Low-profile single and dual vascular access devices

Abstract

A low-profile access port for subcutaneous implantation in a patient's body is disclosed. The access port includes a receiving cup that provides a relatively large subcutaneous target to allow a needle with a catheter to enter the port without difficulty. In one embodiment, a low-profile access port includes a body and a receiving cup, the body including a conduit having an inlet port at a proximal end. The receiving cup is funnel-shaped to guide a needle with a catheter into the conduit through the inlet port. The conduit is defined by the body and extends from the inlet port to an outlet defined by a rod. A bend in the conduit enables the catheter to advance through the bend while preventing the needle from advancing. A valve / seal assembly is also provided in the conduit, and the valve / seal assembly enables the catheter to pass therethrough while preventing fluid backflow. The body includes a radiopaque marker that is configured to identify the access port by x-ray imaging.

Description

[0001] Case information

[0002] This application is a divisional application of the invention patent application with application number 201780070115.X filed on November 10, 2017 and invention name “Low-profile single vascular access device and double vascular access device”.

[0003] CROSS-REFERENCE TO RELATED APPLICATIONS

[0004] This application is a continuation-in-part of U.S. Patent Application No. 14 / 162,113, filed on January 23, 2014, entitled “Low-Profile Access Port,” which claims the benefit of U.S. Provisional Application No. 61 / 755,913, filed on January 23, 2013, entitled “Low Profile Access Port.” This application also claims the benefit of U.S. Provisional Application No. 62 / 421,131, filed on November 11, 2016, entitled “Low-Profile Vascular Access Device”; and U.S. Provisional Application No. 62 / 552,681, filed on August 31, 2017, entitled “Low-Profile Single and Dual Vascular Access Device.” Each of the above applications is incorporated herein by reference in its entirety. Technical Field

[0005] The present application relates to the field of medical devices, and more specifically to low-profile single vascular access devices and dual vascular access devices. Background Art

[0006] Low profile single and dual vascular access devices as described in this application do not currently exist in the art. Summary of the invention

[0007] Briefly, embodiments of the present invention relate to a low-profile access port for subcutaneous implantation in a patient. The access port includes a receiving cup that provides a relatively large subcutaneous target to allow a needle with a catheter to enter the port without difficulty. In addition, the access port includes a valve / seal assembly to allow pressurized fluid to be injected through the port while preventing backflow.

[0008] Thus, in one embodiment, a low-profile access port includes a body and a receiving cup, the body including a conduit having an inlet port at its proximal end. The receiving cup is concave to guide a needle with a catheter into the conduit through the inlet port. When implanted subcutaneously in a patient, the receiving cup is substantially oriented toward the skin surface to facilitate the needle impacting the receiving cup. A valve / seal assembly disposed in the conduit allows the catheter to pass while preventing fluid backflow.

[0009] In another embodiment, a low-profile access port for subcutaneous implantation in a patient is disclosed, the access port comprising a body and a receiving cup, the body comprising a conduit having an inlet port at its proximal end. The receiving cup is funnel-shaped to guide a needle with a catheter into the conduit through the inlet port. The conduit is defined by the body and extends from the inlet port to an outlet defined by a rod. A bend in the conduit enables the catheter to advance through the bend while preventing the needle from advancing. A valve / seal assembly is also provided in the conduit, and the valve / seal assembly enables the catheter to pass therethrough while preventing fluid backflow. The body comprises a radiopaque marker configured to enable identification of the access port by x-ray imaging.

[0010] In view of the above, embodiments herein generally relate to a vascular access device, also referred to herein as an access port, for subcutaneous implantation in a patient. A needle with a catheter such as a peripheral intravenous ("PIV") catheter can be percutaneously accessed into the implanted access port so that the PIV catheter can be placed in fluid communication with the access port. In one embodiment, the fluid outlet of the access port is operably connected to an indwelling catheter disposed within a patient's blood vessel to enable infusion of fluid into the patient's blood vessel and / or removal of fluid from the patient's blood vessel via the PIV catheter.

[0011] These and other features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the embodiments of the invention as set forth hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] A more specific description of the present disclosure will be presented with reference to the specific embodiments of the present disclosure shown in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the present invention and therefore should not be considered as limiting the scope of the present invention. Example embodiments of the present invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0013] Figures 1A to 1E shows different views of an access port according to one embodiment;

[0014] Figure 2 yes Figures 1A to 1E A cross-sectional view of a passage port;

[0015] FIG. 3A to FIG. 3C are different views of a low-profile access port according to one embodiment;

[0016] Figure 4 is a top view of a low-profile access port according to one embodiment;

[0017] Figure 5 is a perspective view of a low-profile access port according to one embodiment;

[0018] Figure 6 is a perspective view of a low-profile access port according to one embodiment;

[0019] Fig. 7A and Figure 7B are different views of an access port according to one embodiment;

[0020] Fig. 8A and Figure 8B are different views of an access port according to one embodiment;

[0021] FIG. 9A to FIG. 9G depicts various views of a low-profile vascular access device according to one embodiment;

[0022] Fig.10 yes FIG. 9A to FIG. 9G An exploded view of a passage device;

[0023] Fig.11 yes FIG. 9A to FIG. 9G A cross-sectional view of a passage device;

[0024] FIG. 12A to FIG. 12C depicts various views of a seal according to one embodiment;

[0025] FIG. 13A to FIG. 13C depicts different views of a valve according to one embodiment;

[0026] FIG. 14A to FIG. 14D Depicts the insertion of a catheter FIG. 9A to FIG. 9G The various stages of the access device;

[0027] Fig.15A and Fig. 15B Depicted is a method for FIG. 9A to FIG. 9G Different views of a guide device for use with a passage device;

[0028] FIG. 16A to FIG. 16G depicts various views of a low-profile vascular access device according to one embodiment;

[0029] Fig.17A and Fig. 17B Depicted FIG. 16A to FIG. 16G Different views of the vascular access port;

[0030] Fig.18 yes FIG. 16A to FIG. 16G An exploded view of a vascular access device;

[0031] Fig.19 yes FIG. 16A to FIG. 16G A partially transparent view of a vascular access device;

[0032] Fig. 20 yes FIG. 16A to FIG. 16G a perspective view of a portion of a vascular access device;

[0033] Fig.21A and Fig.21B yes FIG. 16A to FIG. 16G A cross-sectional view of a vascular access device;

[0034] FIG. 22A to FIG. 22C depicts various views of a low-profile vascular access device according to one embodiment;

[0035] Fig.23 yes FIG. 22A to FIG. 22C A partially transparent view of a vascular access device;

[0036] Fig.24 yes FIG. 22A to FIG. 22C A partially transparent view of a portion of a vascular access port;

[0037] FIG. 25A to FIG. 25E depicts various views of a low-profile vascular access device according to one embodiment;

[0038] FIG. 26A to FIG. 26D depicts various views of a low-profile vascular access device according to one embodiment;

[0039] Fig. 27 is a cross-sectional view of a valve / seal configuration according to one embodiment;

[0040] Fig.28 is a cross-sectional view of a valve / seal configuration according to one embodiment;

[0041] Fig.29 is a cross-sectional view of a valve / seal configuration according to one embodiment;

[0042] Fig.30 is a cross-sectional view of a valve / seal configuration according to one embodiment; and

[0043] Fig.31 is a perspective view of a portion of a vascular access device according to one embodiment. DETAILED DESCRIPTION

[0044] Reference will now be made to the drawings, wherein like structures will have like reference numerals. It should be understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the invention and are neither limiting nor necessarily drawn to scale.

[0045] For clarity, it should be understood that "proximal" refers to a direction relatively closer to a clinician using the device described herein, while "distal" refers to a direction relatively farther from the clinician. For example, the end of a catheter placed inside a patient's body is considered to be the distal end of the catheter, while the end of the catheter remaining outside the body is the proximal end of the catheter. In addition, the words "comprising" and "having" used herein (including the claims) shall have the same meaning as the word "including".

