is received into the guide groove 28, which will enable the distal tip to be guided along the groove to the inlet port 16. The needle 42 is then inserted through the inlet port 16 and into the first portion 18A of the conduit 18 until it is stopped by the bend 30. The needle 42 can then be proximally backed out a small distance, and the catheter 40 advanced over the needle such that the catheter bends and advances past the bend 30 into the second portion 18B of the conduit 18. Catheter advancement continues such that a distal end 40A of the catheter 40 advances into and past the hole of the seal 32 and through both slits of the slit valves 34A, 34B of the valve/seal assembly 40. Once the distal end 40A of the catheter 40 has extended distally past the valve/seal assembly 22, further advancement can cease and fluid transfer through the catheter 40 and port 10 can commence, including infusion and/or aspiration through the stem 24. Once fluid transfer is completed, the catheter 40 can be withdrawn proximally through the valve/seal assembly 22 and the conduit, then withdrawn through the surface 44 of the skin and out of the patient.
A valve/seal assembly 122 is disposed within a cavity 120A that is defined by a valve housing 120, which in the present embodiment, is defined by the first body portion 112A. The valve/seal assembly 122 includes a proximal seal 132 with a central hole for catheter passage, two slit valves 134A, 134B each with a slit arranged at a 90-degree offset with respect to the other, and a distal seal 135 with a central hole, also referred to herein as a sphincter seal.
The distal seal 135 includes on its distal surface a frustoconical portion 135A disposed about the seal central hole that is configured to provide a sphincter-like seal about the outer surface of a catheter when it extends through the valve/seal assembly. The frustoconical portion 135A is disposed such that any back-flowing fluid impinging on the frustoconical portion will cause the seal to secure itself about the outer surface of the catheter in an even tighter engagement, thus preventing backflow past the catheter outer surface when high fluid pressures are present, such as in the case of power injection. As mentioned, other valve/seal combinations can also be included in the valve/seal assembly.
In the present embodiment, the receiving cup 114 and portion of the conduit 118 proximal to the valve/seal assembly 122 both include a needle-impenetrable lining that prevents the distal end of a needle from gouging the surface when impinging thereon. This, in turn, prevents the undesirable creation of material flecks dug by the needle. Various suitable materials can be employed for the needle-impenetrable material, including glass, ceramic, metals, etc. In one embodiment, the components of the port 110 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.
In the present embodiment, the CT radiopaque indicia 128 indicate to an observer that the port is capable of power injection of fluids therethrough. In addition to this characteristic, other characteristics can be indicated by various other types of indicia as appreciated by one skilled in the art.
Further, in the present embodiment the top view of the port 110 of
Reference is now made to
In accordance with one embodiment, the access port defines a relatively low profile so as to facilitate ease of placement within the subcutaneous tissue of the patient. Further, the access port is configured to provide a relatively large subcutaneous target to enable the PIV catheter or other suitable catheter-bearing needle to access the port without difficulty. In addition, the access port includes a valve/seal assembly to permit power injection of fluids through the access port. As before, possible applications for the access port described herein include administration of medicaments and other fluids to the patient, pheresis/apheresis, fluid aspiration, etc.
Reference is first made to
The port body first portion 512A defines in the present embodiment a substantially funnel-shaped receiving cup 514 for receiving and directing a catheter-bearing needle (
Together with
The conduit 518 then extends to and through a cavity 520A defined by a valve housing 520 of the port body 12 where a third conduit portion 518C extends to a distal open end of the stem 524 of the port 510. In the present embodiment the conduit 518 is sized so as to enable the catheter 40 (
As mentioned, the valve housing 520, defined by portions of the first and second portions 512A, 512B of the body 512 defines a cavity 520A through which the conduit 518 passes and which houses a valve/seal assembly 522. The valve/seal assembly 522 includes a sealing element, or seal 532, which defines a central hole 532A (
The seal 532 and valve 534 of the valve/seal assembly 522 cooperate to enable fluid-tight passage therethrough of the catheter 40 (
The port 510 in the present embodiment includes an overmolded portion 536 that covers a majority portion of the port body 512. The overmolded portion 536 includes silicone, such as SILASTIC® Q7-4850 liquid silicone rubber or other suitably compliant material and surrounds the body 512 as shown so as to provide a relatively soft surface for the port 510 and reduce patient discomfort after port implantation within the patient body. The overmolded portion 536 includes in one embodiment predetermined suture locations 538, best seen in
The needle 42 is manipulated by the clinician and guided by impingement on the receiving cup 514 until the needle distal tip 42B is guided to the inlet port 516. The needle 42 is then inserted through the inlet port 516 and into the first portion 518A of the conduit 518 until it is stopped by the bend 530, as seen in
Once the distal end 40B of the catheter 40 has extended distally past the valve/seal assembly 522, further advancement is prevented by impingement of the catheter distal end against an annular stop surface 539 included in the third conduit portion 518C defined by the stem 524, as shown in
Once the catheter 40 is positioned as shown in
In another embodiment the radiopaque indicia 528 can be included by employing radiopaque material that can be formed as an insert that is insert-molded included in the port body, such as an initially flowable material that is injected into a cavity of the port body before hardening, etc. In embodiments where the port body is metallic, the radiopaque indicia can be formed by metal injection molding, machining, etching, engraving, or otherwise producing a relative thickness difference between the indicia and the surrounding port body material so as to produce an x-ray-discernible contrast that shows up in an x-ray image, similar to
In addition to above designation, other characteristics can be indicated by various other types of radiopaque indicia as appreciated by one skilled in the art.