[0046] Embodiments of the present invention are generally directed to an access port for subcutaneous implantation in a patient. A needle with a catheter, such as a peripheral intravenous ("PIV") catheter, can be percutaneously accessed into the implanted access port to place the PIV catheter in fluid communication with the access port. In one embodiment, the fluid outlet of the access port is operably connected to an indwelling catheter disposed within a patient's blood vessel to enable infusion of fluid into and / or removal of fluid from the patient's blood vessel via the PIV catheter.

[0047] According to one embodiment, the access port defines a low profile for easy placement within the patient's subcutaneous tissue. In addition, the access port is configured to provide a relatively large subcutaneous target so that a PIV catheter or other suitable needle with a catheter can enter the port without difficulty. In addition, the access port includes a valve / seal assembly to allow fluid to be injected through the access port at a relatively high flow rate, for example, approximately 5 ml per second at a pressure of approximately 300 psi (also referred to herein as "power injection"). Possible applications of the access port described herein include administering medications and other fluids to patients, pheresis / apheresis, fluid aspiration, and the like.

[0048] First reference Figures 1A to 1E , which shows various details of a passage port generally designated 10 according to one embodiment. As shown, the port 10 includes a body 12 ( Figure 1E In the present embodiment, the port body 12 comprises a metal such as titanium, and the second portion 12B is press-fitted with the first portion 12A to define the body, but it will be appreciated that the port body may comprise a variety of other materials, including metals, thermoplastics, ceramics, etc.

[0049] In this embodiment, the port body 12 defines a substantially concave receiving cup 14 for receiving and guiding a needle with a catheter ( Figure 2) so that it can be operably connected to the port 10, as further described below. Specifically, the substantially concave shape of the receiving cup 14 is configured to impinge a needle ( Figure 2 ) leads to an inlet port 16 which serves as an opening for a conduit 18 defined by the port body 12. Figure 2 As shown, the open and shallow nature of the receiving cup 14 and its substantially upward orientation (i.e., toward the patient's skin surface) allows the receiving cup to be substantially parallel to the skin surface when subcutaneously implanted beneath the patient's skin (i.e., the receiving cup is substantially parallel to the skin surface when the skin is at rest or not deformed by digital pressure or manipulation), allowing the receiving cup to present a large, easily accessible target when the needle is introduced into the skin. Figure 2 The port 10 is also shown to define a relatively low profile height, which enables the use of a relatively short needle length to access the port after implantation.

[0050] A palpation feature 26 is included in the port body 12 to assist the clinician in locating and / or identifying the port 10 by finger palpation after implantation under the patient's skin. Specifically, the palpation feature 26 in this embodiment includes a ridge 26A disposed near the proximal end of the receiving cup 14 and a ridge 26B disposed above and curving around the distal portion of the receiving cup. Figure 1B The palpation features are shown extending above the generally plane defined by the port 10 to facilitate palpation by the clinician to locate the position and / or orientation of the receiving cup 14. Note that palpation features of various other sizes, configurations, quantities, etc., than those shown and described herein may also be included on the port.

[0051] 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 relative to an adjacent portion of the surface of the receiving cup 14 and extends distally along the receiving cup surface from a proximal portion of the receiving cup to provide a guide path to guide the distal tip of the needle with the catheter toward the inlet port 16 once the needle strikes the guide groove. This in turn reduces the chance of the needle slipping through and out of the receiving cup 14 during insertion. Note that these and other similar features, although different in shape and configuration, may also be included on other ports disclosed herein.

[0052] like Figure 1E As best shown in FIG. 1 , the port body 12 further defines a conduit 18 as a path through which a percutaneously inserted catheter may pass so as to place the catheter in fluid communication with the port 10. As shown, the conduit 18 communicates with the receiving cup 14 through the inlet port 16. A first conduit portion 18A of the conduit 18 extends from the inlet port 16 to the receiving cup 14. Figure 1EThe viewing angle shown is shown in a downwardly inclined direction extending distally to the bend 30, where the second conduit portion 18B of the conduit is slightly inclined upward and changes direction at a predetermined angle θ1. Note that in one embodiment, the angular orientation θ1 is approximately 37 degrees, but can be different in other embodiments, including angles less than 37 degrees in one embodiment. In one embodiment, the magnitude of the angle θ1 depends 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.

[0053] The conduit 18 then extends to and through the cavity 20A defined by the valve housing 20 of the port body. The conduit 18 extends to the distal open end of the stem 24 of the port 10. As will be seen, the dimensions of the conduit 18 are such that the conduit 40 ( Figure 2 ) can pass through it.

[0054] As described above, the valve housing 20 defines a cavity 20A through which the conduit passes and which receives the valve / seal assembly 22. The valve / seal assembly 22 includes a sealing element or seal 32, a first slit valve 34A, and a second slit valve 34B, which define a central hole through which the conduit 40 can pass. In one embodiment, the seal 32 and valves 34A, 34B are clamped together and fixed in place within the cavity 20A, such as Figure 1E In this embodiment, the slits of the slit valves 34A, 34B are rotationally offset by approximately 90 degrees from each other, but other relationships are possible.

[0055] The seal 32 and valves 34A, 34B of the valve / seal assembly 22 cooperate to allow the conduit 40 ( Figure 2 ) can pass through fluid-tightly while also preventing fluid from flowing back through the valve / seal assembly. In fact, in one embodiment, the seals disclosed herein prevent fluid from flowing around the outside of the catheter when the catheter passes through the seal arrangement, and the valves are adapted to prevent fluid flow when no catheter passes through them. In this way, when the catheter 40 is not inserted therein, the valve / seal assembly 22 seals to prevent air or fluid from passing therethrough. In this embodiment, the seal 32 and valves 34A, 34B include silicone, but other suitable compliant materials may also be used.

[0056] The port 10 in this embodiment includes an overmolded portion 36 covering the port body 12. The overmolded portion 36 includes silicone or other suitable compliant material and surrounds the body 12 as shown to provide a relatively soft surface for the port 10 and reduce discomfort to the patient after the port is implanted. The overmolded portion 36 includes two predetermined suture locations 38, such as Figure 1CAs best shown, the port 10 is used to suture the patient's tissue, but if desired, the sutures can pass through other parts of the overmolded portion. The overmolded portion 36 also defines a relatively flat bottom surface 36A to provide a stable surface for positioning the port 10 within the tissue cavity after implantation. Figure 3C The port shown includes a bottom surface having a slightly rounded profile.

[0057] Figure 2 Detail regarding the insertion of a catheter 40 disposed on a needle 42 is depicted according to one embodiment. As shown, after locating the port 10 through transdermal palpation of the palpation feature 26, the clinician pierces the skin surface 44 using the needle 42 with the catheter and inserts the needle until its distal tip 42A strikes a portion of the receiving cup 14. Note that because the orientation of the receiving cup 14 is substantially parallel to the skin surface, the needle 42 can strike the receiving cup at a relatively steep insertion angle θ2, which facilitates easy insertion of the needle into the body. In fact, in one embodiment, a needle inserted substantially orthogonally through the patient's skin can strike the receiving cup of the access port.

[0058] The needle 42 is manipulated until the distal tip 42A is received in the guide channel 28, which will enable the distal tip to be guided along the guide channel to the inlet port 16. The needle 42 is then inserted through the inlet port 16 into the first portion 18A of the tubing 18 until stopped by the bend 30. The needle 42 can then be withdrawn proximally a short distance and the catheter 40 advanced over the needle so that the catheter bends and advances through the bend 30 into the second portion 18B of the tubing 18. The catheter continues to be advanced so that the distal end 40A of the catheter 40 is advanced into and through the hole of the seal 32 and through the two slits of the slit valve 34A, 34B of the valve / seal assembly 40. Once the distal end 40A of the catheter 40 has been extended distally through the valve / seal assembly 22, further advancement can be stopped and fluid transfer through the catheter 40 and the port 10 can begin, including infusion and / or aspiration through the stem 24. Once fluid transfer is complete, catheter 40 may be withdrawn proximally through valve / seal assembly 22 and tubing, and then through skin surface 44 out of the patient's body.

[0059] FIG. 3A to FIG. 3C Detail of an access port 110 according to another embodiment is depicted. Note that various similarities exist between the port 10 and other ports shown and described herein. Therefore, only selected aspects of the port are discussed below. As shown, the port 110 includes a body 112, which in turn includes a first body portion 112A and a second body portion 112B, which are Figure 3C1. The body 112 in this embodiment comprises a thermoplastic, such as acetyl resin in this embodiment. Thus, in this embodiment, the first body portion 112A and the second body portion 112B are ultrasonically welded to each other to define the body 12. As previously described, the receiving cup 114 is included in the body 112 and is operably connected to the conduit 118 via the inlet port 116. In addition, it is noted that a variety of materials can be used to define the port body, receiving cup, conduit, etc.

[0060] The valve / seal assembly 122 is disposed within a cavity 120A defined by the valve housing 120, which in this embodiment is defined by the first body portion 112A. The valve / seal assembly 122 includes a proximal seal 132 having a central hole for passage of a catheter, two slit valves 134A, 134B, each having a slit offset 90 degrees relative to each other, and a distal seal 135 (also referred to herein as a sphincter seal) having a central hole.

[0061] The distal seal 135 includes on its distal surface a frustoconical portion 135A disposed about the seal center hole, the frustoconical portion being configured to provide a sphincter-like seal around the outer surface of the catheter when the catheter is extended through the valve / seal assembly. The frustoconical portion 135A is configured so that any backflow fluid impinging on the frustoconical portion will cause the seal to secure itself around the outer surface of the catheter in a tighter engagement, thereby preventing backflow through the outer surface of the catheter when high fluid pressures are present, such as in the case of power injection. As described above, other valve / seal combinations may also be included in the valve / seal assembly.

[0062] In this embodiment, the receiving cup 114 and the portion of the conduit 118 proximal to the valve / seal assembly 122 both include a needle-impermeable liner that prevents the distal end of the needle from scratching the surface when it strikes the surface. This in turn prevents unwanted fragments of material from being dug out by the needle. A variety of suitable materials can be used for the needle-impermeable material, including glass, ceramic, metal, etc. In one embodiment, the components of the port 110 are all non-metallic, such that the port is considered safe for magnetic resonance imaging (MRI), whereby the port does not produce undesirable artifacts in MRI images taken of a patient when the port is implanted therein.

[0063] Figure 4Additional features of the port 110 according to another embodiment are depicted. As shown, in this embodiment, the receiving cup 18 includes radiopaque markings 128 to indicate the characteristics of the port 110. Here, the radiopaque markings 128 include "C" and "T" formed of a radiopaque material (such as tungsten, bismuth trioxide, etc.) so as to be visible through x-ray imaging techniques after the port is implanted. For example, the radiopaque material can be formed as an embedded molded insert included in the port body, such as an initially flowable material injected into a cavity of the port body prior to hardening, etc. In embodiments where the port body is metal, the radiopaque markings can be formed by etching, engraving, or otherwise creating a relative thickness difference between the markings and the surrounding port body material so as to produce an x-ray discernible contrast that is displayed in an x-ray image.

[0064] In this embodiment, the CT radiopaque marker 128 indicates to the viewer that the port is capable of performing a hydrodynamic injection therethrough. In addition to this characteristic, other characteristics may be indicated by various other types of markers, as will be appreciated by those skilled in the art.

[0065] Furthermore, in this embodiment, Figure 4 The top view of the port 110 shows that the port body 112 in the area surrounding the receiving cup 114 defines a generally triangular shape, which can be palpated by the clinician after implantation and can indicate not only the location of the receiving cup, but also specific characteristics of the port, such as its ability to be used for power injection. Of course, in other embodiments, the receiving cup can define a shape other than a triangle.

[0066] Figure 4 Also shown are three palpation features 126 distributed around the perimeter of the receiving cup 114, i.e., three suture plugs 126A disposed in corresponding holes defined in the port body 112. In this embodiment, the suture plugs 126A include raised silicone bumps and can be used to locate the position of the receiving cup 114 after implantation when the clinician palpates them prior to needle insertion into the patient. In other embodiments, the port may include various other palpation features.

[0067] Figure 5 Depicted are details of a low profile port 210 according to one embodiment, including a body 212 defining a concave receiving cup 214 and an inlet port 216 positioned slightly off-center relative to the receiving cup. A stem 224 is included as a fluid outlet.

[0068] Figure 6 A low-profile port 210 is depicted according to another embodiment, wherein the body 212 defines additional surface features, including a raised palpation feature 226 distal to the receiving cup 214. Figure 5 and Figure 6 , it will be appreciated that the port may be configured in a variety of shapes and configurations to provide a low profile solution for providing vascular access. It is also noted that the shape, design and configuration of the receiving cup may vary from that explicitly shown and described herein.

[0069] Fig. 7A and Figure 7B Various details of a low-profile dual-body access port 310 are depicted according to one embodiment, wherein each port body 312 defines a receiving cup 314 that faces laterally and includes an inlet port 316 that leads to a conduit 318. The conduit 318 extends distally to a valve / seal assembly 322 disposed in a valve housing 320, which in this embodiment is defined by a portion of the body 312. The conduit 318 extends through a port 324. A compliant overmolded portion 324 covers portions of each body 312 of the port 310 and operably couples the bodies to one another. The body 312 can include any suitable material, including metals, thermoplastics, and the like.

[0070] Fig. 8A and Figure 8B Various details of a low-profile dual-body access port 410 are depicted according to one embodiment, wherein a port body 412 defines dual fluid paths. Each fluid path includes a receiving cup 414 defined by the body 412 and extending from the Fig. 8A and Figure 8B 4. The receiving cup 414 is oriented generally upward from the perspective shown. Each receiving cup 414 includes an inlet port 416 and defines an opening to a conduit 418. Each conduit 418 extends distally to a valve / seal assembly 422 disposed in a valve housing 420, which in this embodiment is defined by a portion of the body 412. The conduit 418 extends through the port 424. The body 412 can include any suitable material, including metal, thermoplastic, etc.

[0071] Reference now FIG. 9A to FIG. 30 , which describes various details of embodiments generally relating to vascular access devices (also referred to herein as access ports, for subcutaneous implantation in a patient). A needle with a catheter, such as a peripheral intravenous ("PIV") catheter, can be percutaneously accessed into an implanted access port, which will be described, so that the PIV catheter can be placed in fluid communication with the access port. In one embodiment, the fluid outlet of the access port is operably connected to an indwelling catheter disposed within a patient's blood vessel to enable infusion of fluid into the patient's blood vessel and / or removal of fluid from the patient's blood vessel via the PIV catheter.

[0072] According to one embodiment, the access port defines a relatively low profile for easy placement within the patient's subcutaneous tissue. In addition, the access port is configured to provide a relatively large subcutaneous target so that a PIV catheter or other suitable needle with a catheter can enter the port without difficulty. In addition, the access port includes a valve / seal assembly to allow fluid to be powered injected through the access port. As previously described, possible applications of the access port described herein include administering medications and other fluids to patients, single collection, fluid aspiration, etc.

[0073] First reference FIG. 9A to FIG. 9G , which shows various details of a vascular access device (also referred to as an "access port" or "port") generally designated 510 according to one embodiment. As shown, port 510 includes a body 512 (defined in this embodiment by a first portion 512A and a second portion 512B). Fig.9E In the present embodiment, the port body 512 comprises a metal such as titanium, and the second portion 512B is press-fitted with the first portion 512A to define the body, but it will be appreciated that the port body may comprise a variety of other materials, including metals, thermoplastics, ceramics, etc.