As in other embodiments described herein, in one embodiment the perimeter of the receiving cup (or other suitable location) can include palpation features, such as three raised bumps in the overmolded portion 536 to assist in locating the position of the receiving cup 514 post-implantation when they are palpated by a clinician prior to needle insertion into the patient. Various other palpation features could be included with the port, in other embodiments, including disposal on the receiving cup itself, etc.
Reference is now made to
Both port body first portions 812A define in the present embodiment a substantially funnel-shaped receiving cup 814 for receiving and directing the catheter-bearing needle 42 (
Note that, as already mentioned, palpation features can be included with the port body 812 in one embodiment to assist a clinician to locate and/or identify the port 810 via finger palpation after implantation under the skin of the patient. Note that a variety of sizes, configurations, numbers, etc., of palpation features can be included on the port. In another embodiment, a guide groove can be defined on the receiving cup 814 to be longitudinally aligned with the inlet port 816 of the conduit 818, as discussed in connection with the embodiment of
In an embodiment, the receiving cup 814 is covered by a septum 840. The septum 840 can be a self-sealing, needle penetrable septum, capable of receiving multiple needle piercings to allow access to the receiving cup 814 there below. Accordingly, the septum 840 can be made of a suitable needle-penetrable material, such as silicone, or the like. The septum 840 includes an outer surface 842 and an inner surface 844 opposite that of the outer surface 842 and substantially facing receiving cup 814. Either of the outer or inner surfaces 842, 844 can be flat or slightly convex. In an embodiment, the inner surface 844 is substantially flat while the outer surface 842 is convex to align with the rounded outer surface of the overmolded portion 836 and provide a continuous outer profile to the port 810. Advantageously, the septum 840 completes a convexly rounded outer profile to the port 810 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 840 can prevent tissue ingrowth into the receiving cup 814, and associated conduits 818, that would otherwise obstruct the path of the needle entering the device. Accordingly, the septum 840 prevents additional surgeries required to remove such obstructions or to replace the device 810 prematurely. It will be appreciated that septum 840 can also be applied to any embodiment disclosed herein.
As best seen in
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
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 812, each define a space through which the conduit 818 passes and in which is housed a valve/seal assembly 822. In the present embodiment and as best seen in
As mentioned, the slits 834A of the slit valve 834 are orthogonally offset from one another by about 90 degrees in the present embodiment, though other relationships are possible, including the use of two single-slit valves sandwiched together with one another. Note that in the present embodiment the slit valve 834 includes a central depression (as in previous embodiments, such as is shown in
As with previous embodiments, the seal 832 and slit valve 834 of the valve/seal assembly 822 cooperate to enable fluid-tight passage therethrough of the catheter 40 (see, e.g.,
The port 810 in the present embodiment includes an overmolded portion 836 that covers a portion of the port body 812, including a majority portion of each of the two first portions 818A. The overmolded portion 836 includes silicone, such as SILASTIC® Q7-4850 liquid silicone rubber or other suitably compliant material and surrounds the portions of the body 812 as shown in
In one embodiment, it is appreciated that the receiving cups 814 can be oriented in other configurations.
Reference is now made to
The port body first portion 612A defines in the present embodiment two substantially funnel-shaped receiving cups 614 for receiving and directing the catheter-bearing needle 42 (
In particular, the substantially funneled-shape of each receiving cup 614 is configured to direct the catheter-bearing needle 42 impinging thereon toward an inlet port 616 that serves as an opening for a respective one of two conduits 618 defined by the port body 612, one conduit for each receiving cup. The open and shallow nature of each receiving cup 614, 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 610.