[0074] In this embodiment, the first portion 512A of the port body defines a substantially funnel-shaped receiving cup 514 for receiving and guiding a needle with a catheter ( Fig.14A ) so that it is operably connected to the port 510, as further described below. Specifically, the substantially funnel-shaped shape of the receiving cup 514 is configured to impinge a needle ( Fig.14A ) leads to an inlet port 516 which serves as an opening for a conduit 518 defined by the port body 512. FIG. 14A to FIG. 14D As shown, the open and shallow nature of the receiving cup 514, which is angled toward the patient's skin surface, enables the receiving cup to present a large, easy entry target for the needle as it is introduced into the skin. Fig. 9B and Fig. 9C The port 510 is further shown to define a relatively low profile height, which enables the use of a relatively short needle length to access the port after implantation. Note that a palpation feature can be included in the port body 512 to assist the clinician in locating and / or identifying the port 510 by finger palpation after implantation under the patient's skin, as in other embodiments herein. Additionally, in another embodiment, a guide groove can be defined on the receiving cup 514 to longitudinally align with the inlet port 516 of the conduit 518, similar to Figure 1A The access port 10 is shown.

[0075] Combination FIG. 9A to FIG. 9G , while referring to Fig.10 and Fig.11 .like Fig.11 As best shown in FIG. 5 , the port body 512 further defines a conduit 518 as a path through which a percutaneously inserted catheter may pass so as to place the catheter in fluid communication with the port 510 and an indwelling catheter attached to its shaft 524. As shown, the conduit 518 is in fluid communication with the receiving cup 514 through the inlet port 516. A first conduit portion 518A of the conduit 518 extends from the inlet port 516 to the receiving cup 514. Fig.11 The perspective view shown extends distally in a downwardly inclined direction to a bend 530, wherein the second conduit portion 518B of the conduit is substantially horizontal (from Fig.11 Note that in one embodiment, the predetermined angle at bend 530 is approximately 34 degrees, but can vary in other embodiments, including in one embodiment, an angle less than or greater than 34 degrees. In one embodiment, the size of the predetermined angle at bend 530 depends 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.

[0076] The conduit 518 then extends to and through the cavity 520A defined by the valve housing 520 of the port body 12, with the third conduit portion 518C extending to the distal open end of the stem 524 of the port 510. In this embodiment, as will be seen, the conduit 518 is sized so that the catheter 40 ( Fig.14A ) can pass through the pipeline to reach the predetermined point.

[0077] As described above, the valve housing 520 defined by the first and second portions 512A, 512B of the body 512 defines a cavity 520A through which the conduit 518 passes and which houses the valve / seal assembly 522. The valve / seal assembly 522 includes a sealing element or seal 532 that defines the conduit 40 ( Fig.14A ) can pass through the center hole 532A ( FIG. 12A to FIG. 12C ), the slit valve comprises two intersecting slits 534A ( FIG. 13A to FIG. 13C In one embodiment, the seal 532 and valve 534 are clamped together and fixed in place within the cavity 520A, wherein the seal 532 is disposed proximal to the valve 534, such as Fig.11 In this embodiment, the slits 534A of the slit valve 534 are orthogonally offset from each other by about 90 degrees, but other relationships are possible. Note that the valve 534 includes a central recess 535 to facilitate the transition of the passage of the conduit 40 from the seal 532 to the valve.

[0078] The seal 532 and valve 534 of the valve / seal assembly 522 cooperate to allow the catheter 40 ( Fig.14A) can pass through the conduit 518 in a fluid-tight manner, while also preventing fluid from flowing back through the valve / seal assembly. In fact, in one embodiment, the seals disclosed herein prevent fluid from flowing around the outside of the conduit when the conduit is placed through the seal 532, while the valve 534 is adapted to prevent fluid from flowing when no conduit is passing through them. Thus, when the conduit 40 is not inserted therein, the valve / seal assembly 522 seals to prevent air or fluid from passing through the conduit 518. In this embodiment, the seal 532 and the valve 534 are composed of silicone, such as the silicone provided by Dow Corning. Q7-4850 liquid high temperature silicone, but other suitable compliant materials may also be used. In one embodiment, seal 532 and valve 534 include silicone oil, such as NuSil Technology Med 400 silicone oil, to enhance lubricity and extend component life. In another embodiment, silicone oil is injected into the silicone.

[0079] The port 510 in this embodiment includes an overmold portion 536 that covers a majority of the port body 512. The overmold portion 536 includes silicone, such as Q7-4850 liquid high temperature silicone or other suitable compliant material, and as shown, surrounds the body 512 to provide a relatively soft surface for the port 510 and reduce patient discomfort after the port is implanted in the patient. In one embodiment, the overmolded portion 536 includes a predetermined suture location 538, such as Fig.9F As shown, it is used to suture the port 510 to the patient's tissue, but if desired, the suture can pass through other parts of the overmolded portion. The overmolded portion 536 also defines a relatively flat bottom surface 536A to provide a stable surface for positioning the port 510 in the tissue cavity after implantation in the patient's body.

[0080] Fig. 9C and Figure 9G The first body portion 512A is shown defining a securing ridge 537 that serves as an anchor to prevent relative movement between the overmolded portion 536 and the body 512. The securing ridge 537 can vary in shape, number, configuration, etc. Note that in one embodiment, the overmolded portion 536 is molded onto the body 512 during the molding process. In another embodiment, the overmolded portion 536 is formed separately and then adhered to the body 512, such as by a Med A adhesive. Thus, these and other configurations are contemplated.

[0081] FIG. 14A to FIG. 14DDetailed description of inserting a catheter 40 disposed on a needle 42 into a port 510 (already implanted subcutaneously in a patient) is depicted according to one embodiment. After locating the port 510 (optionally by transdermal palpation of palpation features, such as the overmolded portion 536 and / or the top of the receiving cup 514), the clinician pierces the skin surface using the needle 42 with the catheter and inserts the needle until its distal tip 42B strikes a portion of the receiving cup 514, such as Fig.14A As shown. Note that because the orientation of the receiving cup 514 is substantially angled toward the skin surface, the needle 42 can strike the receiving cup at a relatively steep insertion angle, which facilitates easy insertion of the needle into the body. In fact, in one embodiment, a needle inserted substantially orthogonally through the patient's skin can strike the receiving cup of the access port. In another embodiment, the insertion angle of the needle 42 can be relatively shallow, similar to the current insertion angle of intravenous catheters.

[0082] The clinician manipulates the needle 42 and guides the needle 42 by striking 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 into the first portion 518A of the conduit 518 until it is stopped by the bend 530, as shown in FIG. Fig. 14B The needle 42 may then be withdrawn a short distance proximally and the catheter 40 advanced over the needle such that the catheter bends and advances through the bend 530 into the second portion 518B of the conduit 518, as shown. Fig. 14C The catheter continues to be advanced so that the distal end 40B of the catheter 40 is advanced into and through the hole 532A of the seal 532 and through the two slits 534A of the slit valve 534 of the valve / seal assembly 522. Note that the length of the second conduit portion 518B is sufficient to allow the cross-sectional shape of the distal portion of the catheter 40 to return from the elliptical shape imposed thereon by its passage through the conduit bend 530 to a substantially circular shape.

[0083] Once the distal end 40B of the catheter 40 has been extended distally through the valve / seal assembly 522, further advancement is prevented by the catheter distal end striking an annular stop surface 539 included in the third conduit portion 518C defined by the stem 524, as shown in FIG. Fig.14D shown, and in Fig.11 524. In one embodiment, the stop surface 539 is defined as an annular shoulder and is sized to prevent the advancement of a catheter of one size (e.g., a 14 gauge catheter) while allowing a 16 gauge catheter to pass. In another embodiment, the stop surface is not included in the conduit 518, thereby allowing the catheter 40 to be fully advanced through the distal end of the rod 524 if necessary. Note that the port conduit can be configured to accommodate one or more catheter gauge sizes, including 14 gauge, 16 gauge, 18 gauge, etc.

[0084] Once the catheter 40 is Fig.14D Positioned as shown, needle 42 can be completely removed and fluid transfer through catheter 40 and port 510 can begin, including infusion and / or aspiration through an indwelling catheter attached to stem 524. (Note that in one embodiment, needle 42 can be removed at another stage of the catheterization process.) Packing of catheter 40 can also be performed as desired. Once fluid transfer is complete, catheter 40 can be withdrawn proximally through valve / seal assembly 522 and tubing 518, and then withdrawn out of the patient's body through the skin surface.

[0085] Fig.9F It is depicted that in this embodiment, the receiving cup 514 includes a radiopaque marking 528 to indicate the characteristics of the port 510. Here, the radiopaque marking 528 includes an "IVCT" alphanumeric designation defined as a depression or indentation in the titanium material forming the first body portion 512A so as to be visible by x-ray imaging techniques after implantation of the port. The "IVCT" designation indicates that the port 510 is configured for powered injection and is also configured to receive a peripheral IV catheter therein.

[0086] In another embodiment, the radiopaque marker 528 can be included by employing a radiopaque material that can be formed as an insert that is insert molded into the port body, such as an initially flowable material that is injected into a cavity of the port body prior to hardening, etc. In embodiments where the port body is metal, the radiopaque marker can be formed by metal injection molding, machining, etching, engraving, or otherwise creating a relative thickness difference between the marker and the surrounding port body material to produce an x-ray discernible contrast that is displayed in an x-ray image, similar to Fig.9F .

[0087] In addition to the above-described indicia, other characteristics may be indicated by various other types of radiopaque markings, as will be appreciated by those skilled in the art.

[0088] 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 help locate the position of the receiving cup 514 after implantation when the clinician palpates these bumps prior to needle insertion into the patient. In other embodiments, the port can include various other palpation features, including treatments on the receiving cup itself, etc.

[0089] Fig.15A and Fig. 15B Details of the guide device 550 are described, which can be placed in FIG. 9A to FIG. 9GThe guide device 550 is shown as being positioned on the patient's skin at the top of the implantation location of the port 510 to help guide the needle 42 through the skin to impact on the receiving cup 514 as needed. As shown, the guide device 550 includes a body 552 that defines a cavity 554 in which a portion of the subcutaneously implanted port 510 will reside when the guide device is pressed against the skin above the port. A notch 556 is included on the body 552, which is partially defined by a ridge 558. The notch 556 enables the needle 42 to pass through, thereby passing through the skin and inserting into the port 510. A marking line 560 is included on the ridge 548 to help the clinician place the needle 42 in the proper orientation and position to impact the receiving cup 514 as needed. Note that the shape, size, and other configurations of the guide device may vary from that shown and described herein.

[0090] Reference now FIG. 25A to FIG. 25E , which shows various details of a dual lumen vascular access device, generally designated 810, according to one embodiment. As shown, port 810 includes a body 812, which in this embodiment is defined by two similarly shaped portions: a single first portion 812A and a single second portion 812B ( Fig.25C ). In the present embodiment, the first and second portions 812A, 812B of the port body comprise a metal such as titanium, and the second portion is press-fitted with the first portion to define the body, but it will be appreciated that the port body may comprise a variety of other materials, including metals, thermoplastics, ceramics, etc., and may include other joining methods, including adhesives, ultrasonic or other welding, interference fit, etc.

[0091] In this embodiment, the two port body first portions 812A define a substantially funnel-shaped receiving cup 814 for receiving and guiding a needle 42 with a catheter ( Fig.14A ) so that it can be operably connected to the port 810 in a manner similar to that described above. In particular, the substantially funnel-shaped shape of each receiving cup 814 is configured to direct the needle 42 with the catheter impinging thereon to the inlet port 816, which serves as the opening of the corresponding conduit 818 defined by the port body 812. The open and shallow nature of each receiving cup 814, which is angled toward the patient's skin surface, enables the receiving cup to present a large, easy entry target for the needle as it is introduced into the skin and toward the subcutaneously implanted access port 810. Fig.25B Access port 810 is further shown to define a relatively low profile height, which enables the use of a relatively short needle length to access the subcutaneous access port after implantation.

[0092] Note that, as already mentioned, in one embodiment, palpation features may be included in the port body 812 to assist the clinician in locating and / or identifying the port 810 by finger palpation after implantation under the patient's skin. Note that palpation features of various sizes, configurations, quantities, etc. may be included on the port. In another embodiment, such as in combination with Figure 1A to Figure 2 As discussed in the embodiments of the present invention, a guide groove can be defined on the receiving cup 814 to align longitudinally with the inlet port 816 of the conduit 818. The guide groove 28 can be defined as a depression relative to an adjacent portion of the surface of the receiving cup 814 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 needle with the catheter toward the inlet port 816 once the needle strikes the guide groove. This in turn reduces the chance of the needle slipping through and out of the receiving cup 814 during insertion. Note that these and other similar features, although different in shape and configuration, can also be included on other ports disclosed herein.

[0093] like Fig.25D As best shown in FIG. 1 , the port body 812 further defines two conduits 818, each of which serves as a path into which a percutaneously inserted catheter may be partially inserted so as to place the catheter in fluid communication with the port 810 and an indwelling dual lumen catheter of two fluid outlets 824A operably attached to the port's stem 824. As shown, the conduits 818 of each port body first portion 812A are in fluid communication with its corresponding receiving cup 814 via the inlet port 816. The first conduit portion 818A of the conduits 818 extends from the inlet port 816 to the inlet port 816. Fig.25D The viewing angle shown is shown in a downwardly inclined direction extending distally to a conduit bend 830, wherein the second conduit portion 818B of the conduit extends at a predetermined angle relative to the first conduit portion. Note that in one embodiment, the predetermined angle at the bend 830 is approximately 34 degrees, but can vary therefrom in other embodiments, including angles less than or greater than 34 degrees in one embodiment. In one embodiment, the magnitude of the predetermined angle at the bend 830 depends 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 830 acts as a needle stop feature, preventing the needle 42 from being advanced along the conduit 818 through the bend 830.

[0094] like Fig.25DAs shown, the second conduit portion 818B of each port body first portion 812A extends distally to a cavity 820A defined by the press-fit engagement of the port body first portion and the second portion 812B. Two third conduit portions 818C are defined by the second portion 812B of the port body 812 and extend in a partially arcuate fluid path from each cavity 820A to a fluid outlet 824A disposed distally of the rod 824. In this embodiment, the conduit 818 is sized so that the catheter 40 ( Fig.14A ) is able to pass therethrough and through cavity 820A.

[0095] As described above, the cavity 820A defined by the engagement of the corresponding first portion 812A and the second portion 812B of each free port body 812 each defines a space through which the conduit 818 passes, and the valve / seal assembly 822 is accommodated in the space. Fig.25C and Fig.25D As shown, the valve / seal assembly 822 includes a sealing element or seal 832 and a slit valve 834, wherein the sealing element or seal defines the conduit 40 ( Fig.14A , 14D ) can pass through the central hole 832A, and the slit valve includes two orthogonal intersecting slits 834A through which the catheter can also pass. In one embodiment, the seal 832 and the slit valve 834 are clamped together and fixed in place within the correspondingly sized cavity 820A, wherein the seal is disposed proximally of the slit valve, such as Fig.25D shown.

[0096] As described above, in this embodiment, the slits 834A of the slit valve 834 are orthogonally offset from each other by approximately 90 degrees, but other relationships are possible, including using two single slit valves clamped together. Note that in this embodiment, the slit valve 834 includes a central depression (as in previous embodiments, for example, Fig.13A 832 to facilitate the passage transition of the conduit 40 from the seal 832 to the valve. In other embodiments, more than one seal and / or slit valve may be used in the valve / seal assembly.

[0097] As with the previous embodiments, the seal 832 and slit valve 834 of the valve / seal assembly 822 cooperate to allow the catheter 40 (see, e.g., Fig.14A) can pass through the conduit 818 in a fluid-tight manner, while also preventing fluid from flowing back through the valve / seal assembly. In fact, in one embodiment, the seals disclosed herein prevent fluid from flowing around the outside of the conduit when the conduit is disposed through the seal 832, while the valve 834 is adapted to prevent fluid from flowing when no conduit is passing through them. Thus, when the conduit 40 is not inserted therein, the valve / seal assembly 822 seals to prevent air or fluid from passing through the conduit 818. In this embodiment, the seal 832 and valve 834 are composed of silicone, such as the silicone provided by Dow Corning. Q7-4850 liquid high temperature silicone, but other suitable compliant materials may also be used. In one embodiment, the seal 832 and valve 834 include silicone oil, such as NuSil Technology Med 400 silicone oil, to enhance lubricity and extend component life. In another embodiment, the silicone oil is injected into the silicone.