The port body 612 further defines a palpation feature 637, here configured as a raised surface interposed between the longitudinally aligned receiving cups 614. As mentioned above, the palpation feature 637 is included with the port body 612 to assist a clinician to locate and/or identify the port 610 via finger palpation after implantation under the skin of the patient. Note that a variety of sizes, configurations, numbers, etc., of palpation features can be included on the port. In another embodiment, a guide groove can be defined on each receiving cup 614 to be longitudinally aligned with the inlet port 616 of the conduit 618, as in previous embodiments.
As best seen in
The first portion 618A of the relatively more distal of the two receiving cups 614 extends to a cavity 620A defined by and proximate to the distal portion of the first portion 612A of the port body 612, as best seen in
The conduit 618 for the relatively more distal receiving cup 614 extends from the cavity 620A to a third conduit portion 618C defined by the second portion 612A of the port body 612, as seen in
As mentioned, the cavities 620A, each disposed in the fluid pathway defined by the various portions of the conduits 618, each define a space through which the conduit 618 passes and in which is housed a valve/seal assembly 622. In the present embodiment and as best seen in
In the present embodiment, the seal 632 and valves 634 are composed of silicone, such as SILASTIC® Q7-4850 liquid silicone rubber available from Dow Corning Corporation, though other suitably compliant materials can be employed. In one embodiment, silicone oil, such as NuSil Technology Med 400 silicone oil, is included with the seal 632 and valves 634 to enhance lubricity and extend component life. In another embodiment, the silicone oil is infused into the silicone. Also, and as has been mentioned with other embodiments, other seal/valve configurations can also be employed in the port 610.
Reference is now made to
The port body first portion 712A defines in the present embodiment two substantially concavely-shaped receiving cups 714, side-by-side in a spaced-apart arrangement, for receiving and directing the catheter-bearing needle 42 (
The open and shallow nature of each receiving cup 714, 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 710.
The port body 712 includes a plurality of palpation features 737, here implemented as ridges extending distally from the receiving cups 714, to assist a clinician to locate and/or identify the port 710 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
As mentioned, the cavities, each defined by the junction of the respective first portion 712A and the second portion 712B of the port body 712, each define a space through which the conduit 718 passes and in which is housed the valve/seal assembly 722. In the present embodiment and as best seen in
As mentioned, the slits of the slit valves 734 are orthogonally offset from one another by about 90 degrees in the present embodiment, though other relationships are possible, including the use of a single slit valve including two orthogonal slits. These and other modifications to this and the other valve/seal assembly embodiments herein are therefore contemplated.
As with previous embodiments, the seal 732 and slit valves 734 of the valve/seal assembly 722 cooperate to enable fluid-tight passage therethrough of the catheter 40 (see, e.g.,
Though not explicitly shown here, the port 710, as with other embodiments herein, can include radiopaque indicia configured to enable the port to be radiographically identified after implantation into the patient body. In one embodiment, the indicia include the letters “IV” and “CT” to indicate suitability of the port 710 to receive peripheral IV catheters and that the port is capable of power injection of fluids therethrough. Of course, a variety of other indicia, including letters, numbers, symbols, etc., may be used.
Though single and dual-port configurations have been described herein, it is appreciated that ports including more than two receiving cups are contemplated. Note also that certain of the receiving cups described herein are described as funnel shaped, while other receiving cups are described herein as concavely shaped. It is noted that that the receiving cups can interchangeably include aspects of one or the other, or both, of these receiving cup shapes, according to a particular embodiment.
In
Reference is now made to
The port body first portion 912A defines in the present embodiment a plurality of substantially funnel-shaped receiving cups 914 for receiving and directing the catheter-bearing needle 42 (
In an embodiment, port body 912 includes sets of receiving cups 914A, 914B that include individually defined receiving cups 914 similar to those shown in
The substantially funneled-shape of each receiving cup 914 is configured to direct the catheter-bearing needle 42 impinging thereon toward a corresponding inlet port 916 for each cup 914. Each set of receiving cups 914A, 914B then communicates with a single conduit 918, i.e. conduit 918A, 918B respectively. The conduits 918A, 918B, in turn communicate with a corresponding stem fluid outlet 924A, 924B of port stem 924, as described herein. Further, each of the conduits 918 can include valve/seal assemblies 922, 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 916/conduit 918 routing is disclosed in
Advantageously, this allows a user to access a conduit 918 via multiple needle entry points. Accordingly, the port 910 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 918.