[0098] The port 810 in this embodiment includes an overmold portion 836 that covers a portion of the port body 812, including a majority of each of the two first portions 818A. The overmold portion 836 includes silicone, such as Q7-4850 liquid high temperature silicone or other suitable compliant material, and such as Fig.25A and Fig.25B The overmolded portion 836 is shown surrounding a portion of the body 812 to provide a relatively soft surface for the port 810 and reduce discomfort to the patient after the port is implanted in the patient. The overmolded portion 836 also enables the clinician to suture through one or more different portions of the overmolded portion to enable the port 810 to be fixed in the subcutaneous patient tissue cavity. The overmolded portion 836 also defines a relatively flat bottom surface 836A to provide a stable surface for positioning the port 810 in the tissue cavity after implantation in the patient.

[0099] Fig.25B The first body portions 812A are shown to each define a securing ridge 837 that serves as an anchor to prevent relative movement between the overmolded portion 836 and the body 812. The securing ridges 837 can vary in shape, number, configuration, etc. Note that in one embodiment, the overmolded portion 836 is molded onto the body 812 during the molding process. In another embodiment, the overmolded portion 836 is formed separately and then adhered to the body 812, such as by a Med A adhesive. Thus, these and other configurations are contemplated.

[0100] Fig.25EThe lower surface of the receiving cup 814 is shown to include radiopaque markings 828 configured to enable the port 810 to be radiographically identified after implantation in a patient. In this embodiment, each of the markings 828 includes the letters "IV" and "CT" to indicate that the port 810 is suitable for receiving a peripheral IV catheter and that the port can be used for fluid dynamic injection. Of course, various other markings may be used, including letters, numbers, symbols, etc.

[0101] FIG. 26A to FIG. 26D Various details of a port 810 are depicted according to another embodiment, wherein a port body 812 defines a FIG. 25A to FIG. 25E The illustrated embodiment has a relatively thinner profile, which is made possible by defining a cutout 870 on the two receiving cups 814 of each first portion 812A of the port body 812. This enables the receiving cups 814 to be relatively close to each other. The receiving cups 814 can be joined to each other along the cutout 870 by welding, gluing, forming the welding cups as a single component, etc.

[0102] In one embodiment, it will be appreciated that the receiving cup 814 may be oriented in other configurations. Fig.31 An example is given in which a partially exploded view of a port 810 is shown without the overmolded portion 836, and thus includes two first portions 812A and second portions 812B. As shown, the receiving cups 814 are angled relative to each other so that the perimeter 814A of a corresponding one of the receiving cups lies in an imaginary plane 890A that is not parallel to another plane 890B in which the perimeter 814B of the other receiving cup lies. This is in contrast to another embodiment, for example Fig.25A The embodiment shown, wherein the receiving cup 814 lies substantially in a single imaginary plane. Fig.31 The configuration causes the receiving cups 814 to be tilted relative to each other, such as Fig.31 As shown (note that the first body portion 812A shown disconnected from the second body portion 812B (for clarity) will be Fig.31 In one embodiment, this in turn desirably allows the height profile of the access port 810 to be slightly lowered, and can also allow the needle 42 inserted therein to be relatively closer to the patient's skin. Note that the receiving cup can be tilted in a variety of different configurations other than those shown and described herein.

[0103] Reference now FIG. 16A to FIG. 21B, which depicts details of a dual lumen vascular access device, generally designated 610, according to one embodiment. As shown, the port 610 includes a body 612, which in this embodiment is defined by a first portion 612A and a relatively smaller second portion 612B, which is partially received within the first portion. In this embodiment, the port body first and second portions 612A, 612B include a metal such as titanium, and the second portion is press-fitted into engagement with the first portion to define the body, but it is understood that the port body may include a variety of other materials, including metals, thermoplastics, ceramics, etc., and may include other joining methods, including adhesives, ultrasonic or other welding, interference fits, etc.

[0104] In this embodiment, the first portion 612A of the port body defines two substantially funnel-shaped receiving cups 614 for receiving and guiding the needle 42 with the catheter ( Fig.14A ) to be operably connected to the port 610 in a manner similar to that described above. The receiving cup 614 in this embodiment is arranged to be substantially aligned along the longitudinal axis of the port 610, although other positions of the receiving cup are also possible, including side by side, spaced apart, staggered, etc.

[0105] Specifically, the substantially funnel-shaped shape of each receiving cup 614 is configured to direct a catheter-carrying needle 42 impinging thereon toward an inlet port 616 that serves as the opening of a respective one of two conduits 618, one for each receiving cup, defined by the port body 612. The open and shallow nature of each receiving cup 614, angled toward the patient's skin surface, enables the receiving cup to present a large, easily accessible target for the needle as it is introduced into the skin and toward the subcutaneously implanted access port 610. Fig. 16C and Fig.16F Access port 610 is further shown to define a relatively low profile height, which enables the use of a relatively short needle length to access the subcutaneous access port after implantation.

[0106] The port body 612 further defines a palpation feature 637, here configured as a raised surface inserted between the longitudinally aligned receiving cups 614. As described above, the palpation feature 637 is included in the port body 612 to assist the clinician in locating and / or identifying the port 610 by digital palpation after implantation under the patient's skin. Note that palpation features of various sizes, configurations, quantities, etc. may be included on the port. In another embodiment, a guide groove may be defined on each receiving cup 614, longitudinally aligned with the inlet port 616 of the conduit 618, as in the previous embodiment.

[0107] like Fig.17A , Fig. 17B and Fig.19As shown, the port body 612 further defines the above-mentioned two conduits 618, each of which serves as a path into which a percutaneously inserted catheter can be partially inserted so as to place the catheter in fluid communication with the port 610 and the two fluid outlets 624A of the rod 624 of the port operably attached. As shown, the two conduits 618 of the first portion 612A of the port body are in fluid communication with their respective receiving cups 614 through corresponding inlet ports 616. The first conduit portion 618A of each conduit 618 is connected from the corresponding inlet port 616 to the receiving cup 614. Fig.17A The perspective shown is tilted downwardly and extends distally to the conduit bend 630 ( Fig.19 ), wherein the first conduit portion extends distally at a predetermined angle relative to the first conduit portion proximal to the conduit bend. In one embodiment, the magnitude of the predetermined angle at the bend 630 depends 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 conduit itself, etc. It is also noted that the conduit bend 630 acts as a needle stop feature, preventing the needle 42 from being advanced through the bend 630 along the conduit 618.

[0108] The relatively distal first portions 618A of the two receiving cups 614 extend into a cavity 620A defined by and proximal to the distal portion of the first portion 612A of the port body 612, such as Fig.18 and Fig.19 The relatively proximal first portion 618A of the two receiving cups 614 also extends into a cavity 620A defined by the distal portion of the first portion 612A of the port body 612, but relatively more proximal distal to the distal portion ( Fig.18 and Fig.19 ).like Fig.17A and Fig. 17B As shown, the second conduit portion 618B of the latter conduit 618 is defined by the second portion 612A of the port body 612 and extends distally from its corresponding cavity 620A until it is connected to the third conduit portion 618C defined by the second portion 612A of the port body, and the third conduit portion extends through the second portion and the rod 624 until it terminates at a corresponding one of the fluid outlets 624A ( Fig. 20 ).

[0109] like Fig. 20 As shown, the conduit 618 for the relatively 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, the third conduit portion extending through the second portion and the stem 624 until terminating at a corresponding one of the fluid outlets 624A. Fig.21A and Fig.21BAs shown, a fluid path from the inlet port 616 to the rod fluid outlet 624A is defined for each receiving cup 614. In this embodiment, the size of the conduit 618 is such that the conduit 40 ( Fig.14A ) can pass through cavity 620A.