In an embodiment, each the receiving cups 914 within a set can be oriented along a similar plane, such that they are co-aligned. In an embodiment, each of the receiving cups 914 within a set are angled with respect to one another such that a perimeter 990 of a first receiving cup 914 lies in an imaginary plane 990A that is non-parallel the planes defined by the perimeters of the other receiving cups 914 within the set, for example plane 990B defined by a second receiving cup 914, as 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
Advantageously, the length and flexibility of the extension legs 70 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 10 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 10. 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
The port 1010, or portions thereof, can include palpation features 1026. For example, bifurcation hub 1016, end caps 1018, or combinations thereof can include palpation features that can indicate a position and/or orientation of the port body 1012, arms 1014, or the like, as discussed herein. Further, port 1010, portions thereof, or indicia included therewith, can include metals, such as titanium, that are radiopaque thus allowing the port 1010 to be located and identified using a suitable imaging modality, as discussed herein. For example, end cap 1018, arm 1014, bifurcation hub 1016, or combinations thereof, can include a radiopaque material to indicate a position and/or orientation of the port 1010, 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 1016 and the end cap 1018 can include differently shaped palpation features 1026/radiopaque indicia to indicate to a user a flow direction. A needle 42 can then be inserted at an obtuse angle relative to the flow direction. It will be appreciated that the needle 42 can also be inserted substantially orthogonal to the longitudinal axis of the port 1010.
A portion of the arms 1014 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 1022 of the arms 1014. Further, a lower wall 1024 of the arms can include a needle-impenetrable material, for example, plastic, metal, or the like. The upper and lower walls 1022, 1024 can be defined relative to the transverse axis. As noted the arms 1014 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 1024 is needle impenetrable, the material is also sufficiently compliant to conform to the patient's body. In an embodiment, a portion of the inner surface of the lumen 1020 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 1010 via through-skin palpation or imaging, a clinician uses the catheter-bearing needle 42 to pierce a skin surface 44 and an upper wall of the port arm 1014, the latter including a needle-penetrable material. The needle 42 is inserted until a distal tip 42A thereof impinges on a lower wall 1024 of the arm 1014, which is formed of a needle-impenetrable material.
The needle 42 can then be proximally backed out a small distance, and the catheter 40 advanced over the needle such that the catheter bends and advances into the lumen 1020 of the arm 1014. Once the distal end 40A of the catheter 40 is in fluid communication with the arm lumen 1020, further advancement can cease and fluid transfer through the catheter 40 and port 1010 can commence, including infusion and/or aspiration through the stem 24. Once fluid transfer is completed, the catheter 40 can be withdrawn proximally and then withdrawn through the surface 44 of the skin and out of the patient.
Advantageously, the port 1010 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 1014.
Reference is now made to
Each elongate chamber 1114 can extend longitudinally in a side by side arrangement. In an embodiment, as shown in
Each chamber 1114 includes a septum 1140, formed of a self-sealing, needle-penetrating material, such as silicone. The port 1110 includes a needle guide 1142 disposed either above or below the septum 1140. The needle guide 1142 can be formed of a needle impenetrable material. In an embodiment, the needle guide 1142 can be formed either as a separate piece from that of port body 1112 or formed monolithically therewith. In an embodiment, the needle guide 1142 be formed as a separate piece from that of the septum 1140 and disposed either above or below the septum 1140. In an embodiment, the septum 1140 is overmolded onto the needle guide 1142 such that the needle guide is disposed within the septum 1140. In an embodiment, the needle guide 1142 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 1142 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 1114 and associated septa, provide a larger area with which to access the port while also maintaining a slim overall profile. The needle guide 1142 can guide a clinician to access the port at a different position, thus promoting tissue healing. For example, dialysis is performed every 2-3 days, the clinician can access the device at a first position 1144A proximate the proximal end of the needle guide 1142. During subsequent dialysis treatments, the clinician can use the needle guide 1142 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 position 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 1114 and associated septa 1140 can allow some variation in needle access within a given position 1144 so that the septum is not traversed in exactly the same position each time, thus improving septum longevity.
In an embodiment, as shown in
It will be appreciated that the port body 1112 can be formed of a suitable biocompatible material, as discussed herein. The port body 1112 can be formed of a needle impenetrable material, optionally each chamber 1114 can include a needle impenetrable material lining an inner surface thereof, as discussed herein. As shown, port 1110 includes two wells 1114 formed in a port body 1112 as a single monolithic piece, although it will be appreciate that any number of wells can be formed in the port 1110 and fall within the scope of the present invention. In an embodiment, the port 1110 can include a single chamber 1114 formed in the port body 1110. In an embodiment, the port 1110 can include wells 1114 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
Each of the first and second conduits 1212A, B, outer shell portions 1236A, B, and stem assembly 1224, 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 1212, 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 embodiment, the port 1210 further includes a portion of the outer shell 1236 that is overmolded onto a portion of the port body 1212. For example, proximal portion 1236A of the outer shell 1236 is formed of a compliant material, such as silicone, or similar suitable material as discussed herein and is overmolded onto the port body 1212.
Each of the first and second conduits 1212A, 1212B further include a valve/seal assembly 1222, such as valve/seal assembly 1222A, 1222B. Each valve/seal assembly 1222 includes a seal 1232 and a valve 1234 disposed in a valve/seal housing 1220. Each valve seal housing 1220 is disposed at a distal end of the respective first and second conduits 1212A, 1212B and secured in place with a nozzle 1221, e.g. nozzle 1221A, B. A distal end of the nozzle 1221 is received within a proximal end of the outer shell distal portion 1236B. Accordingly, the port body 1212, including the respective valve/seal assemblies 1220, nozzles, 1221 and stem 1224 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 embodiments described herein, for example palpation features, indicia, septa, guide grooves, valves, seals, etc., can be included with the port 1210.
The catheter 1250 includes an annular collar 1256 disposed proximate a proximal end which co-operates with a locking member 1260, and will be discussed in more detail herein. The catheter 1250 also includes a cuff 1258. The cuff 1258 can be made of, for example DACRON™, or similar suitable material. The cuff 1258 serves as an ingrowth cuff to further secure the catheter upon implantation within the body.
Referring to
The locking member 1260 includes an upper and lower portion 1266, 1268 that extend proximally to define an upper and lower surface of the locking member 1260, respectively. The upper and lower portions 1266, 1268 further define openings in the left and rights sides of the locking member 1260. 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 1260 further includes protrusions 1272 disposed at a distal end of the locking member 1260 and extend transversely inwards. Protrusions 1272A, 1272B extend transversely downwards from a distal end of the upper portion 1266, and protrusions 1272C, 1272D extend transversely upwards from a distal end of the lower portion 1268. The protrusions 1272 co-operate with slots 1274 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 1260 includes a resilient material such that an upper and lower portions 1266, 1268 are able to flex slightly. Accordingly, as the locking member 1260 is urged distally to engage the housing 1224C the upper and lower portions 1266, 1268 flex outward allowing the housing 1224C to be received within the space defined by the upper and lower portions 1266, 1268 of the connector. Further, the protrusions 1272 can include a chamfer to facilitate sliding over a distal portion of the housing 1224C and engage the slots 1274. Accordingly, the locking member can securely engage the housing 1224C and can align the catheter 1250 with the stem 1224.
Advantageously, the catheter assembly 1200 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 1212 can be configured to receive different gauge needles, catheters, or the like by exchanging the body conduits 1212A, 1212B, nozzles, 1221, valve assemblies 1222, or the like. Similarly, the catheter 1250 and stem assemblies 1224 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 1210, locking member 1260 and catheter 1250 can also co-operate to define a substantially smooth outer profile to the catheter system 1200. 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.
Embodiments of the invention may be embodied in other specific forms without departing from the spirit of the present disclosure. The described embodiments are to be considered in all respects only as illustrative, not restrictive. The scope of the embodiments is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.
This application is a continuation-in-part of U.S. patent application Ser. No. 15/809,879, filed Nov. 10, 2017, now U.S. Pat. No. 11,420,033, which claims the benefit of U.S. Provisional Application No. 62/421,131, filed Nov. 11, 2016, and U.S. Provisional Application No. 62/552,681, filed Aug. 31, 2017, and which is a continuation-in-part of U.S. patent application Ser. No. 14/162,113, filed Jan. 23, 2014, now U.S. Pat. No. 10,463,845, which claims the benefit of U.S. Provisional Application No. 61/755,913, filed Jan. 23, 2013. This application also claims the benefit of U.S. Provisional Application No. 62/657,662, filed Apr. 13, 2018, and U.S. Provisional Application No. 62/732,928, filed Sep. 18, 2018. Each of the aforementioned applications is incorporated by reference into this application.
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