[0110] As described above, the cavities 620A, each disposed in a fluid path defined by a different portion of the conduit 618, each define a space through which the conduit 618 passes, and in which the valve / seal assembly 622 is accommodated. FIG. 17A to FIG. 18 As shown, each valve / seal assembly 622 includes a sealing element or seal 632 and two adjacently placed slit valves 634, the sealing element or seal 632 defining a conduit 40 ( Fig.14A , Fig.14D ) can pass through the center hole 632A ( Fig.21B ), each slit valve includes a single slit 634A through which a catheter can also pass (the valves are arranged so that the slits are orthogonal to each other). In one embodiment, the seal 632 and slit valve 634 are clamped together and fixed in place within the correspondingly sized cavity 620A, wherein the seal is disposed proximal to the slit valve, such as Fig.17A and Fig. 17B In another embodiment, the valve / seal assembly includes a single seal and a single double-slit valve, as in the previous embodiment.

[0111] In this embodiment, the seal 632 and valve 634 are composed of silicone, such as that provided by Dow Corning. Q7-4850 liquid high temperature silicone, but other suitable compliant materials may also be used. In one embodiment, the seal 632 and valve 634 include silicone oil, such as NuSil Technology Med 400 silicone oil, to enhance lubricity and extend component life. In another embodiment, the silicone oil is injected into the silicone. In addition, as described in other embodiments, other seal / valve configurations may also be used in the port 610.

[0112] Reference now FIG. 22A to FIG. 24, which shows various details of a dual lumen vascular access device, generally designated 710, according to one embodiment. As shown, the port 710 includes a body 712, which in this embodiment is defined by a first portion 712A that defines a majority of the exterior of the port body and a second portion 712B that can be mated to the first portion. In this embodiment, the first and second portions 712A, 712B of the port body include a metal such as titanium, and the second portion is press-fitted into engagement with the first portion to define the body 212, but it will be appreciated that the port body can include a variety of other materials, including metals, thermoplastics, ceramics, etc., and can include other joining methods, including adhesives, ultrasonic or other welding, interference fits, etc.

[0113] In this embodiment, the port body first portion 712A defines two substantially concave receiving cups 714 that are disposed side by side in a spaced-apart arrangement for receiving and guiding a catheter-carrying needle 42 ( Fig.14A ) to be operably connected to the port 710 in a manner similar to that described above. In particular, the substantially concave shape of each receiving cup 714 is configured to direct the impingement of the catheter-carrying needle 42 thereon to the inlet port 716, which serves as the opening of the corresponding conduit 718 defined by the port body 712.

[0114] The open and shallow nature of each receiving cup 714 , angled toward the patient's skin surface, enables the receiving cup to present a large, easy entry target for the needle as it is introduced into the skin and toward the subcutaneously implanted access port 710 . Fig.22A and Fig. 22B Access port 710 is further shown to define a relatively low profile height, which enables the use of a relatively short needle length to access the subcutaneous access port after implantation. Fig. 22C Details of the bottom of the port body 712 are depicted. Note that in this and other embodiments, the receiving cup can define different surfaces, including funnel-shaped, concave, hemispherical surfaces, and the like.

[0115] The port body 712 includes a plurality of palpation features 737, here implemented as ridges extending distally from the receiving cup 714, to assist the clinician in locating and / or identifying the port 710 by digital palpation after implantation under the patient's skin. Note that palpation features of various sizes, configurations, quantities, etc., may be included on the port.

[0116] like Fig.23 and Fig.24As best shown in the figure, the port body 712 also defines two conduits 718, each of which serves as a path into which a percutaneously inserted catheter can be partially inserted so as to place the catheter in fluid communication with the port 710 and the two fluid outlets 724A of the rod 724 operably attached to the port. As shown, the two conduits 718 of the first portion 712A of the port body are each in fluid communication with their respective receiving cups 714 via the inlet port 716 and extend distally to the valve / seal assembly 722, which is disposed in a cavity defined by the joint cooperation of the first portion 712A and the second portion 712B of the port body. As with other embodiments herein, each conduit 718 extends along a path from the first portion 712A to the second portion 712B before continuing to the cavity in which the valve / seal assembly is disposed. Fig.23 The perspective shown is in a downwardly sloping direction extending distally from the corresponding inlet port 716 to the bend in the conduit. Note that the bend in the conduit can be ideally used as a needle stop feature to prevent the needle 42 from being advanced through the bend along the conduit 718. The conduit extends distally through the valve / seal assembly 722 and through the port body second portion 712B to the fluid outlet of the stem 724. In this embodiment, the conduit 718 is sized so that the catheter 40 ( Fig.14A ) is able to pass through the valve / seal assembly 722.

[0117] As described above, the cavities defined by the engagement of the respective first and second portions 712A, 712B of each free port body 712 each define a space through which the conduit 718 passes, and in which the valve / seal assembly 722 is accommodated. Fig.23 and Fig.24 As shown, each of the two valve / seal assemblies 722 includes a sealing element or seal 732 and two slit valves 734, wherein the sealing element or seal defines the conduit 40 ( Fig.14A , Fig.14D ) through a central hole through which a catheter can pass, the slit valves each comprising a single slit and positioned adjacent to each other so that the slits are substantially orthogonal to each other, and the catheter can also pass through the slit. In one embodiment, the seal 732 and the slit valve 734 are clamped together and fixed in place in a cavity of corresponding size, wherein the seal is disposed proximal to the slit valve, such as Fig.23 and Fig.24 shown.

[0118] As described above, in this embodiment, the slits of the slit valve 734 are orthogonally offset from each other by about 90 degrees, but other relationships are possible, including the use of a single slit valve including two orthogonal slits. Thus, these and other modifications to this and other valve / seal assembly embodiments herein are contemplated.

[0119] As with the previous embodiments, the seal 732 and slit valve 734 of the valve / seal assembly 722 cooperate to allow the catheter 40 (see, e.g., Fig.14A ) can pass through the conduit 718 in a fluid-tight manner, while also preventing fluid from flowing back through the valve / seal assembly. In fact, in one embodiment, the seals disclosed herein prevent fluid from flowing around the outside of the conduit when the conduit is disposed through the seal 732, while the valve 734 is adapted to prevent fluid from flowing when no conduit is passing through them. Thus, when the conduit 40 is not inserted therein, the valve / seal assembly 722 seals to prevent air or fluid from passing through the conduit 718. In this embodiment, the seal 732 and valve 734 are composed of silicone, such as the silicone provided by Dow Corning. Q7-4850 liquid high temperature silicone, but other suitable compliant materials may also be used. In one embodiment, the seal 732 and valve 734 include silicone oil, such as NuSil Technology Med 400 silicone oil, to enhance lubricity and extend component life. In another embodiment, the silicone oil is injected into the silicone.

[0120] Although not explicitly shown herein, as with other embodiments herein, port 710 can include radiopaque markings configured to enable the port to be radiographically identified after implantation in a patient. In one embodiment, the markings include the letters "IV" and "CT" to indicate that port 710 is suitable for receiving a peripheral IV catheter and that the port can be used for fluid dynamic injection. Of course, various other markings can be used, including letters, numbers, symbols, etc.

[0121] Although single-port and dual-port configurations have been described herein, it should be understood that ports including more than two receiving cups are contemplated. It is also noted that certain receiving cups described herein are described as funnel-shaped, while other receiving cups are described herein as concave. It is noted that the receiving cups may interchangeably include aspects of one, the other, or both of these receiving cup shapes, depending on the particular embodiment.

[0122] Figures 27 to 30 Depicts details of various possible configurations of valve / seal assemblies according to example embodiments. Fig. 27 In FIG. 3 , the seal 32 includes a central depression 380 similar to the depression 35 of the valve 34 , but relatively steeper. Fig.28 In the embodiment, two seals are included, namely the seal 32 and a second seal 382 inserted between the seal 32 and the valve 34. The second seal 382 includes a central hole 382A, which has a smaller diameter than the hole 32A of the seal 32. Fig.29 comprises a similar construction, but the aperture 382A is similar in size to the aperture 32A. Fig.28 and Fig.29 In the embodiment shown, the valve 34 includes a small central depression 35.

[0123] exist Fig.30 In the embodiment, the seal 32 includes a relatively small diameter central hole 32A, and the valve 34 includes a relatively large central recess 35. Note that Figures 27 to 30 The valve / seal assembly shown is oriented in the figure so that the catheter pierces the seal and valve in a direction corresponding to from the top of the page toward the bottom of the page.

[0124] Without departing from the spirit of the present disclosure, the embodiments of the present invention may be implemented in other specific forms. The described embodiments should be considered illustrative and not restrictive in all aspects. Therefore, the scope of the embodiments is indicated by the appended claims rather than by the above description. All changes within the equivalent meaning and scope of the claims are included within the scope of the claims.

Claims

1. A low-profile access port for subcutaneous placement within a patient, comprising: A body comprising a rod, the body comprising: two receiving cups, each receiving cup being funnel-shaped to guide a needle with a catheter into an access port defined in the respective receiving cup, wherein each receiving cup includes a radiopaque marker configured to enable identification of the access port by x-ray imaging, and wherein the two receiving cups each include a cutout in a cross-section of a cup perimeter, wherein the two receiving cups merge along the cutout to provide communication between the two receiving cups; two conduits defined by the body, each conduit extending between a respective said inlet port and a respective fluid outlet defined by a stem of the body, each conduit defining a bend distal to the respective said inlet port and configured to prevent further distal advancement of the needle; Two valve / seal assemblies, each valve / seal assembly is disposed in the corresponding conduit distal to the corresponding bend and is configured to allow the catheter to pass therethrough, each valve / seal assembly comprising: a sealing member defining a central aperture; and A valve comprising two intersecting slits; An overmold portion covers a portion of the body, wherein the body further includes a retaining ridge configured to provide an anchor to prevent relative movement between the body and the overmold portion.

2. The access port of claim 1, further comprising: A stop surface is defined in the respective conduit distal to the respective valve / seal assembly, the stop surface being configured to prevent further distal advancement of the catheter after the catheter has passed through the valve / seal assembly.

3. The access port of claim 1, wherein the intersecting slits of each valve are defined orthogonally relative to each other.

4. An access port according to claim 1, wherein the conduit comprises a substantially circular cross-sectional shape, wherein each seal and each valve comprises silicone, and wherein the length of each conduit between the corresponding bend and the corresponding valve / seal assembly is sufficient to enable the distal end of the conduit to return to the substantially circular cross-sectional shape after passing through the bend and before the distal end of the conduit passes through the valve / seal assembly.

5. An access port according to claim 4, wherein each valve includes a central recess, wherein at least one of the seal and the valve of each valve / seal assembly includes silicone oil, and wherein the catheter is configured as one of a 14Ga, 16Ga, and 18Ga size catheter.

6. The access port of claim 1, wherein the body comprises at least one of a metal, a thermoplastic, and a ceramic.

7. The access port of claim 6, wherein the body comprises titanium.

8. The access port of claim 1 wherein the radiopaque indicia of each receiving cup comprises alphanumeric characters.

9. The access port of claim 8, wherein the radiopaque marking of each receiving cup comprises an alphanumeric character designation of "IV CT".

10. The access port of claim 1 wherein the overmolded portion comprises a compliant material.

11. The access port of claim 1 , wherein the overmolded portion comprises silicone, and further comprising suturing locations configured to enable a clinician to suture the access port within a tissue cavity within the patient.

12. The access port of any one of claims 1 to 11, wherein the radiopaque marking is included in a lower surface of the respective receiving cup.

13. A low-profile access port for subcutaneous placement within a patient, comprising: A body comprising a rod, the body comprising: first and second receiving cups, each of the first and second receiving cups being funnel-shaped to direct a needle with a catheter into a corresponding one of first and second inlet ports defined in the first and second receiving cups, respectively; first and second conduits in communication with corresponding ones of the first and second inlet ports, each of the conduits being in fluid communication with a fluid outlet defined by a stem of the body; and first and second valve / seal assemblies disposed in a corresponding one of the first and second conduits, the first and second valve / seal assemblies each comprising a seal defining a central aperture and at least one valve including a slit, Each of the first and second receiving cups includes a cutout in a cup perimeter cross-section, wherein the first receiving cup merges with the second receiving cup along the cutout to provide communication between the first and second receiving cups, Wherein a perimeter of the first receiving cup and a perimeter of the second receiving cup are angled relative to each other.

14. The access port of claim 13, wherein the valve / seal assembly comprises the seal and a single valve comprising two intersecting slits.

15. The access port of claim 14, wherein the two intersecting slits are defined orthogonally in the valve.

16. The access port of claim 13, wherein the body comprises a first portion and a second portion coupled to one another.

17. The access port of claim 16, wherein the valve / seal assembly is inserted into a cavity defined between the first and second portions of the body.

18. The access port of claim 13, wherein the first and second receiving cups are substantially aligned with a longitudinal axis of the body.

19. The access port of claim 18, wherein the first and second inlet ports are disposed on opposite sides of the longitudinal axis of the body.

20. The access port of claim 13, wherein the first and second receiving cups are arranged side by side.

21. The access port according to claim 13 further includes a stop surface defined in each of the first and second conduits distal to the valve / seal assembly, each stop surface being configured to prevent further distal advancement of the catheter after the catheter passes through the valve / seal assembly, and wherein the stop surface includes an annular shoulder.

22. The access port of claim 13, wherein each of said first and second conduits defines a conduit bend to prevent passage of said needle in said catheter-carrying needle while allowing passage of said catheter.

23. The access port of claim 22, wherein the first and second valve / seal assemblies are each disposed distally of the conduit bend of the respective first and second conduits.

24. The access port of claim 13, further comprising a compliant overmold portion disposed about at least a portion of the body of the access port.

25. The access port of claim 13, further comprising at least one palpation feature configured to enable a clinician to palpate the position of the access port when the access port is subcutaneously implanted.

26. A low-profile access port for subcutaneous placement within a patient, comprising: A body comprising a rod, the body comprising: first and second receiving cups, each of the first and second receiving cups being funnel-shaped to direct a needle with a catheter into a corresponding one of first and second inlet ports defined in the first and second receiving cups, respectively, the first and second receiving cups being arranged side by side; first and second conduits in communication with corresponding ones of the first and second inlet ports, each of the conduits being in fluid communication with a fluid outlet defined by a stem of the body; and first and second valve / seal assemblies disposed in a corresponding one of the first and second conduits, the first and second valve / seal assemblies each comprising a seal defining a central aperture and at least one valve including a slit, Each of the first and second receiving cups includes a cutout in a cup perimeter cross-section, wherein the first receiving cup merges with the second receiving cup along the cutout to provide communication between the first and second receiving cups, The perimeter of the first receiving cup is arranged in an imaginary first plane, the perimeter of the second receiving cup is arranged in an imaginary second plane, and the first plane and the second plane are not parallel to each other.

27. The access port of claim 26, wherein the first and second receiving cups are disposed on opposite sides of a longitudinal axis of the body.

28. The access port of claim 26, wherein the body comprises a first portion and a second portion coupled to one another.

29. The access port of claim 28, wherein the first and second valve / seal assemblies are each inserted into a respective cavity defined between the first and second portions of the body.

30. The access port of claim 26, further comprising a compliant overmold portion disposed about at least a portion of the body of the access port.

31. The access port of claim 26, wherein the body further comprises a radiopaque marker configured to enable identification of the access port by x-ray imaging.

32. The access port of claim 31 , wherein the radiopaque marking is configured to indicate that the access port enables powered injection of fluid therethrough.

33. The access port of claim 32 wherein the radiopaque marking comprises an alphanumeric character designation of "IV CT".

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